BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC TRANSCATHETER VALVE

    MDR report key: 19778557 · Received July 18, 2024

    Report

    Report Number
    2025587-2024-04059
    Event Type
    Injury
    Date Received
    July 18, 2024
    Date of Event
    May 24, 2024
    Report Date
    July 18, 2024
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CITATION: HIOKI H, ET AL. SIZE OF SELF-EXPANDABLE TRANSCATHETER HEART VALVE AND MID-TERM ADVERSE EVENTS AFTER TRANSCATHETER AORTIC VALVE REPLACEMENT. AM J CARDIOL 2024; 223:156-164. DOI: HTTPS://DOI.ORG/10.1016/J.AMJCARD.2024.05.018. EARLIEST DATE OF PUBLICATION USED FOR DATE OF EVENT. MEDTRONIC PRODUCTS REFERENCED: EVOLUT R (PRODUCT CODE NPT, PMA# P130021) AND EVOLUT PRO (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. SELECT PATIENT INFORMATION CANNOT BE INCLUDED IN REGULATORY REPORT DUE TO REGIONAL PRIVACY REGULATIONS. 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 IMPACT OF PROSTHESIS SIZE ON ADVERSE EVENTS AFTER TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) USING SELF-EXPANDABLE VALVES. ONLY MEDTRONIC EVOLUT R AND EVOLUT PRO VALVES WERE IMPLANTED IN THE STUDY POPULATION OF 1,400 PATIENTS. DURING FOLLOW-UP, THE AUTHORS OBSERVED 201 ALL-CAUSE DEATHS, INCLUDING 68 CARDIOVASCULAR DEATHS. THE AUTHORS FOUND THAT VALVE SIZE WAS NOT ASSOCIATED WITH A HIGHER INCIDENCE OF ALL-CAUSE DEATH, NOR WAS ANY EVIDENCE PRESENTED TO SUGGEST THAT A MEDTRONIC VALVE OR ITS FUNCTION CONTRIBUTED TO ANY OF THE DEATHS. THE FOLLOWING POST-PROCEDURAL ADVERSE EVENTS WERE ALSO RECOUNTED IN THE ARTICLE: PROSTHESIS-PATIENT MISMATCH, PARAVALVULAR LEAK (MILD TO SEVERE), PERMANENT PACEMAKER IMPLANTATION, ISCHEMIC STROKE, BLEEDING (LIFE-THREATENING OR MAJOR), VASCULAR COMPLICATIONS (MAJOR OR MINOR), REHOSPITALIZATION DUE TO HEART FAILURE, AND ACUTE KIDNEY INJURY. NO FURTHER INFORMATION WAS PROVIDED PERTAINING TO MEDTRONIC PRODUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1645134 MEDTRONIC TRANSCATHETER VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV NPT MEDTRONIC HEART VALVES DIVISION MDT-TRANS VALVE

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization| R| L