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| Device Problem
Insufficient Information (3190)
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| Patient Problems
Death (1802); Unspecified Infection (1930); Pain (1994); No Clinical Signs, Symptoms or Conditions (4582)
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| Event Date 03/12/2016 |
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Event Type
Injury
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Manufacturer Narrative
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(b)(4).(b)(6).It should be noted that the gore-tex® soft tissue patch instructions for use addresses the following adverse reactions among others: ¿possible adverse reactions with the use of any tissue deficiency prosthesis may include, but are not limited to, contamination, infection, inflammation, adhesion, fistula formation, seroma formation, hematoma, and recurrence.¿.
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Event Description
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It was reported to gore in a lawsuit complaint that a patient underwent a hernia repair in 1999 whereby a "gore-tex soft tissue patch and gore-tex dual mesh¿ were implanted.The lawsuit complaint states that the patient ¿¿suffered serious bodily injuries, including infection, extreme pain, and ultimately death.¿ the lawsuit complaint alleges the patient date of death as (b)(6) 2016.The lawsuit complaint alleges that the patient ¿¿incurred substantial medical expenses, and experienced significant mental and physical pain and suffering, and ultimately died from her injures.¿ the lawsuit complaint states the patient ¿¿suffered extreme pain, suffering, mental and emotional anguish, loss of life, expenses of hospitalization and burial expenses.The foregoing losses and injuries are permanent.¿ additional event specific information was not provided.
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Event Description
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The medical records include the following medical history: (b)(6) 2011: small hiatal hernia.(b)(6) 2012: entocort.Recurrent exacerbation of anemia.History: crohns, diverticulosis, spastic bowel, reflux, dyspepsia.(b)(6) 2012: stable appearing abdominal wall hernia containing anterior wall of transverse colon.(b)(6) 2012 history: fibromyalgia, diabetes mellitus, urinary incontinence, obesity, hysterectomy.Entocort.Weight 188.6 pounds, bmi 33.4.(b)(6) 2012: prednisone.(b)(6) 2012 prednisone, entocort.(b)(6) 2013: anemia.Deep punched-out ulcers in ileum.Persistent ulcers.Entocort, prednisone.Multiple shallow antral ulcers.Weight 175 pounds, bmi 31.(b)(6) 2013: suprapubic abscess, status post spontaneous drainage.Prednisone.(b)(6) 2013: history: copd [chronic obstructive pulmonary disease]; cigarette smoker approximately 40 pack year history, quitting in 2010.(b)(6) 2013: history: chronic abdominal pain.Prednisone daily.(b)(6) 2013: start on remicade.(b)(6) 2013: remicade infusion.Weight 170 pounds, bmi 30.1.(b)(6) 2014: hydrocortisone, infliximab [remicade].(b)(6) 2014: hydrocortisone.Infliximab.(b)(6) 2014: noncompliance.Monitor for evolution to a connective tissue disorder with history high inflammation markers, double-stranded dna.(b)(6) 2014: remicade infusions.Weight 178.2 pounds, bmi 32.6.(b)(6) 2014: prednisone.(b)(6) 2014: noncompliance.(b)(6) 2014: ,.(b)(6) 2014:.(b)(6) 2014: hydrocortisone, infliximab.(b)(6) 2014: abdominal wall abscess.(b)(6) 2014: placement of percutaneous drainage catheter into anterior abdominal wall abscess.(b)(6) 2014: total parenteral nutrition.(b)(6) 2014: history: inflammatory arthritis related to inflammatory bowel disease.Intermittent prednisone.Remicade.Total parenteral nutrition.