BEUDAMED
    FDA Adverse Event Death Summary report: N

    AFX SYSTEM

    MDR report key: 4173639 · Received October 15, 2014

    Report

    Report Number
    2031527-2014-00301
    Event Type
    Death
    Date Received
    October 15, 2014
    Date of Event
    September 22, 2014
    Report Date
    September 22, 2014
    Manufacturer
    ENDOLOGIX, INC.
    Product Code
    MIH
    PMA / PMN Number
    P040002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE REMAINS IMPLANTED IN THE PATIENT AND IS THEREFORE, NOT AVAILABLE FOR ANALYSIS. MEDICAL RECORDS AND IMAGING WERE PROVIDED AND REVIEWED BY AN INTERNAL CLINICAL REPRESENTATIVE WITH THE FOLLOWING IMPRESSION: THERE WERE SUBOPTIMAL MEDICAL DOCUMENTATION AND IMAGING STUDIES AVAILABLE FOR THIS REVIEW. PRODUCT USE WAS INCONGRUENT WITH THE IFU DUE TO: AN AORTIC NECK LENGTH OF 10 MM AND A RIGHT COMMON FEMORAL ARTERY OF LESS THAN 6.5MM. CAUTIONARY PRODUCT USE CONDITIONS THAT MIGHT HAVE CONTRIBUTED TO THIS EVENT INCLUDED: A CONCOMITANT DISSECTED, THORACIC ANEURYSM AND AN ANGLED, SEVERELY CALCIFIED LEFT AORTO-ILIAC JUNCTION. PERI-AORTIC FAT WAS THICK, BUT NO STRANDING WAS NOTED. THE DIFFICULT CANNULATION OF THE LEFT AORTO-ILIAC JUNCTION AND THE AORTIC THROMBECTOMY THAT WAS NEEDED TO RESTORE DISTAL BLOOD FLOW TO THE LEFT ILIAC ARTERY POST STENT DEPLOYMENT, MIGHT HAVE CONTRIBUTED TO THE REPORTED OUTCOME DUE TO THE INCREASED RISK OF EMBOLI AND THROMBUS FORMATION. THE PROXIMAL TYPE IA ENDOLEAK AND TREATMENT WITH ANGIOPLASTY AND ANOTHER COMPETITOR'S INFRARENAL AORTIC EXTENSION WERE SUBSTANTIATED BY MEDICAL DOCUMENTATION ONLY. A TOTAL OF TWO COMPETITOR'S PROXIMAL EXTENSIONS WERE PLACED. THE REPORTED RETURN TO THE OPERATING ROOM FOR AGGRESSIVE BALLOONING TO TREAT THE PROXIMAL ENDOLEAK (AND THE REPORTED STENT MIGRATION OF THE COMPETITOR'S PROXIMAL STENT) COULD NOT BE SUBSTANTIATED AS THESE IMAGE STUDIES AND REPORTS WERE NOT AVAILABLE FOR REVIEW. THE PATIENT WAS HEMODYNAMICALLY LABILE POST OPERATIVELY AND BECAME SEPTIC THE NEXT DAY AND REQUIRED AN URGENT RETURN TO THE OPERATING ROOM. THE ASCENDING BOWEL WAS ISCHEMIC. THE COMPLICATION OF BOWEL ISCHEMIA, SEPSIS, AND ACUTE RENAL FAILURE WERE SUBSTANTIATED. THE EVENT OF A BOWEL RESECTION AND AN ILEOSTOMY, ALONG WITH A HEMODIALYSIS CATHETER, WERE CONFIRMED. THE REPORTED DEATH AND THE CAUSE OF DEATH COULD NOT BE SUBSTANTIATED DUE TO LACK OF INFORMATION. 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 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, A ROOT CAUSE FOR THE REPORTED EVENT COULD NOT BE DETERMINED; HOWEVER, PATIENT ANATOMY AND PROCEDURE CONTEXT ARE LIKELY FACTORS. THERE WAS NO EVIDENCE THAT ENDOLOGIX DEVICE CONTRIBUTED TO THIS EVENT.

    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 UPON COMPLETION OF A HYBRID EVAR CASE, A LEAK WAS DETECTED COMING FROM THE COMPETITOR'S AORTIC EXTENSION AND REINTERVENTION WAS PERFORMED, HOWEVER THE PATIENT DID NOT WELL POST PROCEDURE AND DIED. REPORTEDLY, IMPLANT OF THE BIFURCATED DEVICE WAS PERFORMED UNEVENTFULLY, AND THEN PROCEEDED TO IMPLANT A MEDTRONIC THORACIC PIECE, AS THIS WAS A LARGE ANEURYSM. POST-DIL WAS PERFORMED AT THE PROXIMAL SECTION OF THE IMPLANTS AND THE THORACIC DEVICE PULLED DOWN A LITTLE BIT. THE PHYSICIAN IMPLANTED AN ENDURANT AORTIC CUFF (36 DIAMETERX 49 LENGTH) AND REPEATED POST-DIL. FINAL ANGIOGRAM SHOWED GOOD SEAL. THE GROINS WERE CLOSED. DISTAL PULSES WERE CHECKED AND NO PULSE WAS FELT ON THE LEFT LEG (LCIA). BRACHIAL ACCESS (ARM) SHOWED ODD PULSATILE BLEED FROM THE PROXIMAL AORTA (ENDURANT CUFF). IMAGING SHOWED THE BIFURCATED DEVICE WAS PATENT WITH NO ISSUES NOTED. THE PATIENT WAS TAKEN BACK TO THE OR AND AGGRESSIVE BALLOON DILATATION WAS PERFORMED IN ALL DEVICES. THE PULSATILE BLEEDING WAS NO LONGER PRESENT. THERE WAS GOOD SEAL AND THE PROCEDURE WAS THEN CONCLUDED. HOWEVER, THE PATIENT DIED SOME UNSPECIFIED TIME POST-PROCEDURE. THE CAUSE OF DEATH WAS INDICATED AS ISCHEMIC BOWEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    653100 AFX SYSTEM INFRARENAL BIFURCATED STENT GRAFT MIH ENDOLOGIX, INC. BA28-100/I16-40 1252322-026

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Death