BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESOLUTE INTEGRITY RX CORONARY STENT SYSTEM

    MDR report key: 2121749 · Received May 19, 2011

    Report

    Report Number
    9612164-2011-00459
    Event Type
    Malfunction
    Date Received
    May 19, 2011
    Date of Event
    April 21, 2011
    Report Date
    April 21, 2011
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION, RESULTS: RESTENOSIS AFTER PREVIOUS BALLOON ANGIOPLASTY, MODERATE CALCIFICATION AND MODERATE TORTUOSITY. STENT DAMAGE, FAILURE TO DELIVER STENT. TARGET LESION PRE-DILATION IS RECOMMENDED PRIOR TO ATTEMPTED STENT DELIVERY. CONCLUSIONS: RESTENOSIS AFTER PREVIOUS BALLOON ANGIOPLASTY, MODERATE CALCIFICATION AND MODERATE TORTUOSITY. TARGET LESION PRE-DILATION IS RECOMMENDED PRIOR TO ATTEMPTED STENT DELIVERY.

    Description of Event or Problem · 1

    THE PHYSICIAN INTENDED TO IMPLANT A 2.75 MM DIAMETER X 12 MM LENGTH RESOLUTE INTEGRITY RAPID EXCHANGE (RX) DRUG-ELUTING STENT TO TREAT A LESION IN THE 2ND OBTUSE MARGINAL. THE TARGET LESION WAS REPORTED TO BE A RESTENOSIS AFTER PREVIOUS BALLOON ANGIOPLASTY AND EXHIBITED 90% STENOSIS, MODERATE CALCIFICATION AND MODERATE TORTUOSITY. THE STRUTS OF THE RESOLUTE INTEGRITY STENT WERE OBSERVED TO BE DAMAGED AFTER THE FIRST ATTEMPT TO DELIVER THE DEVICE. PRE-DILATION WAS THEN PERFORMED USING A 2.0 MM X 20 MM BALLOON TO 20 ATM. THE 30% STENOSIS REMAINED FOLLOWING THIS PRE-DILATION. A 2.78 MM X 8 MM RESOLUTE INTEGRITY STENT WAS THEN SUCCESSFULLY IMPLANTED TO THE 2ND OBTUSE MARGINAL. THE DEVICE HAD BEEN INSPECTED PRIOR TO USE WITH NO ABNORMALITIES NOTED. THE PATIENT IS REPORTED TO BE FINE AND NO CLINICAL SEQUELAE WERE REPORTED. PLEASE NOTE THAT THIS DEVICE (B)(4) IS DISTRIBUTED OUTSIDE THE UNITED STATES; HOWEVER, IT IS SIMILAR TO THE UNITED STATES DISTRIBUTED PRODUCT - (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESOLUTE INTEGRITY RX CORONARY STENT SYSTEM NIQ MEDTRONIC IRELAND NA 0004749672

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR