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Additional details regarding the patient's clinical course were ascertained from a review of medical records and are as follows: relevant medical information: (b)(6) 2011: (b)(6) hospital.(b)(6), apnp.History and physical.Neurogenic bladder, refractory overactive bladder secondary to cerebrovascular accident march 2010.Has tried multiple therapies for bladder spasms, nothing successful.Presents for robotic assisted cystectomy with ileal conduit, laparoscopic lysis of adhesions, ventral hernia repair.History of seizure disorder due to closed head trauma 1970, last seizure (b)(6) 2011, cerebral vascular accident during embolization of avm, pulmonary embolism 03/10 status post ivc filter, appendectomy, incisional hernia repair x 2, cesarean section x 3, greenfield filter placement.Does not drink, does not use illicit drugs, has been using cigarettes, 35 pack-year smoking history.Weight gain of 30 lbs over last 3 months, left peripheral visual changes since stroke, left sided weakness.Exam: weight 235 lbs, bmi 31.Left lower extremity cooler than right, wheelchair bound, mood depressed.Impression/plan: based on acc criteria, may proceed to operating room without further cardiac evaluation.(b)(6) 2011: (b)(6) hospital.(b)(6).Radiology-ct urogram without and with contrast.Indication: bladder replaced by other means.Unspecified urinary incontinence.Status post indiana pouch ¿ assess urinary tract anatomy.History: 52-year-old female status post indiana pouch creation, following cystectomy for intolerable bladder spasms.The purpose of the study is to delineate ureteral anatomy to convert the indiana pouch to a conduit.Findings: small abdominal wall hernia identified.Impression: no renal or ureteric calculi.Status post indiana pouch creation with expected postoperative changes.Interval resolution of previously noted ureteral and pelvic calyceal dilatation.A small segment of the right mid ureter not opacified, no filling defects within the opacified ureters and pelvicalyceal systems.(b)(6) 2011: (b)(6) hospital.(b)(6), md.Operative report.Preoperative diagnosis: neurogenic bladder.Postoperative diagnosis: neurogenic bladder.Procedure performed: laparoscopic lysis of adhesions.Robotic-assisted cystectomy.Indications: history of stroke secondary to an avm which has now been fixed, and she has had refractory neurogenic bladder since that time.Presents for operative resection.Findings: extensive adhesions to prior ventral hernia repair.Description of procedure: ¿the patient was identified.Consent was obtained.She was brought to the operating room and placed on the table in supine position.She was given iv antibiotics.Sequential compression devices were placed, and general anesthesia was introduced.Her arms were tucked to her sides.Her legs were placed in allen stirrups.All pressure points were padded.A foley catheter was placed to gravity drainage.She was prepped and draped in the standard sterile fashion.Pneumoperitoneum was established by a [sic] open cannula entry above the umbilicus.The abdomen was insufflated to 15 mmhg.There were immediately multiple dense adhesions to her anterior abdominal wall and prior mesh hernia repair including bowel adhesions.We were able to place right lower quadrant ports x 2 and lyse these adhesions enough to place our remaining ports and docked the robot.We took down the remaining adhesions in the midline.We then mobilized the left colon, identified the ureter crossing the iliac vessels and dissected down towards the ureteral hiatus where it was divided between hem-o-lok clips.Then we placed a sponge stick in the vagina and developed a plane between the vagina and the bladder and used a harmonic scalpel to divide the left bladder pedicle.A similar dissection was performed on the right side.We then dropped the bladder off the anterior abdominal wall and divided the urethra in the midline.The urethral stump was oversewn with a running v-loc suture.The specimen was then placed in an endopouch retriever.At this point, we had a malfunction of the robot and could not perform any further dissection.We then docked the robot and mobilized the left colon up to and beyond the hepatic flexure in order to allow dr.Guralnick to create an indiana pouch.The patient was then given to this physician, dr.Guralnick, who performed the remaining portion of the procedure.He will dictate this separately.At the termination of my portion of the case, there were no complications.¿.(b)(6) 2011: (b)(6) hospital.(b)(6), md.Operative report.Preoperative diagnosis: neurogenic bladder, incisional hernia.Postoperative diagnosis: neurogenic bladder, incisional hernia.Procedure performed: continent urinary diversion (indiana pouch), incisional hernia repair, wound block.Dr.(b)(6) performed robotic cystectomy portion of procedure and this will be dictated separately.Description of procedure: ¿when i entered the operating room, the bladder had already been placed in the specimen bag but left in the abdomen.Dr.