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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE II; VENTRICULAR (ASSISST) BYPASS
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THORATEC CORPORATION HEARTMATE II; VENTRICULAR (ASSISST) BYPASS Back to Search Results
Device Problem Fracture (1260)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/12/2020
Event Type  Injury  
Event Description
Heartmate ii left ventricular assist device (lvad) presented to his implanting center with pump stops; investigation revealed internal driveline fracture which would require surgical lvad exchange.Unfortunately, patient was deemed too high risk for exchange at his implanting center and was transferred to this lvad center requesting a 2nd opinion regarding surgical candidacy.Patient was deemed an appropriate candidate for lvad exchange.Heartmate 2 to heartmate 3 lvad was exchanged, discharged home following heparin to coumadin bridging and heart failure medication titration 3 weeks later.
 
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Brand Name
HEARTMATE II
Type of Device
VENTRICULAR (ASSISST) BYPASS
Manufacturer (Section D)
THORATEC CORPORATION
6035 stoneridge dr
pleasanton CA 94588
MDR Report Key10016991
MDR Text Key189589359
Report Number10016991
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 Nurse
Type of Report Initial
Report Date 04/28/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/01/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator No Information
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/18/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA04/28/2020
Device Age7 YR
Event Location Home
Date Report to Manufacturer05/01/2020
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Life Threatening; Required Intervention;
Patient Age22265 DA
Patient Weight143
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