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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: THORATEC CORPORATION THORATEC HEARTMATE 3 LVAS IMPLANT KIT VENTRICULAR (ASSISST) BYPASS

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THORATEC CORPORATION THORATEC HEARTMATE 3 LVAS IMPLANT KIT VENTRICULAR (ASSISST) BYPASS Back to Search Results
Model Number 106524US
Device Problems Insufficient Flow or Under Infusion (2182); Material Twisted/Bent (2981); Therapeutic or Diagnostic Output Failure (3023); Appropriate Term/Code Not Available (3191)
Patient Problem Failure of Implant (1924)
Event Date 02/26/2021
Event Type  malfunction  
Event Description
Heartmate 3 lvad implanted more than three years ago. The patient was admitted to the hospital for vad low flow alarms. Ct-angio performed a day before that confirmed a twist of the outflow graft. Patient underwent surgical repair of his outflow graft. A sternal wire was placed into the costal margin laterally and wrapped this around the pump, causing it to move to the patient's left and relieving the kink in the outflow graft. The patient tolerated the procedure.
 
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Brand NameTHORATEC HEARTMATE 3 LVAS IMPLANT KIT
Type of DeviceVENTRICULAR (ASSISST) BYPASS
Manufacturer (Section D)
THORATEC CORPORATION
6035 stoneridge drive
pleasanton CA 94588
MDR Report Key11700089
MDR Text Key246483209
Report Number11700089
Device Sequence Number1
Product Code DSQ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 04/13/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/21/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number106524US
Device Catalogue Number106524US
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA04/13/2021
Device Age4 YR
Event Location Home
Date Report to Manufacturer04/21/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 04/21/2021 Patient Sequence Number: 1
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