BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COREVALVE TRANSCATHETER AORTIC VALVE

    MDR report key: 18623592 · Received February 1, 2024

    Report

    Report Number
    2025587-2024-00545
    Event Type
    Injury
    Date Received
    February 1, 2024
    Date of Event
    January 1, 2023
    Report Date
    February 1, 2024
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS IS A SYSTEM REPORT. THE SECTION D INFORMATION IS FOR THE PRIMARY DEVICE, WHICH WAS IN USE WITH THE FOLLOWING: COREVALVE ACCUTRAK DELIVERY CATHETER SYSTEM (DCS), PRODUCT ID: DCS, LOT NUMBER(S): UNKNOWN. CITATION: DAI H, FAN J, HE Y, ET AL. TECHNICAL SUCCESS AFTER TRANSCATHETER AORTIC VALVE REPLACEMENT FOR BICUSPID VERSUS TRICUSPID AO RTIC STENOSIS. J CLIN MED. 2023;12(1):343. PUBLISHED 2023 JAN 1. DOI:10.3390/JCM12010343 EARLIEST DATE OF PUBLICATION USED FOR DATE OF EVENT. 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. 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.

    Description of Event or Problem · 0

    LITERATURE WAS REVIEWED REGARDING THE OUTCOMES BETWEEN PATIENTS WITH BICUSPID AND TRICUSPID AORTIC STENOSIS UNDERGOING TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR). ALL PATIENTS WERE TREATED WITH A FIRST-GENERATION SELF-EXPANDING TAVR SYSTEM (MEDTRONIC COREVALVE, VENUS MEDTECH VENUSA, MICROPORT VITAFLOW, OR PEIJIA MEDICAL TAURUSONE). WITHIN ONE YEAR OF TAVR, THE AUTHORS OBSERVED 31 DEATHS (CARDIOVASCULAR = 21, NON-CARDIOVASCULAR = 10). NO EVIDENCE WAS PRESENTED TO SUGGEST THAT A MEDTRONIC PRODUCT OR ITS FUNCTION CONTRIBUTED TO ANY OF THE DEATHS. OTHER OUTCOMES DOCUMENTED IN THE ARTICLE: CONVERSION TO SURGERY, CORONARY OBSTRUCTION (WITH OR WITHOUT PERCUTANEOUS CORONARY INTERVENTION), AORTIC DISSECTION, ANNULAR RUPTURE (WITH OR WITHOUT PERICARDIAL DRAINAGE), MYOCARDIAL INFARCTION, STROKE (DISABLING OR NON-DISABLING), NEW ATRIAL FIBRILLATION, PERMANENT PACEMAKER IMPLANTATION, SECOND VALVE IMPLANTATION, VALVE DISLOCATION/EMBOLIZATION, PATIENT-PROSTHESIS MISMATCH, HEART FAILURE, LIFE-THREATENING BLEEDING, AND VASCULAR/ACCESS-RELATED COMPLICATION REQUIRING STENT PLACEMENT OR SURGERY. NO ADDITIONAL ADVERSE OUTCOMES WERE NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1109814 COREVALVE TRANSCATHETER AORTIC VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV NPT MEDTRONIC HEART VALVES DIVISION CRS

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Male Life Threatening| R| S "SEE H10...."