BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESOLUTE INTEGRITY RX

    MDR report key: 8119885 · Received November 30, 2018

    Report

    Report Number
    9612164-2018-03434
    Event Type
    Malfunction
    Date Received
    November 30, 2018
    Date of Event
    November 6, 2018
    Report Date
    January 28, 2019
    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

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    PRODUCT ANALYSIS SUMMARY: SHELF CARTON RETURNED WITHOUT THE DEVICE, THE ACCOUNT CONFIRMED THE DEVICE WAS DISCARDED, AND WILL NOT BE RETURNED. THE LOT NUMBER ON THE SHELF CARTON MATCHED WITH THE LOT NUMBER REPORTED ON GCH. THE PRODUCT SIZE IS AS REPORTED ON GCH. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    AN ATTEMPT WAS MADE TO USE ONE RESOLUTE INTEGRITY RX CORONARY DRUG ELUTING STENT TO TREAT A MODERATELY TORTUOUS, MILDLY CALCIFIED LESION EXHIBITING 95% STENOSIS LOCATED IN THE MID CIRCUMFLEX (CX) ARTERY. THE DEVICE WAS INSPECTED WITH NO ISSUES. NEGATIVE PREP WAS NOT PERFORMED. THE LESION WAS PRE-DILATED. THE DEVICE PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. IT WAS REPORTED THAT STENT DEFORMATION OCCURRED IN VIVO DURING POSITIONING/ADVANCEMENT TO THE LESION. THE PROCEDURE WAS COMPLETED USING ANOTHER MEDTRONIC STENT. THE PATIENT IS REPORTED TO BE ALIVE WITH NO INJURY. IT IS STATED THAT THE EVENT WAS DUE TO USE OF THE DEVICE IN DIFFICULT LESION MORPHOLOGY/ANATOMY, MEANING THAT THE EVENT WAS PROCEDURAL RELATED AND NOT DEVICE RELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    959545 RESOLUTE INTEGRITY RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND 0008797959

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR