BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPLETE SE ILIAC

    MDR report key: 5183295 · Received October 28, 2015

    Report

    Report Number
    9612164-2015-01704
    Event Type
    Injury
    Date Received
    October 28, 2015
    Date of Event
    September 28, 2015
    Report Date
    November 10, 2015
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIO
    PMA / PMN Number
    P090006
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT HISTORY OF LIFESTYLE LIMITING CLAUDICATION ON RIGHT. THE PATIENT PRESENTED FOR PTA STENTING OF CHRONIC TOTAL OCCLUSION OF THE RIGHT EXTERNAL ILIAC ARTERY. FOLLOWING STENT DEPLOYMENT THE DELIVERY SYSTEM WAS BEING REMOVED AND THE INNER CATHETER OF THE DEPLOYMENT SYSTEM REMAINED ON THE WIRE. X-RAY SHOWED THE CATHETER TIP IN THE VESSEL. ATTEMPTS MADE TO RETRIEVE THE TIP USING A SNARE WERE UNSUCCESSFUL. THE TIP WAS NAVIGATED INTO A REDUNDANT PELVIC VESSEL. THE STENTING PROCEDURE WAS COMPLETED SUCCESSFULLY. PATIENT WAS ADMITTED OVERNIGHT AND WAS DISCHARGED THE FOLLOWING DAY.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE PHYSICIAN WAS ATTEMPTING TO USE A COMPLETE SE DEVICE. THE TARGET LESION WAS THE RIGHT DISTAL ILIAC ARTERY AND HAD 90% STENOSIS, SEVERE CALCIFICATION AND SEVERE VESSEL TORTUOSITY. THE DEVICE WAS REMOVED FROM PACKAGING PER IFU AND INSPECTED WITH NO ISSUES NOTED. THE DEVICE WAS PREPPED PER THE IFU WITH NO ISSUES IDENTIFIED. RESISTANCE WAS NOT ENCOUNTERED ADVANCING THE COMPLETE SE DEVICE AND EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. THE DEVICE WAS DELIVERED AND THE STENT DEPLOYED WITHOUT ISSUE. AFTER DEPLOYMENT, THE STENT CATHETER WAS BEING REMOVED AND A LOT OF RESISTANCE WAS FELT DURING THE REMOVAL. THE LESION THAT WAS STENTED WAS HEAVILY CALCIFIED AND TORTUOUS. IT WAS REPORTED THAT THERE WAS A HEAVY AMOUNT OF CALCIFIED STENOSIS AT THE TURN IN THE ARTERY. THE CATHETER TIP GOT HUNG UP AT THIS LESION ON A STRUT. THE PHYSICIAN PULLED A LITTLE THEN FELT THE RESISTANCE. AN ATTEMPT WAS MADE TO ADVANCE THE STENT CATHETER, BUT IT WAS STUCK ON THE STRUT. THE PHYSICIAN GOT IT LOOSE AND THEN THE RADIOPAQUE MARKER FELL OFF AND INTO THE EXTERNAL ILIAC. IT TRAVELED DOWN TO THE PERONEAL, BUT IT WAS REMOVED AND PLANTED IN THE HYPOGASTRIC ARTERY. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    716769 COMPLETE SE ILIAC STENT, ILIAC NIO MEDTRONIC IRELAND 0007277305

    Patients

    Seq Age Sex Outcome Treatment
    1 00079 YR Hospitalization| R