BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3F AORTIC BIOPROSTHETIC HEART VALVE

    MDR report key: 2832325 · Received November 14, 2012

    Report

    Report Number
    2031780-2012-00010
    Event Type
    Injury
    Date Received
    November 14, 2012
    Date of Event
    October 26, 2012
    Report Date
    March 27, 2013
    Manufacturer
    MEDTRONIC ATS 3F THERAPEUTICS
    Product Code
    LWQ
    PMA / PMN Number
    P060025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS SUPPLEMENTAL REPORT IS BEING SENT TO UPDATE THE MANUFACTURING DATE AND EXPIRATION DATE OF THIS DEVICE, WHICH WAS INACCURATE IN THE INITIAL REPORT. NO FURTHER ADDITIONAL INFORMATION HAS BEEN RECEIVED.

    Additional Manufacturer Narrative · 1

    ANALYSIS: NO PRODUCT WAS RETURNED. CONCLUSION: THE DEVICE HISTORY RECORD WAS REVIEWED AND SHOWED THAT THIS PRODUCT MET ALL MANUFACTURING SPECIFICATION FOR PRODUCT RELEASED FOR DISTRIBUTION. NO ISSUES WERE IDENTIFIED THAT WOULD HAVE IMPACTED THIS EVENT. IT WAS REPORTED THAT THE PARAVALVULAR LEAK WAS SUSPECTED TO BE DUE TO SUTURE TECHNIQUE, NOT A MALFUNCTION OF THE VALVE. THE MEDTRONIC SALES REPRESENTATIVE WHO ATTENDED THE CASE SAID IT WAS CLEAR FROM THE SURGEON THAT THE ISSUE WAS SUTURE RELATED. THE SURGEON USES A RUNNING SUTURE TECHNIQUE AND THE SUTURE FRACTURED CAUSING DEHISCENCE BETWEEN THE VALVE AND ANNULUS. AN INTERRUPTED SUTURE TECHNIQUE IS RECOMMENDED FOR IMPLANTATION OF THE ATS 3F AORTIC BIOPROSTHESIS, MODEL 1000 PER THE IFU, 50-0010-003. (B)(6). (B)(4).

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THAT THIS BIOPROSTHETIC VALVE, IMPLANTED 10 MONTHS DURATION, WAS EXPLANTED DUE TO PARAVALULAR LEAK CONFIRMED ON ECHOCARDIOGRAM. IT WAS REPORTED THAT THE PARAVALULAR LEAK WAS SUSPECTED TO BE DUE TO SUTURE TECHNIQUE, NOT A MALFUNCTION OF THE VALVE. THE SURGEON USES A RUNNING SUTURE TECHNIQUE AND THE SUTURE BROKE CAUSING DEHISCENCE BETWEEN THE VALVE AND ANNULUS. THE PATIENT WAS REPORTED TO BE DOING WELL AFTER REVISION, AND THE VALVE WAS NOT RETURNED FOR ANALYSIS.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THAT THIS BIOPROSTHETIC VALVE, IMPLANTED 10 MONTHS DURATION, WAS EXPLANTED DUE TO PARAVALVULAR LEAK CONFIRMED ON ECHOCARDIOGRAM. IT WAS REPORTED THAT THE PARAVALVULAR LEAK WAS SUSPECTED TO BE DUE TO SUTURE TECHNIQUE, NOT A MALFUNCTION OF THE VALVE. THE SURGEON USES A RUNNING SUTURE TECHNIQUE AND THE SUTURE BROKE CAUSING DEHISCENCE BETWEEN THE VALVE AND ANNULUS. THE PATIENT WAS REPORTED TO BE DOING WELL AFTER REVISION, AND THE VALVE WAS NOT RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 3F AORTIC BIOPROSTHETIC HEART VALVE HEART-VALVE, MECHANICAL LWQ MEDTRONIC ATS 3F THERAPEUTICS 1000-25

    Patients

    Seq Age Sex Outcome Treatment
    1 00077 YR Hospitalization| R