BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESOLUTE INTEGRITY RX

    MDR report key: 2881843 · Received December 20, 2012

    Report

    Report Number
    9612164-2012-01820
    Event Type
    Injury
    Date Received
    December 20, 2012
    Date of Event
    October 16, 2012
    Report Date
    November 28, 2012
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P110013
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION RESULTS: INHERENT RISK OF PROCEDURE-STENT DISLODGEMENT. NO RESULTS AVAILABLE SINCE NO EVALUATION PERFORMED - DEVICE OR PROCEDURAL IMAGES NOT PROVIDED FOR REVIEW. CONCLUSION: INHERENT RISK OF PROCEDURE-STENT DISLODGEMENT. UNABLE TO CONFIRM COMPLAINT - DEVICE OR PROCEDURAL IMAGES NOT PROVIDED FOR REVIEW. (B)(4).

    Description of Event or Problem · 1

    INTERVENTIONAL GUIDE WIRES WERE PLACED INTO CORONARY ARTERIES TO INTRODUCE CORONARY STENTS AND BALLOONS. AS THE RESOLUTE INTEGRITY DRUG ELUTING STENT WAS BEING POSITIONED INTO A CORONARY ARTERY, IT SLIPPED OFF ITS BALLOON. THE BALLOON WAS REMOVED AND A SNARE RETRIEVAL DEVICE WAS USED TO REMOVE THE STENT FROM THE CORONARY ARTERY. PROCEDURE CONTINUED SUCCESSFULLY. NO CLINICAL SEQUELAE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESOLUTE INTEGRITY RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND 0006150519

    Patients

    Seq Age Sex Outcome Treatment
    1 00069 YR Required Intervention