BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MYNX VASCULAR CLOSURE DEVICE

    MDR report key: 1895119 · Received November 10, 2010

    Report

    Report Number
    3004939290-2010-00122
    Event Type
    Injury
    Date Received
    November 10, 2010
    Date of Event
    October 13, 2010
    Report Date
    October 13, 2010
    Manufacturer
    ACCESSCLOSURE, INC.
    Product Code
    MGB
    PMA / PMN Number
    P040044
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    RADIOLOGIC TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED; ONLY THE SURGICALLY REMOVED SUBSTANCE IN A PLASTIC CAPPED CONTAINER. THE SPECIMEN WAS CONSERVED IN FORMALDEHYDE. IT CONSISTED OF SURGICAL GAUZE WITH APPROXIMATELY 10 PIECES (1-20MM SIZES) OF SPECIMEN. THE INDIVIDUAL SPECIMENS ARE AMORPHOUS CONVOLUTED BROWN-BLACK BODIES WITH SMOOTH SURFACE, AND RELATIVELY HOMOGENEOUS IN COLOR. ONE VERY SMALL SEGMENT OF THE RETURNED MATERIAL HAD A POROUS APPEARANCE UNDER HIGH MAGNIFICATION. WITH THE EXISTING MEANS OF MICROSCOPY, THE CHEMICAL/BIOLOGICAL NATURE OF THE SPECIMENS COULD NOT BE CONCLUSIVELY DETERMINED. BASED ON THE INFORMATION PROVIDED AND THE INVESTIGATION PERFORMED, THE ROOT CAUSE OF THE REPORTED SEALANT MISDEPLOYMENT COULD NOT BE CONCLUSIVELY DETERMINED. THE REVIEW OF THE LHR (LOT F1022905) INDICATED THAT THE MYNX DEVICE MET ALL ESTABLISHED PERFORMANCE CRITERIA PRIOR TO SHIPMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO THE ACI SALES PROFESSIONAL THAT A (B)(6) MALE, WITH A HISTORY OF HYPERTENSION, PERIPHERAL VASCULAR DISEASE, AND CORONARY ARTERY DISEASE UNDERWENT A PERIPHERAL INTERVENTION (ILIAC STENT) PROCEDURE ON (B)(6) 2010. A 6F SHEATH WAS USED TO ACCESS THE LEFT CFA. PERI-PROCEDURAL MEDS INCLUDED HEPARIN. POST-PROCEDURE, THE FEM ANGIO SHOWED NORMAL VESSEL SIZE AND GOOD STICK LOCATION. NO 50/50 CONTRAST WAS USED TO PREP THE BALLOON. A REGISTERED RADIOLOGY TECH, TRAINED TO THE MYNX PROCEDURE, PROCEEDED TO DEPLOY THE MYNX DEVICE PER IFU. HOWEVER, UPON DEVICE REMOVAL, PULSATILE BLOOD FLOW WAS OBSERVED THROUGH THE ADVANCER TUBE. THE TECHNICIAN APPLIED ADDITIONAL MANUAL COMPRESSION FOR 5-10 MINUTES. HEMOSTASIS WAS REPORTEDLY ACHIEVED. LATER THAT EVENING THE PATIENT NOTED TINGLING IN HIS LEFT FOOT. THE NEXT DAY THE PATIENT HAD ISCHEMIC SYMPTOMS IN HIS LEFT CALF AND THIGH. A FEMORAL ANGIOGRAM SHOWED A CLOT IN THE LEFT POPLITEAL. ASPIRATION TECHNIQUE WAS ATTEMPTED USING A 5F GUIDE CATH AND SOME THROMBUS WAS REMOVED. STENTING TO THE ANTERIOR TIBIAL ARTERY (ATA) WAS PERFORMED AND ADEQUATE FLOW TO THE DISTAL LEG WAS RESTORED. HOWEVER, THE POST-ASPIRATION ANGIOGRAM STILL SHOWED THROMBUS IN THE POPLITEAL AND THE PATIENT WAS PUT ON TPA TRANSFUSION OVERNIGHT. THE NEXT DAY ((B)(6) 2010) ANOTHER ANGIOGRAM WAS TAKEN WHICH SHOWED THAT THE THROMBUS REMAINED. A VASCULAR SURGEON WAS CONSULTED WHO PROCEEDED TO SURGICALLY REMOVE A "FOAM LIKE" MATERIAL BELIEVED TO BE SEALANT AND THROMBUS. HOWEVER, IT WAS REPORTED THAT THE THROMBUS REFORMED ALMOST IMMEDIATELY. THE SURGEON ATTEMPTED TO SURGICALLY REMOVE IT A SECOND TIME AND WAS ABLE TO REMOVE THE THROMBUS SUCCESSFULLY. THE REMOVED SUBSTANCE AND THROMBUS WAS NOT SENT TO THE PATH LAB. THE PATIENT REMAINS HOSPITALIZED. ON 10/19/10, RECEIVED ADDITIONAL INFORMATION FROM ACI SALES REP REPORTING THAT PATIENT IS SCHEDULED TO HAVE HIS LEG AMPUTATED ON (B)(6) 2010. ON 10/26/10, THE ACI SALES PROFESSIONAL CONFIRMED WITH THE PHYSICIAN THAT THE PATIENT DID UNDERGO AN AMPUTATION (EXACT DATE UNKNOWN) AND WAS TRANSFERRED TO ANOTHER HOSPITAL TO TREAT THE STROKE/CEREBRAL HEMORRHAGE. THE PHYSICIAN REPORTED THAT THE PATIENT IS DOING WELL AND IS IMPROVING. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MYNX VASCULAR CLOSURE DEVICE MGB MGB ACCESSCLOSURE, INC. MX6700 F1022905

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention| S PERI-PROCEDURAL HEPARIN