BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POWERLINK SYSTEM

    MDR report key: 4110619 · Received September 23, 2014

    Report

    Report Number
    2031527-2014-00285
    Event Type
    Injury
    Date Received
    September 23, 2014
    Date of Event
    September 10, 2014
    Report Date
    September 10, 2014
    Manufacturer
    ENDOLOGIX, INC.
    Product Code
    MIH
    PMA / PMN Number
    P040002
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ENDOLOGIX CONTINUES TO INVESTIGATE THE REPORTED EVENT. ENDOLOGIX WILL SUBMIT A SUPPLEMENTAL REPORT IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE. DEVICE WAS DISCARDED AT FACILITY.

    Additional Manufacturer Narrative · 1

    BASED UPON THE INVESTIGATION FINDINGS, THE REPORTED ENDOLEAK HAS BEEN CONFIRMED. THE EXPLANTS WERE NOT RETURNED FOR EVALUATION. CAUTIONARY PRODUCT USE CONDITIONS THAT MIGHT HAVE CONTRIBUTED TO THIS COMPLICATION WERE: MODERATE/SEVERE CALCIFICATIONS AT THE AORTIC NECK, BIFURCATION, AND BILATERAL ILIACS; THE LONG TERM USE OF ANTIPLATELET AND ANTICOAGULATION THERAPY; MORBID OBESITY; AND, CHRONIC RENAL DISEASE, AND THE PATIENT'S INABILITY TO TOLERATE CONTRASTED SURVEILLANCE (DELAY IN DIAGNOSIS). GIVEN THE PATIENT'S MEDICAL HISTORY AND THE LONGEVITY OF THE DEVICE, AORTIC REMODELING AND/OR DISEASE PROGRESSION MIGHT HAVE CONTRIBUTED TO THIS COMPLAINT. NOTABLY, THE PATIENT REFUSED TO BE TREATED FOR AN ENDOLEAK AT 55 MONTHS POST IMPLANT, WHEN THEY URGENTLY PRESENTED FOR UNRESOLVED BACK PAIN, BUT BEFORE THE DIAGNOSTIC ANGIOGRAM. THERE WAS A CONFIRMED, RAPIDLY EXPANDING SAC THREE MONTHS PRIOR TO THE CONVERSION. THE BURDEN OF THE EXTRA STENTS WITHIN THE PROXIMAL SYSTEM MIGHT HAVE CHANGED THE INTEGRITY OF THE SYSTEM AND MOST LIKELY WAS THE CAUSE OF THE STENT COLLAPSE AND THE CONFIRMED TYPE IIIB ENDOLEAK. THE INTEGRITY OF THE SYSTEM MIGHT HAVE BEEN CHANGE BY THE DIAGNOSTIC INSTRUMENTATION THREE MONTHS PRIOR, AND/OR THE PRESENCE OF A COMPETITOR'S STENT AND MODERATELY SEVERE CALCIFICATIONS WITHIN THE LEFT ILIAC PORTION OF THE BIFURCATED STENT. A MANUFACTURING RECORD REVIEW WAS PERFORMED, THE LOT MET ALL RELEASE CRITERIA WITH NO RELATED ISSUES OR DEVIATIONS THAT WOULD EXPLAIN THE REPORTED EVENT. THE LOT USAGE HISTORY SHOWED THAT ALL UNITS WERE CONSUMED AND NO OTHER UNITS WERE INVOLVED IN ANY SIMILAR EVENT. THE PRODUCT LABELING WAS REVIEWED AND CONFIRMED THAT THE REPORTED EVENT IS ADEQUATELY CAPTURED IN THE EXISTING LABELING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT APPROXIMATELY 58 MONTHS POST-IMPLANT OF A BIFURCATED DEVICE, TWO INFRARENAL AND ONE SUPRARENAL AORTIC EXTENSIONS, A CT SCAN REVEALED AN ENDOLEAK. THE PHYSICIAN WAS UNCERTAIN OF THE TYPE, BUT FELT IT MIGHT HAVE BEEN COMING FROM THE BIFURCATED DEVICE. REPORTEDLY, THE ANEURYSM SAC HAD ENLARGED. THE PHYSICIAN ELECTED TO BRING THE PATIENT BACK AND EXPLANTED THE DEVICES. UPON REMOVAL OF THE EXPLANTED DEVICES, TWO PERFORATIONS WERE NOTED IN THE BIFURCATED DEVICE, ONE IN THE MID MAIN BODY AND ONE LOWER BUT ABOVE THE SUTURE LINE AT THE BIFURCATION. THE PATIENT TOLERATED THE PROCEDURE WELL AND WAS DISCHARGED TO REHAB IN GOOD CONDITION. NOTE: THE PATIENT HAD BEEN LOST FOR FOLLOW UP FOR SOME TIME PRIOR TO THE LAST VISIT WHERE THE ENDOLEAK WAS FOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    590582 POWERLINK SYSTEM INFRARENAL BIFURCATED STENT GRAFT MIH ENDOLOGIX, INC. 28-16-140BL W09-2056-014

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention