BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARACORPOREAL VENTRICULAR ASSIST DEVICE

    MDR report key: 4915063 · Received July 15, 2015

    Report

    Report Number
    2916596-2015-01272
    Event Type
    Injury
    Date Received
    July 15, 2015
    Date of Event
    May 11, 2015
    Report Date
    June 16, 2015
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A DIRECT RELATIONSHIP BETWEEN THE DEVICE AND THE REPORTED EVENTS COULD NOT BE DETERMINED. THE PUMP WAS DISCARDED FOLLOWING EXPLANT AND WAS NOT AVAILABLE FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORDS REVEALED THE DEVICE MET APPLICABLE SPECIFICATIONS. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 1

    THE PATIENT WAS IMPLANTED WITH A PARACORPOREAL LEFT VENTRICULAR ASSIST DEVICE ON (B)(6)2014. IT WAS REPORTED THAT THE PATIENT EXPERIENCED SEVERAL COMPLICATIONS INCLUDING A RIGHT MIDDLE CEREBRAL ARTERY STROKE WITH BOTH ISCHEMIC AND HEMORRHAGIC CONVERSIONS, AS WELL AS KNOWN FIBRIN STRANDS IN THE PUMP HOUSING. THE PATIENT PRESENTED DURING THE LAST ADMISSION WITH A LOW GRADE FEVER AND BLOOD CULTURES (B)(6) FOR (B)(6). REPEAT BLOOD CULTURES CONTINUED TO BE POSITIVE DESPITE CHANGING OF ANTIBIOTICS. THE PATIENT HAD BEEN RECENTLY LISTED FOR HEART TRANSPLANT; HOWEVER, GIVEN THE HISTORY OF STROKE AND RECURRENT INFECTIONS, IT WAS DECIDED THAT SHE WAS TOO HIGH RISK FOR HEART TRANSPLANT AND WAS MADE INACTIVE ON THE TRANSPLANT LIST. AFTER REVIEWING SERIAL ECHOCARDIOGRAMS, IT WAS FELT THAT THE PATIENT HAD SOME MYOCARDIAL RECOVERY SINCE VAD IMPLANTATION AND A DECISION WAS MADE TO ATTEMPT TO WEAN OFF THE VAD. WEANING OCCURRED OVER APPROXIMATELY ONE AND A HALF WEEKS. THE PUMP WAS EXPLANTED ON (B)(6) 2015. THE PATIENT WAS SUBSEQUENTLY DISCHARGED HOME. THE PARACORPOREAL DEVICE HAD REPORTEDLY BEEN FUNCTIONING AS EXPECTED. IT WAS DISCARDED BY THE HOSPITAL AFTER REMOVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    459394 PARACORPOREAL VENTRICULAR ASSIST DEVICE VENTRICULAR ASSIST DEVICE DSQ THORATEC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention