BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESOLUTE INTEGRITY RX CORONARY STENT SYSTEM

    MDR report key: 2102992 · Received May 12, 2011

    Report

    Report Number
    9612164-2011-00422
    Event Type
    Malfunction
    Date Received
    May 12, 2011
    Date of Event
    April 15, 2011
    Report Date
    April 16, 2011
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL: RESULTS: (DEVICE OR CINE IMAGES HAVE NOT BEEN RETURNED FOR REVIEW), (POSSIBLE INTERACTION WITH THE DEPLOYED XIENCE STENT). CONCLUSION: (POSSIBLE INTERACTION WITH THE DEPLOYED XIENCE STENT).

    Description of Event or Problem · 1

    THE PHYSICIAN WAS ATTEMPTING TO DEPLOY A 2.25 MM DIAMETER X 22 MM LENGTH RESOLUTE INTEGRITY RAPID EXCHANGE (RX) DRUG ELUTING STENT TO TREAT A LESION IN THE DISTAL RCA IN A PT. A XIENCE PRIME STENT WAS IMPLANTED BEFORE THE RESOLUTE INTEGRITY STENT IN THE MID RCA DURING THE SAME PROCEDURE. IT WAS REPORTED THAT THE STENT DISLODGED UPON REMOVAL FROM RCA, AFTER A FAILED ATTEMPT TO PASS THE LESION. IT WAS REPORTED THAT THE PHYSICIAN TRIED TO RETRIEVE THE DISLODGED STENT; HOWEVER, WAS UNABLE TO DO SO. THE DISLODGED STENT WAS LEFT IN THE PROXIMAL RCA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESOLUTE INTEGRITY RX CORONARY STENT SYSTEM NIQ MEDTRONIC IRELAND NA 0004881069

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK