BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESOLUTE INTEGRITY RX

    MDR report key: 2903546 · Received January 9, 2013

    Report

    Report Number
    9612164-2013-00042
    Event Type
    Injury
    Date Received
    January 9, 2013
    Date of Event
    December 9, 2012
    Report Date
    December 12, 2012
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P110013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PATIENT HAD AN ACUTE MI ON THE DAY OF THE INDEX PROCEDURE AND A 2.75MM DIAMETER X 12MM LENGTH RESOLUTE INTEGRITY DRUG ELUTING STENT WAS IMPLANTED IN THE PATIENT. IT WAS REPORTED THAT THE PATIENT PRESENTED TO HOSPITAL APPROXIMATELY 2 WEEKS LATER WITH A STENT THROMBOSIS. NO OTHER CLINICAL SEQUELAE WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    11040 RESOLUTE INTEGRITY RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND 0005831874

    Patients

    Seq Age Sex Outcome Treatment
    1 WAFARIN