BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESOLUTE ONYX RX

    MDR report key: 5864459 · Received August 10, 2016

    Report

    Report Number
    9612164-2016-00827
    Event Type
    Malfunction
    Date Received
    August 10, 2016
    Date of Event
    July 8, 2016
    Report Date
    August 25, 2016
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P110013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE STENT WAS POSITIONED ON THE BALLOON BETWEEN THE MARKER BANDS AS PER SPECIFICATIONS. THE DISTAL SHAFT WAS BUNCHED 0.8CM PROXIMAL TO THE PROXIMAL INNER SHAFT MARKER. THE PROXIMAL BALLOON PILLOW FOLDS WERE PARTIALLY OPEN AND DISTURBED. THERE WAS DEFORMATION TO THE 25TH AND 26TH DISTAL STENT WRAPS WITH STRUTS RAISED. THERE WAS DAMAGE TO THE DISTAL TIP. (B)(4).

    Additional Manufacturer Narrative · 1

    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

    THE PHYSICIAN WAS ATTEMPTING TO USE A RESOLUTE ONYX DRUG-ELUTING STENT DURING A PROCEDURE TO TREAT A LESION IN AN UNKNOWN VESSEL. THE LESION WAS PRE-DILATED. THERE WERE NO ISSUES NOTED WHEN REMOVING THE RESOLUTE ONYX FROM THE HOOP/TRAY. NO ISSUES WERE NOTED DURING INSPECTION OR PERP PRIOR TO USE. A MDT GUIDEWIRE WAS INSPECTED PRIOR TO USE WITH NO DAMAGE NOTED. DURING AN ANGIOPLASTY PROCEDURE, A NON-MDT 6F GUIDE CATHETER AND THE MDTGUIDE WIRE WERE ADVANCED TO THE LESION WITHOUT DIFFICULTY. THE PHYSICIAN HAD DIFFICULTY ADVANCING THE RESOLUTE ONYX TO THE LESION. THERE WAS RESISTANCE FELT WITH THE GUIDEWIRE WHEN THE RESOLUTE ONYX WAS ADVANCED. NO ATTEMPT WAS MADE TO DEPLOY THE STENT. EXCESSIVE FORCE WAS USED DURING DELIVERY. IT IS REPORTED THE PHYSICIAN FELT DIFFICULTY DURING ATTEMPTS TO REMOVE THE STENT. THE STENT WAS REMOVED EVENTUALLY WITH GREAT DIFFICULTY AND WAS DAMAGED. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. NO PATIENT INJURY REPORTED. PLEASE NOTE THAT THIS DEVICE, RESOLUTE ONYX IS NOT MARKETED IN THE UNITED STATES; HOWEVER, IT IS SIMILAR TO THE UNITED STATES MARKETED PRODUCT RESOLUTE INTEGRITY. THIS EVENT IS BEING REPORTED ONLY AS A MALFUNCTION BECAUSE OF THE SIMILAR DEVICE REQUIREMENT IN 803 WHICH IS LIMITED TO MALFUNCTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    518067 RESOLUTE ONYX RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND 0007896237

    Patients

    Seq Age Sex Outcome Treatment
    1