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Additional details regarding the patient's clinical course were ascertained from a review of medical records and are as follows: relevant medical information: ¿ (b)(6) 2010: pikeville medical center.Salvador d.Ramos ii, do.Consultation.Came to my office today seeking laparoscopic bariatric surgical treatment for her longstanding morbid obesity.Weight 233.4 lbs., bmi 39.9.Exam: abdomen obese contour; no hernia; no mass; nontender; nondistended.Impression: morbidly obese female.¿ (b)(6) 2010: pikeville medical center.Salvador d.Ramos ii, do.Operative report.Preoperative diagnosis: cholelithiasis, abdominal pain, dysphagia, gastroesophageal reflux.Postoperative diagnosis: cholelithiasis, abdominal pain, dysphagia, gastroesophageal reflux, mild distal esophageal erosion with mild stenosis, antral gastritis, small hiatal hernia.Procedure: laparoscopic cholecystectomy.Intraoperative esophagogastroduodenoscopy with biopsy and gastroesophageal dilatation.- (b)(6) 2010: pikeville medical center.Salvador d.Ramos ii, do.Discharge summary.Admitted: (b)(6) 2010.Final diagnosis: cholelithiasis; abdominal pain; history of esophageal stenosis; gastroesophageal reflux.Hospital course: was admitted electively to undergo laparoscopic cholecystectomy with intraoperative egd, as the patient has a history of esophageal stenosis.States that she started to have the same symptoms when her esophagus was closing off.Has a history of esophageal dilatation x1.The procedure went well.Was able to tolerate a clear liquid diet the same day after the surgery.On postoperative day #1, patient was doing well.Was able to tolerate soft foods.Was then discharged.¿ (b)(6) 2010: pikeville medical center.Salvador d.Ramos ii, do.Operative report.Preoperative diagnosis: morbid obesity.Postoperative diagnosis: morbid obesity, moderate amount of intra-abdominal adhesions.Procedure: laparoscopic roux-en-y gastric bypass and lysis of adhesions.- (b)(6) 2010: pikeville medical center.Salvador d.Ramos ii, do.Discharge summary.Admitted: (b)(6) 2010.Final diagnosis: morbid obesity and moderate amount of intra-abdominal adhesions.Hospital course: 55-year-old morbidly obese female, who was electively admitted to undergo laparoscopic roux-en-y gastric bypass.The procedure went well except for some moderate amount of intra-abdominal adhesions, which was taken down carefully.The patient did well.The gastrograffin swallow study was performed the next day, which showed no leak or obstruction.She was promptly started on bariatric stage i liquid diet, which she was able to tolerate.On postoperative day #2, the patient was discharged.¿ (b)(6) 2010: pikeville medical center.Salvador d.Ramos ii, do.Operative report.Preoperative diagnosis: small bowel obstruction.Postoperative diagnosis: small-bowel obstruction secondary to phytobezoar (fibrinous food stuff), enterotomy, and removal of phytobezoar.Procedure: diagnostic laparoscopy converted to exploratory laparotomy with enterotomy and removal of phytobezoar.- (b)(6) 2010: pikeville medical center.Salvador d.Ramos ii, do.Discharge summary.Admitted: (b)(6) 2010.Final diagnosis: small bowel obstruction secondary to large phytobezoar.Hospital course: admitted through the emergency department with diagnosis of small bowel obstruction.Was taken to the operating room and i found a large phytobezoar that is causing the small-bowel obstruction.This was then removed through an enterotomy and the enterotomy was primarily closed.The patient remained having a nasogastric tube for decompression and foley catheter for fluid balance monitoring for the first 2 days after surgery.The nasogastric tube and the foley were then removed.Was started on clear liquid diet and was advanced to fulls the next few days.Continued to do well and she was then discharged home.¿ (b)(6) 2011: pikeville medical center.Salvador d.Ramos ii, do.History and physical.Underwent gastric bypass in april 2010.Actually developed a small bowel obstruction secondary to ___ [sic] bezoar in december 2010 and underwent an exploratory laparotomy with removal of bezoar.This small bowel obstruction has nothing to do with the surgery itself as the bezoar was found approximately 100 cm from the jejunojejunostomy anastomosis.Has been doing well since, however started complaining of nausea, vomiting, and abdominal pain in her upper abdomen.The cat scan of the abdomen and pelvis did show a partial small bowel obstruction in the proximal small intestine.Was also complaining of nausea, vomiting, and abdominal pain, so i have decided to keep the patient for a 23-hour observation admission.History of morbid obesity, hypertension, depression, cholelithiasis.Surgical history of appendectomy 1973, tummy tuck 2003, gastric bypass 2010, exploratory laparotomy 2010.Exam: abdomen slightly to moderately distended.There was also moderate tenderness to the upper quadrant of the abdomen, especially on the left side.Impression: partial small bowel obstruction, nausea, vomiting, and abdominal pain.- (b)(6) 2011: pikeville medical center.Salvador d.Ramos ii, do.Dischargesummary.Admitted: (b)(6) 2011.Final diagnosis: nausea, vomiting, abdominal pain, partial small bowel obstruction.Hospital course: underwent gastric bypass in april 2010.Was doing well, and started to have some abdominal pain in december, which she was taken to surgery and there was a large phytobezoar that cause her to have a complete small bowel obstruction.This procedure was done as an open procedure.Again presented to the emergency room.Cat scan showed partial small-bowel obstruction.Abdomen was distended.A nasogastric tube was placed for gastrointestinal decompression.Was placed on nothing by mouth status for 2 days until her abdominal distension subsided and she was not feeling nauseated anymore.On hospital day #3, nasogastric was placed on suction for 6 hours.Was able to tolerate this with no nausea and abdominal distension.Was then discontinued and was given a clear liquid diet.Was able to tolerate it.Was then discharged home.Implant preoperative complaints: ¿ (b)(6) 2012: pikeville medical center.Amy olsen-johnson, md.History and physical.The patient is status post gastric bypass approximately 20 months who presents with complaints of abdominal pain and fatigue.Has been feeling this way for approximately 3 weeks.Also complains of significant constipation.Mother passed away last week as well and she is feeling some situational depression over that.Has been counseled today on how much exercise she is doing, her protein intake and appetite.Is currently on a stage-6 diet and is not exercising because of her abdominal pain.History of gastroesophageal reflux; constipation; gastric bypass; exploratory laparotomy for small-bowel obstruction.No tobacco, no alcohol, and no illicit drugs.Weight 148.6 lbs., bmi 24.6.Exam: abdomen soft, nontender, and nondistended except for a large hernia defect in her right upper abdomen.This is very tender to touch, but is reducible.Impression: incisional hernia after exploratory laparotomy for bowel obstruction approximately 8 months ago.Plan: laparoscopic hernia repair likely with mesh.Has been counseled on the risks, benefits, and alternatives of the exploratory laparoscopy with hernia repair and mesh placement including bleeding, infection, and chronic pain with the likelihood of recurrence if she does not keep her protein stores up appropriately.¿ (b)(6) 2012: pikeville medical center.Amy olsen-johnson, md.Indication: the patient is a 57-year-old female who had gastric bypass and then had exploratory laparotomy for bowel obstruction.She now reports a painful hernia at her abdominal wall and desires it repaired.She fully understands the risks, benefits, alternatives of procedure including recurrence and wishes to proceed.Implant procedure: laparoscopic exploration with takedown of adhesions, and repair of incisional hernia.[implant: gore® dualmesh® plus biomaterial, 1dlmcp04/8706163, 15 cm x 19 cm x 1mm thick, oval] implant date: (b)(6) 2012 (hospitalization (b)(6) 2012) ¿ (b)(6) 2012: pikeville medical center.Amy olsen-johnson, md.Operative report.Preoperative diagnosis: large incisional hernia.Postoperative diagnosis: large incisional hernia, adhesions.Anesthesia: general endotracheal.Estimated blood loss: 50 cc.¿ procedure: ¿the patient was brought to the operating room and placed on the operating table.After general endotracheal anesthesia was obtained, the patient¿s abdomen was prepped with hibiclens solution, draped in a sterile fashion.Using an 11 blade knife, an incision was made on the left lateral abdominal wall and using an optiview technique, the abdomen was entered and insufflated to 15 mmhg co2 gas.Once that port was placed, two additional ports were placed under direct vision to allow for working ports.It became apparent very early that the patient had a densely adherent bowel to abdominal wall in multiple places, but in particular on the left side of the hernia sac.These were taken down with sharp dissection.This required approximately 45 minutes of work in order to get all of adhesions taken down to examine the hernia.The hernia was approximately 15 x 15 cm in diameter and required closure in order to have any chance of avoiding recurrence given the size of it.She had three incisions placed on the left side close to the edge of the fascial defect and sutures were placed through this incision through the abdominal wall at the edge of the fascia and into the abdominal cavity and brought out through another set of stab incisions on the other side of the defect.These were then again brought through in a u-type fashion to attempt to bring the fascia together.Over the course of approximately an hour, several sutures were placed and the defect was brought together to allow for mesh placement over a closed fascial defect.Once this was complete, an addition relaxing incision was made on the right lateral to give a little more of a tension-free repair.Next a piece of gore-tex mesh was placed over the entire area to include about 3 cm overlap and tacked in place using a protack.Once this was complete, a picture was taken.The ports were removed from the abdominal wall without difficulty and incisions were closed with 4-0 monocryl subcuticular stitches.The patient was placed in a binder after glue was applied to the laparoscopic port sites, and the patient was awakened from anesthesia and taken to pacu in good condition.Her family was informed of findings.¿ ¿ (b)(6) 2012: pikeville medical center.Implant sticker.Gore dualmesh® plus biomaterial.Ref catalogue number: 1dlmcp04.Lot batch code: 8706163.W.L.Gore & associates.Implant sticker.Dualmesh etpfe 15x19.¿ the records confirm a gore® dualmesh® plus biomaterial (1dlmcp04/ 8706163) was implanted during the procedure.¿ (b)(6) 2012: pikeville medical center.Amy olsen-johnson, md.Discharge summary.Admitted: (b)(6) 2012.Final diagnosis: incisional hernia.History of present illness: underwent exploratory laparotomy for bowel obstruction several months ago and now has pain in her abdomen.Has had ventral hernia there.Will proceed to the operating room for definitive treatment.Hospital course: the patient was admitted, taken to the operating room for repair of ventral hernia with mesh.The patient did well, had some pain postoperatively that we had to get under control prior to discharge.Is eating, ambulating and drinking without difficulty prior to discharge.Discharge instructions: high-protein diet.Is to wear abdominal binder at all times and she will contact me with any problems with her wound or with her abdomen.¿ (b)(6) 2012: pikeville medical center.Discharge instructions.No lifting greater than 10 lbs.Relevant medical information: ¿ [unknown date, 2/??/12]: [reviewer note: missing first page].[facility ni].Amy johnson, md.Office notes.¿regards to the need for her to eat a balanced diet with at least 1500 to 2000 calories per day in order to improve what i consider a chronic malnourished state.Is fatigued and feeling depressed today and has expressed that to me.I have expressed to her the importance of support group and ongoing attendance, although she does not attend.She has been counseled multiple times on vitamin intake and she has seen out nutritionist again today and has been evaluated.Has also been given a detailed summary of what she must take in over the next couple of weeks to improve her diet and nutritional status.Past labs have reveal malnourished state.History of chronic constipation; chronic fatigue and she is in a postoperative state; malnutrition.Past surgical history of (two weeks ago), patient underwent re-repair of her incisional hernia with mesh.Weight 140 lbs., bmi 23.2.Exam: abdomen recent hernia repair.Grossly intact.Wound is clean, dry, intact, and appropriately tender.Patient is wearing an abdominal binder today.Impression: malnutrition; anorexia with possible psychological component status post incisional hernia repair two week ago.Plan: will see nutritionist today and will get a very detailed two-week diet for which she must comply.Explant preoperative complaints: ¿ (b)(6) 2020: pikeville medical center.Amy johnson, md.History and physical.Ventral hernia: symptoms began 2 years ago.Aggravating factors include exertion.Needs surgical repair.(b)(6) 2020 ct scan findings: prior ventral hernia repair with re-herniation above prior placed mesh.Has cardiology risk assessment today and dr.Hattab has given pulmonary clearance.States right upper quadrant pain and tenderness on daily basis that worsens after meals.Status post bowel resection in 2010, ventral hernia repair january 2012 with superior aspect recurrence versus new hernia.Problem list: onset (b)(6) 2016: chronic nonspecific abdominal pain.Onset 12/10/13: fatigue/malaise, abnormal weight gain.Medical history: anemia, depression/anxiety, gastroesophageal reflux disease, hypoglycemia, thyroid disease, vitamin b12 deficiency, vitamin d deficiency.Surgical history: appendectomy, cholecystectomy, gastric bypass, colon resection, tubal ligation, incisional hernia repair, ventral hernia repair, hiatal hernia repair, diagnostic laparoscopy.Smoking status: former smoker.Wt.222.4 lbs., bmi 39.4.Exam: obese.Abdomen: obese, abdominal tenderness, reducible ventral hernia.Impression/plan: ventral hernia.Understands risk of hybrid hernia repair; will likely need another piece of mesh superiorly.Will attempt to place scope and plan the incision before opening given how many adhesions she has had in past.Biggest risk is recurrence.Understands she cannot lift afterward for months.Has a portion of what appears to be her roux limb between the mesh and the abdominal wall superiorly.Unspecified abdominal pain.(b)(6) 2020: no interval changes.¿ (b)(6) 2020: pikeville medical center.Perioperative record.Asa class 2.Wt.222 lbs., bmi 36.9.¿ (b)(6) 2020: pikeville medical center.Amy olsen-johnson, md.Indication: the patient is a 66-year-old female who continues to complain of severe crampy pain in her abdomen whenever she eats and also, she has pain to her right side randomly.I fixed a repaired a [sic] hernia in her with mesh years ago and it appears that she has a piece of bowel over the superior aspect of the mesh, and we will take her to the operating room for definitive management, which will probably be to just retack the mesh after reducing the hernia.She understands risks, benefits, and alternatives to procedure and wished to go ahead.Explant procedure: diagnostic laparoscopy with reduction of superior and inferior hernias around contracted mesh.Laparoscopic mesh removal.Explant date: (b)(6) 2020 [hospitalization dates unknown] ¿ (b)(6) 2020: pikeville medical center.Amy olsen-johnson, md.Operative report.Preoperative diagnosis: recurrent hernia above previously placed mesh.Postoperative diagnosis: recurrent hernia above previously placed mesh plus hernia inferiorly and contracted mesh.Anesthesia: general endotracheal.Estimated blood loss: minimal.Fluids: see anesthesia record.Specimen: mesh.¿ wound class: clean.¿ procedure: ¿the patient was taken to the operating room, placed supine on the operating room table.After general endotracheal anesthesia was obtained, the patient¿s abdomen was prepped with chloraprep solution and draped in a normal sterile fashion.Using #11 blade knife, an incision was made laterally and inferiorly to the left and taken down the fascia using optiview technique.The abdomen was entered under direct vision and insufflated.Two additional ports were placed in the left upper abdomen and my attention was turned to taking down adhesions.There were dense adhesions on the abdominal wall involving small bowel.We also did find the area where it was obvious that she had had a hernia superiorly over the mesh.I took that bowel down.There was also herniated omentum inferiorly also over the mesh.We took this down.The mesh appeared to be contracted and it was not fitting well, and i decided to take it out.This was taken out with harmonic scalpel and a blunt dissection.I made a small incision in the midline and took the mesh out.I decided, based on what the small amount of herniated abdominal wall looked like, that i would currently not replace the mesh given what this last piece of mesh did and how she felt with it and will make a decision about replacement at some point in the future.Her abdomen was deflated.The ports were removed.Skin at all sites was closed with 4-0 monocryl subcuticular stitch.Glue was applied.The patient was awakened from anesthesia without difficulty and taken to pacu in good condition.Family was informed of findings.¿ ¿ (b)(6) 2020: [facility ni].Intraoperative report.Asa 2 mild systemic disease.Height 5¿5¿, weight 222 lbs, bmi 36.9.Procedure service: bariatrics.Specimen: explanted mesh.Type: permanent section in formalin.Relevant medical information: ¿ (b)(6) 2021: pikeville medical center.Nicholas schaub, md.History and physical.Follow-up abdominal hernia.Symptoms began 6 years ago.I am asked to see in consultation for abdominal wall hernia.History of gastric bypass in 2010; few months after surgery, taken back for small bowel obstruction which required resection of about 2 ½ feet of small intestine.Second operation performed through a midline incision.Subsequently, developed a hernia and underwent laparoscopic repair a few years later.Follow-up scan showed accumulation of small bowel above the mesh.Back to surgery in 2020 for mesh removal.No further imaging or evaluation since then.At first office visit a few weeks ago, hernia was noted along midline.Ct scan showed moderate-size ventral hernia.Today, reports intermittent pain associated with hernia site.Has not been able to lift heavy objects or stretch due to discomfort.Wt.220.2 lbs., bmi 39.01.Abdomen: soft, reducible hernia, mild tenderness around the hernia site.Impression/plan: moderate-sized incisional hernia.Has never undergone open approach.Discussed hernia repair with the patient in detail including technique benefits and risks.Her procedure will be performed the next few weeks.¿ (b)(6) 2021: pikeville medical center.Nicholas schaub, md.Operative report.Preoperative diagnosis: incisional hernia.Postoperative diagnosis: incisional hernia.Procedure: incisional hernia repair with mesh.Implant: prolene.Assistant: none.Blood loss: minimal.Findings: ventral hernia measuring approximately 7 x 6 cm in the midline superior to the umbilicus.Mild intra-abdominal adhesions.Specimens: none.- indications: the patient is a 66-year-old female who previously underwent exploratory laparotomy and bowel resection in the past.Just she developed an incisional hernia and underwent laparoscopic repair, although the mesh was later removed for hernia recurrence.Due to increasing size of the hernia and pain, recommendations were made to proceed with open repair.The procedure was discussed with the patient in detail including benefits and risks.- procedure: ¿the patient was identified, brought to the or, placed on the or table in supine position.After the placement of scds, she was induced with general anesthesia.She received antibiotics prior to incision.The previous midline incision contained a moderate-sized hernia superior to the umbilicus.The scar at the midline was incised and the scar was removed.The subcutaneous tissue down to the fascia was divided with cautery.The fascia was carefully divided just superior to the hernia and so as to not injure any underlying structures.The abdomen was entered sharply and there were mildly intra-abdominal adhesions.The hernia defect in the middle was then completely visualized if the sac was divided in the midline with cautery.Approximately 30 minutes was required for adhesiolysis.Adhesiolysis within the abdomen was performed using metzenbaum scissors and cautery.Once this was performed, the fascia was then divided superiorly and inferiorly to the hernia defect to provide adequate exposure for a rives-stoppa repair.The defect measured approximately 7 x 6 cm.On both sides of the abdomen, the subcutaneous fat was separated from the fascia using cautery.This allowed better mobilization of the fascia for closure in the midline.The rectus sheath on both sides was then entered using cautery.A plane was created posterior to the fascia on both sides for placement of the prolene mesh.Once both sides were sufficiently mobilized, the posterior rectus fascia was closed in the midline using looped pds suture.Next, a prolene mesh was then cut to fit within the space beneath the rectus muscle.This was then placed within the intended space and anchored to the overlying fascia and muscle using #1 prolene sutures.This was placed circumferentially.Once the mesh was fully secured, the cavity was then irrigated.The anterior rectus fascia was then closed using looped pds suture.Due to the large subcutaneous space, a drain was placed via a left lower quadrant stab incision.This drain was placed in the subcutaneous space.The skin was closed with 3-0 vicryl suture in the dermis, followed by staples.The skin was cleaned and dried and a sterile dressing was placed.The patient was awakened from anesthesia and transferred to the recovery room in stable condition.All needle, instrument, and sponge counts were correct at the end of the case.¿ - (b)(6) 2021: pikeville medical center.Intraoperative record.Asa class: 3.Wt.218 lbs., bmi 36.4.- (b)(6) 2021: pikeville medical center.Implant sticker.Prolene mesh.Ethicon, llc.The investigation has been completed.Based upon the totality of the information received over the course of the investigation and reported by gore in the previously submitted medical record narratives the following conclusions have been reached.As previously reported, all pertinent medical records requested may not have been received.In the absence of additional information or medical records from the complainant, this event file will be closed with the information provided.It should be noted that the gore® dualmesh® plus biomaterial instructions for use include warnings and addresses the following adverse reactions among others: ¿possible adverse reactions with the use of any tissue deficiency prosthesis may include, but are not limited to, contamination, infection, inflammation, adhesion, fistula formation, seroma formation, hematoma, and recurrence.¿¿ medical records that indicate mesh ¿movement¿ or that the device led to a recurrence may reflect a recurrence as a function of a patient¿s poor tissue quality leading to fascial dehiscence or loss of anchorage of fixation, or may be related to the hernia type, individual patient comorbidities, and technical and procedural aspects of the repair.These factors include but are not limited to, fixation type, mesh shape/sizing used, and defect closure decisions.Additionally, a new, unrelated hernia can occur but may be referred to as a recurrent hernia.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.As with any surgical procedure, there are always risks of complications for surgical repair of hernias and soft tissue deficiencies, with or without mesh.¿these may include but are not limited to, adhesions and related harms, bleeding, bowel obstruction, compromised device biocompatibility, contamination which may lead to patient harms, device damage, dysphagia, erosion or extrusion and related harms, exposure or protrusion and related harms, fever, fistula, gerd recurrence, defect recurrence and related harms, ileus, increased procedure time and related harms, irritation or inflammation, infection, mesh migration, mesh contraction, pain, paresthesia, perforation, revision/re-intervention, seroma or hematoma and related harms, tissue ischemia, wound complications and wound dehiscence and additional intervention including surgery.Many of the potential complications are associated with the patient¿s underlying disease progression, co-morbidities, additional medical history and/or other surgical procedures.The above inherent risks are typically detailed in standard informed consent documents.The device was not able to be returned to gore for evaluation; therefore, a direct product analysis could not be conducted.Review of the manufacturing records verified that the lot met all pre-release specifications.The plus antimicrobial product coating contains silver carbonate [approximately 800 micrograms per cubic centimeter of product (¿g/cm3)], and chlorhexidine diacetate [approximately 1600 micrograms per cubic centimeter of product (¿g/cm3)].W.L.Gore & associates, inc.(gore) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by gore, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Blank fields present on this report include required fields and fields determined to be not applicable.Blank required fields indicate that the information was not provided, was deemed unavailable or was not applicable.This report does not constitute an admission or a conclusion by fda, gore, or its associates that the device, gore or its associates caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects" or has "malfunctioned".These words are included in the report and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.
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The investigation has been completed.Based upon the totality of the information received over the course of the investigation and reported by gore in the previously submitted medical record narratives the following conclusions have been reached.As previously reported, all pertinent medical records requested may not have been received.In the absence of additional information or medical records from the complainant, this event file will be closed with the information provided.It should be noted that the gore® dualmesh® plus biomaterial instructions for use include warnings and addresses the following adverse reactions among others: ¿possible adverse reactions with the use of any tissue deficiency prosthesis may include, but are not limited to, contamination, infection, inflammation, adhesion, fistula formation, seroma formation, hematoma, and recurrence.¿ medical records that indicate mesh ¿movement¿ or that the device led to a recurrence may reflect a recurrence as a function of a patient¿s poor tissue quality leading to fascial dehiscence or loss of anchorage of fixation, or may be related to the hernia type, individual patient comorbidities, and technical and procedural aspects of the repair.These factors include but are not limited to, fixation type, mesh shape/sizing used, and defect closure decisions.Additionally, a new, unrelated hernia can occur but may be referred to as a recurrent hernia.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.As with any surgical procedure, there are always risks of complications for surgical repair of hernias and soft tissue deficiencies, with or without mesh.These may include but are not limited to, adhesions and related harms, bleeding, bowel obstruction, compromised device biocompatibility, contamination which may lead to patient harms, device damage, dysphagia, erosion or extrusion and related harms, exposure or protrusion and related harms, fever, fistula, gerd recurrence, defect recurrence and related harms, ileus, increased procedure time and related harms, irritation or inflammation, infection, mesh migration, mesh contraction, pain, paresthesia, perforation, revision/re-intervention, seroma or hematoma and related harms, tissue ischemia, wound complications and wound dehiscence and additional intervention including surgery.Many of the potential complications are associated with the patient¿s underlying disease progression, co-morbidities, additional medical history and/or other surgical procedures.The above inherent risks are typically detailed in standard informed consent documents.The device was not able to be returned to gore for evaluation; therefore, a direct product analysis could not be conducted.Review of the manufacturing records verified that the lot met all pre-release specifications.C1: the plus antimicrobial product coating contains silver carbonate [approximately 800 micrograms per cubic centimeter of product (g/cm3)], and chlorhexidine diacetate [approximately 1600 micrograms per cubic centimeter of product (g/cm3)].W.L.Gore & associates, inc.(gore) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by gore, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Blank fields present on this report include required fields and fields determined to be not applicable.Blank required fields indicate that the information was not provided, was deemed unavailable or was not applicable.This report does not constitute an admission or a conclusion by fda, gore, or its associates that the device, gore or its associates caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects" or has "malfunctioned".These words are included in the report and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.
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