BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AFX SYSTEM

    MDR report key: 4233344 · Received November 6, 2014

    Report

    Report Number
    2031527-2014-00315
    Event Type
    Malfunction
    Date Received
    November 6, 2014
    Date of Event
    November 1, 2014
    Report Date
    October 7, 2014
    Manufacturer
    ENDOLOGIX, INC.
    Product Code
    MIH
    PMA / PMN Number
    P040002
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, 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

    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 WAS ADEQUATE MEDICAL DOCUMENTATION AND THERE WERE SUBOPTIMAL IMAGING STUDIES AVAILABLE FOR THIS REVIEW. PRODUCT APPROPRIATENESS AND PATIENT CANDIDACY COULD NOT BE FULLY ASSESSED DUE TO LACK OF INFORMATION. USING THE PRE IMPLANT ANGIOGRAM PHOTO FOR ASSESSMENT, PRODUCT USE MIGHT HAVE BEEN INCONGRUENT WITH THE IFU DUE TO THE ESTIMATED AORTIC DIAMETER OF LESS THAN 18 MM WITH THE EXCEPTION OF THE FOCAL SACCULAR ANEURYSM. CAUTIONARY PRODUCT USE INCLUDED THE IMPENDING RUPTURE AND THE MODERATE-CALCIFICATIONS SEEN THROUGHOUT THE AORTIC STRUCTURE. ONE MONTH POST IMPLANT, SUBSTANTIATED STENT GRAFT COLLAPSE OF THE AORTIC EXTENSION WAS OBSERVED; DIAMETER WAS REDUCED BY APPROXIMATELY 50% AS IT SHIFTED TO THE RIGHT SIDE. THE FOCAL ANEURYSM SAC DECREASED IN SIZE. SEVEN MONTHS POST IMPLANT, THERE WAS SUBSTANTIATED EVIDENCE OF: BIFURCATED MAIN BODY OCCLUSION; BILATERAL LIMB STENT OCCLUSION; BILATERAL COMMON ILIAC ARTERY OCCLUSION; AND, NEAR COMPLETE STENT GRAFT COLLAPSE OF THE AORTIC EXTENSION [RIGHT TO LEFT SHIFT]. THE LIMITATIONS OF THE SUBOPTIMAL CT IMAGES AND THE UNRECOGNIZED AND/OR UNTREATED AORTIC EXTENSION ONE MONTH POST IMPLANT MIGHT HAVE CONTRIBUTED TO THE CONFIRMED OCCLUSIONS. THERE WAS NO EVIDENCE OF TREATMENT AT THE POINT IN TIME; THE FINAL PROCEDURAL AND PATIENT OUTCOME WAS NOT KNOWN. 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, THE ROOT CAUSE FOR THE REPORTED AORTIC EXTENSION COLLAPSE AND OCCLUSIONS

    Description of Event or Problem · 1

    IT WAS REPORTED THAT APPROXIMATELY 7 MONTHS POST-IMPLANT OF A BIFURCATED DEVICE AND AN INFRARENAL AORTIC EXTENSION, A COMPUTED TOMOGRAPHY SCAN REVEALED A TOTALLY SHUT DOWN AORTIC STENT GRAFT. THE IMAGES SHOWED THE AORTIC EXTENSION HAD REVERSED STRATA, BLOOD HAD GOT BEHIND IT AND PUSHED OVER THE TOP OF THE GRAFT, RESULTING IN THE BLOOD BECOMING CAUGHT UP. THE PHYSICIAN IS DETERMINING A COURSE OF ACTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT APPROXIMATELY 7 MONTHS POST-IMPLANT OF A BIFURCATED DEVICE AND AN INFRARENAL AORTIC EXTENSION, A COMPUTED TOMOGRAPHY SCAN REVEALED A TOTALLY SHUT DOWN AORTIC STENT GRAFT. THE IMAGES SHOWED THE AORTIC EXTENSION HAD REVERSED STRATA, BLOOD HAD GOT BEHIND IT AND PUSHED OVER THE TOP OF THE GRAFT, RESULTING IN THE BLOOD BECOMING CAUGHT UP. THE PHYSICIAN BROUGHT THE PATIENT BACK APPROXIMATELY A MONTH LATER AND PERFORMED AN AXILLO-FEMORAL BYPASS AND AN OPEN REPAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    713853 AFX SYSTEM INFRARENAL PROXIMAL EXTENSION STENT GRAFT MIH ENDOLOGIX, INC. A25-25/C75 V 1164313-002

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Required Intervention