BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESOLUTE INTEGRITY OTW

    MDR report key: 2821909 · Received November 7, 2012

    Report

    Report Number
    9612164-2012-01632
    Event Type
    Injury
    Date Received
    November 7, 2012
    Date of Event
    October 9, 2012
    Report Date
    October 9, 2012
    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

    EVALUATION RESULTS: INHERENT RISK OF PROCEDURE-FAILURE TO DELIVER STENT AND DISSECTION. PATIENT'S CONDITION AFFECTED EFFECTIVENESS OF DEVICE-HEAVILY CALCIFIED, MOST LIKELY PREVENTED DEPLOYMENT AND CONTRIBUTED TO THE VESSEL DISSECTION. NO RESULTS AVAILABLE SINCE NO EVALUATION PERFORMED. EVALUATION CONCLUSION: KNOWN INHERENT RISK OF PROCEDURE-FAILURE TO DELIVER STENT AND DISSECTION. DEVICE FAILURE/LACK OF EFFECTIVENESS RELATED TO PATIENT CONDITION-HEAVILY CALCIFIED, MOST LIKELY PREVENTED DEPLOYMENT AND CONTRIBUTED TO THE VESSEL DISSECTION. UNABLE TO CONFIRM COMPLAINT-DEVICE OR PROCEDURAL IMAGES NOT PROVIDED FOR REVIEW. (B)(4)

    Description of Event or Problem · 1

    IT IS REPORTED THAT A RESOLUTE INTEGRITY DRUG ELUTING STENT WAS UNABLE TO CROSS A HEAVILY CALCIFIED ARTERY. A DISSECTION IS REPORTED TO HAVE OCCURRED. ANOTHER BRAND DEVICE WAS USED TO COMPLETE THE CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESOLUTE INTEGRITY OTW STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND 0006132963

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization