BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESOLUTE INTEGRITY RX

    MDR report key: 3132424 · Received May 29, 2013

    Report

    Report Number
    9612164-2013-00582
    Event Type
    Injury
    Date Received
    May 29, 2013
    Date of Event
    May 16, 2013
    Report Date
    May 17, 2013
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P110013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION, RESULTS: INHERENT RISK OF PROCEDURE (DISSECTION). CONCLUSION: INHERENT RISK OF PROCEDURE (DISSECTION).

    Description of Event or Problem · 1

    DURING THE INDEX PROCEDURE, THE PATIENT HAD ONE RESOLUTE INTEGRITY DRUG ELUTING STENT IMPLANTED IN THE LAD. IT AS REPORTED THAT DURING IMPLANTATION WITH THIS STENT, A DISSECTION OCCURRED, THIS WAS TREATED WITH A SECOND RESOLUTE INTEGRITY DRUG ELUTING STENT. INVESTIGATOR HAS ASSESSED THAT THE EVENT WAS POSSIBLY RELATED TO THE DEVICE. IT IS REPORTED THAT THE PATIENT RECOVERED WITH TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236937 RESOLUTE INTEGRITY RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND 0006583482

    Patients

    Seq Age Sex Outcome Treatment
    1 00059 YR Required Intervention