BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCUTRAK DELIVERY CATHETER SYSTEM

    MDR report key: 10136287 · Received June 9, 2020

    Report

    Report Number
    2025587-2020-01843
    Event Type
    Injury
    Date Received
    June 9, 2020
    Date of Event
    February 7, 2020
    Report Date
    June 9, 2020
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: VAN DER WULP ET AL. INCIDENCE AND PREDICTORS OF VASCULAR COMPLICATIONS IN TRANSAXILLARY TAVI. EUROINTERVENTION. 2020 FEB 7;15(15):E1325-E1331. DOI: 10.4244/EIJ-D-19-00588. EARLIEST DATE OF PUBLISH USED FOR EVENT DATE. 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 VIA LITERATURE REGARDING INCIDENCE AND PREDICTORS OF VASCULAR COMPLICATIONS IN TRANSAXILLARY ACCESS FOR TRANSCATHETER AORTIC VALVE IMPLANTATION (TAVI). ALL DATA WERE COLLECTED FROM A SINGLE CENTER BETWEEN JANUARY 2014 AND DECEMBER 2017. THE STUDY POPULATION INCLUDED 200 PATIENTS (PREDOMINANTLY FEMALE, MEAN AGE 80 YEARS). NON-MEDTRONIC INTRODUCER SHEATHS WERE UTILIZED THE MOST OFTEN. MEDTRONIC COREVALVE AND EVOLUT R BIOPROSTHETIC VALVES WERE IMPLANTED PREDOMINANTLY, THEREFORE THE ACCUTRAK AND ENVEO R DELIVERY CATHETER SYSTEMS WERE ALSO UTILIZED PREDOMINANTLY. THE NUMBER OF DEVICES OR PRODUCT IDENTIFICATION NUMBERS WERE NOT PROVIDED. AMONG ALL PATIENTS SIX IN-HOSPITAL DEATHS OCCURRED. ONE DEATH OCCURRED AT TWO DAYS POST-IMPLANT DUE TO A MAJOR VASCULAR COMPLICATION IN WHICH AUTOPSY REVEALED A RUPTURE OF THE LEFT SUBCLAVIAN ARTERY OSTIUM. AFTER DISCHARGE, 18 PATIENTS DIED WITHIN ONE YEAR, NONE OF WHICH EXPERIENCED A TAVI-RELATED VASCULAR COMPLICATION. NO FURTHER DETAILS WERE PROVIDED ON THESE DEATHS. THE TYPE OF VALVE IMPLANTED IN THESE PATIENTS WAS NOT SPECIFIED. BASED ON THE AVAILABLE INFORMATION MEDTRONIC PRODUCT WAS NOT DIRECTLY ASSOCIATED WITH THE DEATH(S). AMONG ALL PATIENTS, PERI-PROCEDURAL ADVERSE EVENTS INCLUDED: VASCULAR COMPLICATIONS CONSISTING OF DISSECTION (32), STENOSIS (1), AND PERFORATION OR RUPTURE OF THE LEFT SUBCLAVIAN/AXILLARY ARTERY (1 MAJOR, 1 MINOR) REQUIRING INTERVENTION. BASED ON THE AVAILABLE INFORMATION MEDTRONIC PRODUCT WAS NOT DIRECTLY ASSOCIATED BUT MAY HAVE CAUSED OR CONTRIBUTED TO THE ADVERSE EVENT(S). NO ADDITIONAL ADVERSE PATIENT EFFECTS OR PRODUCT PERFORMANCE ISSUES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    596849 ACCUTRAK DELIVERY CATHETER SYSTEM AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT MEDTRONIC HEART VALVES DIVISION DCS UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention