BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCUTRAK DELIVERY CATHETER SYSTEM

    MDR report key: 8437957 · Received March 20, 2019

    Report

    Report Number
    2025587-2019-00995
    Event Type
    Injury
    Date Received
    March 20, 2019
    Date of Event
    February 1, 2019
    Report Date
    March 20, 2019
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: PASCUAL I ET AL. SELF-EXPANDING TRANSCATHETER AORTIC VALVE IMPLANTATION FOR DEGENERATED MITROFLOW BIOPROSTHESIS: EARLY OUTCOMES. INT J CARDIOL. 2019 FEB 1. PII: S0167-5273(18)32020-5. DOI: 10.1016/J.IJCARD.2019.01.094. [EPUB AHEAD OF PRINT] 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 THE 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 THE SAFETY AND EFFECTIVENESS OF VALVE-IN-VALVE TRANSCATHETER AORTIC VALVE IMPLANTATION (TAVI) WITH A SELF-EXPANDING VALVE IN PATIENTS WITH DEGENERATED MITROFLOW BIOPROSTHETIC AORTIC VALVES. ALL DATA WERE COLLECTED FROM A SINGLE CENTER BETWEEN MARCH 2012 AND DECEMBER 2017. THE STUDY POPULATION INCLUDED 45 PATIENTS (PREDOMINANTLY MALE; MEAN AGE 80 YEARS), 11 OF WHICH WERE IMPLANTED WITH A MEDTRONIC COREVALVE BIOPROSTHETIC VALVE AND 34 WERE IMPLANTED WITH A MEDTRONIC EVOLUT R BIOPROSTHETIC VALVE (23 AND 26 MM PROSTHESIS SIZES WERE USED). NO SERIAL NUMBERS WERE PROVIDED. AMONG ALL PATIENTS, 2 DEATHS OCCURRED DURING THE 30-DAY FOLLOW-UP PERIOD DUE TO CARDIOVASCULAR CAUSES. BASED ON THE AVAILABLE INFORMATION, MEDTRONIC PRODUCT DID NOT CAUSE OR CONTRIBUTE TO THESE DEATHS. AMONG ALL PATIENTS, ADVERSE EVENTS INCLUDED: PERMANENT PACEMAKER IMPLANTATION DUE TO HIGH GRADE ATRIO-VENTRICULAR BLOCK POST-TAVI (3 CASES), TRANSIENT DIPLOPIA (DOUBLE VISION) SUGGESTIVE OF TRANSIENT ISCHEMIC ATTACK (1 CASE), MODERATE-SEVERE PATIENT-PROSTHESIS MISMATCH POST-TAVI (27 CASES), AND MAJOR VASCULAR COMPLICATIONS: FEMORAL OCCLUSION THAT REQUIRED IMPLANT OF A COVERED STENT (1 CASE), AND PSEUDOANEURYSM THAT REQUIRED SURGERY (1 CASE). BASED ON THE AVAILABLE INFORMATION, MEDTRONIC PRODUCT MAY HAVE CAUSED OR CONTRIBUTED TO THESE ADVERSE EVENTS. NO ADDITIONAL ADVERSE PATIENT EFFECTS OR PRODUCT PERFORMANCE ISSUES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    230299 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