BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM, EUROPE

    MDR report key: 7036027 · Received November 15, 2017

    Report

    Report Number
    2916596-2017-02765
    Event Type
    Malfunction
    Date Received
    November 15, 2017
    Date of Event
    October 18, 2017
    Report Date
    March 12, 2018
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORT OF A BROKEN PUMP CABLE BEND RELIEF WAS CONFIRMED THROUGH PHOTOS THAT WERE TAKEN BY ABBOTT CLINICAL SPECIALISTS DURING AN ON SITE VISIT. IT WAS REPORTED THAT THE ISSUE OCCURRED OVER TIME DUE TO THE PATIENT¿S ACTIVE LIFESTYLE. THERE WERE NO REPORTED ALARMS OR INTERRUPTIONS IN LVAD SUPPORT AS A RESULT OF THE BROKEN PUMP CABLE BEND RELIEF. THE PATIENT REMAINS ONGOING ON LVAD SUPPORT AND NO FURTHER ISSUES HAVE BEEN REPORTED AT THIS TIME. A REVIEW OF THE DEVICE HISTORY RECORDS REVEALED NO DEVIATIONS FROM MANUFACTURING OR QUALITY ASSURANCE SPECIFICATIONS. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 1

    THE PATIENT¿S WEIGHT WAS NOT PROVIDED. FDA APPROVAL FOR HEARTMATE 3 LVAS WAS RECEIVED ON 23 AUGUST 2017. DEVICE WAS MANUFACTURED PRIOR TO THE UDI LABELING IMPLEMENTATION. APPROXIMATE AGE OF DEVICE ¿ 3 YEARS AND 4 MONTHS. THE PATIENT REMAINS ONGOING ON LVAD SUPPORT. NO FURTHER INFORMATION WAS PROVIDED. 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 HEARTMATE 3 LEFT VENTRICULAR ASSIST DEVICE (LVAD) ON (B)(6) 2014. IT WAS REPORTED THAT AFTER OVER 3 YEARS OF SUPPORT, THE PATIENT REPORTED A BROKEN DRIVELINE BEND RELIEF ON THE EXTERNAL PORTION OF THE PUMP CABLE WHERE IT CONNECTS TO THE MODULAR CABLE. THERE WAS NO REPORTED IMPACT TO PUMP FUNCTION OR TO THE PATIENT. IT WAS REPORTED THAT THE ISSUE OCCURRED OVER TIME DUE TO THE PATIENT¿S ACTIVE LIFESTYLE. ON (B)(6) 2017, A REPAIR OF THE DRIVELINE BEND RELIEF WAS PERFORMED. THE OLD AND BROKEN BEND RELIEF WAS REMOVED AND A NEW THICKER BUT STILL MOVABLE PLASTIC COVER WAS ATTACHED AND CLOSED WITH MEDICAL SILICONE. RESCUE TAPE WAS APPLIED TO STABILIZE THE ENTIRE REPAIRED AREA. THE PATIENT WAS DISCHARGED HOME AND IS REPORTEDLY DOING FINE. NO FURTHER INFORMATION WAS PROVIDED. A FINAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER¿S INVESTIGATION IS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    814026 HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM, EUROPE LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR