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U.S. Department of Health and Human Services

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

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THORATEC SWITZERLAND GMBH THORATEC CENTRIMAG CENTRIMAG BLOOD PUMP Back to Search Results
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.
 
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Brand NameTHORATEC CENTRIMAG
Type of DeviceCENTRIMAG 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 Key6327918
MDR Text Key67317326
Report Number2916596-2017-00305
Device Sequence Number1
Product Code DWA
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/07/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/13/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date01/31/2019
Device Catalogue Number102953
Other Device ID NumberN/A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/13/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/31/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 02/13/2017 Patient Sequence Number: 1
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