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Additional details regarding the patient's clinical course were ascertained from a review of medical records and are as follows: implant preoperative complaints: on (b)(6) 2008: (b)(6) md.History and physical.Obese, chronic abdominal pain and irritable bowel syndrome type symptoms for a long time.Abdominal pain progressed extensively last 2 months.Recent chronic constipation.Abdominal aortic aneurysm repair twice.Nausea/vomiting recently.Weight: 281 lbs.Impression/plan: ventral hernia; repair per laparoscopy per dr.(b)(6).On (b)(6) 2008: (b)(6) center.[signature (b)(6) [not indicated].History and physical.Ventral hernia containing small bowel and transverse colon.Occlusion of aortic-hepatic graft, celiac stenosis, visceral aneurysm [illegible] at base pancreas [illegible].Medical history: hypertension, high cholesterol, depression, migraines, back pain.Clot left arm 2002 and 2008.Surgical history: right inguinal hernia, back, vascular.310 lbs.On (b)(6) 2008: (b)(6) md.Indication for procedure: ¿the patient presents with a ventral hernia.¿ implant#: 1 procedure: laparoscopic repair of ventral hernia with polytetrafluoroethylene soft tissue patch.[implant gore® dualmesh® plus biomaterial, 1dlmcp08/05729033, 26cm x 34cm x 1mm thick, oval].Implant#: 1 date: on (b)(6) 2008 [hospitalization dates on (b)(6) 2008].On (b)(6) 2008: (b)(6) md.Operative report.Preoperative diagnoses: incisional hernia.Morbid obesity.Postoperative diagnoses: same plus extensive adhesions and incarcerated omentum, small bowel, and transverse colon.Assistant: (b)(6), cst.Anesthesia: general.Anesthesiologist: dr.(b)(6).Complications: none.Estimated blood loss: less than 10 ml.Type of mesh: 26 x 34 cm ptfe soft tissue patch.Findings: extensive adhesions (requiring 1.5 hours for lysis).Incarcerated small bowel, transverse colon, and omentum (no evidence of bowel injury once lysis of adhesions was completed).Procedure: the patient presents with a ventral hernia.Description of procedure: ¿the patient was taken to the operating area where general anesthetic was administered.The abdomen was prepped and draped in a sterile manner.This included duraprep and ioban.Prophylactic antibiotics were administered.The abdomen was entered using a 12 mm optical trocar, which was placed into the midlateral abdomen under direct laparoscopic control.Once the peritoneal cavity was safely entered, the abdomen was then insufflated with carbon dioxide to a pressure of 15 mmhg.After a satisfactory pneumoperitoneum had been established, diagnostic laparoscopy was undertaken with a 10 mm, 45 degree viewing laparoscope.Insertion of the laparoscope revealed no evidence of visceral or vascular perforation at the trocar entry site.Five mm trocar(s) were placed to allow the introduction of working instruments.Lysis of adhesions was undertaken with sharp dissection.Once the lysis of adhesions was completed, the hernia was defined.A ptfe patch was selected to allow overlap onto the surrounding tissues for at least 4-5 cm in all directions.The patch was placed into the abdominal cavity with the roughened surface facing the overlying musculature, while the smooth surface faced the underlying peritoneum.Ethibond sutures had been placed around the circumference of the patch.These sutures were brought through the abdominal wall at previously marked sites and then tied in place.The patch was then further secured by the circumferential application of titanium tacks at its periphery.Additional tacks were then placed more centrally to assure maximal adherence between the patch and the overlying musculature.A final inspection was made to ensure hemostasis was adequate and to confirm that there was no evidence of visceral or vascular injury.Closure was then begun.The 12 mm trocar site was closed at the fascia level with 0 vicryl using a carter-thomason suture passer.Skin at all sites was closed with a subcuticular suture of 4-0 monocryl.All sites were circumferentially infiltrated with 0.25% marcaine with epinephrine.Indermil was applied at each site.The patient tolerated the procedure well.Sponge counts were correct.¿ on (b)(6) 2008: [facility ni].Photographs.Procedure: laparoscopic ventral hernia.Surgeon: dr.(b)(6).[photographs].On (b)(6) 2008:(b)(6) hospital.Implant record.Mesh dual plus 26x34cmx1mm.Lot number: 05729033.Manufacturer: gore.Expiration date: 2010-12.Catalog number: 1dlmcp08.Implant site: abdomen.Quantity: 1.Implant verified: yes.On (b)(6) 2008: (b)(6) md.Discharge summary.Discharge diagnosis: ventral hernia.Operation performed: laparoscopic repair of ventral hernia with ptfe patch.Required approximately one and a half hours for lysis of adhesions and reduction of incarcerated tissues.Hernia defect large enough that a 26 x 34 cm ptfe patch was required.Postoperatively, hospital stay prolonged by 3 issues: significant pain requiring ongoing intravenous analgesics, urinary retention requiring repeat in/out catheterization and replacement of foley catheter, component of ileus with delay in return of