BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC TRANSCATHETER VALVE

    MDR report key: 24333255 · Received February 13, 2026

    Report

    Report Number
    9617601-2026-01195
    Event Type
    Injury
    Date Received
    February 13, 2026
    Date of Event
    November 7, 2024
    Report Date
    February 13, 2026
    Manufacturer
    MEDTRONIC MEXICO S. DE R.L. DE CV
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CITATION: STILL SA, XIE R, VARDAS PN, EUDAILEY KW, LEWIS CT, DAVIES JE. EXPLANTATION OF TRANSCATHETER AORTIC BIOPROSTHESES IN A VERY HIGH RISK POPULATION. ANN THORAC SURG. 2026;121(1):120-126. DOI:10.1016/J.ATHORACSUR.2025.04.025 AS STATED ON THE FIRST PAGE OF THE ARTICLE, ¿PRESENTED AT THE SEVENTY-FIRST ANNUAL MEETING OF THE SOUTHERN THORACIC SURGICAL ASSOCIA TION, AUSTIN, TX, NOV 7-10, 2024.¿ EARLIEST DATE OF PRESENTATION USED FOR DATE OF EVENT. EARLIEST APPROVED COREVALVE/EVOLUT 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 TRANSCATHETER AORTIC BIOPROSTHESIS EXPLANTATION IN HIGH-RISK PATIENTS. THE STUDY POPULATION CONSISTED OF 33 PATIENTS WHO UNDERWENT EXPLANTATION OF A MEDTRONIC (COREVALVE / EVOLUT PRO, N = 11) OR NON-MEDTRONIC (SAPIEN, N = 22) TRANSCATHETER VALVE TYPE. THE MEDIAN TIME TO EXPLANTATION WAS 815 DAYS (2.2 YEARS) AND THE REASONS FOR EXPLANT INCLUDED: BIOPROSTHETIC DEGENERATION/STENOSIS, ENDOCARDITIS, SEVERE PARAVALVULAR LEAK, AND VENTRICULAR SEPTAL DEFECT WITH PROGRESSIVE HEART FAILURE. POST- OPERATIVE OUTCOMES COMPRISED: RENAL FAILURE REQUIRING DIALYSIS, RESPIRATORY FAILURE, PACEMAKER IMPLANTATION, AND RE-ENTRY FOR BLEEDING. ADDITIONALLY, THE AUTHORS RECORDED THIRTY-DAY, ONE-YEAR, AND THREE-YEAR MORTALITY RATES OF 6%, 18.6%, AND 38.4%, RESPECTIVELY. HOWEVER, NO EVIDENCE WAS PRESENTED TO SUGGEST A CAUSAL RELATIONSHIP BETWEEN A MEDTRONIC PRODUCT AND ANY DEATHS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    394591 MEDTRONIC TRANSCATHETER VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV NPT MEDTRONIC MEXICO S. DE R.L. DE CV MDT-TRANS VALVE

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Male Life Threatening| R| H