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| Model Number 1DLMCP04 |
| Device Problems
No Apparent Adverse Event (3189); Insufficient Information (3190)
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| Patient Problems
Adhesion(s) (1695); No Clinical Signs, Symptoms or Conditions (4582)
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| Event Date 11/02/2015 |
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Event Type
Injury
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Manufacturer Narrative
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(b)(6).It should be noted that the gore® dualmesh® plus biomaterial instructions for use 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.¿.
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Event Description
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It was reported to gore that the patient underwent laparoscopic ventral hernia repair on (b)(6) 2006, whereby a gore® dualmesh® plus biomaterial was implanted.The complaint alleges that on (b)(6) 2015, an additional procedure occurred whereby the gore device was explanted.It was reported the patient alleges the following injuries: mesh removal (2x), additional surgeries, extensive adhesions.Additional event specific information and medical records have been requested.
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Manufacturer Narrative
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Updated results code.Conclusion code remains unchanged.
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Manufacturer Narrative
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Added medical history.Conclusion code remains unchanged.Added medical record information.Additional details regarding the patient's clinical course were ascertained from a review of medical records and are as follows: records prior to (b)(6) 2006, including records for the initial colon resection, were not provided.Operative records dated (b)(6) 2006 indicate the patient underwent laparoscopic repair of ventral incisional hernia with dual mesh.Preoperative/postoperative diagnosis ¿ventral incisional hernia.¿ the records state: ¿the patient is a 54-year-old patient of (b)(6) with an incisional hernia, midline from previous colon resection.¿ operative records dated (b)(6) 2006 state: ¿¿a veress needle was inserted into the left upper quadrant with co2 insufflation performed.A right upper quadrant 5 mm trocar was inserted via optiview and a second, third and fourth 5 mm trocars were placed in the left upper quadrant, right lower quadrant and left lower quadrant under direct vision.Release of incarcerated bowel and adhesions was performed extensively with the harmonic scalpel.Once these were released, there was noted to be an extensive ventral incisional hernia.¿ operative records dated (b)(6) 2006 state: ¿an 18 x 24 cm dual mesh was then marked and inserted through a widened 12 mm trocar site in the right lower quadrant, and sutured with 0 gore suture circumferentially in 1 to 1.5 inch spaces tacked to the abdominal wall with multiple tacks around the edges.Noted to be nicely placed without any bleeding or abnormality seen at the end of the operative procedure.The abdomen was then desufflated and the ports removed.The 12 mm trocar was closed with the mesh anteriorly, as well as a 4-0 monocryl subcuticular stitches to close all port sites.Injected with 0.5% with epinephrine.The gore suture holes were then closed with glue." the operative records confirm a gore® dualmesh® plus biomaterial (lot#03448974) was used during the procedure; however, the item number listed on the operative records is listed as 1dkmcp04.The item number for this lot # is 1dlmcp04.Product identification label was not provided in the records.Records between (b)(6) 2006 and (b)(6) 2015 were not provided.Operative records dated (b)(6) 2015 indicate the patient underwent exploratory laparotomy with extensive lysis of for over 1 hour time during the procedure, completion colectomy including resection of ileosigmoid anastomosis, with resection of the remaining sigmoid colon and proximal rectum, with ileocolic anastomosis with eea 29 stapler.¿ preoperative/postoperative diagnosis: ¿sigmoid colon cancer.Patient with a history of colon cancer in the past.Also, patient with lynch syndrome by a family history, negative by genetic testing, but definitely lynch syndrome positive by family history.¿ operative records dated (b)(6) 2015 state: findings: ¿this was a very difficult, time-consuming operation due to the patient¿s extensive adhesions.Patient had a mesh hernia repair in the past.There were significant adhesions of the abdominal wall to the mesh, which required very tedious dissection and adhesiolysis.¿ operative records dated (b)(6) 2015 state: ¿patient had a midline scar from above the xiphoid extending down inferior to the umbilicus.There was a virginal area several centimeters inferior to the umbilicus to the pubis.I excised a good portion of the scars.I made out my incision.We had to perceived the incision higher, several centimeters inferior to the xiphoid and down distally just superior to the pubic symphysis.An area of scar was actually excised.A knife was used to make this incision.Bovie electrocautery was used to excise the skin of the scar and reach subcutaneous tissue, fascia, peritoneum in the midline.There were extensive adhesions to the abdominal wall.We lysed these sharply with metzenbaum scissors¿:.¿it was quite tedious and time consuming.¿ also, at the area the umbilicus or just above the umbilicus, was where we encounted the mesh.There were small bowel adhesions to the mesh that were very carefully lysed.We cut the mesh with scissors, heading all the way up superiorly the proximal extent of our incision.During the procedure, there were probably only 2 or 3 small serosal tears, no full-thickness injuries.Serosal tears were repaired with lembert-type 3-0 vicryl seromuscular interrupted with no full thickness injuries.These serosal tears were expected with this very extensive adhesiolysis, extensive adhesions.¿ operative records dated (b)(6) 2015 state: ¿¿.Lysed extensive adhesions, interloop adhesions, adhesions to the abdominal wall, and laterally, etc, to free up the small bowel.The patient had an ileo probable descending colon anastomosis from the past.We mobilized on the white line of toldt laterally on the right side.Now, we freed up our small bowel adhesions to see the ileocolic anastomosis.Quite extensive adhesiolysis as stated.We were able to mobilize the sigmoid laterally on either side.We were able to find the ureter on either side; the right and left ureter.Now, we created a blunt window between the mesorectum and the sacral promontory.We scored all the way up to the inferior mesenteric vessels without difficulty.¿ operative records dated (b)(6) 2015 continue: ¿the patient bad a very fatty inferior mesenteric trunk.We sequentially freed up some of this fat with 2-0 vicryl ties, and then we were able to assure that we were well away from our ureter on either side.At this point though, we decided to divide the ileum just proximal anastomosis, sequentially ligating and dividing the ileum with associated mesentery at this level with 2-0 vicryl ties double ligation on the stay-in side; and then also at this point, then we were able to now free up some of the lateral mesentery or fatty tissue from retroperitoneum sharply with bovie electrocautery and also with clamping and ligating.¿ operative records dated (b)(6) 2015 state: ¿at this point, high ligation of the inferior mesenteric vessels was performed using a couple clampings on either side with 2-0 vicryl; double ligation on the stay in side, single ligation on the some-out side.The larger come-out side was suture ligated with a 2-0 vicryl stick tie tied down without difficulty.Now, in total mesorectal excision type fashion, the proximal rectum was mobilized posteriorly and some lateral mobilization as well.We selected a portion of the proximal rectum which was about 5cm distal from the area of ink, which was in either the distal sigmoid or rectosigmoid.We sequentially ligated the mesorectum at this level in the proximal rectum with 2-0 vicryl ties, with double ligation on the stay in side, and this was completely mobilized.¿ operative records dated (b)(6) 2015 state: ¿the rectal catheter was removed.The level of the rectum was then divided using curved cutter green stapler contour ethicon without difficulty.Specimen was taken off the field.I opened it up on the back table.The scar of the polypectomy site was seen in either the distal sigmoid or rectosigmoid.It was marked with a small stitch.It was measured 5cm from the distal margin.Distal margin was marked with a long stitch.The specimen was ileodescending or ileosigmoid anastomosis.I guess the anastomosis was in the ileosigmoid colon i should say, instead of the ileodesending colon as i stated above; sigmoid colon and proximal rectum.At this point, hemostasis was noted to be achieved within the abdomen.¿ operative records dated (b)(6) 2015 state: ¿as stated, there were 2 or three serosal tears that were repaired during the procedure in the small bowel with no full thickness injuries.We very carefully searched the extent of the small bowel for further adhesions that were necessary.No evidence of any small bowel injuries were noted whatsoever.At this point the wound was protected with blue towels.We cut off the distal ileal______[sic].Excellent bleeding edge to the distal ileum was noted.A 2-0 prolene pursestring was placed in the usual fashion.The eea 29 anvil was them placed within this opening of the ileum and then tied down without difficulty, looped around and tied around again.¿ operative records dated 11/2/2015 state: ¿saline was placed in the pelvis.Air was insufflated with an 8-inch using a bulb syringe.No evidence of rectal stump leak was noted.¿ the records state ¿¿now inserted the eea 29 stapler within the anus.It was brought out to the end of the staple line.The pin was opened up just adjacent to the staple line and the anvil was then placed on the pin.¿closed the stapler, fired the stapler, removed the stapler.Excellent proximal and distal donuts were noted.Saline was placed in the pelvis once again.I grasped the distal ileum proximal to the ileorectal anastomosis.¿ the records state ¿¿ performed a flexible sigmoidoscopy and visualized the anastomosis.Excellent, well perfused, excellent anastomosis was noted, with very healthy bowel in the ileum proximal the anastomosis itself, in the rectum distally.No evidence of anastomotic leak was noted.¿ operative records dated (b)(6) 2015 state: ¿now, because of the mesh, we used a permanent suture in the superior portion of the incision, or we used it in the entire incision actually.The wound was closed using two, #2 nylon sutures without difficulty, approximately every inch and a half or so, or #1 vicryl internal retention sutures tied down without difficulty.Prior to closing the fascia etc., we infiltrated the subcutaneous incision site and the fascia with 20ml of exparel diluted in 80ml of sterile saline.We closed the fascia as stated above.We irrigated the wound with a large amount of saline.Bovie electrocautery was used to achieve hemostasis in a few select places.The skin was closed with staples and that was for closure of the fascia and all as well, we had used the closing tray and changed our gloves.Now, we closed the skin with staples.¿ operative note addendum dated (b)(6) 2015 states: ¿i reinforced the anastomosis with 4 cc of tisseel during the operation.Also, prior to closure, we removed some of the laparoscopic staples from the mesh, which appeared to be protruding into the abdomen·.Those were removed.They had been previously placed a long time ago by (b)(6).I then closed as previously stated.¿ operative records dated (b)(6) 2015 indicate the patient underwent 1.Exploratory laparotomy with abdominal washout.2.Primary repair of jejunal perforation.3.Flexible sigmoidoscopy.Preoperative diagnosis ¿free intraperitoneal air, concerning for a viscus perforation with peritonitis.Postoperative diagnosis ¿1.Feculent peritonitis.2.Jejunal perforation." operative records dated (b)(6) 2015 state: ¿the patient is a 63-year-old male, who underwent a completion total colectomy with ileorectal anastomosis with (b)(6) last monday.The patient was discharged home on thursday doing well.The patient had acute onset of severe abdominal pain saturday afternoon that continued to worsen.The patient contacted me at 6:00 p.M.And i recommended emergent evaluation in the er.The patient was transported by ems to the emergency department.¿ operative records dated (b)(6) 2015 state: ¿the area was in extremis, diaphoretic, with an acute abdomen.An abdominal x-ray showed a significant volume of free intraperitoneal air.I combined with this clinical exam and i recommended emergent laparotomy and exploration for concern of a viscus injury, either in the small bowel or at the previous anastomosis.The patient had significant abdominal distention.His previously placed staples were removed.The subcutaneous tissues were bluntly dissected down.The knots from the abdominal closure were identified.¿ operative records dated (b)(6) 2015 state: ¿it appeared that there were likely 3 sutures used in closure _____[sic] from 2 different knots in the midline.We sharply cut one of these and then a large volume of feculent stool poured out the wound.A suction catheter was placed in this and the remaining suture was quickly removed under direct visualization to open the abdominal wound up.We were able to evacuate a large volume of stool on entering into the abdomen.The patient clearly had a peritonitis reaction with significant edema of the bowel wall, with a _____[sic] exudate coating most of the loops of bowel.¿ operative records dated 11/8/2015 state: ¿they were all erythematous and dilated.There were noted adhesions to the anterior abdominal wall, which were able to be gently taken down to allow for placement of an alexis wound retractor to aid in exposure.The patient had numerous interloop adhesions.After evacuating a large volume of stool, we noted that we had nearly a liter of feculent stool that was removed from the abdomen.On initial inspection of the anterior abdominal wall, we noted a jejunal perforation under the epigastric incision.There was solid stool beneath this.This was closed primarily with 3-0 vicryl sutures.