BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THV 1000-29 3F AORTIC BIO 29MM

    MDR report key: 3221724 · Received July 11, 2013

    Report

    Report Number
    2031780-2013-00003
    Event Type
    Injury
    Date Received
    July 11, 2013
    Date of Event
    June 12, 2013
    Report Date
    June 12, 2013
    Manufacturer
    MEDTRONIC ATS 3F THERAPEUTICS
    Product Code
    LWR
    PMA / PMN Number
    P060025
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ANALYSIS: WITHOUT THE RETURN OF THE PRODUCT, NO DEFINITIVE CONCLUSION CAN BE MADE REGARDING THE CLINICAL OBSERVATION. SHOULD THE PRODUCT BE RETURNED, A FOLLOW-UP REPORT WILL BE SUBMITTED. CONCLUSION: THE DEVICE HISTORY RECORD WAS REVIEWED AND SHOWED THAT THIS PRODUCT MET ALL MANUFACTURING SPECIFICATIONS FOR PRODUCT RELEASED FOR DISTRIBUTION. NO ISSUES WERE IDENTIFIED THAT WOULD HAVE IMPACTED THIS EVENT. THE VALVE WAS NOT RETURNED FOR ANALYSIS. WITHOUT THE RETURN OF THE VALVE, NO DEFINITIVE CONCLUSION CAN BE MADE REGARDING THE CLINICAL OBSERVATION. (B)(4). (B)(6).

    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 THAT APPROXIMATELY 4.5 YEARS POST IMPLANT OF THIS BIOPROSTHETIC VALVE, THE PATIENT PRESENTED WITH SHORTNESS OF BREATH. DURING THE TRANSTHORACIC ECHOCARDIOGRAM (TTE) SHOWED WHAT THE PHYSICIAN FELT WAS CALCIFICATION OR VEGETATION. THE PHYSICIAN THEN DECIDED TO DO A REOPERATION. DURING THE REOPERATION AFTER THE STERNOTOMY PROCEDURE THE PHYSICIAN NOTED THAT THE CONCERN WITH THE VALVE WAS A TEAR IN THE LEAFLET. NO VEGETATION WAS EVER CONFIRMED ON THE VALVE. THE VALVE WAS REPLACED WITH NO OTHER ADVERSE PATIENT EFFECTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    320757 THV 1000-29 3F AORTIC BIO 29MM HEART-VALVE, NON-ALLOGRAFT TISSUE LWR MEDTRONIC ATS 3F THERAPEUTICS 1000

    Patients

    Seq Age Sex Outcome Treatment
    1 00060 YR Required Intervention