BEUDAMED
    FDA Adverse Event Death Summary report: N

    MEDTRONIC TRANSCATHETER VALVE

    MDR report key: 12030695 · Received June 21, 2021

    Report

    Report Number
    2025587-2021-01945
    Event Type
    Death
    Date Received
    June 21, 2021
    Date of Event
    March 6, 2021
    Report Date
    June 21, 2021
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: KHAN J., ET AL. PREVENTING CORONARY OBSTRUCTION DURING TRANSCATHETER AORTIC VALVE REPLACEMENT: RESULTS FROM THE MULTICENTER INTERNATIONAL BASILICA REGISTRY. JACC CARDIOVASC INTERV. 2021 MAY 10;14(9):941-948. PMID: 33958168. DOI: 10.1016/J.JCIN.2021.02.035. EPUB 2021 MAR 6 EARLIEST DATE OF PUBLISH USED FOR DATE OF EVENT AND DATES OF DEATH. [MEDTRONIC PRODUCTS REFERENCED: COREVALVE/EVOLUT R/EVOLUT PRO/EVOLUT PRO PLUS (PMA# P130021; PRODUCT CODE: NPT); HANCOCK (PMA# P870078, PRODUCT CODE: DYE); FREESTYLE (PMA# P970031; PRODUCT CODE: LWR); 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 · 1

    MEDTRONIC RECEIVED INFORMATION VIA LITERATURE REGARDING THE SAFETY OF INTENTIONALLY LACERATION BIOPROSTHETIC VALVE LEAFLETS TO PREVENT CORONARY ARTERY OBSTRUCTION. ALL DATA WERE RETROSPECTIVELY COLLECTED FROM MULTIPLE CENTERS IN NORTH AMERICA AND EUROPE BETWEEN JUNE 2017 AND DECEMBER 2020. THE STUDY POPULATION INCLUDED 214 PATIENTS (PREDOMINANTLY FEMALE, MEAN AGE 75 YEARS), 85 OF WHICH UNDERWENT TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) WITH MEDTRONIC SELF-EXPANDING BIOPROSTHETIC VALVES, WHICH INCLUDED EVOLUT R, EVOLUT PRO AND EVOLUT PRO PLUS VALVES (UNIQUE DEVICE IDENTIFIER NUMBERS NOT PROVIDED). OF THE STUDY POPULATION, 17 PATIENTS WERE PREVIOUSLY IMPLANTED WITH MEDTRONIC SURGICAL AORTIC BIOPROSTHESES, WHICH INCLUDED FREESTYLE, MOSAIC, HANCOCK AORTIC VALVES AND TWO PATIENTS WERE PREVIOUSLY IMPLANTED WITH MEDTRONIC COREVALVE BIOPROSTHETIC VALVES. AMONG ALL MEDTRONIC SELF-EXPANDING TAVR PATIENTS, ONE DEATH WAS NOTED TO OCCUR AFTER CORONARY OBSTRUCTION. DESPITE INTERVENTION TO SNARE THE VALVE AND RELIEVE THE OBSTRUCTION, THE PATIENT DEVELOPED CARDIOGENIC SHOCK AND SUBSEQUENTLY EXPIRED. THE ARTICLE NOTED OVERALL POST-PROCEDURE 30-DAY MORTALITY WAS 2.8%, THOUGH NO FURTHER DETAILS REGARDING OTHER DEATHS WERE NOTED. BASED ON THE AVAILABLE INFORMATION MEDTRONIC PRODUCT MAY HAVE BEEN ASSOCIATED WITH THE DEATHS. AMONG ALL MEDTRONIC SELF-EXPANDING TAVR PATIENTS, ADVERSE EVENTS INCLUDED: CORONARY OBSTRUCTION REQUIRING INTERVENTION, STROKES, LIF E-THREATENING BLEEDING, MAJOR VASCULAR COMPLICATIONS, AND VALVE-RELATED DYSFUNCTION REQUIRING REPEAT PROCEDURES. BASED ON THE AVAILABLE INFORMATION MEDTRONIC PRODUCT WAS DIRECTLY ASSOCIATED WITH THE ADVERSE EVENTS. AMONG ALL MEDTRONIC SURGICAL VALVE AND COREVALVE PATIENTS, ADVERSE EVENTS INCLUDED: FAILED BIOPROSTHETIC VALVES REQUIRING TAVR. BASED ON THE AVAILABLE INFORMATION MEDTRONIC PRODUCT WAS DIRECTLY 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
    929528 MEDTRONIC TRANSCATHETER VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV NPT MEDTRONIC HEART VALVES DIVISION MDT-TRANS VALVE

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Death| L| R