BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM, EU

    MDR report key: 8652603 · Received May 29, 2019

    Report

    Report Number
    2916596-2019-02356
    Event Type
    Injury
    Date Received
    May 29, 2019
    Date of Event
    May 13, 2019
    Report Date
    August 22, 2019
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION D4, H4: ADDITIONAL INFORMATION. MANUFACTURER'S INVESTIGATION CONCLUSIONS: EVALUATION OF THE SUBMITTED LOG FILE CONFIRMED LOW SPEED AND PUMP STOPS ON (B)(6) 2019 1:12PM WHILE THE SYSTEM WAS CONNECTED TO THE POWER MODULE. THE EVENT CORRESPONDED TO ALARMS FOR LOW SPEED AND LOW FLOW HAZARD. BASED ON PREVIOUS COMPLAINT EXPERIENCE THE EVENTS APPEAR CONSISTENT WITH A POTENTIAL DRIVELINE ISSUE, HOWEVER, NO PRODUCT WAS RETURNED FOR EVALUATION. THEREFORE, A ROOT CAUSE FOR THE EVENTS COULD NOT BE CONCLUSIVELY DETERMINED. THE HMII IFU AND PATIENT HANDBOOK ADDRESS DRIVELINE DAMAGE INCLUDING HOW TO IDENTIFY SIGNS OF POTENTIAL DAMAGE AND RESPOND SHOULD PATIENTS SUSPECT DAMAGE. THE PATIENT UNDERWENT A PUMP EXCHANGE ON (B)(6) 2019. A REQUEST FOR THE PUMP BY ABBOTT PERSONNEL REVEALED THE PUMP WAS RETAINED BY THE ACCOUNT. THE COMPLAINT WOULD BE REOPENED TO INCORPORATE THE EVALUATION OF THE VAD SHOULD IT BE RETURNED AT A LATER TIME. DEVICE HISTORY RECORDS WERE REVIEWED AND SHOWED NO DEVIATION FROM MANUFACTURING OR QA SPECIFICATIONS. THE IMPLANT KIT WAS SHIPPED ON (B)(6) 2014 ON ORDER (B)(4). NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 1

    THE PREVIOUS PERCUTANEOUS LEAD REPAIR WAS REPORTED UNDER MFR. #2916596-2018-03078. THE APPROXIMATE AGE OF THE DEVICE WAS 4 YEARS AND 10 MONTHS. NO FURTHER INFORMATION WAS PROVIDED. THE PATIENT REMAINS ONGOING ON THE REPLACEMENT DEVICE. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    THE PATIENT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE ON (B)(6) 2014. IT WAS REPORTED THAT THE PATIENT VISITED THE OUTPATIENT CLINIC TODAY ROUTINELY. THE VAD COORDINATOR SWITCHED THE PATIENT FROM BATTERY TO POWER MODULE SUPPORT. THE PUMP COULDN'T MAINTAIN FIXED SPEED DIRECTLY AND THE PATIENT WAS SWITCHED BACK TO BATTERY SUPPORT IMMEDIATELY. AN EXTERNAL PERCUTANEOUS LEAD REPLACEMENT WAS PERFORMED AT THAT TIME, AND THE INVESTIGATION OF THE REPLACED LEAD DID NOT REVEAL A ROOT CAUSE. REGARDING THE RECENT LOW SPEED EVENTS, THE HEALTHCARE TEAM HIGHLY SUSPECTED A SHORT TO SHIELD CONDITION IN THE INTERNAL PORTION OF THE PERCUTANEOUS LEAD. X-RAYS SHOWED A SHARP ANGLE IN THE LEAD. A PUMP EXCHANGE WAS PERFORMED ON (B)(6) 2019. THE EXCHANGE WENT AS PLANNED AND THE PATIENT IS DOING WELL. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    442458 HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM, EU LEFT VENTRICULAR ASSIST SYSTEM DSQ THORATEC CORPORATION 106016

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R