BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THORATEC® HEARTMATE 3® LVAS IMPLANT KIT

    MDR report key: 20523964 · Received October 24, 2024

    Report

    Report Number
    2916596-2024-06881
    Event Type
    Injury
    Date Received
    October 24, 2024
    Date of Event
    October 9, 2024
    Report Date
    December 27, 2024
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013297
    PMA / PMN Number
    P160054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE MANUFACTURER¿S INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: THE PUMP REMAINS IN USE SUPPORTING THE PATIENT. A CORRELATION BETWEEN THE DEVICE AND THE REPORT OF STROKE COULD NOT BE CONCLUSIVELY DETERMINED. STROKE IS LISTED IN THE INSTRUCTIONS FOR USE AS A POTENTIAL ADVERSE EVENT THAT MAY BE ASSOCIATED WITH THE USE OF HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM. STROKE HAS BEEN PREVIOUSLY INVESTIGATED AND WILL CONTINUE TO BE MONITORED THROUGH QUALITY DATA REVIEWS, WHICH ARE CONDUCTED ON PRODUCTION AND POST PRODUCT SIGNALS TO EVALUATE IF PRODUCTS ARE CONFORMING TO PRODUCT REQUIREMENTS. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE EMERGENCY ROOM WITH STROKE LIKE SYMPTOMS, A LEFT SIDED FACIAL DROOP AND DYSARTHRIA. A COMPUTED TOMOGRAPHY (CT) SCAN OF THE HEAD WAS NEGATIVE. THE PATIENT'S INTERNATIONAL NORMALIZED RATIO (INR) WAS 1.8, THE PATIENT HAD A GOAL OF 1.8 TO 2.2 DUE TO HISTORY OF GASTROINTESTINAL (GI) BLEEDING (CS-202957). THE LEFT SIDED FACIAL DROOP HAD RESOLVED BUT THE PATIENT STILL HAD SLOW SPEECH. THE PATIENT WAS ADMITTED FOR OBSERVATION AND CONSULTATION WITH NEUROLOGY. THE PATIENT DENIED ANY ALARMS OR WARNINGS. THERE WERE NO POWER SPIKES UPON INTERROGATION OF THE DEVICE. THE LOG FILES WERE REVIEWED AND CONTAINED CLUSTERS OF PULSATILITY INDEX (PI) EVENTS AS WELL AS ROUTINE POWER SOURCE CHANGES. NO UNUSUAL ROTOR FAULTS, PUMP TEMPERATURE, OR ANY OTHER ABNORMAL PUMP FAULTS WERE SEEN IN THE LOG FILE. EVALUATION BY THE NEUROLOGY TEAM CONCLUDED THAT THERE WAS SUSPICION THAT THE CAUSE WAS POSSIBLY A SMALL RIGHT BASAL GANGLIA STROKE WITH CONSIDERATION OF SUBTHERAPEUTIC INR. INR GOAL WAS INCREASED TO 2-3. PATIENT ALSO WAS PUT ON ACETYLSALICYLIC ACID (ASA) 81 MG. THE PATIENT WAS CLEARED BY NEUROLOGY AND WAS STABLE AS ALL NEUROLOGICAL SYMPTOMS HAVE RESOLVED. THE PATIENT WAS CLEARED FOR DISCHARGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1789890 THORATEC® HEARTMATE 3® LVAS IMPLANT KIT VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106524US 6266198 00813024013297

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Male Hospitalization| R