Catalog Number 1DLMC04 |
Device Problem
Insufficient Information (3190)
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Patient Problems
Adhesion(s) (1695); Pain (1994); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/25/2010 |
Event Type
Injury
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Manufacturer Narrative
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(b)(6).It should be noted that although the brand name and lot# of a gore device has not been provided, the instructions for use for the vast majority of gore¿s eptfe patch products that are indicated for the reconstruction of soft tissue deficiencies include the following warnings among others: ¿possible 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 open ventral hernia repair on (b)(6) 2005 whereby an alleged gore device was implanted.The complaint alleges that on (b)(6) 2010, an additional procedure occurred whereby the gore device was explanted.It was reported the patient alleges the following injuries: mesh removal, additional surgery, lysis of adhesions, pain.Additional event specific information was not provided.
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Manufacturer Narrative
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Added medical history.Added brand name.Conclusion code remains unchanged.Product identification records were not provided, therefore, a review of the manufacturing records could not be performed.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) 2005, including operative reports/possible pathology reports from two prior hernia repairs, were not provided.(b)(6) 2005: (b)(6): discomfort mostly in the left lower quadrant but entire abdomen sore.Pmh: type ii diabetes, umbilical hernia.She has had two hernia surgeries as well as a cholecystectomy.Meds: metformin.Social hx: smoked cigarettes for 22 years averaging about 2 packs/day, quit two years ago; no alcohol.Exam: no bowel movements x 24 to 36 hours; last bowel movement was only some small pellets.Abdomen obese, slightly distended, mildly tympanic to percussion.Bowel sounds present upper quadrants only.Diffusely tender with most of the tenderness to begin in the left lower quadrant with some guarding.No hernia is identified although she does have peri-umbilical tenderness.Impression/plan: abdominal pain of uncertain etiology; type ii diabetes; exogenous obesity.Ct of the abdomen will be obtained.She well be kept on liquids only.(b)(6) 2005: (b)(6) radiology - ct abdomen with/without contrast.Reason: severe llq abd pain.Impression: there is a ventral hernia with loops of small bowel herniating through the sac.There is no evidence of obstruction seen.(b)(6) 2005: (b)(6).Operative report.Preop diagnosis: strangulated ventral hernia and bilateral ovarian cysts.Postop diagnosis: possible perforation small bowel within the hernia with abscess in the hernia sac, bilateral small ovarian cysts, large incarcerated ventral hernia with adhesions.Operation: attempted laparoscopy, conversion to laparotomy, excision of excess hernial sac, partial omentectomy and resection of small bowel segment with anastomosis and repair of ventral hernia with dual mesh.Findings: a laparoscopy was attempted.However, there were several adhesions and clear visualization of the peritoneal cavity was not possible.Hence, the procedure was converted into an open laparotomy.There was evidence of dense adhesions of the bowel to the hernia sac.There was erosion of the previously placed mesh with omental adhesions.There was also evidence of entrapped segment of small and large bowel within the hernia sac with possible small perforation of the small bowel with frank pus within the hernia sac.There were small cysts palpable in the ovary, but of no consequence.There was some cloudy fluid within the peritoneal cavity.Procedure: ¿the patient was placed in the supine position on the operating table and after adequate general anesthesia, the patient was catheterized and the abdomen itself was prepped and draped in the usual sterile fashion.The patient had a large hernia just below the umbilicus.The left lateral aspect of the abdomen was chosen.A transverse incision was made.This was then deepened through the subcutaneous tissue.The fascia was penetrated with a verre¿s needle and co2 insufflation was done.The verre¿s needle was removed and the laparoscope was introduced using a visiport.There was evidence of dense adhesions and the laparoscope could not be maneuvered within the peritoneal cavity to get visualization of the peritoneal contents.After attempting a few times, the laparoscope was withdrawn and it was decided to open the abdominal cavity for exploration.The previous midline incision was now used.This was then deepened through the subcutaneous tissue.The hernia sac was easily identified.This was then dissected out by sharp dissection all around.The peritoneal sac was now opened.There was gross evidence of pus within the peritoneal cavity.Cultures were obtained for both aerobic and anaerobic cultures.There was also evidence of a significant amount of omentum within the hernia sac.The adhesions were released.There was a segment of small bowel which was within the hernia sac which was involved with some necrotic tissue on the anterior mesenteric border because of the involvement within the hernia sac.There was no frank perforation demonstrated.However, there was evidence of peritoneal exudate and pus close to this area indicating possible the source of the abscess to be from this segment of the small bowel.The segment of the small bowel was isolated.The excess of the hernia sac was now excised for better visualization.There was evidence of multiple pockets within this hernia sac.The omentum that was adherent in these areas was released by sharp dissection.There was also evidence of omentum densely adherent to the superior portion of the wound where there was a mesh placement from previous surgery.The incision was extended beyond the hernia into the previously placed mesh.The disrupted sutures from the previous surgery itself were identified.Some of these sutures were removed.The omental adhesions were also released.The large bowel was easily reduced.There was no evidence of any injury to this area.The small bowel segment that was isolated was now approached.Bowel clamps were applied on either side and a small segment of the small bowel involving this area was divided using a gia stapler on either side.The mesentery between this segment was also divided between clamps and excised.Using another gia stapler, the anastomosis was created in a side to side fashion in the small bowel and the opening made by the blades of the gia was now approximated using #3-0 silk sutures in a continuous fashion.The bowel clamps were removed.The anastomosis was intact.It was viable without any tension and there was no evidence of any leakage noted.The defect in the mesentery was also approximated using #3-0 silk interrupted sutures.The bowel contents were ran through the anastomosis without any evidence of leakage.The entire peritoneal cavity was thoroughly irrigated until the return was clear.Palpation of the ovaries on either side revealed small cysts within the ovary, but of no consequence and it was decided to leave this alone.After the entire peritoneal cavity was thoroughly irrigated, 1 gram of ancef was left within the peritoneal cavity.In view of the previous episodes of multiple ventral hernias and recurrence and the obese nature of the patient, she was a candidate for a recurrence of the ventral hernia and hence it was decided to repair this also with a mesh.In view of the infection, the mesh was thoroughly soaked in the antibiotic solution and anchored to the anterior abdominal wall using a protacker.This was a dual mesh with a smooth surface against the peritoneum.The excess of the mesh was secured to the edge of the fascial defect using #0 polysorb suture.Interrupted prolene sutures were placed anteriorly to bring the fascia in opposition.The subcutaneous tissue was then approximated using #2-0 polysorb interrupted sutures.The skin was approximated using staples.The wound was also infiltrated with.25% marcaine for post op analgesia.The small defect on the left side of the abdomen where laparoscopy was attempted was now also closed using #0 polysorb interrupted suture and the skin was approximated with staples.Sterile dressings were applied.A large abdominal binder was also applied.The patient was awakened and returned to the recovery room in stable condition.Cultures were taken from the hernial contents for both aerobic and anaerobic specimens consisted of hernia sac as well as part of the omentum and a small segment of small bowel.Estimated blood loss was less than 100ccs.The patient remained stable throughout the procedure and transferred to the recovery room in stable condition.¿ product identification records for the alleged ¿dual mesh¿ were not provided.(b)(6) 2005: (b)(6).Patient account detail/charges.Goretex dual mesh 15 cm x 19 cm x 1.(b)(6) 2005: (b)(6).Microbiology report.Culture other source; comments: pus from abd cavity.Result: escherichia coli.(b)(6) 2005: [date discrepancy; collected during the (b)(6) 2005 procedure].Harrison community hospital.Pathology report.Specimens: ventral hernia sac.Small bowel.Gross: specimen consists of multiple portions of thick fibrous tissue measuring in aggregate 13 x 8cm.It is focally congested.A representative portion is submitted for microscopic examination.Also noted are three portions of omental adipose tissue measuring in aggregate 11 x 7.5 x 2cm.No gross abnormality is identified.Specimen consists of a small segment of small bowel measuring 5.5cm in length and 2.5cm in diameter.The mesenteric adipose tissue is focally congested.The mucosal surface is normal.A few representative sections are submitted for microscopic examination.Microscopic: multiple sections demonstrate a fibromembranous hernia sac with focal congestion and focal recent hemorrhages.No evidence of malignancy is identified.No inflammation is seen.Multiple sections from the small bowel reveal focally congested serosa.Also, focal subserosal hemorrhages are noted.In foci, the serosal surface is covered with acute inflammatory cells.No evidence of malignancy is identified.Diagnosis: hernia sac, ventral hernia.A small segment of small bowel showing focal acute peritonitis.