BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THV 1000-29 3F AORTIC BIO 29MM

    MDR report key: 3620471 · Received February 10, 2014

    Report

    Report Number
    2031780-2014-00001
    Event Type
    Injury
    Date Received
    February 10, 2014
    Date of Event
    January 13, 2014
    Report Date
    January 13, 2014
    Manufacturer
    MEDTRONIC ATS 3F THERAPEUTICS
    Product Code
    LWR
    PMA / PMN Number
    P060025
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    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: BASED ON THE DHR REVIEW OF THIS PRODUCT, THERE WAS NO ISSUE IDENTIFIED REGARDING MANUFACTURING AND STERILIZATION (RAW MATERIALS, MANUFACTURING TIME PERIOD, PACKAGING AND LABELLING, OR STERILIZATION LOAD) THAT WOULD HAVE IMPACTED THIS EVENT. ALSO, THE INFORMATION RECEIVED DID NOT INCLUDE THE ORGANISM WHICH HAS CAUSING THE ENDOCARDITIS. HOWEVER, THIS EVENT THE OCCURRENCE OF ENDOCARDITIS IS GREATER THAN 12 MONTHS POST IMPLANT. BASED ON THE DESCRIPTIVE COMMENTS OUTLINED FROM THE JOURNAL LITERATURE, COMPLAINTS WHICH OCCURRED GREATER THAN 12 MONTHS POST IMPLANT ARE LARGELY CONSIDERED TO BE COMMUNITY ACQUIRED. THEREFORE, IT IS HIGHLY UNLIKELY THAT THE ENDOCARDITIS ORIGINALLY CAME FROM THE DEVICE AND/OR MANUFACTURING VALVE PROCESS. REGURGITATION AND STROKE ARE KNOWN FAILURE MODES. THE CAUSE OF THE REGURGITATION AND STROKE ARE UNKNOWN. ATTEMPTS TO GATHER INFORMATION HAVE BEEN ATTEMPTED WITHOUT SUCCESS. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THAT 26 MONTHS POST IMPLANT OF THIS BIOPROSTHETIC VALVE, THE PATIENT PRESENTED WITH VALVE REGURGITATION, KNOWN STOKE/TIA, AND ENDOCARDITIS. THE PATIENT HAS A PAST MEDICAL HISTORY OF LEFT BRACHIAL ARTERY OCCLUSION IN (B)(6) 2012 WITH SURGICAL THROMBECTOMY SPECIMEN SHOWING THROMBUS AND LEFT LEG LOWER EXTREMITY THROMBECTOMY ON (B)(6) 2014. THE PATIENT HAD THEIR VALVE EXPLANTED AND REPLACED WITH NO FURTHER ADVERSE PATIENT EFFECTS. DEVICE RETURN HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    86788 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 00066 YR Required Intervention