BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESOLUTE INTEGRITY OTW

    MDR report key: 3223709 · Received July 12, 2013

    Report

    Report Number
    9612164-2013-00709
    Event Type
    Injury
    Date Received
    July 12, 2013
    Date of Event
    June 15, 2013
    Report Date
    June 15, 2013
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P110013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: ROOT CAUSE IS UNDETERMINED. NO DEVICE OR PROCEDURAL IMAGES WERE PROVIDED FOR REVIEW. STENT THROMBOSIS AND MI. CONCLUSIONS: STENT THROMBOSIS AND MI. ROOT CAUSE IS UNDETERMINED. DEVICE OR PROCEDURAL IMAGES NOT PROVIDED FOR REVIEW. (B)(4).

    Description of Event or Problem · 1

    PHYSICIAN IMPLANTED A RESOLUTE INTEGRITY OTW DRUG ELUTING STENT IN THE LAD VESSEL TO TREAT A STEMI EVENT. THE LESION WAS PRE-DILATED. IT WAS REPORTED THAT THE RESOLUTE STENT WAS NOT FULLY EXPANDED. IMPLANTATION WAS SUCCESSFUL AND NO COMPLICATIONS WERE REPORTED. PATIENT WAS DISCHARGED ON PLAVIX. APPROXIMATELY 4 DAYS LATER THE PATIENT WAS HOSPITALIZED DUE TO STENT THROMBOSIS OF THE RESOLUTE STENT, PATIENT SUFFERED A STEMI. PHYSICIAN CHANGED THE PATIENT¿S MEDICATION FROM PLAVIX TO BRELENTA AND PERFORMED A REVASCULARISATION USING TWO NON-MEDTRONIC STENTS TO TREAT THE THROMBUS. THE RELATIONSHIP TO THE DEVICE WAS NOT ASSESSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    322967 RESOLUTE INTEGRITY OTW STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 00042 YR Required Intervention