BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESOLUTE INTEGRITY RX

    MDR report key: 2820195 · Received November 6, 2012

    Report

    Report Number
    9612164-2012-01628
    Event Type
    Malfunction
    Date Received
    November 6, 2012
    Date of Event
    October 1, 2012
    Report Date
    October 8, 2012
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P110013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION RESULTS AND CONCLUSION: CAUSED BY ANOTHER DRUG/DEVICE- STENT CAUGHT ON A PREVIOUSLY DEPLOYED STENT. NO RESULTS AVAILABLE SINCE NO EVALUATION PERFORMED. (B)(4).

    Description of Event or Problem · 1

    THE PHYSICIAN WAS ATTEMPTING TO IMPLANT A RESOLUTE INTEGRITY DRUG ELUTING STENT IN THE RCA. THE LESION WAS PRE-DILATED; HOWEVER, THE STENT STRUT GOT CAUGHT ON A PREVIOUSLY DEPLOYED STENT AND BECAME DAMAGED. NO PATIENT OR PROCEDURAL ISSUES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESOLUTE INTEGRITY RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND 0006126775

    Patients

    Seq Age Sex Outcome Treatment
    1