BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC SURGICAL TISSUE VALVE

    MDR report key: 12838002 · Received November 18, 2021

    Report

    Report Number
    2025587-2021-03493
    Event Type
    Injury
    Date Received
    November 18, 2021
    Date of Event
    August 7, 2020
    Report Date
    November 18, 2021
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    DYE
    PMA / PMN Number
    P990064
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CITATION: BIANCARI F, PYKÄRI J, SAVONTAUS M, LAINE M, HUSSO A, VIRTANEN M, MAARANEN P, NIEMELÄ M, MÄKIKALLIO T, TAURIAINEN T, ESKOLA M, RAIVIO P, VALTOLA A, JUVONEN T, AIRAKSINEN J. EARLY AND LATE PACE-MAKER IMPLANTATION AFTER TRANSCATHETER AND SURGICAL AORTIC VALVE REPLACEMENT. CATHETER CARDIOVASC INTERV. 2021 MAR;97(4):E560-E568. DOI: 10.1002/CCD.29177. EARLIEST DATE OF PUBLISH USED FOR DATE OF EVENT. MEDTRONIC PRODUCTS REFERENCED: HANCOCK (PMA# P980043, PRODUCT CODE DYE), MOSAIC (PMA# P990064, PRODUCT CODE DYE). EARLIEST APPROVED PRODUCT USED FOR PRODUCT CODE AND PMA#. 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 VIA LITERATURE REGARDING EARLY AND LATE PACEMAKER IMPLANT AFTER THE IMPLANT OF A SURGICAL AORTIC VALVES (SAV) AND TRANSCATHETER AORTIC VALVES (TAV). ALL DATA WERE COLLECTED FROM THE FIVE-MEDICAL CENTER FINNVALVE REGISTRY BETWEEN 2008 AND 2017. THE STUDY POPULATION INCLUDED 4,010 SAV PATIENTS AND 1,897 TAV PATIENTS. SAV PATIENTS WERE PREDOMINANTLY MALE, MEAN AGE 75 YEARS AND TAV PATIENTS WERE PREDOMINANTLY FEMALE, MEAN AGE 81 YEARS. MULTIPLE MANUFACTURER¿S DEVICES WERE IMPLANTED IN THE STUDY POPULATION. AMONG ALL PATIENTS, IMPLANTATIONS WITH MEDTRONIC DEVICES INCLUDED 87 COREVALVE, 11 ENGAGER, 155 EVOLUTR OR EVOLUTPRO, 231 HANCOCK II, AND 80 MOSAIC. THE REMAINING PATIENTS WERE IMPLANTED WITH A NON-MEDTRONIC SAV OR TAV. NO UNIQUE DEVICE IDENTIFIER NUMBERS WERE PROVIDED. AMONG ALL PATIENTS, ADVERSE EVENTS INCLUDED: ATRIAL FIBRILLATION (AFIB) AND ELECTROCARDIOGRAM (ECG) CHANGES TREATED WITH PERMANENT PACEMAKER. BASED ON THE AVAILABLE INFORMATION A MEDTRONIC PRODUCT MAY HAVE BEEN ASSOCIATED WITH THE ADVERSE EVENT(S). NO ADDITIONAL ADVERSE PATIENT EFFECTS OR PRODUCT PERFORMANCE ISSUES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1734070 MEDTRONIC SURGICAL TISSUE VALVE REPLACEMENT HEART-VALVE DYE MEDTRONIC HEART VALVES DIVISION MDT-TISSUE VALVE

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Male Required Intervention