BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS

    MDR report key: 3873933 · Received June 5, 2014

    Report

    Report Number
    2916596-2014-00918
    Event Type
    Injury
    Date Received
    June 5, 2014
    Date of Event
    March 20, 2014
    Report Date
    May 6, 2014
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORT OF DRIVELINE COMPROMISE WAS CONFIRMED BASED ON THE EVALUATION OF THE RETURNED PUMP, SERIAL # (B)(4); HOWEVER, THE REPORT OF A SUSPECTED DRIVELINE FRACTURE WAS NOT CONFIRMED. THE PUMP WAS RETURNED WITH THE DRIVELINE CUT APPROXIMATELY 8" FROM THE PUMP END BEND RELIEF AND THE SEVERED PORTION OF THE DRIVELINE WAS RETURNED. EXAMINATION OF THE PROXIMAL PUMP PORTION OF THE DRIVELINE FOUND SOME BREAKDOWN OF THE BRAIDED SHIELD ADJACENT TO THE PUMP HOUSING. ELECTRICAL CONTINUITY TESTING OF BOTH SECTIONS OF THE DRIVELINE DID NOT REVEAL ANY DISCONTINUITIES OR ELECTRICAL SHORTS, ALTHOUGH VISUAL INSPECTION OF THE PROXIMAL PUMP PORTION OF THE DRIVELINE IDENTIFIED A SMALL BREACH IN THE BROWN WIRE INSULATION BENEATH THE SHIELD BREAKDOWN ADJACENT TO THE PUMP HOUSING. SOME EVIDENCE OF ABRASION AGAINST THE BRAIDED SHIELD WAS NOTED ALONG THE COLORED INSULATION OF SEVERAL OF THE ADJACENT WIRES; HOWEVER, THE INNER CONDUCTORS WERE NOT EXPOSED AT THIS LOCATION. THE REMAINDER OF THE DRIVELINE APPEARED UNREMARKABLE. THE OBSERVED WIRE DAMAGE APPEARED TO BE THE RESULT OF ABRASION AGAINST THE BRAIDED SHIELD DUE TO REPETITIVE MOVEMENT. A REVIEW OF DEVICE HISTORY RECORDS SHOED NO DEVIATIONS FROM MANUFACTURING OR QA SPECIFICATIONS. NO FURTHER INFORMATION IS AVAILABLE. THE MANUFACTURER IS CLOSING ITS FILE ON THIS EVENT.

    Description of Event or Problem · 1

    THE PATIENT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE. IT WAS REPORTED THAT THE PATIENT UNDERWENT A PUMP EXCHANGE FOR A DRIVELINE MALFUNCTION. A SUSPECTED DRIVELINE FRACTURE WAS ALSO REPORTED. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    328821 HEARTMATE II LVAS DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 104911 132459

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention