BEUDAMED
    FDA Adverse Event Death Summary report: N

    CARDIVA MEDICAL INC., VASCADE MVP

    MDR report key: 10429016 · Received August 19, 2020

    Report

    Report Number
    3004182619-2020-00012
    Event Type
    Death
    Date Received
    August 19, 2020
    Date of Event
    July 23, 2020
    Report Date
    August 19, 2020
    Manufacturer
    CARDIVA MEDICAL, INC.
    Product Code
    MGB
    PMA / PMN Number
    P120016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED COMPLAINT WAS REVIEWED BY (B)(6) ON 7/24/2020 AND ASSESSED TO BE REPORTABLE. THE REVIEW OF THE DHR WAS UNABLE TO BE PERFORMED AS THE DEVICE LOT NUMBER IS UNKNOWN. THE DEVICE WAS NOT RETURNED FOR INVESTIGATION PER THE REPORTED EVENT, THE PATIENT SUFFERED FROM DEEP VEIN THROMBOSIS, WHICH LIKELY CAUSED A PULMONARY EMBOLISM, RESULTING IN THE PATIENT'S DEATH. WHILE DEPLOYMENT OF COLLAGEN PARTIALLY OR FULLY INTO THE VESSEL CAN CONTRIBUTE TO PULMONARY EMBOLISM, IN THIS CASE THE MORE LIKELY CAUSE IS THE DIAGNOSED CONDITION OF DEEP VEIN THROMBOSIS. DEEP VEIN THROMBOSIS, OR DVT, IS A BLOOD CLOT THAT FORMS IN A VEIN DEEP IN THE BODY. MOST DEEP VEIN CLOTS OCCUR IN THE LOWER LEG OR THIGH. IF THE VEIN SWELLS, THE CONDITION IS CALLED THROMBOPHLEBITIS. A DEEP VEIN THROMBOSIS CAN BREAK LOOSE AND CAUSE A SERIOUS PROBLEM IN THE LUNG, CALLED A PULMONARY EMBOLISM. THE DEVICE WAS NOT RETURNED. NO DEVICE MALFUNCTION WAS REPORTED. CONCLUSION: PULMONARY EMBOLISM AND DEEP VEIN THROMBOSIS ARE KNOWN COMPLICATIONS OF ENDOVASCULAR PROCEDURES AND/OR CLOSURE. IN THIS CASE THE PATIENT'S KNOWN DIAGNOSIS OF DVT WAS THE MOST LIKELY CAUSE OF THE PULMONARY EMBOLISM AND DEATH. BASED ON THE HIGH BASELINE RISK OF PATIENTS UNDERGOING PERCUTANEOUS TRANSCATHETER PROCEDURES DUE TO MEDICAL HISTORY AND THE INTERVENTIONAL PROCEDURE ITSELF, CARDIVA ASSERTS THAT THE VASCADE MVP VCS DOES NOT CONTRIBUTE TO THE RISK OF INCREASED DVT, AND BY DESIGN, IS INTENDED TO MITIGATE THE RISK OF VENOUS STASIS BY ALLOWING UNINTERRUPTED BLOOD FLOW DURING CLOSURE AND REDUCING TIMES TO HEMOSTASIS AND AMBULATION. THE RISK OF USE ERROR RESULTING IN INTRAVASCULAR COLLAGEN DEPLOYMENT AND SUBSEQUENT RISK OF THROMBOEMBOLISM IS MITIGATED TO ACCEPTABLE LEVELS.

    Description of Event or Problem · 1

    THE PATIENT UNDERWENT A CARDIAC ABLATION TO TREAT SUPRAVENTRICULAR TACHYCARDIA. THE VASCADE MVP DEVICE WAS SELECTED FOR CLOSURE AND INSERTED INTO THE SHEATH. THE DISC WAS DEPLOYED, THE SHEATH WAS REMOVED, AND TEMPORARY HEMOSTASIS WAS ACHIEVED. FLUOROSCOPY WAS NOT UTILIZED TO VERIFY DISC PLACEMENT. THE KEY WAS INSERTED INTO THE LOCK/GRIP AND THE BLACK SLEEVE WAS RETRACTED TO EXPOSE THE COLLAGEN. THE COLLAGEN WAS STRIPPED OFF THE DEVICE AND THE DEVICE WAS REMOVED. FINAL HEMOSTASIS ACHIEVED WITH THE DEVICE AND PATIENT DISCHARGED THAT DAY. TWO WEEKS LATER, PATIENT WENT TO EMERGENCY ROOM WITH SUPRAVENTRICULAR TACHYCARDIA, WAS GIVEN MEDICATION AND WAS SENT HOME. PATIENT CALLED HIS DOCTOR THE NEXT DAY TO INFORM HIM OF EMERGENCY ROOM VISIT AND TO INFORM DOCTOR THAT LEG WAS SWOLLEN FROM GROIN TO FOOT WHICH WAS NOT ATTENDED IN THE EMERGENCY ROOM. PATIENT INFORMED TO RETURN TO HOSPITAL BUT HE DID NOT. PATIENT HAD DEEP VEIN THROMBOSIS AND DIED FROM PULMONARY EMBOLISM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    888634 CARDIVA MEDICAL INC., VASCADE MVP VASCADE MVP MGB CARDIVA MEDICAL, INC. 800-612C UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Death