BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AFX

    MDR report key: 6115384 · Received November 19, 2016

    Report

    Report Number
    2031527-2016-00542
    Event Type
    Injury
    Date Received
    November 19, 2016
    Date of Event
    October 21, 2016
    Report Date
    October 21, 2016
    Manufacturer
    ENDOLOGIX INC.
    Product Code
    MIH
    UDI-DI
    00818009013637
    PMA / PMN Number
    P040002
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED. BASED ON THE ADDITIONAL INFORMATION RECEIVED, CLINICAL FOUND EVIDENCE TO SHOW THAT THERE WAS A DISTAL MIGRATION OF THE PROXIMAL CUFF BY 2.1CM.

    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.

    Additional Manufacturer Narrative · 1

    AT THE COMPLETION OF THE COMPLAINT INVESTIGATION, BASED ON THE INFORMATION RECEIVED, THE CLINICAL EVALUATION WAS ABLE TO CONFIRM THE REPORTED TYPE 1A ENDOLEAK. ADDITIONALLY THERE WAS EVIDENCE TO REASONABLY SUPPORT THE FOLLOWING OBSERVATIONS; A TYPE 2 ENDOLEAK AND DISTAL MOVEMENT OF THE INITIAL PROXIMAL EXTENSION. THE CLINICAL EVALUATION ALSO IDENTIFIED PATIENT ANATOMY AS A POTENTIAL CONTRIBUTING FACTOR TO THE REPORTED EVENT. 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. THERE HAVE BEEN NO ADDITIONAL ADVERSE EVENTS REPORTED FOR THIS PATIENT.

    Description of Event or Problem · 1

    IT WAS REPORTED A PATIENT HAD AN INITIAL PROCEDURE ON (B)(6) 2016 WITH A BIFURCATED STENT AND SUPRARENAL AORTIC EXTENSION. ON (B)(6) 2016 PATIENT WAS HAVING ABDOMINAL PAIN AND COMPUTED TOMOGRAPHY (CT) SHOWED A TYPE 1A ENDOLEAK. ON (B)(6) 2016 THE PHYSICIAN ELECTED TO IMPLANT AN ADDITIONAL SUPRARENAL AORTIC EXTENSION TO SEAL THE ENDOLEAK. PATIENT IS IN STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    766447 AFX SUPRARENAL AORTA UNI-ILIAC MIH ENDOLOGIX INC. A28-28/C95-O20 V 1472816-022 00818009013637

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention BIFURCATED- 1484286-003