(b)(6) 2005: (b)(6).Discharge summary.Summary: presented to the emergency department complaining of non- specific discomfort in her chest.By the following morning, chest pain resolved, was c/o diffuse abdominal discomfort, seemed to begin in left lower abdominal quadrant.No bowel movements for 24 to 36 hours and she says that was just a few small ¿pellets¿.Had two or three similar episodes over past year each treated with antibiotics.The patient was agreeable to surgery and this was performed on (b)(6) 2005.Localized perforation was found with pus in the abdomen.She did quite well post operatively.Did run low-grade temp for couple of days.There was some chilling with temp of 102 degrees on night of (b)(6) 2005.Iv unasyn and flagyl which had been discontinued with change to oral medication was restarted.Within 12 hours the patient was again feeling better.The erythema noted in the lower wound area a day earlier had much decreased by (b)(6) 2005.There was no wound drainage at all.There was no fluctuance.Normal bowel function resumed by (b)(6) 2005.The wound continued to look good post operatively.The operative culture grew e coli with broad antibiotic sensitivities.White blood count was not elevated.She denied any abdominal pain.The maximum temperature was 100 degrees in the 24 hours prior to discharge on (b)(6) 2005.The source of the temperature did not seem to be from any kind of wound infection or intra-abdominal source.The patient was discharged home on cipro.Final diagnosis: abdominal wall hernia with strangulation and bowel perforation.Type ii diabetes mellitus.(b)(6) 2006: (b)(6).Operative report.Pre/postop diagnosis: recurrent ventral hernia.Operation: repair of recurrent ventral hernia.Findings: the patient had a recurrent ventral hernia just above the umbilicus.On opening, it was found to be a loculated hernia.The patient had a previous dual core mesh and one end of the mesh in the upper right corner had been pulled away from the edge with recurrence from the site.The patient also had prior ventral hernia repair with marlex mesh prior to the dual mesh and that area had given way with recurrence of the hernia in this location.The mesh could be straightened out and was enough to secure it and hence this was fixed in a different fashion to the edge of the fascia and the repair was done.Procedure: ¿the patient was placed in the supine position on the operating table and after adequate general anesthesia, the patient was catheterized and the abdomen was prepped and draped in the usual sterile fashion.The hernia was found to be palpable just above the umbilicus and the previous surgical scar was now excised in an elliptical fashion and extended down to the umbilical level.The hernial sac was easily identified.This was then dissected out in a sharp fashion down to the fascial level.The fascial edge was well outlined and this was then opened.The sac was freed.There was no entrapment of omentum or bowel in the hernia itself at this point.This was then dissected out.Minimal adhesions of the omentum to the fascial edge were released and this revealed the previously placed dual mesh which was pulled away from the right upper corner and the takers [sic] were found to be not adherent to the fascia and the mesh was rolled up on itself.The patient also had a multi-loculated hernia extending to the right.The excess of the sac was now trimmed and sent for pathology.The fascial defect was well outlined.The takers [sic] that were loose on the mesh were removed.This was traced down and the lower part of the hernial repair was intact.Hence, this was left alone and where the mesh had pulled away from the fascial edge, this was now stretched out and it was found to be enough to bridge the gap.At the top portion of the hernia sac, there was previously placed marlex mesh which was eroded, but not found to be through the peritoneum.The dual mesh was now stretched and it was found to be adequate to cover the defect.After the multi-loculated pockets were removed and the fascial edge was cleared, the previously placed dual mesh was now secured to the edge of the fascia using #0 prolene.The edge of the mesh was secured to the fascia using a running #0 prolene suture.It was also secured by interrupted #0 prolene mattress sutures to secure the fascia to the mesh.This was done to cover the defect.The fascia that was freed was left intact to avoid tension on the repair.The subcutaneous tissue was then approximated to the fascia by interrupted #2-0 polysorb sutures to avoid the dead space.The wound was infiltrated with.25% marcaine for post op analgesia.The subcutaneous tissue was approximated using #3-0 polysorb interrupted sutures and the skin was approximated using staples.The patient was then awakened and returned to the recovery room in stable condition.¿ (b)(6) 2006: (b)(6).Pathology report.Specimen #: (b)(6).Specimen: hernia sac.Gross: specimen consists of two portions of hernia sac measuring together 9.5 x 10 cm.One portion reveals a small portion of adipose tissue on the other surface.No section is submitted for microscopic examination.Microscopic: no section was submitted for microscopic examination.Diagnosis: hernia sac, ventral hernia.Records between (b)(6) 2006 and (b)(6) 2009 were not provided.(b)(6) 2009: (b)(6).Operative report.Please note that due to the difficult nature of this advanced laparoscopic case, (b)(6) was asked to be assisting surgeon.Operations: diagnostic laparoscopy, laparoscopic lysis of adhesions, laparoscopic roux-en-y gastric bypass, egd, open incisional hernia repair, open adhesiolysis.Anesthesia: general endotracheal anesthesia.Pre/postop diagnosis: morbid obesity with a bmi of 56 and significant weight-related comorbidities including type ii diabetes, hypertension, osteoarthritis, and gastroesophageal reflux disease, and multiple recurrent incisional hernias.Operative indications: the patient is a 51-year-old woman with morbid obesity and bmi of 56 with significant weight-related comorbidities including type ii diabetes, hypertension, osteoarthritis, and gastroesophageal reflux disease who was evaluated by multidisciplinary bariatric team.She was evaluated and deemed to be an appropriate candidate for a roux-en-y gastric bypass.Also of note, she is a jehovah¿s witness and has had 3 previous attempts at incisional hernia repair as well as an acute exploration for small bowel obstruction and bowel resection.She presents electively after discussion of the significant risks, benefits, and alternatives of the operative procedure.Operative findings: ¿significant adhesions from previous multiple hernia repairs.Gastric bypass completed laparoscopically.150-cm antecolic, antegastric roux limb.3-cm pouch.Negative intraoperative leak test and patent gastrojejunostomy.Large hernia defect of approximately 8 cm in size at the inferior aspect of previously placed mesh containing a significant amount of distal jejunum and ileum.Primary closure of hernia defect.Operative procedure: the patient brought to the operating room, placed in the supine position.After induction of general endotracheal anesthesia and placement of appropriate monitoring lines, the abdomen was prepped and draped in usual sterile fashion.A foley catheter had been place [sic] previously.Appropriate perioperative antibiotics were administered.A 5-mm optical trocar was used to gain entrance into the peritoneal cavity in the right upper quadrant.Diagnostic laparoscopy revealed extensive adhesions in the mid to lower abdomen secondary to previous multiple hernia repairs.Additional 5-mm trocar was placed in left upper quadrant and we proceeded with a sharp adhesiolysis.This part of the adhesiolysis took 90 minutes.This allowed us to free up the uppermost part of the abdomen.The additional 10-mm trocar was then placed in the left lower abdomen and 5-mm trocar was placed in the right upper abdomen and a 10-mm trocar was placed in the right lower abdomen.The nathanson retractor was fashioned in typical manner.We initially began by identifying the phreneosophageal fat pad.This was dissected free and left pillar of the diaphragm was identified.We then turned our attention to the pars flaccida.This was opened using the hook electrocautery and the retrogastric space was identified.A blue load of the endo gia stapler with the seamguard was used to control the descending branch of the left gastric artery.A single firing of the endo gia blue load 60 was used to create a horizontal gastric pouch and 2 more firings in the vertical direction with the endo gia 60 load was used to completely separate the gastric pouch from the gastric remnant.Hemostasis was excellent and controlled with hook electrocautery.Ray-tec was inserted in the peritoneal cavity.We then turned our attention to the omentum.This was elevated cephalad and the transverse mesocolon was elevated.The ligament of treitz was identified and confirmed by the imv.We then proceeded to run the small bowel from the duodenum until 200 cm to ensure that there were not adhesions tethering the bowel.This was indeed true.We then identified the ligament of treitz again and approximately 30 cm distal to this, this was transected using a white load of the endo gia stapler.The roux limb was then marked with blue tape.A 150-cm roux limb was then measured.We then proceeded to perform a side-to-side jejunojejunostomy.A 10-in.2-0 vicryl stitch was placed between the common channel and the biliopancreatic limb.A 15-in.Ethibond stitch was then placed proximal