BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESOLUTE ONYX RX

    MDR report key: 8098881 · Received November 22, 2018

    Report

    Report Number
    9612164-2018-03327
    Event Type
    Malfunction
    Date Received
    November 22, 2018
    Date of Event
    November 9, 2018
    Report Date
    February 12, 2019
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P160043
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    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

    THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT OR CELL OF A STENT. IT WAS REPORTED THAT PARTIAL STENT DISPLACEMENT OCCURRED DURING DELIVERY TO/AT THE LESION. THE STENT WAS REMOVED FROM THE PATIENT ON ITS OWN DELIVERY SYSTEM. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    PRODUCT ANALYSIS SUMMARY: AN EMPTY SHELF CARTON WAS RETURNED. THE ACCOUNT CONFIRMED THAT THE DEVICE WAS DISCARDED AND WOULD NOT BE RETURNED. THE LOT NUMBER ON THE SHELF CARTON IS AS REPORTED ON GCH. THE DEVICE 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 A RESOLUTE ONYX RX CORONARY DRUG ELUTING STENT TO TREAT A MODERATELY TORTUOUS, MILDLY CALCIFIED LESION LOCATED IN THE MID LAD. THE DEVICE WAS INSPECTED WITH NO ISSUES. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES. THE LESION WAS PRE-DILATED. 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 AND THAT STENT DISLODGEMENT OCCURRED DURING DELIVERY TO/AT THE LESION. IT IS INDICATED THAT THE STENT BEGAN TO FALL OFF THE BALLOON. THE STENT WAS REMOVED FROM THE PATIENT ON THE DEVICE. THE PROCEDURE WAS COMPLETED USING ANOTHER MEDTRONIC STENT OF THE SAME MODEL AND SIZE. THE PATIENT IS REPORTED TO BE ALIVE WITH NO INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    938605 RESOLUTE ONYX RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND 0009215786

    Patients

    Seq Age Sex Outcome Treatment
    1