BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COREVALVE TRANSCATHETER AORTIC VALVE

    MDR report key: 14219533 · Received April 27, 2022

    Report

    Report Number
    2025587-2022-01101
    Event Type
    Injury
    Date Received
    April 27, 2022
    Date of Event
    November 15, 2021
    Report Date
    April 27, 2022
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CITATION: ALPERI A, ET AL. TRANSCATHETER VERSUS SURGICAL AORTIC VALVE REPLACEMENT IN PATIENTS WITH COMPLEX CORONARY ARTERY DISEASE. JACC CARDIOVASC INTERV. 2021 NOV 22;14(22):2490-2499. DOI: 10.1016/J.JCIN.2021.08.073. AVAILABLE ONLINE 15 NOVEMBER 2021. EARLIEST DATE OF PUBLISH USED FOR DATE OF EVENT. NO UNIQUE DEVICE IDENTIFIER (SERIAL/LOT) NUMBERS WERE PROVIDED; WITHOUT THIS INFORMATION IT COULD NOT BE DETERMINED WHETHER THESE OBSERVATIONS HAVE BEEN PREVIOUSLY REPORTED. WITHOUT RETURN OF THE PRODUCT, NO DEFINITIVE CONCLUSION CAN BE MADE REGARDING THE CLINICAL OBSERVATIONS. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    MEDTRONIC RECEIVED INFORMATION FROM A LITERATURE ARTICLE REGARDING THE OUTCOMES OF TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PLUS PERCUTANEOUS CORONARY INTERVENTION (PCI) VERSUS SURGICAL AORTIC VALVE REPLACEMENT (SAVR) PLUS CORONARY ARTERY BYPASS GRAFTING (CABG) IN PATIENTS WITH PRE-EXISTING CORONARY ARTERY DISEASE AND AORTIC STENOSIS. ALL DATA WAS COLLECTED FROM MULTIPLE CENTERS ACROSS NORTH AMERICA AND EUROPE BETWEEN 2007 AND 2019. OF THE 202 PATIENTS INCLUDED IN THE TAVR + PCI GROUP (PREDOMINANTLY MALE, MEAN AGE (B)(6)), AN UNSPECIFIED PROPORTION WERE IMPLANTED WITH A MEDTRONIC COREVALVE TRANSCATHETER VALVE. NO UNIQUE DEVICE IDENTIFIER NUMBERS WERE PROVIDED. IN THE TAVR + PCI GROUP, THE ALL-CAUSE MORTALITY RATE WAS 11.6% AFTER A MEDIAN FOLLOW-UP OF THREE YEARS. NO STATEMENT WAS MADE SUGGESTING A CAUSAL OR CONTRIBUTORY RELATIONSHIP BETWEEN COREVALVE AND THE DEATHS. IN THE TAVR + PCI GROUP, POST-OPERATIVE ADVERSE EVENTS INCLUDED: MYOCARDIAL INFARCTION, STROKE, MODERATE TO SEVERE AORTIC REGURGITATION, PATIENT-PROSTHESIS MISMATCH, ELEVATED MEAN GRADIENT (>20 MM HG), REPEAT CORONARY REVASCULARIZATION, AND CARDIAC REHOSPITALIZATION. ALTHOUGH A DIRECT CORRELATION WAS NOT MADE, COREVALVE MAY HAVE BEEN ASSOCIATED WITH THESE ADVERSE EVENTS. NO ADDITIONAL ADVERSE PATIENT EFFECTS OR PRODUCT PERFORMANCE ISSUES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1840600 COREVALVE TRANSCATHETER AORTIC VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV NPT MEDTRONIC HEART VALVES DIVISION CRS

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Male Hospitalization| L| R