BEUDAMED
    FDA Adverse Event Death Summary report: N

    CARDIVA VASCADE 6/7F VCS

    MDR report key: 16975770 · Received May 22, 2023

    Report

    Report Number
    3004182619-2023-00009
    Event Type
    Death
    Date Received
    May 22, 2023
    Date of Event
    April 3, 2023
    Report Date
    May 22, 2023
    Manufacturer
    CARDIVA MEDICAL, INC.
    Product Code
    MGB
    PMA / PMN Number
    P120016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED FOR INVESTIGATION. PER THE REPORTED EVENT, FLUOROSCOPY WAS NOT UTILIZED AND FINAL HEMOSTASIS WAS ACHIEVED. FOUR HOURS AFTER THE PROCEDURE THE PATIENT DEVELOPED A COLD LEG AND SURGERY WAS PERFORMED TO REMOVE AN OBJECT THAT WAS NOT IDENTIFIED FROM THE POPLITEAL ARTERY. IT IS NOT KNOWN IF THIS IS THE COLLAGEN PLUG OR BIOLOGICAL MATERIAL. FLUOROSCOPY WAS NOT UTILIZED FOR DEVICE DEPLOYMENT. IT SHOULD BE NOTED THAT IMAGING IS SPECIFIED IN THE IFU TO LOCATE THE DISC POSITION WITH RESPECT TO ARTERIOTOMY LOCATION. IMAGING ALSO ALLOWS THE USER TO ASSESS THE SEVERITY OF THE VASCULAR DISEASE AND OTHER VESSEL CHARACTERISTICS. CONCLUSION: IMAGING WAS NOT UTILIZED TO VERIFY DISC PLACEMENT; THEREFORE, IT CANNOT BE DETERMINED IF THE DISC WAS PROPERLY PLACED FOR DEPLOYMENT. ADDITIONAL PROCEDURAL FACTORS SUCH AS SHEATH EXCHANGE, INSERTION OF CLOSURE DEVICE IN CONJUNCTION WITH THE DEGREE OF THE VASCULAR DISEASE AND CONDITION (CALCIFICATION NEAR THE ARTERIOTOMY SITE), AND INSUFFICIENT HYDRATION TIME OF THE COLLAGEN MAY HAVE BEEN CONTRIBUTING FACTORS TO THIS EVENT BUT THIS IS UNKNOWN. IN ADDITION, THE PATHOLOGY REPORT WHICH WOULD DETERMINE THE NATURE/CHARACTERISTICS OF THE MATERIAL REMOVED FROM THE POPLITEAL ARTERY WAS NOT PROVIDED. THEREFORE, WE ARE UNABLE TO DETERMINE WHETHER THE MATERIAL THAT CAUSED THE OCCLUSION WAS THE COLLAGEN PLUG OR OTHER TYPE OF EMBOLUS (E.G. ATHEROSCLEROTIC PLAQUE, THROMBUS).

    Description of Event or Problem · 0

    LEG ATHERECTOMY WAS PERFORMED AND THE VASCADE 6/7F WAS UTILIZED TO CLOSE THE CFA POST PROCEDURE. THE VASCADE 6/7F DEVICE WAS SELECTED FOR CLOSURE THE DISC WAS INSPECTED AND THE TIP OF THE DEVICE WAS MOMENTARILY DIPPED IN SALINE. THE DISC WAS DEPLOYED, THE SHEATH WAS REMOVED, AND TEMPORARY HEMOSTASIS WAS ACHIEVED. THE KEY WAS INSERTED INTO THE LOCK/GRIP AND THE BLACK SLEEVE WAS RETRACTED TO EXPOSE THE COLLAGEN, WHICH WAS ALLOWED TO DWELL FOR 30 SECONDS. THE PUSH ROD WAS UTILIZED TO STRIP THE COLLAGEN FROM THE DEVICE, AND THE DEVICE WAS REMOVED. AFTER DEVICE WAS REMOVED PRESSURE WAS HELD FOR 5 MINUTES. AT THIS POINT, THE USER OBSERVED A SMALL HEMATOMA AND ADDITIONAL PRESSURE WAS HELD TO COMPRESS THE HEMATOMA FOR 10 MINUTES. DOPPLER WAS PERFORMED ON BOTH LEGS AND FOOT PULSES WERE PRESENT AND DOCUMENTED. SITE HAD FINAL HEMOSTASIS AND PATIENT WAS MOVED TO PACU AT 4:00 PM. AT 8:00 PM IT WAS DETERMINED THAT THE PATIENT HAD COLD FOOT AND PATIENT WAS TRANSFERRED TO THE OPERATING ROOM FOR SURGERY TO CORRECT. SURGERY WAS PERFORMED AND NO FOREIGN BODY WAS LOCATED IN THE CFA, BUT THE SURGEON REMOVED "SOMETHING" FROM THE RIGHT POPLITEAL ARTERY. SURGERY WAS COMPLETED, PATIENT WAS EXTUBATED AND TRANSFER TO RECOVERY. PATIENT WOKE UP AND WAS ALERT. PATIENT THEN WENT IN TO CARDIAC ARRHYTHMIA AND THE MEDICAL TEAM WAS NOT ABLE TO RESUSCITATE. IT IS NOTED THAT FLUOROSCOPY/IMAGING WAS NOT PERFORMED TO VERIFY DISC PLACEMENT BEFORE THE DEPLOYMENT OF THE COLLAGEN. IN ADDITION, THE PATHOLOGY REPORT TO DETERMINE THE MATERIAL REMOVED FROM THE POPLITEAL ARTERY WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    807823 CARDIVA VASCADE 6/7F VCS VASCADE 6/7F MGB CARDIVA MEDICAL, INC. 700-580I UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Male Death