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Thoratec Corporation Issues Update on Worldwide Medical Device Correction Notification
Relating to Sealed Outflow Graft Used With HeartMate II® Left Ventricular Assist System
Donald A. Middlebrook
FOR IMMEDIATE RELEASE - March 19, 2012 - PLEASANTON, Calif, -- On February 23, 2012, Thoratec Corporation initiated a voluntary worldwide medical device correction notification of all serial numbers of the HeartMate II® Left Ventricular Assist Systems (HM II LVAS) having Catalog No. 104692, 103393, 104911, or 104912. Thoratec took this action based upon reports of the sealed outflow graft bend relief not being properly connected to the HeartMate II LVAS. The reported incidence of the defect, disconnected outflow graft bend relief, is 0.91% (29/3,200). Of these 29 incidents, 24 were observed in x-ray images or during surgical procedures, and were thus unlikely to be related to patient symptoms. However, in at least one reported case, it is noted that the disconnected bend relief may have contributed to the need for reoperation. The bend relief is designed to prevent kinking of the outflow conduit that connects the HeartMate II pump to the ascending aorta.
Disconnection of the bend relief from the outflow graft may result in one or more of the following symptoms: low pump flow, hemolysis, fluctuations in pump flow, speed and/or power, or worsening symptoms of heart failure. The incidence of surgical interventions possibly related to disconnected outflow graft bend reliefs is 0.16% (5/3,200). Four of these five patients continue on VAD support, and one of these five died of multi-organ failure after several days of ECMO support; however, it is important to note that it is not clear that the disconnected outflow graft bend relief caused or contributed to this patient’s condition. It is also possible for bleeding to occur, if the disconnected bend relief causes abrasion of the graft and required repair in three patients. The incidence of bleeding related to abrasion or cutting of the graft is 0.10% (3/3,200).
For all new HeartMate II LVAS implant procedures, clinicians have been instructed to follow the revised instructions for use that clarify the recommended procedure for securing the bend relief to the outflow graft. Clinicians have also been advised to consider the possibility of a disconnected outflow graft bend relief if a HeartMate II LVAS patient exhibits symptoms such as low pump flow, hemolysis, bleeding, fluctuations in pump flow, speed and/or power, or worsening symptoms of heart failure. Patients should be treated according to best clinical judgment and standard clinical practice guidelines. Clinicians have also been advised to immediately report to Thoratec any additional cases of disconnected outflow bend reliefs.
The affected systems were distributed to 226 hospitals and distributors throughout the United States, Europe, Canada and other countries. The HM II LVAS can be identified by the catalog number located on the label of the package. Devices that have been implanted can be identified by the catalog numbers on the adhesive labels that were provided for inclusion in the patient’s medical records. Since initiating the medical device correction notification on February 23, 2012, the company has contacted all hospitals to whom sealed outflow grafts have been distributed. Subsequently, the company has received signed acknowledgement forms from surgeons at all affected U.S. hospitals and the majority of affected international customers, verifying that customers have reviewed the notification and understand the information provided. Thoratec is not requesting that any product be returned to the company.
The medical device correction notification sent to hospitals on February 23, 2012 identified the reported incident rate over the past two years since the introduction of the sealed outflow graft and described potential symptoms of the problem. Hospitals with ongoing HeartMate II LVAS patients should contact Thoratec if they have any questions. The labeling for the HeartMate II LVAS has been revised with the updated risk information related to disconnected bend reliefs. Copies of this press release may be found on Thoratec's website, http://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: http://www.fda.gov/medwatch/report.htm
- Regular Mail: use postage-paid FDA form 3500 available at: http://www.fda.gov/MedWatch/getforms.htm. Mail to MedWatch 5600 Fishers Lane, Rockville, MD 20852-9787
- Fax: 1-800-FDA-0178