BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESOLUTE INTEGRITY RX

    MDR report key: 3891352 · Received June 24, 2014

    Report

    Report Number
    9612164-2014-00671
    Event Type
    Malfunction
    Date Received
    June 24, 2014
    Date of Event
    May 25, 2014
    Report Date
    August 15, 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

    RESULTS: STENT DISLODGEMENT. CONCLUSION: STENT DISLODGEMENT. (B)(4).

    Additional Manufacturer Narrative · 1

    EVALUATION RESULTS: INHERENT RISK OF PROCEDURE (FAILURE TO DELIVER STENT AND STENT DEFORMATION). PATIENT CONDITION AFFECTED EFFECTIVENESS OF THE DEVICE (CALCIFIED LESION WITH 80% STENOSIS FOLLOWING PRE-DILATATION. DIFFICULT LESION ANATOMY WAS REPORTED TO HAVE CONTRIBUTED TO THE EVENT). DEFORMATION PROBLEM. NO RESULTS AVAILABLE SINCE NO EVALUATION WAS PERFORMED. EVALUATION CONCLUSION: KNOWN INHERENT RISK OF PROCEDURE (FAILURE TO DELIVER STENT AND STENT DEFORMATION). DEVICE FAILURE/LACK OF EFFECTIVENESS RELATED TO PATIENT CONDITION DEVICE (CALCIFIED LESION WITH 80% STENOSIS FOLLOWING PRE-DILATATION. DIFFICULT LESION ANATOMY WAS REPORTED TO HAVE CONTRIBUTED TO THE EVENT). UNABLE TO CONFIRM COMPLAINT. (B)(4).

    Description of Event or Problem · 1

    THE PHYSICIAN WAS TREATING A CALCIFIED LESION IN THE MID CX. THE LESION EXHIBITED 85% STENOSIS AND WAS PRE-DILATED PRIOR TO THE ATTEMPTED PLACEMENT OF THE RSINT30026X STENT. THE LESION HAD 80% STENOSIS FOLLOWING PRE-DILATATION. THE RESOLUTE INTEGRITY STENT COULD NOT CROSS THE LESION AND WAS REMOVED. UPON REMOVAL IT WAS REPORTED THAT THE STENT STRUTS WERE DAMAGED. THE FAILURE TO CROSS THE LESION WAS REPORTED TO HAVE BEEN DUE TO THE DIFFICULT LESION ANATOMY. THE PROCEDURE WAS COMPLETED WITH ANOTHER PRODUCT. NO CLINICAL SEQUELAE WERE REPORTED.

    Description of Event or Problem · 1

    DEVICE EVALUATION: THE DEVICE WAS RETURNED WITHOUT THE STENT ON PRESENT ON THE DELIVERY SYSTEM . CRIMP IMPRESSIONS WERE VISIBLE ALONG THE WORKING LENGTH OF THE BALLOON. THERE WAS NO EVIDENCE OF DAMAGE TO THE BALLOON. THE DELIVERY SYSTEM WAS KINKED ON THE HYPOTUBE AT 21CM AND 87CM DISTAL TO THE STRAIN RELIEF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    368198 RESOLUTE INTEGRITY RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND 0006944842

    Patients

    Seq Age Sex Outcome Treatment
    1