BEUDAMED
    FDA Adverse Event Death Summary report: N

    AFX

    MDR report key: 6216909 · Received December 31, 2016

    Report

    Report Number
    2031527-2016-00604
    Event Type
    Death
    Date Received
    December 31, 2016
    Date of Event
    December 2, 2016
    Report Date
    February 27, 2017
    Manufacturer
    ENDOLOGIX INC.
    Product Code
    MIH
    PMA / PMN Number
    P040002
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE THE INCIDENT SAMPLE HAS NOT BEEN RECEIVED FOR EVALUATION. IF THE SAMPLE IS RECEIVED OR IF ADDITIONAL INFORMATION PERTINENT TO THE INCIDENT IS OBTAINED, A FOLLOW-UP REPORT WILL BE SUBMITTED. DEVICES HAVE NOT BEEN RETURNED.

    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 BILATERAL TYPE 1B ENDOLEAKS, RUPTURE, ACUTE RENAL FAILURE, ACUTE BLOOD LOSS AND MULTIPLE ORGAN FAILURE. THE CLINICAL ASSESSMENT ALSO IDENTIFIED A TYPE 2 ENDOLEAK AT 17 MONTHS POST IMPLANT. THE CLINICAL EVALUATION ADDITIONALLY FOUND EVIDENCE TO REASONABLY SUGGEST THE FOLLOWING CONTRIBUTING FACTORS TO THE REPORTED EVENT; OFF LABEL USE, PATIENT ANATOMY AND CALCIFIED ILIAC LANDING ZONES. THE COMPLICATIONS OF THE RUPTURE, MASSIVE BLOOD LOSS, SHOCK AND MULTIPLE ORGAN FAILURE POST-ENDOVASCULAR REPAIR COUPLED WITH PREEXISTING COMORBIDITIES MOST LIKELY CONTRIBUTED TO THE PATIENT'S DEMISE SEVEN DAYS POST ENDOVASCULAR REPAIR. THE REVIEW OF MANUFACTURING LOT CONFIRMED ALL DEVICES MET SPECIFICATIONS PRIOR TO RELEASE. THE EVENT DEVICES HAVE NOT BEEN RETURNED 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

    PATIENT INITIALLY IMPLANTED WITH A BIFURCATED STENT, A SUPRARENAL AORTIC EXTENSION, AND A LIMB EXTENSION ON (B)(6) 2015. THE PATIENT CAME IN EMERGENTLY WITH A RUPTURE, THERE WAS A BILATERAL ILIAC RUPTURE CONNECTED TO THE ABDOMINAL RUPTURE. THE PHYSICIAN IDENTIFIED BILATERAL TYPE 1B ENDOLEAKS. THE PHYSICIAN ELECTED TO IMPLANT 3 OVATION LIMB EXTENSIONS TO SEAL THE ENDOLEAK. THE PROCEDURE WAS COMPLETED AND COMPUTED TOMOGRAPHY (CT) SCAN DID NOT SHOW ANY LEAKS. THE PATIENT WAS TREATED FOR BLOOD LOSS AND THE RETROPERITONEAL SPACE WAS EVACUATED. FOLLOWING THE PROCEDURE THE PATIENT TRANSFERRED TO THE INTENSIVE CARE UNIT. ON (B)(6) 2016 THE PATIENT WAS REPORTED TO BE IN RENAL FAILURE AND RECEIVING HYDRATION, PATIENT WAS ALSO ON VENTILATION. ON (B)(6) 2016 THE PATIENT EXPIRED DUE TO MULTIPLE ORGAN FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    866717 AFX LIMB MIH ENDOLOGIX INC. I20-13/C88F SA 1047364-003

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Death| R AORTO UNI-ILIAC [SUPRARENAL]- (B)(4)| BIFURCATED- (B)(4)