BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC TRANSCATHETER VALVE

    MDR report key: 21400530 · Received February 18, 2025

    Report

    Report Number
    2025587-2025-01280
    Event Type
    Injury
    Date Received
    February 18, 2025
    Date of Event
    January 1, 2025
    Report Date
    February 17, 2025
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D10: THIS IS A SYSTEM REPORT. THE SECTION D INFORMATION IS FOR THE PRIMARY DEVICE, WHICH WAS IN USE WITH THE FOLLOWING: MEDTRONIC TRANSCATHETER DELIVERY SYSTEM, PRODUCT ID: MDT-TRANS DCS, LOT NUMBER(S): UNKNOWN. CITATION: VAN ROYEN N, ET AL. EARLY OUTCOMES OF THE NOVEL MYVAL THV SERIES COMPARED TO SAPIEN THV SERIES AND EVOLUT THV SERIES IN IN DIVIDUALS WITH SEVERE AORTIC STENOSIS. EUROINTERVENTION. 2025; 21: E105-E118. PUBLISHED ONLINE E-EDITION JANUARY 2025. DOI: 10.4244/EIJ-D-24-00951 EARLIEST DATE OF PUBLICATION USED FOR DATE OF EVENT. MEDTRONIC TRANSCATHETER VALVE BRANDS REFERENCED IN THE ARTICLE: 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.

    Description of Event or Problem · 0

    LITERATURE WAS REVIEWED REGARDING THE OUTCOMES OF TRANSCATHETER AORTIC VALVE IMPLANTATION (TAVI) WITH THE MYVAL VALVE BRANDS COMPARED TO THE SAPIEN AND EVOLUT VALVE BRANDS. THE STUDY POPULATION CONSISTED OF 768 ELIGIBLE TAVI PATIENTS WHO WERE RANDOMIZED TO ONE OF THREE GROUPS: THE NON-MEDTRONIC MYVAL VALVE GROUP (N = 384), THE NON-MEDTRONIC SAPIEN VALVE GROUP (N = 192), OR THE MEDTRONIC EVOLUT VALVE GROUP (N = 192). IN THE EVOLUT GROUP, THE AUTHORS DOCUMENTED THE FOLLOWING ADVERSE OUTCOMES: SECOND VALVE IMPLANTED DUE TO SUBOPTIMAL POSITION OF THE FIRST VALVE, STROKE, BLEEDING, MAJOR VASCULAR COMPLICATIONS, AORTIC REGURGITATION (MILD TO SEVERE), ACUTE KIDNEY INJURY, AND CONDUCTION DISTURBANCES NECESSITATING PERMANENT PACEMAKER IMPLANT. THE SPECIFIC CONDUCTION DISTURBANCES INCLUDED: COMPLETE HEART BLOCK, SECOND-DEGREE ATRIOVENTRICULAR (AV) BLOCK, COMBINATION OF FIRST-DEGREE AV BLOCK AND LEFT BUNDLE BRANCH BLOCK, AND FIVE-SECOND PAUSE. ADDITIONALLY, SIX DEATHS OCCURRED IN THE EVOLUT GROUP. HOWEVER, THERE WAS NO EVIDENCE PRESENTED TO SUGGEST A CAUSAL OR CONTRIBUTORY RELATIONSHIP BETWEEN MEDTRONIC PRODUCT AND THE DEATHS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2670391 MEDTRONIC TRANSCATHETER VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV NPT MEDTRONIC HEART VALVES DIVISION MDT-TRANS VALVE

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Male Required Intervention| L "SEE H11...."