BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC SURGICAL ANNULOPLASTY PRODUCTS

    MDR report key: 15058111 · Received July 19, 2022

    Report

    Report Number
    2025587-2022-01964
    Event Type
    Injury
    Date Received
    July 19, 2022
    Date of Event
    January 20, 2022
    Report Date
    July 21, 2022
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    KRH
    PMA / PMN Number
    K960356
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CITATION: ARAFAT AA, ET AL. THE INFLUENCE OF MITRAL VALVE PATHOLOGY ON THE CONCOMITANT TRICUSPID VALVE REPAIR. JOURNAL OF CARDIAC SURGERY. 2022 APR;37(4):739-746. DOI: 10.1111/JOCS.16250. EPUB 2022 JAN 20. EARLIEST DATE OF PUBLISH USED FOR DATE OF EVENT. MEDTRONIC PRODUCTS REFERENCED: DURAN (PMA# K960356, PRODUCT CODE KRH), TRI-AD (PMA# K093903, PRODUCT CODE KRH). 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.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION RECEIVED FROM THE CORRESPONDING PHYSICIAN/AUTHOR STATED THAT THE STUDY WAS NOT SPECIFIC TO MEDTRONIC DEVICES AND THEY DID NOT PERFORM A SUB-GROUP ANALYSIS. HOWEVER, THE PHYSICIAN/AUTHOR ADDED THAT MEDTRONIC DEVICES DID NOT HAVE A CAUSAL RELATIONSHIP WITH ANY OF THE OBSERVED DEATHS OR NON-DEATH 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 EFFECT OF MITRAL VALVE PATHOLOGY ON CONCOMITANT TRICUSPID VALVE REPAIR. ALL DATA WAS RETROSPECTIVELY COLLECTED FROM A SINGLE CENTER BETWEEN JANUARY 2009 AND MAY 2019. THE STUDY POPULATION INCLUDED 480 PATIENTS (PREDOMINANTLY FEMALE, MEDIAN AGE 53.5 YEARS) WHO UNDERWENT TRICUSPID VALVE REPAIR CONCOMITANT WITH MITRAL VALVE SURGERY FOR RHEUMATIC OR DEGENERATIVE DISEASE. TRICUSPID VALVE REPAIR WAS PERFORMED USING EITHER FLEXIBLE BANDS (SORIN SMB50, EDWARDS COSGROVE-EDWARDS, AND MEDTRONIC DURAN); RIGID RINGS (EDWARDS MC3 AND MEDTRONIC TRI-AD); OR THE DE VEGA TECHNIQUE. AN UNDISCLOSED NUMBER OF PATIENTS RECEIVED A MEDTRONIC ANNULOPLASTY PRODUCT (DURAN BAND OR TRI-AD RING). NO UNIQUE DEVICE IDENTIFIER NUMBERS WERE PROVIDED. AMONG ALL 480 PATIENTS, THE MORTALITY RATES AT SEVEN YEARS POST-REPAIR WERE 4.8% AND 3% IN GROUPS 1 (PATIENTS WITH RHEUMATIC MITRAL VALVE DISEASE) AND 2 (PATIENTS WITH DEGENERATIVE MITRAL VALVE DISEASE), RESPECTIVELY. NO STATEMENT WAS MADE SUGGESTING A CAUSAL OR CONTRIBUTORY RELATIONSHIP BETWEEN MEDTRONIC PRODUCT AND THE DEATHS. AMONG ALL 480 PATIENTS, NON-DEATH ADVERSE EVENTS INCLUDED: POST-OPERATIVE INTRA-AORTIC BALLOON PUMP OR EXTRACORPOREAL MEMBRANE OXYGENATION SUPPORT, VENTILATED FOR MORE THAN 48 HOURS, OPEN STERNUM, RE-INTUBATION, RE-OPENING FOR BLEEDING OR HEMODYNAMICS, RECURRENT T RICUSPID REGURGITATION (MODERATE TO SEVERE), AND TRICUSPID VALVE RE-INTERVENTION. ALTHOUGH A DIRECT CORRELATION WAS NOT MADE, MEDTRONIC PRODUCT MAY HAVE BEEN ASSOCIATED WITH THESE ADVERSE EVENTS. NO ADDITIONAL ADVERSE PATIENT EFFECTS OR PRODUCT PERFORMANCE ISSUES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1719415 MEDTRONIC SURGICAL ANNULOPLASTY PRODUCTS RING, ANNULOPLASTY KRH MEDTRONIC HEART VALVES DIVISION MDT-ANNULOPLASTY

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Female Required Intervention