¿ operative records dated 11/8/2015 continue: ¿this was not in the site of previously noted serosal injury and there were no sutures in the area.It is unclear the etiology and if this was a delayed perforation from a cautery injury or if this was primary perforation.The bowel wall was otherwise just edematous, but there were no telltale signs to indicate the etiology.We then slowly proceeded to gently take down interloop adhesions.The patient had a large pocket of feculence over the liver that we were able to enter into.We were able to work our way down gently into the pelvis _____[sic] retractor was used.There was a lot of stool staining along the sidewalls, more on the right than left, but i could see what appeared to be the site of the anastomosis and there was no gross leak.¿ operative records dated (b)(6) 2015 state: ¿on entering into more the right abdomen, the bowel wall was not as edematous and there were actually several normal appearing loops of bowel.This actually seemed to be loculated off so the peritonitis was more anterior and into the right gutter of the abdomen.It was unclear if there was any issue with the anastomosis and i asked the or staff to _____[sic] a colonoscope with a co2 pneumatic insufflation to evaluate the anastomosis.While this was being obtained, we continued to explore the bowel.I was able to enter into the lesser sac.The patient's remaining omentum that were quite densely adherent to the bowel, i could not fully explore the lesser sac, but there was no stool noted within there.¿ operative records dated (b)(6) 2015 state: ¿i could not take down all the adhesions and was more fearful of actually causing another iatrogenic injury due to the inflammation around all loops of bowel.I was able to take down enough adhesions to run the bowel from the level of the anastomosis proximal into the right abdomen, where the bowel appeared normal.I could identify no further serosal injuries or full-thickness bowel injuries.I performed a second layer of closure with lembert sutures over the primary repair of the previously identified jejunal injury.We were able to ensure there was no luminal compromise within.Drapes were then elevated to maintain sterility along our abdominal incision and the patient was frog-legged and (b)(6) began the initial portion of the flexible sigmoidoscopy.¿ operative records dated 11/8/2015 state: ¿we were able to occlude the bowel and place ___[sic]within the pelvis.He was able to insert the scope.He was then able to fully advance it up to the anastomosis.We scrubbed and changed positions and i drove a flexible sigmoidoscope and he occluded the bowel.I was able to visualize the anastomosis.There was some stool staining around this and this was irrigated.The anastomosis appeared viable and healthy and you could see a healing circumferential eea suture line.There was no pneumatic air leak and we were able to get proximally into the small bowel.The air was then evacuated and i did not feel there was any issue with his eea anastomosis.I then scrubbed back in sterilely.¿ operative records dated (b)(6) 2015 state: ¿we widely irrigated the abdomen, approximately 8 l, to decontaminate the abdominal cavity.I was then confident that there was no other source of injury and we had adequately explored the abdomen.On inspection, the fascia was intact.In the upper abdominal cavity, the patient had previously had a hernia repair with mesh.(b)(6) had excised this mesh.It was tightly adherent to the fascia.It was dark stool stained there and i am concerned that this could become infected.There were several kind of folds within the mesh and i was able to excise this and trim the edges.I could not fully explant the mesh and was fearful if i did we would not have fascia for abdominal closure, and as this patient was quite distended we could not compromise the fascial margin.The fascia was closed with 2 running looped pds sutures with interrupted o vicryl to help prevent a dehiscence of the wound.The subcutaneous tissues were irrigated.We packed the wound open, due to the volume of contamination.¿ pathology report dated (b)(6) 2015 for specimen collected (b)(6) 2015 states: ¿specimen(s) submitted: gross description partial mesh: in formalin labeled "partial mesh" is a 4 x 3.5 x 1 cm aggregate of tan-green to red mesh material.No tissue is identified.No sections are submitted, gross only.Final pathologic diagnosis: partial mesh, (gross examination only).¿ ct abdomen/pelvis dated (b)(6) 2015 state: ¿impression: 1.Interval removal of drainage catheter left side of abdomen.2.Again, postop change anterior abdominal wall hernia repair with mesh.Tiny amount of air and fluid along incision tract and about the mesh repair are slightly increased in volume.Tiny amount of ascites otherwise seen within the abdomen and pelvis, unchanged.3.Small subhepatic fluid collections are again seen and are no worse than previous with perhaps slight improvement in size of collection about left lobe liver.4.Small moderate right pleural effusion and adjacent atelectasis are unimproved.Tiny-small left pleural effusion is moderately improved with slight improvement of adjacent atelectasis.5.Persistent mild apparent thickening of bowel throughout abdomen and pelvis anteriorly.¿ progress note dated (b)(6) 2016 states: ¿[patient] is a 63 y.O.Male seen as in follow up evaluation of here for follow up of enterocutaneous fistula.¿ the records state: ¿there has been protrusion of abdominal mesh from wound for last couple of weeks.Output about 100 to 200 per day.Patients symptoms include: no fever, abx have been stopped pic line is out.Physical exam: abdominal: soft.He exhibits no distension.There is no tenderness.There is no rebound and no guarding.Progress noted dated (b)(6) 2016 states: ¿ec fistula 4 by 2 cm.Mesh protruding from wound and pulled gently form [sic] fistula site and excised-with scissors, additional mesh pulled gently from inside and excised with scissors small amount of mesh palpated inside remains.Plan: continue current bowel regimen as prescribed rtc in 3 weeks¿.¿ ¿likely more mesh will migrate if does will remove in future.Greater chance of fistula closure if all mesh can be removed.Large portion removed today.¿ records dated (b)(6) 2017 indicate the patient underwent small bowel resection with primary anastomosis times 2,small bowel fistula resection with primary repair, small bowel enterotomy repair, repair hernia ventral.Preoperative/postoperative diagnosis ¿fistula of intestine¿ patient with a history of a enterocutaneous fistula x 2 involving small bowel.¿ operative records dated (b)(6) 2017 state: ¿abdomen was prepped with chloraprep x2 patient had a long midline scar we made an incision overlying the long midline scar and also in the region of the upper abdomen we excised the skin along with the area the fistula so we excised scored core of skin along with it.Very carefully we entered the abdomen and very carefully will sequentially lysed adhesions to the abdominal wall.This was very time consuming and tedious.¿ operative records dated (b)(6) 2017 states: ¿we sequentially lysed adhesions small bowel adhesions to the abdominal wall etc.We very carefully freed the region circumferentially around the area of the fistulae near the abdominal wall.This extensive adhesiolysis of small bowel interloop adhesions etc.Small bowel to the abdominal wall took over 2 hours.(b)(6) assisted with her operation in the at this point and assisted with complex decision-making etc.Inherent to the nature of the complexity operation there were some serosal tears that were unavoidable.¿ operative records dated (b)(6) 2017 continue: ¿some of these were in a region that we knew would be resected.These areas were closed with 3-0 vicryl some of these were actually full-thickness tears closed with 3-0 vlcryl interrupted's and the cyst in the serosal type tears as reinforced with seromuscular lnterrupted's.As we freed up all of the fistula regions etc.We realize that there were 2 areas that were going to require resection.There was one area not too far from the ileorectal anastomosis probably you know within 8-1 o inches from this area may be a foot from this area.¿ operative records dated (b)(6) 2017 state: ¿this area had a fistula that was chronic we decided that we would actually resect this area we resected a portion of small bowel probably about 3 inches inside was sequentially ligated and divided the mesentery associating with a associated with the fistula.And then divided the small bowel at either side of this with a gia-75 blue stapler without difficulty.The · remaining defect was closed using a ta 60 blue stapler with care to avoid lining up the linear staple lines excellent bleeding edges were noted.Layered reinforcement suture was placed at the elbow the anastomosis with a 3-0 vicryl seromuscular interrupted.¿ operative records dated (b)(6) 2017 states: ¿was an area proximal to this that was an obvious fistula site this was several inches proximal to this that we felt we would try to just core out the fistula itself in the bowel and we did we are able to get back to good healthy edges.(b)(6) and i will visualize this very carefully we felt that we could close this like in a transverse fashion kind of like a pyloroplasty type closure.Was closed with 3-0 vicryl interrupted's and excellent closure was noted we are very happy with this.So more proximal to this there was an area of a full-thickness 3 that was repaired with 3-0 vicryl interrupted's.¿ operative records dated 4/21/2017 state: ¿we must note that is stated that the serosal tears and a full-thickness injuries were all adherent to the nature of the complexity of this very difficult operation.At this point in the more mid time region of the bowel was an area where there were probably a few fistulas at least 2 to the abdominal wall with some areas that had been deserosalized earlier as stated we resected this area which was about a foot of small bowel we resected this by the sequentially dividing the mesentery coinciding between these 2 points with a 2-0 vicryl lies on the staying inside some of them with double ties.¿ operative records dated (b)(6) 2017 continue: ¿(b)(6) and i decided that a side to side would not be the best for this region for 1 of the injury repairs was about 4-5 inches from this area.We decided to freshen up to either ends cut out the staple line and perform a handsewn 3-0 vicryl single-layer anastomosis was performed in excellent fashion with excellent anastomosis noted.(b)(6) in a very carefully search the abdomen for serosal tears or any further tears we did not find any.We irrigated the abdomen with several liters probably close to 10 l of saline we had some mild small bowel spillage during the operation.This point though there was some mesh that had been removed along with her specimens we removed earlier.¿ operative records dated (b)(6) 2017 state: ¿there is no further mesh within the abdomen i consulted (b)(6) intra-op to assess for complex wound closure.Now used the closing tray we took these attachments were using off the field.We changed our light handles used a new bovie electrocautery new suction device.Changed gown and gloves.¿ the records state: ¿now (b)(6) performed a component separation please see his op report for details.Also fascia was closed by (b)(6).Drains were placed in the subcutaneous tissue skin was closed with staples we irrigated the subcutaneous tissue in the area overlying the fascia large amount of saline prior to doing so.2 10 jp flat drains were placed in the subcutaneous space as stated.Blood loss was 525 cc and no complications patient tolerated the procedure very well all instrument lap counts.¿ additional operative records dated (b)(6) 2017 state: ¿this is a 64 patient which presented with ecf.Intraoperatively after resection of the ecf and associated bowel it was noted there was loss of domain in the fascia requiring a hernia repair.¿ the records state ¿flaps were raised above the fascia on both sides of the incision to the midpoint of the external oblique aponeurosis approximately 11 cm on each side.After the flaps were raised the fascia easily came together without tension.At this point we opted not to perform relaxing incisions.The fascia was closed with a running loop pds suture.The wound bed was irrigated and hemostasis was ensured.Two 19f jp drains were placed in the wound bed and the skin was stapled closed.¿ 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 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.¿ 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: conclusion code remains unchanged.H10/11: added medical record information.Additional details regarding the patient's clinical course were ascertained from a review of medical records and are as follows: records between (b)(6) 2006 and (b)(6) 2013 were not provided.08/09/13: (b)(6).Office note.Newly diagnosed sigmoid colon cancer.Exam: abdominal; soft, no distension, tenderness, rebound or guarding.Long midline scar.Upper abdominal asymptomatic incisional hernia.Assessment: cancer sigmoid colon near anastomosis.Hx subtotal colectomy w/ ileosigmoid anas 2006, hx large abdominal hernia repair w/mesh.Plan: lynch and myh testing discussed.Schedule flex sig.Will need surgery; options will be resection with ileo rectal, apr w/ need ileostomy, or completion proctocolectomy will ileoanal j pouch.Any surgery needs to be done open d/t large midline scar and hx large mesh abdominal hernia repair.Had abdominal ct; ok.10/07/15: our lady of the lake regional medical center.Louis r.Barfield, md.History & physical.Cc: abdominal pain, constipation, diverticulitis.Hpi: seen in evaluation of newly diagnosed sigmoid cancer found in 15 mm polyp tubule-villous adenoma with high grade dysplasia.Ros: gi; diarrhea.Exam: abdominal; soft, no distention, no guarding, long midline scar.Pmh: cancer, colon cancer, colon polyp.Psh: hernia repair, colectomy, excisional hemorrhoidectomy.H/o hernia repair w/large piece of gortex.Plan: surgical resection to consist of open and sigmoid colectomy with likely ileorectal anastomosis, any indicated procedure.Need to do flex sig to assure i can see area of concern.Offered completion proctocolectomy with j pouch and diverting loop ileostomy; does not want, has had no rectal polyps.Wants ileorectal.12/16/15: (b)(6).Office note.Postop exp lap, small bowel resection for small bowel perforation 5 days after completion colectomy w/ileorectal anastomosis on 11/07/15.Wound nurse here.Trouble keeping vac on now.No fever, on iv abx per dr.Azmeh.Exam: abdominal; soft, no distention, tenderness, rebound or guarding.Wound healing, obvious enterocutaneous maturing in mid to upper wound.Suture in area removed with scissors.Wound are [sic] clean and look good, healing well.Meds: enoxaparin, metformin.Plan: continue vac for low wound but will bag fistula w/ ostomy bag.Continue f/u and iv abx.Rtc 3 weeks.01/27/16: (b)(6).Office note.F/u ec fistula.Doing great, is getting smaller.Wound nurse here.No fever, off abx, tolerating diet.Output less than 150 cc/day.Exam: abdominal; soft.Fistula more mature, looks smaller.No mesh palpated; skin looks great.Assessment: improving, fistula smaller, decreased output.Rtc 6 weeks.02/09/16: (b)(6) office note.F/u ec fistula.Inferior to, developed a swelling then started bloody then pus, did not look like stool.No drainage is minimal.Exam: fistula looks unchanged, no mesh seen.Inferior to area there is a new ¾ by ¾ inch area w/ skin ulceration, no obvious drainage.Assessment: new skin ulceration.Ruptured stitch abscess?? association w/ ec fistula??? abx seem to help.States looks a lot better today.Fistula 150 cc per day or less.Overall lower output.Plan: complete abx ordered over weekend.03/09/16: (b)(6) office note.F/u ec fistula.Minimal output now.Inferior to area w/ drainage over last 5 days.Knot around has resolved.Exam: abdominal; soft, no distention, tenderness, rebound or guarding.Ec fistula looks good, appears to [sic] healing.Inferior to small area w/ drainage, mild.Cultured, probed w/ qtip; golf ball sized cavity, no pus now.Plan: levaquin/flagyl 7 days.Wound culture, ct abd/pelvis to rule undrained abscess.Rtc 2 weeks.03/09/16: (b)(6) microbiology-culture exudate/wound/abscess & gram stain.Source: drainage.Site: abdomen.Accession: 16-069-05364.Gram stain report: many wbc/lpf.Many rbc¿s.No epithelial cells/lpf.No organisms seen.Final culture report: few gram-negative rod.Few coliform.Few possible enterococcus.Occasional yeast.This culture shows growth of mixed organisms.A follow-up culture after broad-spectrum antibiotic therapy is recommended.Few mixed skin flora.Final culture report; 03/14/16: no growth of anaerobes.03/23/16: (b)(6) office note.F/u ec fistula and new small anterior abdominal wall abscess that spontaneously drained.Couple teaspoon of drainage from fistula per day.Other open wound no drainage.Wound nurse present.Exam: abdominal; soft, no distention.Fistula looks good.Open wound inferior to, no drainage 1.5 cm deep, does not track.Assessment: fistula of intestine to abdominal wall.Open wound of anterior abdominal wall.Doing well, has completed abx.Plan: high fiber diet, continue current care.Rtc 3 mos, continue home health and wound care.04/18/16: (b)(6).Office note.F/u ec fistula.Minimal output; some days no more than 150 cc/day.Has noticed mesh from wound again for last 3 days.Reports feels really good.Exam: abdominal; soft, no distention or tenderness.Fistula evaluated.Piece of mesh seen; gently pulled out w/ hemostat.A piece about 12 cm 3 cm removed.Mild bleeding, pressure help and silver nitrate at surface of fistula.Pressure held again bleeding has really ceased, under control.Packed w/ dry dressing, pressure dressing.Wound nurse will check tomorrow.Assessment: open wound of anterior abdominal wall.Fistula of intestine to abdominal wall.Foreign body in digestive system.Plan: removal of abdominal wound foreign body as above.Cont.Diet.Home health.Hopefully w/foreign body removal will be more likely to completely close.Rtc 2 to 3 mos or sooner as needed.Wound nurse will follow closely.07/20/16: (b)(6).Office note.F/u ec fistula.Area inferior to main fistula w/ drainage.Fistula w/ only 100 cc today or less.Inferior wound changing twice a day, with pus.Reports less drainage overall.Exam: abdomen; no distention or tenderness.Bag over main fistula.Inferior wound probed w/ qtip; seems to be small cavity less than walnut sized.No cellulitis.Assessment: open wound of anterior abdominal wall.Fistula of intestine to abdominal wall.Plan: repeat ct abd/pelvis to assess/rule out deeper abscess.Augmentin for 10 days.Rtc 2 weeks.Continue wound care per home health.Cx of wound performed.07/21/16: (b)(6).Microbiology-wound culture, drainage.Diagnoses: open wound of anterior abdominal wall, subsequent encounter.Order: aerobic, anaerobic, gram stain.Type: drainage.Source: abdomen.Procedure: culture exudate/wound/abscess & gram stain.Accession: 16-203-09178.Gram stain report: moderate wbc/lpf.Many rbc¿s.No epithelial cell/lpf.Many gram-negative coccobacilli.Moderate gram-positive cocci in pairs.Few gram-positive cocci in chains.Few gram-negative rods.Final culture report: many possible enterococcus.Many gram-negative rod.Many second gram-negative rod.This culture shows growth of mixed organisms.A follow-up culture after broad-spectrum antibiotic therapy is recommended.08/02/16: (b)(6).Office note.F/u ec fistula and small abdominal wound.Fistula 100 cc per day or less.Small wound draining small amount of mucus and purulence.No fever.Exam: abdominal; soft, no distention or tenderness.Fistula looks good.Small wound inferior looks clean 2.5 cm deep.Sero sanguinis discharge now.Assessment: fistula of intestine to abdominal wall, foreign body in digestive system, open wound of anterior abdominal wall.Cx seen-mult organisms.Rec re-culture after broad spectrum abx-no complete.Plan: high fiber diet, re-culture wound as was rec by culture report couple weeks ago.Call after culture results.Wound nurse here; will speak to dr.Azmeh about pending cultures.08/03/16: (b)(6).Microbiology-wound culture, drainage.Diagnoses: open wound of anterior abdominal wall, subsequent encounter.Order: aerobic, anaerobic, gram stain.Type: drainage.Source: abdomen.Procedure: culture exudate/wound/abscess & gram stain.Accession: 16-216-10163.Gram stain report: few wbc/lpf.Many rbc¿s.No epithelial cells/lpf.Many gram-negative rods.Final culture report: moderate coliform.Occasional possible enterococcus.Moderate/many gram-negative rod.This culture shows growth of mixed organisms.A follow-up culture after broad-spectrum antibiotic therapy is recommended.11/02/16: (b)(6).Office note.F/u ec fistula.Much less drainage, appears to be closing.Doing better lower area.Did bactrim for 2 weeks; wants to get back on, saw big improvement.Exam: abdominal; soft, no distention or tenderness.Looks great.Plan: bactrim ds for 2 weeks.High fiber diet.Rtc 6 months.Does not want surgery; i agree at this time.01/18/17: (b)(6).Office note.F/u ec fistula.Minimal output but seems to connect to other opening.Exam: abdominal; soft, no distention, tenderness, rebound, or guarding.2 small openings, minimal drainage but with irritation at skin surrounding more so than before.Assessment: fistula of intestine to abdominal wall.Open wound of anterior abdominal wall, new flare of irritation.Strongly considering exp lap w/ bowel resection and fistula repair sometime before the summer.Recent flex sig was ok.Plan: continue current care.Bactrim/flagyl for 10 days.03/08/17: (b)(6).Office note.F/u ec fistula.Still with output about 100 cc/day, tolerating diet.Ros: no fever, no chills.Exam: abdominal; soft, no distention, rebound, or guarding.Ec fistula openings x 2, close to each other, look stable, no cellulitis.Social: never smoker, no alcohol.Assessment: fistula of intestine to abdominal wall, hx colon cancer; stage ii, pre-diabetes.Plan: surgical resection to consist of open and exploratory lap w/ small bowel resection and enterocutaneous fistula repair.Ct abd/pelvis for cancer reasons.Neomycin, flagyl day before.Hold metformin day before and am of, hold aspirin for 7 days before, dr.Dis flex last month normal.05/04/17: (b)(6).Office note.Seen postop after small bowel resection and component separation type closure (only extensive fascia mobilization).Reports overall having difficulty.Good bm¿s, no fever but clear reddish drainage; increasing.Exam: abdomen; soft, non-tender, non-distended.Mild erythema extending about one inch on either side of incision.Small area of separation or opening in skin in mid incision 5 mm in size with serous fluid draining from, no pus.Fascia seems intact.Dx: seroma, wound cellulitis after surgery.Assessment: overall doing well; no abdominal pain.Plan: augmentin, regular diet, appt.Monday, probiotics.05/08/17: (b)(6).Office note.Postop small bowel resections for ec fistula.Reports overall doing well.Exam: abdomen; soft, non-tender, non-distended and erythema better, almost resolved, minimal serous drainage.Dx: pre-diabetes, wound cellulitis after surgery.Plan: liberalize diet, no heavy lifting for total of 6 wks post-op for all abdominal wall to heal and prevent incisional hernia, ok to drive.05/24/17: (b)(6).Office note.Postop small bowel resection and ec fistula repair 5 weeks ago.Doing great, good bm¿s.Exam: abdomen; soft, non-tender, non-distended, looks great.04/02/18: (b)(6).Office note.F/u small bowel resection and ec fistula repair.Symptoms: diarrhea, bm after every time he eats.Here for cancer f/u.Reports improvement in abdominal pain, bowel function.Wt.103 kg (227 lb).Exam: abdominal; soft, no distention, tenderness, rebound or guarding.Scar noted.Assessment: recent flex sig per dr.Bay; normal.Dr.Spell mentions he feels like cancer in remission.Has gallstones, possibly common bile duct stone; seeing appropriate physicians.Continue current bowel regimen as prescribed.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 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.¿ 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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B7: added medical history.H6: conclusion code remains unchanged.H10/11: added medical record information.Additional details regarding the patient's clinical course were ascertained from a review of medical records and are as follows: (b)(6) 2014: (b)(6) medical center.(b)(6).Ed physician notes.Hpi: abdominal pain, below navel, nausea, 2 days.Pmh: diverticulitis, colon cancer.Exam: gi; soft, tenderness-moderate, suprapubic.Impression: abdominal pain, diverticulitis.Plan: discharge home, antibiotics.(b)(6) 2014: (b)(6) medical center.(b)(6).Radiology-ct abd/pelvis w/o iv contrast.History: lower abdominal pain.Impression: findings compatible with diverticulitis involving sigmoid colon.Specifically, inflammatory change surrounding a diverticulum off the caudal dorsal aspect of sigmoid colon with some inflammatory change.No loculated abscess collection or extraluminal air present.Diffuse thickening throughout the colon over an 11 cm length which may be related to chronic diverticular change.Postop change right hemicolectomy.Postop change anterior abdominal wall hernia repair.(b)(6) 2015: (b)(6).Radiology-ct abd/pelvis w/iv contrast.History: left lower quadrant pain.Impression: thickening of sigmoid colon, several centimeters beyond the anastomosis extending over several centimeter length and milder thickening throughout the mid to mid distal sigmoid colon.No significant adjacent fluid or fat stranding (as was present on prior exam).No loculated fluid collection or abscess.Findings may represent early/resolving or chronic diverticulitis.10/07/15: (b)(6).History & physical.Cc: abdominal pain, constipation, diverticulitis.Hpi: seen in evaluation of newly diagnosed sigmoid cancer found in 15 mm polyp tubule-villous adenoma with high grade dysplasia.Ros: gi; diarrhea.Exam: abdominal; soft, no distention, no guarding, long midline scar.Pmh: cancer, colon cancer, colon polyp.Psh: hernia repair, colectomy, excisional hemorrhoidectomy.Plan: surgical resection to consist of open and sigmoid colectomy with likely ileorectal anastomosis, any indicated procedure.Need to do flex sig to assure i can see area of concern.Offered completion proctocolectomy with j pouch and diverting loop ileostomy; does not want, has had no rectal polyps.Wants ileorectal.(b)(6) 2015: (b)(6).Radiology-xr abdomen.History: pain, nausea; question free air.Findings: no evidence of free peritoneal air.Hernia clips projecting over the abdomen.Impression: very limited study secondary to elevated body mass index.No gross foreign body.(b)(6) 2015: (b)(6) medical center.(b)(6).Discharge summary.Hospital course: underwent procedure with no intraoperative complications.Tolerated procedure well.Following procedure, patient provided with ertapenem for antibiosis, given that we manipulated his intraabdominal mesh and, though there was no gross fecal contamination, the procedure was clean contaminated by definition.On postop day 3, doing well, ambulating independently, pain controlled on oral medications, voiding, tolerating low residue diet with no nausea or vomiting, having appropriate bowel function.Discharged home with strict return criteria.Discharge instructions: no lifting greater than 10 pounds for 6 weeks.F/u dr.(b)(6) 2 weeks.(b)(6) 2015: (b)(6) medical center.(b)(6).Ed physician notes.Cc: severe abdominal pain and distention s/p colon resection on monday; reports fever and chills x 1 day, unable to urinate x 3 hours.Ros: gi; abdominal pain, moderate, suprapubic, dull, achy, pressure, nausea, vomiting, no diarrhea, constipation, or rectal bleeding.Exam: gi; abdominal distention, linear surgical incision with staples in place; minor serosanguinous drainage from top of incision.No fluctuance noted.Tenderness; moderate, suprapubic.Rebound negative, bowel sounds silent.Alb 2.9 l.Addendum: presents with inability to urinate; noted had surgery for colon cancer last week; removed most of colon.Notes for last few hours has lower abdominal pain, cannot urinate.On exam is diaphoretic, has large midline incision with staples; skin not red, but is a light brown discharge from the top incision.Plain film shows large amount of pneumoperitoneum not present on discharge film.Given this we immediately discussed with colorectal surgeon; took immediately to or.(b)(6) 2015: (b)(6) medical center.(b)(6).Radiology-xr abdomen flat and erect.Impression: free peritoneal air that should be resolved within the week; findings suspicious for viscous leak.(b)(6) 2015: (b)(6) medical center.(b)(6).History and physical.Cc: acute abdominal pain.Hpi: family called this evening stating patient was in extremis with acute onset of abdominal pain and urinary retention.Instructed them to promptly come to emergency department.Abdominal x-ray showed moderate amount of free intraperitoneal air.States when he went home on thursday, having numerous bowel movements all day long.Has passed gas and had bowel movements today; acute onset of pain mid-afternoon.States more severe in right lower quadrant, 10/10; cannot voluntarily move on the stretcher.Psh: what sounds like extended right hemicolectomy with ileo-descending anastomosis, recent completion colectomy with ileo-colonic anastomosis.Temp 99.2.General; uncomfortable, profusely diaphoretic, laying on wet sheet from perspiration, erythematous face, appears acutely uncomfortable.Abdomen; diffusely distended, staple line intact with some mild ecchymosis around incision line.Severe diffuse abdominal tenderness, worse on right with guarding/rebound tenderness.Abdominal x-ray; has moderate free intraperitoneal air, highly concerning for a viscous leak.Assessment/plan: emergent exploratory laparotomy.Discussed the likelihood of leak at anastomosis; if significant will require takedown of this connection with an end ileostomy.On review of operative note from dr.(b)(6), i should note patient had significant adhesions with over an hour of adhesiolysis from previous mesh placed for hernia repair.There were several serosal defects repaired, but no full-thickness injury.Nonetheless, there is a possibility of a missed injury to the small bowel from this extensive adhesiolysis.If this is found, will try to temporarily repair it; may need a small bowel resection.Patient and family all agreed to proceed with surgery and understand the risks, benefits, alternatives.Risks including bleeding, infection, worsening sepsis, postoperatively an intraabdominal abscess or hernia, wound infection and need for recurrent surgery or blood transfusion were all reviewed.Does appear to have an acute kidney injury with an elevated creatinine.I think this is all due to intra-abdominal infection, volume depletion from intra-abdominal infection.Will proceed with aggressive fluid hydration, watch labs closely.Going emergently to operating room in light of this sepsis and concern for bowel leak.(b)(6) 2015: (b)(6) medical center.Microbiology-bacterial cultures.Procedure: culture fluid (body fluid-not csf) with gram stain.Accession: 15-311-05928.Source: abdominal fld.Body site: abdomen.Free text source: from surgery.Final report: many possible enterococcus, many presumptive candida albicans/c.Dubliniensis, moderate/many coag (-) staph, many possible haemophilus sp., many possible lactobacillus sp.If further identification or susceptibility testing is clinically indicated, please contact microbiology within 3 days of this report.This culture shows growth of mixed organisms.A follow-up culture after broad-spectrum antibiotic therapy is recommended.Gsd: occasional wbc/1pf, no epithelial cells/1pf, many gram positive cocci in chains suggestive of streptococcus, many gram positive rods, moderate gram positive cocci in cluster suggestive of staphylococcus, moderate yeast, few negative cocci, occasional gram negative rods.(b)(6) 2015: (b)(6) medical center.Microbiology-bacterial cultures.Procedure: culture anaerobic.Accession: 15-311-05929.Source: abdominal fluid.Body site: abdomen.Free text source: from surgery.Final report: mixed culture (>=5 aerobic & anerobic isolates) strongly suggests polymicrobial infection or contamination with normal mucosal bacterial.(b)(6) 2015: (b)(6).Pathology report.Accession: 10846440.Clinical data: small bowel perforation.Final pathologic diagnosis: partial mesh gross examination only; [illegible].Specimen(s) submitted; gross description: partial mesh; [illegible] labeled ¿partial mesh¿ [illegible] x 35 x 1 cm [illegible].[nurse reviewer note: poor copy, mostly illegible].(b)(6) 2015: (b)(6) medical center.(b)(6).Consultation.Hpi: admitted to icu following emergent laparotomy for small bowel perforation and peritonitis.Presented to ed tonight with abdominal pain, urinary retention.Had gross fecal contamination (>1) attributed to small bowel leak.Surgery tonight uncomplicated per dr.(b)(6) except for presumed aspiration at anesthesia induction.Ng tube inserted at the time yielded feculent material; later also suctioned from endotracheal tube.Impression/plan: small bowel perforation, peritonitis, sepsis syndrome; now s/p exploratory laparotomy with washout, enterotomy repair and removal (from previous hernia repair).Continue fluid resuscitation, add micafungin to zosyn, ngt/wound care per surgery, anticipate need for additional washout in or.Acute respiratory failure; cxr suggests developing aspiration pneumonitis, sputum culture sent.Acute kidney injury; follow labs/urine output closely with fluid replacement.(b)(6) 2015: (b)(6) medical center.(b)(6).Wound care documents.Consulted for vac to midline abdomen.Surgical incision, wound length 25.5 cm; wound width 6 cm; wound depth 4 cm.Wound description: full thickness, non-granulating, internal sutures, adipose tissue and fascia visible.Drainage: serous; amount small, odor none.(b)(6) 2015: (b)(6) medical center.(b)(6).Progress note.Called by wound nurse; stool or pus in wound when vac changed.Pt feels ok.Wound upper and lower abd-suction of wound with pus or liquid stool, small amount.Abd.Exam benign.Abscess versus [illegible] fistula.Abd.Exploration would be very dangerous [illegible] due to risk of bowel injury, etc.Addendum: ct abdomen left abdominal to pelvic abscess, very minimal free air, ø extravasation of contrast.Ct guided drainage tomorrow.Replace wound vac per wound nurse in am.Start tpn tomorrow.(b)(6) 2015: (b)(6) medical center.(b)(6).Radiology-ct abd/pelvis w/wo iv contrast.History: abdominal pain, generalized.Impression: midline abdominal wound with underlying mesh.Left lower quadrant abscess near ileorectal anastomosis, with decompression to midline abdominal wound; measures 18.7 x 3.1 cm in greatest trans-axial dimensions and appears to decompress at midline abdominal wound.Small free air underneath the abdominal mesh.There is no definite oral contrast within this collection.This collection could be drained percutaneously.(b)(6) 2015: (b)(6) medical center.(b)(6).Progress note.Noted to have purulent drainage from incision yesterday.Wvac dc¿d; started wtd dressings.Ct abd/pelvis; + [illegible] abscess.Abd minimally distended, ttp, dressings c/d/i.A/p: ir guided drainage of [illegible] abscess this am.Will discuss resume wvac following drainage.(b)(6) 2015: (b)(6) medical center.(b)(6).Radiology-ct-guided abdominal abscess drainage.Using ct guidance, an 18-gauge needle was placed into the fluid collection and the j guidewire was advanced.A 10 french pigtail catheter was placed into the fluid collection over the guidewire.Approximately 20 cc of cloudy red-colored fluid was aspirated.The catheter was secured in place with 0 silk suture and connected to external drainage.Follow-up ct showed no evidence of bleeding or other complication.Tolerated procedure well.Impression: successful ct-guided abdominal abscess drainage.(b)(6) 2015: (b)(6) medical center.Microbiology-bacterial cultures.Procedure: culture exudate/wound/abscess & gram stain.Accession: 15-321-06884.Source: abscess.Body site: abdomen.Free text source: surgery/abdomen abscess syringe.Final report: verified 11/20/15; occasional presumptive candida albicans/c.Dubliniensis (1 colony observed).In-house susceptibilities are not available for this isolate.If susceptibilities are clinically indicated, please contact microbiology within 3 days of this report.Stains: gsd.Verified 11/17/15; moderate wbc/1pf.Moderate rbc¿s.No epithelial cells/1pf.No organisms seen.(b)(6) 2015: (b)(6) medical center.Microbiology-bacterial cultures.Procedure: culture anaerobic.Accession: 15-321-06885.Source: abscess.Body site: abdomen.Free text source: surgery/abdomen abscess syringe.Final report: no growth of anaerobes.(b)(6) 2015: (b)(6) medical center.(b)(6).Consultation.Cc: hyperglycemia.Hpi: has had bouts of hyperglycemia since admission.Has remained on lantus sliding scale; moderate control.Average blood sugar 179 over last 24 hours.Assessment/plan: hyperglycemia; no known history of diabetes; check a1c to determine long term control of blood sugars.Suspect hyperglycemia is multifactorial secondary to sepsis, recent surgical intervention and tpn.Have sliding scale available as already initiated and adjust lantus as needed.(b)(6) 2015: (b)(6) medical center.(b)(6).Progress note.Called by nurse; yellowish drainage from vac and wound noted.No continuous drainage.Concerning for extracutaneous fistula.Vac drainage now clear.Possibly not draining through sponge.Pt feels great; no abdominal pain, abdomen soft, non-tender.Continue current management; tpn, iv abx, minimal clear liquids.Unsafe to undergo abdominal exploration at this time; very high risk of further bowel injury if surgery performed.Conservative, nonoperative management is indicated.Clinically stable.Will view wound with wound nurse tomorrow.Discussed with family possibility of closure of fistula non-operatively.Surgery should be avoided for 3-6 mos preferably if does not close.(b)(6) 2015: (b)(6) medical center.(b)(6).Radiology-ct abd/pelvis w/iv contrast.Indication: pain, drain check, likely small bowel to abdominal fistula.Comparison: 11/16/15.Impression: resolution of fluid collection about the pigtail drainage catheter in left lower quadrant of abdomen.Unchanged fluid collection along posterior margin of right lobe of liver.Considerable improvement in fluid collection in left subhepatic space.Possible small bowel to abdominal wall fistula along the caudal margin of the ventral abdominal wall mesh graft just above the level of the umbilicus.No associated fluid collection.(b)(6) 2015: (b)(6) medical center.(b)(6).Discharge summary.Diagnosis: abscess of abdominal cavity, cancer of sigmoid colon, enterocutaneous fistula, lynch syndrome, pneumoperitoneum, small bowel perforation.Discharge orders: no lifting more than 20 pounds.No heavy straining.Follow up dr.(b)(6) 2 weeks, dr.(b)(6) 2 weeks.Home today after wound vac set up; will need home invanz and micafungin; will need wound changed per wound nurse¿s orders m, w, f.(b)(6) 2016: (b)(6).Radiology-ct abd/pelvis w/iv contrast.Indication: k63.2 [fistula of intestine].Findings: post anterior abdominal wall repair with an anterior abdominal wall mesh.Impression: enterocutaneous fistula along the midline abdominal wall incision near the level of the umbilicus, arising from a small bowel loop intimately associated with the anterior abdominal wall just to the left of midline.Persistent small pleural effusions, reduced in volume on the right.(b)(6) 2016: (b)(6).Radiology-ct abd/pelvis /iv contrast.Indication: wound anterior abdominal wall.Findings: no drainable abscess.(b)(6) 2017: (b)(6).Radiology-ct chest w/contrast, ct abd/pelvis w/iv contrast.Indication: abdominal pain/constipation/diverticulitis.Impression: multiple small bowel loops are closely adherent to the anterior abdominal wall in the midline with a persistent enterocutaneous fistula.Improved compared to prior.(b)(6) 2017: (b)(6) medical center.(b)(6).H&p.Cc: abdominal pain, constipation, diverticulitis.Hpi: seen in follow-up evaluation of enterocutaneous fistula.Still with output about 100cc per day, tolerating diet.Wt 98.4 kg (217 lb).Exam: abdominal; soft, no distention.Ec fistula openings x 2 close to each other look stable.No cellulitis.Assessment: fistula of intestine to abdominal wall.Plan: recommend surgical resection to consist of open and exploratory lap with small bowel resection and enterocutaneous fistula repair.Increased risks of surgical complications due to medical comorbidities reviewed.(b)(6) 2017: pathology group of louisiana.Yanelba toribio, md.Surgical pathology report.Accession: 10934341.Final pathologic diagnosis: abdominal mesh (gross examination only).Small bowel with enterotomy, resection.Serosal fibrous adhesions with acute and chronic inflammation, granulation tissue and fibrinopurulent exudate.Congestion and mild ischemia.Transmural defect and adherent loops of small bowel (gross examination).Negative for dysplasia or malignancy.Margins are viable.Comment: please correlate with the clinical and operative findings.3.Small bowel enterocutaneous fistula x2, resection.Features compatible with enterocutaneous fistulas.Negative for dysplasia or malignancy.Comment: the specimen consists of small bowel with inflamed serosal fibrous adhesions attached to subcutaneous tissue and inflamed granulation tissue throughout.In addition, there is focal foreign body giant cell reaction.Correlation with the clinical and operative findings is essential.Specimen(s) submitted: gross description.Abdominal mesh: in formalin labeled ¿abdominal mesh¿ is a 14 x 4 x 0.2 cm portion of mesh material with imbedded metallic rivets.No sections submitted, gross only.Small bowel with enterotomy: in formalin labeled ¿small bowel with enterotomy¿ is a 14 cm in length segment of unoriented small bowel which is adherent upon itself.The serosa is ragged tan-red with a 1.8 cm sutured area which is 4.0 cm and 6.5 cm from the resection margins.The sutured area may represent a possible perforation.The corresponding mucosa is red.The remaining mucosa is tan-pink.The bowel well averages 0.2 cm in thickness.The lumen averages 2 cm in diameter.Representative sections are submitted in 3 cassettes as labeled: a-b largest adherent loop of bowel, c sutures area/perforation following initial microscopic evaluation, additional sections of the margin are submitted in one cassettes [sic] as d.Small bowel with enterocutaneous fistula x2: in formalin labeled ¿small bowel with enterocutaneous fistula x2¿ is a 26 cm in length segment of unoriented small bowel.The serosa is ragged tan-red with a 7.2 x 4.2 x 2.4 cm adherent apparent abdominal wall.The abdominal wall is surfaced by a 7 x 1.5 cm pink-grey skin.The skin displays 2 defects which tract to the deep aspect.The apparent fistula tracts measure up to 4 cm in length.The surrounding abdominal wall soft tissue is indurated tan-grey.The apparent fistula tracts involve the small bowel serosa, but do not grossly appear to involve the bowel wall or perforate the lumen.The bowel mucosa is tan-pink, smooth and glistening.The bowel wall averages 0.2 cm in thickness.Representative sections are submitted in 6 cassettes [sic] as labeled: a margins.B-c fistulas.D-f fistula tracts to small bowel.(b)(6) 2017: (b)(6) medical center.(b)(6).Discharge summary.D/c diagnosis: fistula, intestine to abdominal wall.Hospital course: s/p resection with subsequent ecf.Postop did well.Pca/foley off on pod #1.Tol.Some po intake and return of bowel fxn by pod #3.Diet advanced to low res on pod #4; tolerated.On pod #5 jp drains removed, iv abx course completed, amenable to discharge.(b)(6) 2018: (b)(6).Radiology-ct chest w/wo contrast; ct abdomen/pelvis w/o iv contrast.Findings: normal caliber small bowel.No inflammatory changes about the bowel.No free fluid or free air.Impression: no evidence of malignancy in chest, abdomen or pelvis.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 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.¿ 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 health effect- clinical code.H6: updated investigation conclusions.H6: health effect impact code: f26: no health consequences or impact.Previous patient code (1695) was reported based on the original complaint and is no longer applicable per gore¿s investigation.The investigation has been completed.Based upon gore¿s investigation there is no available information that reasonably suggests that a gore device may have caused or contributed to death, serious injury or reportable malfunction, and is no longer considered reportable.This event will be closed as no problem detected.Section c1: name: plus antimicrobial product coating.Manufacturer/compounder: w.L.Gore & associates, inc.Lot number: 03448974.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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