BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AFX

    MDR report key: 6211859 · Received December 28, 2016

    Report

    Report Number
    2031527-2016-00592
    Event Type
    Injury
    Date Received
    December 28, 2016
    Date of Event
    November 28, 2016
    Report Date
    February 22, 2017
    Manufacturer
    ENDOLOGIX INC.
    Product Code
    MIH
    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 COMPLAINT INVESTIGATION, BASED ON THE INFORMATION RECEIVED, THE CLINICAL EVALUATION WAS ABLE TO CONFIRM ANEURYSM SAC GROWTH AND A TYPE 1B ENDOLEAK OF THE LEFT COMMON ILIAC ARTERY (LCIA). A TYPE 1B ENDOLEAK OF THE RIGHT COMMON ILIAC ARTERY (RCIA) OR THE TYPE 3B ENDOLEAK COULD NOT BE CONFIRMED. THE CLINICAL EVALUATION ADDITIONALLY FOUND FURTHER EVIDENCE TO REASONABLY SUGGEST THE FOLLOWING CONTRIBUTING FACTORS TO THE REPORTED EVENT; OFF LABEL USE, PATIENT ANATOMY AND CALCIFICATION IN THE ILIAC LIMBS. 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 EVALUATION. THE ROOT CAUSE OF THE REPORTED EVENT IS UNKNOWN. THERE IS NOT ENOUGH INFORMATION TO DETERMINE THE ROOT CAUSE OF THE REPORTED EVENT. THERE HAVE BEEN NO ADDITIONAL ADVERSE EVENTS REPORTED FOR THIS PATIENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD AN INITIAL PROCEDURE ON (B)(6) 2013 WITH A BIFURCATED STENT, A SUPRARENAL AORTIC EXTENSION, AND A LIMB STENT GRAFT. A FOLLOW UP COMPUTED TOMOGRAPHY (CT) SHOWED THE PATIENT HAD ANEURYSM SAC GROWTH AND A POTENTIAL TYPE 1B ENDOLEAK. THE CT DID NOT SHOW CONTRAST IN THE ANEURYSM SAC, HOWEVER DUE TO THE PATIENT'S COMPLEX ILIAC ANATOMY THE PHYSICIAN IDENTIFIED A POSSIBLE BILATERAL TYPE 1B ENDOLEAK FROM THE ILIAC LIMBS. THE PATIENT HAS NOT HAD A SUBSEQUENT ENDOVASCULAR PROCEDURE AND HAS NOT BEEN SCHEDULE FOR A RE-INTERVENTION AT THIS TIME. THERE HAVE BEEN NO ADDITIONAL ADVERSE EVENTS REPORTED FOR THIS PATIENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED, THE PATIENT HAD A SECONDARY PROCEDURE AND THE PHYSICIAN ELECTED TO IMPLANT AN ADDITIONAL BIFURCATED STENT, A SUPRARENAL AORTIC EXTENSION, AND TWO LIMB EXTENSIONS TO SEAL THE LEAK. THE PHYSICIAN WAS NOT ABLE TO CONFIRM THE TYPE OF ENDOLEAK THE PATIENT HAD, HOWEVER, THE PHYSICIAN RELINED THE INITIAL IMPLANTS AND EXTENDING THE STENTS IN THE ILIAC LIMBS TO COVER A TYPE 3B LEAK AS WELL AS A TYPE 1B ENDOLEAK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    860641 AFX BIFURCATED MIH ENDOLOGIX INC. BA25-90/I20-30 1080684-007

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention AORTO UNI-ILIAC [SUPRARENAL]- (B)(4)| LIMB- (B)(4)