BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AFX SYSTEM

    MDR report key: 3852044 · Received June 5, 2014

    Report

    Report Number
    2031527-2014-00162
    Event Type
    Injury
    Date Received
    June 5, 2014
    Date of Event
    May 6, 2014
    Report Date
    May 13, 2014
    Manufacturer
    ENDOLOGIX, INC.
    Product Code
    MIH
    PMA / PMN Number
    P040002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, 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 PATIENT.

    Additional Manufacturer Narrative · 1

    BASED UPON THE INVESTIGATION FINDINGS, THE REPORTED EVENT IS INCONCLUSIVE BASED ON CLINICAL ASSESSMENT. MEDICAL RECORDS AND COMPUTED TOMOGRAPHY IMAGES WERE PROVIDED AND REVIEWED BY A CLINICAL SPECIALIST WITH THE FOLLOWING IMPRESSION: THERE WERE SUBOPTIMAL MEDICAL RECORDS AND IMAGING STUDIES PROVIDED FOR THIS ASSESSMENT. THERE MIGHT HAVE BEEN PRODUCT USE THAT WAS INCONGRUENT WITH SIZING RECOMMENDATIONS: THE AORTIC CUFF WAS TWO SIZES BIGGER THAN THE MAIN BODY. THIS MIGHT HAVE CONTRIBUTED TO THIS EVENT. THE FINAL POSITION OF THE AORTIC CUFF CANNOT BE ASSESSED; THIS AREA WAS NOT INCLUDED IN THE FINAL ANGIOGRAM IMAGE. THE PRIOR ANGIOGRAM DEMONSTRATED A SUPRARENAL CUFF POSITION BELOW THE RENAL ARTERIES; IT WAS UNCLEAR IF THIS WAS AN INTENTIONAL POSITION. NO ENDOLEAK WAS REPORTED OR SEEN ON THE LIMITED ANGIOGRAM, THEREFORE CANNOT BE SUBSTANTIATED. ACUTE RENAL FAILURE WAS SUBSTANTIATED, WHICH MIGHT BE DESCRIBED AS A COMPLICATION. THE DEATH DUE TO ACUTE RENAL FAILURE WAS 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. BASED UPON THE INVESTIGATION FINDINGS, THE ROOT CAUSE COULD NOT BE DETERMINED AS THE ENDOLEAK COULD NOT BE SUBSTANTIATED. THE DEATH IS ATTRIBUTED TO ACUTE RENAL FAILURE. THERE WERE NO INDICATION THE DEVICE WAS A FACTOR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE EMERGENCY ROOM (ER) SYMPTOMATIC, WITH A LARGE ANEURYSM. AN EMERGENT IMPLANTATION OF A BIFURCATED DEVICE AND A SUPRARENAL AORTIC EXTENSION, AND TWO ILIAC EXTENSIONS WAS PERFORMED. DURING THE EMERGENT PRESENTATION AN ANGIO GRAM WAS PERFORMED AND AN ENDOLEAK WAS IDENTIFIED. THE ANEURYSM WAS TREATED WITH THE REFERENCED STENT GRAFTS. IT WAS INDICATED THAT THE RENAL'S WERE OPEN AND DISEASED AND FILLED UP QUICKLY. POST PROCEDURALLY THE PATIENTS CREATININE WENT FROM 1 TO 5. REPORTEDLY AFTER PROCEDURE THE PATIENT WAS INTUBATED AND PUT IN DIALYSIS. THE PATIENT EXPIRED THAT NIGHT DUE TO KIDNEY FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    328567 AFX SYSTEM INFRARENAL BIFURCATED STENT GRAFT MIH ENDOLOGIX, INC. BA25-120/I16-40 1200667-005

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Other