BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTWARE® VENTRICULAR ASSIST SYSTEM

    MDR report key: 4854544 · Received June 18, 2015

    Report

    Report Number
    3007042319-2015-01251
    Event Type
    Injury
    Date Received
    June 18, 2015
    Date of Event
    March 7, 2015
    Report Date
    June 12, 2015
    Manufacturer
    HEARTWARE, INC
    Product Code
    DSQ
    PMA / PMN Number
    P100047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE SITE DISPOSED OF THE PUMP AND WOULD NOT BE RETURNED TO THE MANUFACTURER FOR EVALUATION. REVIEW OF THE MANUFACTURING DOCUMENTATION CONFIRMED THAT THE ASSOCIATED DEVICE MET ALL REQUIREMENTS FOR RELEASE. THE REPORTED "HIGH POWER" EVENT COULD NOT BE CONFIRMED VIA REVIEW OF THE CONTROLLER LOG FILES SINCE LOG FILES WERE NOT AVAILABLE FOR ANALYSIS. THERE IS NO EVIDENCE TO SUGGEST THAT A DEVICE MALFUNCTION CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. ALTHOUGH A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED, CLINICAL AND PATIENT FACTORS MAY HAVE CONTRIBUTED. HEARTWARE WILL SUBMIT A SUPPLEMENTAL REPORT WHEN NEW FACTS ARISES WHICH MATERIALLY ALTERS INFORMATION SUBMITTED IN A PREVIOUSMDR 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. PER THE INSTRUCTIONS FOR USE (IFU): HIGH WATTS ALARMS, ARE AN INDICATION THAT THE PUMP WATTS HAS EXCEEDED THE HIGH POWER ALARM THRESHOLD, MAY BE INDICATIVE OF THROMBUS OR OTHER TISSUE FRAGMENTS IN THE PUMP, WHICH ARE KNOWN POTENTIAL COMPLICATIONS ASSOCIATED WITH ALL PATIENTS IMPLANTED WITH VADS AS OUTLINED IN THE LABELING. THE INSTRUCTIONS FOR USE ADDRESSES SETTING PARAMETERS FOR THE HIGH POWER ALARM THRESHOLD, HOW TO RECOGNIZE HIGH WATT ALARMS AND GUIDELINES FOR OPTIMAL PATIENT MANAGEMENT (INCLUDING THERAPEUTIC ANTICOAGULATION GUIDELINES). BASED ON THE AVAILABLE INFORMATION A DEFINITIVE CONCLUSION CANNOT BE MADE REGARDING FACTORS POTENTIALLY CONTRIBUTING TO THE REPORTED SUSPECTED PUMP THROMBUS; HOWEVER, IN ADDITION TO REQUIRED ADEQUATE ANTICOAGULATION, LVAD PUMP CANDIDATES OFTEN POSSESS SEVERAL RISK FACTORS FOR INTRAVASCULAR COAGULATION WHICH MAY INCLUDE ARTERIAL AND/OR VENOUS VASCULAR DISEASE, CHRONIC LOW FLOW STATE AND DECREASED MOBILITY. THE SUBMISSION OF THIS REPORT OR RELATED INFORMATION TO THE FDA, AND ITS RELEASE BY FDA, DOES NOT REFLECT A CONCLUSION BY THE PARTY SUBMITTING THIS REPORT OR THE FDA THAT THE REPORT OR RELATED INFORMATION IS AN ADMISSION THAT THE MANUFACTURER, THEIR EMPLOYEES, OR THE DEVICE CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT. THE MANUFACTURER WILL SUBMIT A SUPPLEMENTAL REPORT WHEN NEW FACTS ARISE WHICH MATERIALLY ALTER INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT. MISSING INFORMATION FROM THIS REPORT IS IDENTIFIED AS A BLANK, UNKNOWN AND AS NO INFORMATION (NI), THIS INFORMATION WAS NOT PROVIDED IN THE REPORTED EVENT OR AVAILABLE AT THE TIME OF REPORT SUBMISSION. THE COMPANY IS SEEKING THIS INFORMATION THROUGH THE EVENT INVESTIGATION. H3 PUMP HAS BEEN DISPOSED OF

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE INTERMACS REPORT STATE THAT THE PATIENT WAS URGENTLY ADMITTED TO HOSPITAL TO UNDERGO SURGICAL INTERVENTION FOR DIAGNOSIS OF PROBABLE LVAD THROMBOSIS AND WAS ADMITTED TO TICU. THE PATIENT PRESENTS WITH LVAD ALARMS, HIGH FLOWS AND HIGH WATTS AND SEVERE HEMOLYSIS, LDH 2555. THE PATIENT WAS TREATED WITH TPA 30 MG AND HEPARIN DRIP. WITH ECHO DOPPLER APICAL CANNULA SEEN (UNABLE TO EXCLUDE CANNULA) THROMBUS WITH DOPPLER DUE TO INTERFERENCE/ SHADOWING FROM LVAD HARDWARE) POOR SOUND TRANSMISSION. THE FOLLOWING DAY, RESOLUTION OF FLOWS AND POWERS ON LVAD AFTER RECEIVING THE TPA WERE NOTED." IT WAS ALSO REPORTED THAT "HEART TRANSPLANT WAITING LIST AT HOSPITAL HAS BEEN CHANGED TO 1A. IT WAS NOTED THAT ON THE 3RD DAY POST ADMISSION, THE LDH WAS DECREASING, 1970. ON THE 4TH DAY POST ADMISSION, LDH WAS 187 AND THE LVAD CURRENTLY FUNCTIONING WELL. IT WAS NOTED ON (B)(6)2014 THAT THE LVAD WAS CURRENTLY FUNCTIONING WELL AND GIVEN THE SEVERITY OF THROMBOSIS EVENT, THE PATIENT MUST REMAIN INPATIENT WHILE AWAITING TRANSPLANT. (B)(6)2015, PATIENT WAS TAKEN TO THE OR FOR EXPLANT OF LVAD AND HEART TRANSPLANTATION." NO OTHER INFORMATION AVAILABLE AT THIS TIME. INVESTIGATION IS IN PROGRESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    398307 HEARTWARE® VENTRICULAR ASSIST SYSTEM CIRCULATORY ASSIST SYSTEM DSQ HEARTWARE, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization| L| O| R