BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HANCOCK

    MDR report key: 8680772 · Received June 7, 2019

    Report

    Report Number
    2025587-2019-01865
    Event Type
    Injury
    Date Received
    June 7, 2019
    Date of Event
    July 12, 2012
    Report Date
    June 7, 2019
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    LWR
    PMA / PMN Number
    P790007
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: LURZ P ET AL. IMPACT OF REDUCTION IN RIGHT VENTRICULAR PRESSURE AND/OR VOLUME OVERLOAD BY PERCUTANEOUS PULMONARY VALVE IMPLANTATION ON BIVENTRICULAR RESPONSE TO EXERCISE: AN EXERCISE STRESS REAL-TIME CMR STUDY. EUR HEART J. 2012 OCT;33(19):2434-41. DOI: 10.1093/EURHEARTJ/EHS200. EPUB 2012 JUL 12. EARLIEST DATE OF PUBLISH USED FOR EVENT DATE IN. 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 THE 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 THE USE OF REAL-TIME CARDIAC MAGNETIC RESONANCE IMAGING TO EVALUATE POTENTIAL DIFFERENCES IN BIVENTRICULAR RESPONSE TO EXERCISE IN PATIENTS WITH PULMONARY STENOSIS AND PULMONARY REGURGITATION PRE- AND POST- PERCUTANEOUS PULMONARY VALVE IMPLANTATION. THE STUDY POPULATION INCLUDED 17 PATIENTS (PREDOMINANTLY MALE; MEAN AGE 19 YEARS; MEAN WEIGHT 62 KG), 2 OF WHICH WERE PREVIOUSLY IMPLANTED WITH MEDTRONIC HANCOCK VALVED CONDUITS (NO SERIAL NUMBERS PROVIDED). AMONG ALL PATIENTS, ADVERSE EVENTS INCLUDED: PULMONARY STENOSIS (WITH HIGH RIGHT VENTRICULAR OUTFLOW TRACT MEAN GRADIENTS) OR PULMONARY REGURGITATION REQUIRING PERCUTANEOUS PULMONARY VALVE IMPLANTATION. 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
    471241 HANCOCK HEART-VALVE, NON-ALLOGRAFT TISSUE LWR MEDTRONIC HEART VALVES DIVISION HC150-12

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Required Intervention