BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AFX

    MDR report key: 5340413 · Received December 29, 2015

    Report

    Report Number
    2031527-2015-00517
    Event Type
    Injury
    Date Received
    December 29, 2015
    Date of Event
    November 25, 2015
    Report Date
    December 1, 2015
    Manufacturer
    ENDOLOGIX
    Product Code
    MIH
    PMA / PMN Number
    P040002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    1

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE CLINICAL EVALUATION CONFIRMED THE PRESENCE OF A TYPE 2 ENDOLEAK, A TYPE 3B ENDOLEAK AND STENT MIGRATION. A TYPE 1A ENDOLEAK COULD NOT BE CONFIRMED WITH DATA PROVIDED. PATIENT PRE-IMPLANT IMAGING WAS NOT AVAILABLE. THE MANUFACTURING EVALUATION DID NOT REVEAL ANY ISSUES OR DEVIATIONS THAT WOULD EXPLAIN THE REPORTED EVENT. THE ROOT CAUSE WAS INCONCLUSIVE, THERE IS NOT ENOUGH INFORMATION TO DETERMINE THE ROOT CAUSE OF THE EVENT. POTENTIAL CONTRIBUTING FACTORS ARE THE PATIENT IS ON ANTIPLATELET THERAPY, THE ORIGINAL IMPLANT OF THE DEVICE WAS PLACED LOWER THAN THE OPTIMAL LOCATION WITHIN THE ARTERY WHICH RESULTED IN A DECREASE IN STENT OVERLAP.

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE EVENT WILL NOT BE RETURNED FOR EVALUATION AS IT REMAINS IMPLANTED IN THE PATIENT. IF ADDITIONAL INFORMATION PERTINENT TO THE INCIDENT IS OBTAINED, A FOLLOW-UP REPORT WILL BE SUBMITTED. ADDITIONAL DEVICE: MODEL: A28-28/C95 INFRARENAL AORTIC EXTENSION, LOT: W11-2748-007, REL. DATE: 07/19/2011, EXP. DATE: 04/30/2012.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD A PROCEDURE ON (B)(6) 2011 WITH A BIFURCATED DEVICE AND AN INFRARENAL AORTIC EXTENSION. PATIENT HAD A FOLLOW UP (B)(6) 2015 AND THE SCANS WERE REVIEWED AND DISPLAYED A PROXIMAL ENDOLEAK AND A TYPE II AND AAA SAC EXPANDED OF ALMOST 2 CM. THE PHYSICIAN ELECTED TO TREAT THE PATIENT ON (B)(6) 2015 BY RELINING WITH A BIFURCATED DEVICE AND A SUPERNAL AORTIC EXTENSION. PATIENT IS DOING WILL AFTER POST-SECONDARY PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    857325 AFX BIFURCATED MIH ENDOLOGIX BA25-80/16-40 W11-3489-008

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention