BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESOLUTE INTEGRITY RX

    MDR report key: 3972603 · Received August 1, 2014

    Report

    Report Number
    9612164-2014-01015
    Event Type
    Malfunction
    Date Received
    August 1, 2014
    Date of Event
    June 16, 2014
    Report Date
    July 12, 2014
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P110013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION RESULTS: INHERENT RISK OF PROCEDURE (STENT DEFORMATION). PATIENT¿S CONDITION AFFECTED EFFECTIVENESS OF DEVICE (LESION MORPHOLOGY ¿ CALCIFICATION). (NO RESULTS AVAILABLE SINCE NO EVALUATION PERFORMED - DEVICE OR PROCEDURAL IMAGES NOT PROVIDED FOR REVIEW). (NONE) ¿ DEVICE NOT RETURNED FOR EVALUATION. EVALUATION CONCLUSIONS: DEVICE FAILURE/LACK OF EFFECTIVENESS RELATED TO PATIENT CONDITION (LESION MORPHOLOGY ¿ CALCIFICATION). INHERENT RISK OF PROCEDURE (STENT DEFORMATION). (B)(4).

    Description of Event or Problem · 1

    PHYSICIAN ATTEMPTED TO DEPLOY A RESOLUTE INTEGRITY 2.25X12MM DRUG ELUTING STENT. DURING DELIVERY STENT FAILED TO CROSS THE CALCIFIED LESION IN THE PROXIMAL OBTUSE MARGINAL DUE TO RESISTANCE CAUSED BY A LARGE AMOUNT OF CALCIUM. IT WAS REPORTED THERE WAS AN ACUTE ANGLE AT OSTIUM. IT WAS REPORTED THAT LEADING EDGE OF STENT BECAME DISFIGURED. THE LESION WAS PRE-DILATED AGAIN AND A RESOLUTE INTEGRITY 2.25X12MM STENT WAS USED TO COMPLETE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    451321 RESOLUTE INTEGRITY RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND 0007014236

    Patients

    Seq Age Sex Outcome Treatment
    1 00032 YR