BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT II BIFURCATED STENT GRAFT

    MDR report key: 6294187 · Received February 1, 2017

    Report

    Report Number
    2953200-2017-00136
    Event Type
    Injury
    Date Received
    February 1, 2017
    Date of Event
    January 20, 2017
    Report Date
    January 20, 2017
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTED INFORMATION: SEX, DATE OF BIRTH. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    OTHER RELEVANT DEVICE(S): ETLW1616C93EJ, SN (B)(4).

    Description of Event or Problem · 1

    AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 4.4 CM IN DIAMETER ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT ONE WEEK POST ENDURANT IMPLANT PROCEDURE, CT SCAN IMAGES SHOWED THROMBOSIS WAS OCCLUDING THE ENDURANT STENT GRAFTS STARTING FROM RIGHT COMMON ILIAC ARTERY TO THE BIFURCATED PART OF THE MAIN BODY BIFURCATED STENT GRAFT SYSTEM. THE ENDURANT CONTRALATERAL LIMB STENT GRAFT WAS CRUSHED AT TERMINAL BY THE MAIN BODY IPSILATERAL LIMB, AND THROMBOEMBOLISM OCCURRED IN THE RIGHT LEG. DURING THE INITIAL PROCEDURE STENT GRAFTS WERE APPROXIMATELY 20 MM IN DIAMETER, THE FINAL ANGIOGRAM SHOWED THERE WAS NO ABNORMALITY IN THE BLOODSTREAM AND THEREFORE NO KISSING BALLOON TECHNIQUE (KBT) WAS PERFORMED. THE PHYSICIAN ELECTED TO PERFORM A THROMBECTOMY WITH A FOGARTY CATHETER AND TWO ENDURANT ILIAC LIMBS WERE IMPLANTED BOTH SIDES RESPECTIVELY STARTING FROM BELOW THE MAIN BODY BIFURCATION, AND KBT WAS THEN PERFORMED. THE EVENT WAS RESOLVED. PER THE PHYSICIAN THE CAUSE OF THE EVENT IS RELATED TO THE PATIENT ANATOMY. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    76300 ENDURANT II BIFURCATED STENT GRAFT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND ETBF2816C145EJ

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention