BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HANCOCK

    MDR report key: 5439000 · Received February 16, 2016

    Report

    Report Number
    2025587-2016-00188
    Event Type
    Injury
    Date Received
    February 16, 2016
    Date of Event
    October 27, 2015
    Report Date
    January 19, 2016
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    LWR
    PMA / PMN Number
    P980043
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    TITLE: RISK FACTORS FOR DEVELOPMENT OF ENDOCARDITIS AND REINTERVENTION IN PATIENTS UNDERGOING RIGHT VENTRICLE TO PULMONARY ARTERY VALVED CONDUIT PLACEMENT CITATION: J THORAC CARDIOVASC SURG. 2016 FEB;151(2):432-441.E2. EPUB 2015 OCT 27. AUTHORS: CARLOS M. MERY, MD, MPH, FRANCISCO A. GUZMAN-PRUNEDA, MD, LUIS E. DE LEON, MD, WEI ZHANG, PHD, MATTHEW D. TERWELP, BS, CLAIRE E. BOCCHINI, MD, IKI ADACHI, MD, JEFFREY S. HEINLE, MD, E. DEAN MCKENZIE, MD, AND CHARLES D. FRASER, JR, MD DATE OF E-PUBLISH USED FOR EVENT DATE. NO UNIQUE DEVICE IDENTIFIER (SERIAL/LOT) NUMBERS WERE PROVIDED; WITHOUT THIS INFORMATION IT CANNOT BE DETERMINED WHETHER THIS EVENT HAS BEEN PREVIOUSLY REPORTED. (B)(4).

    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 OF A STUDY PERFORMED TO EVALUATE THE INCIDENCE AND RISK FACTORS FOR ENDOCARDITIS AND REINTERVENTION IN PATIENTS UNDERGOING PLACEMENT OF A RIGHT VENTRICLE-TO-PULMONARY ARTERY (RV-PA) VALVE CONDUIT. THE STUDY WAS CONDUCTED FROM 1995 TO 2014 AND INCLUDED 586 PATIENTS (PREDOMINANTLY FEMALE; MEAN AGE 4 YEARS) WHO UNDERWENT PLACEMENT OF A TOTAL OF 792 VALVED CONDUITS (474 PRIMARY PLACEMENTS AND 318 REPLACEMENTS). OF THE 792 CONDUITS, MEDTRONIC PRODUCTS INCLUDED 245 BOVINE JUGULAR GRAFTS (SERIAL NUMBERS NOT PROVIDED), AND 137 PORCINE HETEROGRAFTS (SERIAL NUMBERS NOT PROVIDED). THE MEDIAN DURATION OF CONDUIT FOLLOW-UP WAS 7 YEARS DURING WHICH THERE WERE 37 MORTALITIES INCLUDING 18 PERIOPERATIVE DEATHS; NONE OF THE DEATHS WERE DIRECTLY CORRELATED WITH OR ATTRIBUTED TO MEDTRONIC PRODUCT. DURING THE FOLLOW-UP PERIOD THERE WERE 23 CONDUITS THAT DEVELOPED ENDOCARDITIS INCLUDING 14 BOVINE JUGULAR GRAFTS AND 5 PORCINE HETEROGRAFTS. THE MEDIAN TIME FROM CONDUIT IMPLANT TO ENDOCARDITIS DIAGNOSIS FOR BOVINE JUGULAR GRAFTS WAS 7 YEARS (RANGE OF 34 DAYS TO 10 YEARS), AND FOR PORCINE HETEROGRAFTS WAS 2 YEARS (RANGE OF 1 YEAR TO 5 YEARS). THE OVERALL PRESENCE OF SIGNIFICANT STENOSIS WAS SIMILAR AMONG THE DIFFERENT CONDUIT TYPES, HOWEVER STENOSIS WAS MOST COMMONLY SEEN AT THE DISTAL ANASTOMOSIS IN BOVINE JUGULAR GRAFTS AND AT THE PROXIMAL ANASTOMOSIS OR WITHIN THE CONDUIT IN PORCINE HETEROGRAFTS. ADDITIONALLY, 40 OF THE BOVINE JUGULAR GRAFTS AND 8 OF THE PORCINE HETEROGRAFTS THAT REQUIRED INTERVENTION WERE NOTED WITH MODERATE TO SEVERE INSUFFICIENCY. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    96158 HANCOCK HEART-VALVE, NON-ALLOGRAFT TISSUE LWR MEDTRONIC HEART VALVES DIVISION HC100-18

    Patients

    Seq Age Sex Outcome Treatment
    1 00004 YR Required Intervention