BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC TRANSCATHETER DELIVERY SYSTEM

    MDR report key: 12089521 · Received June 29, 2021

    Report

    Report Number
    2025587-2021-02034
    Event Type
    Injury
    Date Received
    June 29, 2021
    Date of Event
    February 17, 2021
    Report Date
    June 29, 2021
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: DEBINSKI M, ET AL. LONG-TERM OUTCOMES OF TRANSCATHETER SELF-EXPANDING AORTIC VALVE IMPLANTATIONS IN INOPERABLE AND HIGH SU RGICAL-RISK PATIENTS WITH SEVERE AORTIC STENOSIS: A SINGLE-CENTER SINGLE-VALVE REGISTRY. KARDIOL POL. 2021 MAR 25;79(3):319-326. DOI: 10.33963/KP.15821. EPUB 2021 FEB 17. EARLIEST DATE OF PUBLISH USED FOR DATE OF EVENT. MEDTRONIC PRODUCTS: ACCUTRAK DELIVERY CATHETER SYSTEM (PMA# P130021, PRODUCT CODE NPT), ENVEO R DELIVERY CATHETER SYSTEM (PMA# P130021, PRODUCT CODE NPT), ENVEO PRO DELIVERY CATHETER SYSTEM (PMA# P130021, PRODUCT CODE NPT). 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. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION FROM A LITERATURE ARTICLE REGARDING PATIENT OUTCOMES FOLLOWING TRANSCATHETER AORTIC VALVE IMPLANTATION (TAVI) AND IDENTIFICATION OF THE BASELINE AND PROCEDURE RELATED FACTORS INFLUENCING LONG TERM SURVIVAL. ALL DATA WAS COLLECTED FROM A SINGLE CENTER BETWEEN AUGUST 2012 AND JUNE 2020. THE STUDY POPULATION INCLUDED 248 PATIENTS AND WAS PREDOMINANTLY FEMALE WITH A MEDIAN AGE OF 81 YEARS. ALL PATIENTS UNDERWENT TAVI WITH MEDTRONIC TRANSCATHETER VALVE SYSTEMS: COREVALVE (93), EVOLUT R (147), OR EVOLUT PRO (8). NO UNIQUE DEVICE IDENTIFIER NUMBERS WERE PROVIDED. DURING APPROXIMATELY 8 YEARS OF OBSERVATION, 92 PATIENTS DIED AND 76% OF THE DEATHS WERE CLASSIFIED AS CARDIOVASCULAR. HOWEVER, THE CIRCUMSTANCES OF THE DEATHS WERE NOT DISCLOSED, AND A DIRECT CORRELATION WAS NOT MADE BETWEEN MEDTRONIC PRODUCT AND THE DEATHS. AMONG ALL PATIENTS, PROCEDURAL AND POST-PROCEDURAL ADVERSE EVENTS INCLUDED: SECOND VALVE IMPLANTED; URGENT STERNOTOMY; UNSPECIFIED VALVE REINTERVENTION; BALLOON POST DILATION TO OPTIMIZE VALVE EXPANSION; STROKE; MYOCARDIAL INFARCTION; NEW PERMANENT PACEMAKER IMPLANTATION; LIFE THREATENING, DISABLING, OR MAJOR BLEEDING; BLOOD TRANSFUSION; MAJOR VASCULAR COMPLICATIONS; MILD TO SEVERE PARAVALVULAR LEAK; VALVE THROMBOSIS (RESOLVED WITH VITAMIN K ANTAGONIST TREATMENT); AND PERIPHERAL ANGIOPLASTY/SURGERY. NO ADDITIONAL ADVERSE PATIENT EFFECTS OR PRODUCT PERFORMANCE ISSUES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    983674 MEDTRONIC TRANSCATHETER DELIVERY SYSTEM AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV NPT MEDTRONIC HEART VALVES DIVISION MDT-TRANS DCS UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention