BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC TRANSCATHETER VALVE

    MDR report key: 19361053 · Received May 21, 2024

    Report

    Report Number
    2025587-2024-03026
    Event Type
    Injury
    Date Received
    May 21, 2024
    Date of Event
    March 12, 2019
    Report Date
    June 5, 2024
    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
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CITATION: WAKSMAN R, CORSO PJ, TORGUSON R, ET AL. TAVR IN LOW-RISK PATIENTS: 1-YEAR RESULTS FROM THE LRT TRIAL. JACC CARDIOVASC INTERV. 2019;12(10):901-907. DOI:10.1016/J.JCIN.2019.03.002 EARLIEST DATE OF PUBLICATION USED FOR DATE OF EVENT. MEDTRONIC TRANSCATHETER AORTIC VALVES THAT MAY HAVE BEEN USED IN THE STUDY: COREVALVE (PRODUCT CODE NPT, PMA# P130021), EVOLUT R (PRODUCT CODE NPT, PMA# P130021), EVOLUT PRO (PRODUCT CODE NPT, PMA# P130021), EVOLUT PRO+ (PRODUCT CODE NPT, PMA# P130021), AND EVOLUT FX (PRODUCT CODE NPT, PMA# P130021). 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. 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

    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

    LITERATURE WAS REVIEWED REGARDING THE OUTCOMES OF TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) IN LOW-RISK PATIENTS. THE STUDY POPULATION CONSISTED OF 200 LOW-SURGICAL-RISK PATIENTS WHO UNDERWENT TAVR WITH COMMERCIALLY AVAILABLE TRANSCATHETER HEART VALVES (MANUFACTURER/BRAND NAMES NOT DISCLOSED). WITHIN ONE YEAR OF TAVR, THE AUTHORS OBSERVED SIX ALL-CAUSE DEATHS. NO EVIDENCE WAS PRESENTED TO SUGGEST THAT A MEDTRONIC PRODUCT OR ITS FUNCTION CONTRIBUTED TO ANY OF THE DEATHS. ADDITIONAL ADVERSE COMPLICATIONS INCLUDED: NON-DISABLING STROKE, LIFE-THREATENING OR MAJOR BLEEDING, MAJOR VASCULAR COMPLICATIONS, MYOCARDIAL INFARCTION, CORONARY ARTERY OBSTRUCTION, NEED FOR A SECOND TRANSCATHETER VALVE, NEW ONSET ATRIAL FIBRILLATION, NEW (POST-TAVR) PERMANENT PACEMAKER IMPLANTATION, PARAVALVULAR LEAK (GREATER THAN MILD), REINTERVENTION (SURGICAL EXPLANT AND REPLACEMENT) DUE TO ENDOCARDITIS, AND REHOSPITALIZATION FOR VARIOUS REASONS (CARDIAC, HEART FAILURE SYMPTOMS, AORTIC STENOSIS SYMPTOMS OR PROCEDURE-RELATED). NO ADDITIONAL ADVERSE OUTCOMES WERE NOTED.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED FROM THE AUTHORS STATED THAT MEDTRONIC PRODUCT DID NOT CAUSE OR CONTRIBUTE TO ANY OF THE OBSERVED ADVERSE OUTCOMES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1427007 MEDTRONIC TRANSCATHETER VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV NPT MEDTRONIC HEART VALVES DIVISION MDT-TRANS VALVE

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Male Hospitalization| R| L