BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THV 1000-23 3F AORTIC BIO 23MM

    MDR report key: 2605062 · Received June 8, 2012

    Report

    Report Number
    2031780-2012-00005
    Event Type
    Injury
    Date Received
    June 8, 2012
    Date of Event
    May 9, 2012
    Report Date
    March 27, 2014
    Manufacturer
    MEDTRONIC ATS 3F THERAPEUTICS
    Product Code
    LWR
    PMA / PMN Number
    P060025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    ANALYSIS: THE DEVICE WAS DISCARDED BY THE CUSTOMER AND WILL NOT BE RETURNED FOR ANALYSIS. CONCLUSION: WITHOUT THE RETURN OF THE PRODUCT, NO DEFINITIVE CONCLUSION CAN BE MADE REGARDING THE CLINICAL OBSERVATION. THE CAUSE OF THE BROKEN SUTURE / PARAVALVULAR LEAK MAY HAVE BEEN INCORRECT SUTURE TECHNIQUE OR SUTURE. THE TYPE OF SUTURE USED OR THE SUTURE TECHNIQUE USED WERE NOT PROVIDED. THE IFU HAS SEVERAL INSTRUCTIONS FOR SUTURE TECHNIQUE: "TO AFFIX EACH TAB TO THE AORTIC WALL, USE THREE (3) SEPARATE MATTRESS SUTURES WITH PLEDGETS: TWO (2) LATERAL SUTURES AND ONE (1) HORIZONTAL SUTURE." AND "AN INTERRUPTED SUTURE TECHNIQUE IS RECOMMENDED FOR IMPLANTATION OF THE ATS 3F AORTIC BIOPROSTHESIS, MODEL 1000. BRAIDED SUTURE IS RECOMMENDED FOR THE ANNULAR SUTURES." 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. (B)(6). (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 THAT THIS BIOPROSTHETIC VALVE WAS EXPLANTED AFTER A (B)(6) MONTH IMPLANT DURATION DUE TO PARAVALVULAR LEAK SECONDARY TO A BROKEN SUTURE. THE VALVE WAS REPLACED WITH MOSAIC VALVE, WITH NO ADVERSE PATIENT EFFECTS REPORTED. THE VALVE WAS DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THV 1000-23 3F AORTIC BIO 23MM HEART-VALVE, NON-ALLOGRAFT TISSUE LWR MEDTRONIC ATS 3F THERAPEUTICS 1000

    Patients

    Seq Age Sex Outcome Treatment
    1 00055 YR Required Intervention