BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COREVALVE TRANSCATHETER AORTIC VALVE

    MDR report key: 8822679 · Received July 24, 2019

    Report

    Report Number
    2025587-2019-02324
    Event Type
    Injury
    Date Received
    July 24, 2019
    Date of Event
    April 4, 2019
    Report Date
    July 25, 2019
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION RECEIVED FROM THE PHYSICIAN/AUTHOR STATED THAT MEDTRONIC PRODUCT DID NOT CAUSE OR CONTRIBUTE TO THE OBSERVED ADVERSE EVENTS. UPDATED DATA: A.4 - MEAN PATIENT WEIGHT ADDED (163 LBS/74 KGS). MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    CITATION: MACH M ET AL. IMPACT OF COPD ON OUTCOME IN PATIENTS UNDERGOING TRANSFEMORAL VERSUS TRANSAPICAL TAVI. THORAC CARDIOVASC SURG. 2019 JUN;67(4):251-256. DOI: 10.1055/S-0039-1685177. EPUB 2019 APR 4. 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. (B)(4). A SUPPLEMENTAL REPORT WILL BE ISSUED. [(B)(4)].

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION VIA LITERATURE REGARDING THE IMPACT OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD) ON OUTCOMES IN PATIENTS WHO UNDERWENT TRANSFEMORAL OR TRANSAPICAL TRANSCATHETER AORTIC VALVE IMPLANTATION. ALL DATA WERE COLLECTED FROM TWO CENTERS BETWEEN NOVEMBER 2008 AND DECEMBER 2016. THE STUDY POPULATION INCLUDED 1,842 PATIENTS (PREDOMINANTLY FEMALE; MEAN AGE 80 YEARS), AN UNSPECIFIED NUMBER OF WHICH WERE IMPLANTED WITH MEDTRONIC COREVALVE BIOPROSTHETIC VALVES (NO SERIAL NUMBERS PROVIDED). AMONG ALL PATIENTS, 96 DEATHS OCCURRED WITHIN 30 DAYS POST IMPLANT. MULTIPLE MANUFACTURERS WERE NOTED IN THE LITERATURE; BASED ON THE AVAILABLE INFORMATION, MEDTRONIC PRODUCT WAS NOT DIRECTLY ASSOCIATED WITH THE DEATHS. AMONG ALL PATIENTS, ADVERSE EVENTS INCLUDED: NEW PERMANENT PACEMAKER IMPLANTATION, REOPERATION FOR CARDIAC PROBLEM, CONVERSION TO SURGICAL AORTIC VALVE REPLACEMENT, MYOCARDIAL INFARCTION, REINTUBATION, NEURO COMPLICATIONS, MAJOR STROKE, PARAVALVULAR LEAK (UNKNOWN SEVERITY), AND MAJOR BLEEDING. OTHER ADVERSE EVENTS INCLUDED: MAJOR ACCESS RELATED COMPLICATIONS (NO INTERVENTIONS WERE REPORTED). BASED ON THE AVAILABLE INFORMATION, MEDTRONIC PRODUCT MAY HAVE BEEN ASSOCIATED WITH THE ADVERSE EVENTS. NO ADDITIONAL ADVERSE PATIENT EFFECTS OR PRODUCT PERFORMANCE ISSUES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    614674 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