BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTWARE VENTRICULAR ASSIST SYSTEM-SEWING RING

    MDR report key: 7865753 · Received September 11, 2018

    Report

    Report Number
    3007042319-2018-04348
    Event Type
    Injury
    Date Received
    September 11, 2018
    Date of Event
    September 7, 2018
    Report Date
    December 20, 2018
    Manufacturer
    HEARTWARE, INC.
    Product Code
    DSQ
    PMA / PMN Number
    P100047
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT EVENT SUMMARY: SEWING RING ASSOCIATED WITH (B)(4) WITH LOT NUMBER R022597 WAS NOT RETURNED FOR EVALUATION. REVIEW OF THE MANUFACTURING AND INSPECTION RECORDS CONFIRMED THAT THE SEWING RING MET ALL REQUIREMENTS PRIOR TO RELEASE. VISUAL EVIDENCE PROVIDED BY THE SITE REVEALED THAT THE POLYESTER WAS PARTIALLY DETACHED FROM THE METAL RING, THUS CONFIRMING THE REPORTED EVENT. BASED ON HISTORICAL REVIEW OF SIMILAR EVENTS, THE MOST LIKELY ROOT CAUSE OF THE SEWING RING DAMAGE MAY BE ATTRIBUTED TO DEVIATIONS FROM PROCEDURE DURING THE MANUFACTURING PROCESS. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR TREATMENT NOT DIAGNOSIS. THE VENTRICULAR ASSIST SYSTEM IS INDICATED FOR USE AS A BRIDGE TO CARDIAC TRANSPLANTATION AND DESTINATION THERAPY IN PATIENTS WHO ARE AT RISK OF DEATH FROM REFRACTORY END-STAGE LEFT VENTRICULAR HEART FAILURE. THE SYSTEM IS DESIGNED FOR IN-HOSPITAL AND OUT-OF-HOSPITAL SETTINGS. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, DURING IMPLANT, THE VENTRICULAR ASSIST DEVICE (VAD) SEWING RING TEXTILE DETACHED FROM THE METAL PORTION WITH BLOOD LEAKAGE FROM THE LEFT VENTRICLE TO THE PERICARDIAL SPACE. THE SEWING RING WAS EXCHANGED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    704537 HEARTWARE VENTRICULAR ASSIST SYSTEM-SEWING RING VENTRICULAR (ASSISST) BYPASS DSQ HEARTWARE, INC. 1153

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Life Threatening| R