BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESOLUTE INTEGRITY RX

    MDR report key: 4033453 · Received August 25, 2014

    Report

    Report Number
    9612164-2014-01130
    Event Type
    Malfunction
    Date Received
    August 25, 2014
    Date of Event
    July 30, 2014
    Report Date
    July 30, 2014
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P110013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION RESULTS: INHERENT RISK OF PROCEDURE ¿ (STENT DEFORMATION). RELATED TO ANOTHER DEVICE ¿ (RESISTANCE FELT WHILE THE DEVICE WAS INSIDE THE GUIDELINER). EVALUATION CONCLUSIONS: OPERATIONAL CONTEXT CONTRIBUTED TO EVENT ¿ (RESISTANCE FELT WHILE THE DEVICE WAS INSIDE THE GUIDELINER). INHERENT RISK OF PROCEDURE ¿ (STENT DEFORMATION). (B)(4).

    Description of Event or Problem · 1

    PHYSICIAN ATTEMPTED TO DEPLOY ONE RESOLUTE INTEGRITY DRUG-ELUTING STENT (3.00 X 34) THROUGH INNER CATHETER (GUIDELINER, JLL) DURING THE PCI. THE PHYSICIAN FELT RESISTANCE OF THE RELEVANT DEVICE, AND IT WAS REMOVED OUTSIDE OF THE PATIENT BODY AND CONFIRMED THAT STENT STRUT WAS INVERTED. THE PHYSICIAN STOPPED USING THE RELEVANT DEVICE AND USED ANOTHER ONE (SAME MODEL AS REPLACEMENT) TO CONTINUE THE OPERATION. THERE WAS NO ADVERSE EVENT TO THE PATIENT. NO CLINICAL SEQUELAE WERE REPORTED. EVALUATION SUMMARY: THE STENT WAS POSITIONED BETWEEN THE MARKER BANDS AS PER SPECIFICATIONS. SOME STRUTS ON THE 1ST DISTAL STENT SEGMENT WERE RAISED. THE DISTAL TIP WAS DAMAGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    512555 RESOLUTE INTEGRITY RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND 0006865875

    Patients

    Seq Age Sex Outcome Treatment
    1