BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC SURGICAL CONDUIT

    MDR report key: 16675312 · Received April 4, 2023

    Report

    Report Number
    2025587-2023-01347
    Event Type
    Injury
    Date Received
    April 4, 2023
    Date of Event
    August 9, 2022
    Report Date
    April 4, 2023
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    MWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CITATION: HOASHI T.; ET AL. LONG-TERM INFLUENCE OF ATRIAL SWITCH OPERATION ON HEMODYNAMICS AFTER THE RASTELLI PROCEDURE. PEDIATR CARDIOL. 2023 MAR;44(3):624-630. DOI: 10.1007/S00246-022-02982-1. EPUB 2022 AUG 9. EARLIEST DATE OF PUBLICATION USED FOR DATE OF EVENT. MEDTRONIC PRODUCTS REFERENCED: HANCOCK (PMA# H020003, PRODUCT CODE: MWH); CONTEGRA (PMA# P790007, PRODUCT CODE: LWR). 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

    LITERATURE WAS REVIEWED REGARDING HEMODYNAMIC OUTCOMES AFTER PERFORMING RASTELLI AND ATRIAL SWITCH PROCEDURES TO TREAT PEDIATRIC CONGENITAL HEART DISEASE. THERE WERE PATIENTS WHO EXPERIENCED POST-PROCEDURE ATRIAL TACHYCARDIA AND VENTRICULAR TACHYCARDIA, REQUIRING CATHETER ABLATION INTERVENTIONS IN SOME PATIENTS. THE DEVICES REMAIN IN USE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    382702 MEDTRONIC SURGICAL CONDUIT PULMONIC VALVED CONDUIT MWH MEDTRONIC HEART VALVES DIVISION MDT-CONDUIT

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR Male Required Intervention