BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PALMAZ XL STENT PER 40MM UNMOUNTED

    MDR report key: 943190 · Received April 10, 2007

    Report

    Report Number
    1016427-2007-00043
    Event Type
    Malfunction
    Date Received
    April 10, 2007
    Date of Event
    October 2, 2006
    Report Date
    March 15, 2007
    Manufacturer
    CORDIS CORPORATION
    Product Code
    FGE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    REPORT RECEIVED INDICATED THAT THE PALMAZ STENT WAS DEPLOYED, HOWEVER, DEVICE WAS UNABLE TO FULLY OPEN. THE PRODUCT WAS INSPECTED PRE USE WITHOUT ANY ABNORMALITIES SEEN. THE PATIENT'S ANATOMY WAS SMALL WITH CALCIFIED AND TORTUOUS ILIAC ARTERIES. THE PHYSICIAN HAD DIFFICULTY ADVANCING THE 18FR SHEATH THROUGH THE EXTERNAL ILIAC ARTERY, THEREFORE, A CONDUIT WAS PLACED ON THE PATIENT'S RIGHT SIDE. THERE WAS ALSO DIFFICULTY ADVANCING THE STENT DELIVERY SYSTEM (SDS) TO THE INTENDED SITE DUE TO PATIENT'S DIFFICULT ANATOMY. FOLLOWING PLACEMENT OF A GORE EXCLUDER AAA ENDOPROSTHESIS IN THE ABDOMINAL AORTA, A PROXIMAL TYPE I ENDOLEAK WAS NOTED. A PALMAZ BALLOON-EXPANDABLE STENT WAS DEPLOYED PROXIMALLY IN AN ATTEMPT TO RESOLVE THE PROXIMAL TYPE I ENDOLEAK, HOWEVER, THIS DEVICE WOULD NOT FULLY OPEN. IT WAS REPORTED THAT "A B-BRAUN Z-MED BALLOON WAS USED TO BALLOON THE STENT, HOWEVER, AS DESCRIBED "WATERMELON SEEDED" OFF THE BALLOON HEAD." CLARIFICATION OF THE "WATERMELON SEEDED" TERM USED WAS REQUESTED, HOWEVER, WAS NOT PROVIDED. IT WAS REPORTED, HOWEVER, THAT THERE WAS NO STENT MOVEMENT AND STENT WAS PLACED IN THE INTENDED SITE. THE DEVICE HAD DIFFICULTY ACHIEVING SUFFICIENT WALL APPOSITION DUE TO TORTUOUS PATIENT ANATOMY. THROUGH VARIED TECHNIQUES OF INSERTION AND INFLATION OF SEVERAL BALLOONS, THE DEVICE-ACHIEVED FIXATION AGAINST THE AORTIC WALL, RESOLVING THE ENDOLEAK. IT IS NOT KNOWN AT WHAT ATMOSPHERES WAS THE BALLOON INFLATED TO DEPLOY THE STENT. IT WAS ALSO INDICATED THAT PATIENT EXPIRED THE NEXT DAY. THE OFFICIAL CAUSE OF DEATH WASMESENTERIC ISCHEMIA. THE CAUSE OF THE MESENTERIC ISCHEMIA WAS UNK. THIS EVENT WAS REPORTED TO THE FDA BY W.L. GORE AND ASSOCIATES, INC UNDER MDR# 2953161-2006-00098.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PALMAZ XL STENT PER 40MM UNMOUNTED ENDOVASCULAR SDS/STENTS (FGE) FGE CORDIS CORPORATION NA N1004301

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR 18FR SHEATH| B-BRAUN Z-MED BALLOON