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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES GORE DUALMESH® BIOMATERIAL MESH, SURGICAL, POLYMERIC

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W.L. GORE & ASSOCIATES GORE DUALMESH® BIOMATERIAL MESH, SURGICAL, POLYMERIC Back to Search Results
Catalog Number 1DLMC08
Device Problem Material Erosion (1214)
Patient Problems Erosion (1750); Abnormal Vaginal Discharge (2123)
Event Date 06/04/2010
Event Type  Injury  
Manufacturer Narrative

(b)(6). A review of the manufacturing records verified that the lot met all pre-release specifications. Additional details regarding the patient¿s clinical course were ascertained from a review of medical records and are as follows: records dated (b)(6) 2009 indicate: ¿this is a (b)(6) woman who was involved in an atv accident and suffered severe injuries, including a t12 compression fracture. ¿ ¿she underwent spinal fusion. She [has] also been a paraplegic since that time. She was managing her bladder with a suprapubic catheter but has really not liked the way that works for her. She has had multiple infections and other problems. She has also had some urinary incontinence, event with the catheter in place. ¿ exam notes from (b)(6) 2009 state: ¿abdomen:¿she has a suprapubic catheter in place. There is some minimal purulent drainage around this catheter. ¿ ¿pelvic: examination reveals no prolapse. ¿ assessment and plan states: ¿neurogenic bladder, neurogenic bowel. ¿ operative records dated (b)(6) 2009 indicate the following procedure were performed: ileocystoplasty, hypercontinent urethral sling using gore-tex mesh, malone antegrade continence enema (mace) tube placement, and monti catheterizable stoma creation. Post-operative diagnoses were indicated as neurogenic bladder, neurogenic bowel, and poor bladder compliance. The (b)(6) 2009 procedure notes state: ¿dissection was carried down to the midline fascia¿extensive adhesions were noted in the cephalad portion of the peritoneal cavity. However, the mid-peritoneal cavity and pelvis were without the adhesions. ¿ ¿once the augmentation portion of the case was completed, attention was now turned to placement of the hypercontinent sling. The endopelvic fascia was opened on either side of the urethra. The space was cleared between the urethra and the anterior wall of the vagina¿a long piece of gore-tex mesh was then passed underneath the urethra. The edges were crossed, and the gore-tex mesh was then tacked down under tension to cooper¿s ligament bilaterally with prolene sutures. ¿ the (b)(6) 2009 confirm a gore dualmesh biomaterial ((b)(4)) was implanted during the hypercontinent sling procedure. Records dated (b)(6) 2010 state the patient ¿¿comes in today with a history of difficulty catheterizing herself in her catheterizable stoma. She still leaks from her suprapubic tube site even though the tube has been out. ¿ ¿we recatheterized her stoma for her¿. I think the best solution would be to close the vesicocutaneous fistula open and plan a macroplastique injection of the urethra so she can catheterize from that point. ¿ records dated (b)(6) 2010 indicate ¿excision of vesicocutaneous fistula and cystoscopy with macroplastique infection¿ was performed to treat ¿vesicutaneous fistula and intrinsic sphincter deficiency. ¿ the records state: ¿since [the 2009 surgery] her previous suprapubic tube, which had been removed, had been leaking urine and did not close. We elected to bring her to the operating room for closure as well as adding macroplastique to her already placed hypercontinence sling. ¿ operative findings state: ¿the vesicocutaenous fistula was removed without incident and macroplastique was injected to left and right urethral mucosa near the bladder neck. ¿ there was no mention of the gore device in the (b)(6) 2010 records. Records dated (b)(6) 2010 indicate: ¿mesh erosion. ¿ ¿mesh has eroded through vaginal wall. ¿ operative records dated (b)(6) 2010 state ¿excision and debridement of vaginal and periurethral granulation tissue¿ were performed for diagnoses of ¿urethral sling mesh erosion. ¿ the records state: ¿the patient presented to the urology clinic after being seen by her gynecologist for increased discharge from the vagina which was thought to [be] arising from her wound in relation to her urethral sling. At the time of examination, the portion of the mesh was excised in clinic. It was decided to take her to the operative suite for additional excision of mesh under sedation. ¿ records from the gynecology visit and in-office excision were not provided. Operative findings from the (b)(6) 2010 procedure indicate: ¿no evidence of retained urethral sling gore-tex mesh was noted. There was a moderate amount of granulation tissue that was excised and divided during the procedure. ¿ ¿there was noted to be a defect in the vaginal mucosa on the left anterior portion of the vagina roughly 1 cm in diameter. ¿ ¿the wound was then inspected with a right angle clamp with several suspicious tissues that could never be identified as gore-tex mesh. These were excised and the urethra did remain intact during this entire procedure. ¿ ¿no additional evidence of mesh was noted. ¿ operative records dated (b)(6) 2011 indicate ¿vaginal exploration and debridement of wound with closure¿ was performed for a diagnosis of ¿nonhealing vaginal wound. ¿ the records state: ¿she had a ___ sling placed that did erode, and the mesh has been previously excised in the operating room previously as well as in the office. ¿ operative findings state: ¿along the anterior vaginal wall, there was an area of granulation tissue that was friable. Exploration showed no further exposed or palpable mesh. ¿ the procedure notes from (b)(6) 2011 further state: ¿further exploration and dissection laterally¿revealed some granulation tissue along the anterior wall. This was freed and removed. There was no evidence of mesh at this point. ¿ ¿once complete exploration had been performed and it was deemed there was no further mesh, the anterior vaginal mucosa was closed¿¿ a surgical pathology report dated (b)(6) 2011 regarding a specimen dated (b)(6) 2011 indicates: ¿final diagnosis: vagina: debridement: granulation tissue. Foreign body reaction. ¿ ¿gross description: received in formalin in a single container labeled ¿vaginal debridement¿ are four, 0. 2 x 0. 1 cm to 1. 6 x 0. 7 x 0. 3 cm tan-white to tan-brown tissue fragments with possible clots which are submitted entirely in a single cassette. ¿ it should be noted that the instructions for use for gore® dualmesh® biomaterial provides the following warning among others: ¿when using this device as a permanent implant exposure occurs, treat to avoid contamination or device removal may be necessary. " gore has requested additional information from the reporter.

 
Event Description

A review of medical records describe that a patient underwent ileocystoplasty, hypercontinent urethral sling, malone antegrade continence enema tube placement, and monti catheterizable stoma creation, and a gore® dualmesh biomaterial was used during the procedure. The medical records further describe that approximately 1 year later, ¿the patient presented to the urology clinic after being seen by her gynecologist for increased discharge from the vagina which was thought to [be] arising from her wound in relation to her urethral sling. Records state the ¿mesh had eroded through vaginal wall¿, and an additional procedure was performed whereby the gore device was excised and removed. Additional, event specific information has not been provided.

 
Manufacturer Narrative

Corrected event date. Added additional medical history. Added explant date. Corrected conclusion code. Corrected previously reported medical record information. Added additional medical record information. Corrected information from previous report: records dated (b)(6) 2010 (corrected from (b)(6) 2010 on initial report) state the patient ¿¿comes in today with a history of difficulty catheterizing herself in her catheterizable stoma. She still leaks from her suprapubic tube site even though the tube has been out. ¿ ¿we recatheterized her stoma for her¿. I think the best solution would be to close the vesicocutaneous fistula open and plan a macroplastique injection of the urethra so she can catheterize from that point. ¿ records dated (b)(6) 2010 indicate ¿excision of vesicocutaneous fistula and cystoscopy with macroplastique injection¿ ("injection" corrected from "infection" on initial report) was performed to treat ¿vesicocutaneous fistula and intrinsic sphincter deficiency. ¿ additional details regarding the patient¿s clinical course were ascertained from a review of medical records and are as follows: records dated (b)(6) 2010 indicate: ¿she is not having any leakage from her vesicocutaneous fistula. This is completely fine. The wounds were all healed. We removed her other tubes. She can now begin catheterization. ¿ records dated (b)(6) 2010 state: ¿she comes in today to have her tubes examined again. I do not see anything else to make me concerned with anything else that was going on. ¿ ¿everything else looks very good. ¿ records dated (b)(6) 2010 state: ¿the patient presents for a genitourinary problem and foreign material (gauze) hanging out of vagina. The onset was 3 days ago. The course/duration of symptoms is constant. The character of symptoms is foul smell. ¿ ¿3 days ago she noticed that some gauze was hanging from her vagina. Since then she notes that there is a foul smell and she feels like she is having lower left quadrant pain. She also notes that there was continent of urine before but now urine constantly leaks from the vaginal region. ¿ ¿of note, the patient intermittently caths herself (suprapubic and mace/urine and stool). ¿ exam notes state: ¿external genitalia normal but stool and urine present in area; on speculum exam ~3in mesh with blue stitches seen attached to roof of vagina; small amount of blood in vaginal vault; no cmt; no masses palpated. ¿ diagnosis notes state: ¿urinary tract infection; bladder sling has eroded through vagina. ¿ records dated (b)(6) 2010 indicate the patient ¿¿. Was originally status post mace ileocystoplasty with hypercontinent urethral sling with gore-tex and a maze procedure with a catheterizable stoma in (b)(6) 2009. This was complicated by a vesicocutaneous fistula, and she underwent excision of¿that with macroplastic injection on (b)(6) 2010. Recently she has noted a foreign body in her vagina, and was evaluated in the er and was noted to have part of the mesh sticking out. She is returning today for further evaluation. ¿ pelvic exam notes from the (b)(6) 2010 visit state: ¿exam revealed part of her gore-tex sticking out at the introitus. This was cut out and pulled out. ¿ assessment/plan notes state: ¿erosion of mesh. This was excised. ¿ clinic notes from (b)(6) 2010 state: ¿the patient notes to have noted discharge from her vagina. She was seen by her gynecologist last week who noted that the wound from the sling placement was possibly eroded through the vaginal wall, and she presents today in clinic for management of this. ¿ pelvic exam notes indicate: ¿reveals drainage from the vaginal vault. There is noted to be erosion of mesh through the vaginal vault. ¿ the records indicate the patient was scheduled for excision of the mesh. Records dated (b)(6) 2010 state: ¿she had vaginal discharge and was noted to have granulation tissue per the vagina and underwent a resection of this on (b)(6) 2010. ¿ ¿since her september surgery she has noted to have persistent vaginal discharge that is yellow and foul-smelling. She is presenting again today for reevaluation¿she has no bloody discharge in her urine. ¿ exam notes state: ¿vaginal exam reveals a well-healing surgical incision with remaining vicryl stitches in place. There appears to be no discharge from the surgical incision whatsoever. There is a foul-smelling yellow discharge globally in her vagina. The urethra itself has no urine leaking and there is no evidence of granulation tissue or exposed mesh. ¿ assessment notes state: ¿¿now with what appears to be bacterial vaginosis. ¿ the records indicate the patient was treated with flagyl. Records dated (b)(6) 2011 indicate: ¿she has had some persistent vaginal discharge and was recently seen by her gynecologist which noticed evidence of mesh erosion in the bladder. She returns today for removal. ¿ exam notes state: ¿on vaginal exam, she does have some exposed mesh along the anterior most portion of the vagina. This was removed with sharp dissection. A vaginal packing was left in place. ¿ plan notes state: ¿she did have a culture performed at her gynecologist which show klebsiella and e-coli that are both sensitive to cipro. We will give her a course of that today. ¿ records dated (b)(6) 2011 indicate the patient ¿¿had a vaginal exploration and debridement of wound with closure on (b)(6) 2011¿she indicates that she has been having vaginal discharge which is very much like the discharge she had prior to her recent surgical procedure. The patient also indicates that she has been having some chills intermittently for the past 2 weeks. She has had no fever as far as she is aware of. She does have some lower abdominal discomfort. ¿ exam notes state: ¿she has lower abdominal discomfort and pressure. On vulvovaginal exam the vulvovaginal area is slightly erythematous. There is greenish discharge that is somewhat malodorous from the vaginal vault. There is no tenderness with palpation. The vaginal walls are pink. No tenderness with palpation is noted. ¿ the records indicate a vaginal culture was sent due to the patient¿s continued greenish discharge. Ct results dated (b)(6) 2011 state: ¿ct of the pelvis was performed with iv and oral contrast¿¿ for ¿pelvic pain, drainage. ¿ impression of the ct indicates: ¿thickened and ill-defined cervix and vagina may be related to inflammatory versus infectious process. Diffuse perineal and inguinal edema and probable cellulitis. No focal fluid collection visualized. Right pelvic cystocutaneous fistula. Operative changes of ileocystoplasty. ¿ records dated (b)(6) 2011 indicates: ¿the patient presents with vaginal discharge. The onset was gradual. The duration is she states she has had the discharge for the past year. It has interfered with sexual intercourse with her husband. There were exacerbating factors including poor hygiene and sexual activity. There were relieving factors including sexual abstinence. It is a large amount, thick, green and malodorous. The symptom occurs constantly and chronically. ¿ ¿¿she had a vaginal culture in (b)(6) 2011, which grew heavy gbbs, she also had a ct of the pelvis at that time which showed ¿diffuse perineal and inguinal edema and probable cellulitis. ¿¿ exam notes state: ¿vulva/labia are normal in appearance, no lesions; there is a gray, thick mucous, malodorous discharge from vagina; introitus appears mildly erythemic and irritated; there are no visible lesions on vaginal walls¿¿ an addendum dated (b)(6)/2011 states: ¿vaginal wet prep specimen revealed clue cells and numerous wbcs; pt was called to inform of bacterial vaginosis infection. ¿ records dated (b)(6) 2011 also indicate: ¿spoke with patient at length about her discharge and her back pain/flank pain. She states that the odor permeates her house. She thinks that she was treated with flagyl in approximately (b)(6) 2010; but it did not clear the discharge or the odor. Discussed good hygiene and daily showering to keep mace stoma irrigated to keep bowel movements regular every 1-2 days so it does not drain stool. ¿ records dated (b)(6) 2011 state the patient presented ¿¿to [follow up] from previous treatment of odorous vaginal discharge in which she was found to have bacterial vaginosis and a heavy growth of e-coli in the vaginal discharge. She reports that the discharge and odor has cleared up since taking the flagyl and augmentin medications. She thinks she has a vaginal yeast infection now along with some yeast growth under the breasts. ¿ ¿she has also been having some urinary accidents recently since being on the lasix for fluid retention. ¿ diagnosis from the (b)(6) 2011 exam states: ¿urinary incontinence; candidiasis of female genitalia; candidiasis of skin. ¿ records dated (b)(6) 2011 state: ¿she is here today for [complaints of] odorous vaginal green/yellow discharge. Pt was here in april for the same odorous discharge was found to have bv and a e-coli infection. She was treated with flagyl and augmentin. Her symptoms resolved within 2 wks. Symptoms were improved until she started her menstrual cycle and after this, her discharge and odor returned. ¿ exam notes state: ¿normal genitalia for age, no excessive vaginal discharge today, appears to have normal discharge; mild erythema over labia¿swab for wet prep and vaginal culture taken from posterior vaginal canal. ¿ ¿she has a monti stoma and does intermittent catheterizations. She has a mace port for bowel control and does every other day irrigations to have a bowel movement. This port was previously leaking and appeared to be draining toward the vagina area, but is no longer leaking since she is doing more frequent irrigations. ¿ an addendum dated 6/10/2011 regarding culture results taken (b)(6) 2011 indicate: ¿many wbcs; no trichomonas vaginalis seen; no yeast seen; clue cells seen. ¿ records dated (b)(6) 2011 state: ¿she is on flagyl and a z-pak and this seems to be doing well at the current time. The amount of discharge is diminished. ¿ records dated (b)(6) 2011 indicate: ¿(b)(6) woman who (b)(6) 2006 had an atv accident. In fact, the device rolled over and she suffered a t12 fracture which unfortunately rendered her paraplegic. She is motor zero and has some sensation to deep pressure in her legs. She has had several urological procedures and now has an abdominal catheter site through which she catheterizes herself intermittently¿¿ the records further state ¿ever since the accident there has been a pain at the junction between sensation and lateral sensation which is at the upper buttock area. At times the pain can travel down towards her inguinal areas. The pain was recently manageable up until (b)(6) 2010 where during a therapy session she fell and contused presumably her conus area. Allegedly there also was evidence of some fracture in the area of the previous fusion that was performed in 2006. ¿ ¿past surgical history: she in early 2000 underwent a gastric bypass and lost about 125 pounds. She lost from being about (b)(6). After accident she gained a fair amount of weight again she today weighed in at (b)(6). She has also had several operations, including, tummy tucks and excessive skin resections on lower extremities. ¿ ¿conclusively, mrs. (b)(6) has deafferentation pain corresponding to the site of the spinal cord injury. ¿ ¿we will initially try spinal cord stimulation and if not effective, then root stimulation which would necessitate partial removal of the hardware. ¿ records dated (b)(6) 2011 indicate the patient was seen for evaluation of dyspareunia and urinary incontinence. The records state: ¿dr. Neal used gor-tex [sic] mesh for her urethral sling in 2009, since that time she has had problems with erosion of the mesh and chronic vaginal infections, vaginal odor, dyspareunia. Dr neal has removed some of the mesh at different time intervals, the last removal was done in the office in (b)(6) 2011. Her vaginal infection improved after this. Now her urethral incontinence has returned. She would like another macroplastique injection to stop the incontinence, would like the mesh removed if possible. ¿ the 11/21/2011 records indicate: ¿genital pain; dyspareunia; vaginal odor; neurogenic bladder, urinary incontinence. Course: having vaginal odor and dyspareunia possibly related to mesh sling erosion; urinary incontinence returned, would like macroplastique injection. ¿ records dated (b)(6) 2012 indicate the patient was implanted with a trial spinal cord stimulator. Records dated (b)(6) 2012 indicate the trial was successful and the patient was implanted with a spinal cord stimulator. Records dated (b)(6) 2012 indicate ¿wound dehiscence with infected spinal cord stimulator. ¿ on this date the patient underwent ¿removal of epidural spinal cord stimulator tidal lead and removal of entire spinal cord stimulation system with irrigation and debridement. ¿ records dated (b)(6) 2012 indicate a cystoscopy was performed and the patient received a macroplastique injection. It should be noted that the instructions for use for gore® dualmesh® biomaterial provides the following warning among others: ¿when using this device as a permanent implant exposure occurs, treat to avoid contamination or device removal may be necessary. " "strict aseptic techniques should be followed. If an infection develops, it should be treated aggressively. An unresolved infection may require removal of the material. ¿ ¿possible adverse reactions with the use of any tissue deficiency prosthesis may include, but are not limited to, contamination, infection, inflammation, adhesion, fistula formation, seroma formation, hematoma, and recurrence. ¿.

 
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Brand NameGORE DUALMESH® BIOMATERIAL
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
W.L. GORE & ASSOCIATES
flagstaff AZ
Manufacturer (Section G)
MEDICAL WOODY MOUNTAIN B/P
3750 w. kiltie lane
flagstaff AZ 86005
Manufacturer Contact
claire west
1500 n. 4th street
flagstaff, AZ 
9285263030
MDR Report Key5998235
MDR Text Key56442115
Report Number2017233-2016-00771
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK992189
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type OTHER
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/13/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/04/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date01/22/2011
Device Catalogue Number1DLMC08
Device LOT Number04157587
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured01/23/2006
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 10/04/2016 Patient Sequence Number: 1
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