BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AFX2

    MDR report key: 6058937 · Received October 26, 2016

    Report

    Report Number
    2031527-2016-00497
    Event Type
    Injury
    Date Received
    October 26, 2016
    Date of Event
    July 19, 2016
    Report Date
    September 29, 2016
    Manufacturer
    ENDOLOGIX INC.
    Product Code
    MIH
    UDI-DI
    00818009014870
    PMA / PMN Number
    P040002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AT THE COMPLETION OF THE INVESTIGATION, THE CLINICAL EVALUATION WAS ABLE TO CONFIRM THE CONTRALATERAL LIMB ENDOKNOT AND DIFFICULTY RESOLVING THE ENDOKNOT. ADDITIONALLY, THE CLINICAL EVALUATION WAS ABLE TO CONFIRM A TYPE 2 ENDOLEAK. THE CLINICAL ASSESSMENT WAS BASED ON NO MEDICAL RECORDS AND ADEQUATE PATIENT IMAGES. A MANUFACTURING OR DESIGN ISSUE HAS NOT BEEN IDENTIFIED OR SUSPECTED BASED ON THE EVALUATION OF THE REPORTED EVENT. 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; PATIENT ANATOMY, PATIENT HISTORY OF PERIPHERAL VASCULAR DISEASE WITH CALCIFICATIONS IN THE ILIACS, SHEATH EXCHANGES/MANIPULATIONS DURING RESOLUTION OF THE WIRE WRAP, AND ANGIOPLASTY OF THE LEFT ILIAC LIMB OF THE BIFURCATED DEVICE WITH A CODA BALLOON MIGHT HAVE CONTRIBUTED TO THE DISSECTION, AND SUBSEQUENT NEGATIVE SEQUELAE. DEVICES REMAIN IMPLANTED IN THE PATIENT.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING PATIENT INITIAL PROCEDURE ON (B)(6) 2016 THE CONTRA-LIMB WIRE BECAME ENTANGLED RESULTING IN AN ENDOKNOT. THE PHYSICIAN WAS ABLE TO RECONCILE THE KNOT WHICH PROLONGED THE PROCEDURE. POST PROCEDURE THE PATIENT WAS TAKEN BACK TO THE OPERATING ROOM FOR AN ISCHEMIC LEG AS WELL AS AN OCCLUDED LEFT EXTERNAL ILIAC ARTERY DUE TO A DISSECTION. THE PHYSICIAN COMPLETED A SURGICAL EXPLORATION OF THE LEFT COMMON FEMORAL ARTERY WITH PATCH ANGIOPLASTY AND PLACED STENTS IN THE LEFT COMMON ILIAC ARTERY AS WELL AS THE LEFT EXTERNAL ILIAC ARTERY TO RESOLVE THE DISSECTION AND OCCLUSION. HIS RECOVERY WAS COMPLICATED BY ACUTE ENCEPHALOPATHY WITH CONFUSION AND A MINIMAL LEFT SIDE RETROPERITONEAL HEMATOMA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    707654 AFX2 BIFURCATED MIH ENDOLOGIX INC. BEA25-70/I16-30 1355831-010 00818009014870

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Required Intervention INFRARENAL AORTO UNI-ILIAC- (B)(4)