BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXOSEAL VASCULAR CLOSURE DEVICE (VCD)

    MDR report key: 2213073 · Received August 16, 2011

    Report

    Report Number
    9616099-2011-00646
    Event Type
    Injury
    Date Received
    August 16, 2011
    Date of Event
    July 14, 2011
    Report Date
    July 19, 2011
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    MGB
    PMA / PMN Number
    P100013
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION RECEIVED FROM AN ACCOUNT INDICATED THAT AFTER USE OF THE EXOSEAL THE PLUG WAS FOUND TO BE INTRAVASCULAR AND HAD ALSO EMBOLIZED DISTAL TO THE ACCESS SITE. THE INDICATION FOR THE PROCEDURE WAS DUE TO A RESTENOSIS OF A NON-STENTED SEGMENT OF THE SFA. AN ANTEGRADE APPROACH WAS USED. THE PATIENT HAD A PROCEDURE DONE TO TREAT A LESION IN THE SUPERFICIAL FEMORAL ARTERY. THE 7F CSI WAS PUSHED A LITTLE MORE INTO THE STENTED SEGMENT TO HAVE A STABLE ACCESS DURING EXOSEAL INSERTION. THE DOCTOR THOUGHT THAT BECAUSE OF THE STENT DESIGN WITH WOVEN, CLOSED CELLS, THIS WOULDN'T BE AN ISSUE. THE CSI WAS PULLED BACK AND THE PULSATILE BLEED BACK WAS SEEN. THE CSI WAS LOCKED TO THE COWLING WITH AUDIBLE CLICK AND THEN CSI AND EXOSEAL WERE PULLED BACK. AFTER A WHILE, THE PULSATILE BLEED BACK STOPPED COMPLETELY AND IN THE SAME MOMENT, THE INDICATOR WINDOW CHANGED TO BLACK/BLACK. DURING THE RETRACTION OF THE SYSTEM THE WINDOW WASN'T FLICKERING, IT WAS ALWAYS ON WHITE/BLACK. THE DOCTOR DECIDED TO DEPLOY THE PLUG ANYWAY AND PRESSED THE RELEASE BUTTON. HE HELD THE SYSTEM IN PLACE FOR 2 SECONDS AND THEN HE REMOVED EXOSEAL AND THE CSI AT THE SAME TIME. THEN HE MADE A MANUAL COMPRESSION FOR ABOUT 5 MINUTES AND AFTER THAT, HE COULDN'T SEE ANY BLEEDING AND SO THE CASE WAS DONE FOR HIM. THE PATIENT RECEIVED A LIGHT COMPRESSION BANDAGE AS THE HOSPITAL PROTOCOL RECOMMENDS. AFTER THAT THE DOCTOR TRIED TO FEEL THE FEET PULSES BUT COULDN'T FIND ANY. SO HE DECIDED TO MAKE A DUPLEX. THE DUPLEX SHOWED PATENT VESSELS AND SO THE PATIENT WAS SENT TO HIS ROOM. THE DAY AFTER ((B)(6) 2011) THE PATIENT CAME BACK FOR A DUPLEX AS RECOMMENDED BY THE HOSPITAL PROTOCOL AND ON THIS DUPLEX THE DOCTOR COULD SEE, THAT THE LEFT POPLITEAL ARTERY WAS OCCLUDED. THE DECISION WAS TO REDO AN INTERVENTION AFTER 5 DAYS. FIVE DAYS POST INDEX, ANGIOGRAPHY WAS PERFORMED AND THERE WAS SOMETHING HANGING ON THE STENT. THE PHYSICIAN ATTEMPTED TO PASS WITH A DIAGNOSTIC CATHETER, HOWEVER, WAS NOT ABLE TO. THE PHYSICIAN WAS ABLE TO PASS WITH A BALLOON AND DISLODGED PARTICLE, WHICH WENT FURTHER DISTALLY. THE PHYSICIAN WAS ABLE TO PLACE A STENT OVER THIS PARTICLE. FINAL ANGIO CONTROL STILL SHOWED IRREGULARITIES, THE DOCTOR THOUGHT THAT IF THIS WAS THE PLUG, IT WOULD DISSOLVE WITH TIME AND SO HE CONCLUDED THE PROCEDURE. THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. REVIEW OF THIS LOT REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. NO OTHER ISSUES WERE NOTED THAT WERE CONSIDERED POTENTIALLY RELATED TO THE REPORTED COMPLAINT. LOWER ARTERIAL EMBOLI ARE A LISTED AS A POTENTIAL RISK ASSOCIATED WITH THE USE OF THE EXOSEAL. THE IFU CAUTIONS AGAINST THE USE OF THIS DEVICE IN THE AREA OF A STENTED SEGMENT, AND THAT IF PROPER INDICATION ISN'T OBSERVED IN THE INDICATOR WINDOW TO ABORT THE PROCEDURE AND USE MANUAL COMPRESSION. REVIEW OF THE INFORMATION PROVIDED SUGGESTS THAT PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THE REPORTED EVENTS.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WILL BE SUBMITTED UPON 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    THE PATIENT HAD A PROCEDURE DONE TO TREAT A LESION IN THE SUPERFICIAL FEMORAL ARTERY. THE PHYSICIAN USED A 7F EXOSEAL TO SEAL THE PUNCTURE SITE. DURING RETRACTION THE DISTAL WIRE GOT CAUGHT AND THE PHYSICIAN CONTINUED TO RETRACT A LITTLE MORE, THEN THE WINDOW WAS BLACK/WHITE SO HE CONTINUED WITH THE DEPLOYMENT STEPS. SUDDENLY BLOOD FLOW STOPPED AND THE WINDOW CHANGED FROM BLACK/WHITE TO BLACK/BLACK. THE PHYSICIAN RETRIEVED THE SHEATH AND THE EXOSEAL AND DID MANUAL COMPRESSION FOR 5 MINUTES. THE PATIENT WAS CONTROLLED WITH DUPPLEX. THE STENT WAS PERFUSED AND AT THE LEVEL OF TRIFURCATION, BLOOD FLOW WAS GOOD, AS WELL AS IN THE LOWER ARTERIES. THE NEXT DAY A DUPPLEX CONTROL WAS DONE AND AT THE LEVEL OF THE STENT THERE WERE SOME ABNORMALITIES. FIVE DAYS POST INDEX, ANGIOGRAPHY WAS PERFORMED AND THERE WAS SOMETHING HANGING ON THE STENT. THE PHYSICIAN ATTEMPTED TO PASS WITH A DIAGNOSTIC CATHETER, HOWEVER WAS NOT ABLE TO. THE PHYSICIAN WAS ABLE TO PASS WITH A BALLOON AND DISLODGED PARTICLE, WHICH WENT FURTHER DISTAL. THE PHYSICIAN WAS ABLE TO PLACE A STENT OVER THIS PARTICLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention