Thoratec Corporation Provides Additional Information Related to Worldwide Urgent Medical Device Correction Letter Regarding Use

  Thoratec Corporation Provides Additional Information Related to Worldwide
  Urgent Medical Device Correction Letter Regarding Use of the HeartMate II®
                        LVAS Pocket System Controller

PR Newswire

PLEASANTON, Calif., March 17, 2014

PLEASANTON, Calif., March 17, 2014 /PRNewswire/ --On March 4, 2014, Thoratec
Corporation initiated a voluntary worldwide Medical Device Correction in order
to update its labeling and training materials for the HeartMate II^® LVAS
Pocket System Controller (the "Pocket Controller"). The following information
is provided as a reinforcement of the initial release.

Failure to completely connect the driveline during the process of exchanging
Pocket System Controllers has resulted in serious injuries and deaths.
Patients who received the Pocket Controller as a replacement for an older
model (EPC System Controller) may be at a higher risk of experiencing
difficulty in the controller exchange process, as there are differences
between the two controller models, especially differences related to the
connection of the driveline. As of February 4, 2014, the rate of serious
injury or death during the process of controller exchange for patients who
converted to the Pocket Controller from the EPC Controller was 1.5% (8/523),
while the rate for patients who received the Pocket Controller at the time of
implant was 0.1% (1/1619).

Patients who are using the HeartMate II LVAS Pocket Controller should
immediately contact their doctor for retraining on use of the device and to
receive updated Patient Handbook information if they have not been contacted
by their doctor already. Pocket Controllers can be identified by the
following model information that shows on the label on the controller: REF
105109.

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.

  oOnline: http://www.fda.gov/medwatch/report.htm
  oRegular 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
  oFax: 1-800-FDA-0178

Web site: http://www.thoratec.com

SOURCE Thoratec Corporation

Website: http://www.thoratec.com
Contact: Technical - Donald A. Middlebrook, (925) 730-4117, or General - (800)
528-2577, both of Thoratec
 
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