BEUDAMED
    FDA Adverse Event Death Summary report: N

    AFX SYSTEM

    MDR report key: 4119944 · Received September 25, 2014

    Report

    Report Number
    2031527-2014-00272
    Event Type
    Death
    Date Received
    September 25, 2014
    Date of Event
    August 21, 2014
    Report Date
    August 28, 2014
    Manufacturer
    ENDOLOGIX, INC.
    Product Code
    MIH
    PMA / PMN Number
    P040002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, 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 HAS BEEN DISCARDED.

    Additional Manufacturer Narrative · 1

    BASED UPON THE INVESTIGATION FINDINGS, THE REPORTED EVENT HAS BEEN CONFIRMED. THE DEVICE WAS NOT RETURNED FOR EVALUATION AND REMAINED IN THE PATIENT. THERE WERE SUBOPTIMAL MEDICAL DOCUMENTATION AND IMAGING STUDIES AVAILABLE FOR THIS REVIEW. PRODUCT USE WAS FOUND TO BE INCONGRUENT WITH THE IFU AND MIGHT HAVE CONTRIBUTED TO THIS COMPLAINT DUE TO: THE INFRARENAL AORTA WAS > 32 MM IN DIAMETER, AND THE RCIA WAS > 23 MM IN DIAMETER. CAUTIONARY PRODUCT USE CONDITIONS THAT MIGHT HAVE CONTRIBUTED TO THIS COMPLAINT WERE: CONCOMITANT THORACIC ANEURYSM; AND, THE PROXIMAL CUFF WAS TWO SIZES LARGER IN DIAMETER THAN THE BIFURCATED STENT. OTHER CONTRIBUTORY FACTORS ARE: AORTIC REMODELING; THE MARGINALLY ACCEPTABLE OVERLAP OF THE PROXIMAL CUFF (2.5 - 3.0 CM) AT INDEX; AND, MANIPULATION OF THE COMPONENTS IN 2012 FOR AN ENDOLEAK IIIA. THERE WAS RADIOLOGIC EVIDENCE OF: STENT FRACTURE; STRANDING; COMPONENT SEPARATION BETWEEN THE INITIAL PROXIMAL EXTENSION AND THE BIFURCATED STENT. AN ENDOLEAK WAS NOT VISUALIZED DUE TO THE NON-CONTRASTED NATURE OF THE EVENT CT SCAN, BUT THE EXPLANT PHOTOS DEMONSTRATED A STRUT FRACTURE AND FABRIC TEAR OF THE ANTERIOR BIFURCATION (PRESUMED ENDOLEAK IIIB). THE RUPTURE, CONVERSION, EXPLANT AND DEATH WERE CONFIRMED BY MEDICAL DOCUMENTATION. THE DEATH NOTE RECORDED THE INTRAOPERATIVE DEATH AS A RESULT OF A TEAR IN THE ANTERIOR AORTA, AND CONSEQUENTIAL SEVERE ANEMIA WITH COAGULOPATHY, AND MYOCARDIAL INFARCTION. 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 HAVE BEEN 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, AN EXACT ROOT CAUSE COULD NOT BE CONCLUSIVELY DETERMINED BASED UPON AVAILABLE INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT APPROXIMATELY 30 MONTHS POST IMPLANT OF A BIFURCATED DEVICE, INFRARENAL AORTIC EXTENSION AND A LIMB EXTENSION, AN ENDOLEAK WAS IDENTIFIED. REPORTEDLY, THE PATIENT PRESENTED WITH A RUPTURE, AND THE BIFURCATED STENT STRUT PUNCTURED THE FABRIC OF THE DEVICE AND CAUSED AN ENDOLEAK. THE STENT WAS ALSO EMBEDDED IN THE AORTIC WALL. THE PHYSICIAN ELECTED TO EXPLANT THE DEVICES AND SEWED IN A SURGICAL GRAFT TO RECOVER. THE PATIENT DID NOT MAKE IT THROUGH THE NIGHT AND EXPIRED. THE CAUSE OF DEATH IS INCONCLUSIVE. ADDITIONAL NOTE: PRIOR TO THIS EVENT THERE WAS A SECONDARY PROCEDURE REPORTED INVOLVING THIS PATIENT MEDWATCH #2031527-2014-00272. IT WAS PERFORMED ON (B)(6) 2012 A CT SCAN IDENTIFIED A DISCONNECT BETWEEN THE AORTIC EXTENSION AND THE BIFURCATED DEVICE. REPORTEDLY, THERE WAS NO ENDOLEAK PRESENT. THE PATIENT WAS TREATED WITH AN INFRARENAL AORTIC EXTENSION, WHICH SUCCESSFULLY BRIDGED THE DEVICES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    597225 AFX SYSTEM INFRARENAL BIFURCATED STENT GRAFT MIH ENDOLOGIX, INC. BA25-70/I16-30 W11-4892-017

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Death| R