BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC SURGICAL CONDUIT

    MDR report key: 20044073 · Received August 22, 2024

    Report

    Report Number
    2025587-2024-04765
    Event Type
    Injury
    Date Received
    August 22, 2024
    Date of Event
    November 16, 2023
    Report Date
    August 22, 2024
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    LWR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EG
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CITATION: YASMIN ABDELRAZEK ALI. POST-RIGHT VENTRICLE TO PULMONARY ARTERY CONDUIT: SHORT- AND INTERMEDIATE-TERM OUTCOMES: A SINGLE-CENTER STUDY. THE CARDIOTHORACIC SURGEON. PUBLISH DATE; 2023 VOLUME(ISSUE): 31:23. DOI.ORG/10.1186/S43057-023-00115-9.   EARLIEST DATE OF PUBLICATION USED FOR DATE OF EVENT.   MEDTRONIC PRODUCTS REFERENCED: CONTEGRA (PMA# H020003, PRODUCT CODE MWH), HANCOCK CONDUIT (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 SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE 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. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    LITERATURE WAS REVIEWED REGARDING THE OUTCOME OF PATIENTS WITH CONGENITAL HEART DISEASE (CHD) WHO HAD SURGICAL PLACEMENT OF RIGHT VENTRICLE TO PULMONARY ARTERY CONDUITS WITH A FOCUS ON THE RISK FACTORS FOR REDO-SURGERY. THE STUDY POPULATION INCLUDED 33 PATIENTS WITH A MEAN AGE OF 8.3 YEARS WHO WERE PREDOMINANTLY MALES (54.5%).  MULTIPLE MANUFACTURER¿S DEVICES WERE IMPLANTED IN THE STUDY POPULATION. MEDTRONIC VALVES THAT WERE IMPLANTED INCLUDE: 17 CONTEGRA VALVED CONDUIT AND 2 HANCOCK VALVED CONDUIT. AMONG ALL PATIENTS, ADVERSE EVENTS INCLUDED: HIGH GRADIENTS, STENOSIS, SEVERE CONDUIT REGURGITATION, RV-TO-PA CONDUITS REDO REPLACEMENT AND TRANSCATHETER INTERVENTIONS. NO ADDITIONAL ADVERSE PATIENT EFFECTS OR PRODUCT PERFORMANCE ISSUES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1311856 MEDTRONIC SURGICAL CONDUIT HEART-VALVE, NON-ALLOGRAFT TISSUE LWR MEDTRONIC HEART VALVES DIVISION MDT-CONDUIT

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR Male Hospitalization| R| L