BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESOLUTE INTEGRITY RX

    MDR report key: 6475384 · Received April 10, 2017

    Report

    Report Number
    9612164-2017-00424
    Event Type
    Injury
    Date Received
    April 10, 2017
    Date of Event
    January 18, 2017
    Report Date
    March 15, 2017
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P110013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    JOURNAL ARTICLE TITLE: COMPARISON OF DURABLE-POLYMER ZOTAROLIMUS-ELUTING AND BIODEGRADABLE-POLYMER BIOLIMUS-ELUTING CORONARY STENTS IN PATIENTS WITH CORONARY ARTERY DISEASE 3-YEAR CLINICAL OUTCOMES IN THE RANDOMIZED SORT OUT VI TRIAL J A C C : CARDI O V A SC U LAR INT E RVENT IONS V O L. 1 0 , NO . 3 , 2 0 1 7 ª 2 0 1 7 B Y T H E AMERICAN C O L L EGE OF CARDI O L O GY FOUNDAT ION P UB L I SHED B Y E L S E V I E R I S S N 1 9 3 6 - 8 7 9 8 / $ 3 6 . 0 0 H T T P : / / D X . D O I . O R G / 1 0 . 1 0 1 6 / J . J C I N . 2 0 1 6 . 1 1 . 0 0 7 2 5 5 ¿ 6 4 SORT OUT VI 3-YEAR CLINICAL OUTCOMES. PT AGE: AVERAGE AGE. PT GENDER: MAJORITY GENDER. DATE OF EVENT: DATE OF PUBLICATION.

    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 COMPARING RESOLUTE INTEGRITY DES VS A COMPETITOR BRAND DES THAT 1502 PATIENT RECEIVED RESOLUTE INTEGRITY RX DRUG ELUTING STENTS. COMBINED TARGET VESSELS INCLUDED THE LEFT MAIN, LAD, LCX, RCA AND SAPHENOUS VEIN GRAFT WITH A PERCENTAGE EXHIBITING CTO <(>&<)> BIFURCATION LESIONS. DURING THE INDEX PROCEDURE, IT WAS REPORTED THAT 26 CASES EXPERIENCED STENT DELIVERY FAILURE. COMBINED 6 <(>&<)> 12 MONTH FOLLOW UPS INCLUDED THE FOLLOWING ADVERSE EVENTS. MACE, DEATH, CARDIAC DEATH, MI, TVR, TLR AND STENT THROMBOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    259662 RESOLUTE INTEGRITY RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Life Threatening| R