BEUDAMED
    FDA Adverse Event Death Summary report: N

    AFX

    MDR report key: 6049520 · Received October 22, 2016

    Report

    Report Number
    2031527-2016-00495
    Event Type
    Death
    Date Received
    October 22, 2016
    Date of Event
    July 2, 2016
    Report Date
    September 23, 2016
    Manufacturer
    ENDOLOGIX INC.
    Product Code
    MIH
    UDI-DI
    00818009014450
    PMA / PMN Number
    P040002
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AT THE COMPLETION OF THE INVESTIGATION, THE CLINICAL EVALUATION WAS ABLE TO CONFIRM THE TYPE 3B ENDOLEAK. ADDITIONALLY, THE CLINICAL EVALUATION ALSO FOUND EVIDENCE TO SUPPORT STENOSIS, DISSECTION, TYPE IA ENDOLEAK THAT OCCURRED DURING THE INITIAL IMPLANT. THE CLINICAL ASSESSMENT WAS BASED ON SUB OPTIMAL MEDICAL RECORDS AND SUB OPTIMAL PATIENT IMAGES. 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 ROOT CAUSE OF THE REPORTED EVENT IS UNKNOWN, THERE IS NOT ENOUGH INFORMATION TO DETERMINE THE ROOT CAUSE OF THE REPORTED EVENT. THE EVENT DEVICES REMAIN IMPLANTED IN THE PATIENT AND WERE NOT RETURNED FOR FURTHER EVALUATION. THE CLINICAL EVALUATION FOUND FURTHER EVIDENCE TO REASONABLY SUGGEST THE FOLLOWING CONTRIBUTING FACTORS TO THE REPORTED EVENT; OFF LABEL USE, PATIENT ANATOMY, SIGNIFICANT PERIPHERAL VASCULAR DISEASE, BILATERAL ILIAC DISEASE WITH CALCIFICATION, CALCIFICATION IN THE RIGHT ILIAC, AND CONTRIBUTING FACTORS TO THE TYPE 3B ENDOLEAK; INTRAOPERATIVE ANGIOPLASTY OF THE LIMB DUE TO STENOSIS OF THE NATIVE VESSEL AND/OR A MANUFACTURING DEFECT.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING INITIAL IMPLANT OF A LIMB EXTENSION A TYPE 3B ENDOLEAK WAS IDENTIFIED WHEN THE OPERATIVE ANGIOGRAM WAS COMPLETED. THE PHYSICIAN SEALED THE ENDOLEAK BY IMPLANTING AN ADDITIONAL LIMB EXTENSION. POST OPERATIVE DAY 6 THE PATIENT EXPIRED WHILE IN HOSPICE CARE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    700669 AFX LIMB MIH ENDOLOGIX INC. I16-16/C55F SA 1358971-009 00818009014450

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Death BIFURCATED STENT- 1356565-010| INFRARENAL AORTO UNI-ILIAC- 1252542-002| LIMB EXTENSION- 1252578-002| LIMB EXTENSION- 1298057-024| LIMB EXTENSION- 1299320-003| SUPRARENAL AORTA UNI-ILIAC- 1449830-017