BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AFX

    MDR report key: 6175751 · Received December 15, 2016

    Report

    Report Number
    2031527-2016-00582
    Event Type
    Injury
    Date Received
    December 15, 2016
    Date of Event
    November 9, 2016
    Report Date
    February 7, 2017
    Manufacturer
    ENDOLOGIX INC.
    Product Code
    MIH
    PMA / PMN Number
    P040002
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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 ANEURYSM SAC GROWTH. THE REPORTED UNKNOWN ENDOLEAK WAS DETERMINED TO BE A TYPE 3A ENDOLEAK. ADDITIONALLY THERE WAS EVIDENCE TO REASONABLY SUPPORT THE FOLLOWING OBSERVATIONS; A TYPE 2 ENDOLEAK, A NEAR TOTAL STENT CAGE COLLAPSE, AND RENAL ISCHEMIA. THE CLINICAL EVALUATION ADDITIONALLY FOUND EVIDENCE TO REASONABLY SUGGEST THE FOLLOWING CONTRIBUTING FACTORS TO THE REPORTED EVENT; OFF LABEL USE, PATIENT ANATOMY, MULTIPLE LARGE LUMBAR ARTERIES, AND RENAL ISCHEMIA POTENTIALLY FROM PLANNED COVERING OF THE RENAL ARTERIES. 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. DEVICES REMAIN IMPLANTED IN THE PATIENT AND WERE NOT AVAILABLE FOR FURTHER INVESTIGATION. 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.

    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.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED, THE PATIENT HAD A SECONDARY INTERVENTION ON (B)(6) 2016. THE PHYSICIAN ELECTED TO IMPLANT AN ADDITIONAL BIFURCATED STENT AND AN INFRARENAL AORTIC EXTENSION TO SEAL THE ENDOLEAK.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD AN INITIAL PROCEDURE ON (B)(6) 2013 WITH A BIFURCATED STENT, AN INFRARENAL AORTIC EXTENSION, AND A SUPRARENAL AORTIC EXTENSION. A FOLLOW UP COMPUTED TOMOGRAPHY (CT) DONE ON (B)(6) 2016 SHOWED AN UNKNOWN ENDOLEAK WITH POSSIBLE SAC GROWTH. THE PHYSICIAN PLANS TO RE-LINE THE INITIAL DEVICES. A SECONDARY INTERVENTION HAS NOT BEEN SCHEDULED, THE PATIENT REMAINS IN STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    828727 AFX BIFURCATED MIH ENDOLOGIX INC. BA25-100/I16-40 1047099-010

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention INFRARENAL AORTO UNI-ILIAC- (B)(4)| SUPRARENAL AORTA UNI-ILIAC- (B)(4)