BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WALLSTENT

    MDR report key: 1253121 · Received December 5, 2008

    Report

    Report Number
    2134265-2008-04611
    Event Type
    Injury
    Date Received
    December 5, 2008
    Report Date
    November 5, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    NIO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    SAME EVENT AS MFR REPORT #: 2134265-2008-04610. IT WAS REPORTED IN A JOURNAL ARTICLE FROM JOURNAL VASCULAR INTERVENTIONAL RADIOLOGY 2008; 19:1506-1508; "LATE TYPE III ENDOLEAK AND GRAFT FAILURE OF AN ANCURE STENT-GRAFT", THAT A FABRIC GRAFT EROSION OCCURRED DUE TO CONTACT WITH THE WALLSTENTS. AN ASYMPTOMATIC PATIENT WITH CHRONIC RENAL INSUFFICIENCY PRESENTED WITH AN INTERVAL 2CM ANEURYSM ENLARGEMENT WITH ACTIVE FLOW WITHIN THE ANEURYSM SAC. SIX YEARS EARLIER, THE PATIENT HAD ANOTHER MANUFACTURER'S ENDOGRAFT PLACED FOR A 5.7CM INFRARENAL AORTIC ANEURYSM. THIS OPERATION WAS COMPLICATED BY KINKING OF THE GRAFT LIMBS, WHICH REQUIRED THE PLACEMENT OF BILATERAL KISSING ILIAC WALLSTENTS. THREE YEARS LATER, SURVEILLANCE IMAGING REVEALED SAC ENLARGEMENT FROM A TYPE II ENDOLEAK, TREATED WITH A TRANSLUMBAR GLUE INJECTION. DURING THE REPORTED EVENT, CT SCAN SHOWED NO EVIDENCE OF RUPTURE OR RETROPERITONEAL HEMORRHAGE. AORTOGRAPHY REVEALED A LARGE TYPE III ENDOLEAK IN THE MID-PORTION OF THE ENDOGRAFT. THE MAIN BODY OF THE ENDOGRAFT WAS SHORTENED BY THE HIGH-RIDING WALLSTENTS, WHICH CAUSED THE CONTRALATERAL LIMB TO BECOME CONSTRAINED WITHIN THE IPSILATERAL LIMB. THE CONTRALATERAL GATE COULD NOT BE SUCCESSFULLY CANNULATED FROM THE CONTRALATERAL SIDE, AND AN AORTIC EXTENDER CUFF WAS PLACED TO CONVERT THE DEVICE TO AN AORTOUINI-ILIAC CONFIGURATION. A LEFT COMMON ILIAC PLUG WAS PLACED AND A RIGHT-TO-LEFT FEMORAL-TO-FEMORAL BYPASS WAS PERFORMED. FOLLOWING THE SURGERY AND CONFIRMED 12 MONTHS LATER, NO FLOW WAS DETECTED WITHIN THE SAC OR THE LEFT ILIAC ARTERY. THE GRAFT FABRIC EROSION LEADING TO THE ENDOLEAK WAS ATTRIBUTED TO THE WALLSTENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WALLSTENT NONE NIO BOSTON SCIENTIFIC

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Required Intervention GUIDANT ANCURE ENDOGRAFT