Thoratec HeartMate II Left Ventricular Assist System
The Thoratec HeartMate II Left Ventricular Assist
System, manufactured by Thoratec Corporation, is a small blood pump that was
approved in April 2008. It has been used in children, women and small men to
help pump blood throughout the body while they await a heart transplant.
On
October 24, 2008, Thoratec Corporation initiated a mechanical heart recall
for their HeartMate II Left Ventricular Assist Systems (HM II LVAS), with catalogue
numbers 1355 to 102139 which have been distributed since clinical studies began
in November 2003. According to the Thoratec press release posted to the FDA's website, over time the wear and fatigue of the percutaneous (needle puncture)
lead connecting the HeartMate II LVAS blood pump with the system controller
could cause damage that may cause the pump to malfunction. Replacement of the
pump would require a second operation that could result in serious injury or
even death to the patient.
Since the clinical trials in 2003, approximately 1,972 people have had these
artificial hearts implanted, and it is estimated that a significant number
of these people could be damaged due to the lead.
The estimated 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. Thoratec has confirmed
that at least 27 of these leads caused the pump to malfunction, and lead to
pump replacement surgery. All of the 27 patients survived the surgery. However,
in five cases, pump replacement was not possible, and the patients died. The
leads now being recalled were distributed to 153 hospitals and distributors
throughout the U.S., Europe, Canada and other countries.
According to the press release posted on the FDA's website, "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."
Thoratec will also revise its labeling to include updated risk information on
the percutaneous lead damage. Patients who have been implanted with a HeartMate
II LVAS should contact their doctors immediately to determine the wear and fatigue
of the lead, as well as proper instruction on its management and care.
At Reyes | Browne | Reilley,
we have worked with many individuals and families who have been injured by a
dangerous product. If you or a loved one has suffered injury, or a family member
has died as a result of the implantation of the Thoratec HeartMate II Left Ventricular
Assist System and the malfunction of its pump, fill out our questionnaire to
the right of this page for a free consultation.