(b)(6) 2015 developed right abdominal and pelvic abscess with polymicrobial flora secondary to infected mesh.Intraoperative cultures have anaerobes, streptococcus anginosus, escherichia coli, coryneform bacteria.History: gastroesophageal reflux disease.(b)(6) 2015 bmi 30.37, weight 171.4 pounds.(b)(6) 2015 abdominal abscess.(b)(6) 2015 prednisone.(b)(6) 2015 abdominal abscess, recurrent.History: overactive bladder, ulcerative colitis, severe arthritis prednisone-dependent.(b)(6) 2015 total parenteral nutrition.(b)(6) 2015 weight 77.8 kilograms.Asa 3.Abdominal wall abscess.(b)(6) 2015 prednisone daily.Infected mesh, small bowel fistula.History: infection of abdominal mesh.Respiratory failure, elective intubation.(b)(6) 2015 abscess drainage insertion.[wound] vacuum therapy discontinued.(b)(6) 2015 prednisone.(b)(6) 2015 remicade.Infection resolved.Incision healed.(b)(6) 2015 infected feet.(b)(6) 2016: blood in stool.Gastrointestinal bleed.(b)(6) 2016:chronic anemia.History: crohn¿s disease with many surgeries remicade.Questionable angiodysplasia mid gastric body, cauterized, clip placed.(b)(6) 2016: diverticular bleed.History: multiple abdominal surgeries for hernia repairs with subsequent infection, replacement.(b)(6) 2016:asa 4e [emergent].Gib [gastrointestinal bleed], s/p [status post] cardiac arrest.(b)(6) 2016:severe gastrointestinal bleeding status post procedure.Upper and lower, pouring blood from ileal stoma, orogastric tube.(b)(6) 2016:: expired.Preliminary cause of death: infection surgical history: cesarean sections [1982, 1986], 1998: small intestine rupture with repair in mexico.2007: laparoscopic appendectomy, small bowel resection.(b)(6) 2015 history: cholecystectomy, colostomy.(b)(6) 2015 placement of percutaneous drainage catheter into anterior abdominal wall abscess using ultrasound guidance.(b)(6) 2015 laparotomy with lysis of extensive intraabdominal adhesions.Removal of abdominal wall mesh.Debridement of abdominal wall including the skin and the muscle layers.Small bowel resection with side-to-side anastomosis of two segments of small bowel.Placement of gastrostomy tube, large wound vac [vacuum assist closure].The operation overall extremely difficult, tedious and it is not a routine operation.(b)(6) 2016 history: crohn disease with many surgeries.(b)(6) 2016 surgery: total colectomy with end ileostomy.Extensive lysis of adhesions.Small bowel resection with primary anastomosis.Excision of 7 different small bowel diverticula.Repair of multiple serosal tears, at least 7-8 different areas of small bowel.Placement of gastrostomy tube.
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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: records prior to (b)(6) 2011; including operative report for the alleged implant of a gore device, were not provided.On (b)(6) 2011: fp [family practice] adult clinic.(b)(6) , md.Office notes.Diagnostic results: ct abdomen/pelvis.Indication: possible crohn disease.History diverticulosis.Generalized abdominal pain 2-3 years.Findings: small hiatal hernia is seen.Impression: small ventral hernia containing anterior wall of transverse colon without evidence of obstruction.Mesenteric adenitis.Scattered colonic diverticulosis.Dr.(b)(6).On (b)(6) 2012: (b)(6) clinic.(b)(6) , md.Office notes.Presents with very nonspecific pain, sometimes epigastric region, sometimes left upper quadrant, sometimes left lower quadrant.Has had multiple surgeries, has hernias.Has mesh related to hernia repair.Colonoscopy showed definitive ulcers in terminal ileum.I felt she had crohn¿s, serology negative for crohn¿s.After i put her on entocort, patient had complete resolution of diarrheal symptoms, pain got better.Unfortunately, we had to take her off nonsteroidals because of recurrent exacerbation of anemia with ulcers in terminal ileum.Has chronically elevated inflammatory markers, not sure why.Impression/plan: pain may or may not be related to pathology i had seen on endoscopy.It could be related to hernias, scar tissue.Repeat cat scan abdomen, continue entocort.Gastrointestinal: tender, ventral hernia.