BEUDAMED
    FDA Adverse Event Death Summary report: N

    CARDIVA MEDICAL, INC. VASCADE 5F VCS

    MDR report key: 12029706 · Received June 19, 2021

    Report

    Report Number
    3004182619-2021-00009
    Event Type
    Death
    Date Received
    June 19, 2021
    Date of Event
    November 28, 2020
    Report Date
    June 18, 2021
    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 DEVICE WAS NOT RETURNED FOR INVESTIGATION. ARTERIAL OCCLUSION: IT IS UNKNOWN IF FLUOROSCOPY OF THE DISC POSITION BEFORE COLLAGEN DEPLOYMENT WAS NOT OBTAINED, AND THE IMAGES WERE NOT PROVIDED TO CARDIVA MEDICAL INC. 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 DEVICE WAS NOT RETURNED, AND IMAGES OF THE SHEATH AND FLUOROSCOPY OF THE DEVICE PLACEMENT WERE NOT OBTAINED. NO DEVICE MALFUNCTION WAS REPORTED. 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. RETROPERITONEAL BLEED: A COMPLICATION SUCH AS RETROPERITONEAL BLEEDING ARE GENERAL COMPLICATIONS WHICH MAY BE RELATED TO THE ENDOVASCULAR PROCEDURE OR THE VASCULAR CLOSURE PROCEDURE. PER THE REPORT, HEMOSTASIS WAS ACHIEVED WITH THE DEVICE. IT WAS ALSO NOTED THAT THE PATIENT HAD SEVERE ILLNESS WHICH COULD HAVE CONTRIBUTED TO THE ISSUES AND COMPLICATIONS, BUT THIS IS NOT KNOWN.

    Description of Event or Problem · 1

    A REVIEW WAS CONDUCTED OF THE MAUDE DATABASE ON 5/21/21 AND THIS EVENT WAS LOCATED AND HAD NOT PREVIOUSLY BEEN REPORTED BY THE HOSPITAL. CARDIVA MEDICAL DID NOT RECEIVE A MEDWATCH REPORT COPY WHICH IS NORMALLY MAILED. PER MEDWATCH REPORT: A (REDACTED) YEAR-OLD FEMALE ADMITTED (REDACTED) 2020 VIA ED WITH SEPSIS, PNEUMONIA, NSTEMI (NON-ST SEGMENT ELEVATION MYOCARDIAL INFARCTION"), ELEVATED TROPONIN. UNDERWENT LEFT HEART CATH VIA RFA, CLOSURE WITH VASCADE DEVICE NOTED UNSUCCESSFUL. POST-PROCEDURE, DEVELOPED RESPIRATORY DISTRESS, INTUBATED. DEVELOPED RETROPERITONEAL HEMORRHAGE WITH ACUTE LIMB ISCHEMIA REQUIRING RETURN TO SURGERY FOR RIGHT ILIOFEMORAL THROMBECTOMY VIA GROIN INCISION, AND 4-COMPARTMENT FASCIOTOMIES. OPERATIVE FINDINGS: COLLAGEN PLUG FROM VASCADE DEVICE WAS DEPLOYED INTO RIGHT SUPERFICIAL FEMORAL ARTERY CAUSING OCCLUSION OF THE COMMON FEMORAL ARTERY, SUPERIOR FEMORAL ARTERY, AND PROFUNDA, WITH RIGHT LOWER EXTREMITY COMPARTMENT SYNDROME. PT CRITICALLY ILL IN THE OPERATING ROOM, MAXED OUT ON PRESSERS, WITH ARDS. WITH WORSENING STATUS, FAMILY OPTED FOR COMFORT MEASURES AND PT EXPIRED (REDACTED) 2020. NO OTHER INFORMATION PROVIDED AND UNABLE TO FOLLOW UP AS THE LOCATION AND USER IS NOT KNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    926413 CARDIVA MEDICAL, INC. VASCADE 5F VCS VASCADE 5F MGB CARDIVA MEDICAL, INC. 700-500DX G500DX200723A

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Death| R