BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MYNX VASCULAR CLOSURE DEVICE

    MDR report key: 1051858 · Received May 21, 2008

    Report

    Report Number
    3004939290-2008-00037
    Event Type
    Injury
    Date Received
    May 21, 2008
    Date of Event
    April 20, 2008
    Report Date
    May 20, 2008
    Manufacturer
    ACCESSCLOSURE, INC.
    Product Code
    MGB
    PMA / PMN Number
    P040044
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR EVAL AND THE LOT NUMBER WAS NOT PROVIDED FOR LOT HISTORY REVIEW. BASED ON THE INFO PROVIDED AND INVESTIGATION PERFORMED, THE ROOT CAUSE OF THE OCCLUSION COULD NOT BE DETERMINED. GIVEN THAT THE MYNX DEVICE WAS REPORTEDLY USED WITHOUT COMPLICATION AND HEMOSTASIS ACHIEVED, THERE IS NO EVIDENCE TO SUGGEST THAT THE DEVICE DID NOT MEET SPECIFICATIONS OR PERFORM AS INTENDED PER IFU. PER THE MYNX IFU, THE SAFETY AND EFFECTIVENESS OF THE MYNX HAVE NOT BEEN ESTABLISHED IN PTS WITH CLINICALLY SIGNIFICANT PVD IN THE VICINITY OF THE PUNCTURE, OR IN PTS WITH ARTERIES LESS THAN 5MM IN THE AREA OF THE PUNCTURE SITE. THEREFORE, THESE WERE NOT PART OF THE APPROVED INDICATIONS, RATHER DEVIATIONS FROM THE IFU. SUBSEQUENT REVIEW OF THE CASE WAS PERFORMED BY AN OUTSIDE MEDICAL ADVISOR, WHICH STATED THAT DURING THE PROCEDURE IN 2008, THE MYNX DEVICE WAS POTENTIALLY DEPLOYED INADVERTENTLY INTRA-ARTERIAL INTO THE LEFT CFA. THIS PROBABLY CAUSED A PARTIAL OCCLUSION OF FLOW IN THE CFA AND THIS LEAD TO PROGRESSIVE ISCHEMIA OF THE FOOT OVER THE NEXT 4 DAYS. THE PT WAS INTERVENED ON FIVE DAYS LATER, AND SINCE ASPIRATION THROMBECTOMY WAS NOT SUCCESSFUL, AN OPERATIVE EMBOLECTOMY WAS PERFORMED WITH RESTORATION OF ADEQUATE INFLOW AND OUTFLOW (BASED ON ANGIOGRAPHY AND OPERATIVE REPORT FINDINGS). THE INCORRECT MYNX DEVICE DEPLOYMENT WAS THEREFORE RESPONSIBLE FOR A RETURN TO THE OR FOR AN OBSTRUCTION OF FLOW TO THE LEFT CFA AND THEREBY CAUSED ISCHEMIA TO THE LEFT FOOT. THE OPERATION WAS SUCCESSFUL AND BOTH INFLOW AND OUTFLOW WERE RE-ESTABLISHED AND THE PT'S VASCULAR STATUS APPEARED TO RETURN TO BASELINE, HOWEVER, IT IS DIFFICULT TO ASSESS THE DEGREE OF HEMODYNAMIC COMPROMISE THIS CAUSED TO THE DISTAL CIRCULATION. THE DECISION FOR SUBSEQUENT AMPUTATION WAS BASED ON INADEQUATE DISTAL LEG AND FOOT PERFUSION, AND THE SURGEON PROBABLY FELT FURTHER REVASCULARIZATION ATTEMPTS WOULD BE FUTILE DUE TO THE PT'S SEVERE DISTAL VESSEL PVD IN AN ALREADY COMPROMISED LIMB. THE MEDICAL ADVISOR BELIEVES THE COMPROMISED PERFUSION OF THE DISTAL LEG AND FOOT WAS NOT A DIRECT CAUSE OF THE INCORRECT MYNX DEPLOYMENT. THE INFLOW OF THE LEG WAS ADEQUATE AS IT HAS SUSTAINED FLOW TO ALLOW HEALING OF THE AMPUTATION SITE.

