BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTEGRA

    MDR report key: 5312953 · Received December 20, 2015

    Report

    Report Number
    2025587-2015-01352
    Event Type
    Injury
    Date Received
    December 20, 2015
    Date of Event
    July 1, 2015
    Report Date
    November 24, 2015
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    MWH
    PMA / PMN Number
    H020003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). TITLE: MEDIUM TERM FOLLOW-UP AFTER PERCUTANEOUS PULMONARY VALVE REPLACEMENT WITH THE MELODY VALVE CITATION: IJC HEART <(>&<)> VASCULATURE 7 (2015) 92¿97 AUTHORS: BJORN COOLS, WERNER BUDTS, RUTH HEYING, DERIZE BOSHOFF, BENEDICTE EYSKENS, STEFAN FRERICH, ELS TROOST, MARC GEWILLIG. NO UNIQUE DEVICE IDENTIFIER (SERIAL/LOT) NUMBERS WERE PROVIDED; WITHOUT THIS INFORMATION IT CANNOT BE DETERMINED WHETHER THIS EVENT HAS 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 REVIEW THAT A RETROSPECTIVE STUDY WAS PERFORMED TO EVALUATE MIDTERM FOLLOW UP AFTER TH E IMPLANT OF TRANSCATHETER BIOPROSTHETIC PULMONARY VALVES. THE STUDY TOOK PLACE AT A SINGLE MEDICAL CENTER IN (B)(6) BETWEEN 2006 AND 2014. THE STUDY POPULATION INCLUDED 112 VALVES AND 111 PATIENTS (GENDER NOT PROVIDED; MEAN AGE 19.3 YEARS), ALL OF WHICH WERE IMPLANTED WITH A MEDTRONIC TRANSCATHETER BIOPROSTHETIC PULMONARY VALVE (SERIAL NUMBERS NOT PROVIDED). IT WAS REPORTED THAT 14 VALVES WERE IMPLANTED, VALVE-IN-VALVE, INTO A PREVIOUSLY IMPLANTED MEDTRONIC PULMONARY VALVED CONDUIT (SERIAL NUMBERS NOT PROVIDED) DUE TO STENOSIS. ADDITIONALLY, 2 VALVES WERE IMPLANTED, VALVE-IN-VALVE, INTO A PREVIOUSLY IMPLANTED MEDTRONIC BIOPROSTHETIC AORTIC ROOT (SERIAL NUMBERS NOT PROVIDED); THE REASON FOR THE VALVE-IN-VALVE WAS NOT PROVIDED. AMONG ALL STUDY PATIENTS 3 DEATHS OCCURRED, ALL OF WHICH WERE DEEMED UNRELATED TO THE DEVICE. AMONG ALL PATIENTS THE FOLLOWING ADVERSE EVENTS OCCURRED: 6 INCIDENTS OF TYPE 1 STENT FRACTURES (1 NON-PRE-STENT AND 5 PRE-STENTED), 3 INCIDENTS OF MILD STENT RECOMPRESSION, 2 INCIDENTS OF INCREASED GRADIENT MEASUREMENTS REQUIRING EXPLANT (45 AND 47 MONTHS POST IMPLANT), 3 INCIDENTS OF RE-DILATION DUE TO SOMATIC GROWTH, 1 INCIDENT OF PULMONARY ARTERY PERFORATION WHICH WAS REPAIRED SURGICALLY, AND 8 INCIDENTS OF ENDOCARDITIS. REGARDING THE ENDOCARDITIS CASES, 2 WERE TREATED WITH SURGICAL REPLACEMENT (16 AND 38 MOTHS POST IMPLANT) AND 6 WERE TREATED WITH ANTIBIOTICS. OF THE GROUP THAT RECEIVED ANTIBIOTICS, 2 WERE ALSO TREATED WITH A VALVE-IN-VALVE PROCEDURE. THE BACTERIA WERE REPORTED TO BE CORYNEBACTERIUM PSEUDO DIPHTHERITICUM (N = 1), HACEK (N = 3), STAPHYLOCOCCUS AUREUS (N = 1), STREPTOCOCCUS VIRIDANS (N = 2) AND STREPTOCOCCUS SANGUINIS (N = 1). NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    839067 CONTEGRA CONDUIT,VALVED,PULMONIC MWH MEDTRONIC HEART VALVES DIVISION CONTEGRA

    Patients

    Seq Age Sex Outcome Treatment
    1 00019 YR Required Intervention