BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESOLUTE INTEGRITY RX

    MDR report key: 6092073 · Received November 10, 2016

    Report

    Report Number
    9612164-2016-01164
    Event Type
    Injury
    Date Received
    November 10, 2016
    Date of Event
    February 10, 2015
    Report Date
    November 11, 2016
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P110013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PHYSICIAN INDICATED THAT THE CAUSE OF THIS EVENT WAS NOT DUE TO A RESOLUTE DEVICE. 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

    PHOTOGRAPHIC REVIEW: STILL IMAGES PROVIDED IN JOURNAL AND THESE IMAGES PROVIDE A VISUAL REPRESENTATION OF WHAT WAS DOCUMENTED IN THE JOURNAL ARTICLE. DATE OF PUBLICATION JOURNAL ARTICLE: SUCCESSFUL ROTATIONAL ATHERECTOMY FOR A REPETITIVE RESTENOSIS LESION WITH UNDEREXPANSION OF DOUBLE LAYER DRUG-ELUTING STENTS DUE TO HEAVILY CALCIFIED PLAQUE M. KAWATA ET AL. CARDIOVASC INTERV AND THER (2016) 31:65¿69 DOI 10.1007/S12928-015-0319-3 .

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    A RESOLUTE INTEGRITY RX DRUG ELUTING STENT WAS IMPLANTED BY IVUS GUIDE IN THE PREVIOUSLY IMPLANTED NON-MDT STENT. THE STENT WAS THEN POST-DILATED. IT WAS REPORTED THAT INCOMPLETE DILATATION REMAINED. ONE YEAR POST PCI 90% RESTENOSIS OCCURRED. THE PHYSICIAN DECIDED TO ABLATE THE DOUBLE LAYERED STENTS WITH CALCIFICATION BY ROTATIONAL ATHERECTOMY. A LAUNCHER GUIDING CATHETER WAS INTRODUCED AND A NON-MDT ROTA WIRE WAS PLACED ACROSS THE LESION. INITIALLY A BURR WAS USED BUT FAILED TO CROSS THE LESION. THE PHYSICIAN USED A SMALLER SIZED BURR TO START THE ABLATION AND ALL STENT STRUTS OF THE PREVIOUSLY DEPLOYED STENTS DISAPPEARED AT THE RESTENOSIS SITE. THE LESION WAS PRE-DILATED AND A NON-MDT STENT IMPLANTED. 6 MONTH LATER THE FOLLOW UP REVEALED NEITHER RESTENOSIS NOR PREI-STENT CONTRAST STAINING AT THE TARGET LESION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    743549 RESOLUTE INTEGRITY RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention