MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH THORATEC CENTRIMAG; CENTRIMAG BLOOD PUMP

Catalog Number 102953

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Infarction, Cerebral (1771); Death (1802)

Event Date 01/12/2017

Event Type  Death  

Manufacturer Narrative

The referenced driveline infection was reported under medwatch mfr report# 2916596-2016-01464.(b)(4).The approximate age of device: 8 days.(calculated from date of implant to date removed) the device will not be returned for evaluation.No further information was provided.A supplemental report will be submitted when the manufacturer's investigation is completed.

Event Description

The patient was implanted with a left ventricular assist device (lvad).It was reported that the patient was explanted due to chronic driveline infection and recurrent bacteremia.The patient was then supported by an extracorporeal circulatory support device; however, the patient experienced a severe ischemic stroke and expired on (b)(6) 2017.

Manufacturer Narrative

A correlation between the device and the reported driveline infection and ischemic stroke could not be conclusively determined.Driveline infection and stroke are listed in the instructions for use as potential adverse events that may be associated with the use of the heartmate ii left ventricular assist system.A review of the device history records, including the sterilization and packaging documentation, found no deviations from manufacturing specifications.The manufacturer is closing the file on this event.

• Brand Name: THORATEC CENTRIMAG
• Type of Device: CENTRIMAG BLOOD PUMP
• Manufacturer (Section D): THORATEC SWITZERLAND GMBH; technoparkstrasse 1; zurich CH-80 05; SZ CH-8005
• Manufacturer (Section G): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• Manufacturer Contact: kathy reilly ; 6101 stoneridge dr.; pleasanton, CA 94588 ; 9257380163
• MDR Report Key: 6327918
• MDR Text Key: 67317326
• Report Number: 2916596-2017-00305
• Device Sequence Number: 1
• Product Code: DWA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 07/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2019
• Device Catalogue Number: 102953
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/19/2017
• Initial Date FDA Received: 02/13/2017
• Supplement Dates Manufacturer Received: 06/13/2017
• Supplement Dates FDA Received: 07/07/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/31/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 35 YR
• Patient Weight: 105