(b)(6) 2012: (b)(6) dr.(b)(6) radiology ¿ ct abdomen/pelvis.Indication: crohn¿s disease, history enlarged lymph nodes.Findings: surgical material is noted throughout the abdomen.Surgical material is noted in anterior abdominal wall.Impression: stable mesenteric lymphadenopathy.Stable appearing abdominal wall hernia containing anterior wall of transverse colon.(b)(6) 2012: b)(6) clinic.(b)(6) md.Office notes.Overall patient is somewhat decondioned [sic].Gastrointestinal: tender.(b)(6) 2012: (b)(6) clinic.(b)(6) md.Office notes.Last week she called, apparently was more sick.Had pain, nausea, vomiting.Discomfort and pain epigastric up to midabdominal region.Impression/plan: based on history, she might have had partial obstruction which has resolved.Abdomen: incisional hernia.Some epigastric pain.(b)(6) 2012: (b)(6) md.Procedure report.Colonoscopy.Indication: crohn¿s, anemia.Evaluated status, activity.Postoperative diagnosis: deep punched-out ulcers in ileum.Impression/plan: persistent ulcers, couple of them are deep.Certainly, could be source of blood loss.I am not convinced entocort is totally keeping it in remission.(b)(6) 2013: (b)(6) clinic.(b)(6) , md.Office notes.Follow up colonoscopy.Active ulcers in spite of being on entocort.I stopped entocort, started on prednisone.Impression/plan: spent time going over all risks of anti-tnf agents like humira and remicade.Will definitely wean down prednisone.Strongly consider initiating some other treatment for both inflammatory arthropathy and crohn¿s disease.(b)(6) 2014: (b)(6) md.Procedure report.Colonoscopy with cold biopsy.Postoperative diagnosis: ileal ulcers.Only 2 small ones remaining.Very insignificant compared to what we found before.Indication: crohn¿s disease.Anemia, etiology not clear.Treating aggressively for crohn¿s with remicade.Impression/plan: couple residual ileal ulcers.Overall, i think crohn¿s is under control.[anemia] is probably related to anemia of chronic disease.(b)(6) 2014: (b)(6) md.Emergency department note.Impression: abdominal infection.Admitted.This also could be result of a extension of her crohn¿s disease vis-à-vis a fee [sic] fistula to abdominal wall.Abdomen: erythema, swelling mid abdominal wall.Old scar there with erythema, appears to be somewhat deep seated.(b)(6) 2014: (b)(6) md.Consultation.Abdominal wall abscess.She mentioned 7 operations, some maybe for crohn disease, others for hernia surgery, those included implantation of mesh.4-5 days abdominal pain.Ct abdomen, pelvis positive for abdominal wall abscess.Abscess is above her mesh but could be communicating with her mesh, also with her intestine, especially with history of crohn disease.Impression: most recent surgery 2007.I am worried about infection, fistula.Plan: ct guided drainage, culture, fistulagram.(b)(6) 2014: (b)(6) radiology ¿ ct abdomen/pelvis.Indication: umbilical abdomen pain 5 days, elevated white blood cells 16.5.Impression: subcutaneous abscess involving right paracentral abdominal wall which closely abuts a probable dehisced surgical site.Surgical changes from partial small bowel resection.Small midline abdominal wall hernia superior to the fluid collection containing fat and transverse colon.(b)(6) 2014: (b)(6) history and physical.Skin: erythema surrounding mid abdomen measuring approximately 20 x 25 cm, poorly demarcated overlying an area of swelling with fluctuance consistent with ct findings of abscess.I cannot clinically identify hernia as patient is in significant pain.Impression/plan: subcutaneous abscess, incisional hernia.Antibiotics, surgical consult.