BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE 3 LVAS IMPLANT KIT

    MDR report key: 13736488 · Received March 11, 2022

    Report

    Report Number
    2916596-2022-01206
    Event Type
    Injury
    Date Received
    March 11, 2022
    Date of Event
    December 31, 2018
    Report Date
    March 21, 2022
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    PMA / PMN Number
    P160054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    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 COMPLETED.

    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 ON (B)(6) 2018 THE PATIENT HAD NEUROLOGIC DYSFUNCTION AND WAS ADMITTED TO AN EXTERNAL HOSPITAL DUE TO NOTICEABLE LEFT HEMIPARESIS SYMPTOMOLOGY. A COMPUTED TOMOGRAPHY (CT) SCAN OF THE HEAD FOUND A LARGE-LUMEN RIGHT FRONTAL INTRACEREBRAL SPACE-OCCUPYING LESION WITH A MIDLINE SHIFT. THE PATIENT REPORTED THAT THEY HAD BEEN SUFFERING FROM A MOVEMENT DISORDER OF THE LEFT SIDE OF THE BODY FOR ABOUT 5 WEEKS. ON 02JAN2019, THE PATIENT WAS ADMITTED TO THE REPORTING HOSPITAL FOR A NEUROSURGICAL CONSULT. INTERNATIONAL NORMALIZED RATIO (INR) WAS 1.13 AND ACTIVATED PARTIAL THROMBOPLASTIN CLOTTING TIME (APTT) WAS 33 SECONDS. THE PATIENT WAS AWAKE AND NOT ORIENTED AND PUPILS WERE NARROW. THE PATIENT HAD DISCRETE FACIAL PARESIS ON THE LEFT SIDE AND THERE WAS TONGUE DEVIATION TO THE RIGHT. HEMIPARESIS AS WELL AS NEGLECT TO THE LEFT WAS CONFIRMED. A CT OF THE HEAD ON (B)(6) 2019 SHOWED A RIGHT FRONTAL HEMORRHAGE THAT WAS NOT PROGRESSIVE IN SIZE COMPARED TO THE PREVIOUS CT, WITH THE ONSET OF RESORPTION. AT THE TIME OF THE STROKE THE PATIENT WAS ON HEPARIN, AND THE PATIENT WAS PUT ON ISOCOR. ON 04JAN2019 INR WAS 1.27 AND APTT WAS 55 SECONDS. THE PATIENT WAS TRANSFERRED BACK TO THE HOSPITAL WHERE THEY WERE ORIGINALLY ADMITTED IN RESPIRATORY AND HEMODYNAMICALLY STABLE CONDITION. THE PATIENT WAS DISCHARGED HOME ON (B)(6) 2019.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1150894 HEARTMATE 3 LVAS IMPLANT KIT VENTRICULAR (ASSISST) BYPASS DSQ THORATEC CORPORATION 106524INT 5473460

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Male Required Intervention| H| L