BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESOLUTE INTEGRITY RX

    MDR report key: 3192412 · Received June 27, 2013

    Report

    Report Number
    9612164-2013-00671
    Event Type
    Injury
    Date Received
    June 27, 2013
    Date of Event
    December 1, 2013
    Report Date
    December 10, 2013
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P110013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION RESULTS: INHERENT RISK OF PROCEDURE ¿ (HAEMORRHAGE). EVALUATION CONCLUSIONS: INHERENT RISK OF PROCEDURE ¿ (HAEMORRHAGE). (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    APPROXIMATELY 6 MONTHS POST THE INDEX PROCEDURE THE PATIENT WAS HOSPITALIZED DUE TO A GI BLEED. A BLOOD TRANSFUSION WAS CARRIED OUT AND THE OUTCOME IS REPORTED AS CONTINUING. INVESTIGATOR HAS INDICATED THE EVENT WAS NOT RELATED TO THE STUDY DEVICE.

    Description of Event or Problem · 1

    DURING INDEX PROCEDURE THE PATIENT HAD ONE RESOLUTE INTEGRITY DRUG-ELUTING STENT DEPLOYED AT LAD WHICH CAUSED A DISSECTION. ANOTHER RESOLUTE INTEGRITY DRUG-ELUTING STENT WAS IMPLANTED AS TREATMENT OF THE DISSECTION. INVESTIGATOR INDICATED THAT THE EVENT WAS DEFINITELY RELATED TO THE STUDY DEVICE. PATIENT RECOVERED. IT IS REPORTED THAT APPROXIMATELY 11 DAYS POST INDEX PROCEDURE, THE PATIENT HAD A GI BLEED. INVESTIGATOR HAS ASSESSED THAT THE EVENT WAS POSSIBLY RELATED TO THE DEVICE. IT IS REPORTED THAT THE PATIENT IS CONTINUING WITH TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    292714 RESOLUTE INTEGRITY RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND 0006556753

    Patients

    Seq Age Sex Outcome Treatment
    1 00076 YR Hospitalization| R CLOPIDOGREL AND ASPIRIN.