BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTOUR 3D ANNULOPLASTY RING

    MDR report key: 10517840 · Received September 10, 2020

    Report

    Report Number
    2025587-2020-02801
    Event Type
    Injury
    Date Received
    September 10, 2020
    Date of Event
    May 29, 2020
    Report Date
    September 24, 2020
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    KRH
    PMA / PMN Number
    K101212
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    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

    ADDITIONAL INFORMATION RECEIVED FROM THE PHYSICIAN/AUTHOR STATED THAT MEDTRONIC PRODUCT DID NOT CAUSE OR CONTRIBUTE TO THE OBSERVED ADVERSE EVENTS.

    Additional Manufacturer Narrative · 1

    CITATION: PETERS A., ET AL. MULTIMODALITY IMAGING TO GUIDE TRANSCATHETER TREATMENT OF SEVERE DEGENERATIVE TRICUSPID REGURGITATION WITH TRICUSPID VALVE-IN-RING IMPLANTATION AND PARAVALVULAR LEAK CLOSURE. ECHOCARDIOGRAPHY, 2020; 37:912-916. FIRST PUBLISHED: 29 MAY 2020. HTTPS://DOI.ORG/10.1111/ECHO.14743. EARLIEST DATE OF PUBLISH USED FOR EVENT DATE IN. MEDTRONIC PRODUCTS REFERENCED: CONTOUR 3D ANNULOPLASTY RING (PMA# K101212, 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 A (B)(6)-YEAR-OLD FEMALE PATIENT WITH A HISTORY OF MITRAL VALVE ENDOCARDITIS WITH MECHANICAL MITRAL VALVE REPLACEMENT AND PROGRESSIVE TRICUSPID REGURGITATION (TR) WITH RESULTANT RIGHT VENTRICULAR OVERLOAD. SHE UNDERWENT TRICUSPID ANNULOPLASTY REPAIR USING A 32-MM MEDTRONIC CONTOUR 3D RING (NO SERIAL NUMBER WAS PROVIDED). THE PATIENT LATER DEVELOPED TRICUSPID VALVE DEGENERATION RESULTING IN SEVERE TR WITH RIGHT HEART FAILURE, ASCITES AND LOWER EXTREMITY EDEMA, REQUIRING MULTIPLE HOSPITAL RE-ADMISSIONS. CARDIAC COMPUTERIZED TOMOGRAPHY (CT) REVEALED SEVERE CENTRAL TRICUSPID REGURGITATION. THE PATIENT UNDERWENT TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE)- GUIDED TRANSCATHETER TRICUSPID VALVE-IN-RING REPLACEMENT WITH A 29-MM NON-MEDTRONIC PROSTHETIC VALVE. NO ADDITIONAL ADVERSE PATIENT EFFECTS OR PRODUCT PERFORMANCE ISSUES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    980534 CONTOUR 3D ANNULOPLASTY RING RING, ANNULOPLASTY KRH MEDTRONIC HEART VALVES DIVISION 690R

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Hospitalization| R UNKNOWN ST. JUDE MECHANICAL HEART VALVE