BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTWARE® VENTRICULAR ASSIST SYSTEM

    MDR report key: 6186162 · Received December 19, 2016

    Report

    Report Number
    3007042319-2016-04459
    Event Type
    Death
    Date Received
    December 19, 2016
    Date of Event
    December 14, 2016
    Report Date
    December 14, 2016
    Manufacturer
    HEARTWARE, INC
    Product Code
    DSQ
    PMA / PMN Number
    P100047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) WAS RETURNED TO HEARTWARE FOR EVALUATION. NO DEVICE MALFUNCTION WAS REPORTED AGAINST (B)(4); THEREFORE, THE PURPOSE OF THIS ANALYSIS IS SOLELY TO EVALUATE THE PERFORMANCE OF THE RETURNED DEVICE AGAINST CURRENT MANUFACTURING/DESIGN SPECIFICATIONS. ANALYSIS OF THE PUMP REVEALED THAT THE DEVICE MET SPECIFICATIONS; THE DEVICE PASSED VISUAL EXAMINATION, DIMENSIONAL VERIFICATION AND FUNCTIONAL TESTING. PATHOLOGICAL EVALUATION DID NOT REVEAL ANY EVIDENCE OF THROMBUS. REVIEW OF LOG FILES REVEALED NORMAL POWER CONSUMPTION THROUGH (B)(6) 2016. OF NOTE, PER THE EVENT DETAILS, THE SURGEON DID NOT BELIEVE THE CAUSE OF DEATH TO BE DEVICE RELATED. BASED ON THE INVESTIGATION CONDUCTED, THERE IS NO EVIDENCE OF ANY MALFUNCTION THAT COULD HAVE PREVENTED THE PUMP FROM FUNCTIONING AS INTENDED. HEARTWARE WILL SUBMIT A SUPPLEMENTAL REPORT WHEN NEW FACTS ARISES WHICH MATERIALLY ALTERS INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT.

    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 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. THE IMPLANTATION OF A VAD IS AN INVASIVE PROCEDURE REQUIRING GENERAL ANESTHESIA, MEDIAN STERNOTOMY, A VENTILATOR AND CARDIOPULMONARY BYPASS. A USER MUST FULLY CONSIDER THE RISKS OF THIS DEVICE WITH THAT OF OTHER TREATMENT MODALITIES BEFORE DECIDING TO PROCEED WITH DEVICE IMPLANTATION. THESE SURGICAL PROCEDURES ARE ASSOCIATED WITH NUMEROUS RISKS. DEATH, BLEEDING, RENAL DYSFUNCTION, AND MULTI SYSTEM ORGAN FAILURE ARE KNOWN POTENTIAL ADVERSE EVENTS ASSOCIATED WITH THE IMPLANTATION OF ALL VADS AS OUTLINED IN THE INSTRUCTIONS FOR USE. HEARTWARE WILL SUBMIT A SUPPLEMENTAL REPORT IF NEW FACTS ARISES WHICH MATERIALLY ALTERS INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED FROM THE SITE THAT THE PATIENT WHO WAS IMPLANTED ON (B)(6) 2016.  THE PATIENT WAS TRANSPORTED TO THE INTENSIVE CARE UNIT (ICU) AND SHORTLY POST ARRIVAL BECAME HEMODYNAMICALLY UNSTABLE.  THE LVAD WAVEFORM WAS PREVIOUSLY NORMAL, CHANGED TO ARTIFACT ALONG WITH CHANGES TO PULMONARY ARTERY (PA) WAVEFORM AND ARTERIAL. THE MAP DROPPED TO THE 40S AND THE PA LINE WAS FOUND TO HAVE MIGRATED. THE LINE WAS RUNNING VASOACTIVE DRUGS IN IT.  THE PATIENT WAS FOUND TO BE ACIDOTIC AND THE HEMOGLOBIN WAS 6. THE PATIENT WAS URGENTLY LINED UP AND RESUSCITATED. THE PATIENT WAS TAKEN BACK TO THE OPERATING ROOM (OR) THAT NIGHT FOR BLEEDING. THAT NIGHT THE PATIENT TAMPONADED AND WAS AGAIN TAKEN TO THE OR ON (B)(6) FOR EVACUATION AND THE CHEST WAS LEFT OPEN. PER SURGEON REPORT, THE PUMP WAS RUNNING FINE BUT THE PATIENT HAD SHOCK LIVER/ DISSEMINATED INTRAVASCULAR COAGULATION (DIC) AND THE PATIENT CONTINUED TO BLEED. THE PATIENT WAS ON CONTINUOUS RENAL REPLACEMENT THERAPY (CRRT). THE PATIENT HAD AN EXPLORATION AGAIN ON (B)(6). THE PATIENT CONTINUED TO BLEED, WAS MAXIMIZED ON SUPPORT AND MORE AND MORE HEMODYNAMICALLY UNSTABLE SO AFTER DISCUSSION WITH THE FAMILY THE DECISION WAS MADE TO WITHDRAW. THEY WILL DO AN AUTOPSY AND THEN SEND THE PUMP IN FOR ASSESSMENT.  THE SURGEON FELT THE SHOCK LIVER/ DISSEMINATED INTRAVASCULAR COAGULATION (DIC)/BLEEDING AND MULTIORGAN FAILURE WERE THE CAUSE. NO ADDITIONAL INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    836605 HEARTWARE® VENTRICULAR ASSIST SYSTEM CIRCULATORY ASSIST SYSTEM, PRODUCT CODE, PRODUCT CODE DSQ HEARTWARE, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Death