BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP

    MDR report key: 11474448 · Received March 12, 2021

    Report

    Report Number
    3007042319-2021-01946
    Event Type
    Death
    Date Received
    March 12, 2021
    Date of Event
    March 5, 2021
    Report Date
    April 8, 2021
    Manufacturer
    HEARTWARE, INC.
    Product Code
    DSQ
    PMA / PMN Number
    P100047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION OF THIS EVENT IS PENDING AND A SUPPLEMENTAL REPORT WILL BE SENT UPON ITS COMPLETION. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    A SUPPLEMENTAL REPORT IS BEING SUBMITTED FOR DEVICE EVALUATION. PRODUCT EVENT SUMMARY: THE VENTRICULAR ASSIST DEVICE (VAD) WAS NOT RETURNED FOR EVALUATION. THIS COMPLAINT IS ASSOCIATED WITH A CLINICAL ADVERSE EVENT. INFORMATION PROVIDED BY THE SITE INDICATED THAT THE PATIENT WAS HOSPITALIZED WITH A SPONTANEOUS SUBARACHNOID BLEED (SAB); A CRANIAL COMPUTED TOMOGRAPHY SCAN CONFIRMED THE SAB WITH VENTRICULAR COLLAPSE AND CEREBROSPINAL FLUID CIRCULATION DISORDER WITH AN ANEURYSM ON THE LEFT SIDE. AN EXTERNAL VENTRICULAR DRAIN WITH AN INTRACRANIAL PRESSURE MEASUREMENT WERE PLACED. HOWEVER, THE PATIENT SUBSEQUENTLY DIED. BASED ON THE AVAILABLE INFORMATION, THERE IS NO EVIDENCE TO INDICATE THAT A DEVICE MALFUNCTION OR PERFORMANCE ISSUE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT PER THE INSTRUCTIONS FOR USE, NEUROLOGICAL DYSFUNCTION AND DEATH ARE KNOWN POTENTIAL COMPLICATIONS ASSOCIATED WITH THE IMPLANTATION OF A VAD. THERE WAS NO EVIDENCE THAT THE PATIENT HAD A HISTORY OF NEUROLOGICAL DYSFUNCTION EVENTS. POSSIBLE CLINICAL FACTORS THAT MAY HAVE CONTRIBUTED TO THIS EVENT INCLUDE THE PATIENT¿S PRE-EXISTING HISTORY AND RELATED COMORBIDITIES, INCLUDING THE REPORTED PRESENCE OF PREEXISTING INTRACEREBRAL ANEURYSMS, THE PROGRESSION OF THEIR UNDERLYING DISEASE, ISSUES RELATED TO THE THERAPEUTIC USE OF ANTICOAGULANT AND ANTIPLATELET MEDICATIONS AND THE PATIENT'S COMPLEX POST-OPERATIVE COURSE. THERE ARE POSSIBLE PATIENT, PHARMACOLOGICAL AND PROCEDURAL FACTORS THAT MAY HAVE CONTRIBUTED TO THIS EVENT. INVESTIGATION OF THIS EVENT IS COMPLETED AND THE FILE WILL BE CLOSED. IF NEW INFORMATION IS RECEIVED, THE FILE WILL BE RE-OPENED AND A SUPPLEMENTAL WILL BE SUBMITTED. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VENTRICULAR ASSIST DEVICE (VAD) PATIENT WAS HOSPITALIZED WITH A SPONTANEOUS SUBARACHNOID BLEED (SAB) AND AN INTERNATIONAL NORMALIZED RATIO (INR) OF 4.3. A CRANIAL COMPUTED TOMOGRAPHY (CCT) WAS PERFORMED WHICH CONFIRMED THE SAB WITH VENTRICULAR COLLAPSE, CEREBROSPINAL FLUID CIRCULATION DISORDER WITH P3 ANEURYSM ON THE LEFT SIDE. EMERGENCY RIGHT FRONTAL PLACEMENT OF A EXTERNAL VENTRICULAR DRAIN (EVD) WITH AN INTRACRANIAL PRESSURE (ICP) MEASUREMENT WERE PLACED. THE PATIENT SUBSEQUENTLY DIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    372649 HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP VENTRICULAR (ASSIST) BYPASS DSQ HEARTWARE, INC. 1104

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Death