BEUDAMED
    FDA Adverse Event Other Summary report: N

    ZENITH FENESTRATED AAA ENDOVASCULAR GRAFT PROXIMAL BODY

    MDR report key: 3810307 · Received April 22, 2014

    Report

    Report Number
    9680654-2014-00005
    Event Type
    Other
    Date Received
    April 22, 2014
    Date of Event
    March 14, 2014
    Report Date
    April 17, 2014
    Manufacturer
    WILLIAM A. COOK AUSTRALIA
    Product Code
    MIH
    PMA / PMN Number
    P020018
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE INFORMATION PROVIDED, THE ENDOLEAK WAS BETWEEN THE RENAL FENESTRATION OF THE FENESTRATED GRAFT AND THE COVERED RENAL STENT, REVIEW OF THE ORDER FORM FROM THE PHYSICIAN AND THE FENESTRATION LAYOUT DRAWING USED TO MANUFACTURE THE DEVICE CONFIRMS THAT THE GRAFT WAS MANUFACTURED ACCORDING TO SPECIFICATION. THE IFU DOES NOT SPECIFY WHAT SIZE VISCERAL STENTS SHOULD BE PLACED INTO THE FENESTRATIONS, AND ONLY STATES "INTRODUCE APPROPRIATELY SIZED BALLOON EXPANDABLE STENT AND ADVANCE TO THE OSTIUM OF THE FENESTRATION/VESSEL. ADVANCE STENT PARTIALLY INTO THE VESSEL, LEAVING APPROXIMATELY 4-5 MM OF STENT IN THE AORTA. INFLATE THE BALLOON TO FLARE THE INTRA-AORTIC SEGMENT OF THE STENT." THE IFU DOES STATE TO ENSURE THERE ARE NO ENDOLEAKS DURING FINAL ANGIOGRAM AND THAT ENDOLEAK IS A POTENTIAL ADVERSE EVENT. NO INFORMATION WAS RECEIVED ON THE COVERED RENAL STENT THAT WAS USED IN THE RENAL FENESTRATION WHERE THE LEAK WAS FOUND. THEREFORE, IT IS POSSIBLE THAT THE VISCERAL STENT WAS NOT ADEQUATELY SIZED/FLARED FOR THE 6 X 8MM SMALL FENESTRATION AND AN ADEQUATE SEAL WAS NOT ACHIEVED. AS IMAGING WAS NOT RECEIVED, AN EXACT ROOT CAUSE CANNOT BE DETERMINED. FROM THE INFORMATION PROVIDED, THERE IS NO EVIDENCE THAT A DEVICE NON-CONFORMITY OR DEFICIENCY CONTRIBUTED TO THE COMPLAINT. BETWEEN APRIL 1, 2009 AND APRIL 1, 2014, THERE HAVE BEEN (B)(4) REPORTS OF AN ENDOLEAK AT A FENESTRATION FOR ZFEN-P DEVICES. DURING THIS TIME, THERE HAVE BEEN (B)(4) ZFEN-P DEVICES SOLD. THEREFORE, THE OCCURRENCE RATE IS (B)(4). NO CORRECTIVE ACTION REQUIRED AS THERE IS NO EVIDENCE THAT THE DEVICE WAS NOT MANUFACTURED ACCORDING TO SPECIFICATION AND THERE IS NO EVIDENCE THAT A DEVICE NON-CONFORMITY OR DEFICIENCY CONTRIBUTED TO THE ENDOLEAK. THE MANUFACTURER WILL CONTINUE TO MONITOR FOR SIMILAR OCCURRENCES.

    Description of Event or Problem · 1

    PATIENT UNDERWENT EVAR WITH A ZENITH FENESTRATED ENDOVASCULAR GRAFT (PROXIMAL SEAL ABOVE THE RENALS). THE PATIENT ALSO RECEIVED ILIAC LIMB GRAFTS AND ONE COVERED RENAL STENT. THE MAXIMUM AORTIC DIAMETER WAS 56 MM, WITH AN INVERTED FUNNEL PROXIMAL NECK AND PARTIAL NECK PLAQUE/THROMBUS. THERE WERE NO DIFFICULTIES DEPLOYING ANY OF THE COMPONENTS. A MOLDING BALLOON WAS USED DURING THE STUDY PROCEDURE, BUT NO DETAILS OF WHERE IT WAS USED WERE PROVIDED. THE COMPLETION ANGIOGRAM SHOWED THAT THE DEVICES WERE PATENT WITH NO EVIDENCE OF EXTERNAL COMPRESSION, FLOW-LIMITING KINKS, OR THROMBUS. A TYPE III ENDOLEAK WAS PRESENT AT A GRAFT OVERLAP JOINT BETWEEN THE ZFEN-P AND THE COVERED RENAL STENT. THE TREATING PHYSICIANS AGREED NO ACTION WAS TO BE TAKEN REGARDING THE TYPE III ENDOLEAK; THE EXACT LOCATION OF THE LEAK COULD NOT BE DETERMINED AND IT WAS FELT IT WOULD RESOLVE WITH REVERSAL OF HEPARIN. THE PATIENT HAS BEEN DISCHARGED. NO ADVERSE OUTCOMES WERE REPORTED. NO INFORMATION HAS BEEN RECEIVED REGARDING THE PATIENT SINCE THE STUDY PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    244063 ZENITH FENESTRATED AAA ENDOVASCULAR GRAFT PROXIMAL BODY NONE MIH WILLIAM A. COOK AUSTRALIA AC932337

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR