BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE-TEX SUTURE

    MDR report key: 3092322 · Received April 22, 2013

    Report

    Report Number
    2017233-2013-00242
    Event Type
    Injury
    Date Received
    April 22, 2013
    Date of Event
    January 14, 2004
    Report Date
    March 28, 2013
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    GAW
    PMA / PMN Number
    P820083
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE ARTICLE DID NOT SPECIFY THE NUMBER OF SUTURES USED IN THE CHORDAE REPLACEMENT PROCEDURE 14 YEARS EARLIER. THE SUTURE HAS NOT BEEN RETURNED AND THE LOT# WAS NOT PROVIDED IN THE ARTICLE. CONSEQUENTLY, A DIRECT PRODUCT ANALYSIS AND REVIEW OF THE MANUFACTURING RECORDS COULD NOT BE PERFORMED. BASED ON THE AVAILABLE INFORMATION, A ROOT CAUSE CANNOT BE DETERMINED. IT SHOULD BE NOTED THAT THE POTENTIAL FOR SUCH EVENTS IS ADDRESSED IN THE INSTRUCTIONS FOR USE: "POSSIBLE ADVERSE REACTIONS INCLUDE, BUT ARE NOT LIMITED TO, CALCIFICATION OF THE SUTURE." ALL INFORMATION HAS BEEN MADE AVAILABLE FOR TRACKING TRENDING AND FOLLOW UP. CITATION: BUTANY J, COLLINS M, DAVID T. RUPTURED SYNTHETIC EXPANDED POLYTETRAFLUOROETHYLENE CHORDAE TENDINEAE. CARDIOVASCULAR PATHOLOGY 2004; 13:182-184.

    Description of Event or Problem · 1

    THE JOURNAL ARTICLE, RUPTURED SYNTHETIC EXPANDED POLYTETRAFLUOROETHYLENE CHORDAE TENDINAE DISCUSSED A PATIENT THAT UNDERWENT MITRAL VALVE REPAIR WITH REPLACEMENT OF CHORDAE TENDINEAE WITH EPTFE SUTURES. FOURTEEN YEARS LATER, TWO-DIMENSIONAL ECHOCARDIOGRAPHY SHOWED A SLIGHTLY LATER, TWO-DIMENSIONAL ECHOCARDIOGRAPHY SHOWED A SLIGHTLY ENLARGED LEFT ATRIUM AND A STENOTIC, REGURGITANT MITRAL VALVE. THE PATIENT UNDERWENT A SECOND PROCEDURE IN WHICH A CABG (X2) AND A MVR WERE PERFORMED. THE SUTURES WERE FOUND AT EXPLANTATION TO HAVE RUPTURED. PATHOLOGICAL EXAMINATION OF EXCISED TISSUE REVEALED A NARROW RIM OF THROMBUS AROUND THE SUTURE AND WITHIN THE INTERSTICES OF THE SYNTHETIC MATERIAL. PATCHY AREAS OF CALCIFICATION AS WELL AS FIBROUS AND ELASTIC TISSUE IN THE TISSUE SURROUNDING THE SUTURE AND WITHIN ITS INTERSTICES WERE ALSO SEEN. OTHER AREAS SHOWED LARGE CALCIFIC NODULES DISTORTING THE SUTURE ARCHITECTURE WHILE OTHERS APPEARED TO BE COMPLETELY REPLACED BY CALCIUM SALTS WITH ONLY SMALL AREAS OF EPTFE REMAINING. THE PATIENT TOLERATED THE SECOND PROCEDURE WELL AND WAS DISCHARGED TO HOME SIX DAYS POST OPERATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171768 GORE-TEX SUTURE GAW/SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE GAW W.L. GORE & ASSOCIATES

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention