BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COREVALVE TRANSCATHETER AORTIC VALVE

    MDR report key: 12807122 · Received November 12, 2021

    Report

    Report Number
    2025587-2021-03438
    Event Type
    Injury
    Date Received
    November 12, 2021
    Date of Event
    July 5, 2020
    Report Date
    November 12, 2021
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CITATION: ZOUARI F, ET AL. CONDUCTION DISTURBANCES IN LOW SURGICAL RISK PATIENTS UNDERGOING TRANSCATHETER AORTIC VALVE REPLACEMENT WITH SELF EXPANDABLE OR BALLOON EXPANDABLE VALVES. CARDIOVASC INTERV THER. (B)(6) 2021; 36(3):355-362. DOI: 10.1007/S12928-020-00687-X. EPUB (B)(6) 2020. 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.

    Description of Event or Problem · 0

    MEDTRONIC RECEIVED INFORMATION FROM A LITERATURE ARTICLE REGARDING THE INCIDENCE OF PERMANENT PACEMAKER IMPLANTATION AND LEFT BUNDLE BRANCH BLOCK IN LOW-RISK PATIENTS COMPARED TO INTERMEDIATE-/HIGH-RISK PATIENTS UNDERGOING TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR). ALL DATA WAS COLLECTED FROM A SINGLE CENTER OF THE 637 PATIENTS INCLUDED IN THE STUDY POPULATION (PREDOMINANTLY FEMALE, MEAN AGE (B)(6), 269 UNDERWENT TAVR WITH A MEDTRONIC COREVALVE TRANSCATHETER VALVE. NO UNIQUE DEVICE IDENTIFIER NUMBERS WERE PROVIDED. AMONG ALL PATIENTS, 44 IN-HOSPITAL DEATHS OCCURRED, INCLUDING 4 LOW-RISK PATIENTS IMPLANTED WITH COREVALVE. THE CIRCUMSTANCES OF THE DEATHS WERE NOT DISCLOSED, AND NO STATEMENT WAS MADE SUGGESTING A CAUSAL OR CONTRIBUTORY RELATIONSHIP BETWEEN MEDTRONIC PRODUCT AND THE DEATHS. AMONG ALL PATIENTS, ADVERSE EVENTS INCLUDED: NEED FOR SECOND VALVE IMPLANTATION DURING TAVR PROCEDURE; NEW PERMANENT PACEMAKER IMPLA NTATION; STROKE; NEW ONSET LEFT BUNDLE BRANCH BLOCK; PERSISTENT LEFT BUNDLE BRANCH BLOCK AT HOSPITAL DISCHARGE; MAJOR BLEEDING; AND MAJOR VASCULAR COMPLICATIONS. MEDTRONIC PRODUCT MAY HAVE BEEN ASSOCIATED WITH THE ADVERSE EVENTS. NO ADDITIONAL ADVERSE PATIENT EFFECTS OR PRODUCT PERFORMANCE ISSUES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1705944 COREVALVE TRANSCATHETER AORTIC VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV NPT MEDTRONIC HEART VALVES DIVISION CRS

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Female Life Threatening| R