bowel function.Eventually, pain control improved and released on oral dilaudid.Able to void spontaneously, ileus resolved; passing flatus, bowel movements.At discharge, vital signs stable, afebrile, ambulating independently.Laparoscopic trocar sites healing well without infection.Underlying hernia repair intact and solid.No evidence of significant hematoma, seroma or peritoneal signs.Provided with written postoperative instructions, prescription for dilaudid.See in office in approximately 2 weeks.Relevant medical information: on (b)(6) 2008: (b)(6).Questionnaire.Indicate following problems after surgery.Nausea, vomiting, constipation.Are you still taking pain pills: yes; percocet/norco.Pain score: 6.Able to resume normal activities around the house: no; attempting.Returned to work: no.Comments: fall x 3.On (b)(6) 2008: (b)(6).Questionnaire.Indicate following problems after surgery: cough producing yellow or green mucous, drainage of pus from an incision.Last week temperature 103; positive bronchitis.Prescribed keflex [nurse reviewer note: handwritten; possibly by physician].Still taking pain pills: yes; norco.Pain score: 5.Able to resume normal activities around the house: yes, with several breaks and having to take medications after or during.Returned to work: no, return date estimate on (b)(6) 2008.Comments: do not understand why i am not able to lay on left side without pain going to 8, only able to lay on right side with pillows propping me up and no longer than 20 minutes.Trying to sit at computer like i would at work, but within less than 3 hours, i have to lay down and take a pain pill-pain increasing.On (b)(6) 2008: tower surgical, inc.(b)(6) md.Prescription.May resume work on (b)(6) 2008: (b)(6) center.[signature (b)(6)].Telephone call.Caller: self.Physician: (b)(6).Message: picked up her god child and has pain on left side of breast with muscle spasm.He weighs about 20 plus pounds.Pain is 6-9 stab.Is this normal? response: probable muscle strain.Apply ice.Continue current medications.Notified-she understands.On (b)(6) 2008.She should work only 3 to 4 hours per day for the first 2 weeks.On (b)(6) 2009: (b)(6) hospital.[signature (b)(6)].Radiology ¿ upper gi series without kub scout.Indication: abdominal pain, vomiting for couple weeks.17 hernias repaired a few months ago.Impression: no hernia.Mild to moderate gastroesophageal reflux.On (b)(6) 2015: (b)(6) md.Office notes.Abdominal pain right upper quadrant radiating into back; onset 4 months ago.Distinctly different compared to chronic abdominal pain.Associated symptoms are nausea/vomiting/diarrhea.Ct: cholelithiasis with distended gallbladder.History of multiple abdominal surgeries; most significant are aorto-hepatic artery bypass for visceral aneurysm and laparoscopic repair of incisional hernia with large ptfe patch.Weight: 336.6 lbs., bmi 61.3.Obese abdomen, well-healed midline surgical scar, mild right upper quadrant tenderness.Impression/plan: chronic calculous cholecystitis.Recommend laparoscopic cholecystectomy.On (b)(6) 2015: (b)(6) md.History and physical.Right upper quadrant pain associated with nausea; lost 18 or 19 pounds as result of nausea/vomiting.Had multiple abdominal surgeries related to aneurysm in celiac artery; had aorta to hepatic bypass 6/2002 and ligation of gastroduodenal artery aneurysm 3/2005.History of blood clot in arm 10 years ago; treated with anticoagulation for 6 months.Surgical history: exploratory laparotomy 2014.Impression/plan: cholelithiasis; laparoscopic cholecystectomy on (b)(6) 2015.Deemed acceptable cardiovascular risk.On (b)(6) 2015: (b)(6) hospital.Inpatient hospitalization [hospitalization dates unknown].On (b)(6) 2015: (b)(6) md.Operative report.Preoperative diagnosis: chronic calculous cholecystitis.Postoperative diagnosis: chronic calculous cholecystitis.Operation performed: laparoscopic cholecystectomy.Assistant: dr.(b)(6).Anesthesia: general anesthetic, by dr.(b)(6).Procedure: ¿the patient is a 47-year-old female, with a previous history of a visceral aneurysm, including aorta-to-hepatic artery bypass, and laparoscopic repair of an incisional hernia with a 26 x 34 cm ptfe patch, who presents now with symptomatic chronic calculous cholecystitis.She was taken to the operating room, where a general anesthetic was administered.The abdomen was prepped and draped in a sterile manner.Prophylactic intravenous antibiotics were given.Given the previous ptfe patch which was placed in the midline, the abdomen was entered in the right subcostal area, at approximately the anterior axillary line, using a 5 mm optical xcel trocar.Once the peritoneal cavity was safely entered, the abdomen was insufflated with carbon dioxide to a pressure of 15 mmhg.After satisfactory pneumoperitoneum had been established, diagnostic laparoscopy was undertaken with a 5 mm 45-degree viewing laparoscope.Insertion of the laparoscope revealed no evidence of visceral or vascular perforation at the trocar entry site.Further inspection revealed a moderate degree of adhesions between the omentum and the previously-placed