BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESOLUTE ONYX RX

    MDR report key: 8293115 · Received January 31, 2019

    Report

    Report Number
    9612164-2019-00377
    Event Type
    Malfunction
    Date Received
    January 31, 2019
    Date of Event
    December 31, 2018
    Report Date
    March 28, 2019
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    UDI-DI
    00643169556980
    PMA / PMN Number
    P160043
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ANALYSIS SUMMARY: THE STENT WAS POSITIONED ON THE BALLOON BETWEEN THE MARKER BANDS AS PER SPECIFICATIONS. NO DEFORMATION WAS EVIDENT TO THE STENT. NO DEFORMATION WAS EVIDENT TO THE DISTAL TIP. THE INNER LUMEN PATENCY WAS VERIFIED WITH A 0.015 INCH MANDREL. NO OTHER DAMAGE EVIDENT TO THE REMAINDER OF THE DEVICE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    PMA NUMBER IS P160043. 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 ONYX RX CORONARY DRUG ELUTING STENT TO TREAT A TORTUOUS LESION LOCATED IN THE CIRCUMFLEX (CX) ARTERY. IT WAS REPORTED THAT THE STENT FAILED TO CROSS THE LESION AND IT WAS NOTED THAT THE WIRE FRAYED. NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    86704 RESOLUTE ONYX RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND 0009215791 00643169556980

    Patients

    Seq Age Sex Outcome Treatment
    1