BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POWERLINK SYSTEM

    MDR report key: 4090727 · Received September 15, 2014

    Report

    Report Number
    2031527-2014-00275
    Event Type
    Injury
    Date Received
    September 15, 2014
    Date of Event
    June 18, 2013
    Report Date
    August 27, 2014
    Manufacturer
    ENDOLOGIX, INC.
    Product Code
    MIH
    PMA / PMN Number
    P040002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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 REMAINS IMPLANTED IN PATIENT.

    Additional Manufacturer Narrative · 1

    THE DEVICE REMAINS IMPLANTED IN THE PATIENT AND IS THEREFORE, NOT AVAILABLE FOR ANALYSIS. COMPUTED TOMOGRAPHY IMAGING AND ANGIOGRAM WERE PROVIDED AND REVIEWED BY AN INTERNAL CLINICAL REPRESENTATIVE WITH THE FOLLOWING IMPRESSION: THERE WAS NO MEDICAL DOCUMENTATION AND SUBOPTIMAL IMAGING STUDIES AVAILABLE FOR THIS REVIEW. PRODUCT APPROPRIATENESS AND PATIENT CANDIDACY COULD NOT BE FULLY ASSESSED. BASED ON THE SIZING SHEET, PRODUCT USE WAS CONGRUENT WITH THE IFU. THE NON-CONTRAST CT DEMONSTRATED AN INTERVAL SAC INCREASE WITH A NOTABLE DISRUPTION OF THE CALCIFICATIONS SEEN ON THE RIGHT POSTERIOR ANEURYSM SAC. THERE WAS CALCIFICATION NOTED IN THE BIFURCATED MID-BODY NEAR THE SITE OF THE CONFIRMED ENDOLEAK TYPE IIIB (BY ANGIOGRAPHY). THERE WAS SUBSTANTIAL EVIDENCE OF: AN ENDOLEAK TYPE IIIB AT 43 MONTHS POST INDEX. AT 29 MONTHS POST INDEX, THERE MIGHT HAVE BEEN A SMALL ENDOLEAK TYPE IIIB VERSES A PARTIAL STENT COLLAPSE (AND FABRIC BILLOWING). THE SECONDARY PROCEDURE, A COMPETITOR'S STENT RELINING, WAS REPORTED TO BE SUCCESSFUL WITH NO NEGATIVE PATIENT SEQUELA; DUE TO LACK OF INFORMATION, THIS REPORT COULD NOT BE SUBSTANTIATED. 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. ALTHOUGH AN EXACT ROOT CAUSE COULD NOT BE CONCLUSIVELY DETERMINED BASED UPON AVAILABLE INFORMATION, THE CALCIUM NEAR THE ENDOLEAK COULD HAVE CONTRIBUTED TO THE STENT GRAFT DAMAGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT APPROXIMATELY 14.3 MONTH POST IMPLANT OF A BIFURCATED DEVICE, AN ENDOLEAK WITH NO ANEURYSM EXPANSION WAS OBSERVED DURING REGULAR EXAMINATION. THE PHYSICIAN ELECTED TO MONITOR THE PATIENT. TWELVE MONTHS LATER, A CT SCAN ((B)(6) 2014) SHOWED AN ENDOLEAK WITH ANEURYSM EXPANSION. THE TYPE OF ENDOLEAK WAS UNABLE TO BE DETERMINED. APPROXIMATELY A MONTH LATER ((B)(6) 2014), CATHETER ANGIOGRAPHY SHOWED A LEAK COMING FROM THE STENT GRAFT TO THE ANEURYSM. THE PHYSICIAN BROUGHT THE PATIENT BACK APPROXIMATELY 11 DAYS LATER ((B)(6) 2014) AND IMPLANTED A COMPETITOR'S BIFURCATED DEVICE, PLACED JUST BELOW THE RENAL ARTERIES, WHICH RESOLVED THE ENDOLEAK. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    569635 POWERLINK SYSTEM INFRARENAL BIFURCATED STENT GRAFT MIH ENDOLOGIX, INC. 25-16-140BL W10-2523

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Required Intervention