BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURAN ANCORE RING

    MDR report key: 12247281 · Received July 29, 2021

    Report

    Report Number
    2025587-2021-02406
    Event Type
    Injury
    Date Received
    July 29, 2021
    Date of Event
    September 28, 2020
    Report Date
    October 19, 2021
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    KRH
    PMA / PMN Number
    K032810
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    A CORRECTION IS BEING SUBMITTED FOR FIELD B1. 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 · 1

    CITATION: LEE H., ET AL. IS PROPHYLACTIC TRICUSPID ANNULOPLASTY BENEFICIAL FOR DEGENERATIVE MITRAL VALVE REPAIR? ANN THORAC SURG. 2021 MAY;111(5):1502-1511. PMID: 33002510. DOI: 10.1016/J.ATHORACSUR.2020.07.037. EPUB 2020 SEP 28 EARLIEST DATE OF PUBLISH USED FOR DATE OF EVENT. MEDTRONIC PRODUCTS REFERENCED: DURAN ANCORE (PMA# K960356, 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. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION VIA LITERATURE REGARDING LONG-TERM OUTCOMES OF PERFORMING PROPHYLACTIC TRICUSPID VALVE ANNULOPLASTY FOR PATIENTS WHO LATER REQUIRED MITRAL VALVE REPAIR SURGERY. ALL DATA WERE RETROSPECTIVELY COLLECTED FROM A SINGLE CENTER BETWEEN DECEMBER 1997 AND DECEMBER 2013. THE STUDY POPULATION INCLUDED 151 PATIENTS (PREDOMINANTLY FEMALE, MEAN AGE 58 YEARS), 12 OF WHOM WERE IMPLANTED WITH MEDTRONIC DURAN ANCORE ANNULOPLASTY RINGS (UNIQUE DEVICE IDENTIFIER NUMBERS NOT PROVIDED). AMONG ALL PATIENTS, OVER A 10-YEAR FOLLOW-UP PERIOD THERE WERE 14 DEATHS, WITH FIVE DEATHS NOTED TO BE CARDIAC-RELATED. MULTIPLE MANUFACTURERS WERE INVOLVED AND NO FURTHER INFORMATION WAS PROVIDED. BASED ON THE AVAILABLE INFORMATION MEDTRONIC PRODUCT WAS NOT DIRECTLY ASSOCIATED WITH THE DEATHS. AMONG ALL PATIENTS, ADVERSE EVENTS INCLUDED: TRICUSPID REGURGITATION, POST-OPERATIVE MITRAL REGURGITATION REQUIRING RE-OPERATION, LATE MODERATE-SEVERE MITRAL REGURGITATION, NEED FOR PERMANENT PACEMAKER IMPLANTATION FOR SICK SINUS SYNDROME. BASED ON THE AVAILABLE INFORMATION, MEDTRONIC PRODUCT MAY HAVE BEEN ASSOCIATED WITH THE ADVERSE EVENTS. ONE MEDTRONIC DURAN ANCORE PATIENT REQUIRED RE-OPERATION FOR SEVERE MITRAL STENOSIS FROM RING PANNUS FORMATION. BASED ON THE AVAILABLE INFORMATION, MEDTRONIC PRODUCT WAS DIRECTLY ASSOCIATED WITH THE ADVERSE EVENT. NO ADDITIONAL ADVERSE PATIENT EFFECTS OR PRODUCT PERFORMANCE ISSUES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1144495 DURAN ANCORE RING RING, ANNULOPLASTY KRH MEDTRONIC HEART VALVES DIVISION 620R

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Life Threatening| R