BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESOLUTE INTEGRITY RX

    MDR report key: 6529112 · Received April 28, 2017

    Report

    Report Number
    9612164-2017-00528
    Event Type
    Injury
    Date Received
    April 28, 2017
    Date of Event
    July 4, 2016
    Report Date
    April 2, 2017
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P110013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    JOURNAL NAME: YANSEI MEDICAL JOURNAL TITLE OF ARTICLE: NOBORI-BIOLIMUS-ELUTING STENTS VERSUS RESOLUTE ZOTAROLIMUS-ELUTING STENTS IN PATIENTS UNDERGOING CORONARY INTERVENTION: A PROPENSITY SCORE MATCHING LITERATURE REFERENCE: HTTPS://DOI.ORG/10.3349/YMJ.2017.58.2.29 RECEIVED: JULY 4, 2016 REVISED: OCTOBER 22, 2016 ACCEPTED: OCTOBER 31, 2016. (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

    IT WAS REPORTED IN A JOURNAL ARTICLE THAT 858 PATIENTS IN A STUDY RECEIVED RESOLUTE INTEGRITY RX DRUG ELUTING STENTS. TARGET LESIONS TREATED WITH RESOLUTE INTEGRITY STENTS INCLUDED LM, LM-LAD, RCA AND LCX-RAMUS. LM INVOLVEMENT IN 416 PATIENTS. LESIONS EXHIBITED SEVERE CALCIFICATION, >90% TORTUOSITY WITH A PERCENTAGE CONTAINING THROMBUS. COLLECTIVE ADVERSE EVENTS AT ONE YEAR FOLLOW UP INCLUDED DEATH, TVR, TLR NON Q MI, BLEEDING AND STROKE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311161 RESOLUTE INTEGRITY RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Life Threatening| R