BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC TRANSCATHETER VALVE

    MDR report key: 24638568 · Received March 19, 2026

    Report

    Report Number
    9617601-2026-01894
    Event Type
    Injury
    Date Received
    March 19, 2026
    Date of Event
    November 20, 2025
    Report Date
    March 27, 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
    NC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: B5 (SECOND PARAGRAPH). 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

    CITATION: EDWARDS J, CARROLL Z, LOVELACE M, MANDEL J, CARTER L, KLINE T. IMPACT OF EARLY ATRIOVENTRICULAR NODAL BLOCKER USE POST-TRANSCATHETER AORTIC VALVE REPLACEMENT. CATHETER CARDIOVASC INTERV. 2026;107(1):351-356. DOI:10.1002/CCD.70357 EARLIEST DATE OF PUBLICATION 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 THE USE OF ATRIOVENTRICULAR (AV) NODAL BLOCKER MEDICATION FOLLOWING TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR). THE STUDY POPULATION CONSISTED OF 756 TAVR PATIENTS, WITH 381 THAT RECEIVED AN AV NODAL BLOCKER WITHIN 48 HOURS OF TAVR AND 375 THAT DID NOT. VARIOUS VALVE TYPES WERE USED IN THE STUDY, ENCOMPASSING FIVE MEDTRONIC BRANDS (COREVALVE, EVOLUT R, EVOLUT PRO, EVOLUT PRO+, EVOLUT FX; N = 123) AND SIX NON-MEDTRONIC BRANDS (N = 633). AMONG ALL 756 PATIENTS, THE FOLLOWING ADVERSE OUTCOMES OCCURRED: ADMINISTRATION OF AV NODAL BLOCKER MEDICATION, SECOND-DEGREE OR HIGHER AV BLOCK, AND PERMANENT PACEMAKER IMPLANTATION. THE AUTHORS ALSO OBSERVED DEATHS WITHIN THIRTY DAYS OF TAVR. HOWEVER, NO EVIDENCE WAS PRESENTED TO SUGGEST A CAUSAL RELATIONSHIP BETWEEN A MEDTRONIC PRODUCT AND ANY DEATHS. ADDITIONAL INFORMATION RECEIVED FROM THE CORRESPONDING AUTHOR STATED THAT A CAUSAL RELATIONSHIP BETWEEN MEDTRONIC DEVICES AND ANY DEATHS IS UNKNOWN AS CAUSE OF DEATH WAS NOT COLLECTED AND IS NOT AVAILABLE. THE AUTHOR ALSO ADDED THAT THE STUDY ONLY EVALUATED ALL-CAUSE MORTALITY. LASTLY, THE AUTHOR NOTED THAT DEVICE SERIAL/LOT NUMBERS AND RETURN STATUS ARE NOT AVAILABLE.

    Description of Event or Problem · 0

    LITERATURE WAS REVIEWED REGARDING THE USE OF ATRIOVENTRICULAR (AV) NODAL BLOCKER MEDICATION FOLLOWING TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR). THE STUDY POPULATION CONSISTED OF 756 TAVR PATIENTS, WITH 381 THAT RECEIVED AN AV NODAL BLOCKER WITHIN 48 HOURS OF TAVR AND 375 THAT DID NOT. VARIOUS VALVE TYPES WERE USED IN THE STUDY, ENCOMPASSING FIVE MEDTRONIC BRANDS (COREVALVE, EVOLUT R, EVOLUT PRO, EVOLUT PRO+, EVOLUT FX; N = 123) AND SIX NON-MEDTRONIC BRANDS (N = 633). AMONG ALL 756 PATIENTS, THE FOLLOWING ADVERSE OUTCOMES OCCURRED: ADMINISTRATION OF AV NODAL BLOCKER MEDICATION, SECOND-DEGREE OR HIGHER AV BLOCK, AND PERMANENT PACEMAKER IMPLANTATION. THE AUTHORS ALSO OBSERVED DEATHS WITHIN THIRTY DAYS OF TAVR. 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
    705911 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 78 YR Male Required Intervention| L