BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESOLUTE INTEGRITY RX

    MDR report key: 5905929 · Received August 26, 2016

    Report

    Report Number
    9612164-2016-00912
    Event Type
    Injury
    Date Received
    August 26, 2016
    Date of Event
    February 10, 2015
    Report Date
    August 29, 2016
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P110013
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    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

    (B)(4). TITLE : SUCCESSFUL ROTATIONAL ATHERECTOMY FOR A REPETITIVE RESTENOSIS LESION WITH UNDEREXPANSION OF DOUBLE LAYER DRUG-ELUTING STENTS DUE TO HEAVILY CALCIFIED PLAQUE CARDIOVASC INTERV AND THER (2016) 31:65¿69 DOI 10.1007/S12928-015-0319-3. 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.

    Description of Event or Problem · 1

    PATIENT PRESENTED WITH 90 % RESTENOSIS OF A PREVIOUSLY DEPLOYED STENT IN THE PROX LAD LESION. THE PHYSICIAN IMPLANTED ONE RESOLUTE INTEGRITY RX DRUG ELUTING STENT TO THE TARGET LESION FOLLOWED BY POST DILATATION. INCOMPLETE DILATATION REMAINED. APPROXIMATELY SIX MONTHS LATER, 50 % STENOSIS WAS OBSERVED, AND ONE YEAR LATER, 90 % RESTENOSIS WAS PRESENT. THE CALCIFIED, DOUBLE-LAYER STENTS WERE ABLATED BY ROTATIONAL ABLATION, ALONG WITH BALLOON DILATATION AND THE IMPLANT OF 3 NON MDT STENTS..

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    560187 RESOLUTE INTEGRITY RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention