5 Deaths Prompt Heart Pump Recall

[OhioChick]

Source: Internet Broadcasting Systems, Inc./AP

POSTED: 4:30 pm EDT October 26, 2008

PLEASANTON, Calif. -- The maker of a mechanical heart pump is recalling some versions of the device after the deaths of five people.

The California-based Thoratec Corp. is urging patients to have their implants checked. The warning follows 27 confirmed reports of cases in which wear and fatigue of an electrical wire required the devices to be replaced.

The company said the reports came over five years and involved nearly 2,000 implants. In five cases, the device could not be replaced and the patients died.

The affected devices were distributed directly to 87 hospitals throughout the United States and other countries, the company said on its Web site.

Customers and patients with questions may contact the company at 1-800-528-2577.

The FDA said the implantable ventricular assist devices are mechanical pumps that help a person’s heart that is too weak to pump blood through the body. They're designed to provide sufficient blood flow to a damaged or diseased heart, and are often used as a patient waits for a heart transplant. It is sometimes referred to as a “bridge to transplant” since it can help a patient survive until a heart transplant can be performed.

The FDA said the device was recalled because the air-driven may develop leaks when used externally, and that could result in not enough blood flow to and from the heart.

Read more: http://www.newsnet5.com/health/17806135/detail.html

[whistle]

1. Does Dick Cheney have one of those?

[NV Whino]

2. Ah, damn. You beat me to it.

[whistle]

3. Again?

[pinniped]

13. No. That POS is an android asshole.

[nolabear]

4. Uh, how does that work, exactly?

Of all the things I don't want recalled, it's the thing that makes my heart beat!

[mike6640]

6. The recalled model uses

an external compressor and pneumatic drive line to power an implanted pump with a diaphragm.

I don't think they would be any fun to transport or maintain, but it beats dying before available transplant.

M

[alittlelark]

5. My Brother in Law works for the company

My Sis-in-Law posts here sometimes. We just had brunch w/them in Brentwood (N.Ca Brentwood) and saw a Thoratec box in their garage as I was leaving.....

Weird.

I called them - I wasn't even sure what company he worked for.

Weird.

[alittlelark]

7. So out of 100 ppl w/ an implant >.3 have problems

Those are better odds than most antibiotics.


<snip> "The company said the reports came over five years and involved nearly 2,000 implants. In five cases, the device could not be replaced and the patients died."

[LeftyMom]

10. Yeah, but most antibiotic failures or reactions aren't fatal.

I've had bad reactions to more antibiotics than I care to think of (at this point I just tell medical personnel which ones I CAN take) and I seem to be alive. :shrug:

Sorta like the difference between a car recall for bad headlight switch and one for potential brake failures. Even if the frequency of the former is much higher, the latter is a good deal more dangerous when it goes.

[prozacnation]

8. Not a recall - correct information below

My husband works for Thoratec. The truth is there is a device correction not a recall. It's obvious that someone stands to gain by leaking misleading and incorrect information to the public. Please listen to the conference call tomorrow morning to get the accurate story. There is a conference call scheduled for 8:30 am PDT.

This is from Thoratec's website:

Thoratec Corporation Issues Worldwide Medical Device Correction of HeartMate II(R) Left Ventricular Assist System

PLEASANTON, Calif., Oct. 24 /PRNewswire-FirstCall/ -- Thoratec Corporation is initiating a worldwide medical device correction of all serial numbers of the HeartMate II Left Ventricular Assist Systems (HM II LVAS) having Catalogue No. 1355 or 102139, which have been distributed since the beginning of clinical studies in November 2003. Over time, wear and fatigue of the percutaneous lead connecting the HeartMate II LVAS blood pump with the System Controller may result in damage that could interrupt pump function, require reoperation to replace the pump and potentially result in serious injury or death. The estimated probability of the need for pump replacement due to percutaneous lead damage is 1.3% at 12 months, 6.5% at 24 months and 11.4% at 36 months.

Patients who are currently being supported by a HeartMate II LVAS should contact their doctors, who can assess the wear and fatigue of the percutaneous lead as well as provide proper instruction on management and care of the lead.

Thoratec is voluntarily issuing an Urgent Medical Device Correction notice after confirming 27 reports where wear and fatigue to the percutaneous lead necessitated pump replacement. These reports occurred over five years of clinical experience with 1,972 implants. All patients who have undergone a replacement of the HeartMate II pump survived the operation and were alive at least 30 days postoperatively. In five cases, pump replacement was not feasible and the patients expired.

The affected systems were distributed to 153 hospitals and distributors throughout the United States, Europe, Canada and other countries. The HM II LVAS can be identified by the catalogue number located on the label of the package.


Full article -

http://phx.corporate-ir.net/phoenix.zhtml?c=95989&p=irol-newsArticle&ID=1217183&highlight=


Another article. Source:Bloomberg.com

Thoratec Says Five Patients Died While Using Heart (Update2)

By Andrew Pollack

Oct. 24 (Bloomberg) -- Thoratec Corp. said five people died while using its mechanical heart that is smaller than a D-cell battery and urged doctors and patients to check the devices for damage.

Thoratec's shares plunged 52 percent to $12 in extended trading on the Nasdaq Stock Market at 5:21 p.m. New York time after the announcement.

Thoratec said it received 27 reports over five years of wear and fatigue to an electrical wire connected to its HeartMate II device, which caused the pump to fail. In five cases, replacement of the heart pump ``was not feasible'' and the patients died, the Pleasanton, California-based company said in a statement on PR Newswire.

Thoratec said 1,972 devices have been implanted in the five years since clinical trials began on HeartMate II. The mechanical heart, approved by U.S. regulators in April, circulates the blood to help patients survive until a transplant organ becomes available. The pump, which fits children, women and small men, was expected to help Thoratec in a $3 billion U.S. market for patients awaiting life-saving transplants.

There is a 1.3 percent probability the wire fatigue will result in the need for a pump replacement at 12 months, the company said in its statement. The probability of a replacement rises to 6.5 percent at 24 months and 11.4 percent at 36 months, Thoratec said.


http://www.bloomberg.com/apps/news?pid=newsarchive&sid=avDTTrtCRGGA

[NV Whino]

12. Thanks for updating with accurate information.

[UndertheOcean]

9. The hearts function is that of pump ? why is it then very hard to build

an Artificial Heart , I always wondered about that

[Thor_MN]

11. I beleive this device only assists a weak but functioning heart.

From what little I know, it is kind of like automated CPR. The device gives a extra push to the outside of the heart each time the heart beats. The difficult part of making an artificial heart is finding a pump housing that will not cause the blood to clot and/or pump mechanism that will not damage the blood cells. With these devices, they are not actually in contact with the blood. The tissue of the weak but functional heart itself is between the device and the blood stream.

[mike6640]

14. You are mostly correct,

This device pumps blood through itself and has anti clotting internal surfaces.

M

[Posteritatis]

15. Most pumps are rather less critical if something goes wrong

A partial or complete artificial heart, on the other hand, had better work as close to perfectly as possible for its (not necessarily the patients' - they get replaced over time if the patient's still around) entire life expectancy.

Making something that gets the blood circulating isn't necessarily the hard part. You don't even need the heart's mechanical motion in a replacement - there's replacements out there which are pretty much just a turbine or jet that circulate the blood without a tangible pulse. The reliability factor, on the other hand, is absolutely huge, because showing up five minutes after something goes wrong is already too late.