BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESOLUTE INTEGRITY RX

    MDR report key: 3012740 · Received March 20, 2013

    Report

    Report Number
    9612164-2013-00316
    Event Type
    Injury
    Date Received
    March 20, 2013
    Date of Event
    February 15, 2013
    Report Date
    February 18, 2013
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P110013
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION RESULTS: INHERENT RISK OF PROCEDURE-STENT DISLODGEMENT/FAILURE TO DELIVER STENT. PATIENT'S CONDITION AFFECTED EFFECTIVENESS OF DEVICE-LESION MORPHOLOGY (VERY CALCIFIED). NO RESULTS AVAILABLE SINCE NO EVALUATION PERFORMED- DEVICE OR PROCEDURAL IMAGES NOT PROVIDED FOR REVIEW. EVALUATION CONCLUSION: INHERENT RISK OF PROCEDURE-STENT DISLODGEMENT/FAILURE TO DELIVER STENT. UNABLE TO CONFIRM COMPLAINT - DEVICE OR PROCEDURAL IMAGES NOT PROVIDED FOR REVIEW. DEVICE FAILURE/LACK OF EFFECTIVENESS RELATED TO PATIENT CONDITION-LESION MORPHOLOGY (VERY CALCIFIED). (B)(4).

    Description of Event or Problem · 1

    THE PHYSICIAN WAS ATTEMPTING TO IMPLANT A RESOLUTE INTEGRITY DRUG ELUTING STENT IN THE MID CX WHICH WAS REPORTED TO BE A VERY CALCIFIED LESION. NO ABNORMALITY WAS NOTED DURING PREPARATION OF THE DEVICE. DURING DELIVERY THE STENT DISLODGED FROM THE BALLOON AND INFORMATION PROVIDED CONFIRMS THE STENT WAS PROBABLY DAMAGED BY CALCIFICATION AND "NOTHING WAS EASY" DURING THE PROCEDURE. THE STENT WAS REMOVED FROM THE PATIENT AND NO CLINICAL SEQUELAE REPORTED. PATIENT IS FINE POST PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    115561 RESOLUTE INTEGRITY RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND 0006549034

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention