BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OBTRYX SYSTEM

    MDR report key: 2001548 · Received February 25, 2011

    Report

    Report Number
    3005099803-2011-00492
    Event Type
    Injury
    Date Received
    February 25, 2011
    Date of Event
    March 25, 2010
    Report Date
    February 3, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    FTL
    PMA / PMN Number
    K040787
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A REVIEW OF THE MANUFACTURING RECORDS FOR THIS LOT SHOWED NO EVIDENCE OF MANUFACTURING RELATED POTENTIAL CAUSE FOR THIS EVENT.

    Description of Event or Problem · 1

    THE PATIENT PRESENTED WITH "TWINGES OF PAIN" AND SPOTTING ON (B)(6), 2010. DURING THIS FOLLOW UP VISIT, DR. (B)(6) CONFIRMED EROSION OF THE MESH AND PRESCRIBED PREMARIN CREAM AND ANTIBIOTICS.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN OBTRYX TRANSOBTURATOR SLING WAS USED DURING A SLING SURGERY PROCEDURE FOR BLADDER SUPPORT. ACCORDING TO THE COMPLAINANT, THE SLING PERFORATED INTO THE VAGINA. IT WAS REPORTED THAT THIS OCCURRED ABOUT ONE YEAR AGO. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE AND THE PATIENT'S CURRENT CONDITION ARE UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN OBTRYX HALO TRANSOBTURATOR SLING SYSTEM WAS USED DURING A SLING SURGERY PROCEDURE FOR BLADDER SUPPORT ON (B)(6), 2010. THE INITIAL PROCEDURE WAS COMPLETED SUCCESSFULLY WITH THIS DEVICE WITH NO PATIENT COMPLICATIONS. TWO MONTHS AFTER THE INITIAL PROCEDURE, THE PATIENT EXPERIENCED "TWINGES OF PAIN" AND SPOTTING. THREE MONTHS AFTER THE INITIAL PROCEDURE, THE PATIENT BEGAN EXPERIENCING LOWER BACKACHES. THE PATIENT WAS THEN PRESCRIBED PREMARIN CREAM BY A UROLOGIST AND IS STILL TAKING IT TO DATE. THE PATIENT WAS THEN REFERRED TO THE IMPLANTING PHYSICIAN WHO CONFIRMED THAT THE OBTRYX MESH HAD ERODED INTO THE VAGINAL WALL AND RECOMMENDED THAT THE PATIENT CONTINUE TO TAKE PREMARIN. THE PATIENT STATED THAT THE PREMARIN SEEMED TO BE THICKENING THE SKIN BUT THAT THE PAIN STILL PERSISTS AND THE MESH CAN BE FELT IN THE VAGINA. ON (B)(6), 2011, THE PATIENT CONSULTED A UROLOGIST AND GYNECOLOGIST IN MADISON, WI WHO BOTH CONFIRMED MESH EXPOSURE AND RECOMMENDED SURGICAL REMOVAL OF THE MESH. THE PATIENT IS SCHEDULED FOR REMOVAL OF THE MESH ON (B)(6), 2011. THE PATIENT HAS THE SAME LEVEL OF INCONTINENCE AS BEFORE THE PROCEDURE AND CONTINUES TO EXPERIENCE PAIN AND LOWER BACKACHES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OBTRYX SYSTEM MESH, SURGICAL, POLYMERIC FTL BOSTON SCIENTIFIC - MARLBOROUGH M0068505000 0ML9092901

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Other