BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXOSEAL VASCULAR CLOSURE DEVICE (VCD)

    MDR report key: 3102991 · Received May 9, 2013

    Report

    Report Number
    9616099-2013-00282
    Event Type
    Injury
    Date Received
    May 9, 2013
    Date of Event
    April 12, 2013
    Report Date
    April 15, 2013
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    MGB
    PMA / PMN Number
    P100013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SIX HOURS AFTER USE OF AN EXOSEAL FOR VASCULAR CLOSURE, IT WAS NOTED THAT THE PATIENT¿S LEG BECAME ISCHEMIC, COLD LEG AND BLUE FOOT. THE PATIENT IS A (B)(6) FEMALE WITH A LIVER TUMOR. THE PHYSICIAN (IR) USED TERUMO AZUR COILS TO EMBOLIZE THE TUMOR, IN THE EARLY AFTERNOON. THE 5FR EXOSEAL WAS DEPLOYED, THREE MINUTES OF LIGHT PRESSURE WAS HELD, AND THE ARTERY WAS SUCCESSFULLY CLOSED. APPROXIMATELY SIX HOURS POST PROCEDURE THE PATIENT¿S LEG BECAME ISCHEMIC. THE PATIENT WAS TAKEN INTO THE OPERATING ROOM AND THE PHYSICIAN FORMED A CUT DOWN ON THE COMMON FEMORAL. THROMBECTOMY OF THE SUPERFICIAL FEMORAL ARTERY (SFA) USING A FORGARTY BALLOON WAS CONDUCTED. AS THE PHYSICIAN PULLED OUT THE BALLOON, HE FOUND SOMETHING WHITE AND STRINGY IN THE SFA. THE INITIAL REACTION WAS THAT THE WHITE AND STRINGY MATERIAL WAS THE EXOSEAL PLUG. THE PHYSICIAN SENT MATERIAL TO THE PATHOLOGY LAB FOR INVESTIGATION. THE PHYSICIAN ALSO OBSERVED THAT ALL THREE TIBIAL VESSELS WERE FULL OF CLOT. THE PHYSICIAN USED THE ANGIOJET TO REMOVE CLOT FROM THE TIBIAL VESSELS. THE PHYSICIAN WAS ABLE TO OPEN TWO TIBIAL VESSELS. THE NEXT DAY THE ANTERIOR TIBIAL WAS CLOSED AGAIN, LEAVING ONLY THE POSTERIOR TIBIAL TO FILL THE FOOT. IT WAS NOTED THAT THERE WAS ALSO THROMBUS FOUND IN THE PATIENT¿S ABDOMEN AND ALSO THE OTHER LEG. RESULTS OF THE PATHOLOGY REPORT CONDUCTED TO THE SAMPLE EXTRACTED FROM THE SFA INDICATED THAT THE SAMPLE CONTAINED ONLY THROMBUS. AS PER THE REPORTER, THERE IS NO EVIDENCE THAT THE EXOSEAL CAUSED THIS PATIENT¿S BLOOD FLOW OCCLUSION IN THE LEG. THE CAUSE OF THIS PATIENT¿S THROMBUS FORMATION IN BOTH LEGS AND ABDOMEN IS CURRENTLY BEING INVESTIGATED BY THE PHYSICIAN. THE REPORTER INDICATED THAT THE PHYSICIAN HAS USED EXOSEAL EVERY DAY FOR THE PAST EIGHTEEN MONTHS AND IS VERY SKILLED IN USING THE DEVICE. THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND SHOWED THAT THESE LOTS OF PRODUCTS MET ALL REQUIREMENTS PER THE APPLICABLE MANUFACTURING QUALITY PLAN. BASED ON THE INFORMATION PROVIDED, THERE ARE POSSIBLE PATIENT FACTORS (MULTIPLE LOCATIONS OF THROMBUS FORMATION WITH UNKNOWN CAUSE) THAT MAY HAVE CONTRIBUTED TO THE EVENT REPORTED. BASED ON THE PATHOLOGY REPORT RESULTS, THERE IS NO EVIDENCE TO SUGGEST THAT THE LEG ISCHEMIA EXPERIENCED POST PROCEDURE IS RELATED TO THE EXOSEAL DEVICE. NEITHER THE DHR NOR THE INFORMATION AVAILABLE FOR REVIEW INDICATE THAT THERE IS A DESIGN OR MANUFACTURING RELATED ISSUE, THEREFORE NO CORRECTIVE ACTION IS REQUIRED.

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS NOT AVAILABLE FOR EVALUATION AND TESTING. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    AFTER USE OF AN EXOSEAL IT WAS NOTED THAT SIX HOURS AFTER THE INTERVENTION, THE PATIENT'S LEG BECAME ISCHEMIC, WITH A COLD LEG AND BLUE FOOT. THE PATIENT IS A (B)(6) FEMALE WITH A LIVER TUMOR. THE PHYSICIAN (IR) USED TERUMO AZUR COILS TO EMBOLIZE THE TUMOR, IN THE EARLY AFTERNOON. THE 5FR EXOSEAL WAS DEPLOYED, THREE MINUTES OF LIGHT PRESSURE WAS HELD, AND THE ARTERY WAS SUCCESSFULLY CLOSED. APPROXIMATELY SIX HOURS POST PROCEDURE THE PATIENT'S LEG BECAME ISCHEMIC. THE PATIENT WAS TAKEN INTO THE OPERATING ROOM AND THE PHYSICIAN FORMED A CUT DOWN ON THE COMMON FEMORAL, AND DID MANUAL THROMBECTOMY OF THE SUPERFICIAL FEMORAL ARTERY (SFA) USING A FORGARTY BALLOON. AS THE PHYSICIAN PULLED OUT THE BALLOON, HE FOUND SOMETHING WHITE AND STRINGY IN THE SFA. THE INITIAL REACTION WAS THAT THE WHITE AND STRINGY MATERIAL WAS THE EXOSEAL PLUG. THE PHYSICIAN SENT MATERIAL TO THE PATHOLOGY LAB FOR INVESTIGATION. THE PHYSICIAN ALSO OBSERVED THAT ALL THREE TIBIAL VESSELS WERE FULL OF CLOT. THE PHYSICIAN USED THE ANGIOJET TO TRY TO REMOVE CLOT FROM THE TIBIAL VESSELS. THE PHYSICIAN WAS ABLE TO OPEN TWO TIBIAL VESSELS. THE NEXT DAY THE ANTERIOR TIBIAL WAS CLOSED AGAIN, LEAVING ONLY THE POSTERIOR TIBIAL TO FILL THE FOOT. ADDITIONAL INFORMATION WAS RECEIVED AND NOTED THAT THE PATHOLOGY REPORT SHOWED THAT WHAT WAS REMOVED FROM THE PATIENTS SFA WAS ONLY THROMBUS. AS PER THE CONTACT, THERE IS NO EVIDENCE THAT THE EXOSEAL CAUSED THIS PROBLEM AT ALL. IT WAS NOTED THAT THERE WAS ALSO THROMBUS FOUND IN THE PATIENT'S ABDOMEN AND OTHER LEG WHICH WAS INTERVENED ON. THE CAUSE OF THE PATIENT SHOOTING EMBOLI IS UNKNOWN BUT THE EXOSEAL HAS BEEN RULED OUT IN THIS CASE. PHYSICIAN HAS USED EXOSEAL EVERY DAY FOR THE PAST EIGHTEEN MONTHS AND IS VERY SKILLED IN USING THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204246 EXOSEAL VASCULAR CLOSURE DEVICE (VCD) VASCULAR CLOSURE DEVICE MGB CORDIS DE MEXICO NA 15806795

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Hospitalization| L| R TERUMO AZUR COILS