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| Model Number 1DLMCP08 |
| Device Problems
Use of Device Problem (1670); Microbial Contamination of Device (2303); Insufficient Information (3190)
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| Patient Problems
Adhesion(s) (1695); Unspecified Infection (1930); Pain (1994); Infection, Pyrogenic (2246)
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| Event Date 05/08/2014 |
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Event Type
Injury
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Manufacturer Narrative
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(b)(4) (b)(6).It should be noted that the gore dualmesh® plus biomaterial instructions for use includes warnings and addresses the following adverse reactions among others: ¿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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Event Description
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It was reported to gore that the patient underwent laparoscopic incisional hernia repair on (b)(6) 2013 whereby a gore dualmesh® plus biomaterial was implanted.The complaint alleges that on (b)(6) 2014, an additional procedure was performed whereby explant of the gore device was performed.It was reported the patient alleges the following injuries: abdominal pain, adhesions, infected mesh, abdominal abscess, drainage of wound, wound vac, and revision surgery.Additional event specific information was not provided.
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Manufacturer Narrative
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A2: added date of birth.H6: corrected results code.Conclusion code remains unchanged.Additional details regarding the patient's clinical course were ascertained from a review of medical records and are as follows: operative records dated 12/13/2011 indicate the patient underwent laparoscopic adhesiolysis, celiotomy with end descending colostomy, and laparoscopic placement of prophylactic paracolostomy hernia mesh.Postoperative diagnoses state: ¿1.History of imperforate anus with pull-through rectoplasty (at birth) - now with fecal incontinence secondary to no anal sphincter.2.Extensive small bowel adhesions.¿ ¿a 15 cm circular parietex stomal hernia mesh was selected.¿ ¿the mesh was introduced into the abdomen.¿ ¿the most lateral gore-tex sutures were then placed under laparoscopic visualization.I had to reposition two of the other gore-tex sutures.¿ ¿a secure strap was used to affix the mesh circumferentially to the abdominal wall (except where the colon entered the mesh laterally).Completion abdominal survey demonstrated no bleeding, no visceral injury, and no undue tension on the colon (even with a pressure of 6 mm).¿ operative records dated 12/15/2011 indicate the patient underwent release of a small bowel obstruction, mesh explant, and colostomy revision.Postoperative diagnoses are indicated as small bowel obstruction and ischemic colostomy.Findings state: ¿the patient is a 57-year-old white male who underwent technically uneventful end descending colostomy, extensive adhesiolysis, and prophylactic paracolostomy herniorrhaphy on december 13, 2011.He did well december 14th, but this morning (december 15th) he became distended and tender.Abdominal x-ray demonstrated a small bowel obstruction.At operation, his colostomy was found to be ischemic both visibly and by doppler examination.When i opened his abdomen, i found his obstruction to be the last 10 inches of his terminal ileum and not expected to be a problem at adhesiolysis two days ago.Since the end of the colostomy was ischemic, i decided to remove the mesh (which angulated the colon and might decrease blood flow).When i revised the colostomy, there was dopplerable flow in the shortened/revised segment.¿ records between 2011 and 2013 were not provided.Admission records dated 7/30/2013 state: ¿patient is a 59-year-old white male who had permanent colostomy created in the left mid abdomen two years ago as end result of multiple procedures for imperforated anus.The stoma started bulging out several months ago and it hurts.¿ exam notes state: ¿abdomen: moderately protuberant.There is midline vertical scar.There is diffuse bulging around the scar.Left mid abdominal colostomy is involved in this diffuse bulge and has pushed out appearance.Mucosa is intact and no normal.No masses or organomegaly are palpable.Additional data: cat scan of the abdomen and pelvis shows parastomal hernia showing incarcerated loop of small bowel compressing the colon exiting through the abdominal wall.There is also diffuse incisional hernia extending from the midline incision.¿ assessment and planning notes from the 7/30/2013 procedure state: ¿1.Incisional and parastomal hernias.2.Hypertension and dyslipidemia.3.Gastroesophageal reflux disease.¿ ¿laparoscopic gore -tex patch repair of the hernia was recommended.Procedure was explained in detail.Possible complications of bleeding, infection, injury to intraabdominal structures and conversion to open procedure were explained.Postoperative pain, disability and scar formation were discussed as well.¿ ¿patient understands that most important risk is infection since colostomy will not be able to completely isolated out of the operative field.All measures will be taken to prevent it.¿ operative records dated 7/30/2013 indicate the patient underwent laparoscopic repair of incisional and parastomal hernias with mesh.The records state: ¿iodine-impregnated adhesive was used to cover all exposed skin and colostomy site.¿ ¿adhesions between the omentum and the anterior abdominal wall and the upper abdomen were lysed sharply.This exposed enough of the left flank that it allowed placement of three additional trocars in that area under direct vision.There were extensive adhesions between the omentum and loops of small bowel along the right paramedian vertical incision.Meticulous sharp dissection ensued to lyse the adhesions.After lower abdomen was approached, the adhesions became more dense and at this point, an aberrant small bowel laceration occurred in the process of dissecting a loop of small bowel from the undersurface of the scar.The bowel continued to be mobilized distally and proximally to the laceration.During this bowel, remained empty and no spillage of enteric contents of any kind occurred.¿ the 7/30/2013 operative report continues: ¿a decision was made to suture repair the laceration and continue with hernia repair.Repair was accomplished using interrupted #2-0 ethibond sutures that closed the laceration in single layer.Closure was inspected and it was completed without contracting the bowel, the area was irrigated with neosporin solution.Dissection continued until all adhesions of omentum and small bowel and anterior abdominal wall were lysed.Next, attention was directed towards the left mid abdominal colostomy.There was loop of small bowel that was incarcerated through the fascial opening alongside the exiting segment of colon.Again, sharp dissection was used to free the loop of bowel and mesentery from the hernia and the colon itself.The bowel was returned to its natural position.Adhesions between the colon and mesentery and the fascial edges were the hernia defects were lysed so that everything was exposed and the only colon and its mesentery will be passing through the repair patch.¿ the 7/30/2013 operative records state: ¿enough visualization was achieved lateral to the colostomy site along the left pericolic gutter.Peritoneum was irrigated and good hemostasis and no enteric content leaks were seen.Next, transabdominally placed spinal needle was used to mark the extent of parastomal hernia, incisional hernia and anticipate the repair.Generous overlay will be maintained passed the hernia entrance.Measurements were taken on deflated abdomen.Appropriate shape and size dual mesh gore-tex patch was then selected for the repair.Small opening was created in the patch where the anticipated colostomy site is and slit in the patch was also created using scissors to place the patch around the stoma site.The patch was marked for proper orientation and then cardinal sutures of gore -tex sutures were placed.¿ the 7/30/2013 records continue: ¿patch was rolled and inserted into the peritoneum through the 10 mm trocar site.Patch was unrolled intraperitoneally and positioned centrally underneath the hernia defects.Patch surrounding the colostomy site and when patch was positioned, the cardinal sutures of gore-tex were pulled through the abdominal wall using small stab incisions and suture passer.Care was taken to stretch the patch tightly against the undersurface of the anterior abdominal wall.When this was assured, sutures were tied and knots were buried subcutaneously.Next, the titanium tacks were used to secure the perimeter of the patch to the peritoneum at 1 cm intervals.Additional titanium tacks were used to secure the patch around the stoma site and secure the split portion of the patch which is lateral to the stoma.¿ the 7/30/2013 records continue: ¿next, transabdominally placed sutures of gore-tex were used to further secure the patch.Three of these sutures were placed to secure the split part of the patch lateral to the stoma.Six other sutures were placed around perimeter of the patch under direct vision using suture passer and small stab incisions.Peritoneum was irrigated again and good hemostasis and no enteric content leaks were seen.Next, #0 vicryl was placed through the fascia at the 10 mm trocar site using endoclosure instrument.All trocars were removed under direct vision and pneumoperitoneum was deflated.Vicryl was tied obtaining secure fascial closure.The adhesive was removed from the anterior abdominal wall keeping the colostomy still covered.Skin was then closed at all incision using staples.The incisions in the proximity of colostomy were then sealed with dermabond glue.¿ the records indicate a gore dualmesh® plus (1dlmcp08/10960269) was implanted during the procedure.Records between 7/30/2013 and 5/8/2014 were not provided.Operative records dated 5/8/2014 indicate the patient underwent ¿abdominal abscess drainage, debridement of abdominal wall, and removal of infected mesh.¿ indications for the procedure state: ¿abdominal wall abscess, sepsis.¿ findings from the 5/8/2014 procedure state: ¿abdominal wall abscess from infected mesh.¿ the 5/8/2014 records state: ¿after establishing general anesthesia, the abdomen was prepped and draped in standard fashion.The area of necrotic skin in the lrq was incised.The area of necrotic skin was in a previous paramedian incision.Wound cultures were sent of the fluid as well as the necrotic skin.A large amount of purulent material was aspirated.The intraperitoneal mesh was easily seen in the base of the wound.The mesh pulled through the incision easily.Tacking sutures were found as well as metal tacks at the rim of the mesh.The mesh was found to have a hole through it to allow the llq ostomy to pass.The mesh on the cut to allow it to come around the ostomy.There was a small portion of the mesh that was densely adherent to the left side of the abdomen and was left in-situ.The abdomen was then copiously irrigated and a wound vac was placed.Two wound vac sponge pieces were used.Records detailing the origin of the abscess and infection were not provided.A culture report regarding the specimens collected during the 5/8/2014 procedure were not provided.Operative records dated 11/24/2014 indicate the patient underwent ¿exploratory laparotomy, removal of infected mesh, takedown of ecf, lysis of adhesions of greater than 2 hours, repair of enterotomy, resection of ecf tract, repair of parastomal hernia.¿ postoperative diagnosis states: ¿infected mesh, enterocutaneous fistula.¿ complications from the procedure state: ¿small enterotomy.¿ the 11/24/2014 operative report states: ¿a midline laparotomy was performed using a knife and electrocautery.Once the fascia was encountered, the abdomen was carefully entered at the superior aspect of the incision.Dense adhesions were encountered and were taken down bluntly and sharply using a metzenbaum scissors.The rlq was addressed first.While taking down adhesions and opening the rest of the incision, a small enterotomy was made in a loop of small bowel.This was temporarily closed using a 3-0 silk.The small bowel was matted up to the rlq, where his previous wound was.As the small bowel was taken down, the fistula tract was also encountered and taken down.The fistula on the small bowel side was extremely small and was oversewn w/ 3-0 vicryl.After a significant period of time, the anterior abdominal wall was freed.¿ the 11/24/2014 operative report continues: ¿our attention was then paid to the llq.Once again, dense adhesions were encountered at the abdominal wall side.After taking these down, a loop of small bowel was seen entering the stoma site.This hernia was taken down using a metzenbaum scissors.A small serosal tear was repaired using 3-0 silk.Once the adhesions were taken down, the mesh was then found.Around the mesh and some of the adhesions, there were small pockets of puss that were encountered.The fluid was send for cultures.The mesh was not frankly purulent, however it was slightly discolored, i.E.Green tint.Several metal tacs were taken from the abdominal wall and the mesh was able to be freed.This was taken off and sent for specimen.The colon, itself, looked intact and viable.The underside of the stoma had a large defect.This was imbricated using 2-0 silk w/ 2 figure of eight sutures, thus closing the hernia defect.1 finger was able to be passed along the colon, but not 2.¿ the 11/24/2014 operative report continues: ¿in order to better evaluated the small bowel for any other injuries or abnormalities, a loa was performed in the areas of surgery.Because of the extensive nature of adhesions, only the pertinent areas were lysed and not the entire length of the small and large bowel, in fear of further injury.The small enterotomy was examine and was less than 1/2 of the diameter of the lumen.This was closed w/ a series of interrupted 3-0 vicryl sutures, closed in 2 layers.After completion, there was a patent lumen.Once we were satisfied w/ the removal of the mesh and ecf takedown, the abdomen was irrigated w/ over 2l ns.Next, a elliptical incision was made around the ecf in the abdominal wall, 1.5x1.2cm.4-0 nylon was used to close the superficial side of the wound in interrupted fashion.The underside was closed using 2-0 silk.Two round blake drains were placed in both lower quadrants, one draining the fistula side and the other draining around the colostomy, where the mesh had been.These were secured using 2-0 nylon.The abdomen was then closed using 1 pds x 2.The skin was loosely closed w/ staples and packed w/ kerlix packing, gauze and tape.¿ a surgical pathology report dated 11/24/2014 regarding a specimen collected the same day states: ¿diagnosis foreign material and associated tissue, abdominal mesh, excision: - polarizable foreign material with associated chronic inflammation and fibrosis consistent with mesh.Specimen description: mesh (abdominal).Operative procedure: exploratory laparotomy.Patient information/history/diagnosis: infected mesh, ecs.Gross: the specimen is received in a single container ¿and consists of four irregularly-shaped pieces of possible fabric mesh that are 4 x 0.7 x 0.1 cm, 3.5 x 0.1 x 0.1 cm, 6.5 x 5.4 x 0.1 cm, and 8 x 1.8 x 0.1 cm.There is pink fibrous tissue attached to the mesh.Representative sections are submitted in cassette a1.¿ ¿microscopic: ¿the slide shows predominantly foreign material with a small rim of fibrosis containing chronic inflammatory cells.¿ a culture report regarding the fluid specimen collected during the 11/24/2014 procedure was not provided.Operative records dated 12/3/2014 state the patient underwent: ¿1.Re-exploration of abdomen.2.Debridement of right abdominal wall.3.Implantation of mesh.4.Application of wound vac negative pressure device.¿ the records state: ¿this 60-year-old patient has had a long complex history.About a week ago, he underwent an abdominal exploration and had a small bowel fistula resected and repaired.Unfortunately, the patient has an area of his right lower quadrant abdominal wall that is blackened full-thickness necrosis.The patient had his fascia closed at the last operation and had the skin partially closed and was in a wound vac.There is no evidence of fistula preoperatively at this time.¿ the 12/3/2014 operative report states: ¿the colostomy was removed.The staples on the abdominal wall were removed.I also opened the fascia of the midline abdominal wound.The area of necrosis was about 8 square cm on the right lateral side of the abdomen.The patient has parallel old incisions midline and in right paramedian and the area of necrosis was right in the center part of the right paramedian incision.We opened the abdomen.There was no evidence of fistula reforming again inside the abdomen.The actual previous fistula repair was not visualized and neither do we see any succus entericus inside the abdomen.We took down the fascia particularly on the right side toward the area that was necrosed and undermined to the area of necrotic abdominal wall.¿ the 12/3/2014 records state: ¿we debrided the area of abdominal wall, which is about 8 cm in diameter.This was a full-thickness necrosis and full-thickness debridement including skin, subcutaneous tissue, and fascia.The bowel underneath was largely matted and as mentioned before, no evidence of any fistula or for that matter any infection was actually seen.My suspicion is that this necrosed probably because it was under too much tension.We undermined the fascia on the left side of the wound towards the colostomy, but did not get all the way to the colostomy on the left side and therefore left it alone.The multiple adhesions were not taken down.We just took down enough adhesions for the actual debridement of the abdominal wall.The debridement of the abdominal wall was done with forceps, scalpel, and metzenbaum scissors.¿ the 12/3/2014 operative report continues: ¿we were then left with an abdominal wall wound that was going to be difficult to close.There is no easy boundary of fascia to pull together on the right side because the fascia is far out on the flank on the right side realizing that we could not close the fascia.I decided to put a piece of vicryl mesh closing over the right-sided abdominal wall defect and connecting it to the left side of the fascia of the abdominal wound.This was sutured in place with 0 vicryl interrupted sutures and this was placed without tension.We used also a single-layer of this vicryl mesh.As i mentioned before, this was sutured to the fascia on the left side of the abdominal wall and little fascia and skin we could find on the right side of the abdominal wall defect.This left the bridge of fascia, skin, and tissue between the midline abdominal wound and the right side of the abdominal wound which had been debrided.¿ the 12/3/2014 records state: ¿my thought was that if we tried to reapproximate the fascia, we would probably get more skin and fascia necrosis because we had to place this under even more tension to get this closed.I therefore decided to treat the entire wound with wound vac over the top of it.The wound size itself was 20 cm long, 8 cm wide, and 4 cm deep.This is wound #1 in the midline abdominal wound.The right-sided abdominal wound separately was 4 cm long, 1 cm deep, and 2 cm wide.A wound vac was tailored to fit in this area and we used a foam bridge between the right-sided abdominal wound and the midline abdominal wound.The wound vac appeared to be intact.We placed a new stoma bag over the stoma.The right lower quadrant drain was just posterior to the necrotic wound on the right side and therefore was removed.The left lower quadrant abdominal wound drain was left in place and on suction bulb.¿ operative records dated 12/19/2014 indicate the patient underwent split thickness skin graft to abdomen and application of a wound vac.Postoperative diagnosis is noted as ¿open abdominal wound.¿ the records state the patient ¿¿is a 60 y.O.Man admitted¿on 5/8/2014 with abdominal abscess.He was transferred here from outside hospital with abdominal pain.Pt has an extensive surgical history.He had what sounds like a pull through for an imperforate anus after birth.This was revised twice and and he had another procedure in 2011 when he woke up with a colostomy ( as per patient ).He had an episode of bowel obstruction after that and underwent surgery in jun, 2013 with placement of mesh.He was admitted in may 2014 w/ issues w/ rlq wound.He had a wound vac on for several week, but recently he hasn't been feeling well, less energy and overall lethargic.No [fever/chills], no [nausea/vomiting].He has noticed increasing pain around stoma and rlq and purulent drainage from the wound in the rlq.Ex-lap, removal of infected mesh, repair of parastomal hernia, loa, repair of enterotomy, ecf takedown, removal of ecf tract on 11/24/2014.Underwent excision of necrotic tissue and closure of abdomen with vicryl mesh and wound vac placement on 12/2/14.¿ the 12/19/2014 operative notes state: ¿a 0.016 inch split thickness skin graft was harvested from the right thigh with a dermatome.The abdominal wounds were minimally sharply debrided.The skin graft was meshed 2:1 and affixed to the abdominal wounds with staples at the skin edge and with 3-0 vicryl interrupted sutures in the wound bed.A xeroform was applied to the skin graft and a wound vac applied.The total skin graft and wound vac areas were 141 cm2.A new ostomy appliance was applied.The donor site had xeroform, bacitracin and an opsite applied.It was then wrapped with a kerlix.¿ findings from the procedure state: ¿good granulation tissue in wound bed.¿ operative records dated 12/1/2015 indicate the patient underwent ¿exploratory laparotomy with takedown of multiple enterocutaneous fistulae, small-bowel resection with enteroenterostomy.¿ postoperative diagnosis states: ¿multiple intracutaneous fistula, status post repair of ventral hernia with mesh complicated by infection and removal of the mesh.¿ findings from the 12/1/2015 procedure state: ¿at surgery, the patient was found to have 2 distinct enterocutaneous fistulae.A small fistula was identified in the right lateral mid abdomen which proved to be approximately 10 cm from a double barrel fistula along the midline at the site of the previously placed skin graft.This entire segment of small bowel was resected in conjunction with the fistulae, skin, and subcutaneous tissue, and a primary anastomosis achieved using a gia stapling device.Other than adhesions as noted throughout the abdomen, no other pathology was encountered.The patient had previously undergone a left iliac colostomy which had been present for many years as treatment for an imperforate anus.¿ additional operative records dated 12/1/2015 indicate the patient underwent ¿ventral hernia repair with bilateral abdominal components separation and placement of strattice mesh¿ for a diagnosis of ¿enterocutaneous fistula with ventral abdominal wounds with associated hernia.¿ the records state: ¿the patient is a 61 y.O.Male with a history of multiple abdominal surgeries and bowel resections who has multiple enterocutaneous fistulae.He was referred by dr.Brabbee for consideration of complex abdominal wall reconstruction.He has a left paramedian colostomy.He has open wounds of the midline and right paramedian area with fistula formation.¿ the 12/1/2015 records state: ¿dr.Brabbee performed his procedure first and will be described under separate dictation.Once that was completed, there was a 20 x 30 cm defect of the abdominal wall.There was no intraabdominal bowel contamination.The colostomy was still in the left paramedian position through the midportion of the rectus muscle.It was decided that a components separation would be performed with an underlay bridging strattice mesh placement.¿the records indicate a non-gore device was implanted in the procedure.Surgical pathology records dated 12/1/2015 regarding a specimen collected the same day states: ¿specimen description: fistula.¿ ¿final diagnosis: result: skin and small intestine, resection, take-down and repair: - enterocutaneous fistula.¿ fibrosis, chronic inflammation and polarizable foreign material with multinucleated giant cells.¿ ¿operative procedure: takedown and repair of enterocutaneous fistula, hernia incisional repair-actual: complex wound closure with possible component separation and possible strattice.¿ the 12/1/2015 surgical pathology report continues: ¿microscopic description: sections of the bowel margins show viable small intestine.There is an enterocutaneous fistula with small intestine in continuity with the skin.The dermis has vascular telangiectasia and chronic inflammation and fibrosis.There is polarizable suture material within the fibrous tissue surrounded by multinucleated giant cells.¿ operative records dated 12/8/2015 indicate the patient underwent a limited colonoscopy via stoma.The records state: ¿a 61-year-old male 7 days status post takedown of enterocutaneous fistulae and repair of abdominal wall hernia defect with a previous history of a colostomy in whom there has been no colostomy output since surgery.Due to the type of surgery performed, there was some concern about whether obstruction was present at the site of the previously constructed colostomy.Endoscopy is being performed at this time to assess for patency of the stoma.At endoscopy, a pediatric colonoscope was passed easily through the stoma and fascia into the more proximal colon to the level of the hepatic flexure.There was a moderate amount of mucus plugging present within the colon, but no obvious fecal content.¿ a potential relationship, if any, between the alleged injuries or complications and the gore device is unclear from the provided information at this time.It should be noted that the gore dualmesh® plus biomaterial instructions for use includes warnings and addresses the following adverse reactions among others: ¿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.¿ w.L.Gore & associates, inc.(gore) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by gore, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Blank fields present on this report include required fields and fields determined to be not applicable.Blank required fields indicate that the information was not provided, was deemed unavailable or was not applicable.This report does not constitute an admission or a conclusion by fda, gore, or its associates that the device, gore or its associates caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ""defects"" or has ""malfunctioned"".These words are included in the report and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.".
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Manufacturer Narrative
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Additional details regarding the patient's clinical course were ascertained from a review of medical records and are as follows: on (b)(6) 2014: (b)(6).Lab.Wbc 14.7 high.On (b)(6) 2014: (b)(6).Patrick rose, md.Office notes.History of gastroesophageal reflux disease.Current every day smoker, 1 pack per day.Did smoke ¿pot¿ in past.On (b)(6) 2014: (b)(6).(b)(6) , md.Physician order.Depo-testosterone injection every 2 weeks.On (b)(6) 2014: (b)(6).(b)(6) , md.Office notes.Follows with his colorectal surgeon, most recently about two weeks ago, was ¿scoped¿, since then has worsening pain rlq at site of incisional hernia.He is concerned that hernia is getting worse but feels his surgeon ¿won¿t listen to him¿ regarding these concerns.Hernia is not reducible but this is not new.Plan: will get ct.??/??/??: [missing records: records for the ct scan showing ¿right lower quadrant fluid collection 9 20.4 x 3.8 cms noted (most likely abscess) in connection with mesh and underlying skin.Fluid level noted within abscess and rim enhancement.Intestinal thickening noted around fluid collection and by ostomy¿ were not provided.] on (b)(6) 2014: (b)(6).(b)(6) , md.History and physical.Abdominal wall infection about 3 days.History of present illness: transferred from osh with right lower quadrant abdominal pain.Extensive surgical history.Had what sounds like a pull through for an imperforate anus after birth, revised twice, another procedure 2011 when he woke up with a colostomy.Episode of bowel obstruction after that, surgery june 2013 with placement of mesh.Doing well since, however, started having vague abdominal discomfort approximately 2 weeks ago.Colonoscopy (b)(6) 2015, normal.2 days ago increasing abdominal pain.Noted increase redness, bulging yesterday am, went to osh.Weight 181 pounds 3.2 ounces.Bmi 27.56.Abdomen: erythema, tender swelling right lower quadrant with overlying skin changes.Ostomy left lower quadrant.Paramedian and port sites scars noted.Drainage of pus and stool from right paramedian scar, history of hernia repair at that site several years ago.Ct abdomen/pelvis: right lower quadrant fluid collection 9 20.4 x 3.8 cms noted (most likely abscess) in connection with mesh and underlying skin.Fluid level noted within abscess and rim enhancement.Intestinal thickening noted around fluid collection and by ostomy.Impression: abdominal pain, right lower quadrant abdominal wall abscess with probably infected mesh.History of gastroesophageal reflux disease.Plan: admit.Will need wound exploration, drainage of abscess, possible excision of mesh in operating room.On (b)(6) 2014: [missing records: a pathology report detailing analysis of the device removed during the 05/08/14 procedure was not provided.] on (b)(6) 2014: (b)(6).Microbiology.Wound culture.Source: abscess/abdomen.Final report: moderate growth mixed enteric flora isolated.On (b)(6) 2014: (b)(6).Microbiology.Anaerobic/aerobic culture.Source: drainage/abdomen.Final report: heavy growth polymicrobial mixed enteric flora isolated.Gram stain: few gram-negative rods, rare gram-positive rods, many wbc seen.On (b)(6) 2014: (b)(6).Microbiology.Anaerobic/aerobic culture.Source: tissue/abdomen.Final report: heavy growth mixed enteric flora isolated.Gram stain: many gram-negative rods, few gram-positive rods, moderate wbc seen.On (b)(6) 2014: (b)(6).(b)(6) , md.Progress notes.Pod 2 status post wound debridement, removal of mesh in rlq.Vac in place with what appears to be liquid stool under dressing.Stop antibiotics.On (b)(6) 2014: (b)(6).(b)(6) , md.Progress notes.Complaints of abdominal pain at wound vac site.Wound vac removed.At base of wound, drainage consistent with gi mucous.No fistula seen.Leave off wound vac, use safe gel twice daily for now.On (b)(6) 2014: (b)(6).(b)(6) , md.Progress notes.Wound today has no pus, yellowish fluid still coming out.I am still concerned that there is an underlying fistula, but i did not see it in operating room or at bedside.On (b)(6) 2014: (b)(6).(b)(6) , md.Radiology ¿ ct abdomen/pelvis.Indication: abdominal wall abscess with infected mesh status post removal of mesh.Impression: right abdominal wound noted.Foci of gas, high density material concerning for oral contrast noted within anterior abdominal wall concerning for fistulous formation, possibly from adjacent small bowel.Small bilateral fat-containing inguinal hernias.On (b)(6) 2014: (b)(6).(b)(6) , md.Discharge summary.Admit date: (b)(6) 2014.Admitting diagnosis: abdominal wall abscess at site of surgical wound.Operation: abdominal wound exploration with removal of 90% mesh from abdominal wall (residual mesh around colostomy).Hospital course: postoperative course unremarkable with exception of fistula formation that was low output and controlled temporarily with wound vac with intention that it may heal on its own accord.Instructions: activity as tolerated.Wound care: wound vac with home health.On (b)(6) 2014: (b)(6).(b)(6) , md.Radiology ¿ ct abdomen/pelvis.Indication: peristomal abscess.Impression: no peristomal abscess seen.Near-complete healing of right abdominal wall wound.On (b)(6) 2014: (b)(6).(b)(6) , md.History and physical.Drainage from abdominal wound.Patient wants something done to fix his problem of drainage.Output does not look like enteric contents.Likely to be infected mesh.There was residual mesh left around the stoma after operation in may.I suspect that it is infected.Removal would likely need a separate incision, possibly relocation of stoma.Repeat ct.Weight 195 pounds 1.6 ounces.Bmi 29.67.Abdomen: rlq with healing wound with 1 cm bubble of purulent drainage.Around stoma site tender to palpation.I am able to express pus out of the rlq when i push around the stoma.Plan: admit.On (b)(6) 2014: (b)(6).(b)(6) , md.Radiology ¿ ct abdomen/pelvis.Indication: trauma.Findings: mesh is noted within anterior abdominal wall lateral to ostomy.Impression: ostomy in left anterior abdomen without evidence for obstruction or abscess.Small loop of small bowel extends into the ostomy track then back to the abdomen without evidence for mucosal thickening or obstruction.On (b)(6) 2014: (b)(6).(b)(6) , md.Progress notes.Options and potential problems explained.He understands the hernia is not likely to be repaired tomorrow.Will likely need a separate operation in future.He understands some intestine may need to be removed, possibly relocate stoma.Potential complications explained include bleeding, infection, hernias, repeat operations, damage to other organs.He requests we proceed with operation.On (b)(6) 2014: (b)(6).(b)(6) , md.Brief postoperative note.Pre-operative diagnosis: infected mesh, ecf [enterocutaneous fistula].Post-operative diagnosis: same.Procedure: laparotomy exploratory-general.Removal of infected mesh, takedown of enterocutaneous fistula, lysis of adhesions of greater than 2 hours, repair of enterotomy, resection of enterocutaneous fistula tract, repair of parastomal hernia.Findings: ¿several small abscess cavities around the infected mesh, dense adhesions, enterotomy of small bowel, ecf [enterocutaneous fistula] to small bowel.¿ specimens removed: infected mesh.Complications: none.On (b)(6) 2014: (b)(6).Microbiology.Anaerobic/aerobic culture.Source: abscess/abdomen.Final report: no organisms seen, many wbc seen.On (b)(6) 2014: (b)(6).Lab.Wbc 13.8 high.On (b)(6) 2014: (b)(6).(b)(6) , md; (b)(6) , md.Progress notes.Wbc 12.1 high.Abdomen: midline wound healing appropriately, no signs infection.Rlq wound with desiccated skin, not overt signs of infection.On (b)(6) 2014: (b)(6).Lab.Wbc 10.7 high.On (b)(6) 2014: (b)(6).(b)(6) , md.Progress notes.Abdomen: midline wound vac in place.Rlq skin with desiccated skin 3x4cm.Plan: spoke with patient regarding rlq wound and need for debridement/excision, placement of mesh.Continue to monitor, most likely or tomorrow.On (b)(6) 2014: (b)(6).(b)(6) , md.Progress notes.(b)(6) 2014 prealbumin 5.0 low.On (b)(6) 2014: (b)(6).(b)(6) , md.Radiology ¿ ct abdomen/pelvis.Addendum.Indication: abdominal distention, evaluate for obstruction, level of fistula.Impression: no evidence bowel obstruction, fistula.On (b)(6) 2014: (b)(6).(b)(6) , md.Progress notes.Abdomen: succus from right lower portion of wound, skin intact.Impression/plan: working to control fistula output.Home health nursing established.On (b)(6) 2014: (b)(6).(b)(6) , md.Discharge summary.Admit date: (b)(6) 2014.Admitting diagnosis: open wound of abdominal wall, anterior, complicated.Hospital course: subsequently developed ec [enterocutaneous] fistula.Will be managed with wound vac for hopeful closure.He continues to smoke despite counseling.Abdomen: rlq wound granulating slowly with mesh extruding and trimmed (ethibond as well), midline with 50% upper split-thickness skin graft take and hypertrophic granulation tissue in periphery, lower midline wound open and granulating with small midline succus drainage.Disposition: home.Activity: no lifting, driving or strenuous exercise until seen in follow-up.Stop smoking! on (b)(6) 2014: (b)(6).(b)(6) , md.History and physical.Fistula output not controlled, keeps leaking with vac.Abdomen: vac intact, reactive erythema around periphery of wound.On (b)(6) 2015: (b)(6).(b)(6) , md.Discharge summary.Admit date: (b)(6) 2014.Admitting diagnosis: open wound abdominal wall, anterior, complicated.Enterocutaneous fistula.Hospital course: while admitted, enterocutaneous fistula increased in size, now draining consistently.Has taken quite a bit of time to manage wound.Abdomen: two enterocutaneous fistulas visible and probably 1 or 2 inferiorly developing.Disposition: home.On (b)(6) 2015: (b)(6).Phone call.Linda with home health states current wound care is not successful, wound is getting worse, leaking.Wound vac in home, sheila kramer has a way to bridge fistulas with xeroform to then be able to wound vac the wounds.She wants to know if this is okay with dr.Troop.On (b)(6) 2015: (b)(6).Phone call.Lisa with home health called, next appointment is wednesday.Wanted to let you know that for the past couple days the two middle fistulas have been having formed stool come out of them, very high output, ostomy has very little output.Stoma pale, not moist.On (b)(6) 2015: (b)(6).Phone call.Patient called, abdomen getting distended, everything appears to be coming out of fistula not ostomy.Advising patient to go to emergency department.He will try to get there this evening, no one around to take him now.On (b)(6) 2015: (b)(6).Phone call.Lisa with home health called, abdomen very distended, lot of pain.Output from fistulas, no output from ostomy.She was told patient needs to the emergency department.He called yesterday with concerns and was told at that time to go.On (b)(6) 2015: (b)(6).(b)(6) , md.History and physical.Presents to emergency department with stool coming from midline wound.Has had same amount of drainage from midline wound.Noticed stool coming out past couple days.Abdomen: mildly distended.Midline wound with 2 fistulas, presumably 1 is small bowel and other is colon.Plan: developing a colocutaneous fistula.On (b)(6) 2015: (b)(6).(b)(6) , md.Office notes.Follow-up.Ostomy has little output, most of the output coming through fistula.Weight 170 pounds.Abdomen: stoma with minimal output, midline enterocutaneous fistula with liquid stool coming through.Right lower quadrant small wound with minimal amounts of drainage, most likely enterocutaneous fistula developing, midline wound covered, patient states healing better.History of open wound of abdominal wall, anterior, complicated; ventral hernia, recurrent; enterocutaneous fistula.Impression/plan: enterocutaneous fistulas.Spent great deal of time talking regarding future of care.Informed him it may ultimately lead to him having all of his output through his stoma without further surgical intervention, due to potential complicated nature of his surgical options.He states he is aware hem may need to deal with this for rest of his life.Surgery and recovery would be difficult, would not even be a consideration for several months.On (b)(6) 2015: (b)(6).Phone call.Patient called wanting dr.(b)(6) to write letter to courts stating he has not been able to leave his home since (b)(6) 2014 due to illness, nurse care.Trying to get off probation, they must have letter from doctor so he doesn¿t have to go back to court and release him from probation from dui.Dr.(b)(6) approved the letter.On (b)(6) 2015: (b)(6).(b)(6) , md.Office notes.He has terrible dentition which likely does contribute to his multiple gi issues.On (b)(6) 2015: (b)(6).(b)(6) , md.Consultation.Us today shows bilateral inguinal hernias.Abdomen: well-healed ventral incisions split-thickness skin graft midline with at least 3 fistulas on right.I can feel right inguinal hernia, has bilateral testicular pain.Could not feel hernia on left.Plan: discussed risks of bleeding, infection, injury to intestines, most hernias are now repaired with mesh (he does not want any mesh).He can follow-up with dr.Troop for hernias or dr.(b)(6) may want to address when the ventral hernia and fistulas are addressed.On (b)(6) 2015: (b)(6).(b)(6) , md.Office notes.Protein calorie malnutrition, on tpn for almost a month.On (b)(6) 2017: (b)(6).Phone call.Patient¿s neighbor called stating she has observed patient selling his oxycodone and he also goes around bragging about it.Sells them for $15/pill and goes buy meth.She is concerned because he has a young girlfriend living with him that is pregnant and has 3 other children living there.She knew his date of birth, address, doctor.On (b)(6) 2017: (b)(6).(b)(6) , md.Office notes.Urine drug screen sent, patient states medications were stolen a week and a half ago.On (b)(6) 2017: (b)(6).Office notes.Patient with large amounts of methamphetamines in urine, no evidence of oxycodone, per dr.Rose, no further refills of controlled substances but will still see patient for other chronic issues.On (b)(6) 2018: (b)(6).Office notes.Patient was a no show on (b)(6) 2019.A potential relationship, if any, between the alleged injuries or complications and the gore device has not been established at this time based on available information.It should be noted that the instructions for gore® dualmesh® plus biomaterial use includes warnings and addresses the following adverse reactions among others: ¿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.¿ the gore® dualmesh® plus biomaterial instructions for use also states: ¿strict aseptic techniques should be followed.If an infection develops, it should be treated aggressively.An unresolved infection may require removal of the material.¿ w.L.Gore & associates, inc.(gore) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by gore, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Blank fields present on this report include required fields and fields determined to be not applicable.Blank required fields indicate that the information was not provided, was deemed unavailable or was not applicable.This report does not constitute an admission or a conclusion by fda, gore, or its associates that the device, gore or its associates caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects" or has "malfunctioned".These words are included in the report and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.
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Manufacturer Narrative
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H6: updated patient codes.H6: updated device code.H6: updated conclusion codes.Previous patient codes (1994, 1695, 1930, 1690, 3191 used for ¿drainage of wound¿ and ¿wound vac¿) were reported based on the original complaint and are no longer applicable per gore¿s investigation.The investigation has been completed.In the absence of additional information or medical records from the complainant, this event file will be closed with the information provided.The following information was determined from the medical records.Medical records: the known medical records span december 13, 2011 through august 15, 2019 and not all records received in this time span are relevant to the gore® dualmesh® plus biomaterial.Records from july 30, 2013 through january 29, 2014 were not provided.Patient information: medical history: imperforate anus at birth, fecal incontinence, bowel obstruction with ischemia, incisional hernia, parastomal hernia, hypertension, hyperlipidemia, gastroesophageal reflux disease, smoker: (b)(6) 2014: 1 pack/day.Prior surgical procedures: pull through for imperforate anus with revision x2 [unknown date].(b)(6) 2011: laparoscopic adhesiolysis, celiotomy with end descending colostomy and laparoscopic placement of prophylactic paracolostomy parietex hernia mesh.(b)(6) 2011: release of small bowel obstruction, mesh explant and colostomy revision.Implant preoperative complaints: (b)(6) 2013: ¿patient is a 59-year-old white male who had permanent colostomy created in the left mid abdomen two years ago as end result of multiple procedures for imperforated anus.The stoma started bulging out several months ago and it hurts.¿ ¿abdomen: moderately protuberant.There is midline vertical scar.There is diffuse bulging around the scar.Left mid abdominal colostomy is involved in this diffuse bulge and has pushed out appearance.Mucosa is intact and no normal.No masses or organomegaly are palpable.¿ ¿cat scan of the abdomen and pelvis shows parastomal hernia showing incarcerated loop of small bowel compressing the colon exiting through the abdominal wall.There is also diffuse incisional hernia extending from the midline incision.¿ (b)(6) 2013: ¿laparoscopic gore-tex patch repair of the hernia was recommended.Procedure was explained in detail.¿ ¿patient understands that most important risk is infection since colostomy will not be able to completely isolated out of the operative field.All measures will be taken to prevent it.¿ implant procedure: laparoscopic repair of incisional and parastomal hernias with mesh.Implant: gore® dualmesh® plus biomaterial (10960269/ 1dlmcp08) 26cm x 34 cm, oval.Implant date: (b)(6) 2013 [hospitalization dates unknown].Description of hernia being treated: ¿adhesions between the omentum and the anterior abdominal wall and the upper abdomen were lysed sharply.This exposed enough of the left flank that it allowed placement of three additional trocars in that area under direct vision.There were extensive adhesions between the omentum and loops of small bowel along the right paramedian vertical incision.Meticulous sharp dissection ensued to lyse the adhesions.After lower abdomen was approached, the adhesions became more dense and at this point, an aberrant small bowel laceration occurred in the process of dissecting a loop of small bowel from the undersurface of the scar.The bowel continued to be mobilized distally and proximally to the laceration.During this bowel, remained empty and no spillage of enteric contents of any kind occurred.A decision was made to suture repair the laceration and continue with hernia repair.Repair was accomplished using interrupted #2-0 ethibond sutures that closed the laceration in single layer.Closure was inspected and it was completed without contracting the bowel, the area was irrigated with neosporin solution.Dissection continued until all adhesions of omentum and small bowel and anterior abdominal wall were lysed.Next, attention was directed towards the left mid abdominal colostomy.There was loop of small bowel that was incarcerated through the fascial opening alongside the exiting segment of colon.Again, sharp dissection was used to free the loop of bowel and mesentery from the hernia and the colon itself.The bowel was returned to its natural position.Adhesions between the colon and mesentery and the fascial edges were [sic] the hernia defects were lysed so that everything was exposed and the only colon and its mesentery will be passing through the repair patch.Enough visualization was achieved lateral to the colostomy site along the left pericolic gutter.Peritoneum was irrigated and good hemostasis and no enteric content leaks were seen.Next, transabdominally placed spinal needle was used to mark the extent of parastomal hernia, incisional hernia and anticipate the repair.Generous overlay will be maintained passed the hernia entrance.Measurements were taken on deflated abdomen.Appropriate shape and size dual mesh gore-tex patch was then selected for the repair.¿ implant size and fixation: ¿small opening was created in the patch where the anticipated colostomy site is and slit in the patch was also created using scissors to place the patch around the stoma site.The patch was marked for proper orientation and then cardinal sutures of gore-tex sutures were placed.Patch was rolled and inserted into the peritoneum through the 10 mm trocar site.Patch was unrolled intraperitoneally and positioned centrally underneath the hernia defects.Patch surrounding the colostomy site and when patch was positioned, the cardinal sutures of gore-tex were pulled through the abdominal wall using small stab incisions and suture passer.Care was taken to stretch the patch tightly against the undersurface of the anterior abdominal wall.When this was assured, sutures were tied and knots were buried subcutaneously.Next, the titanium tacks were used to secure the perimeter of the patch to the peritoneum at 1 cm intervals.Additional titanium tacks were used to secure the patch around the stoma site and secure the split portion of the patch which is lateral to the stoma.Next, transabdominally placed sutures of gore-tex were used to further secure the patch.Three of these sutures were placed to secure the split part of the patch lateral to the stoma.Six other sutures were placed around perimeter of the patch under direct vision using suture passer and small stab incisions.Peritoneum was irrigated again and good hemostasis and no enteric content leaks were seen.Next, #0 vicryl was placed through the fascia at the 10 mm trocar site using endoclosure instrument.¿ no post-operative records were provided.Explant preoperative complaints: (b)(6) 2014: ¿follows with his colorectal surgeon, most recently about two weeks ago, was ¿scoped¿, since then has worsening pain rlq at site of incisional hernia.He is concerned that hernia is getting worse but feels his surgeon ¿won¿t listen to him¿ regarding these concerns.Hernia is not reducible but this is not new.¿ (b)(6) 2014: ¿abdomen: erythema, tender swelling right lower quadrant with overlying skin changes.Ostomy left lower quadrant.Paramedian and port sites scars noted.Drainage of pus and stool from right paramedian scar, history of hernia repair at that site several years ago.Ct abdomen/pelvis: right lower quadrant fluid collection 20.4 x 3.8 cms noted (most likely abscess) in connection with mesh and underlying skin.Fluid level noted within abscess and rim enhancement.Intestinal thickening noted around fluid collection and by ostomy.Impression: abdominal pain, right lower quadrant abdominal wall abscess with probably infected mesh.¿ partial explant procedure: abdominal abscess drainage, debridement of abdominal wall and removal of ¿infected mesh.¿ partial explant date: (b)(6) 2014 [hospitalized (b)(6) 2014].¿after establishing general anesthesia, the abdomen was prepped and draped in standard fashion.The area of necrotic skin in the lrq [lower right quadrant] was incised.The area of necrotic skin was in previous paramedian incision.Wound cultures were sent of the fluid as well as the necrotic skin.A large amount of purulent material was aspirated.The intraperitoneal mesh was easily seen in the base of the wound.The mesh pulled through the incision easily.Tacking sutures were found as well as metal tacks at the rim of the mesh.The mesh was found to have a hole through it to allow the llq [left lower quadrant] ostomy to pass.The mesh on the [sic] cut to allow it to come around the ostomy.There was a small portion of the mesh that was densely adherent to the left side of the abdomen and was left in-situ.The abdomen was then copiously irrigated and a wound vac was placed.Two wound vac sponge pieces were used.¿ relevant medical information: (b)(6) 2014: microbiology: ¿wound culture.Source: abscess/abdomen.Final report: moderate growth mixed enteric flora isolated.¿ (b)(6) 2014: microbiology: ¿anaerobic/aerobic culture.Source: drainage/abdomen.Final report: heavy growth polymicrobial mixed enteric flora isolated.¿ (b)(6) 2014: microbiology: ¿anaerobic/aerobic culture.Source: tissue/abdomen.Final report: heavy growth mixed enteric flora isolated.¿ (b)(6) 2014: ¿pod [post-operative day] 2 status post wound debridement, removal of mesh in rlq [right lower quadrant].Vac in place with what appears to be liquid stool under dressing.Stop antibiotics.¿ (b)(6) 2014: ¿complaints of abdominal pain at wound vac site.Wound vac removed.At base of wound, drainage consistent with gi mucous.No fistula seen.Leave off wound vac, use safe gel twice daily for now.¿ (b)(6) 2014: ¿wound today has no pus, yellowish fluid still coming out.I am still concerned that there is an underlying fistula, but i did not see it in or at bedside.¿ (b)(6) 2014: ct abdomen/pelvis: ¿right abdominal wound noted.Foci of gas, high density material concerning for oral contrast noted within anterior abdominal wall concerning for fistulous formation, possibly from adjacent small bowel.Small bilateral fat-containing inguinal hernias.¿ (b)(6) 2014: discharge summary: ¿postoperative course unremarkable with exception of fistula formation that was low output and controlled temporarily with wound vac with intention that it may heal on its own accord.¿ explant #2 preoperative complaints: (b)(6) 2014: ct abdomen/pelvis: ¿no peristomal abscess seen.Near-complete healing of right abdominal wall wound.¿ (b)(6) 2014: ¿patient wants something done to fix his problem of drainage.Output does not look like enteric contents.Likely to be infected mesh.There was residual mesh left around the stoma after operation in may.I suspect that it is infected.Removal would likely need a separate incision, possibly relocation of stoma.¿ ¿rlq with healing wound with 1 cm bubble of purulent drainage.Around stoma site tender to palpation.I am able to express pus out of the rlq when i push around the stoma.¿ (b)(6) 2014: ct abdomen/pelvis: ¿findings: mesh is noted within anterior abdominal wall lateral to ostomy.Impression: ostomy in left anterior abdomen without evidence for obstruction or abscess.Small loop of small bowel extends into the ostomy track then back to the abdomen without evidence for mucosal thickening or obstruction.¿ explant #2 procedure: exploratory laparotomy, removal of ¿infected mesh,¿ take down of ecf [enterocutaneous fistula], lysis of adhesions of greater than 2 hours, repair of enterotomy, resection of ecf tract, repair of parastomal hernia.Explant #2 date: (b)(6) 2014 [hospitalization dates unknown].¿a midline laparotomy was performed using a knife and electrocautery.Once the fascia was encountered, the abdomen was carefully entered at the superior aspect of the incision.Dense adhesions were encountered and were taken down bluntly and sharply using a metzenbaum scissors.The rlq was addressed first.While taking down adhesions and opening the rest of the incision, a small enterotomy was made in a loop of small bowel.This was temporarily closed using a 3-0 silk.The small bowel was matted up to the rlq, where his previous wound was.As the small bowel was taken down, the fistula tract was also encountered and taken down.The fistula on the small bowel side was extremely small and was oversewn w/ 3-0 vicryl.After a significant period of time, the anterior abdominal wall was freed.¿our attention was then paid to the llq.Once again, dense adhesions were encountered at the abdominal wall side.After taking these down, a loop of small bowel was seen entering the stoma site.This hernia was taken down using a metzenbaum scissors.A small serosal tear was repaired using 3-0 silk.Once the adhesions were taken down, the mesh was then found.Around the mesh and some of the adhesions, there were small pockets of puss that were encountered.The fluid was send [sic] for cultures.The mesh was not frankly purulent, however it was slightly discolored, i.E.Green tint.Several metal tacs were taken from the abdominal wall and the mesh was able to be freed.This was taken off and sent for specimen.The colon, itself, looked intact and viable.The underside of the stoma had a large defect.This was imbricated using 2-0 silk w/ 2 figure of eight sutures, thus closing the hernia defect.1 finger was able to be passed along the colon, but not 2.In order to better evaluated [sic] the small bowel for any other injuries or abnormalities, a loa was performed in the areas of surgery.Because of the extensive nature of adhesions, only the pertinent areas were lysed and not the entire length of the small and large bowel, in fear of further injury.The small enterotomy was examine [sic] and was less than 1/2 of the diameter of the lumen.This was closed w/ [with] a series of interrupted 3-0 vicryl sutures, closed in 2 layers.After completion, there was a patent lumen.Once we were satisfied w/ [with] the removal of the mesh and ecf takedown, the abdomen was irrigated w/ over 2l [liters] ns [normal saline].Next, a elliptical incision was made around the ecf in the abdominal wall, 1.5x1.2cm.4-0 nylon was used to close the superficial side of the wound in interrupted fashion.The underside was closed using 2-0 silk.Two round blake drains were placed in both lower quadrants, one draining the fistula side and the other draining around the colostomy, where the mesh had been.These were secured using 2-0 nylon.The abdomen was then closed using 1 pds x 2.The skin was loosely closed w/ staples and packed w/ kerlix packing, gauze and tape.¿ findings: ¿several small abscess cavities around the infected mesh, dense adhesions, enterotomy of small bowel, ecf to small bowel.¿ relevant medical information: (b)(6) 2014: microbiology: ¿anaerobic/aerobic culture.Source: abscess/abdomen.Final report: no organisms seen, many wbc seen.¿ (b)(6) 2014: ¿midline wound healing appropriately, no signs infection.Rlq wound with desiccated skin, not overt signs of infection.¿ (b)(6) 2014: ¿spoke with patient regarding rlq wound and need for debridement/excision, placement of mesh.Continue to monitor, most likely or tomorrow.¿ (b)(6) 2014: re-exploration of abdomen, debridement of right abdominal wall, implantation of mesh, application of wound vac negative pressure device. ¿the colostomy was removed.The staples on the abdominal wall were removed.I also opened the fascia of the midline abdominal wound.The area of necrosis was about 8 square cm on the right lateral side of the abdomen.The patient has parallel old incisions midline and in right paramedian and the area of necrosis was right in the center part of the right paramedian incision.We opened the abdomen.There was no evidence of fistula reforming again inside the abdomen.The actual previous fistula repair was not visualized and neither do we see any succus entericus inside the abdomen.We took down the fascia particularly on the right side toward the area that was necrosed and undermined to the area of necrotic abdominal wall.We debrided the area of abdominal wall, which was about 8 cm in diameter.This was a full-thickness necrosis and full-thickness debridement including skin, subcutaneous tissue, and fascia.The bowel underneath was largely matted and as mentioned before, no evidence of any fistula or for that matter any infection was actually seen.My suspicion is that this necrosed probably because it was under too much tension.We undermined the fascia on the left side of the wound towards the colostomy, but did not get all the way to the colostomy on the left side and therefore left it alone.The multiple adhesions were not taken down.We just took down enough adhesions for the actual debridement of the abdominal wall.The debridement of the abdominal wall was done with forceps, scalpel, and metzenbaum scissors.We were then left with an abdominal wall wound that was going to be difficult to close.There is no easy boundary of fascia to pull together on the right side because the fascia is far out on the flank on the right side realizing that we could not close the fascia.I decided to put a piece of vicryl mesh closing over the right-sided abdominal wall defect and connecting it to the left side of the fascia of the abdominal wound.This was sutured in place with 0 vicryl interrupted sutures and this was placed without tension.We used also a single-layer of this vicryl mesh.As i mentioned before, this was sutured to the fascia on the left side of the abdominal wall and little fascia and skin we could find on the right side of the abdominal wall defect.This left the bridge of fascia, skin, and tissue between the midline abdominal wound and the right side of the abdominal wound which had been debrided.My thought was that if we tried to reapproximate the fascia, we would probably get more skin and fascia necrosis because we had to place this under even more tension to get this closed.I therefore decided to treat the entire wound with wound vac over the top of it.The wound size itself was 20 cm long, 8 cm wide, and 4 cm deep.This is wound #1 in the midline abdominal wound.The right-sided abdominal wound separately was 4 cm long, 1 cm deep, and 2 cm wide.A wound vac was tailored to fit in this area and we used a foam bridge between the right-sided abdominal wound and the midline abdominal wound.The wound vac appeared to be intact.We placed a new stoma bag over the stoma.The right lower quadrant drain was just posterior to the necrotic wound on the right side and therefore was removed.The left lower quadrant abdominal wound drain was left in place and on suction bulb.¿ records indicate a non-gore device was implanted during the (b)(6) 2014 procedure.Conclusion: it should be noted that the gore® dualmesh® plus biomaterial instructions for use includes warnings and addresses the following adverse reactions among others: ¿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.¿ the gore® dualmesh® plus biomaterial instructions for use also warns, ¿strict aseptic techniques should be followed.If an infection develops, it should be treated aggressively.An unresolved infection may require removal of the material.¿ the gore® dualmesh® plus biomaterial instructions for use also states, ¿to help maintain strict asepsis during surgery, special precautions and extremely careful preoperative site preparations are necessary.When operative infection is suspected, dissection of involved tissues should be considered.Any postoperative infection should be aggressively treated at the earliest possible time.An unresolved infection may require removal of the device.Staged repairs should be considered when gore® dualmesh® plus biomaterial will be subjected to gross contamination or infection.¿ the gore® dualmesh® plus biomaterial instructions for use also warns, ¿when using this device as a permanent implant and exposure occurs, treat to avoid contamination, or device removal may be necessary.¿ procedure and specific patient factors may contribute to or cause infection, leading to contamination, exposure, lack of incorporation and/or seeding of device.Procedure related factors may include adherence to clinical guidelines on infection risk management, contamination of device prior to or during implant, and post-operative wound management.Patient risk factors may include diabetes, smoking, age, malnutrition, immunosuppressive therapy, post-operative instruction noncompliance, and hygiene.Individual medical decisions, if inconsistent and/or non-conforming to the device manufacturer¿s recommendations, ifu, or recognized best practices, may result in or contribute to an adverse event.As with any surgical procedure, there are always risks of complications for surgical repair of hernias and soft tissue deficiencies, with or without mesh.These may include but are not limited to, adhesions and related harms, bleeding, bowel obstruction, dysphagia, erosion or extrusion and related harms, exposure or protrusion and related harms, fever, fistula, gerd recurrence, recurrence, ileus, increased procedure time and related harms, irritation or inflammation, infection, pain, paresthesia, perforation, revision / re-intervention, seroma or hematoma and related harms, wound complications and wound dehiscence.Many of the potential complications are associated with the patient¿s underlying disease progression, co-morbidities, additional medical history and/or other surgical procedures.The above inherent risks are typically detailed in standard informed consent documents.The device was not able to be returned to gore for evaluation; therefore, a direct product analysis could not be conducted.Review of the manufacturing records verified that the lot met all pre-release specifications.All available information has been placed on file for use in product surveillance tracking, trending and follow-up.Section c1: name: plus antimicrobial product coating.Manufacturer/compounder: w.L.Gore & associates, inc.Lot number 10960269.Additional manufacturer narrative: the plus antimicrobial product coating contains silver carbonate [approximately 800 micrograms per cubic centimeter of product (g/cm3)], and chlorhexidine diacetate [approximately 1600 micrograms per cubic centimeter of product (g/cm3)].W.L.Gore & associates, inc.(gore) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by gore, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Blank fields present on this report include required fields and fields determined to be not applicable.Blank required fields indicate that the information was not provided, was deemed unavailable or was not applicable.This report does not constitute an admission or a conclusion by fda, gore, or its associates that the device, gore or its associates caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects" or has "malfunctioned".These words are included in the report and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.
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Search Alerts/Recalls
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