ptfe patch.Additional working ports were placed in the right upper quadrant, avoiding the adhesions.A 12 mm trocar was placed in the right mid abdomen, again avoiding the adhesions.The patient was then placed into reverse trendelenburg position, with the right side rotated up to facilitate exposure of the gallbladder.The gallbladder was noted to be distended and chronically inflamed, with a fibrotic appearance.Moderate adhesions between the gallbladder and the omentum were noted.The fundus of the gallbladder was grasped and retracted cephalad.The adhesions between the omentum and the gallbladder were taken down with the harmonic scalpel.Care was taken to avoid injury to the transverse colon and the duodenum during this lysis of adhesions.Once the infundibulum of the gallbladder had been freed from the adhesions, it was grasped and retracted inferiorly/laterally.The peritoneum overlying the triangle of calot was then divided both anteriorly and posteriorly.It should be noted that the aorta-to-hepatic bypass graft was further to the patient¿s left, and it was nowhere near the triangle of calot.We thus did not visualize this graft.The cystic artery was identified, lying within the triangle of calot.It was treated with the harmonic scalpel immediately adjacent to its point of entry into the gallbladder wall, and then divided.The cystic duct was identified and traced to its junction with the gallbladder, as well as to its junction with the common duct.Care was taken to accurately define the critical view, identifying the gallbladder/cystic duct junction from both the anterior and posterior perspectives.Once the critical view had been obtained, the cystic duct was doubly clipped and then divided.Care was taken to assure that the clips were fully and securely across the cystic duct.Care was also taken to assure that the clips did not impinge on the common duct.The gallbladder was now removed from the liver bed using the harmonic scalpel.This provided excellent hemostasis.A final inspection was undertaken to confirm that hemostasis was adequate, that there was no bile leak, and that there was no evidence of injury to the adjacent viscera.The gallbladder was placed into a specimen extraction bag and delivered through the larger trocar site.The fascia at this site was then closed with #1 polysorb using the carter-thomason suture passer.Skin at all sites was closed with subcuticular sutures of 4-0 monocryl.All sites were circumferentially infiltrated with 0.25% marcaine with epinephrine.Indermil was applied at each site.The patient tolerated the procedure well, with no vital sign instability or other complications.Estimated blood loss was less than 10 ml.Sponge counts were correct.¿ on (b)(6) 2015: (b)(6) hospital.Inpatient hospitalization, on (b)(6) 2015.On (b)(6) 2015: (b)(6) md.Emergency department visit.Presents with fever/chills, diffuse abdominal pain, productive cough, hematuria.Laparoscopic cholecystectomy 1 week ago.Gastrointestinal: soft, decreased bowel sounds, diffusely tender, obesity limits evaluation.White blood cell count 11.6 h.Impression/plan: postoperative fever, ascites, tachycardia, mild leukocytosis, abdominal pain.Consult dr.(b)(6); recommends admit, broad spectrum antibiotics, intravenous fluids, ask hospitalist to consult on medical issues.Admit to inpatient unit.On (b)(6) 2015: (b)(6).Radiology ¿ ct abdomen/pelvis with contrast.Indication: fever, abdominal pain, tachycardia.Findings: postsurgical change with mesh of large ventral abdominal wall hernia and focal anterior eventration is grossly unchanged since on (b)(6) 2013.Impression: small to moderate volume ascites, greater than expected for postsurgical timeline.Chronic abdominal vascular abnormalities including occlusion of the celiac axis.Postsurgical ventral abdominal wall hernia repair in unchanged configuration since on (b)(6) 2013.On (b)(6) 2015: (b)(6) laboratory.Microbiology.Blood culture x 2.Final: no growth.Hepatobiliary scan.Impression: positive for bile leak.On (b)(6) 2015: (b)(6) md.History and physical.Laparoscopic cholecystectomy on (b)(6) 2015; stayed overnight due to issues with nausea, discharged on (b)(6) 2015.Called into office on (b)(6) 2015 complaining of continuous oozing from lower abdominal incision after she slipped and fell in bathroom; instructed how to apply direct pressure and pressure dressing.Advised i would be happy to see her in office; patient would like to try above plan first since lives in martinsville.Yesterday, sister called office concerned about patient¿s abdominal pain/fever.Since saturday, having intermittent fevers to 101 degrees.Complained of right lower quadrant pain, chills, loss of appetite, poor oral intake.Sister concerned she was acting ¿funny¿ and sleeping a lot.Reports incisions do not appear infected, no drainage.Multiple co-morbidities which include pancreatitis.Advised to take to (b)(6) emergency room last night.On emergency room arrival, temperature 101.7.Admitted for further evaluation, possible bile leak and sepsis.Kept nothing by mouth, intravenous fluids and zosyn started.Hida scan confirmed bile leak.Will need drain.Transfer to (b)(6) university.Addendum: discussed nature of bile leak after cholecystectomy and how endoscopic retrograde cholangiopancreatography and drain will help symptoms and heal leak.Abdomen obese, soft, tender to palpation in right upper quadrant.Incisions well-healed with small amount of reactive erythema, do not appear infected and no longer draining.Plan to transfer to methodist.On (b)(6) 2015: (b)(6) md.Office notes.Readmitted on (b)(6) 2015 with abdominal pain, fever- bile leak.Endoscopic retrograde cholangiopancreatography on (b)(6) 2015 for bile leak at cystic duct stump; discharged on (b)(6) 2015.Right sided abdominal pain, 7/10; states she was told this may take a while to resolve.Using percocet.Continues intermittent nausea/vomiting but decreasing.Continues on augmentin to complete 10-day course.Gastrointestinal: soft, nontender, nondistended.Trocar sites well healed without cellulitis, seroma or drainage.Impression/plan: looks good! right-sided abdominal pain as expected after bile leak, no drain placed; continue percocet.Bile leak; needs stent removal in 4 to 6 weeks.Nausea/vomiting; history of short segment barrett¿s with mild erosive esophagitis and small hiatal hernia.On proton pump inhibitor twice daily; if symptoms continue once recovered, refer back to dr.Jacobs.Diarrhea may be due to gallbladder removal and/or augmentin.Activity as tolerated.Return to clinic in 3 weeks and follow up to schedule date for stent removal.Relevant medical information: on (b)(6) 2016: incisional hernia repair with nissen.[no medical records provided related to this operative procedure] no records.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® bio-a® tissue reinforcement instructions for use include warnings and addresses the following adverse reactions among others: ¿possible adverse reactions are those typically associated with any implantable prosthesis, and may include, but are not limited to, contamination, infection, inflammation, adhesion, fistula formation, seroma formation, hematoma, and recurrence.¿ procedure and specific patient factors may contribute to or cause infection, leading to contamination, exposure, lack of incorporation and/or seeding of device.Procedure related factors may include adherence to clinical guidelines on infection risk management, contamination of device prior to or during implant, and post-operative persistent/symptomatic seroma and wound management.Patient risk factors may include diabetes, smoking, age, malnutrition, immunosuppressive therapy, post-operative instruction noncompliance, and hygiene.Individual medical decisions, if inconsistent and/or non-conforming to the device manufacturer¿s recommendations, ifu, or recognized best practices, may result in or contribute to an adverse event.As with any surgical procedure, there are always risks of complications for surgical repair of hernias and soft tissue deficiencies, with or without mesh.These may include but are not limited to, adhesions and related harms, bleeding, bowel obstruction, 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.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 and sterilization 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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H6: updated health effect.H6: updated investigation finding.H6: updated investigation conclusions.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® bio-a® tissue reinforcement instructions for use include warnings and addresses the following adverse reactions among others: ¿possible adverse reactions are those typically associated with any implantable prosthesis, and may include, but are not limited to, contamination, infection, inflammation, adhesion, fistula formation, seroma formation, hematoma, and recurrence.¿ procedure and specific patient factors may contribute to or cause infection, leading to contamination, exposure, lack of incorporation and/or seeding of device.Procedure related factors may include adherence to clinical guidelines on infection risk management, contamination of device prior to or during implant, and post-operative persistent/symptomatic seroma and wound management.Patient risk factors may include diabetes, smoking, age, malnutrition, immunosuppressive therapy, post-operative instruction noncompliance, and hygiene.Individual medical decisions, if inconsistent and/or non-conforming to the device manufacturer¿s recommendations, ifu, or recognized best practices, may result in or contribute to an adverse event.As with any surgical procedure, there are always risks of complications for surgical repair of hernias and soft tissue deficiencies, with or without mesh.These may include but are not limited to, adhesions and related harms, bleeding, bowel obstruction, 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 conse 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 and sterilization 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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