BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESOLUTE INTEGRITY RX

    MDR report key: 6116160 · Received November 21, 2016

    Report

    Report Number
    9612164-2016-01179
    Event Type
    Malfunction
    Date Received
    November 21, 2016
    Date of Event
    October 23, 2016
    Report Date
    November 1, 2016
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P110013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THERE WERE NUMEROUS KINKS ALONG THE HYPOTUBE. THERE WAS DEFORMATION TO THE 1ST, 2ND, 3RD AND 4TH DISTAL STENT WRAPS WITH STRUTS BUNCHED AND OVERLAPPING. CRIMP IMPRESSIONS WERE VISIBLE ON THE EXPOSED BALLOON SURFACE .THERE WAS SLIGHT DEFORMATION TO THE DISTAL TIP. (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

    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 TREAT A VERY TORTUOUS LESION IN THE CIRCUMFLEX USING A RESOLUTE INTEGRITY RX DRUG ELUTING. THE DEVICE WAS INSPECTED BEFORE USE WITH NO ISSUES NOTED. THE LESION WAS PRE-DILATED. NO RESISTANCE OR EXCESSIVE FORCE USED DURING DEVICE ADVANCEMENT. A GUIDE LINER WAS USED TO AID DELIVERY. IT WAS REPORTED THAT THE DEVICE FAILED TO CROSS THE TARGET LESION AND THE STENT BECAME DAMAGED. THE PHYSICIAN USED ANOTHER RESOLUTE INTEGRITY STENT TO COMPLETE THE PROCEDURE. NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    769794 RESOLUTE INTEGRITY RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND 0008118943

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR