BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AFX2

    MDR report key: 6153719 · Received December 7, 2016

    Report

    Report Number
    2031527-2016-00571
    Event Type
    Injury
    Date Received
    December 7, 2016
    Date of Event
    November 7, 2016
    Report Date
    February 14, 2017
    Manufacturer
    ENDOLOGIX INC.
    Product Code
    MIH
    UDI-DI
    00818009014542
    PMA / PMN Number
    P040002
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, 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 COMPLAIN INVESTIGATION, BASED ON THE INFORMATION RECEIVED, THE CLINICAL ASSESSMENT WAS ABLE TO CONFIRM THE REPORTED TYPE 3A ENDOLEAK AS WELL AS THE TYPE 1B ENDOLEAK OF THE RIGHT COMMON ILIAC ARTERY (RCIA). ADDITIONALLY THERE WAS EVIDENCE TO SUPPORT AN OBSERVED TYPE 2 ENDOLEAK COMING FROM A LUMBAR ARTERY. THE CLINICAL EVALUATION ADDITIONALLY FOUND EVIDENCE TO REASONABLY SUGGEST THE FOLLOWING CONTRIBUTING FACTORS TO THE REPORTED EVENT; PATIENT ANATOMY, ANTIPLATELET THERAPY, ANTICOAGULATION THERAPY, SUBOPTIMAL ANEURYSMAL LANDING ZONE AND POOR STENT-WALL APPOSITION OF THE RIGHT LIMB OF THE MAIN BODY. 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 EVENT DEVICES REMAIN IMPLANTED IN THE PATIENT AND WERE NOT AVAILABLE FOR FURTHER INVESTIGATION. THE ROOT CAUSE OF THE REPORTED EVENT IS UNKNOWN. THERE IS NOT ENOUGH IN FORMATION TO DETERMINE THE ROOT CAUSE OF THE REPORTED EVENT.

    Description of Event or Problem · 1

    PATIENT WAS INITIALLY IMPLANTED WITH A BIFURCATED STENT AND A SUPRARENAL AORTIC EXTENSION ON (B)(6) 2016. ON (B)(6) 2016 A COMPUTED TOMOGRAPHY (CT) SCAN SHOWED A TYPE 3A ENDOLEAK WITH COMPONENT SEPARATION. THE CT ALSO SHOWED THE DISTAL LIMB OF THE MAIN BODY IN THE RIGHT COMMON ILIAC ARTERY WAS NOT FULLY OPPOSED DISTALLY, THERE WAS NO ENDOLEAK OBSERVED. THE PHYSICIAN ELECTED TO COMPLETE A SECONDARY INTERVENTION ON (B)(6) 2016 TO SEAL THE LEAK AND REPAIR THE RCIA LIMB. THE PHYSICIAN IMPLANTED AN ADDITIONAL SUPRARENAL AORTIC EXTENSION AND AN OVATION LIMB TO RESOLVE THE ISSUES. THE PATIENT WAS STABLE POST PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    802971 AFX2 BIFURCATED MIH ENDOLOGIX INC. BEA28-110/I20-30 1355044-007 00818009014542

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention SUPRARENAL AORTA UNI-ILIAC - (B)(4)