BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC SURGICAL TISSUE VALVE

    MDR report key: 12779588 · Received November 9, 2021

    Report

    Report Number
    2025587-2021-03383
    Event Type
    Injury
    Date Received
    November 9, 2021
    Date of Event
    August 15, 2020
    Report Date
    November 22, 2021
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    DYE
    PMA / PMN Number
    P990064
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CITATION: DAHLBACKA S, ET AL. PATIENT-PROSTHESIS MISMATCH WORSENS LONG-TERM SURVIVAL: INSIGHTS FROM THE FINNVALVE REGISTRY. ANN THORAC SURG. 2021 APR;111(4):1284-1290. DOI: 10.1016/J.ATHORACSUR.2020.06.026. EPUB 2020 AUG 15. EARLIEST DATE OF PUBLISH USED FOR DATE OF EVENT. MEDTRONIC PRODUCTS REFERENCED: HANCOCK II (PMA# P980043, PRODUCT CODE DYE), MOSAIC (PMA# P990064, PRODUCT CODE DYE). 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. THE PHYSICIAN/AUTHOR PROVIDED THE MEAN PATIENT WEIGHT OF THE STUDY POPULATION. B5. ADDITIONAL INFORMATION RECEIVED FROM THE PHYSICIAN/AUTHOR STATED THE PERFORMANCE OF INDIVIDUAL VALVE TYPES WERE NOT ANALYZED NOR THE SUBJECT OF THE STUDY, AND CONSEQUENTLY, THE CAUSAL RELATIONSHIP BETWEEN MEDTRONIC PRODUCT AND THE OBSERVED DEATHS AND NON-DEATH ADVERSE EVENTS IS NOT APPLICABLE. 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 INCIDENCE OF PATIENT-PROSTHESIS MISMATCH (PPM) AND ITS IMPACT ON OUTCOME AFTER SURGICAL AORTIC VALVE REPLACEMENT (SAVR) WITH STENTED BIOPROSTHESES. ALL DATA WAS COLLECTED FROM A FIVE-CENTER NATIONAL REGISTRY BETWEEN JANUARY 2008 TO OCTOBER 2017. OF THE 4,074 PATIENTS INCLUDED IN THE STUDY POPULATION (PREDOMINANTLY MALE, MEAN AGE 75 YEARS), 326 UNDERWENT SAVR WITH A MEDTRONIC BIOPROSTHETIC AORTIC VALVE: HANCOCK II (240) OR MOSAIC (86). NO UNIQUE DEVICE IDENTIFIER NUMBERS WERE PROVIDED. THE AUTHORS STATED 46% OF THE PATIENT POPULATION HAD PPM AFTER SAVR (NO PPM = 2198, MODERATE PPM = 1579, SEVERE PPM = 297). AMONG ALL PATIENTS, SURVIVAL RATES AT 10-YEAR FOLLOW-UP FOR THE NO PPM, MODERATE PPM, AND SEVERE PPM SUBGROUPS WERE 51.8%, 45.5%, AND 38.2%, RESPECTIVELY. NO STATEMENT WAS MADE SUGGESTING A CAUSAL OR CONTRIBUTORY RELATIONSHIP BETWEEN MEDTRONIC PRODUCT AND THE DEATHS. AMONG ALL PATIENTS, EARLY OUTCOMES INCLUDED: STROKE, ATRIAL FIBRILLATION, PERMANENT PACEMAKER IMPLANTATION, AND ELEVATED AORTIC VALV E GRADIENT (= 20 MMHG). REINTERVENTIONS PERFORMED DURING 10-YEAR FOLLOW-UP CONSISTED OF REPEAT SAVR, TRANSCATHETER VALVE-IN-VALVE REPLACEMENT, AND PERCUTANEOUS REPAIR OF PARAVALVULAR REGURGITATION. REASONS FOR REINTERVENTION WERE STRUCTURAL VALVE DETERIORATION, ENDOCARDITIS, OR PARAVALVULAR REGURGITATION. MEDTRONIC PRODUCT MAY HAVE BEEN ASSOCIATED WITH THE ADVERSE EVENTS. NO ADDITIONAL ADVERSE PATIENT EFFECTS OR PRODUCT PERFORMANCE ISSUES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1676340 MEDTRONIC SURGICAL TISSUE VALVE REPLACEMENT HEART-VALVE DYE MEDTRONIC HEART VALVES DIVISION MDT-TISSUE VALVE

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Male Hospitalization| R| L