(b)(6) 2014: (b)(6) re, aerobe/anaerobe: gram stain: many wbc¿s [white blood cells], gram positive cocci, gram negative rods, few gram-positive rods.Culture aerobic/anaerobic: escherichia coli 4 (+), streptococcus anginosus group 4 (+), porphyromaonas prevotella group 4 (+), coryneform rods 1 (+).Source: abscess.(b)(6) 2014: (b)(6) notes.Abdomen distended, irregular contour, localized bulging ruq [right upper quadrant].Rlq [right lower quadrant] firm, tender.(b)(6) 2014: (b)(6) nsultation.Abdomen: erythema mid-abdomen, poorly demarcated.Cultures showing escherichia coli.Impression: once abscess is completely drained, we can get down in area to see if there is communication with bowel.(b)(6) 2014: (b)(6) radiology ¿ ct abdomen/pelvis.Indication: follow up abscess.Impression: stable percutaneous abscess drain with significant decrease size of anterior wall abscess.Some residual purulence at level of umbilicus.Soft tissue gas is noted in adjacent abdominal wall defect with subtle findings suspicious for enteric fistula with an immediately adjacent loop of small bowel.(b)(6) 2014: (b)(6) progress notes.Surgical management agreed with once all infection, pus is drained, the main thing is to determine if there is entero-cutaneous fistula.Crohn¿s disease, no rx [medication] at this time in face of infection.On (b)(6) 2014: (b)(6) south.Microbiology.Accession #: [ni].Culture, aerobe/anaerobe: gram stain: many wbc¿s [white blood cells], moderate gram-positive cocci, rare gram-negative rods.Culture aerobic/anaerobic: escherichia coli 1 (+), coryneform rods 1 (+).Source: abscess.On (b)(6) 2014: (b)(6) south.(b)(6) , md.Progress notes.Better erythema of abdominal wall in affected area.Indurated area periumbilical, right mid-abdomen.On (b)(6) 2014: (b)(6) south.Nurse notes.Right upper quadrant drain, drainage tan, creamy, small amount, dressing dry, intact.Periumbilical drain, drainage tan, small amount, dressing dry, intact.On (b)(6) 2014: (b)(6) hospital system.(b)(6) , do.Radiology ¿ fistulagram/sinus tract.Indication: fistulagram abscess drainage catheter.Impression: abscessogram revealing contrast material contained to abscess cavity, no intra-abdominal extension.On (b)(6) 2014: (b)(6) south.(b)(6) , md.Progress notes.Gastrointestinal: drains in place, minimal drainage.Still some induration in mid-abdomen.On (b)(6) 2014: (b)(6) south.(b)(6) , md.Progress notes.No drainage, looks good.Suspect infected mesh will require removal at some point.On (b)(6) 2015: (b)(6) hospital system.(b)(6) , md.Radiology ¿ ct abdomen/pelvis.Indication: abscess.Impression: interval decrease in fluid and air in anterior abdominal wall subcutaneous tissues.Two percutaneous abdominal wall drains visualized in place.Stable appearing ventral midline abdominal wall hernia containing transverse colon superior to drainage catheters.On (b)(6) 2015: (b)(6) south.(b)(6) , md.Progress notes.Less abd [abdominal] discomfort.Gastrointestinal: distended, appropriate tenderness.On (b)(6) 2015: (b)(6) south.Nurse notes.Pink area above umbilicus continues to improve.Right lateral upper quad [quadrant] drain, drainage tan, small about, dressing dry, intact.Periumbilical area drain, serosanguinous, small amount drainage, dressing dry, intact.On (b)(6) 2015: (b)(6) hospital system.(b)(6) , md.Consultation.Indication: abdominal abscess.Developed right abdominal and pelvic abscess with polymicrobial flora secondary to infected mesh, possible fistula secondary to her previous abdominal surgeries.Admitted (b)(6) 2014 for same problem.Has ct guided drains in place.Dr.