BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THORATEC VENTRICULAR ASSIST DEVICE (VAD) SYSTEM

    MDR report key: 3020540 · Received March 21, 2013

    Report

    Report Number
    2916596-2013-00308
    Event Type
    Injury
    Date Received
    March 21, 2013
    Date of Event
    January 24, 2013
    Report Date
    February 20, 2013
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    PATIENT PRESENTED ON (B)(6) 2013, ACCORDING TO SURGEON: PATIENT DOING VERY WELL - TOLERATING ANTI-COAGULATION, NO HISTORY OF GI BLEEDING. MAP 80'S AND CONTROLLED THROUGHOUT SUPPORT. ONE MONTH PRIOR TO THE EVENT, THE PATIENT PRESENTED WITH A DRIVELINE INFECTION THAT WAS TREATED WITH A COURSE OF IV FOLLOWED BY PO ANTIBIOTICS. HE PRESENTED TO THE E.R. (B)(6) 2013 WITH A ICB. ON EVALUATION TO HOSPITAL HIS INR WAS 2.8, A-LINE PLACED SHOWING DICROTIC NOTCH. ECHO SHOWED AV OPENING WITH EVERY BEAT. RAMP ATTEMPTED AND THEY WERE UNABLE TO CLOSE AV. PFHGB AND LDH NORMAL ON ADMISSION., STOPPED ALL ANTICOAGULATION. WITHIN FIRST WEEK, INCREASING PFHGB > 150. NOW 4 WEEKS POST EVENT: PATIENT'S NEURO STATUS IS IMPROVING. ECHO SHOWS AV CLOSING APPROPRIATELY. LDH AND PFHGB IS NORMAL. SURGEON FEELS LIKE HISTORICALLY THEY HAVE HAD BAD LUCK WITH ICB RECURRING AND CAUSING A DEVASTATING OR LIFE THREATENING STROKE IF LEFT UNTREATED. CURRENTLY THE PATIENT IS STILL OFF ALL ANTI-COAGULATION. SURGEON AND NEUROLOGIST FEEL THIS WAS AN EMBOLIC STROKE THAT POTENTIALLY ORIGINATED FROM WITHIN THE PUMP THAT CAUSED AN ICB. ORIGINAL PLAN TO EXCHANGE THE PUMP IN 4-6 WEEKS ONCE PATIENT CAN TOLERATE ANTI-COAGULATION. NOW HE IS QUESTIONING DECISION BECAUSE THE PATIENT CLINICALLY IS IMPROVING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    118770 THORATEC VENTRICULAR ASSIST DEVICE (VAD) SYSTEM DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 104911 114021

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Life Threatening| O| R