Archive for October 26th, 2008

Ooops: HeartMate II® Left Ventricular Assist System

by Paul Rega, MD — published on October 26th, 2008

Thoratec Corporation Issues Worldwide Medical Device Correction of

Contact:
Thoratec Corporation
1-800-528-2577

FOR IMMEDIATE RELEASE — PLEASANTON, CA — October 24, 2008—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.

Hospitals are being sent an Urgent Medical Device Correction letter identifying the probability and symptoms of the problem, and recommending that the pump be replaced as soon as possible if damage to the percutaneous lead is confirmed. Hospitals are also requested to review the instructions for care of the percutaneous lead with their ongoing HeartMate II LVAS patients. Hospitals with ongoing HeartMate II LVAS patients should contact Thoratec for further instructions if they do not receive the Medical Device Correction letter. The labeling for the HeartMate II LVAS will be revised with the updated risk information related to percutaneous lead damage. Copies of this press release may be found on Thoratec’s website, www.thoratec.com, under Investor Relations/Press Releases.

Clinicians and patients with questions may contact the company at 1-800-528-2577, or if calling from outside the USA, 1-925-847-8600 (7 days a week, 8-5 Pacific Time).

FDA has been informed of this action.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
• Online: www.fda.gov/medwatch/report.htm
• Regular Mail: use postage-paid FDA form 3500 available at:
www.fda.gov/MedWatch/getforms.htm. Mail to MedWatch 5600 Fishers Lane, Rockville, MD
20852-9787
• Fax: 1-800-FDA-0178

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categories: Emergency Medicine

OMNI Postings of 10/26/08

by Paul Rega, MD — published on October 26th, 2008
On this date in 1774, Minute Men were first organized in the colonies.  The wives frustratingly asked why a minute was something to be so proud about.  Half-hour men… now that’s something to crow about!

But I digress…

1)  This is one of the most important articles that have come down the pike regarding the management of survivors of a cardiac arrest.  One of the links is a news summary and the other takes you to the complete text.  You  might want to download and read it somewhere in-between the pelvic exam in Room 5 and I&D-ing that axillary abscess in Room 3.  The report suggested initiating treatments in four main categories: those for brain injury, for myocardial dysfunction, for systemic ischemia and reperfusion response, and for the underlying cause of the cardiac arrest.  The ER is going to be a major part of this.  Finally, the authors suggested that regional cardiac arrest centers, similar to level 1 trauma centers, may improve outcomes and facilitate further research.  Why not?  How about a Level 1 Disimpaction Center?  The level 1,2, or 3 status is determined by the average length of the index finger of the ER staff.
2)  You might be interested in this interview between a UofM ER Doc and Newsweek about why ERs are so crowded.  The reporter asked her if the problem is as severe in other states such as Ohio.  She responded, “What’s an Ohio?”
3)  Do you know how bad Halloween is in terms of injuries to kids?  The statistics here might surprise you.
4)  This is a curious article from the NY Times.  It is reporting on a new phenomenon called Narrative Medicine.  Apparently, a couple of academic centers in the U.S. are reserving residents’ time to read and discuss pertinent literature in order to improve their empathy quotient with regards to their patients.  Nurse:  Doctor, doctor, there’s a code in 338.  Resident:  Just a second, nurse.  I’m finishing up the last quatrain in this sonnet.
Sayonara,
Paul R.
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categories: Emergency Medicine