BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POWERLINK SYSTEM

    MDR report key: 3852005 · Received June 5, 2014

    Report

    Report Number
    2031527-2014-00178
    Event Type
    Injury
    Date Received
    June 5, 2014
    Date of Event
    May 15, 2014
    Report Date
    May 15, 2014
    Manufacturer
    ENDOLOGIX, INC.
    Product Code
    MIH
    PMA / PMN Number
    P040002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    BASED UPON THE INVESTIGATION FINDINGS, THE REPORTED EVENT THAT DESCRIBED AN ANEURYSM ABOVE THE BIFURCATED DEVICE IS INCONCLUSIVE BASED ON THE CLINICAL ASSESSMENT IMAGE REVIEW. THE CASE RECORDS AND IMAGES WERE REVIEWED BY A CLINICAL COMPLAINT SPECIALIST WITH THE FOLLOWING CONCLUSION: PRODUCT USE MIGHT HAVE BEEN INCONGRUENT WITH THE IFU AND SIZING RECOMMENDATIONS DUE TO: THE CUFF AND MAIN BODY WERE THE SAME DIAMETER; THE NECK WAS >15 MM WITH THROMBUS SEEN AT THE INFRA AND SUPRA RENAL AORTA; MURAL THROMBUS; THE PRESENCE OF RENAL INSUFFICIENCY, AND THE INABILITY TO TOLERATE CONTRASTED EXAMS. THESE FINDINGS MIGHT HAVE CONTRIBUTED TO THIS EVENT. GIVEN THE LONGEVITY OF THE DEVICE, NEGATIVE AORTIC REMODELING MIGHT HAVE CONTRIBUTED TO THIS EVENT. THE RENAL STENTS WERE NOTED TO BE PROTRUDING INTO THE AORTA, WHICH MIGHT HAVE CONTRIBUTED TO THE STENT MIGRATION. THERE WAS AN UNREPORTED COMPLICATION OF A LEFT FEMORAL ARTERY THROMBUS, AND SECONDARY PROCEDURE FIVE DAYS POST INDEX PROCEDURE. THERE MIGHT HAVE BEEN EVIDENCE TO SUPPORT A STENT MIGRATION POST PROCEDURE, AN ENDOLEAK 1A AND A COMPLICATION OF A PSEUDOANEURYSM AND THE SECONDARY PROCEDURE. ADDITIONALLY, THERE MIGHT HAVE BEEN EVIDENCE TO SUPPORT AN ENDOLEAK 3A AND/OR 3B, DUE TO THE CONTRAST JET SEEN 27 MM BELOW THE MARGIN, ALONG WITH A STENT COLLAPSE (>50%) AND A VERTICAL SEPARATION OF THE STENTS. 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 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. BASED UPON THE INVESTIGATION FINDINGS, A ROOT CAUSE FOR THE REPORTED ANEURYSM ABOVE THE IMPLANTED STENT DEVICES MAY HAVE BEEN RELATED TO USE OF THE DEVICES OUTSIDE IFU GUIDELINES OR MAY HAVE BEEN THE RESULT OF NEGATIVE AORTIC REMODELING, OVER TIME. THERE WAS NO DEVICE ISSUE REPORTED.

    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 REMAINS IMPLANTED IN PATIENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT APPROXIMATELY 48 MONTHS POST IMPLANT OF A BIFURCATED DEVICE AN INFRARENAL AORTIC EXTENSION THE PATIENT PRESENTED WITH A 3CM ANEURYSM AT THE TOP OF THE GRAFT. REPORTEDLY, THERE WAS NO LEAK, BUT THERE WAS A PSEUDOANEURYSM AT THE TOP OF THE ORIGINAL EXTENSION. THE PHYSICIAN ELECTED TO TREAT THE PATIENT WITH TWO AORTIC EXTENSIONS. THE PATIENT TOLERATED THE PROCEDURE WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    329136 POWERLINK SYSTEM INFRARENAL PROXIMAL EXTENSION STENT GRAFT MIH ENDOLOGIX, INC. 28-28-75L W10-0370-020

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention