BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AFX

    MDR report key: 6074272 · Received November 2, 2016

    Report

    Report Number
    2031527-2016-00510
    Event Type
    Injury
    Date Received
    November 2, 2016
    Date of Event
    September 30, 2016
    Report Date
    October 4, 2016
    Manufacturer
    ENDOLOGIX INC.
    Product Code
    MIH
    PMA / PMN Number
    P040002
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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 REPORTED TYPE 3B ENDOLEAK WAS CONFIRMED. ADDITIONALLY THERE WAS EVIDENCE TO SUPPORT INTRAOPERATIVE STENT MOVEMENT REQUIRING THE PLACEMENT OF AN INFRARENAL AORTIC EXTENSION. THE CLINICAL EVALUATION ADDITIONALLY IDENTIFIED THE FOLLOWING POTENTIAL CONTRIBUTING FACTORS TO THE REPORTED EVENT; ADDITIONAL BALLOONING INVOLVING THE MAIN BODY WHICH MIGHT HAVE COMPROMISED THE FABRIC INTEGRITY AND REMODELING OF THE MAIN BODY OVER TIME MIGHT HAVE CONTRIBUTED TO THE STRUT FRACTURE. 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. THERE HAVE BEEN NO ADDITIONAL ADVERSE EVENTS REPORTED FOR THIS PATIENT AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD AN INITIAL PROCEDURE ON (B)(6) 2013 WITH A BIFURCATED, AN INFRARENAL AORTIC EXTENSION, A SUPRARENAL AORTIC EXTENSION, AND TWO LIMB STENT GRAFTS. A FOLLOW UP COMPUTED TOMOGRAPHY (CT) ON (B)(6) 2016 SHOWED A TYPE 3B ENDOLEAK COMING FROM THE MAIN BODY GRAFT. THE PATIENT WAS ASYMPTOMATIC. THE PHYSICIAN ELECTED TO RELINE THE INITIAL STENTS AND IMPLANTED AN ADDITIONAL BIFURCATED STENT AND AN ADDITIONAL SUPRARENAL AORTIC EXTENSION TO SEAL THE LEAK. THE PATIENT IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    723006 AFX BIFURCATED MIH ENDOLOGIX INC. BA28-90/I20-30 1101189-012

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention INFRARENAL AORTO UNI-ILIAC- (B)(4)| LIMB STENT- (B)(4)| LIMB STENT- (B)(4)| SUPRARENAL AORTA UNI-ILIAC- (B)(4)