BEUDAMED
    FDA Adverse Event Death Summary report: N

    MYNXGRIP (6F/7F) VASCULAR CLOSURE DEVICE

    MDR report key: 3911233 · Received July 2, 2014

    Report

    Report Number
    3004939290-2014-00082
    Event Type
    Death
    Date Received
    July 2, 2014
    Date of Event
    May 20, 2014
    Report Date
    June 11, 2014
    Manufacturer
    ACCESSCLOSURE, INC.
    Product Code
    MGB
    PMA / PMN Number
    P040044
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED; THEREFORE, A PHYSICAL INVESTIGATION COULD NOT BE PERFORMED. BASED ON THE INFORMATION PROVIDED, THE ROOT CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED. THE REVIEW OF THE LHR (LOT F1405504) INDICATED THAT THE DEVICE LOT MET ALL ESTABLISHED PERFORMANCE CRITERIA PRIOR TO SHIPMENT.

    Description of Event or Problem · 1

    THE FOLLOWING INFORMATION WAS REPORTED TO ACI VIA USER FACILITY MEDWATCH REPORT # (B)(4): AN ELDERLY FEMALE WITH BILATERAL LOWER EXTREMITY FOOT WOUNDS AND REST PAIN UNDERWENT ULTRASOUND GUIDED RIGHT COMMON FEMORAL ACCESS, RIGHT LOWER EXTREMITY ARTERIOGRAM, POSTERIOR TIBIAL ATHERECTOMY WITH A 1.25 SOLID CROWN, BALLOON ANGIOPLASTY OF RIGHT PT WITH A 3 X 100 BALLOON, SFA ATHERECTOMY AND BALLOON ANGIOPLASTY WITH A 6 X 200 BALLOON FOR A RUTHERFORD CLASS 5 MINOR TISSUE LOSS OF THE RIGHT LOWER EXTREMITY. SHE DID WELL INTRAOPERATIVELY AND THE IMMEDIATE POSTOPERATIVE PERIOD, BUT THEN HAD PROBLEMS WITH INTERMITTENT HYPOTENSION THAT RESPONDED WELL TO FLUIDS. THERE WAS CONCERN THAT SHE HAD A RETROPERITONEAL BLEED AND BLOOD WAS ORDERED. SHE WAS TAKEN EMERGENTLY TO THE OPERATING ROOM FOR RETROPERITONEAL EXPLORATION AND IDENTIFICATION OF THE BLEEDING. THERE WAS A HOLE TO THE JUNCTION OF THE EXTERNAL AND COMMON FEMORAL ARTERY ON THE ANTERIOR PORTION OF THE ARTERY. THE MYNXGRIP DEVICE COLLAGEN HAD COME OFF COMPLETELY OFF THE HOLE AND THIS WAS LIKELY THE SOURCE OF THE BLEEDING. AROUND ROUGHLY A LITER AND A HALF OF BLOOD IN THE RETROPERITONEUM AND GIVEN THAT NO RHYTHM WAS OBTAINED, IT WAS DECIDED THAT FURTHER MANEUVERS WOULD LIKELY BE FUTILE, AND THE PATIENT WAS DECLARED DECEASED. ON (B)(6) 2014, THE ACI SALES REPRESENTATIVE REPORTED THAT THE PHYSICIAN'S ASSISTANT REPORTED THAT IN HIS OPINION THE MYNXGRIP (6F/7F) VASCULAR CLOSURE DEVICE HAD BEEN DEPLOYED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    385958 MYNXGRIP (6F/7F) VASCULAR CLOSURE DEVICE MGB MGB ACCESSCLOSURE, INC. MX6721 F1405504

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Death| L| R