BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC TRANSCATHETER VALVE

    MDR report key: 25032210 · Received April 29, 2026

    Report

    Report Number
    9617601-2026-02816
    Event Type
    Injury
    Date Received
    April 29, 2026
    Date of Event
    September 15, 2025
    Report Date
    April 29, 2026
    Manufacturer
    MEDTRONIC MEXICO S. DE R.L. DE CV
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CITATION: RAO ET AL. PROSPECTIVE OBSERVATIONAL STUDY ON THE ACCURACY OF PREDICTORS OF PERMANENT PACEMAKER SECONDARY TO HIGH-GRADE AT RIOVENTRICULAR CONDUCTION BLOCK AFTER TAVI (CONDUCT-TAVI). CIRC CARDIOVASC INTERV. 2025 NOV;18(11):E015446. DOI: 10.1161/CIRCINTERVENTIONS.125.015446. EPUB 2025 SEP 15. EARLIEST DATE OF PUBLICATION USED FOR DATE OF EVENT. 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 ACCURACY OF PREDICTORS OF PERMANENT PACEMAKER SECONDARY TO HIGH-GRADE ATRIOVENTRICULAR CONDUCTION BLOCK AFTER TRANSCATHETER AORTIC VALVE IMPLANTATION (TAVI).  THE STUDY POPULATION INCLUDED 200 PATIENTS WHO WERE PREDOMINANTLY MALE.  MULTIPLE MANUFACTURERS¿ DEVICES WERE IMPLANTED IN THE STUDY POPULATION; 123 PATIENTS RECEIVED A MEDTRONIC EVOLUT R (N=101), EVOLUT PRO (N=9), EVOLUT PRO+ (N=7) OR EVOLUT FX (N=6) BIOPROSTHETIC TRANSCATHETER VALVE.  DEATHS OCCURRED IN THE STUDY POPULATION; HOWEVER, THERE WAS NO STATEMENT ESTABLISHING A CAUSAL OR CONTRIBUTORY RELATIONSHIP BETWEEN MEDTRONIC PRODUCT AND THE DEATHS.  AMONG ALL PATIENTS, CLINICAL OBSERVATIONS INCLUDED: ARRHYTHMIA REQUIRING PERMANENT PACEMAKER IMPLANT, MAJOR BLEEDING OR VASCULAR COMPLICATION, STROKE, AND INFECTIVE ENDOCARDITIS.  NO FURTHER INFORMATION WAS PROVIDED PERTAINING TO MEDTRONIC PRODUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1096548 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 NA Male Life Threatening| H| R