BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC TRANSCATHETER VALVE

    MDR report key: 16787298 · Received April 21, 2023

    Report

    Report Number
    2025587-2023-01623
    Event Type
    Injury
    Date Received
    April 21, 2023
    Date of Event
    March 6, 2023
    Report Date
    April 21, 2023
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CITATION: SAJJAD W, ET AL. OUTCOMES OF SELF-EXPANDING TRANSCATHETER AORTIC VALVE REPLACEMENT IN PATIENTS WITH PROHIBITIVE SURGICAL RISK AND EXTREMELY LARGE ANNULAR SIZE: A SINGLE-CENTER CASE CONTROL SERIES. JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY. (B)(6) 2023, 81 (8_SUPPLEMENT) 858. HTTPS://DOI.(B)(6). PRESENTED AT ACC.23/WCC VIRTUAL ON MARCH 6, 2023. DATE OF PRESENTATION 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. 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 OF SELF-EXPANDING TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) IN PATIENTS WITH PROH IBITIVE SURGICAL RISK AND AN EXTRA-LARGE ANNULUS. THE STUDY POPULATION CONSISTED OF PATIENTS WHO UNDERWENT TAVR WITH A 34 MM MEDTRONIC EVOLUT R VALVE OR A 31 MM MEDTRONIC COREVALVE. THE AUTHORS WROTE, ¿OFF-LABEL CASES (CASES) WERE DEFINED AS THOSE WITH PROHIBITIVE SURGICAL RISK AND ANNULUS SIZE BEYOND THE MANUFACTURER GUIDELINES (ANNULUS SIZE >94.1 MM FOR EVOLUT R OR >91.2 MM FOR COREVALVE); THE REST WERE ON-LABEL (CONTROLS).¿ OF 146 PATIENTS, 115 WERE CONTROLS AND 35 WERE CASES. IN-HOSPITAL MORTALITY RATES WERE 5.88% (CASES) AND 1.24% (CONTROLS), RESPECTIVELY. NO EVIDENCE WAS PRESENTED TO SUGGEST THAT A MEDTRONIC VALVE OR ITS FUNCTION CONTRIBUTED TO ANY OF THE DEATHS. OTHER ADVERSE EVENTS THAT OCCURRED WERE DESCRIBED AS FOLLOWS: PARAVALVULAR LEAK/AORTIC INCOMPETENCE (MILD TOSEVERE) AND PACEMAKER IMPLANTATION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    610757 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