BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AFX

    MDR report key: 6213334 · Received December 29, 2016

    Report

    Report Number
    2031527-2016-00596
    Event Type
    Injury
    Date Received
    December 29, 2016
    Date of Event
    September 7, 2016
    Report Date
    December 1, 2016
    Manufacturer
    ENDOLOGIX INC.
    Product Code
    MIH
    PMA / PMN Number
    P040002
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AT THE COMPLETION OF THE INVESTIGATION, BASED ON THE PATIENT INFORMATION RECEIVED, THE CLINICAL EVALUATION WAS NOT ABLE TO CONFIRM AN UNKNOWN ENDOLEAK. ADDITIONALLY THE ENDOLEAK ASSESSED THROUGH THE CLINICAL EVALUATION WAS DETERMINED TO BE A TYPE 2 ENDOLEAK. THE CLINICAL FOUND EVIDENCE TO REASONABLY SUGGEST THE FOLLOWING CONTRIBUTING FACTORS TO THE REPORTED EVENT; SEVERE CALCIFICATION AND PATIENT ANATOMY. A MANUFACTURING OR DESIGN ISSUE HAS NOT BEEN IDENTIFIED OR SUSPECTED BASED ON THE EVALUATION OF THE REPORTED EVENT. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD AN INITIAL PROCEDURE ON (B)(6) 2012 WITH A BIFURCATED STENT AND AN INFRARENAL AORTIC EXTENSION. ON (B)(6) 2015 THE PATIENT HAD A SUBSEQUENT ENDOVASCULAR PROCEDURE TO REPAIR A TYPE 3B ENDOLEAK. THE PHYSICIAN ELECTED TO IMPLANT AN ADDITIONAL BIFURCATED STENT TO SEAL THE ENDOLEAK. ON (B)(6) 2016 FOLLOW UP COMPUTED TOMOGRAPHY (CT) SHOWED AN UNKNOWN ENDOLEAK IN THE MIDDLE OF THE BIFURCATED GRAFT. THE PHYSICIAN DETERMINE THERE WAS NOT AN ENDOLEAK PRESENT AND ELECTED TO MONITOR THE PATIENT. A REVIEW OF PATIENT DATA RECEIVED FOR THE REPORTED EVENT SHOWED THE PATIENT HAS A TYPE 2 ENDOLEAK. THE PATIENT RECORDS ALSO REVEALED THE PATIENT WAS PREVIOUSLY TREATED FOR A TYPE 1B ENDOLEAK OF THE LEFT ILIAC ARTERY IN 2015. THE PHYSICIAN ELECTED TO IMPLANT A NON-ENDOLOGIX STENT AS WELL AS A HYPOGASTRIC PLUG TO SEAL THE ENDOLEAK. THE PATIENT HAS NOT BEEN SCHEDULED FOR A SUBSEQUENT ENDOVASCULAR PROCEDURE TO ADDRESS THE CURRENT TYPE 2 ENDOLEAK. THERE HAVE BEEN NO ADDITIONAL ADVERSE EVENTS REPORTED FOR THIS PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    862150 AFX BIFURCATED MIH ENDOLOGIX INC. BA22-90/I16-30 1032430-008

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Required Intervention AORTO UNI-ILIAC [INFRARENAL]- W11-4072R-028| BIFURCATED- 1341371-018