to this.Enterotomies were made and a white load of the endo gia stapler was used to fashion a side-to-side jejunojejunostomy.Previously placed 2-0 vicryl suture was then used to close the enterotomies.The roux limb was then delivered in the left upper quadrant.This allowed us to identify the mesenteric defect.The mesenteric defect was closed in a running locking fashion of the previously placed ethibond suture.We then proceeded to perform a omental split.This was performed using the harmonic scalpel.The left upper quadrant port site was then secured with a figure-of-eight 0 vicryl suture.We then turned our attention back up to the gastric pouch.The previously placed ray-tec was removed and reinspection of hemostasis demonstrated this to be excellent.The orvil was then passed per mouth into the gastric pouch and a small gastrotomy was made and the orvil was delivered in the peritoneal cavity and removed in a typical manner.The left upper quadrant port site was then dilated and a 21 eea stapler was then inserted into the peritoneal cavity.The roux limb was then identified again and traced back to the jejunojejunostomy to make sure that the mesentery is in appropriate position.The end of the roux limb was then cut and the eea stapler was inserted.We then proceeded to fashion a gastrojejunostomy in a typical manner with a 21 eea stapler.The cut end of the roux limb was then transected with 2 white loads of the endo gia stapler.The medial and lateral 2-0 vicryl suture were then placed at the anastomosis to take tension off of this.Two anterior 2-0 vicryl sutures were placed as well.Saline was then instilled in the peritoneal cavity and the roux limb was occluded.A diagnostic egd was performed.This demonstrated esophagus to be normal.A gastric pouch of 3 cm in length and 3 cm in width was identified.There was no evidence of intraluminal bleeding and the gastrojejunostomy was widely patent.Laparoscopically, there was no evidence of a leak.The saline was then evacuated.The air was then followed down to the jejunojejunostomy, there was no leak here either.The roux limb was then placed in the previously fashioned omental split, and a jp drain was placed anterior to the anastomosis and secured to the skin using a 3-0 ethilon suture.We then turned our attention back to the lower abdomen and pelvis.It was evident that there was a lot of bowel in the lower vertical midline incision.We were unable to dissect this out freely laparoscopically, so the decision was made to convert to open laparotomy for repair of this hernia.All the laparoscopic trocars were removed under direct vision.There was no evidence of bleeding.A previously placed stay suture in the left upper quadrant was tied down.The left upper quadrant port site was irrigated, and this was closed loosely with 3-0 ethilon sutures.All the port sites were closed with 4-0 monocryl sutures and benzoin, steri-strips were applied.We then performed an open hernia repair in the lower abdomen.Approximately 15-cm vertical midline incision was fashioned, dissection was carried down to the skin, subcutaneous tissue until the hernia sac was identified.This was quite a large hernia sac contained a significant amount of bowel.Sharp adhesiolysis was performed.Approximately 60 minutes were spent in dissection to reduce the small bowel contents in its entirety.No enterotomies were made.After this massive small bowel was reduced, the fascia was then closed primarily with interrupted figure-of-eight #1 pds sutures.This was actually performed without undue tension and no further mesh was placed.The wound was then copiously irrigated after closure and hemostasis was assured.A skin stapler was used to reapproximate the skin in this region.Appropriate dressings were applied and the patient was awakened, extubated, transferred to pacu in stable condition.¿ drains: jp x 1.Specimen: none.Complications: none.(b)(6) 2009: (b)(6).Radiology - xr abdomen kub w/upright.Clinical history: bloating.Comparison: none.Impression: parts of both flanks and the extreme upper abdomen are excluded.Multiple mildly dilated loops of large and small bowel are present.A few scattered air-fluid levels are present on the upright examination.Midline skin staples and mesh stays are noted.There is a surgical drain in the upper abdomen near the midline extending to the left.Findings are consistent with postoperative ileus.(b)(6) 2009: (b)(6).Radiology - ct abdomen/pelvis w/contrast.Reason: morbid obesity.Clinical information: presents with cellulitis wound infection s/p laparoscopic gastric bypass and laparotomy for umbilical hernia repair.Result: there has been repair of a midline ventral hernia and mesh material is present along the musculature of the lower anterior abdominal wall.There is some soft tissue infiltration along the incision line, but no fluid collection.There is skin thickening and infiltration of the subcutaneous fat of the right lower quadrant extending from the umbilicus to the inferior aspect of the pannus.Impression: right lower quadrant skin thickening consistent with history of cellulitis.No drainable abdominal fluid collection.(b)(6) 2010: (b)(6).Radiology - ct pelvis w/contrast.Reason: s/p lrygb with obstructive symptoms and abdominal pain.Hx: s/p laparoscopic roux-en-y gastric bypass presented with abdominal pain.Concern for obstruction.Result: abdomen: again noted is a right paramedian ventral hernia that extends around the mesh.It contains a loop of jejunum distal to the jejunojejunostomy.Impression: high grade small bowel obstruction secondary to ventral hernia with thick edematous bowel wall concerning for incarceration.(b)(6) 2010: (b)(6).Operative report.Operation: exploratory laparotomy; lysis of adhesions, extensive; placement of proceed mesh.Anesthesia: get.Pre/postop diagnosis: incarcerated ventral hernia.Operative indications: this is a 52-year-old female with a past medical history significant for morbid obesity, and sequelae, laparoscopic roux-en-y gastric bypass open incisional hernia repair in (b)(6) 2010, who presents with the direct admission from a local ed with a 3-day history of intermittent abdominal pain, nausea, lack of gi function.She states her pain began after performing yard work, and persisted for a variety since with var intensity.She had nausea without emesis and reduced flatus or bm for 2 days now.She denies fevers, chills, or sick contacts.Operative findings: findings included incarcerated small bowel through ventral hernia defect, placement of proceed mesh.No enterotomies.Operation procedure: ¿after consent was signed, pros and cons of procedure were discussed with the patient.The patient was taken to the operating room.Outside the operating room, a huddle took place to confirm the people, the procedure, and the appropriate equipment in the room- specifically the mesh.Once this was confirmed to everybody¿s satisfaction, patient taken into the operating room, placed in supine on the operating table, intubated, and sedated without difficulty.The patient was then given a foley catheter, scd boots were already on, and antibiotics were given.The patient then prepped and draped in standard sterile fashion.An incision took place down the upper abdomen through the skin and subcutaneous tissue, identifying the decusation [sic] of the fascia.The abdomen was then entered sharply.The fascia was then lifted out of the operative field.The abdomen was then entered.The bowel was reduced.Upon initial entry, we find no ischemic bowel, some mild amount of thickening and a loop at the jj with a thick adhesion between the 2 loops at the common channel and the roux limb.The remainder portion of fascia was opened.We then began to excise adhesions, which were throughout the abdomen, varying in thickness and in intensity.Once we did this, we were able to run the small bowel from proximal to distal, identifying the bp limb, the common channel, and the roux limb.These all appeared to be intact.There was no major hernia defects.Once lysis of adhesions of the bowel were to our satisfaction, we began to remove the previous portion of mesh.There was a portion of dual mesh as well as with a portion of dual-sided prolene mesh.These were both removed and sent off the operative field.We were able to free up several centimeters of fascia from the subcutaneous tissue, and the intraabdominal adhesions.This allowed us to size the piece of proceed mesh.The defect itself measured 18 by about 12 cm.Our proceed mesh was 2 cm on each side, wider than this and we then began to sew the proceed mesh into place in a bucket fashion using interrupted pds sutures approximately 2 cm from the fascial edge and 1 cm apart.Once this was completed to our satisfaction, we removed any towels from the belly and examined for any enterotomies.At this particular point in time, we noted that 1 of the stitches had actually gone through the serosa of the colon.This was obviously reduced and this portion sewn over.We did a second check to make sure that again there were no defects or attachments to the bowel.Once this was done to our satisfaction, we then closed the fascia.The fascia had some dissection of the subcutaneous and skin off of it.This was done without much difficulty to approximately 1 cm overlap.We then did 2 looped pds starting at the top and starting at the bottom and then they were tied in between.The patient¿s skin was brought together using some interrupted vicryls and then stapled.Telfa dressings were then applied.Patient tolerated procedure well, sent to pacu in good condition.¿ estimated blood loss: 150 ml.Drains: none.Specimens: previous mesh.Fluids given: approximately 2 l.Continued on attachment.
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Manufacturer Narrative
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D4: added lot #, catalog #, expiration date, di #.H4: added device manufacture date.H6: updated method/results code.Conclusion code remains unchanged.