(b)(6) had already partially mobilized the right colon, as the patient¿s desire for a urinary diversion was an indiana pouch.He had some concerns about some small bowel trauma related to adhesiolysis.Surgical timeout performed.We proceeded to extend the midline port incision that was supraumbilical for the camera port, and this was extended caudally to below the umbilicus skirting it to the left.This was necessary because the left ureter had yet to be tunneled under the sigmoid mesentery, and in addition, additional mobilization of the right colon was going to be necessary.We proceeded to clear off subcutaneous fat off the rectus fascia, and we could identify the hernia defect inferiorly.It was cephalad to where previous mesh had been placed.We left this mesh intact as it appeared to have been epithelialized and was solid.We could delineate the hernia defect on the right lateral aspect of the incision and we could easily find fascial edges around it and once we cleared off the superficial fat overlying the fascia, we had the impression that we would be able to simply reapproximate the fascia with our abdominal wall closure.Inspection of the abdominal cavity was then performed.We identified the cecum and ascending colon.It appeared that this patient had already had an appendectomy and there was quite a bit of omental adhesions to the right colon which were taken down using electrocautery.The hepatic flexure was pretty much taken down already by dr.(b)(6) and we released a few additional adhesions to mobilize it, and then, more proximally in the ascending colon and cecum, we incised the white line of toldt to completely free up this segment.We inspected the small bowel by running it and we did identify an area that was well proximal to the terminal ileum, and this was about 10 to 15 cm in length, where there were multiple serosal tears and, in fact, a small enterotomy was noted.We began to repair the serosal tears with 3-0 vicryl, but as the tears were closed, it was apparent that this was definitely going to narrow the lumen of the bowel.I felt that we could not risk an obstruction here with such a narrow lumen and this combined with the fact that there was also an enterotomy in this area lead us to determine that it would be in the patient¿s best interest to simply resect this 10-15 cm segment of ileum that is well proximal to where our indiana pouch formation is going to be made.Therefore, we created very small mesenteric windows proximally and distally and proceeded to resect this bowel segment and reestablish intestinal continuity in a side-to-side fashion using the gia and ta staplers.Satisfactory anastomosis was noted, and then the mesenteric window reapproximated with 3-0 vicryl.Attention was then turned towards selection of our segment for indiana pouch formation.In the ascending colon, we marked off a point that was just proximal to the area where the right colic artery enters the colon and this will be our distal extent.Then, in the terminal ileum about 10 cm proximal to the ileocecal valve, we placed another stay suture, and this will be our efferent limb.Mesenteric windows were then created and then the intestinal continuity re-established using the gia and ta staplers in a side-to-side fashion.A satisfactory anastomosis was noted, and the mesenteric defect was closed with interrupted 3-0 vicryl.We then retrogradely [sic] irrigated the colon through the opening at the top to clean it out and in so doing, we also noted that the ileocecal valve was incompetent.Next, we detubularized the colon along its tinea and then we proceeded to fold over top to bottom the colon and proceed to suture the lateral walls with 3-0 monocryl to fashion our pouch.We left open a working channel.Next, we proceeded to staple reduce the terminal ileal segment over a 12-french red rubber catheter using the gia stapler.Repeated testing of catheterization was performed and it was noted to catheterize well.Next, we reinforced the ileocecal valve with plication sutures of 2-0 prolene, and again, with each suture placement, we made sure that we were still able to catheterize the channel.Attention was then turned towards our ureterointestinal anastomosis.The left ureter was tunneled underneath the sigmoid mesentery to the right side in a gradual course.Each ureter was then trimmed and spatulated and then direct ureterointestinal anastomoses were performed to the dependent portion of the pouch with the left ureter on the left side of the pouch and the right ureter on the right side of the pouch using interrupted 4-0 monocryl.Each anastomosis was stented with a single j ureteral stent.The blue stent is in the left ureter and the red stent in the right ureter.These stents were secured to the bowel mucosa with 309 chromic, and are left internalized in the pouch, attached to our suprapubic malecot catheter.This is a 22-french catheter placed in the anterior pouch wall and secured with a purestring suture of vicryl.The end of the stents were fed through the eye of the catheter and secured with prolene.Once this was all done, we closed our working channel to complete the pouch closure.Water tightness was tested and noted to be satisfactory.We then brought our suprapubic catheter through the right paramedian port site.It was secured to the skin with nylon.We then chose our site for stoma location.The enterostomal therapist had a mark placed quite lateral just above the level of the area where our suprapubic catheter is located.We felt that our catheterizable limb would not reach that far lateral and we, therefore, had to place it at the same level just more medial than where the stoma site was marked.We excised a small button of skin and then dissected down to the fascia which was perforated and dilated to allow 1 fingerbreadth.The ileal channel was then brought through this and the pouch secured to the abdominal wall with vicryl.The ileal channel was then trimmed and then the stoma matured with interrupted 4-0 vicryl.Again, catheterization ability was confirmed.We elected to leave a 12-french coude tip catheter indwelling in the stoma, but its tip had been cut off so that it can function as a councill catheter as needed.The balloon of the catheter was filled with 5 ml of water and the catheter secured to the skin with nylon.Once this was all done, we placed our 2 jackson-pratt drains through the left-sided abdominal port sites with the more lateral drain draining the pelvis and the more medial drain draining the region of the ureterointestinal anastomoses.Each drain was secured to the skin with nylon.The abdomen was then copiously irrigated and we reinspected our bowel anastomosis and then ran the small bowel one last time and it was all noted to be satisfactory.We then draped the omentum over the abdominal wall fascia in the midline with 0 looped nylon taking care to incorporate the fascial edges that were left on the lateral aspect of the previously noted incisional hernia, and good bites of the fascia were taken and inspection after the closure demonstrated that the hernia had been repaired.The wound was then copiously irrigated, and we then proceeded to inject 0.5% ropivacaine into all skin incisions, and in total 50 ml was used.Then, all skin incisions were closed with staples and dressings applied.I was present, scrubbed, and participated in the entire procedure.Sponge and instrument counts were correct at the end of the procedure.The patient then taken to the recovery room.¿ (b)(6) 2012: (b)(6) hospital.(b)(6), md.Operative report.Preoperative diagnosis: status post cerebrovascular accident.Incontinence.Obesity.Malnutrition.Previous indiana pouch formation.Postoperative diagnosis: status post cerebrovascular accident.Incontinence.Obesity.Malnutrition.Previous indiana pouch formation.Procedure performed: extensive lysis of adhesions.End colostomy.Hartmann pouch.Anesthesia: general endotracheal anesthesia.Clinical summary: history of cva.Underwent indiana pouch; however, this is not functioning well for her.She also has fecal incontinence, she is obese and has a preoperative serum albumin of 2.3.She is having her indiana pouch revised to a simple ileal loop and requested a colostomy for fecal incontinence.Description of procedure: ¿the patient was placed in a supine position and prepped and draped in the usual sterile fashion.She had a preoperative bowel prep, intravenous antibiotics, and subcutaneous anticoagulation.A midline incision was reopened.There were extensive intra-abdominal adhesions including adhesions of the indiana pouch to the abdominal wall.These were all taken down.There was a loop of colon found in the pelvis, and this was taken out of the pelvis to mobilize this, so that we could perform a sigmoid colostomy.The patient had been marked preoperatively in the left upper quadrant for her colostomy.When the bowel had been completely mobilized, the left ureter was identified.We called dr.Guralnick to the operating room and he performed the revision of the indiana pouch to an ileal loop.That is dictated as a separate operative procedure.When he was finished with his operation, we were called to the operating room.The colon was transected using a gia stapling device.The mesentery was controlled using the ligasure.A cruciate incision was made in the anterior and posterior fascia.The patient¿s abdominal wall was approximately 5 inches thick at the site of the stoma marking.The end of the ostomy was brought through the abdominal wall taking care not to twist it.The abdomen was irrigated with saline.The omentum was placed over the intestines.A sheet of subcutaneous tissue was irrigated, and the skin was closed with staples.The stoma was matured using interrupted 3-0 and 4-0 chromic sutures.An appliance was placed over the colostomy, as well as over the urostomy.A dressing was applied, and the patient was returned to the recovery room in good condition.Dr.(b)(6) was present for the surgical procedure as dictated within this note.¿.(b)(6) 2012: (b)(6) hospital.(b)(6), md.Operative report.Preoperative diagnosis: neurogenic bladder, status post robotic cystectomy with indiana pouch creation, with chronic stomal incontinence.Postoperative diagnosis: neurogenic bladder, status post robotic cystectomy with indiana pouch creation, with chronic stomal incontinence.Procedure performed: revision of urinary diversion with conversion of indiana pouch to colon conduit urinary diversion.Anesthesia: general.Estimated blood loss: 200 ml for the gu portion of the procedure.Specimens: none.Complications: none.Indications: history of neurogenic bladder secondary to cva, who is status post robotic cystectomy with an indiana pouch.Her indiana pouch is chronically incontinent and soaks through pads.She has resorted to an indwelling catheter for this.She has tried multiple medical therapies that have been unsuccessful.She presents today for conversion of her indiana pouch to an incontinent urinary diversion.She will also have an end colostomy performed by dr.(b)(6).This is for fecal incontinence.Please refer to dr.(b)(6)¿s note for that portion of the procedure.Description of procedure: ¿informed consent was obtained prior to the procedure.She was brought to the operating suite by the general surgery team and placed under general endotracheal anesthesia by the anesthesia team.This was after a surgical time-out had been performed.Dr.(b)(6)¿s team performed an extensive lysis of adhesions after opening the abdomen.Following this, once they had isolated the indiana pouch, dr.Guralnick was called to the room for completion of his portion of the procedure.We arrived to find the patient open on the operating table with the indiana pouch exposed.We proceeded to complete the exposure of the indiana pouch coming around the catheterizable channel circumferentially.The right lateral margins of the indiana pouch were also freed up from the abdominal sidewall after identification of the left and right ureters.Once the indiana pouch was successfully freed up, we turned our attention to the previously created catheterizable channel.The skin was scored using bovie electrocautery, and this was carried down to the level of the fascia in a circumferential manner.We then eventually carried this through the fascia and brought the catheterizable channel into the abdominal cavity itself.During this, the catheterizable channel, which we had planned on abandoning anyway, did avulse into 2 pieces.The distal portion was recovered from the stomal channel and discarded, and the proximal portion was secured with a babcock clamp.We then proceeded to inspect the indiana pouch for planning of our conversion of her diversion.We detubularized the indiana pouch in the antimesenteric fashion along what we identified as previous suture lines.Once this was detubularized, we freed up a small portion from the mesentery on the medial surface.This resulted in demarcation of nonviable bowel on the lateral borders of the indiana pouch, which was removed with electrocautery.We did trim a substantial portion of the indiana pouch as it was significantly redundant with excess tissue that was not needed for a simple colon conduit.Once we identified this, we proceeded to retubularize the cecum using a 4-0 running vicryl suture on the antimesenteric side.This was carried to the midportion of the of the [sic] channel, we had turned our attention to the distal portion which was reapproximated with interrupted 4-0 vicryl sutures.We then continued our running 4-0 vicryl suture and completed the closure.This was tested and found to be watertight.We then elected to reimplant the right ureter as it was apparent that this would be dragged external to the fascia as we matured our stoma.The previously placed ureteral anastomosis was transected, and the bowel was repaired with a single 4-0 vicryl figure-of-eight suture.We then trimmed approximately 2 cm of ureter and found a suitable location in the proximal portion of the conduit and performed a new urteroenteric anastomosis in this location.We spatulated the ureter and used interrupted 5-0 monocryl sutures to reanastomose the ureter to the bowel.During this time, a right ureteral single-j stent was placed in the usual fashion and brought out through the channel stoma.Once the anastomosis was complete, the channel was checked again and was found to be watertight.We then turned our attention to maturing the stoma.This turned out to be a very difficult process secondary to the patient¿s body habitus and adhesions.Prior to externalizing our stoma, we did create the rosebud maturation everting the bowel mucosa and securing it with interrupted 4-0 vicryl sutures.This was then brought out through the previous catheterizable stoma fascial defect which was enlarged to accept 2 fingerbreadths of space.This was still found to be quite tight and we worked rather diligently to ensure that we had a large enough opening.We still had a difficult time maintaining the stoma, but at the skin surface, however, we were able to mature a rosebud eventually and secured the stoma bud [sic] the skin with interrupted 4-0 vicryl sutures in the usual fashion.We then placed a drain in the right lower quadrant, a 15-french jackson-pratt drain, and secured this to the skin with a 2-0 nylon suture.The case was then turned over to dr.(b)(6) for her portion of the procedure.This concludes urologic portion of the procedure.¿.(b)(6) 2012: (b)(6).(b)(6).Radiology-two view abdomen in the operating room.Indication: evaluate for retained instruments, etc.Findings: no evidence of misplaced sponges, needles, or surgical instruments.Impression: postoperative film demonstrates several drain catheters right mid abdomen and right lower quadrant.Nasogastric tube, ivc filter, and surgical towel clips.Areas of mild gaseous distention of the transverse colon believed to represent a colonic ileus.No obvious misplacement instruments, needles, or sponge markers.(b)(6) 2012: (b)(6) hospital.(b)(6), md.Operative report.Preoperative diagnosis: incontinence around colon conduit stoma with stomal retraction.Postoperative diagnosis: incontinence around colon conduit stoma with stomal retraction.Procedure performed: conversion of colon conduit to ileal conduit with stomal relocation.Preamble: this lady underwent revision of her indiana pouch 2 days ago because of problems with incontinence from the stoma.She initially had an indiana pouch created at the time of a cystectomy for a neurogenic bladder with severe bladder spasms and incontinence.In the procedure 2 days ago, we converted her indiana pouch to a colon conduit and reimplanted the right ureter into it but left the left ureteroinstestinal anastomosis intact.We had trimmed the indiana pouch and configured it into a tubular shape and brought out the stoma at the same location as her original indiana pouch stoma.However, postoperatively the stoma was noted to retract, and it was also noted that it was lying within an abdominal crease, which was contributing to the stomal retraction as well as to significant incontinence around the ostomy appliance.Because the reason for doing the procedure was to deal with incontinence, we felt that it was necessary to relocate the stoma and potentially convert to an actual ileal conduit.It should also be noted that at the procedure 2 days ago, dr.(b)(6) created a colostomy.(b)(6) 2012: (b)(6) hospital.(b)(6), md.Operative report.Preoperative diagnosis: dysfunctional ileal conduit.Postoperative diagnosis: dysfunctional ileal conduit.Procedure performed: exploratory laparotomy.Takedown of ileal conduit.Closure of abdominal wall defect.Closure of wound.Transection of small bowel with end to end anastomosis.Indications: this patient underwent a diverting colostomy by dr.(b)(6) as well as extensive lysis of adhesions to allow dr.Guralnick to perform an ileal loop.In postoperative care, the patient was noted to have leaking of urine outside of the loop with an inability to pouch the ileal loop as formed.She now presents for repeat exploration.Dr.Guralnick has asked me to open the surgical procedure and to assist him in information of the ileal loop.(b)(6) 2014: (b)(6) hospital.(b)(6), md.Radiology-ct abdomen/pelvis without contrast.Indication: abdominal pain.Findings: gastrointestinal no pathologic dilation of large or small bowel, widemouth parastomal hernia has developed left lower quadrant ostomy site, this contains multiple segments of nondilated small bowel and intra-abdominal fat.The hernia measures at least 48 mm in diameter wall the hernia sac measures at least 162 mm in maximal dimension.A second smaller parastomal hernia is developed right lower quadrant ostomy site containing short segment of nondilated small bowel.The neck measures approximately 13 mm in diameter while the hernia sac measures approximately 43 mm in diameter.Impression: bilateral parastomal hernia development, left much larger than right.(b)(6) 2014: (b)(6) clinics.(b)(6), apnp; (b)(6).Office notes.Well known to us, middle-aged woman who suffered a severe stroke and was left with a neurogenic bladder and incontinence.She does have a large left-sided parastomal hernia with loss of domain.Will require surgical repair.Altered mobility and other medical issues seem to make the most appropriate course to attempt to reduce the hernia and repair this via the ostomy site itself rather than reopening the midline as she will have a great deal of difficulty rehabilitating and getting back to at least her baseline level of functionality.Impression/plan: will be admitted the day before the surgery as the patient is unable to manage a bowel prep by herself.The investigation has been completed.Based upon the totality of the information received over the course of the investigation and reported by gore in the previously submitted medical record narratives the following conclusions have been reached.As previously reported, all pertinent medical records requested may not have been received.In the absence of additional information or medical records from the complainant, this event file will be closed with the information provided.It should be noted that the gore® dualmesh® plus biomaterial instructions for use include 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.¿.Medical records that indicate mesh ¿movement¿ or that the device led to a recurrence may reflect a recurrence as a function of a patient¿s poor tissue quality leading to fascial dehiscence or loss of anchorage of fixation, or may be related to the hernia type, individual patient comorbidities, and technical and procedural aspects of the repair.These factors include but are not limited to, fixation type, mesh shape/sizing used, and defect closure decisions.Additionally, a new, unrelated hernia can occur but may be referred to as a recurrent hernia.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, compromised device biocompatibility, contamination which may lead to patient harms, device damage, dysphagia, erosion or extrusion and related harms, exposure or protrusion and related harms, fever, fistula, gerd recurrence, defect recurrence and related harms, ileus, increased procedure time and related harms, irritation or inflammation, infection, mesh migration, mesh contraction, pain, paresthesia, perforation, revision/re-intervention, seroma or hematoma and related harms, tissue ischemia, wound complications and wound dehiscence and additional intervention including surgery.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.Suspect product(s): 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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