BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESOLUTE INTEGRITY RX CORONARY STENT SYSTEM

    MDR report key: 2041161 · Received March 29, 2011

    Report

    Report Number
    9612164-2011-00119
    Event Type
    Injury
    Date Received
    March 29, 2011
    Date of Event
    March 1, 2011
    Report Date
    March 1, 2011
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: STENT DEFORMATION. CALCIFICATION AT SITE OF PROLAPSE LIKELY RESPONSIBLE FOR THE EVENT. CONCLUSIONS: CALCIFICATION AT SITE OF PROLAPSE LIKELY RESPONSIBLE FOR THE EVENT.

    Description of Event or Problem · 1

    THE PHYSICIAN IMPLANTED A 2.5 MM DIAMETER X 22 MM LENGTH RESOLUTE INTEGRITY RAPID EXCHANGE (RX) DRUG-ELUTING STENT TO TREAT A LESION IN THE PROXIMAL RCA. THE DEVICE WAS INFLATED TO 16 ATMS. POST DEPLOYMENT ANGIOGRAM SHOWED SIGNIFICANT TISSUE/PLAQUE PROLAPSE THROUGH THE STENT. THE IVUS CONFIRMED THIS AND BALLOON POST DILATATION WAS PERFORMED, THEN ANOTHER RESOLUTE INTEGRITY STENT DEPLOYED WITHIN THIS STENT. NO OTHER CLINICAL SEQUELAE WERE REPORTED. CINE IMAGE REVIEW: REVIEW OF THE IVUS IMAGES OBSERVED THAT THERE WAS SIGNIFICANT TISSUE/PLAQUE EVIDENT MID STENT AND FROM THIS CONCLUDED THAT PROLAPSE OR GAPPING OCCURRED DURING POST DILATATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESOLUTE INTEGRITY RX CORONARY STENT SYSTEM NIQ MEDTRONIC IRELAND NA 0005228569

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention