BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVAULTA PLUS BIOSYNTHETIC SUPPORT SYSTEM

    MDR report key: 1033840 · Received April 24, 2008

    Report

    Report Number
    1018233-2008-00022
    Event Type
    Injury
    Date Received
    April 24, 2008
    Date of Event
    March 6, 2008
    Report Date
    December 9, 2015
    Manufacturer
    C.R. BARD, INC.
    Product Code
    FTL
    PMA / PMN Number
    K063712
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER IS UNK, THEREFORE, NO REVIEW OF THE DEVICE HISTORY RECORD COULD BE PERFORMED. EROSION IS A WELL KNOWN POTENTIAL COMPLICATION OF THIS TYPE OF PROCEDURE. THE IFU 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 PROD 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.

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY RECORD FOR THE REPORTED LOT NUMBER FOUND NOTHING THAT WOULD CAUSE OR CONTRIBUTE TO THE REPORTED PROBLEM.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    THE INFORMATION PROVIDED BY BARD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BARD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOLLOWING AN ANTERIOR PROCEDURE IN 2008, THE PT REPORTED THAT SHE COULD FEEL THE IMPLANT MATERIAL ERODED THROUGH HER VAGINA. THE PT STATED THAT THE IMPLANT MATERIAL WAS SURGICALLY REMOVED IN THE HOSP ON THE FOLLOWING MONTH. SHE ALSO STATED THAT SHE WAS EXAMINED IN THE ER. THE PT STATED THAT THE MATERIAL HAD A VERY FOUL ODOR. THE PT STATED THAT SHE WAS GIVEN ANTIBIOTICS. THE PT STATED THAT SHE EXPERIENCED PAIN AND CRAMPING. THE PT DESCRIBED HER VAGINA AS MANGLED. ADD'L INFO RECEIVED FROM THE DOCTOR ON NINETEEN DAYS LATER, STATED THAT DURING A THREE WEEK POST-OPERATIVE FOLLOW-UP, THE DOCTOR NOTED AN AREA OF EXPOSED MESH AND A MALODOROUS DISCHARGE. THE PT WAS GIVEN ANTIBIOTICS AND AN ESTROGEN VAGINAL RING. CULTURE RESULTS WERE A NORMAL VAGINAL FLORA. DURING A FOLLOW-UP EXAM ONE WEEK LATER, THE DOCTOR NOTED THAT THERE HAD NOT BEEN ANY HEALING OVER THE MESH OR TISSUE IN-GROWTH. THE DOCTOR CUT THE IMPLANT ARMS, REMOVED THE IMPLANT MATERIAL, AND IRRIGATED THE AREA WITH ANTIBIOTIC SOLUTION. CURRENT STATUS OF THE PT AS OF APPROX ONE AND A HALF MONTHS LATER, WAS DESCRIBED AS FEELING 100% GREAT, PT HAD NO DISCHARGE, AND NO RECURRENT CYSTOCELE.

    Description of Event or Problem · 1

    PER ADDITIONAL INFORMATION RECEIVED, THE PATIENT HAS EXPERIENCED, VAGINAL NUMBNESS/ DYSPAREUNIA, ANXIETY AND DEPRESSION, VAGINAL BLEEDING, ANTERIOR VAGINAL LESION AND EXTENSION, TENDER VAGINAL MUCOSA WITH RETAINED SUTURES, POST TRAUMATIC STRESS DUE TO SURGERY AND COMPLICATIONS.

    Description of Event or Problem · 1

    PER ADDITIONAL INFORMATION RECEIVED, THE PATIENT HAS EXPERIENCED PSYCHOTHERAPY SESSIONS (X5), PELVIC PAIN, EXCISION OF TRANSOBTURATOR SLING, VOIDING DYSFUNCTION, URINARY FREQUENCY AND URGENCY, URINARY INCONTINENCE, LEVATOR SPASM LIKELY SECONDARY TO SLING AND PAIN, POST VOID DRIBBLING AND BURNING WITH URINATION, CHRONIC CHOLECYSTITIS AND CHOLECYSTECTOMY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AVAULTA PLUS BIOSYNTHETIC SUPPORT SYSTEM FTL C.R. BARD, INC. NA CVRI0040

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention AMS MONARC SLING