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Manufacturer Narrative
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Additional details regarding the patient's clinical course were ascertained from a review of medical records and are as follows: ??/??/??: [missing records: records including operative report of ¿previous umbilical herniorrhaphy¿ were not provided.] on (b)(6) 2002: (b)(6) surgery inc.(b)(6) , md.Office notes.Weight 287 lbs.Referred for possible hernia, abdominal.States hernia will bulge at times but can push it back in herself.Medical history: essentially negative.Social: positive for smoking.Abdomen obese.Has epigastric, umbilical hernia; reducible.Impression: ventral hernia involving epigastric portion and umbilical hernia present.The two are in continuity.Difficult to ascertain.Plan: discussed outpatient herniorrhaphy with mesh.Will contact me when it is convenient.On (b)(6) 2002: (b)(6) hospital assn.(b)(6) , md.History and physical.Unchanged from that dictated (b)(6) 2002.Has ventral hernia involving umbilicus with previous umbilical herniorrhaphy.Scheduled for outpatient ventral herniorrhaphy with mesh.On (b)(6) 2002: (b)(6) hospital assn.(b)(6) , md.Operative report.Preoperative diagnosis: ventral hernia.Postoperative diagnosis: ventral hernia.Operative procedure: ventral herniorrhaphy, enterolysis and laparotomy.Procedure: ¿under general endotracheal anesthesia abdomen is opened through the midline.Large hernia sac is present and it is reduced by sharp dissection, incarcerated omentum is present, no bile.The adhesions are taken down by meticulous sharp dissection until the entire sac is freed.Portion of the sac resected.Previous sutures from repair are present.Sheet of composite mesh is selected and secured to the posterior fascia of peritoneum with interrupted sutures of 2-0 monofilament permanent suture.The fascial defect is closed with figure of 8 sutures #1 bralon.Skin approximated with skin clips.Blood loss for the procedure is negligible.¿ on (b)(6) 2002: (b)(6) hospital.Implant sticker: bard composix mesh 3 x 6.On (b)(6) 2002: (b)(6) hospital.(b)(6) , md.Pathology report.Spec #: es02-3598.Final diagnosis: tissue from ventral hernia.Specimen: 1.Hernia sac ¿ ventral.Pre-operative diagnosis: ventral hernia.Post-operative diagnosis: incarcerated ventral hernia.Gross: specimen labeled ventral hernia consists of a flat fragment of membranous white, firm tissue measuring 5 cm in length.On (b)(6) 2002: (b)(6) hospital.(b)(6) , rn.Discharge instructions.Avoid strenuous activity, heavy lifting for 6-8 weeks.On (b)(6) 2012: (b)(6) community hospital.Microbiology.Culture, wound.Culture source: wound.Ward of isolation: outpatient.Comments: source abdominal wound.Organisms identified: staphylococcus aureus.On (b)(6) 2012: (b)(6) community hospital.(b)(6) , rn; [signature illegible].Wound care notes.Wound location: abdomen x 4.Stage ii.Wound type: chronic.Dressings: advanced; adaptic/tegaderm.#1: 2.7 cm l x 5.0 cm w x 0.2 cm deep.#2: 0.9 cm l x 1.0 cm w x 0.2 cm deep.#3: 0.8 cm l x 1.0 cm w x 0.2 cm deep.#4: 1.5 cm l x 0.9 cm w x 0.2 cm deep.All wounds 100% [illegible], superficial, dry with crusted edges.Minimal to no drainage at home.Edges of wound sharply debrided.Advised to have ct of abdomen to see the relationship of open wound with ventral hernia.Previous culture and sensitivity was staphylococcus aureus, which was not mrsa [methicillin resistant staphylococcus aureus].Last hgba1c was 6.0; encouraged to keep sugar under control, keep up with wound care.On (b)(6) 2012: (b)(6) community hospital.(b)(6) , md.Radiology ¿ ct abdomen.Clinical history: ventral hernia.Impression: large ventral hernia with a few loops of small and large bowel herniated through the defect.Clinical correlation suggested.On (b)(6) 2012: [missing records: records of operation where would culture was obtained were not provided.] on (b)(6) 2012: (b)(6) community hospital.Microbiology.Culture, wound.Specimen source: wound.Ward of isolation: operating room.Organisms identified: staphylococcus aureus.A potential relationship, if any, between the alleged injuries or complications and the gore device has not been established at this time based on available information.It should be noted that the instructions for gore® dualmesh® biomaterial use includes warnings and addresses the following adverse reactions among others: ¿possible adverse reactions with the use of any tissue deficiency prosthesis may include, but are not limited to, contamination, infection, inflammation, adhesion, fistula formation, seroma formation, hematoma, and recurrence.¿ 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) 2005: (b)(6).Implant record.Implant/item: goretex dual mesh biomaterial.Size: 15.0 cm x 19.0 cm x 1 mm.Catalogue number: 1dlmc04.Lot number: 03554372.Implant/item: auto suture protack 5mm.The records confirm a gore® dualmesh® biomaterial (1dlmc04/03554372) was implanted during the procedure.A potential relationship, if any, between the alleged injuries or complications and the gore device has not been established at this time based on available information.It should be noted that the gore® dualmesh® biomaterial instructions for use includes warnings and addresses the following adverse reactions among others: ¿possible adverse reactions with the use of any tissue deficiency prosthesis may include, but are not limited to, contamination, infection, inflammation, adhesion, fistula formation, seroma formation, hematoma, and recurrence.¿ 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: health effect ¿ clinical code.H6: updated investigation finding.H6: updated investigation conclusion.H6: health effect impact code: f26: no health consequences or impact.H6: medical device component: g04088: membrane.Previous patient codes (1695, 1994) were reported based on the original complaint and are 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.Therefore, this event is being coded as no clinical signs, symptoms or conditions, no health consequences or impact and will be closed as no problem detected.Medical records: the known medical records span october 9, 2002 through december 20, 2015 and not all records received in this time span are relevant to the gore® dualmesh® biomaterial.Medical records from november 19, 2002 through june 23, 2005, and july 2, 2005 through october 22, 2006, and december 24, 2006 through august 24, 2009 were not provided.Patient information: medical history: smoker: (b)(6) 2002: ¿smoker¿ (b)(6) 2005: 2 packs/day x 22 years, ¿quit 2 years ago.¿ morbid obesity (b)(6) 2002: 287 lbs.(b)(6) 2009: ¿morbid obesity with a bmi 56 and significant weight-related comorbidities.¿ diabetes mellitus, type ii.Hypertension.Gastroesophageal reflux disease [gerd].Prior surgical procedures: ¿ unknown date: umbilical herniorrhaphy.¿ unknown date: cholecystectomy.(b)(6) 2002: ventral herniorrhaphy, enterolysis and laparotomy.Implant bard composix.(b)(6) 2005: attempted laparoscopy, conversion to laparotomy, excision of excess hernial sac, partial omentectomy and resection of small bowel segment with anastomosis and repair of ventral hernia with dual mesh.Implant: gore® dualmesh® biomaterial.(b)(6) 2006: repair of recurrent ventral hernia.(b)(6) 2009: diagnostic laparoscopy, laparoscopic lysis of adhesions, laparoscopic roux-en-y gastric bypass, egd [esophagogastroduodenoscopy] open incisional hernia repair, open adhesiolysis.(b)(6) 2010: exploratory laparotomy; lysis of adhesions, extensive; placement of proceed mesh; release of incarcerated recurrent incisional hernia, permacol reconstruction of the abdominal wall, excision of previously placed synthetic mesh.Relevant medical information: (b)(6) 2002: ¿weight 287 lbs.Referred for possible hernia, abdominal.States hernia will bulge at times but can push it back in herself.Medical history: essentially negative.Social: positive for smoking.Abdomen obese.Has epigastric, umbilical hernia; reducible.Impression: ventral hernia involving epigastric portion and umbilical hernia present.The two are in continuity.Difficult to ascertain.¿ (b)(6) 2002: ventral herniorrhaphy, enterolysis and laparotomy.Implant bard composix.[hospitalization dates unknown] ¿under general endotracheal anesthesia abdomen is opened through the midline.Large hernia sac is present and it is reduced by sharp dissection, incarcerated omentum is present, no bile.The adhesions are taken down by meticulous sharp dissection until the entire sac is freed.Portion of the sac resected.Previous sutures from repair are present.Sheet of composite mesh is selected and secured to the posterior fascia of peritoneum with interrupted sutures of 2-0 monofilament permanent suture.The fascial defect is closed with figure of 8 sutures #1 bralon.¿ implant sticker: ¿bard composix mesh 3 x 6.¿ medical records from november 19, 2002 through june 23, 2005 were not provided.Implant preoperative complaints: (b)(6) 2005: ¿discomfort mostly in the left lower quadrant but entire abdomen sore.¿ ¿no bowel movements x 24 to 36 hours; last bowel movement was only some small pellets.Abdomen obese, slightly distended, mildly tympanic to percussion.Bowel sounds present upper quadrants only.Diffusely tender with most of the tenderness to begin in the left lower quadrant with some guarding.No hernia is identified although she does have peri-umbilical tenderness.¿ (b)(6) 2005: ct abdomen/pelvis [a/p]: ¿there is a ventral hernia with loops of small bowel herniating through the sac.There is no evidence of obstruction seen.¿ implant procedure: attempted laparoscopy, conversion to laparotomy, excision of excess hernial sac, partial omentectomy and resection of small bowel segment with anastomosis and repair of ventral hernia with dual mesh.[implant: gore® dualmesh® biomaterial, 1dlmc04/03554372, 15 cm x 19 cm x 1 mm thick, oval.] implant date: (b)(6) 2005 [hospitalization (b)(6) 2005] description of hernia being treated: ¿a laparoscopy was attempted.However, there were several adhesions and clear visualization of the peritoneal cavity was not possible.Hence, the procedure was converted into an open laparotomy.There was evidence of dense adhesions of the bowel to the hernia sac.There was erosion of the previously placed mesh with omental adhesions.There was also evidence of entrapped segment of small and large bowel within the hernia sac with possible small perforation of the small bowel with frank pus within the hernia sac.There were small cysts palpable in the ovary, but of no consequence.There was some cloudy fluid within the peritoneal cavity.¿ ¿the patient had a large hernia just below the umbilicus.The left lateral aspect of the abdomen was chosen.A transverse incision was made.This was then deepened through the subcutaneous tissue.The fascia was penetrated with a verre¿s needle and co2 insufflation was done.The verre¿s needle was removed and the laparoscope was introduced using a visiport.There was evidence of dense adhesions and the laparoscope could not be maneuvered within the peritoneal cavity to get visualization of the peritoneal contents.After attempting a few times, the laparoscope was withdrawn and it was decided to open the abdominal cavity for exploration.The previous midline incision was now used.This was then deepened through the subcutaneous tissue.The hernia sac was easily identified.This was then dissected out by sharp dissection all around.The peritoneal sac was now opened.There was gross evidence of pus within the peritoneal cavity.Cultures were obtained for both aerobic and anaerobic cultures.There was also evidence of a significant amount of omentum within the hernia sac.The adhesions were released.There was a segment of small bowel which was within the hernia sac which was involved with some necrotic tissue on the anterior mesenteric border because of the involvement within the hernia sac.There was no frank perforation demonstrated.However, there was evidence of peritoneal exudate and pus close to this area indicating possible the source of the abscess to be from this segment of the small bowel.The segment of the small bowel was isolated.The excess of the hernia sac was now excised for better visualization.There was evidence of multiple pockets within this hernia sac.The omentum that was adherent in these areas was released by sharp dissection.There was also evidence of omentum densely adherent to the superior portion of the wound where there was a mesh placement from previous surgery.The incision was extended beyond the hernia into the previously placed mesh.The disrupted sutures from the previous surgery itself were identified.Some of these sutures were removed.The omental adhesions were also released.The large bowel was easily reduced.There was no evidence of any injury to this area.The small bowel segment that was isolated was now approached.Bowel clamps were applied on either side and a small segment of the small bowel involving this area was divided using a gia stapler on either side.The mesentery between this segment was also divided between clamps and excised.Using another gia stapler, the anastomosis was created in a side to side fashion in the small bowel and the opening made by the blades of the gia was now approximated using #3-0 silk sutures in a continuous fashion.The bowel clamps were removed.The anastomosis was intact.It was viable without any tension and there was no evidence of any leakage noted.The defect in the mesentery was also approximated using #3-0 silk interrupted sutures.The bowel contents were ran through the anastomosis without any evidence of leakage.The entire peritoneal cavity was thoroughly irrigated until the return was clear.Palpation of the ovaries on either side revealed small cysts within the ovary, but of no consequence and it was decided to leave this alone.After the entire peritoneal cavity was thoroughly irrigated, 1 gram of ancef was left within the peritoneal cavity.¿ implant size and fixation: ¿in view of the previous episodes of multiple ventral hernias and recurrence and the obese nature of the patient, she was a candidate for a recurrence of the ventral hernia and hence it was decided to repair this also with a mesh.In view of the infection, the mesh was thoroughly soaked in the antibiotic solution and anchored to the anterior abdominal wall using a protacker.This was a dual mesh with a smooth surface against the peritoneum.The excess of the mesh was secured to the edge of the fascial defect using #0 polysorb suture.Interrupted prolene sutures were placed anteriorly to bring the fascia in opposition.The subcutaneous tissue was then approximated using #2-0 polysorb interrupted sutures.The skin was approximated using staples.The wound was also infiltrated with.25% marcaine for post op analgesia.The small defect on the left side of the abdomen where laparoscopy was attempted was now also closed using #0 polysorb interrupted suture and the skin was approximated with staples.¿ post-operative period: [7 days].(b)(6) 2005: microbiology: ¿culture other source; comments: pus from abd cavity.Result: escherichia coli.¿ (b)(6) 2005: discharge summary: ¿no bowel movements for 24 to 36 hours and she says that was just a few small ¿pellets¿.Had two or three similar episodes over past year each treated with antibiotics.The patient was agreeable to surgery and this was performed on (b)(6) 2005.Localized perforation was found with pus in the abdomen.She did quite well post operatively.Did run low-grade temp for couple of days.There was some chilling with temp of 102 degrees on night of (b)(6) 2005.Iv unasyn and flagyl which had been discontinued with change to oral medication was restarted.Within 12 hours the patient was again feeling better.The erythema noted in the lower wound area a day earlier had much decreased by (b)(6) 2005.There was no wound drainage at all.There was no fluctuance.Normal bowel function resumed by (b)(6) 2005.The wound continued to look good post operatively.The operative culture grew e coli with broad antibiotic sensitivities.White blood count was not elevated.She denied any abdominal pain.The maximum temperature was 100 degrees in the 24 hours prior to discharge on (b)(6) 2005.The source of the temperature did not seem to be from any kind of wound infection or intra-abdominal source.The patient was discharged home on cipro.¿ relevant medical information: medical records from july 2, 2005 through october 22, 2006 were not provided.Revision preoperative complaints: no information provided.Revision procedure: repair of recurrent ventral hernia.Revision date: (b)(6) 2006: findings: ¿the patient had a recurrent ventral hernia just above the umbilicus.On opening, it was found to be a loculated hernia.The patient had a previous dual core [sic] mesh and one end of the mesh in the upper right corner had been pulled away from the edge with recurrence from the site.The patient also had prior ventral hernia repair with marlex mesh prior to the dual mesh and that area had given way with recurrence of the hernia in this location.The mesh could be straightened out and was enough to secure it and hence this was fixed in a different fashion to the edge of the fascia and the repair was done.¿ procedure: ¿the hernia was found to be palpable just above the umbilicus and the previous surgical scar was now excised in an elliptical fashion and extended down to the umbilical level.The hernial sac was easily identified.This was then dissected out in a sharp fashion down to the fascial level.The fascial edge was well outlined and this was then opened.The sac was freed.There was no entrapment of omentum or bowel in the hernia itself at this point.This was then dissected out.Minimal adhesions of the omentum to the fascial edge were released and this revealed the previously placed dual mesh which was pulled away from the right upper corner and the takers [sic] were found to be not adherent to the fascia and the mesh was rolled up on itself.The patient also had a multi-loculated hernia extending to the right.The excess of the sac was now trimmed and sent for pathology.The fascial defect was well outlined.The takers [sic] that were loose on the mesh were removed.This was traced down and the lower part of the hernial repair was intact.Hence, this was left alone and where the mesh had pulled away from the fascial edge, this was now stretched out and it was found to be enough to bridge the gap.At the top portion of the hernia sac, there was previously placed marlex mesh which was eroded, but not found to be through the peritoneum.The dual mesh was now stretched and it was found to be adequate to cover the defect.After the multi-loculated pockets were removed and the fascial edge was cleared, the previously placed dual mesh was now secured to the edge of the fascia using #0 prolene.The edge of the mesh was secured to the fascia using a running #0 prolene suture.It was also secured by interrupted #0 prolene mattress sutures to secure the fascia to the mesh.This was done to cover the defect.The fascia that was freed was left intact to avoid tension on the repair.The subcutaneous tissue was then approximated to the fascia by interrupted #2-0 polysorb sutures to avoid the dead space.The wound was infiltrated with.25% marcaine for post op analgesia.The subcutaneous tissue was approximated using #3-0 polysorb interrupted sutures and the skin was approximated using staples.¿ (b)(6) 2006: pathology.¿gross: specimen consists of two portions of hernia sac measuring together 9.5 x 10 cm.One portion reveals a small portion of adipose tissue on the other surface.No section is submitted for microscopic examination.¿ relevant medical information medical records from december 24, 2006 through august 24, 2009 were not provided.(b)(6) 2009: preoperative diagnosis.¿morbid obesity with a bmi of 56 and significant weight-related comorbidities including type ii diabetes, hypertension, osteoarthritis, and gastroesophageal reflux disease, and multiple recurrent incisional hernias.¿ (b)(6) 2009: diagnostic laparoscopy, laparoscopic lysis of adhesions, laparoscopic roux-en-y gastric bypass, egd [esophagogastroduodenoscopy] open incisional hernia repair, open adhesiolysis [hospitalization dates unknown] findings.¿large hernia defect of approximately 8 cm in size at the inferior aspect of previously placed mesh containing a significant amount of distal jejunum and ileum.Primary closure of hernia defect.¿ procedure.¿we then turned our attention back to the lower abdomen and pelvis.It was evident that there was a lot of bowel in the lower vertical midline incision.We were unable to dissect this out freely laparoscopically, so the decision was made to convert to open laparotomy for repair of this hernia.All the laparoscopic trocars were removed under direct vision.There was no evidence of bleeding.A previously placed stay suture in the left upper quadrant was tied down.The left upper quadrant port site was irrigated, and this was closed loosely with 3-0 ethilon sutures.All the port sites were closed with 4-0 monocryl sutures and benzoin, steri-strips were applied.We then performed an open hernia repair in the lower abdomen.Approximately 15-cm vertical midline incision was fashioned, dissection was carried down to the skin, subcutaneous tissue until the hernia sac was identified.This was quite a large hernia sac contained a significant amount of bowel.Sharp adhesiolysis was performed.Approximately 60 minutes were spent in dissection to reduce the small bowel contents in its entirety.No enterotomies were made.After this massive small bowel was reduced, the fascia was then closed primarily with interrupted figure-of-eight #1 pds sutures.This was actually performed without undue tension and no further mesh was placed.The wound was then copiously irrigated after closure and hemostasis was assured.¿ ¿ 8/28/09: x-ray abdomen: ¿findings are consistent with postoperative ileus.¿ ¿ 11/16/09: ct a/p: ¿there has been repair of a midline ventral hernia and mesh material is present along the musculature of the lower anterior abdominal wall.There is some soft tissue infiltration along the incision line, but no fluid collection.There is skin thickening and infiltration of the subcutaneous fat of the right lower quadrant extending from the umbilicus to the inferior aspect of the pannus.¿ explant preoperative complaints: (b)(6) 2010: ct a/p: ¿again noted is a right paramedian ventral hernia that extends around the mesh.It contains a loop of jejunum distal to the jejunojejunostomy.¿ (b)(6) 2010: ¿this is a 52-year-old female with a past medical history significant for morbid obesity, and sequelae, laparoscopic roux-en-y gastric bypass open incisional hernia repair in (b)(6) 2010 (2009), who presents with the direct admission from a local ed with a 3-day history of intermittent abdominal pain, nausea, lack of gi function.She states her pain began after performing yard work, and persisted for a variety since with var (sic) intensity.She had nausea without emesis and reduced flatus or bm for 2 days now.She denies fevers, chills, or sick contacts.¿ explant procedure: exploratory laparotomy; lysis of adhesions, extensive; placement of proceed mesh.Explant date: (b)(6) 2010: ¿an incision took place down the upper abdomen through the skin and subcutaneous tissue, identifying the decusation [sic] of the fascia.The abdomen was then entered sharply.The fascia was then lifted out of the operative field.The abdomen was then entered.The bowel was reduced.Upon initial entry, we find no ischemic bowel, some mild amount of thickening and a loop at the jj with a thick adhesion between the 2 loops at the common channel and the roux limb.The remainder portion of fascia was opened.We then began to excise adhesions, which were throughout the abdomen, varying in thickness and in intensity.Once we did this, we were able to run the small bowel from proximal to distal, identifying the bp limb, the common channel, and the roux limb.These all appeared to be intact.There was no major hernia defects.Once lysis of adhesions of the bowel were to our satisfaction, we began to remove the previous portion of mesh.There was a portion of dual mesh as well as with a portion of dual-sided prolene mesh.These were both removed and sent off the operative field.We were able to free up several centimeters of fascia from the subcutaneous tissue, and the intraabdominal adhesions.This allowed us to size the piece of proceed mesh.The defect itself measured 18 by about 12 cm.Our proceed mesh was 2 cm on each side, wider than this and we then began to sew the proceed mesh into place in a bucket fashion using interrupted pds sutures approximately 2 cm from the fascial edge and 1 cm apart.Once this was completed to our satisfaction, we removed any towels from the belly and examined for any enterotomies.At this particular point in time, we noted that 1 of the stitches had actually gone through the serosa of the colon.This was obviously reduced and this portion sewn over.We did a second check to make sure that again there were no defects or attachments to the bowel.Once this was done to our satisfaction, we then closed the fascia.The fascia had some dissection of the subcutaneous and skin off of it.This was done without much difficulty to approximately 1 cm overlap.We then did 2 looped pds starting at the top and starting at the bottom and then they were tied in between.The patient¿s skin was brought together using some interrupted vicryls and then stapled.¿ ¿please note that because of the emergency nature [sic] this procedure, dr.(b)(6)presence was requested as second surgeon.¿ operative findings: intact roux-en-y gastric bypass.There was no evidence of internal hernia.Incarcerated hernia through a swiss-cheese type defect reduced with excellent viability of the bowel.¿ procedure: ¿a vertical midline incision was fashioned and entrance to the peritoneal cavity was obtained after sharp dissection with a scalpel.There was no vascular or visceral injury upon entering into the upper abdomen.We then proceeded up to the length of the entire incision.There were multiple facial defects and multiple pieces of previously placed synthetic mesh.The hernia defect was identified.An extensive adhesiolysis was then performed greater than 1 hour.After sharp dissection and reduction of the incarcerated piece of small bowel, which constituted the common channel, the bowel did appear pink and viable.No enterotomies were made.We then proceeded with a full adhesiolysis from the duodenum down the ligament of treitz.The roux limb was identified and the jejunojejunostomy was identified.There was no evidence of internal hernia at the jejunojejunostomy.The common channel appeared normal down to the cecum.We then proceeded to excise the previously placed mesh.This passed off table as specimen.The overall defect was approximately 18 x 12 cm.An appropriate size piece of permacol mesh was selected.This was sewn in an underlay fashion with multiple interrupted #1 pds sutures.The fascia was able to be primarily approximated over top of this using 2 looped #1 pds sutures.Subcutaneous tissue was then reapproximated with multiple interrupted 3-0 vicryl sutures.The skin was reapproximated with staples.¿ (b)(6) 2010: pathology.¿received in formalin and labeled ¿explanted mesh¿ are multiple irregular segments of synthetic material aggregating to 18 x 17 x 5 cm.Attached to the synthetic material is abundant firm fibrotic soft tissue.¿ conclusion: it should be noted that the gore® dualmesh® 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.¿ the instructions for use further state: ¿use only nonabsorbable sutures, such as gore-tex® suture, with a noncutting needle (such as taper or piercing point) of appropriate size to anchor the device.The use of absorbable sutures may lead to inadequate anchoring of gore® dualmesh® biomaterial to the host tissue and necessitate reoperation.For best results, use monofilament sutures.Suture size should be determined by surgeon preference and the nature of the reconstruction.¿ staples or helical tacks (also known as helical coils) can be used as an alternative to sutures.¿staple size and staple or tack spacing should be determined by surgeon preference to provide for adequate tissue fixation and to prevent reherniation.¿ 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.It should be noted with use of the device in patients with the potential for growth, tissue expansion, or significant change in body habitus, the surgeon should be aware that the device will not stretch or change with the patient¿s body.Individual medical decisions, if inconsistent and/or non-conforming to the device manufacturer¿s recommendations, ifu, or recognized best practices, may result in or contribute to an adverse event.As with any surgical procedure, there are always risks of complications for surgical repair of hernias and soft tissue deficiencies, with or without mesh.These my 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.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: health effect impact code: f26: no health consequences or impact.H6: medical device component: g04088: membrane.Previous patient codes (1695, 1994) were reported based on the original complaint and are 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.Therefore, this event is being coded as no clinical signs, symptoms or conditions, no health consequences or impact and will be closed as no problem detected.Medical records: the known medical records span october 9, 2002 through december 20, 2015 and not all records received in this time span are relevant to the gore® dualmesh® biomaterial.Medical records from november 19, 2002 through june 23, 2005, and july 2, 2005 through october 22, 2006, and december 24, 2006 through august 24, 2009 were not provided.Patient information: medical history: smoker: (b)(6) 2002: ¿smoker.¿ (b)(6) 2005: 2 packs/day x 22 years, ¿quit 2 years ago.¿ morbid obesity: (b)(6) 2002: 287 lbs.(b)(6) 2009: ¿morbid obesity with a bmi 56 and significant weight-related comorbidities.¿ diabetes mellitus, type ii.Hypertension.Gastroesophageal reflux disease [gerd].Prior surgical procedures: unknown date: umbilical herniorrhaphy.Unknown date: cholecystectomy.(b)(6) 2002: ventral herniorrhaphy, enterolysis and laparotomy.Implant bard composix.(b)(6) 2005: attempted laparoscopy, conversion to laparotomy, excision of excess hernial sac, partial omentectomy and resection of small bowel segment with anastomosis and repair of ventral hernia with dual mesh.Implant: gore® dualmesh® biomaterial.(b)(6) 2006: repair of recurrent ventral hernia.(b)(6) 2009: diagnostic laparoscopy, laparoscopic lysis of adhesions, laparoscopic roux-en-y gastric bypass, egd [esophagogastroduodenoscopy] open incisional hernia repair, open adhesiolysis.(b)(6) 2010: exploratory laparotomy; lysis of adhesions, extensive; placement of proceed mesh; release of incarcerated recurrent incisional hernia, permacol reconstruction of the abdominal wall, excision of previously placed synthetic mesh.Relevant medical information: (b)(6) 2002: ¿weight 287 lbs.Referred for possible hernia, abdominal.States hernia will bulge at times but can push it back in herself.Medical history: essentially negative.Social: positive for smoking.Abdomen obese.Has epigastric, umbilical hernia; reducible.Impression: ventral hernia involving epigastric portion and umbilical hernia present.The two are in continuity.Difficult to ascertain.¿ (b)(6) 2002: ventral herniorrhaphy, enterolysis and laparotomy.Implant bard composix.[hospitalization dates unknown].¿under general endotracheal anesthesia abdomen is opened through the midline.Large hernia sac is present and it is reduced by sharp dissection, incarcerated omentum is present, no bile.The adhesions are taken down by meticulous sharp dissection until the entire sac is freed.Portion of the sac resected.Previous sutures from repair are present.Sheet of composite mesh is selected and secured to the posterior fascia of peritoneum with interrupted sutures of 2-0 monofilament permanent suture.The fascial defect is closed with figure of 8 sutures #1 bralon.¿ implant sticker: ¿bard composix mesh 3 x 6.¿ medical records from november 19, 2002 through june 23, 2005 were not provided.Implant preoperative complaints: (b)(6) 2005: ¿discomfort mostly in the left lower quadrant but entire abdomen sore.¿ ¿no bowel movements x 24 to 36 hours; last bowel movement was only some small pellets.Abdomen obese, slightly distended, mildly tympanic to percussion.Bowel sounds present upper quadrants only.Diffusely tender with most of the tenderness to begin in the left lower quadrant with some guarding.No hernia is identified although she does have peri-umbilical tenderness.¿ (b)(6) 2005: ct abdomen/pelvis [a/p]: ¿there is a ventral hernia with loops of small bowel herniating through the sac.There is no evidence of obstruction seen.¿ implant procedure: attempted laparoscopy, conversion to laparotomy, excision of excess hernial sac, partial omentectomy and resection of small bowel segment with anastomosis and repair of ventral hernia with dual mesh.[implant: gore® dualmesh® biomaterial, 1dlmc04/03554372, 15 cm x 19 cm x 1 mm thick, oval.] implant date: (b)(6) 2005 [hospitalization (b)(6) 2005].Description of hernia being treated: ¿a laparoscopy was attempted.However, there were several adhesions and clear visualization of the peritoneal cavity was not possible.Hence, the procedure was converted into an open laparotomy.There was evidence of dense adhesions of the bowel to the hernia sac.There was erosion of the previously placed mesh with omental adhesions.There was also evidence of entrapped segment of small and large bowel within the hernia sac with possible small perforation of the small bowel with frank pus within the hernia sac.There were small cysts palpable in the ovary, but of no consequence.There was some cloudy fluid within the peritoneal cavity.¿ ¿the patient had a large hernia just below the umbilicus.The left lateral aspect of the abdomen was chosen.A transverse incision was made.This was then deepened through the subcutaneous tissue.The fascia was penetrated with a verre¿s needle and co2 insufflation was done.The verre¿s needle was removed and the laparoscope was introduced using a visiport.There was evidence of dense adhesions and the laparoscope could not be maneuvered within the peritoneal cavity to get visualization of the peritoneal contents.After attempting a few times, the laparoscope was withdrawn and it was decided to open the abdominal cavity for exploration.The previous midline incision was now used.This was then deepened through the subcutaneous tissue.The hernia sac was easily identified.This was then dissected out by sharp dissection all around.The peritoneal sac was now opened.There was gross evidence of pus within the peritoneal cavity.Cultures were obtained for both aerobic and anaerobic cultures.There was also evidence of a significant amount of omentum within the hernia sac.The adhesions were released.There was a segment of small bowel which was within the hernia sac which was involved with some necrotic tissue on the anterior mesenteric border because of the involvement within the hernia sac.There was no frank perforation demonstrated.However, there was evidence of peritoneal exudate and pus close to this area indicating possible the source of the abscess to be from this segment of the small bowel.The segment of the small bowel was isolated.The excess of the hernia sac was now excised for better visualization.There was evidence of multiple pockets within this hernia sac.The omentum that was adherent in these areas was released by sharp dissection.There was also evidence of omentum densely adherent to the superior portion of the wound where there was a mesh placement from previous surgery.The incision was extended beyond the hernia into the previously placed mesh.The disrupted sutures from the previous surgery itself were identified.Some of these sutures were removed.The omental adhesions were also released.The large bowel was easily reduced.There was no evidence of any injury to this area.The small bowel segment that was isolated was now approached.Bowel clamps were applied on either side and a small segment of the small bowel involving this area was divided using a gia stapler on either side.The mesentery between this segment was also divided between clamps and excised.Using another gia stapler, the anastomosis was created in a side to side fashion in the small bowel and the opening made by the blades of the gia was now approximated using #3-0 silk sutures in a continuous fashion.The bowel clamps were removed.The anastomosis was intact.It was viable without any tension and there was no evidence of any leakage noted.The defect in the mesentery was also approximated using #3-0 silk interrupted sutures.The bowel contents were ran through the anastomosis without any evidence of leakage.The entire peritoneal cavity was thoroughly irrigated until the return was clear.Palpation of the ovaries on either side revealed small cysts within the ovary, but of no consequence and it was decided to leave this alone.After the entire peritoneal cavity was thoroughly irrigated, 1 gram of ancef was left within the peritoneal cavity.¿ implant size and fixation: ¿in view of the previous episodes of multiple ventral hernias and recurrence and the obese nature of the patient, she was a candidate for a recurrence of the ventral hernia and hence it was decided to repair this also with a mesh.In view of the infection, the mesh was thoroughly soaked in the antibiotic solution and anchored to the anterior abdominal wall using a protacker.This was a dual mesh with a smooth surface against the peritoneum.The excess of the mesh was secured to the edge of the fascial defect using #0 polysorb suture.Interrupted prolene sutures were placed anteriorly to bring the fascia in opposition.The subcutaneous tissue was then approximated using #2-0 polysorb interrupted sutures.The skin was approximated using staples.The wound was also infiltrated with.25% marcaine for post op analgesia.The small defect on the left side of the abdomen where laparoscopy was attempted was now also closed using #0 polysorb interrupted suture and the skin was approximated with staples.¿ post-operative period: [7 days].(b)(6) 2005: microbiology: ¿culture other source; comments: pus from abd cavity.Result: escherichia coli.¿ ? (b)(6) 2005: discharge summary: ¿no bowel movements for 24 to 36 hours and she says that was just a few small ¿pellets¿.Had two or three similar episodes over past year each treated with antibiotics.The patient was agreeable to surgery and this was performed on (b)(6) 2005.Localized perforation was found with pus in the abdomen.She did quite well post operatively.Did run low-grade temp for couple of days.There was some chilling with temp of 102 degrees on night of (b)(6) 2005.Iv unasyn and flagyl which had been discontinued with change to oral medication was restarted.Within 12 hours the patient was again feeling better.The erythema noted in the lower wound area a day earlier had much decreased by (b)(6) 2005.There was no wound drainage at all.There was no fluctuance.Normal bowel function resumed by (b)(6) 2005.The wound continued to look good post operatively.The operative culture grew e coli with broad antibiotic sensitivities.White blood count was not elevated.She denied any abdominal pain.The maximum temperature was 100 degrees in the 24 hours prior to discharge on (b)(6) 2005.The source of the temperature did not seem to be from any kind of wound infection or intra-abdominal source.The patient was discharged home on cipro.¿ relevant medical information: ¿ medical records from july 2, 2005 through october 22, 2006 were not provided.Revision preoperative complaints: no information provided.Revision procedure: repair of recurrent ventral hernia.Revision date: (b)(6) 2006: findings: ¿the patient had a recurrent ventral hernia just above the umbilicus.On opening, it was found to be a loculated hernia.The patient had a previous dual core [sic] mesh and one end of the mesh in the upper right corner had been pulled away from the edge with recurrence from the site.The patient also had prior ventral hernia repair with marlex mesh prior to the dual mesh and that area had given way with recurrence of the hernia in this location.The mesh could be straightened out and was enough to secure it and hence this was fixed in a different fashion to the edge of the fascia and the repair was done.¿ procedure: ¿the hernia was found to be palpable just above the umbilicus and the previous surgical scar was now excised in an elliptical fashion and extended down to the umbilical level.The hernial sac was easily identified.This was then dissected out in a sharp fashion down to the fascial level.The fascial edge was well outlined and this was then opened.The sac was freed.There was no entrapment of omentum or bowel in the hernia itself at this point.This was then dissected out.Minimal adhesions of the omentum to the fascial edge were released and this revealed the previously placed dual mesh which was pulled away from the right upper corner and the takers [sic] were found to be not adherent to the fascia and the mesh was rolled up on itself.The patient also had a multi-loculated hernia extending to the right.The excess of the sac was now trimmed and sent for pathology.The fascial defect was well outlined.The takers [sic] that were loose on the mesh were removed.This was traced down and the lower part of the hernial repair was intact.Hence, this was left alone and where the mesh had pulled away from the fascial edge, this was now stretched out and it was found to be enough to bridge the gap.At the top portion of the hernia sac, there was previously placed marlex mesh which was eroded, but not found to be through the peritoneum.The dual mesh was now stretched and it was found to be adequate to cover the defect.After the multi-loculated pockets were removed and the fascial edge was cleared, the previously placed dual mesh was now secured to the edge of the fascia using #0 prolene.The edge of the mesh was secured to the fascia using a running #0 prolene suture.It was also secured by interrupted #0 prolene mattress sutures to secure the fascia to the mesh.This was done to cover the defect.The fascia that was freed was left intact to avoid tension on the repair.The subcutaneous tissue was then approximated to the fascia by interrupted #2-0 polysorb sutures to avoid the dead space.The wound was infiltrated with.25% marcaine for post op analgesia.The subcutaneous tissue was approximated using #3-0 polysorb interrupted sutures and the skin was approximated using staples.¿ (b)(6) 2006: pathology.¿gross: specimen consists of two portions of hernia sac measuring together 9.5 x 10 cm.One portion reveals a small portion of adipose tissue on the other surface.No section is submitted for microscopic examination.¿ relevant medical information medical records from december 24, 2006 through august 24, 2009 were not provided.(b)(6) 2009: preoperative diagnosis.¿morbid obesity with a bmi of 56 and significant weight-related comorbidities including type ii diabetes, hypertension, osteoarthritis, and gastroesophageal reflux disease, and multiple recurrent incisional hernias.¿ (b)(6) 2009: diagnostic laparoscopy, laparoscopic lysis of adhesions, laparoscopic roux-en-y gastric bypass, egd [esophagogastroduodenoscopy] open incisional hernia repair, open adhesiolysis [hospitalization dates unknown] findings.¿large hernia defect of approximately 8 cm in size at the inferior aspect of previously placed mesh containing a significant amount of distal jejunum and ileum.Primary closure of hernia defect.¿ procedure.¿we then turned our attention back to the lower abdomen and pelvis.It was evident that there was a lot of bowel in the lower vertical midline incision.We were unable to dissect this out freely laparoscopically, so the decision was made to convert to open laparotomy for repair of this hernia.All the laparoscopic trocars were removed under direct vision.There was no evidence of bleeding.A previously placed stay suture in the left upper quadrant was tied down.The left upper quadrant port site was irrigated, and this was closed loosely with 3-0 ethilon sutures.All the port sites were closed with 4-0 monocryl sutures and benzoin, steri-strips were applied.We then performed an open hernia repair in the lower abdomen.Approximately 15-cm vertical midline incision was fashioned, dissection was carried down to the skin, subcutaneous tissue until the hernia sac was identified.This was quite a large hernia sac contained a significant amount of bowel.Sharp adhesiolysis was performed.Approximately 60 minutes were spent in dissection to reduce the small bowel contents in its entirety.No enterotomies were made.After this massive small bowel was reduced, the fascia was then closed primarily with interrupted figure-of-eight #1 pds sutures.This was actually performed without undue tension and no further mesh was placed.The wound was then copiously irrigated after closure and hemostasis was assured.¿ (b)(6) 2009: x-ray abdomen: ¿findings are consistent with postoperative ileus.¿ (b)(6) 2009: ct a/p: ¿there has been repair of a midline ventral hernia and mesh material is present along the musculature of the lower anterior abdominal wall.There is some soft tissue infiltration along the incision line, but no fluid collection.There is skin thickening and infiltration of the subcutaneous fat of the right lower quadrant extending from the umbilicus to the inferior aspect of the pannus.¿ explant preoperative complaints: (b)(6) 2010: ct a/p: ¿again noted is a right paramedian ventral hernia that extends around the mesh.It contains a loop of jejunum distal to the jejunojejunostomy.¿ (b)(6) 2010: ¿this is a 52-year-old female with a past medical history significant for morbid obesity, and sequelae, laparoscopic roux-en-y gastric bypass open incisional hernia repair in august 9, 2010 (2009), who presents with the direct admission from a local ed with a 3-day history of intermittent abdominal pain, nausea, lack of gi function.She states her pain began after performing yard work, and persisted for a variety since with var (sic) intensity.She had nausea without emesis and reduced flatus or bm for 2 days now.She denies fevers, chills, or sick contacts.¿ explant procedure: exploratory laparotomy; lysis of adhesions, extensive; placement of proceed mesh.Explant date: (b)(6) 2010: ¿an incision took place down the upper abdomen through the skin and subcutaneous tissue, identifying the decusation [sic] of the fascia.The abdomen was then entered sharply.The fascia was then lifted out of the operative field.The abdomen was then entered.The bowel was reduced.Upon initial entry, we find no ischemic bowel, some mild amount of thickening and a loop at the jj with a thick adhesion between the 2 loops at the common channel and the roux limb.The remainder portion of fascia was opened.We then began to excise adhesions, which were throughout the abdomen, varying in thickness and in intensity.Once we did this, we were able to run the small bowel from proximal to distal, identifying the bp limb, the common channel, and the roux limb.These all appeared to be intact.There was no major hernia defects.Once lysis of adhesions of the bowel were to our satisfaction, we began to remove the previous portion of mesh.There was a portion of dual mesh as well as with a portion of dual-sided prolene mesh.These were both removed and sent off the operative field.We were able to free up several centimeters of fascia from the subcutaneous tissue, and the intraabdominal adhesions.This allowed us to size the piece of proceed mesh.The defect itself measured 18 by about 12 cm.Our proceed mesh was 2 cm on each side, wider than this and we then began to sew the proceed mesh into place in a bucket fashion using interrupted pds sutures approximately 2 cm from the fascial edge and 1 cm apart.Once this was completed to our satisfaction, we removed any towels from the belly and examined for any enterotomies.At this particular point in time, we noted that 1 of the stitches had actually gone through the serosa of the colon.This was obviously reduced and this portion sewn over.We did a second check to make sure that again there were no defects or attachments to the bowel.Once this was done to our satisfaction, we then closed the fascia.The fascia had some dissection of the subcutaneous and skin off of it.This was done without much difficulty to approximately 1 cm overlap.We then did 2 looped pds starting at the top and starting at the bottom and then they were tied in between.The patient¿s skin was brought together using some interrupted vicryls and then stapled.¿ ¿please note that because of the emergency nature [sic] this procedure, dr.(b)(6)presence was requested as second surgeon.¿ operative findings: intact roux-en-y gastric bypass.There was no evidence of internal hernia.Incarcerated hernia through a swiss-cheese type defect reduced with excellent viability of the bowel.¿ procedure: ¿a vertical midline incision was fashioned and entrance to the peritoneal cavity was obtained after sharp dissection with a scalpel.There was no vascular or visceral injury upon entering into the upper abdomen.We then proceeded up to the length of the entire incision.There were multiple facial defects and multiple pieces of previously placed synthetic mesh.The hernia defect was identified.An extensive adhesiolysis was then performed greater than 1 hour.After sharp dissection and reduction of the incarcerated piece of small bowel, which constituted the common channel, the bowel did appear pink and viable.No enterotomies were made.We then proceeded with a full adhesiolysis from the duodenum down the ligament of treitz.The roux limb was identified and the jejunojejunostomy was identified.There was no evidence of internal hernia at the jejunojejunostomy.The common channel appeared normal down to the cecum.We then proceeded to excise the previously placed mesh.This passed off table as specimen.The overall defect was approximately 18 x 12 cm.An appropriate size piece of permacol mesh was selected.This was sewn in an underlay fashion with multiple interrupted #1 pds sutures.The fascia was able to be primarily approximated over top of this using 2 looped #1 pds sutures.Subcutaneous tissue was then reapproximated with multiple interrupted 3-0 vicryl sutures.The skin was reapproximated with staples.¿ (b)(6) 2010: pathology.¿received in formalin and labeled ¿explanted mesh¿ are multiple irregular segments of synthetic material aggregating to 18 x 17 x 5 cm.Attached to the synthetic material is abundant firm fibrotic soft tissue.¿ conclusion: it should be noted that the gore® dualmesh® 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.¿ the instructions for use further state: ¿use only nonabsorbable sutures, such as gore-tex® suture, with a noncutting needle (such as taper or piercing point) of appropriate size to anchor the device.The use of absorbable sutures may lead to inadequate anchoring of gore® dualmesh® biomaterial to the host tissue and necessitate reoperation.For best results, use monofilament sutures.Suture size should be determined by surgeon preference and the nature of the reconstruction.¿ staples or helical tacks (also known as helical coils) can be used as an alternative to sutures.¿staple size and staple or tack spacing should be determined by surgeon preference to provide for adequate tissue fixation and to prevent reherniation.¿ 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.It should be noted with use of the device in patients with the potential for growth, tissue expansion, or significant change in body habitus, the surgeon should be aware that the device will not stretch or change with the patient¿s body.Individual medical decisions, if inconsistent and/or non-conforming to the device manufacturer¿s recommendations, ifu, or recognized best practices, may result in or contribute to an adverse event.As with any surgical procedure, there are always risks of complications for surgical repair of hernias and soft tissue deficiencies, with or without mesh.These my 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.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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