BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGRITY RX

    MDR report key: 3924692 · Received July 10, 2014

    Report

    Report Number
    9612164-2014-00782
    Event Type
    Malfunction
    Date Received
    July 10, 2014
    Date of Event
    June 13, 2014
    Report Date
    June 16, 2014
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MAF
    PMA / PMN Number
    P030009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION RESULTS: RELATED TO OPERATIONAL CONTEXT - ROOT CAUSE OF THE STENT DEFORMATION IS MOST LIKELY PROCEDURAL RELATED. FAILURE TO FOLLOW INSTRUCTIONS ¿ FORCE USED WHEN ATTEMPTING TO DELIVER THE DEVICE. (DEFORMATION PROBLEM). EVALUATION CONCLUSIONS: RELATED TO OPERATIONAL CONTEXT - ROOT CAUSE OF THE STENT DEFORMATION IS MOST LIKELY PROCEDURAL RELATED. FAILURE TO FOLLOW INSTRUCTIONS ¿ FORCE USED WHEN ATTEMPTING TO DELIVER THE DEVICE. (B)(4).

    Description of Event or Problem · 1

    PHYSICIAN WAS ATTEMPTING TO DELIVER ONE INTEGRITY BARE METAL STENT (3.50MM X 26MM) TO A LESION IN THE RCA WITH LIGHT TORTUOSITY. DEVICE HAD BEEN PREPARED WITH NO ISSUES NOTED. DURING ADVANCEMENT THE DEVICE BECAME CAUGHT. FORCE WAS USED WHEN RESISTANCE WAS MET AND STENT STRUT DEFORMATION OCCURRED. ANOTHER DEVICE (INTEGRITY 3.0/26MM) WAS USED TO COMPLETE THE PROCEDURE, WITH NO ISSUES REPORTED. NO ADVERSE EVENT TO THE PATIENT. NO CLINICAL SEQUELAE WERE REPORTED. EVALUATION SUMMARY: THE HYPOTUBE WAS KINKED 40.2CM DISTAL TO THE STRAIN RELIEF. THE PROXIMAL BALLOON PILLOW AND THE DISTAL BALLOON FOLDS WERE PARTIALLY EXPANDED WITH LIQUID VISIBLE INSIDE. NUMEROUS STRUTS ON THE 1ST TWO PROXIMAL STENT SEGMENTS WERE RAISED AND DEFORMED. A NUMBER OF STRUTS ON THE 9TH AND 10TH PROXIMAL SEGMENTS WERE MISALIGNED. THE REMAINING SEGMENTS WERE INTACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    402960 INTEGRITY RX STENT, CORONARY MAF MEDTRONIC IRELAND 0006815364

    Patients

    Seq Age Sex Outcome Treatment
    1 00062 YR