BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AFX SYSTEM

    MDR report key: 3806538 · Received May 13, 2014

    Report

    Report Number
    2031527-2014-00129
    Event Type
    Malfunction
    Date Received
    May 13, 2014
    Date of Event
    April 16, 2014
    Report Date
    April 16, 2014
    Manufacturer
    ENDOLOGIX, INC.
    Product Code
    MIH
    PMA / PMN Number
    P040002
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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 REMAINS IMPLANTED IN PATIENTF.

    Additional Manufacturer Narrative · 1

    THE DEVICE REMAINS IMPLANTED IN THE PATIENT HENCE, DEVICE EVALUATION COULD NOT BE PERFORMED. BASED UPON THE INVESTIGATION FINDINGS, THE REPORTED EVENT IS INCONCLUSIVE. THERE WERE SUBOPTIMAL MEDICAL RECORDS AND IMAGING STUDIES PROVIDED FOR THIS ASSESSMENT. THERE WAS NO RADIOLOGICAL EVIDENCE TO SUBSTANTIATE THE REPORTED "JUMP" DURING DEPLOYMENT OTHER THAN THE MISALIGNED CUFF ON THE FINAL ANGIOGRAPHY IMAGE. THERE WAS NO EVIDENCE OF RENAL FAILURE AT DISCHARGE, THERE WAS NO APPARENT INJURY TO THE PATIENT. A MANUFACTURING RECORD REVIEW WAS PERFORMED AND THE LOT MET ALL RELEASE CRITERIA WITH NO ISSUES OR DEVIATIONS THAT WOULD EXPLAIN THE REPORTED EVENT. THE LOT USAGE HISTORY SHOWED THAT NO OTHER UNITS FROM THE SAME LOT HAVE BEEN 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 COULD NOT BE CONCLUSIVELY DETERMINED; HOWEVER, HANDLING OF THE DEVICE MIGHT HAVE BEEN A FACTOR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING IMPLANTATION OF A BIFURCATED DEVICE, AND SUPRARENAL AORTIC EXTENSION, THE CUFF JUMPED UP A FEW MILLIMETERS. REPORTEDLY, THE CUFF JUMPED UP A FEW MILLIMETERS UPON FINAL UNSHEATHING, AND PARTIALLY COVERED THE LEFT RENAL. THE PHYSICIAN ATTEMPTED TO PULL THE CUFF DOWN WITH CODA BALLOON, BUT COULD NOT GET THE CUFF TO MOVE DOWN ANY FURTHER. THE RENALS ARE FILLING AND THE PATIENT TOLERATED THE PROCEDURE WELL, AND WILL RECEIVE A 30-DAY FOLLOW UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    286176 AFX SYSTEM SUPRARENAL PROXIMAL EXTENSION STENT GRAFT (SCS) MIH ENDOLOGIX, INC. A28-28/C95-O20V 1203996-023

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR