BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMPLETE SE ILIAC PERIPHERAL STENT SYSTEM

    MDR report key: 2201513 · Received August 2, 2011

    Report

    Report Number
    9612164-2011-00867
    Event Type
    Malfunction
    Date Received
    August 2, 2011
    Date of Event
    July 4, 2011
    Report Date
    July 4, 2011
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIO
    PMA / PMN Number
    P090006
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION, METHOD: X-RAY, FLUOROSCOPY, IVUS, CT, MRI, ETC. EVALUATION, RESULTS: PATIENT LESION MORPHOLOGY; DOCTOR FOUND THE ANGLE TOO SMALL BETWEEN THE BILATERAL AND ANTERIOR ARTERY. EVALUATION CODES, CONCLUSION: PATIENT LESION MORPHOLOGY; DOCTOR FOUND THE ANGLE TOO SMALL BETWEEN THE BILATERAL AND ANTERIOR ARTERY. CINE IMAGE REVIEW: PROCEDURAL IMAGES DID NOT SHOW THE ATTEMPTED DELIVERY AND DEPLOYMENT OF THE STENT AT THE OTHER SITE IN THE VESSEL.

    Description of Event or Problem · 1

    THE PHYSICIAN WAS ATTEMPTING DEPLOY A 6 MM DIAMETER X 100MM LENGTH COMPLETE SE (SELF EXPANDING) PERIPHERAL STENT TO TREAT A LESION IN A PATIENT. IT WAS REPORTED THAT WHEN THE PHYSICIAN TRIED TO DEPLOY THE STENT, HE FOUND IT DIFFICULT TO DEPLOY. THE PHYSICIAN REPORTED THAT THE ANGLE WAS TOO SMALL BETWEEN THE BILATERAL AND ANTERIOR ARTERY. AFTER SEVERAL ATTEMPTS, THE STENT WAS STRETCHED, AND IT WAS REMOVED AND IMPLANTED IN THE ILIAC ARTERY OF THE PATIENT SUCCESSFULLY. NO PATIENT INJURY OCCURRED AND NO CLINICAL SEQUELAE WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COMPLETE SE ILIAC PERIPHERAL STENT SYSTEM NIO MEDTRONIC IRELAND NA 0005571351

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK