BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AFX

    MDR report key: 6213537 · Received December 29, 2016

    Report

    Report Number
    2031527-2016-00598
    Event Type
    Injury
    Date Received
    December 29, 2016
    Date of Event
    November 28, 2016
    Report Date
    April 24, 2017
    Manufacturer
    ENDOLOGIX INC.
    Product Code
    MIH
    PMA / PMN Number
    P040002
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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

    THE MANUFACTURING LOT EVALUATION CONFIRMED ALL DEVICES MET SPECIFICATIONS PRIOR TO RELEASE. THE DEVICES WERE NOT RETURNED, SO NO EVALUATION COMPLETED. AT THE COMPLETION OF THE CLINICAL ASSESSMENT, CLINICAL WAS ABLE TO FIND SUBSTANTIAL EVIDENCE TO SUPPORT AN EL3A-PARTIAL SEPARATION, EL3B PROXIMAL EXTENSION, AND SUBOPTIMAL SUPRARENAL CUFF POSITION (1CM BELOW THE LEFT RENAL ARTERY) AT 51 MONTHS POST IMPLANT. AT 55 MONTHS POST IMPLANT, AN OPEN REPAIR WITH EXPLANT OF THE AFX SYSTEM AND IMPLANT OF AN AORTOBIILIAC DACRON GRAFT EXPLANT WAS COMPLETED. THE PATIENT EXPIRED ON POST OPERATIVE DAY FIFTEEN ((B)(6) 2017), WITH NO CAUSE OF DEATH PROVIDED TO ENDOLOGIX. THE MOST LIKELY CAUSE OF THE IMPLANT SEPARATION WAS RELATED TO THE REPORTED INCREASE IN THE INFRARENAL AORTIC ANGULATION TO 70 DEGREES. ADDITIONALLY, THE CURRENT SUBOPTIMAL POSITION OF THE PROXIMAL CUFF LIKELY CONTRIBUTED TO THE SEPARATION OF THE COMPONENTS, IT CANNOT BE DETERMINED IF THIS WAS DUE TO USER ERROR AT IMPLANT OR SUBSEQUENT MIGRATION/MOVEMENT DUE TO A LACK OF COMPARATIVE IMAGING. BASED ON THE INFORMATION MADE AVAILABLE TO ENDOLOGIX, WE WERE UNABLE TO DETERMINE ANY PROCEDURE OR USER RELATED ISSUES, OR, OFF-LABEL/CAUTIONARY PRODUCT USE CONDITIONS RELATED TO THIS EVENT. CORRECTION: (B)(4).

    Additional Manufacturer Narrative · 1

    AT THE COMPLETION OF THE COMPLAINT INVESTIGATION, BASED ON THE INFORMATION AVAILABLE, THE CLINICAL EVALUATION COULD NOT CONFIRM THE REPORTED EVENT. ADDITIONALLY THERE IS EVIDENCE TO REASONABLY SUGGEST THE FOLLOWING OBSERVATIONS; A TYPE 3A ENDOLEAK WITH PARTIAL COMPONENT SEPARATION BETWEEN THE MAIN BODY AND PROXIMAL EXTENSION, A TYPE 3B OF THE MID PROXIMAL EXTENSION, AND SUBOPTIMAL PLACEMENT OF THE SUPRARENAL AORTIC EXTENSION. THE CLINICAL EVALUATION ADDITIONALLY FOUND FURTHER EVIDENCE TO REASONABLY SUGGEST THE FOLLOWING CONTRIBUTING FACTOR; 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 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 AT THIS TIME. THERE HAVE BEEN NO ADDITIONAL ADVERSE EVENTS REPORTED FOR THIS PATIENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD AN INITIAL PROCEDURE ON (B)(6) 2012 WITH A BIFURCATED STENT AND SUPRARENAL AORTIC EXTENSION. ON (B)(6) 2016 A FOLLOW UP COMPUTED TOMOGRAPHY(CT) SHOWED ANEURYSM SAC GROWTH AND INCREASED ANGULATION IN THE AORTIC NECK. THE PHYSICIAN HAS NOT COMPLETED OR PLANNED A SECONDARY INTERVENTION. THERE HAVE BEEN NO ADDITIONAL ADVERSE EVENTS REPORTED FOR THIS PATIENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION DISCOVERED DURING CLINICAL ASSESSMENT. ON (B)(6) 2017 (55 MONTHS POST IMPLANT), AN OPEN REPAIR WITH EXPLANT OF THE AFX SYSTEM AND IMPLANT OF AN AORTOBIILIAC DACRON GRAFT EXPLANT WAS COMPLETED. THE PATIENT EXPIRED ON POST OPERATIVE DAY FIFTEEN ((B)(6) 2017), WITH NO CAUSE OF DEATH PROVIDED TO ENDOLOGIX.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    863798 AFX SUPRARENAL AORTIC EXTENSION MIH ENDOLOGIX INC. A34-34/C100-O20 1044103-020

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention AORTO UNI-ILIAC [SUPRARENAL]- 1044103-020