BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVAULTA PLUS BIOSYNTHETIC SUPPORT SYSTEM

    MDR report key: 1150468 · Received September 5, 2008

    Report

    Report Number
    1018233-2008-00063
    Event Type
    Injury
    Date Received
    September 5, 2008
    Report Date
    September 5, 2008
    Manufacturer
    C.R. BARD, INC.
    Product Code
    FTL
    PMA / PMN Number
    K063712
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER IS UNK, THEREFORE, NO REVIEW OF THE DEVICE HISTORY RECORD COULD BE PERFORMED. THE INSTRUCTIONS FOR USE WHICH ACCOMPANIES EACH DEVICE STATES IN THE SECTION LABELED ADVERSE REACTIONS THAT POTENTIAL ADVERSE REACTIONS ARE THOSE TYPICALLY ASSOCIATED WITH SURGICALLY IMPLANTABLE MATERIALS, INCLUDING HEMATOMA, SEROMA, MUCOSAL OR VISCERAL EROSION, INFECTION, INFLAMMATION, SENSITIZATION, DYSPAREUNIA, SCARIFICATION AND CONTRACTION, FISTULA FORMATION, EXTRUSION AND RECURRENCE OF VAGINAL WALL PROLAPSE. PERFORATIONS OR LACERATIONS OF VESSELS, NERVES, BLADDER, BOWEL, RECTUM, OR ANY VISCERA MAY OCCUR DURING NEEDLE PASSAGE. THE PRODUCT IS RECOMMENDED TO ONLY BE USED BY PHYSICIANS WHO ARE TRAINED IN SURGICAL PROCEDURES AND TECHNIQUES REQUIRED FOR PELVIC FLOOR RECONSTRUCTION AND THE IMPLANTATION OF NONABSORBABLE MESHES. THE ROOT CAUSE OF THE REPORTED ABSCESS FORMATION WAS DETERMINED TO BE RELATED TO THE CLINICAL PROCEDURE WHEN COLLAGEN MATERIAL COMES INTO CONTACT WITH THE RELATIVELY FATTY SPACE IN THE ISCHIORECTAL FOSSA ONCE THE DISTAL ARMS ARE PLACED AND THE GRAFT IS TRIMMED ALONG THE MIDLINE. AS SUCH, THE INSTRUCTIONS FOR USE HAVE BEEN UPDATED TO INCLUDE PROCEDURAL CLARIFICATIONS REGARDING GRAFT PREPARATION AND PLACEMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT APPROX SEVEN MONTHS AND ONE WEEK FOLLOWING POSTERIOR AND ANTERIOR PROLAPSE PROCEDURES IN 2007, THE PT EXPERIENCED VAGINAL BLEEDING AND DEVELOPED AN ABSCESS UNILATERALLY ON THE RIGHT DISTAL ARM. THE DR STATED THAT DURING THE PROCEDURE, THE GRAFT HAD BEEN CUT AT THE MIDDLE OF ONE END TO SHORTEN THE MESH TO EXTEND THE ARMS. WHEN THE ARMS WERE PULLED THROUGH, A PORTION OF THE PORCINE DERMIS WAS PULLED INTO THE INCISION. THE PT WAS GIVEN ANTIBIOTICS PRE-OPERATIVELY, INTRA-OPERATIVELY, AND POST-OPERATIVELY. THE DR HAS BEEN SEEING THE PT JUST ABOUT EVERY OTHER DAY TO CLEAN THE ABSCESS. THE DR PERFORMED A REVISION PROCEDURE IN 2008 TO REMOVE A PORTION OF THE ARMS. THE ABSCESS WAS CULTURED AND GRAM POSITIVE, ANAEROBIC ORGANISM. CURRENT STATUS OF PT WAS DESCRIBED AS NOT RESOLVED. NO COMPLICATIONS HAVE BEEN REPORTED ON THE ANTERIOR REPAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AVAULTA PLUS BIOSYNTHETIC SUPPORT SYSTEM FTL C.R. BARD, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention ANTERIOR REPAIR PROCEDURE