BEUDAMED
    FDA Adverse Event Death Summary report: N

    ICAST COVERED STENT

    MDR report key: 3181362 · Received June 14, 2013

    Report

    Report Number
    1219977-2013-00079
    Event Type
    Death
    Date Received
    June 14, 2013
    Date of Event
    May 15, 2013
    Report Date
    May 15, 2013
    Manufacturer
    ATRIUM MEDICAL CORPORATION
    Product Code
    JCT
    PMA / PMN Number
    K050814
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    IN THE PROCESS OF EVALUATING THE EVENT AND OBTAINING ADDITIONAL INFORMATION IN ORDER TO ACCESS THE COMPLAINT. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION. THE PATIENT DIED PRESUMABLY DUE TO HYPOTENSION DUE TO RUPTURED VESSELS AND NOT OF ANY FAULT OF THE ICAST DEVICE.

    Description of Event or Problem · 1

    A COMPLEX FENESTRATION PROCEDURE WAS PERFORMED. AFTER PREP, FENESTRATION AND CUT DOWN, THE FIRST STENT GRAFT WAS DEPLOYED INTO THE THORACIC AORTA AND PICTURES WERE TAKEN. SOON AFTER THE DEPLOYMENT OF THE THORACIC GRAFT, THE PT'S BLOOD PRESSURE IMMEDIATELY DROPPED AND STAFF RUSHED TO STABILIZE PT. AFTER THE PT WAS STABILIZED, THE DOCTORS QUICKLY ADVANCED THE SECOND STENT GRAFT TO SEAL THE ENDO LEAK. ONCE THE SECOND STENT GRAFT WAS DEPLOYED, THE PHYSICIANS THEN ACCESSED THE STOMACH TO ALLOW THE LOST BLOOD TO BE DRAINED OUT. SEVERAL UNITS OF BLOOD WERE GIVEN AND PT WAS STABILIZED. AT THIS POINT, IT WAS UNKNOWN WHERE THE ENDO LEAK ORIGINATED, HOWEVER, PT WAS STABLE AND THEY CONTINUED WITH PROCEDURE. THE FIRST RENAL ARTERY WAS CANNULATED AND STENTED USING A 6X22X120 ICAST STENT. A 10X20MM PTA BALLOON WAS THEN USED TO FLARE THE ICAST INTO THE FENESTRATION. THE PHYSICIAN DID A RUN AND NOTICED THAT THE RENAL ARTERY HAD RUPTURED OR DISSECTED. THE PHYSICIAN DECIDED TO USE A 5X38X120 ICAST STENT TO FIX THE RUPTURE/DISSECTION. THE DEPLOYMENT OF THE 5X38 ICAST SUCCESSFULLY FIXED THE RUPTURE/DISSECTION. THE PHYSICIANS CONTINUED TO TRY AND ACCESS THE OTHER VISCERAL ARTERIES. AFTER SEVERAL FAILED ATTEMPTS TO ACCESS OTHER ARTERIES, THE PT AGAIN HAD A SIGNIFICANT DROP IN BLOOD PRESSURE AND ANESTHESIA RUSHED TO STABILIZE THE PT. AFTER MANY FAILED ATTEMPTS THE PT WAS PRONOUNCED DEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271320 ICAST COVERED STENT JCT ATRIUM MEDICAL CORPORATION 85453 10826186

    Patients

    Seq Age Sex Outcome Treatment
    1 Other PTA BALLOON - 10X20MM