BEUDAMED
    FDA Adverse Event Death Summary report: N

    BERLIN HEART EXCOR PEDIATRIC VAD

    MDR report key: 10987669 · Received December 10, 2020

    Report

    Report Number
    3004582654-2020-00052
    Event Type
    Death
    Date Received
    December 10, 2020
    Date of Event
    December 10, 2020
    Manufacturer
    BERLIN HEART GMBH
    Product Code
    DSQ
    PMA / PMN Number
    P160035
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS REPORTED TO WORK AS INTENDED. THE PATIENT DIED ON (B)(6) 2020.

    Description of Event or Problem · 1

    BERLIN HEART (B)(4) WAS INFORMED, ON (B)(6) 2020 BY THE SITE THAT A PATIENT BEING SUPPORTED WITH THE EXCOR PEDIATRIC VAD SYSTEM WITH A BVAD CONFIGURATION DEVELOPED PULMONARY FAILURE FOLLOWING THE IMPLANT THAT OCCURRED ON (B)(6) 2020. THE PULMONARY FAILURE WAS DUE TO THE PROLONGED OPERATIVE TIME AND EXCESS INTRATHORACIC BLEEDING. THE PATIENT WAS TAKEN TO THE ICU WITH AN OPEN CHEST. THE SITE REPORTED COMPLETE EMPTYING AND FILLING OF BOTH PUMPS AT THIS TIME. THE PATIENT CONTINUED TO DECLINE WITH THE INABILITY TO CONTROL BLEEDING, OXYGENATE, AND VENTILATE. A BEDSIDE RE-EXPLORATION OF THE THORACIC CAVITY WAS CONDUCTED AT THIS TIME. OBSTRUCTION OF THE LUNGS WAS SUSPECTED, BUT NEVER CONFIRMED. ECHO IMAGES REVEALED SEVERE PULMONARY VALVE INSUFFICIENCY, RV DILATION, AND LV COLLAPSE. THE PATIENT EXPIRED DUE TO THESE IRREVERSIBLE COMPLICATIONS ON 11/11/2020.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1452462 BERLIN HEART EXCOR PEDIATRIC VAD VENTRICULAR ASSIST DEVICE DSQ BERLIN HEART GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 2 YR Death| L