BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HANCOCK PULMONIC CONDUIT

    MDR report key: 6537049 · Received May 2, 2017

    Report

    Report Number
    2025587-2017-00719
    Event Type
    Injury
    Date Received
    May 2, 2017
    Date of Event
    April 3, 2012
    Report Date
    April 24, 2017
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    DYE
    PMA / PMN Number
    P870078
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: RÜFFER A ET AL. MID-TERM EXPERIENCE WITH THE HANCOCK PORCINE-VALVED DACRON CONDUIT FOR RIGHT VENTRICULAR OUTFLOW TRACT RECONSTRUCTION. EUROPEAN JOURNAL OF CARDIO-THORACIC SURGERY 42 (2012) 988¿995. DOI:10.1093/EJCTS/EZS103 ADVANCE ACCESS PUBLICATION 3 APRIL 2012 EARLIEST DATE OF PUBLISH USED FOR EVENT DATE. NO UNIQUE DEVICE IDENTIFIER (SERIAL/LOT) NUMBERS WERE PROVIDED; WITHOUT THIS INFORMATION IT COULD NOT BE DETERMINED WHETHER THESE OBSERVATIONS HAVE BEEN PREVIOUSLY REPORTED.

    Additional Manufacturer Narrative · 1

    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 TEN YEAR EXPERIENCE WITH THE HANCOCK VALVED CONDUIT IN RIGHT VENTRICULAR OUTFLOW TRACT (RVOT) RECONSTRUCTION. ALL DATA WERE COLLECTED FROM A SINGLE CENTER BETWEEN AUGUST 2000 AND JULY 2010. THE STUDY POPULATION INCLUDED 63 PATIENTS (PREDOMINANTLY MALE, MEAN AGE 13 YEARS, MEDIAN WEIGHT 44 KG), ALL OF WHICH WERE IMPLANTED WITH MEDTRONIC HANCOCK VALVED CONDUIT. WITHIN THIS POPULATION SIX PATIENTS HAD MEDTRONIC CONTEGRA CONDUIT AND EIGHT PATIENTS HAD HANCOCK CONDUIT PREVIOUSLY IMPLANTED. NO SERIAL NUMBERS WERE PROVIDED FOR ANY OF THE MEDTRONIC PRODUCT. AMONG ALL PATIENT ADVERSE EVENTS INCLUDED: CONDUIT STENOSIS AT THE VALVULAR LEVEL, MEAN SYSTOLIC GRADIENT OF 87 MMHG, AND NOTED PEELING FORMATION THAT MAY LEAD TO TUBULAR NARROWING. TWO PATIENTS WITH CONDUIT STENOSIS UNDERWENT ADDITIONAL INTERVENTION. EXPLANTED CONDUITS SHOWED MASSIVE CALCIFICATION OF VALVE LEAFLETS WITHOUT SIGNS OF TUBULAR NARROWING OR STENOSIS OF THE ANASTOMOTIC SITE. HISTOLOGICAL EXAMINATION REVEALED STRONGLY CALCIFIED CUSPS WITH FOCAL FIBRINOUS AND HAEMORHAGIC SIGNS OF INFLAMMATION. NO ADDITIONAL ADVERSE PATIENT EFFECTS OR PRODUCT PERFORMANCE ISSUES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319647 HANCOCK PULMONIC CONDUIT HEART-VALVE, REPLACEMENT DYE MEDTRONIC HEART VALVES DIVISION 100

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Life Threatening| R