BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESOLUTE INTEGRITY RX

    MDR report key: 5932893 · Received September 7, 2016

    Report

    Report Number
    9612164-2016-00937
    Event Type
    Injury
    Date Received
    September 7, 2016
    Date of Event
    June 26, 2015
    Report Date
    August 7, 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

    EVENT DATE IS DATE OF PUBLICATION ON LINE JOURNAL ARTICLE TITLE: "REVERSE BENT WIRING WITH CRUSADE CATHETER CAN BE A USEFUL TECHNIQUE FOR PENETRATING AN ABRUPT-TYPE ENTRY OF CORONARY OCCLUSION AT BRANCHING OSTIUM" CARDIOVASC INTERV AND THER (2016) 31:245¿249 DOI 10.1007/S12928-015-0340-6. (B)(4).

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    ONE RESOLUTE INTEGRITY RX DRUG ELUTING STENT WAS DEPLOYED AT THE MIDPOINT OF THE LCX, CROSSING OVER THE OBTUSE MARGINAL (OM) BRANCH. ONE YEAR LATER, ALTHOUGH NO IN-STENT RESTENOSIS WAS OBSERVED, SEVERE STENOSIS WAS SEEN AT THE OSTIUM TO MID PORTION OF THE OM BRANCH. ANOTHER RESOLUTE INTEGRITY RX DRUG ELUTING STENT WAS DEPLOYED FROM THE PROXIMAL PART OF THE OM TOWARDS THE OM BRANCH. THE PATIENT SUFFERED FROM MODERATE IN-STENT RESTENOSIS IN THE MID-LCX ARTERY AND TOTAL OCCLUSION AT THE OM BRANCHING OSTIUM WAS OBSERVED. PATIENT ALSO HAD MI BUT IT APPEARS TO BE A VERY MINOR ONE DUE TO THE ONLY "SLIGHT" HYPOKINESIS. THESE LCX LESIONS WERE TREATED WITH PCI.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    585896 RESOLUTE INTEGRITY RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention