BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE AORTIC ROOT BIOPROSTHESIS

    MDR report key: 5530735 · Received March 28, 2016

    Report

    Report Number
    2025587-2016-00366
    Event Type
    Injury
    Date Received
    March 28, 2016
    Date of Event
    August 1, 2011
    Report Date
    March 4, 2016
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    LWR
    PMA / PMN Number
    P970031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ANALYSIS: THE PRODUCT HAS NOT BEEN RETURNED FOR ANALYSIS, THEREFORE NO PRODUCT ANALYSIS CAN BE PERFORMED. CONCLUSION: WITHOUT RETURN OF THE PRODUCT, NO DEFINITIVE CONCLUSIONS COULD BE DRAWN REGARDING THE CLINICAL OBSERVATION. TITLE: DURABILITY OF BIOPROSTHETIC VALVES IN THE PULMONARY POSITION: LONG-TERM FOLLOW-UP OF 181 IMPLANTS IN PATIENTS WITH CONGENITAL HEART DISEASE CITATION: THE JOURNAL OF THORACIC AND CARDIOVASCULAR SURGERY (2001) 142:351¿8 DOI 10.1016/J.JTCVS.2010.12.020. AUTHORS: LEE, C., PARK, C.S., LEE, C.H., KWAK, J.G., KIM, S.J., SHIM, W.S., SONG, J.Y., CHOI, E.Y., LEE, S.Y. MONTH AND YEAR OF PUBLISH WERE 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.

    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 STUDY WAS PERFORMED TO EVALUATE THE DURABILITY OF BIOPROSTHETIC VALVES IN THE PULMONARY POSITION. THE STUDY TOOK PLACE BETWEEN 1993 AND 2004 AND INCLUDED 181 PATIENTS (PREDOMINANTLY MALE WITH A MEAN AGE OF 14.2 ᠹ.8 YEARS). OF THESE PATIENTS, EIGHTY-THREE PATIENTS WERE IMPLANTED WITH A HANCOCK II VALVE AND TWENTY-THREE WERE IMPLANTED WITH A FREESTYLE VALVE. NO SERIAL NUMBERS WERE PROVIDED. AMONG ALL PATIENTS IN THIS STUDY, 10 DEATHS OCCURRED (3 EARLY DEATHS AND 7 LATE DEATHS). NONE OF THE DEATHS WERE ATTRIBUTED TO MEDTRONIC DEVICES. ADVERSE EVENTS INCLUDED; 30 INCIDENTS OF VALVE REPLACEMENT DUE TO STENOSIS, 7 INCIDENTS OF VALVE REPLACEMENT DUE TO ENDOCARDITIS, AND 6 INCIDENTS OF COMBINED STENOSIS WITH REGURGITATION. TEN INCIDENTS OF RE-INTERVENTIONAL BALLOON AORTIC VALVULOPLASTY (BAV) WERE PERFORMED DUE TO STENOSIS AND SUBSEQUENT INCREASED GRADIENT MEASUREMENTS (55 MM HG). EIGHT OF THESE TEN PATIENTS WERE TREATED WITH REOPERATION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185765 FREESTYLE AORTIC ROOT BIOPROSTHESIS HEART-VALVE, NON-ALLOGRAFT TISSUE LWR MEDTRONIC HEART VALVES DIVISION 995

    Patients

    Seq Age Sex Outcome Treatment
    1 00014 YR Required Intervention