BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDEAVOR RX

    MDR report key: 13557411 · Received February 18, 2022

    Report

    Report Number
    9612164-2022-00675
    Event Type
    Injury
    Date Received
    February 18, 2022
    Date of Event
    April 1, 2015
    Report Date
    February 18, 2022
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    JOURNAL ARTICLE: RANDOMISED STUDY OF A BIOABSORBABLE POLYMER-COATED SIROLIMUS-ELUTING STENT: RESULTS OF THE DESSOLVE II TRIAL AUTHORS: WILLIAM WIJNS, MATHIAS VROLIX, STEFAN VERHEYE, DANNY SCHOORS, TON SLAGBOOM, MARCEL GOSSELINK, EDOUARD BENIT, DENNIS DONOHOE, CHARLENE KNAPE, GUILHERME F. ATTIZZANI, ALEXANDRA J. LANSKY, JOHN ORMISTON, THE DESSOLVE II INVESTIGATORS JOURNAL: EUROINTERVENTION YEAR: 2015 REFERENCE: DOI: 10.4244/EIJY14M05_03. PATIENT DEATH WAS ALSO INCLUDED IN THE RESULTS OF THE JOURNAL ARTICLE, HOWEVER NO CAUSAL LINK SUGGESTING THAT THE MEDTRONIC DEVICE USED IN THE PATIENT COHORT MAY HAVE CAUSED OR CONTRIBUTED TO THE DEATH WAS PROVIDED. AVERAGE AGE, MAJORITY GENDER, DATE OF PUBLICATION. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    A JOURNAL ARTICLE TITLED - RANDOMISED STUDY OF A BIOABSORBABLE POLYMER-COATED SIROLIMUS-ELUTING STENT: RESULTS OF THE DESSOLVE II TRIAL - WAS SUBMITTED FOR REVIEW. THE AIM OF THIS STUDY WAS TO COMPARE THE EFFICACY AND SAFETY OF A NON-MEDTRONIC ABSORBABLE POLYMER SIROLIMUS-ELUTING STENT (APSES) WITH THE MEDTRONIC ENDEAVOR ZOTAROLIMUS-ELUTING STENT (ZES). THIS WAS A PROSPECTIVE, SINGLE BLIND, 2:1 UNBALANCED, RANDOMISED, MULTICENTRE, SUPERIORITY TRIAL. A TOTAL OF 184 PATIENTS WERE IMPLANTED WITH A EITHER A APSES (123 PATIENTS) VERSUS A ZES (61 PATIENTS). FOLLOWING STENT IMPLANTATION, ALL PATIENTS UNDERWENT QUANTITATIVE CORONARY ANGIOGRAPHY (QCA), AT BASELINE AND AT NINE MONTHS OF FOLLOW-UP, WHILE A SELECT SUBGROUP ALSO UNDERWENT OPTICAL COHERENCE TOMOGRAPHY (OCT). THE PRIMARY EFFICACY ENDPOINT OF THE STUDY WAS IN-STENT LATE LUMEN LOSS (LLL) AT NINE-MONTH FOLLOW-UP, OF APSES COMPARED TO ZES. THE PRIMARY SAFETY ENDPOINT WAS THE RATE OF MAJOR ADVERSE CARDIAC EVENTS (MACE), DEFINED AS ALL-CAUSE DEATH, Q-WAVE OR NON-Q-WAVE MI AND CLINICALLY DRIVEN TARGET VESSEL REVASCULARISATION (TVR) AT NINE-MONTH FOLLOW-UP. THE SECONDARY PROCEDURAL/ANGIOGRAPHIC ENDPOINTS OF THE STUDY WERE DEVICE, LESION AND PROCEDURAL SUCCESS, IN-SEGMENT LLL, PERCENT DIAMETER STENOSIS, MINIMAL LUMEN DIAMETER (MLD), AND BINARY RESTENOSIS RATES AT NINE-MONTH FOLLOW-UP. THE SECONDARY CLINICAL ENDPOINTS OF THE STUDY, ASCERTAINED IMMEDIATELY AFTER THE INDEX PROCEDURE AND AT EACH SUBSEQUENT FOLLOW-UP, WERE ALL-CAUSE MORTALITY, RATES OF Q-WAVE AND NON-Q-WAVE MI, RATES OF CLINICALLY DRIVEN TARGET LESION REVASCULARISATION (TLR) AND TVR, RATES OF TARGET LESION FAILURE (TLF) AND TARGET VESSEL FAILURE (TVF), AND RATES OF STENT THROMBOSIS (ST). AT NINE MONTHS, THE PRIMARY ENDPOINT WAS MET, WITH A MEAN IN-STENT LLL OF 0.27±0.46 MM IN 103 APSES PATIENTS VERSUS 0.58±0.41 MM IN 52 ZES PATIENTS. THE INCIDENCE OF IN-HOSPITAL AND LONG-TERM ADVERSE CLINICAL EVENTS WAS SIMILAR IN BOTH GROUPS. THE OVERALL MACE RATE AT NINE MONTHS WAS 4.3% (5/117) IN THE APSES AND 6.7% (4/60) IN THE ZES ARM. A SINGLE CARDIAC DEATH WAS OBSERVED IN EACH STUDY GROUP AND TWO PATIENTS IN EACH GROUP SUSTAINED A NON-Q-WAVE MI.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    473981 ENDEAVOR RX CORONARY DRUG-ELUTING STENT NIQ MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Male Required Intervention