BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERLINK SYSTEM

    MDR report key: 3864196 · Received June 10, 2014

    Report

    Report Number
    2031527-2014-00194
    Event Type
    Malfunction
    Date Received
    June 10, 2014
    Date of Event
    June 9, 2014
    Report Date
    June 9, 2014
    Manufacturer
    ENDOLOGIX, INC.
    Product Code
    MIH
    PMA / PMN Number
    P040002
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE REMAINS IMPLANTED IN THE PATIENT, HENCE DEVICE EVALUATION COULD NOT BE PERFORMED. MEDICAL RECORDS AND PROCEDURAL IMAGES WERE PROVIDED FOR CLINICAL ASSESSMENT AND REVIEWED BY AN INTERNAL CLINICAL SPECIALIST WITH THE FOLLOWING IMPRESSION: PRODUCT USE MIGHT HAVE BEEN INCONGRUENT WITH THE IFU AND SIZING RECOMMENDATIONS AND MIGHT HAVE CONTRIBUTED TO THE REPORTED EVENT DUE TO: THE IMPLANTED AORTIC EXTENSION AND BIFURCATED DEVICE WERE THE SAME DIAMETER; MULTIPLE PATENT LUMBAR ARTERIES; AND A PATENT IMA. THE PATIENT'S HISTORY MIGHT HAVE CONTRIBUTED DUE TO: USE OF ANTIPLATELET THERAPY; AORTIC REMODELING DUE TO PERSISTENT ENDOLEAKS; AND DISEASE PROGRESSION. THERE MIGHT HAVE BEEN SUBSTANTIAL RADIOLOGICAL EVIDENCE TO SUPPORT AN EVOLUTION OF A NEW INFRARENAL ANEURYSM AND ENDOLEAK TYPE 2 (LEFT HYPOGASTRIC BRANCH; HIGH LUMBAR; AND THE IMA). THE SECONDARY PROCEDURE WAS SUBSTANTIATED; HOWEVER THE TYPE OF PROXIMAL ENDOLEAK COULD NOT BE DETERMINED, DUE TO THE LACK OF INFORMATION. NO ADDITIONAL RADIOLOGY EXAMS WERE RECEIVED TO SUPPORT EITHER DIAGNOSIS OF AN ENDOLEAK TYPE IA OR IIIA. A MANUFACTURING RECORD REVIEW WAS PERFORMED, THE LOT MET ALL RELEASE CRITERIA WITH NO 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, THE ROOT CAUSE COULD NOT BE CONCLUSIVELY DETERMINED FOR THIS EVENT; HOWEVER, DISEASE PROGRESSION AND AORTIC REMODELING DUE TO PERSISTENT ENDOLEAKS ARE LIKELY FACTORS. (B)(4).

    Additional Manufacturer Narrative · 1

    THE DEVICE REMAINS IMPLANTED IN THE PATIENT, HENCE DEVICE EVALUATION COULD NOT BE PERFORMED. MEDICAL RECORDS AND PROCEDURAL IMAGES WERE PROVIDED FOR CLINICAL ASSESSMENT AND REVIEWED BY AN INTERNAL CLINICAL SPECIALIST WITH THE FOLLOWING IMPRESSION: PRODUCT USE MIGHT HAVE BEEN INCONGRUENT WITH THE IFU AND SIZING RECOMMENDATIONS AND MIGHT HAVE CONTRIBUTED TO THE REPORTED EVENT DUE TO: THE IMPLANTED AORTIC EXTENSION AND BIFURCATED DEVICE WERE THE SAME DIAMETER; MULTIPLE PATENT LUMBAR ARTERIES; AND A PATENT IMA. THE PATIENT'S HISTORY MIGHT HAVE CONTRIBUTED DUE TO: USE OF ANTIPLATELET THERAPY; AORTIC REMODELING DUE TO PERSISTENT ENDOLEAKS; AND DISEASE PROGRESSION. THERE MIGHT HAVE BEEN SUBSTANTIAL RADIOLOGICAL EVIDENCE TO SUPPORT AN EVOLUTION OF A NEW INFRARENAL ANEURYSM AND ENDOLEAK TYPE 2 (LEFT HYPOGASTRIC BRANCH; HIGH LUMBAR; AND THE IMA). 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, THE ROOT CAUSE COULD NOT BE CONCLUSIVELY DETERMINED FOR THIS EVENT; HOWEVER, DISEASE PROGRESSION AND AORTIC REMODELING DUE TO PERSISTENT ENDOLEAKS ARE LIKELY FACTORS.

    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 71 MONTHS POST-IMPLANT OF A BIFURCATED DEVICE AND AN INFRARENAL AORTIC EXTENSION, A PROXIMAL ENDOLEAK WAS IDENTIFIED; HOWEVER, OF UNKNOWN TYPE. THE PATIENT IS BEING MONITORED. THREE MONTHS LATER, THE PATIENT WAS BROUGHT BACK (ON (B)(6) 2014) AND A SECONDARY PROCEDURE WAS PERFORMED. THE PHYSICIAN IMPLANTED A SUPRARENAL AORTIC EXTENSION AS THE AORTA REMODELED AND WANTED ADDITIONAL FABRIC UP TOP TO ACCESSORY RENAL. FINAL ANGIOGRAM SHOWED NO ENDOLEAK PRESENT. THE PATIENT WAS REPORTED TO BE DOING WELL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT APPROXIMATELY 71 MONTHS POST-IMPLANT OF A BIFURCATED DEVICE AND AN INFRARENAL AORTIC EXTENSION, A PROXIMAL ENDOLEAK WAS IDENTIFIED; HOWEVER, OF UNKNOWN TYPE. THE PHYSICIAN WILL PERFORM A SECONDARY PROCEDURE SOMETIME THIS MONTH. THE PATIENT IS BEING MONITORED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    338100 POWERLINK SYSTEM INFRARENAL PROXIMAL EXTENSION STENT GRAFT MIH ENDOLOGIX, INC. 28-28-75RL W08-1134-006

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention