BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AFX SYSTEM

    MDR report key: 4090785 · Received September 15, 2014

    Report

    Report Number
    2031527-2014-00279
    Event Type
    Injury
    Date Received
    September 15, 2014
    Date of Event
    September 3, 2014
    Report Date
    September 3, 2014
    Manufacturer
    ENDOLOGIX, INC.
    Product Code
    MIH
    PMA / PMN Number
    P040002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, 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. DISCARDED AT FACILITY.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS DISCARDED AT THE FACILITY. HOWEVER, MEDICAL RECORDS AND IMAGING STUDIES WERE RECEIVED AND REVIEWED BY AN INTERNAL CLINICAL SPECIALIST WITH THE FOLLOWING IMPRESSION: PRODUCT USE WAS INCONGRUENT WITH THE IFU AND MIGHT HAVE CONTRIBUTED TO THE REPORTED EVENT DUE TO: LCIA DIAMETER WAS GREATER THAN 2.3 CM; AND, THE AORTIC NECK HAD A GREATER THAN 60 DEGREE ANGLE. THE DIFFICULTY DEPLOYING THE SECOND BIFURCATED GRAFT CONFIRMED A WIRE WRAP ISSUE. THE UNCONVENTIONAL REMOVAL OF THE NON-DEPLOYED STENT RESULTED IN VESSEL TEAR OF THE LEFT COMMON FEMORAL ARTERY. A LEFT COMMON FEMORAL ARTERY ENDARTERECTOMY WAS PERFORMED. THE PATIENT'S HOSPITAL COURSE WAS COMPLICATED BY RESPIRATORY INSUFFICIENCY, BUT WAS EVENTUALLY DISCHARGE HOME ON POD 9. A CT SCAN COMPLETED ONE WEEK POST THE EVENT PROCEDURE REPORTED NO ENDOLEAK, BUT DID DESCRIBE A FLAP DISSECTION OF THE RIGHT EXTERNAL ILIAC ARTERY; THIS STUDY WAS NOT AVAILABLE FOR REVIEW. 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 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 ENDOLEAK COULD NOT BE DETERMINED ALTHOUGH THE CLINICAL REVIEW SUGGESTS THAT THE ENDOLEAK AND SUREPASS WIRE WRAPPING DIFFICULTIES MAY HAVE BEEN RELATED TO THE DIFFICULT ANATOMY. THE DEVICE WAS ATTEMPTED TO BE USED OUTSIDE THE RECOMMENDATIONS IN THE IFU, RESULTING IN PLACEMENT DIFFICULTY. IT COULD NOT BE DETERMINED WITH THE AVAILABLE INFORMATION IF A DEVICE ISSUE CONTRIBUTED TO THE REPORTED EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT APPROXIMATELY 15 MONTHS POST-IMPLANT OF A BIFURCATED DEVICE AND A SUPRARENAL AORTIC EXTENSION, THE PATIENT CAME INTO THE OPERATING ROOM AND A CT SCAN REVEALED AN ENDOLEAK. INTRAOPERATIVE ANGIOGRAMS WERE PERFORMED AND IT WAS BELIEVED THE ENDOLEAK WAS COMING FROM THE DISTAL PORTION OF THE ILIAC LIMB, DUE TO AORTIC SAC PRESSURE. A LIMB EXTENSION WAS PLACED IN THE LEFT ILIAC ARTERY AND THE GRAFT WAS BALLOONED TO GAIN WALL APPOSITION. REPEAT ANGIOGRAM SHOWED THE LEAK REMAINED. THE RIGHT ILIAC ARTERY WAS THEN ACCESSED, AND A BALLOON WAS PLACED IN TO TRY TO RULE OUT WHERE THE LEAK MIGHT BE COMING FROM. AFTER TARGETING BOTH ILIACS, IT WAS DECIDED THAT THE LEAK HAD TO BE COMING FROM THE BIFURCATED GRAFT, NEAR THE FLOW DIVIDER. A BIFURCATED DEVICE WAS CHOSEN BY THE PHYSICIANS TO COVER THE ALLEGED TEAR. THE SNARING OF THE DEVICE WAS DECIDED TO START AT THE LEVEL OF THE FLOW DIVIDER TO AVOID GETTING THE CONTRALATERAL WIRE CAUGHT THROUGH A STRUT. AFTER MULTIPLE FAILED ATTEMPTS, THE SHEATH AND THE SNARE WERE PUSHED HIGHER IN THE GRAFT TO ATTEMPT A DIFFERENT ANGLE. AFTER SNARING THE CONTRALATERAL WIRE, THE PHYSICIAN WANTED TO CONFIRM THE WIRE WAS NOT IN ANY STRUTS, SO THE WIRE AND SHEATH WERE PULLED DOWN TO THE BIFURCATION AGAIN. THIS SHOWED NO PULLING OF THE PREVIOUSLY IMPLANTED GRAFT. AFTER THE INNER CORE WAS ADVANCED AND THE GRAFT WAS IN THE SHEATH, THERE WAS A WIRE WRAP PRESENT. THE INNER CORE AND SHEATH WERE ROTATED TO RESOLVE THE WIRE WRAP, BUT DUE TO THE TORTUOSITY OF THE VESSEL, THE WRAP COULD NOT BE RESOLVED COMPLETELY. AT THIS TIME THE PHYSICIAN WANTED TO TRY TO ADVANCE THE GRAFT OUT OF THE SHEATH AND SPIN THE INNER CORE AT THE SAME TIME TO FIX THE LAST AMOUNT OF WIRE WRAP. DUE TO THE ANGLE, THE INNER CORE WOULD NOT ADVANCE UP AND THE SHEATH PULLED BACK EXPOSING THE LIMBS OF THE BIFURCATED GRAFT. THE DEVICE NEEDED TO BE ADVANCED ABOVE THE BIFURCATION TO BE SEATED, BUT DID NOT HAVE ENOUGH STRENGTH TO PUSH PAST THE ANGLE. THE PHYSICIAN SWITCHED OUT THE AMPLATZ WIRE FOR A STIFFER LUNDERQUIST WIRE. THIS ALSO DID NOT HELP THE DEVICE ADVANCE. IT WAS DECIDED, AFTER MULTIPLE ATTEMPTS TO ADVANCE THE DEVICE, THAT IT NEEDED TO BE PULLED OUT. A CUT DOWN WAS PERFORMED ON THE RIGHT FEMORAL ARTERY TO FACILITATE REMOVAL AND THE BIFURCATED DEVICE ATTEMPTED TO BE IMPLANTED AND THE SHEATH WERE SUCCESSFULLY RETRIEVED FROM THE PATIENT. THE INITIALLY IMPLANTED DEVICES (BIFURCATED DEVICE AND A SUPRARENAL AORTIC EXTENSION) REMAINED IN THE PATIENT. A SECOND PHYSICIAN WAS CALLED IN AND A COMPETITOR (B)(4) ENDOGRAFT WAS USED TO RELINE THE INITIALLY IMPLANTED BIFURCATED DEVICE FROM TOP TO BOTTOM. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    568760 AFX SYSTEM INFRARENAL BIFURCATED STENT GRAFT MIH ENDOLOGIX, INC. BA25-80/I20-40 1101058-017

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention