BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESOLUTE ONYX RX

    MDR report key: 5777981 · Received July 8, 2016

    Report

    Report Number
    9612164-2016-00656
    Event Type
    Malfunction
    Date Received
    July 8, 2016
    Date of Event
    June 9, 2016
    Report Date
    June 9, 2016
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P110013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THERE WAS NO DAMAGE TO THE DISTAL TIP OF THE DEVICE. THE STENT WAS POSITIONED ON THE BALLOON BETWEEN THE INNER SHAFT MARKERS AS PER SPECIFICATION REQUIREMENT. THE 15TH DISTAL STENT SEGMENT WAS DEFORMED WITH RAISED STRUTS. STENT OD¿S; PROXIMAL STENT OD IS 0.043INCH; MID STENT OD IS 0.043INCH; DISTAL STENT OD IS 0.042INCH. THE 15TH DISTAL STENT SEGMENT OD IS 0.066INCH. SPECIFICATION IS 0.055INCH MAX. (B)(4). A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. 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

    IT WAS REPORTED THAT THE PHYSICIAN WAS ATTEMPTING TO USE A RESOLUTE ONYX RX DRUG ELUTING STENT TO TREAT A STENOSED RCA OSTIUM LESION IN A SEVERELY CALCIFIED AND MODERATELY TORTUOUS VESSEL. THE DEVICE WAS REMOVED FROM ITS PACKAGING PER IFU AND INSPECTED WITH NO ISSUES NOTED. LESION WAS PRE-DILATED. DURING THE PROCEDURE IT WAS REPORTED THAT THE STENT DEFORMED DURING POSITIONING . PROCEDURE WAS COMPLETED WITH A RESOLUTE ONYX DRUG ELUTING STENT. NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    432737 RESOLUTE ONYX RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND 0007653469

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR