BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CG COMPOSITE RING

    MDR report key: 16330020 · Received February 8, 2023

    Report

    Report Number
    2025587-2023-00463
    Event Type
    Injury
    Date Received
    February 8, 2023
    Date of Event
    September 28, 2022
    Report Date
    February 8, 2023
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    KRH
    PMA / PMN Number
    K061127
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CITATION: LIN X.; ET AL. EARLY CLINICAL OUTCOMES OF THORACOSCOPIC MITRAL VALVULOPLASTY: THE FIRST 90 CASES. HEART SURG FORUM. 2022 SEP 28;25(5): E692-E697. DOI: 10.1532/HSF.4807. PMID: 36317917. E-PUB SEPTEMBER 2022 EARLIEST DATE OF PUBLICATION USED FOR DATE OF EVENT. MEDTRONIC PRODUCTS REFERENCED: CG FUTURE (PMA# K061127, 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.

    Description of Event or Problem · 0

    MEDTRONIC RECEIVED INFORMATION VIA LITERATURE REGARDING CLINICAL OUTCOMES AFTER THORACOSCOPIC MITRAL VALVE REPAIR. ALL DATA WERE COLLECTED FROM A SINGLE CENTER BETWEEN APRIL 2020 AND DECEMBER 2021. THE STUDY POPULATION INCLUDED 90 PATIENTS. MULTIPLE MANUFACTURER¿S DEVICES WERE IMPLANTED IN THE STUDY POPULATION AND ALL 90 PATIENTS WERE IMPLANTED WITH A MEDTRONIC CG FUTURE ANNULOPLASTY RING AS PART OF THE SURGICAL REPAIR. NO UNIQUE DEVICE IDENTIFIER NUMBERS WERE PROVIDED. AMONG ALL PATIENTS, ONE PATIENT DIED DURING POST-DISCHARGE FOLLOW-UP FROM AN UPPER RESPIRATORY TRACT INFECTION. THERE WAS NO STATEMENT OF CAUSAL OR CONTRIBUTORY RELATIONSHIP BETWEEN MEDTRONIC PRODUCT AND THE DEATH. AMONG ALL PATIENTS, ADVERSE EVENTS INCLUDED: UNCONTROLLED AORTIC ROOT BLEEDING AND DEVELOPMENT OF SEVERE MITRAL REGURGITATION REQUIRING FURTHER SURGICAL INTERVENTION; RE-HOSPITALIZATION FOR RECURRENT MITRAL REGURGITATION; PLEURAL EFFUSIONS REQUIRING CHEST DRAINAGE; ACUTE RENAL FAILURE (ARF) REQUIRING RENAL REPLACEMENT THERAPY; LOW CARDIAC OUTPUT; POST-OPERATIVE PULMONARY AND SURGICAL WOUND INFECTIONS. BASED ON THE AVAILABLE INFORMATION 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
    1411457 CG COMPOSITE RING RING, ANNULOPLASTY KRH MEDTRONIC HEART VALVES DIVISION 638R

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Male Required Intervention| L| H