BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESOLUTE INTEGRITY RX

    MDR report key: 8225796 · Received January 8, 2019

    Report

    Report Number
    9612164-2019-00096
    Event Type
    Malfunction
    Date Received
    January 8, 2019
    Date of Event
    August 30, 2018
    Report Date
    January 8, 2019
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P110013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A2=AVERAGE AGE A3= MAJORITY GENDER B3=DATE OF PUBLICATION OPTICAL COHERENCE TOMOGRAPHY PREDICTORS FOR RECURRENT RESTENOSIS AFTER PACLITAXEL-COATED BALLOON ANGIOPLASTY FOR DRUG-ELUTING STENT RESTENOSIS. DOI: 10.1253/CIRCJ.CJ-18-0464. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    548 DRUG-ELUTING STENT (DES) IN-STENT RESTENOSIS (ISR) LESIONS WERE EXCLUSIVELY TREATED WITH PCB ANGIOPLASTY FOR THE FIRST TIME BETWEEN (B)(6)2008 AND (B)(6) 2016. MEDTRONIC ZOTAROLIMUS AND RESOLUTE ZOTAROLIMUS-ELUTING STENTS WERE AMONG THE DES THAT EXHIBITED RESTENOSIS. LESIONS TREATED INCLUDED THE LEFT MAIN, LAD, LEFT CIRCUMFLEX AND RIGHT. THIS STUDY INVESTIGATED THE ASSOCIATION BETWEEN OCT FINDINGS AND MID-TERM ANGIOGRAPHIC OUTCOMES. THE MAIN FINDINGS OF THE STUDY WERE: (1) THE HETEROGENEOUS PATTERN WAS ASSOCIATED WITH RECURRENT RESTENOSIS AT FOLLOW-UP; (2) SMALLER POST-PROCEDURAL MLA, CAUSED PRIMARILY BY PERSISTENT STENT UNDEREXPANSION, WAS ALSO A MAIN CAUSE OF RECURRENT RESTENOSIS; AND (3) PREVIOUS STENT FRACTURE, HETEROGENEOUS PATTERN, AND STENT UNDEREXPANSION WERE INDEPENDENT RISK FACTORS FOR RECURRENT RESTENOSIS

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    21921 RESOLUTE INTEGRITY RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR