BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESOLUTE INTEGRITY RX

    MDR report key: 2894968 · Received January 3, 2013

    Report

    Report Number
    9612164-2013-00013
    Event Type
    Injury
    Date Received
    January 3, 2013
    Date of Event
    December 6, 2012
    Report Date
    December 6, 2012
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P110013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: RESULTS - INHERENT RISK OF PROCEDURE (STENT THROMBOSIS). CONCLUSIONS: INHERENT RISK OF PROCEDURE - (STENT THROMBOSIS). (B)(4).

    Description of Event or Problem · 1

    THE PHYSICIAN SUCCESSFULLY DEPLOYED 2 RESOLUTE INTEGRITY DRUG-ELUTING STENTS OVERLAPPING TO RCA LESION WITH 100% STENOSIS AND EXCESSIVE TORTUOSITY DURING PCI TO TREAT SUB-ACUTE MI. APPROXIMATELY 7 DAYS LATER PATIENT DEVELOPED VF, THROMBUS WAS ASPIRATED AND REMAINING THROMBUS WAS CRUSHED USING A BALLOON CATHETER. ONE NON-MEDTRONIC STENT WAS DEPLOYED IN RCA OVERLAPPING ONE OF THE RESOLUTE INTEGRITY STENTS. THE PATIENT RECOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2247 RESOLUTE INTEGRITY RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND 0006256449

    Patients

    Seq Age Sex Outcome Treatment
    1 00073 YR Required Intervention