BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC TRANSCATHETER VALVE

    MDR report key: 16713530 · Received April 11, 2023

    Report

    Report Number
    2025587-2023-01442
    Event Type
    Injury
    Date Received
    April 11, 2023
    Date of Event
    August 18, 2022
    Report Date
    April 11, 2023
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUATION OF CONCOMITANT MEDICAL PRODUCT(S): SECTION D INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER RELEVANT DEVICE(S): PRODUCT ID: MDT-TRANS DCS (MEDTRONIC TRANSCATHETER DELIVERY SYSTEM). CITATION: SAKURAI Y, ET AL. COMPLETE TRANSCATHETER VERSUS SURGICAL APPROACH TO AORTIC STENOSIS WITH CORONARY ARTERY DISEASE: A SYSTEMATIC REVIEW AND META-ANALYSIS. THE JOURNAL OF THORACIC AND CARDIOVASCULAR SURGERY. 2022 AUG 18;S0022-5223(22)00893-5. DOI: 10.1016/ J.JTCVS.2022.08.006. EARLIEST DATE OF PUBLICATION USED FOR DATE OF EVENT. MEDTRONIC PRODUCTS REFERENCED: COREVALVE (PRODUCT CODE NPT, PMA# P130021), EVOLUT R (PRODUCT CODE NPT, PMA# P130021). EARLIEST APPROVED PRODUCT USED FOR PRODUCT CODE AND PMA#. 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. SELECT PATIENT INFORMATION CANNOT BE INCLUDED IN REGULATORY REPORT DUE TO REGIONAL PRIVACY REGULATIONS. 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 A META-ANALYSIS REVIEW OF TRANSCATHETER AORTIC VALVE REPLACEMENT WITH PERCUTANEOUS CORONARY INTERVENTION VERSUS SURGICAL AORTIC VALVE REPLACEMENT WITH CORONARY ARTERY BYPASS GRAFTING. MEDTRONIC (COREVALVE AND EVOLUT R) AND NON-MEDTRONIC (EDWARDS SAPIEN, SAPIEN XT, AND SAPIEN 3) VALVE TYPES WERE INCLUDED IN THE ANALYSIS. THE AUTHORS EVALUATED ALL-CAUSE MORTALITY AT A WEIGHTED MEAN FOLLOW-UP OF 30.2 MONTHS. NO EVIDENCE WAS PRESENTED TO SUGGEST THAT A MEDTRONIC VALVE OR ITS FUNCTION CONTRIBUTED TO ANY OF THE DEATHS. PERIPROCEDURAL (30-DAY) OUTCOMES EXAMINED WERE AS FOLLOWS: UNSPECIFIED VASCULAR ACCESS COMPLICATIONS, MAJOR BLEEDING, PERMANENT PACEMAKER IMPLANTATION, STROKE, MYOCARDIAL INFARCTION, AND ACUTE KIDNEY INJURY. THE AUTHORS ALSO EXAMINED THE FOLLOWING OUTCOMES AT FOLLOW-UP: MODERATE TO SEVERE PARAVALVULAR LEAK, REHOSPITALIZATION, MYOCARDIAL INFARCTION, STROKE, AND REPEAT CORONARY INTERVENTION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    397066 MEDTRONIC TRANSCATHETER VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV NPT MEDTRONIC HEART VALVES DIVISION MDT-TRANS VALVE

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention| L| H