BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOLUT PRO TRANSCATHETER AORTIC VALVE

    MDR report key: 15920943 · Received December 5, 2022

    Report

    Report Number
    2025587-2022-03412
    Event Type
    Injury
    Date Received
    December 5, 2022
    Date of Event
    August 5, 2022
    Report Date
    December 5, 2022
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CITATION: POTRATZ M, ET AL. HEMODYNAMIC PERFORMANCE OF TWO CURRENT-GENERATION TRANSCATHETER HEART VALVE PROSTHESES IN SEVERELY CALCIFIED AORTIC VALVE STENOSIS. JOURNAL OF CLINICAL MEDICINE. 2022 AUG 5;11(15):4570. DOI: 10.3390/JCM11154570. 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

    MEDTRONIC RECEIVED INFORMATION FROM A LITERATURE ARTICLE REGARDING THE HEMODYNAMIC PERFORMANCE OF TWO CURRENT-GENERATION TRANSCATHETER HEART VALVES IN PATIENTS WITH SEVERELY CALCIFIED AORTIC VALVES. THE AUTHORS CONDUCTED A RETROSPECTIVE SINGLE-CENTER STUDY OF PATIENTS WITH SEVERE CALCIFIED AORTIC VALVE STENOSIS WHO WERE IMPLANTED WITH EITHER A MEDTRONIC EVOLUT PRO VALVE OR A NON-MEDTRONIC EDWARDS SAPIEN 3 VALVE BETWEEN JUNE 2014 AND DECEMBER 2019. AFTER PROPENSITY SCORE-MATCHING, 170 PATIENTS (PREDOMINANTLY FEMALE, MEAN AGE 82.5 YEARS) WERE INCLUDED IN THE EVOLUT PRO GROUP. NO UNIQUE DEVICE IDENTIFIER NUMBERS WERE PROVIDED. IN THE EVOLUT PRO GROUP, THE 30-DAY MORTALITY INCLUDED 5 PATIENTS. NO STATEMENT WAS MADE SUGGESTING A CAUSAL OR CONTRIBUTORY RELATIONSHIP BETWEEN MEDTRONIC PRODUCT AND THE DEATHS. IN THE EVOLUT PRO GROUP, ADVERSE EVENTS AFTER VALVE IMPLANT INCLUDED: ACUTE KIDNEY FAILURE REQUIRING DIALYSIS; BLEEDING (MINOR, MAJOR, OR LIFE-THREATENING); VASCULAR COMPLICATION (MINOR OR MAJOR); DISABLING STROKE; NEW PERMANENT PACEMAKER IMPLANTATION; PARAVALVULAR LEAK (MILD TO MODERATE); AND PATIENT-PROSTHESIS MISMATCH. NO ADDITIONAL ADVERSE PATIENT EFFECTS OR PRODUCT PERFORMANCE ISSUES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2471437 EVOLUT PRO TRANSCATHETER AORTIC VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV NPT MEDTRONIC HEART VALVES DIVISION EVOLUTPRO-23

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Female Required Intervention| L| S