BEUDAMED
    FDA Adverse Event Death Summary report: N

    CARDIVA VASCADE 6/7F VCS

    MDR report key: 7275649 · Received February 15, 2018

    Report

    Report Number
    3004182619-2018-00002
    Event Type
    Death
    Date Received
    February 15, 2018
    Date of Event
    January 18, 2018
    Report Date
    January 18, 2018
    Manufacturer
    CARDIVA MEDICAL, INC.
    Product Code
    MGB
    PMA / PMN Number
    P120016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN ANGIOGRAM OR FLUOROSCOPY OF THE SHEATH AFTER THE EXCHANGE WAS NOT TAKEN TO VERIFY POSITION OF THE DISC BEFORE COLLAGEN DEPLOYMENT. IT SHOULD BE NOTED THAT IMAGING IS SPECIFIED IN THE IFU TO LOCATE THE SHEATH POSITION AND ARTERIOTOMY LOCATION. IMAGING ALSO ALLOWS THE USER TO ASSESS THE SEVERITY OF THE VASCULAR DISEASE, VESSEL TORTUOSITY, AND VESSEL DIAMETER AND IDENTIFY THE PRESENCE OF AN EXISTING STENT OR OTHER IMPLANT AT THE ARTERIOTOMY SITE. THE OCCLUSION WAS CORRECTED WITH SURGERY AND THE FLOW WAS RESTORE TO THE RIGHT FOOR AND THE PATIENT TOLERATED THE SURGERY WELL. IT SHOULD BE NOTED THAT THE PATIENT WAS NOTED TO HAVE PERIPHERAL VASCULAR DISEASE AND CALCIFICATION. IT IS UNCLEAR WHETHER THE OCCLUSION WAS CAUSED BY COLLAGEN OR BIOLOGICAL MATERIALS. THE DEVICE WAS NOT RETURNED, AND IMAGES OF THE SHEATH AND FLUOROSCOPY OF THE DEVICE PLACEMENT WERE NOT OBTAINED. NO DEVICE MALFUNCTION WAS REPORTED.

    Description of Event or Problem · 1

    AN ANGIOGRAM WAS PERFORMED, WHICH NOTED PERIPHERAL VASCULAR DISEASE AND CALCIFICATION. THE VASCADE DEVICE WAS SELECTED FOR CLOSURE AND INSERTED INTO THE SHEATH. THE DISC WAS DEPLOYED, BUT WHEN THE DISC WAS PULLED AGAINST THE ARTERIOTOMY RESISTANCE WAS FELT. AT THIS POINT, THE SHEATH WAS REMOVED, AND THERE WAS MILD OOZING AT THE ACCESS SITE. A FLUOROSCOPY WAS NOT UTILIZED TO VERIFY DISC PLACEMENT. THE TECHNICIAN INSERTED THE KEY INTO THE LOCK/GRIP AND PULLED BACK THE BLACK SLEEVE. AT THIS TIME, THE ENTIRE DEVICE CAME BACK TO THE TRUE ARTERIOTOMY. THE TECHNICIAN CONTINUED TO RETRACT THE BLACK SLEEVE AND DEPLOYED THE COLLAGEN BY UTILIZING THE GREEN PUSH ROD TO STRIP THE COLLAGEN FROM THE DEVICE. THE PATIENT WAS TRANSFERRED TO THE RECOVERY, BUT A FEW MINUTES LATER THE PATIENT COMPLAINED OF PAIN AND COOLNESS TO THE RIGHT FOOT. NO PULSE OR DOPPLER WAS PRESENT. A VASCULAR SURGEON WAS CONSULTED THE PATIENT WAS TRANSFERRED TO THE OPERATING ROOM AND WHERE THE VASCULAR SURGEON PERFORMED A RIGHT FEMORAL ARTERY THROMBECTOMY AND RIGHT FEMORAL ENDARTERECTOMY ON THE PATIENT. THE PATIENT TOLERATED THE SURGERY WELL AND FLOW WAS RESTORED TO THE RIGHT FOOT. THE SURGEON STATED THAT HE LOCATED THE CLOT IN THE LEG BUT WAS UNABLE TO IDENTIFY IT AS COLLAGEN. PATIENT WAS TAKEN TO ICU POST-SURGERY. WHILE IN ICU PATIENT VOMITED WHILE ON HER BACK AND ASPIRATED AND PATIENT PAST AWAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    119059 CARDIVA VASCADE 6/7F VCS VASCADE 6/7F MGB CARDIVA MEDICAL, INC. 700-500DX G500DX171117A

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Death