BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPLETE SE SFA

    MDR report key: 5073921 · Received September 14, 2015

    Report

    Report Number
    9612164-2015-01516
    Event Type
    Injury
    Date Received
    September 14, 2015
    Date of Event
    August 5, 2015
    Report Date
    August 17, 2015
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIP
    PMA / PMN Number
    P110040
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PROCEDURAL IMAGE REVIEW: STILL PROCEDURAL IMAGES WERE PROVIDED FOR REVIEW. THE STILL IMAGES CONFIRMED THAT THE STENT HAD FRACTURED IN-VIVO. (B)(4).

    Description of Event or Problem · 1

    THE PHYSICIAN IMPLANTED A COMPLETE SE DEVICE TO TREAT A MID TO DISTAL RIGHT SFA LESION EXHIBITING A LITTLE VESSEL TORTUOSITY AND MODERATE CALCIFICATION. THE DEVICE WAS REMOVED FROM PACKAGING PER IFU AND INSPECTED WITH NO ISSUES NOTED. DEVICE WAS PREPPED PER THE IFU WITH NO ISSUES IDENTIFIED. IT WAS REPORTED THAT APPROXIMATELY 15 MONTHS POST PROCEDURE DURING A FOLLOW UP LEG PROCEDURE, IT WAS NOTED THAT THE PREVIOUSLY DEPLOYED STENT HAD FRACTURED IN HALF. THIS WAS TREATED WITH A NON-MEDTRONIC STENT. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    607071 COMPLETE SE SFA STENT, SUPERFICIAL FEMORAL ARTERY NIP MEDTRONIC IRELAND 0007090116

    Patients

    Seq Age Sex Outcome Treatment
    1 00069 YR Required Intervention