BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTEGRITY RX

    MDR report key: 4143271 · Received October 6, 2014

    Report

    Report Number
    9612164-2014-01271
    Event Type
    Injury
    Date Received
    October 6, 2014
    Date of Event
    September 5, 2014
    Report Date
    September 8, 2014
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MAF
    PMA / PMN Number
    P030009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS AND CONCLUSIONS: (LESION MORPHOLOGY). (PREVIOUSLY IMPLANTED NON-MEDTRONIC STENT IN VESSEL). (DISLODGED STENT). (DEVICE OR PROCEDURAL IMAGES WERE NOT RETURNED FOR EVALUATION). (B)(4).

    Description of Event or Problem · 1

    IT WAS INTENDED TO USE AN INT30022X BARE METAL STENT TO TREAT A PREVIOUSLY STENTED, MODERATELY TORTUOUS VESSEL IN THE RCA WITH 75-80% CALCIFICATION. IT WAS REPORTED THAT THE LESION WAS AN ECCENTRIC LONG LESION THAT WAS DIFFUSELY DISEASED. THE DEVICE WAS INSPECTED AND PREPPED PRIOR TO USE, WITH NO ISSUES NOTED. DURING THE POSITIONING OF THE STENT, THE PHYSICIAN ENCOUNTERED DIFFICULTY IN CROSSING A PREVIOUSLY IMPLANTED NON-MEDTRONIC STENT. IT IS REPORTED THAT THE INTEGRITY STENT BECAME CAUGHT IN THE PREVIOUSLY DEPLOYED STENT AND DISLODGED FROM THE BALLOON. AN INTEGRITY 2.75 X 08 MM STENT AND A NON-MEDTRONIC BALLOON WERE USED TO DEPLOY THE DISLODGED STENT. NO PATIENT COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    624489 INTEGRITY RX STENT, CORONARY MAF MEDTRONIC IRELAND 0007082824

    Patients

    Seq Age Sex Outcome Treatment
    1 00056 YR Required Intervention