BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC SURGICAL CONDUIT

    MDR report key: 11253429 · Received January 29, 2021

    Report

    Report Number
    2025587-2021-00379
    Event Type
    Injury
    Date Received
    January 29, 2021
    Date of Event
    August 1, 2020
    Report Date
    January 29, 2021
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    LWR
    PMA / PMN Number
    P790007
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: HAYDIN S ET AL. SURGICAL STRATEGIES AND RESULTS FOR REPAIR OF PULMONARY ATRESIA WITH VENTRICULAR SEPTAL DEFECT AND MAJOR A ORTOPULMONARY COLLATERALS: EXPERIENCE OF A SINGLE TERTIARY CENTER. BRAZ J CARDIOVASC SURG. 2020 AUG 1;35(4):445-451. DOI: 10.21470/1678-9741-2019-0055. EARLIEST DATE OF PUBLISH USED FOR DATE OF EVENT. MEDTRONIC PRODUCTS REFERENCED: CONTEGRA CONDUIT (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. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION FROM A LITERATURE ARTICLE REGARDING THE SURGICAL MANAGEMENT AND OUTCOMES OF PATIENTS WITH PULMONARY ATRESIA AND VENTRICULAR SEPTAL DEFECT WITH MAJOR AORTOPULMONARY COLLATERAL ARTERIES. ALL DATA WAS RETROSPECTIVELY COLLECTED FROM A SINGLE CENTER BETWEEN JANUARY 2012 AND OCTOBER 2018. THE STUDY POPULATION INCLUDED 36 PATIENTS AND WAS PREDOMINANTLY MALE WITH A MEDIAN AGE OF 5.5 MONTHS AND A MEDIAN WEIGHT OF 8 KG. IN 14 OF THESE PATIENTS, THE RIGHT VENTRICLE TO PULMONARY ARTERY (RV-PA) CONNECTION WAS PRESERVED WITH THE IMPLANT OF A MEDTRONIC VALVED CONDUIT: CONTEGRA (13) OR HANCOCK (1). NO SERIAL NUMBERS WERE PROVIDED. AMONG ALL PATIENTS, SEVEN DEATHS OCCURRED (3 IN-HOSPITAL, 4 DURING FOLLOW-UP). MULTIPLE MANUFACTURERS DEVICES WERE IMPLANTED IN THE STUDY POPULATION. NONE OF THE DEATHS WERE DIRECTLY ASSOCIATED WITH MEDTRONIC PRODUCT. AMONG ALL PATIENTS, ADVERSE EVENTS INCLUDED: ANTIARRHYTHMIC MEDICATION FOR JUNCTIONAL ECTOPIC TACHYCARDIA, VENTRICULAR TACHYCARDIA, OR FOCAL ATRIAL TACHYCARDIA; PERITONEAL DIALYSIS FOR LOW CARDIAC OUTPUT; NITRIC OXIDE INHALATION THERAPY FOR HIGH RIGHT VENTRICULAR PRESSURE; BACTERIAL SEPTICEMIA; TRANSIENT PHRENIC NERVE PARESIS; CHYLOTHORAX; PLEURAL EFFUSION; PULMONARY HEMORRHAGE; MULTIPLE REINTUBATIONS DUE TO BRONCHIAL HYPERREACTIVITY OR PULMONARY EDEMA; NEED FOR EXTRACORPOREAL MEMBRANE OXYGENATION SUPPORT (WEANED SUCCESSFULLY); REOPERATION DUE TO CONDUIT STENOSIS; REINTERVENTION; AND RV-PA CONDUIT EXPLANTED/REPLACED. 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
    146478 MEDTRONIC SURGICAL CONDUIT HEART-VALVE, NON-ALLOGRAFT TISSUE LWR MEDTRONIC HEART VALVES DIVISION MDT-CONDUIT

    Patients

    Seq Age Sex Outcome Treatment
    1 6 MO Required Intervention