BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESOLUTE INTEGRITY RX

    MDR report key: 4234152 · Received November 7, 2014

    Report

    Report Number
    9612164-2014-01437
    Event Type
    Malfunction
    Date Received
    November 7, 2014
    Date of Event
    October 9, 2014
    Report Date
    December 2, 2014
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P110013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION RESULTS: FAILURE TO FOLLOW INSTRUCTIONS (FORCE WAS APPLIED TO DEVICE DURING DELIVERY). INHERENT RISK OF PROCEDURE (STENT DEFORMATION). PATIENT'S CONDITION AFFECTED EFFECTIVENESS OF DEVICE (TARGET LESION EXHIBITED SEVERE CALCIFICATION, EXCESSIVE TORTUOSITY AND 70-80% STENOSIS). NO RESULTS AVAILABLE SINCE NO EVALUATION PERFORMED (DEVICE NOT RETURNED FOR EVALUATION). EVALUATION CONCLUSION: FAILURE TO FOLLOW INSTRUCTIONS (FORCE WAS APPLIED TO DEVICE DURING DELIVERY). KNOWN INHERENT RISK OF PROCEDURE (STENT DEFORMATION). DEVICE FAILURE/LACK OF EFFECTIVENESS RELATED TO PATIENT CONDITION (TARGET LESION EXHIBITED SEVERE CALCIFICATION, EXCESSIVE TORTUOSITY AND 70-80% STENOSIS). UNABLE TO CONFIRM COMPLAINT (DEVICE NOT RETURNED FOR EVALUATION). (B)(4).

    Description of Event or Problem · 1

    PHYSICIAN WAS ATTEMPTING TO TREAT A LESION IN THE LAD-CX USING A RESOLUTE INTEGRITY DRUG ELUTING STENT. THE LESION WAS SEVERELY CALCIFIED WITH 70-80% STENOSIS AND THE VESSEL WAS EXCESSIVELY TORTUOUS. THE LESION WAS PRE-DILATED WITH A 2.0 X 15MM BALLOON DILATATION CATHETER. THE RESOLUTE INTEGRITY STENTING DEVICE WAS THEN ADVANCED TO THE TARGET LESION BUT IT COULD NOT CROSS THE LESION. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE AND FORCE WAS APPLIED DURING THE ATTEMPTED DELIVERY. PHYSICIAN WITHDREW THE DEVICE AND NOTED THAT THE STENT WAS DAMAGED. A RESOLUTE INTEGRITY 2.75 X 18MM WAS USED TO COMPLETE THE PROCEDURE. THE RESOLUTE INTEGRITY DEVICE HAD BEEN INSPECTED AND PREPPED PRIOR TO USE WITH NO ISSUES NOTED. THE PHYSICIAN INDICATED THAT THE EVENT WAS DUE TO USE OF THE DEVICE IN A DIFFICULT LESION. NO CLINICAL SEQUELAE WERE REPORTED.

    Description of Event or Problem · 1

    EVALUATION SUMMARY: THE DISTAL TIP WAS FLARED INDICATING THAT IT MAY HAVE BEEN STUBBED DURING ADVANCEMENT. A NUMBER OF STRUTS ON THE 8TH AND 9TH PROXIMAL SEGMENTS WERE PARTIALLY RAISED AND DEFORMED. THE REMAINING SEGMENTS WERE INTACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    720321 RESOLUTE INTEGRITY RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND 0007009742

    Patients

    Seq Age Sex Outcome Treatment
    1