BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC TRANSCATHETER DELIVERY SYSTEM

    MDR report key: 13049308 · Received December 20, 2021

    Report

    Report Number
    2025587-2021-03796
    Event Type
    Injury
    Date Received
    December 20, 2021
    Date of Event
    July 20, 2021
    Report Date
    December 20, 2021
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EG
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CITATION: BAHAA H, ET AL. EARLY RESULTS FROM AN EGYPTIAN TRANSCATHETER AORTIC VALVE REGISTRY (EGY-TVR). EGYPT HEART J. 2021 JUL 20;73(1):67. DOI: 10.1186/S43044-021-00189-Y. 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). 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 · 0

    MEDTRONIC RECEIVED INFORMATION FROM A LITERATURE ARTICLE REGARDING THE CLINICAL OUTCOMES OF AN ALL-COMER EGYPTIAN TRANSCATHETER AORTIC VALVE IMPLANTATION (TAVI) REGISTRY. ALL DATA WAS COLLECTED FROM FIVE CENTERS BETWEEN AUGUST 2012 AND DECEMBER 2017. OF THE 96 PATIENTS INCLUDED IN THE STUDY POPULATION (PREDOMINANTLY FEMALE; MEAN AGE 77.2 YEARS; MEAN WEIGHT 88.4 KG), APPROXIMATELY 49 UNDERWENT TAVI WITH A MEDTRONIC COREVALVE OR EVOLUT R VALVE SYSTEM. NO UNIQUE DEVICE IDENTIFIER NUMBERS WERE PROVIDED. OF THE 96 PATIENTS INCLUDED IN THE STUDY, 4 DEATHS OCCURRED WITHIN THIRTY DAYS OF TAVI. NO STATEMENT WAS MADE SUGGESTING A CAUSAL OR CONTRIBUTORY RELATIONSHIP BETWEEN MEDTRONIC PRODUCT AND THE DEATHS. MEDTRONIC TRANSCATHETER VALVES MAY HAVE BEEN ASSOCIATED WITH THE FOLLOWING ADVERSE EVENTS: VALVE-IN-VALVE IMPLANTATION DUE TO MIGRATION OF THE INITIAL VALVE TO THE AORTA; PERMANENT PACEMAKER IMPLANTATION; MILD TO SEVERE AORTIC REGURGITATION; CEREBROVASCULAR (STROKE); CARDIAC TAMPONADE; AND INCREASED PEAK/MEAN PRESSURE GRADIENT. MEDTRONIC DELIVERY CATHETER SYSTEMS MAY HAVE BEEN ASSOCIATED WITH THE FOLLOWING ADVERSE EVENTS: VASCULAR SITE DISSECTION AND/OR TOTAL OCCLUSION REQUIRING STENTING OR SURGICAL REPAIR; AND BLEEDING (LIFE-THREATENING, DISABLING, OR MAJOR). NO ADDITIONAL ADVERSE PATIENT EFFECTS OR PRODUCT PERFORMANCE ISSUES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1947745 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 77 YR Female Disability| L| R