BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESOLUTE INTEGRITY RX

    MDR report key: 3955229 · Received July 24, 2014

    Report

    Report Number
    9612164-2014-00994
    Event Type
    Malfunction
    Date Received
    July 24, 2014
    Date of Event
    June 27, 2014
    Report Date
    June 27, 2014
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P110013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION RESULTS: FAILURE TO FOLLOW INSTRUCTION (EXCESSIVE FORCE USED DURING DELIVERY). INHERENT RISK OF PROCEDURE (STENT DEFORMATION). NO RESULTS AVAILABLE SINCE NO EVALUATION PERFORMED. (NO DEVICE RECEIVED FOR EVALUATION). EVALUATION CONCLUSION: FAILURE TO FOLLOW INSTRUCTION (EXCESSIVE FORCE USED DURING DELIVERY). KNOWN INHERENT RISK OF PROCEDURE (STENT DEFORMATION). UNABLE TO CONFIRM COMPLAINT. (BASED ON THE INFORMATION AVAILABLE NO ROOT CAUSE CAN BE DETERMINED). (B)(4).

    Description of Event or Problem · 1

    DURING AN ATTEMPT TO TREAT A LESION USING RESOLUTE INTEGRITY DRUG ELUTING STENT, IT WAS REPORTED THAT WHILE ADVANCING THE DEVICE TO THE TARGET LESION, PHYSICIAN ENCOUNTERED RESISTANCE. EXCESSIVE FORCE WAS USED WHEN ATTEMPTING TO POSITION THE STENT. THE STENT WAS REMOVED FROM THE PATIENT AND THE PHYSICIAN NOTED THAT THE STENT WAS DAMAGED. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    434933 RESOLUTE INTEGRITY RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND 0007124372

    Patients

    Seq Age Sex Outcome Treatment
    1