BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC TRANSCATHETER VALVE

    MDR report key: 13261585 · Received January 14, 2022

    Report

    Report Number
    2025587-2022-00119
    Event Type
    Injury
    Date Received
    January 14, 2022
    Date of Event
    November 27, 2021
    Report Date
    January 25, 2022
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CITATION: DOWLING C, ET AL. PATIENT-SPECIFIC COMPUTER SIMULATION TO PREDICT LONG-TERM OUTCOMES AFTER TRANSCATHETER AORTIC VALVE REPLACEMENT. J CARDIOVASC COMPUT TOMOGR. 2021 NOV 27;S1934-5925(21)00474-3. DOI: 10.1016/J.JCCT.2021.11.014. EARLIEST DATE OF PUBLISH USED FOR DATE OF EVENT. MEDTRONIC PRODUCTS REFERENCED: COREVALVE (PMA# P130021, PRODUCT CODE NPT), EVOLUT R (PMA# P130021, PRODUCT CODE NPT), EVOLUT PRO (PMA# P130021, PRODUCT CODE NPT). 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. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 0

    UPDATED INFORMATION: A4. MEAN WEIGHT OF THE STUDY POPULATION PROVIDED BY THE PHYSICIAN/AUTHOR. B5. ADDITIONAL INFORMATION RECEIVED FROM THE PHYSICIAN/AUTHOR STATED THAT MEDTRONIC DEVICES DID NOT CAUSE OR CONTRIBUTE TO ANY OF THE OBSERVED DEATHS, NOR WERE THEY DIRECTLY RELATED TO ANY OF THE OBSERVED ADVERSE EVENTS. 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

    MEDTRONIC RECEIVED INFORMATION FROM A LITERATURE ARTICLE REGARDING THE USE OF PATIENT-SPECIFIC COMPUTER SIMULATION TO PREDICT OUTCOMES AFTER TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR). ALL DATA WAS RETROSPECTIVELY COLLECTED FROM MULTIPLE CENTERS BETWEEN 2012 AND 2019. THE STUDY POPULATION INCLUDED 203 PATIENTS (PREDOMINANTLY MALE, MEAN AGE 80.5 YEARS). ALL PATIENTS WERE IMPLANTED WITH A MEDTRONIC TRANSCATHETER VALVE: COREVALVE (N = 20), EVOLUT R (N = 90), OR EVOLUT PRO (N = 93). NO UNIQUE DEVICE IDENTIFIER NUMBERS WERE PROVIDED. AMONG ALL PATIENTS, THE KAPLAN-MEIER ESTIMATE OF THE RATE OF DEATH WAS 18.5% AT TWO YEARS POST-TAVR. THE AUTHORS STATED CAUSE OF DEATH INFORMATION WAS NOT AVAILABLE IN THIS STUDY, NOR DID THEY CORRELATE ANY OF THE DEATHS WITH MEDTRONIC PRODUCT. AMONG ALL PATIENTS, PROCEDURAL AND POST-PROCEDURAL ADVERSE EVENTS INCLUDED: MORE THAN ONE TRANSCATHETER VALVE IMPLANTED, NEW PERMANENT PACEMAKER IMPLANTATION WITHIN 30 DAYS OF TAVR, AND MILD TO SEVERE PARAVALVULAR LEAK. NO ADDITIONAL ADVERSE PATIENT EFFECTS OR PRODUCT PERFORMANCE ISSUES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    730593 MEDTRONIC TRANSCATHETER VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV NPT MEDTRONIC HEART VALVES DIVISION MDT-TRANS VALVE

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Male Required Intervention