BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AFX

    MDR report key: 6065172 · Received October 28, 2016

    Report

    Report Number
    2031527-2016-00504
    Event Type
    Injury
    Date Received
    October 28, 2016
    Date of Event
    September 28, 2016
    Report Date
    September 28, 2016
    Manufacturer
    ENDOLOGIX INC.
    Product Code
    MIH
    PMA / PMN Number
    P040002
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICES INVOLVED IN THE EVENT WILL NOT BE RETURNED FOR EVALUATION, THEY REMAIN IMPLANTED IN THE PATIENT. IF ADDITIONAL INFORMATION PERTINENT TO THE INCIDENT IS OBTAINED, A FOLLOW-UP REPORT WILL BE SUBMITTED. DEVICES REMAIN IMPLANTED IN THE PATIENT.

    Additional Manufacturer Narrative · 1

    AT THE COMPLETION OF THE COMPLAINT INVESTIGATION, BASED ON THE PATIENT DATA AVAILABLE, THE CLINICAL EVALUATION WAS NOT ABLE TO CONFIRM THE REPORTED EVENT. THERE WAS EVIDENCE TO REASONABLY SUGGEST A TYPE 2 ENDOLEAK AND POST IMPLANT BLOOD LOSS OF 500-600ML TO THE LEFT OF A FEMORAL-FEMORAL BYPASS. THE CLINICAL EVALUATION ADDITIONALLY FOUND EVIDENCE TO REASONABLY SUGGEST THE FOLLOWING CONTRIBUTING FACTORS TO THE REPORTED EVENT; OFF LABEL USE AND PATIENT ANATOMY. THE MANUFACTURING EVALUATION DID NOT REVEAL ANY ISSUES OR DEVIATIONS THAT WOULD EXPLAIN THE REPORTED EVENT. THE MANUFACTURING LOT EVALUATION CONFIRMED ALL DEVICES MET SPECIFICATIONS PRIOR TO RELEASE. THE DEVICES REMAIN IMPLANTED IN THE PATIENT AND WERE NOT AVAILABLE FOR FURTHER EVALUATION. THE ROOT CAUSE OF THE REPORTED EVENT IS UNKNOWN. THERE IS NOT ENOUGH INFORMATION TO DETERMINE THE ROOT CAUSE OF THE REPORTED EVENT AT THIS TIME.

    Description of Event or Problem · 1

    PATIENT INITIALLY IMPLANTED WITH A BIFURCATED STENT, TWO SUPRARENAL AORTIC EXTENSIONS, AN INFRARENAL AORTIC EXTENSION, AND A LIMB EXTENSION ON (B)(6) 2013. ON (B)(6) 2015 THE PATIENT HAD AN ADDITIONAL INFRARENAL AORTIC EXTENSION ADDED TO THE LEFT COMMON ILIAC ARTERY TO REPAIR A TYPE 3A COMPONENT SEPARATION OF THE MAIN BODY AND THE LIMB EXTENSION. THE PHYSICIAN ALSO IMPLANTED 3 LIMB STENT GRAFTS IN RIGHT ILIAC DUE TO ANEURYSM GROWTH. A RECENT FOLLOW UP SHOWED A TYPE 3A ENDOLEAK AND COMPLETE COMPONENT SEPARATION OF THE LEFT ILIAC LIMB. THE PHYSICIAN ATTEMPTED TO REPAIR AND WAS NOT ABLE TO ACCESS OR TRACK THE NEW IMPLANT ACROSS THE COMPONENT SEPARATION. THE PHYSICIAN INSTEAD PLUGGED THE LEFT ILIAC LIMB AND RELINED THE RIGHT ILIAC WITH A NON-ENDOLOGIX DEVICE. THE SEPARATION OF THE COMPONENTS IS SUSPECTED TO BE THE RESULT OF AN INFECTION WHICH IS CAUSING THE ANEURYSM SAC TO INCREASE AND CHANGE THE MORPHOLOGY OF THE ILIAC ARTERIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    714708 AFX BIFURCATED MIH ENDOLOGIX INC. BA28-80/I20-40 1101244-025

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Required Intervention BIFURCATED- (B)(4)| INFRARENAL AORTIC EXTENSION- (B)(4)| INFRARENAL AORTIC EXTENSION- (B)(4)| LIMB EXTENSION- (B)(4)| LIMB EXTENSION- (B)(4)| LIMB EXTENSION- (B)(4)| LIMB STENT- (B)(4)| SUPRARENAL AORTIC EXTENSION- (B)(4)| SUPRARENAL AORTIC EXTENSION- (B)(4)