BEUDAMED
    FDA Adverse Event Death Summary report: N

    CARDIVA MEDICAL VASCADE MVP VCS

    MDR report key: 16351475 · Received February 10, 2023

    Report

    Report Number
    3004182619-2023-00003
    Event Type
    Death
    Date Received
    February 10, 2023
    Date of Event
    November 17, 2022
    Report Date
    February 10, 2023
    Manufacturer
    CARDIVA MEDICAL, INC.
    Product Code
    MGB
    PMA / PMN Number
    P120016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AS THE DEVICE WAS NOT RETURNED, IT IS UNABLE TO BE DETERMINED IF THE DIFFICULTY IN REMOVING THE DEVICE WAS RELATED TO A BIOLOGICAL RESPONSE OF THE PATIENT, PLAQUE IN THE ARTERY, THE DEVICE BEING CAUGHT IN A PREVIOUS IMPLANT, A DEVICE MALFUNCTION OR USER ERROR. IN THIS CASE THE PATIENT HAD NUMEROUS ISSUES WHICH CAUSED THE PATIENT TO EXPIRE. THERE IS NO INDICATION THAT THE DEVICE BEING UNABLE TO REMOVED WAS THE CAUSE OF THE PATIENT'S DEATH.

    Description of Event or Problem · 0

    FROM MEDWATCH REPORT (B)(4) : PATIENT WAS TAKEN TO CARDIAC CATHETERIZATION LAB WITH AN ST ELEVATION MYOCARDIAL INFARCTION. DOCTOR (MD) OBTAINED TWO VENOUS ACCESSES AND PLACED TWO VENOUS SHEATHS. THE THIRD TIME, MD ENGAGED AN ARTERY AND THEN PLACED A THIRD SHEATH. THROUGH THIS THIRD SHEATH, MD DID SOME DIAGNOSTICS, SOME TREATMENTS, PLACED A STENT, AND PLACED AN IMPELLA HEART PUMP. WHEN ALL THAT WAS DONE, MD TURNED HIS ATTENTION BACK TO THE VENOUS SHEATHS. ONE WAS USED FOR A CENTRAL LINE; AND THE OTHER MD ATTEMPTED TO CLOSE IT USING A VASCADE VENOUS CLOSURE SYSTEM. UNFORTUNATELY, THE VASCADE VCS GOT STUCK INTO THE COMMON FEMORAL VEIN AND SURGICAL STAFF COULD NOT GET IT OUT. THE PATIENT WAS STABLE AT THAT POINT (HE HAD ALREADY HAD THREE PULSELESS ELECTRICAL ACTIVITY (PEA) ARRESTS AND ACHIEVED RETURN OF SPONTANEOUS CIRCULATION (ROSC) PRIOR TO CATH LAB INTERVENTION. THE MD DID NOT FEEL THAT THE FOREIGN OBJECT IN THE COMMON FEMORAL VEIN WOULD PRESENT AN IMMINENT COMPROMISE FOR THE PATIENT IN LIEU OF HIS MULTIPLE ISSUES, SO MD LEFT THE VASCADE DEVICE IN PLACE IN THE COMMON FEMORAL VEIN WITH A FIGURE-OF-EIGHT STITCH. THIS PATIENT DIED SOON AFTER THIS PROCEDURE, WHEN HE WAS ON FOUR VASOPRESSORS AND HAVING HYPOTENSION AND BRADYCARDIA FROM A JUNCTIONAL ESCAPE RHYTHM. AFTER DISCUSSION WITH FAMILY, ALL DRIPS AND THE IMPELLA HEART PUMP WERE TURNED OFF AND PATIENT EXPIRED. CARDIVA REPRESENTATIVE REACHED OUT TO THE HOSPITAL AND NO OTHER INFORMATION WILL BE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1161496 CARDIVA MEDICAL VASCADE MVP VCS VASCADE MVP MGB CARDIVA MEDICAL, INC. 800-612C G612C220907B

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Unknown Death