BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDTRONIC TRANSCATHETER VALVE

    MDR report key: 19557732 · Received June 18, 2024

    Report

    Report Number
    2025587-2024-03491
    Event Type
    Malfunction
    Date Received
    June 18, 2024
    Date of Event
    May 20, 2024
    Report Date
    June 18, 2024
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CITATION: MERDLER I, CASE BC, BHOGAL S, ET AL. TEMPORAL TRENDS WITH THE EVOLUT FAMILY OF SELF-EXPANDING TRANSCATHETER HEART VALVES: A SINGLE-CENTER EXPERIENCE. CATHETER CARDIOVASC INTERV. PUBLISHED ONLINE MAY 20, 2024. DOI:10.1002/CCD.31088 EARLIEST DATE OF PUBLICATION USED FOR DATE OF EVENT. MEDTRONIC PRODUCTS REFERENCED: EVOLUT PRO SYSTEM (PRODUCT CODE NPT, PMA# P130021) AND EVOLUT PRO+ SYSTEM (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 EVOLUTION BETWEEN THE EVOLUT PRO AND EVOLUT PRO+ VALVE SYSTEMS AND WHETHER THE CHANGES IMPACTED PATIENT OUTCOMES. THE STUDY POPULATION CONSISTED OF 300 PATIENTS WHO ALL UNDERWENT TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) WITH A MEDTRONIC EVOLUT PRO OR PRO+ SYSTEM. OVERALL, THE AUTHORS OBSERVED FOUR IN-HOSPITAL DEATHS FOLLOWING TAVR. NO EVIDENCE WAS PRESENTED TO SUGGEST THAT A MEDTRONIC PRODUCT OR ITS FUNCTION CONTRIBUTED TO ANY OF THE DEATHS. OTHER TAVR OUTCOMES INCLUDED: VALVE EMBOLIZATION (NO INTERVENTION MENTIONED); NEW CONDUCTION DISTURBANCES (COMPLETE ATRIOVENTRICULAR BOCK, LEFT BUNDLE BRANCH BLOCK, OR RIGHT BUNDLE BRANCH BLOCK); NEW PERMANENT PACEMAKER/IMPLANTABLE CARDIOVERTER DEFIBRILLATOR IMPLANTATION; CORONARY OBSTRUCTION; STROKE; NEED FOR RE-INTERVENTION; TAMPONADE; PARAVALVULAR LEAK (ANY DEGREE); AORTIC REGURGITATION (MODERATE OR SEVERE); VALVE MALPOSITION (IMPLANTED ¿TOO HIGH¿); HEMOGLOBIN DROP; BLOOD TRANSFUSIONS; AND MAJOR VASCULAR COMPLICATIONS (ARTERIOVENOUS FISTULA, HEMATOMA, PSEUDOANEURYSM, RETROPERITONEAL BLEED, ARTERIAL PERFORATION, ARTERIAL DISSECTION, AND PERIPHERAL ISCHEMIA). NO FURTHER INFORMATION WAS PROVIDED PERTAINING TO MEDTRONIC PRODUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2322502 MEDTRONIC TRANSCATHETER VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV NPT MEDTRONIC HEART VALVES DIVISION MDT-TRANS VALVE

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Female