BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESOLUTE INTEGRITY RX

    MDR report key: 8494601 · Received April 9, 2019

    Report

    Report Number
    9612164-2019-01217
    Event Type
    Malfunction
    Date Received
    April 9, 2019
    Date of Event
    February 20, 2019
    Report Date
    May 21, 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

    CORRECTION TO PMA NUMBER, PREVIOUSLY REPORTED AS P160043 IN ERROR. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    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. 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.

    Description of Event or Problem · 1

    DURING A PROCEDURE AN ATTEMPT WAS MADE TO USE A RESOLUTE INTEGRITY RX CORONARY DRUG ELUTING STENT TO TREAT MODERATELY TORTUOUS AND CALCIFIED LESION LOCATED IN THE OSTIUM OF THE LEFT MAIN (LM) CORONARY ARTERY. THERE WAS NO DAMAGE NOTED TO THE PACKAGING. IT WAS REPORTED THAT STENT DEFORMATION OCCURRED IN VIVO DURING POSITIONING/ADVANCEMENT. IT IS REPORTED THAT THE PHYSICIAN BELIEVES THE EVENT WAS DUE TO THE USE OF THE DEVICE IN A DIFFICULT LESION MORPHOLOGY/ANATOMY AND NOT DEVICE RELATED. IT IS REPORTED THAT THE PATIENT IS ALIVE WITH NO INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290935 RESOLUTE INTEGRITY RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND RSINT27518X 0009083634

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR