BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COREVALVE TRANSCATHETER AORTIC VALVE

    MDR report key: 8575106 · Received May 2, 2019

    Report

    Report Number
    2025587-2019-01445
    Event Type
    Injury
    Date Received
    May 2, 2019
    Date of Event
    August 28, 2018
    Report Date
    May 2, 2019
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: TRENKWALDER T ET AL. "PROPHYLACTIC ECMO DURING TAVI IN PATIENTS WITH DEPRESSED LEFT VENTRICULAR EJECTION FRACTION." CLIN RES CARDIOL. 2019 APR; 108 (4): 366-374. DOI: 10.1007/S00392-018-1364-6. EPUB 2018 AUG 28. 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. (B)(4). 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 IMPACT OF PROPHYLACTIC VENO-ARTERIAL EXTRACORPOREAL MEMBRANE OXYGENATION IN PATIENTS WITH DEPRESSED LEFT VENTRICULAR EJECTION FRACTION WHO UNDERWENT TRANSCATHETER AORTIC VALVE IMPLANTATION. OUTCOMES WERE DEFINED ACCORDING TO THE VALVE ACADEMIC RESEARCH CONSORTIUM-2 CRITERIA (VARC-2). ALL DATA WERE COLLECTED FROM TWO CENTERS BETWEEN JULY 2010 AND MAY 2015. THE STUDY POPULATION INCLUDED 222 PATIENTS (PREDOMINANTLY MALE; MEAN AGE 80 YEARS), AN UNDISCLOSED NUMBER OF WHICH WERE IMPLANTED WITH A MEDTRONIC COREVALVE BIOPROSTHETIC VALVE OR A MEDTRONIC ENGAGER BIOPROSTHETIC VALVE (NO SERIAL NUMBERS PROVIDED). AMONG ALL PATIENTS, 3 PROCEDURE-RELATED DEATHS OCCURRED. IN ADDITION, THE OVERALL 30-DAY AND 1-YEAR MORTALITY RATES WERE 7.7% (17 PATIENTS) AND 23.0% (51 PATIENTS), RESPECTIVELY. MULTIPLE MANUFACTURERS WERE NOTED IN THE LITERATURE; BASED ON THE AVAILABLE INFORMATION, MEDTRONIC PRODUCT WAS NOT DIRECTLY ASSOCIATED WITH THE DEATH(S). AMONG ALL PATIENTS, ADVERSE EVENTS INCLUDED: VALVE-IN-VALVE IMPLANTATION, NEW PERMANENT PACEMAKER IMPLANTATION, VENTRICULAR RUPTURE REQUIRING CONVERSION TO STERNOTOMY, EMERGENCY EXTRACORPOREAL MEMBRANE OXYGENATION DUE TO LIFE-THREATENING COMPLICATIONS (IDENTIFIED AS LEFT VENTRICULAR PUMP FAILURE WITH OR WITHOUT VENTRICULAR ARRHYTHMIAS AND SEVERE HYPOTENSION), PERICARDIAL TAMPONADE, LIFE-THREATENING/MAJOR BLEEDINGS REQUIRING BLOOD TRANSFUSIONS, MAJOR VASCULAR COMPLICATIONS, AND ACCESS SITE COMPLICATIONS. BASED ON THE AVAILABLE INFORMATION, MEDTRONIC PRODUCT MAY HAVE BEEN ASSOCIATED WITH 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
    368564 COREVALVE TRANSCATHETER AORTIC VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT MEDTRONIC HEART VALVES DIVISION CRS

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention