BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDEAVOR RX

    MDR report key: 20350829 · Received October 2, 2024

    Report

    Report Number
    9612164-2024-04476
    Event Type
    Injury
    Date Received
    October 2, 2024
    Date of Event
    October 31, 2013
    Report Date
    October 21, 2024
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: ANNEX D CODE. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Additional Manufacturer Narrative · 0

    F. FERES, R. A. COSTA, A. ABIZAID, M. B. LEON, J. A. MARIN-NETO, R. V. BOTELHO, S. B. KING III, M. NEGOITA, M. LIU, J. E. T. DE PAULA, J. A. MANGIONE, G. X. MEIRELES, H. J. CASTELLO JR, E. L. NICOLELA, M. A. PERIN, F. S. DEVITO, A. LABRUNIE, D. SALVADORI JR, M. GUSMAO, R. STAICO, J. R. COSTA JR, J. P. DE CASTRO, A. S. ABIZAID, D. L. BHATT. 'THREE VS TWELVE MONTHS OF DUAL ANTIPLATELET THERAPY AFTER ZOTAROLIMUS-ELUTING STENTS THE OPTIMIZE RANDOMIZED TRIAL'. JAMA, NO. 23, 2013, DOI: 10.1001/JAMA.2013.282183. PMID: 24177257. A2: AVERAGE AGE A3: MAJORITY GENDER B3: DATE OF PUBLICATION PATIENT DEATHS WERE ALSO INCLUDED IN THE RESULTS OF THE JOURNAL ARTICLE, HOWEVER NO CAUSAL LINK SUGGESTING THAT THE MEDTRONIC DEVICES USED IN THE PATIENT COHORT MAY HAVE CAUSED OR CONTRIBUTED TO THE DEATHS WAS PROVIDED. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    A JOURNAL ARTICLE WAS SUBMITTED FOR REVIEW TITLED "THREE VS TWELVE MONTHS OF DUAL ANTIPLATELET THERAPY AFTER ZOTAROLIMUS-ELUTING STENTS THE OPTIMIZE RANDOMIZED TRIAL". IN THE OPTIMIZE (OPTIMIZED DURATION OF CLOPIDOGREL THERAPY FOLLOWING TREATMENT WITH THE ZOTAROLIMUS-ELUTING STENT IN REAL-WORLD CLINICAL PRACTICE) TRIAL, THE AIM WAS TO ASSESS THE CLINICAL NON-INFERIORITY OF SHORT-TERM (3MONTHS) VS STANDARD LONG-TERM (12MONTHS) DUAL ANTIPLATELET THERAPY (DAPT) IN PATIENTS WITH CORONARY ARTERY DISEASE UNDERGOING PERCUTANEOUS CORONARY INTERVENTION (PCI) SOLELY WITH A ZOTAROLIMUS-ELUTING STENT. THE OPTIMIZE TRIAL WAS AN OPEN-LABEL, ACTIVE-CONTROLLED, 1:1 RANDOMIZED STUDY INCLUDING 3119 PATIENTS IN BETWEEN APRIL 2010 AND MARCH 2012. AFTER PCI WITH A MEDTRONIC ENDEAVOR ZOTAROLIMUS-ELUTING STENT, PATIENTS WERE PRESCRIBED ASPIRIN (100-200MG DAILY) INDEFINITELY, AND CLOPIDOGREL (75MG DAILY) FOR 3 MONTHS (N = 1563) OR 12 MONTHS (N = 1556), UNLESS CONTRAINDICATED. THE PRIMARY END POINT WAS NET ADVERSE CLINICAL AND CEREBRAL EVENTS (NACCE; A COMPOSITE OF ALL-CAUSE DEATH, MYOCARDIAL INFARCTION [MI], STROKE, OR MAJOR BLEEDING). SECONDARY END POINTS INCLUDED STENT THROMBOSIS ACCORDING TO THE ACADEMIC RESEARCH CONSORTIUM (ARC), TARGET-LESION AND TARGET-VESSEL REVASCULARIZATION (TLR AND TVR), MAJOR ADVERSE CARDIAC EVENTS (MACE, INCLUDING DEATH FROM ANY CAUSE, MI, EMERGENT CORONARY ARTERY BYPASS GRAFT SURGERY, OR TLR), AND ANY BLEEDING. CLINICAL FOLLOW-UP WAS PERFORMED AT 1, 3, 6, AND 12 MONTHS. SEVENTY-SIX PATIENTS REFUSED FOLLOW-UP OR WERE LOST TO FOLLOW-UP, AND THE MAJORITY OF PATIENTS WERE TREATED SOLELY WITH ZOTAROLIMUS-ELUTING STENTS. THERE WERE 4120 CORONARY LESIONS TREATED, AND 42% OF PATIENTS RECEIVED MULTIPLE STENTS. AT 1-YEAR CLINICAL FOLLOW-UP, THE RATES OF ASPIRIN AND CLOPIDOGREL USE WERE 98.9% AND 6.2%, RESPECTIVELY, IN THE SHORT-TERM GROUP AND 98.8%AND 97.9%IN THE LONG-TERM GROUP. NACCE OCCURRED IN 93 PATIENTS RECEIVING SHORT-TERM AND 90 PATIENTS RECEIVING LONG-TERM THERAPY. AT 1 YEAR, TLR OCCURRED IN 53 PATIENTS IN THE SHORT-TERM GROUP AND IN 49 PATIENTS IN THE LONG-TERM GROUP. ANY NEW REVASCULARIZATION AFTER THE PROCEDURE OCCURRED IN 167 PATIENTS TOTAL AND ACCOUNTED FOR ALL CASES OF PROLONGED CLOPIDOGREL USE IN THE SHORT-TERM GROUP (94 PATIENTS). DEFINITE OR PROBABLE STENT THROMBOSIS UP TO 90 DAYS OCCURRED IN 9 PATIENTS IN THE SHORT-TERM GROUP AND IN 11 PATIENTS IN THE LONG-TERM GROUP. ANY BLEEDING COMPLICATIONS OCCURRED IN 80 PATIENTS UP TO 1 YEAR, BUT ONLY 23 CASES WERE CLASSIFIED AS MAJOR BLEEDING ACCORDING TO THE STUDY CRITERIA. PREMATURE DISCONTINUATION OF DAPT WAS EXPERIENCED BY 32 PATIENTS (9 IN THE SHORT-TERM GROUP AND 23 IN THE LONG-TERM GROUP); REASONS FOR DISCONTINUATION WERE CARDIAC SURGERY (10 PATIENTS), HEMORRHAGIC STROKE (2 PATIENTS), NON-CARDIAC SURGERY (3 PATIENTS), AND NON-ADHERENCE OR UNKNOWN CAUSE (17 PATIENTS). PREMATURE INTERRUPTION OF DAPT WAS ASSOCIATED WITH THE OCCURRENCE OF STENT THROMBOSIS IN 5 PATIENTS IN THE SHORT-TERM GROUP AND IN 4 PATIENTS IN THE LONG-TERM GROUP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2162158 ENDEAVOR RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Male Other| R