BEUDAMED
    FDA Adverse Event Death Summary report: N

    VENTRICULAR ASSIST DEVCIE

    MDR report key: 4222471 · Received October 31, 2014

    Report

    Report Number
    2916596-2014-01821
    Event Type
    Death
    Date Received
    October 31, 2014
    Date of Event
    September 30, 2014
    Report Date
    October 3, 2014
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN ADVERSE EVENT OCCURRED WITH NO INDICATION OF A PRODUCT PROBLEM. THEREFORE, ONLY ONE PRODUCT HAS BEEN REPORTED AND THE OTHER HAS BEEN REFERENCED AS CONCOMITANT MEDICAL PRODUCTS. THE VADS WERE RETURNED TO THE MFR FOR EVALUATION AND ARE CURRENTLY BEING ANALYZED. NO FURTHER INFO IS AVAILABLE AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MFR'S INVESTIGATION IS COMPLETED.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: BOTH DEVICES WERE RETURNED FOR EVALUATION. A CORRELATION BETWEEN THE DEVICES AND THE REPORT OF HEMORRHAGIC STROKE COULD NOT BE DETERMINED. VAD- (B)(4) WAS RETURNED ASSEMBLED WITH THE BRAIDED TUBING AND Y-CONNECTOR ATTACHED. EXAMINATION OF THE BLOOD-CONTACTING SURFACES FOUND TISSUE-LIKE DEPOSITIONS OF CLOTTED BLOOD LOOSELY SEATED IN THE INFLOW PORT, OUTFLOW PORT, AND THE BLOOD SAC. THE MAJORITY THE DEPOSITIONS SHOWED LITTLE STRUCTURE AND APPEARED TO BE ACUTE FORMATIONS. THE CAUSE OF THE DEPOSITIONS COULD NOT BE DETERMINED AND THE EVALUATION COULD NOT CONCLUSIVELY CORRELATE THE DEPOSITIONS TO THE REPORTED EVENT. LEAK TESTING WAS CONDUCTED ON THE BLOOD SAC AND PNEUMATIC SIDES OF THE PUMP AND BOTH PASSED THE MANUFACTURER¿S SPECIFICATIONS. VAD-(B)(4) WAS RETURNED ASSEMBLED WITH THE BRAIDED TUBING AND Y-CONNECTOR ATTACHED. EXAMINATION OF THE BLOOD-CONTACTING SURFACES FOUND SMALL, LOOSELY SEATED DEPOSITIONS OF BLOOD IN THE BLOOD SAC AND ON THE OUTFLOW VALVE. THE DEPOSITIONS SHOWED NO STRUCTURE AND APPEARED TO BE ACUTE FORMATIONS. THE CAUSE OF THE DEPOSITIONS COULD NOT BE DETERMINED AND THE EVALUATION COULD NOT CONCLUSIVELY CORRELATE THE DEPOSITIONS TO THE REPORTED EVENT. LEAK TESTING WAS CONDUCTED ON THE BLOOD SAC AND PNEUMATIC SIDES OF THE PUMP AND BOTH PASSED THE MANUFACTURER¿S SPECIFICATIONS. THE INSTRUCTIONS FOR USE LISTS BLEEDING AND NEUROLOGICAL DYSFUNCTION AS POSSIBLE ADVERSE EVENTS THAT MAY BE ASSOCIATED WITH THE USE OF THE VENTRICULAR ASSIST DEVICE (VAD) SYSTEM. A REVIEW OF THE DEVICE HISTORY RECORDS REVEALED THAT THE DEVICES MET APPLICABLE SPECIFICATIONS. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 1

    THE PT WAS IMPLANTED WITH VENTRICULAR ASSIST DEVICES. THE VAD COORDINATOR REPORTED THE PT BEGAN HAVING NEUROLOGICAL STATUS CHANGES ON (B)(6) 2014. AT THAT TIME, THE PT'S INR WAS 3.7. FFP AND PLATELETS WERE GIVEN TO DUE TO ELEVATED INR. A CT SCAN WAS PERFORMED ON 10/01 AND A SUBARACHNOID HEMORRHAGE WAS NOTED ON THE CT SCAN. NEUROLOGICAL STATUS IMPROVED ON (B)(6) AND THE PT WAS UP ON THE CARDIAC CHAIR AND AMBULATING. ON (B)(6), NEUROLOGICAL STATUS BEGAN TO CHANGE AGAIN AND TWO MORE CT SCANS WERE PERFORMED AND TWO OTHER AREAS OF SUBARACHNOID HEMORRHAGE WERE NOTED. THE FAMILY DECIDED TO DISCONTINUE SUPPORT ON (B)(6) 2014 AND THE PT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    698038 VENTRICULAR ASSIST DEVCIE DSQ: VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 14086-2550-000 141879

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Death