    Description of Event or Problem · 1

    A MALE WITH HISTORY OF CEREBROVASCULAR DISEASE, CVAX3, CAD STATUS POST CABG, SEVERE PERIPHERAL VASCULAR DISEASE, HYPERTENSION AND DIABETES (INSULIN-CONTROLLED), UNDERWENT PERIPHERAL INTERVENTION IN 2008. THE PT HAS A HISTORY OF BILATERAL CRITICAL ISCHEMIA, WITH MULTIPLE ANGIOPLASTIES OF THE LEFT CFA AND DISTAL VESSELS ON APPROX TWO AND A HALF MONTHS EARLIER, AND LEFT PARTIAL FOOT AMPUTATION ON THREE DAYS LATER, DUE TO GANGRENE. HE WAS ADMITTED ON THE FOLLOWING MONTH FOR REHABILITATION AND WOUND CARE (INCLUDING HYPERBARIC TREATMENT FOR NON-HEALING WOUND OF THE LEFT FOOT.) PHYSICAL EXAMINATION OF THE LEFT LOWER EXTREMITY NOTED VENOUS STASIS, ARTERIAL ISCHEMIC CHANGES AND LOWER EXTREMITY SCABBED AREAS CONSISTENT WITH ISCHEMIC ULCERS. DUE TO ISCHEMIC SYMPTOMS OF HIS RIGHT FOOT, THE PT SUBSEQUENTLY UNDERWENT AN UNCOMPLICATED PERIPHERAL INTERVENTION FOR RIGHT LEG CRITICAL LIMB ISCHEMIA VIA CONTRALATERAL APPROACH (ACCESS) OF THE LEFT COMMON FEMORAL ARTERY ON ORIGINAL DATE. SUCCESSFUL SFA ANGIOPLASTY AND STENT GRAFT PLACEMENT WAS PERFORMED ALONG WITH SUCCESSFUL PERONEAL, POSTERIOR TIBIAL AND TIBIAL PERONEAL TRUNK ANGIOPLASTIES. THE MYNX DEVICE WAS REPORTEDLY USED TO CLOSE THE LEFT CFA ACCESS SITE WITHOUT COMPLICATION AND THE PT WAS TRANSFERRED TO THE SKILLED NURSING FACILITY UNIT OF THE HOSPITAL IN STABLE CONDITION. THE PT REPORTEDLY HAD SEVERE DIFFUSE ATHERO-OCCLUSIVE DISEASE IN THE LEFT FEMORAL ARTERY, WITH SEGMENTS IN THE REGION OF THE PUNCTURE SITE BEING 3.9 AND 4.4 MM IN DIAMETER. FOUR DAYS LATER, ON FOUR DAYS LATER, IT WAS NOTED THAT THE PT'S LEFT FOOT WAS COLD, AND HE WAS STARTED ON HEPARIN DRIP. ON THE NEXT DAY, HE UNDERWENT BALLOON ANGIOPLASTY OF THE POPLITEAL AND SFA AND ASPIRATION THROMBECTOMY ON THE LEFT CFA, HOWEVER, ASPIRATION REPORTEDLY RETRIEVED ONLY SOME OF THE CLOT, AND THE PT WAS TRANSFERRED TO THE OPERATING ROOM WHERE SUCCESSFUL EMBOLECTOMY WAS PERFORMED IN THE CFA, SFA, AND PROFUNDA. THROMBUS AND WHAT WAS REPORTED TO BE MYNX SEALANT BY THE PHYSICIAN WAS ALSO RETRIEVED AT THE ARTERIOTOMY SITE, AND ADEQUATE INFLOW WAS NOTED POST PROCEDURE. THE PATHOLOGY REPORT DOCUMENTED "FRAGMENTS OF IRREGULARLY SHAPED PINK TAN FIBROVASCULAR SOFT TISSUE, FOREIGN MATERIAL, AND CLOTTED BLOOD." POST OPERATIVELY, THE PT WAS MONITORED AND FOUND TO HAVE A COOL LEFT FOOT ON THE FOLLOWING DAY. ON EXAM, HE HAD A PALPABLE FEMORAL AND POPLITEAL PULSE BUT LOST A DOPPLER SIGNAL TO THE LEFT ANKLE. THE PT WAS SUBSEQUENTLY TAKEN TO THE OPERATING ROOM FOR AN ABOVE KNEE AMPUTATION ON THE NEXT DAY, WHICH HE SUCCESSFULLY UNDERWENT, AND WAS TRANSFERRED TO THE SKILLED NURSING UNIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MYNX VASCULAR CLOSURE DEVICE MYNX VASCULAR CLOSURE DEVICE MGB ACCESSCLOSURE, INC. MX6700 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention ANTIBIOTICS| ASA| BACTRIM| CIPRO| ZETIA| AVODART| SIMVASTATIN| FLOMAX