(b)(6) recommended 4-6 weeks iv [intravenous] antibiotics to cool down infection, then consider taking mesh out.Intraoperative cultures have anaerobes, streptococcus anginosus, escherichia coli, coryneform bacteria.Abdomen: slightly distended.2 drains right lower quadrant.Impression: right lower abdominal abscess, possibility infected mesh.On (b)(6) 2015: (b)(6) south.Nurse notes.Healed pink area above umbilicus.Right upper quadrant drain removed today, dressing dry, intact.Periumbilical drain removed today, dressing dry, intact.On (b)(6) 2015: (b)(6) hospital system.(b)(6) , md.Discharge summary.Admit date: (b)(6) 2014.Subcutaneous abscess.Presented to emergency room secondary to 5-day course of abdominal pain.Hospital course: antibiotics.Underwent surgical incision and drainage of abscess, drain put in.Sent home on iv [intravenous] antibiotics for 6 weeks.Has mesh on abdominal area that will need to be removed.Will try to do this in 4 weeks.Discharged in stable condition.On (b)(6) 2015: id [infectious disease] clinic.Phone call.Pharmacist called to say patient, family having problems with grasping the iv [intravenous] pump they sent out.Will send different delivery system, but had concerns if the patient can keep up with zosyn [antibiotic] every 6 hours.On (b)(6) 2015: (b)(6) office notes.Hospital follow up, abdominal abscess/iv [intravenous] antibx [antibiotics].Abdominal abscess resolving.Also might have infected mesh.Daptomycin [antibiotic] added to zosyn.Impression/plan: if infection keeps on coming back mesh might need to come out.On (b)(6) 2015: clinic.Phone call.Homecare nurse calling to say she is unsure how often patient is taking zosyn iv [intravenous].States they have on record every 8 hours, pharmacy states every 6 hours.Advised that medication is supposed to be daptomycin every 24 hours, zosyn every 6 hours.On (b)(6) 2015: notes.Follow up abdominal abscess.Completed 6 wks [weeks] iv [intravenous] antibiotics for abdominal abscess.Crp [c-reactive protein] trending up may be due to stoppage of remicade for ulcerative colitis.Impression/plan: infected prosthetic mesh of abdominal wall, abdominal abscess.Start po [by mouth] [antibiotics] x 4 weeks step down therapy.With recurrence of abscess after completion of antibiotics mesh would need to come out as well.Abdomen: scar clean.On (b)(6) 2015: (b)(6)office notes.Hospital follow up.Doing well on remicade.Unfortunately, with her underlying diabetes and other issues, she developed an abdominal abscess.It was drained.She has mesh so i did talk to dr.(b)(6)is obviously potential infection for the mesh.Impression/plan: obviously has infection in abdomen.As per discussion with dr.(b)(6) it obviously had some communication with the mesh.I can not for one moment believe with underlying diabetes and a mesh in place that she is not a high risk for getting infection again and these infections may also be opportunistic infections.I am extremely hesitant to start remicade again.Will put on prednisone.We will have to make concrete decision about this mesh.I think best thing would be to remove mesh and later put in a new mesh.Obviously this is difficult surgery and surgeon is obviously reluctant to jump into it.Nonetheless, it is very important that we have to consider definite management because she is going to be on immunosuppressive therapy for rest of her life.On (b)(6) 2015: (b)(6) office notes.Ab [abdomen] pain.Had abdominal wall abscess, has mesh in.Drainage done, antibiotics.Because of a difficult surgical problem it was felt we should try seeing how she does on antibiotics.Because surgery with removal of mesh would be a higher morbidity.Impression/plan: abdominal abscess.This will need definitive treatment with drainage and surgery to remove mesh, probably healing by secondary intention.The patient has clearly shown that this mesh is infected and antibiotics, drainage are not going to be working for her.Abdomen: marked edema, recurrent abscess in abdominal wall.On (b)(6) 2015: (b)(6) story and physical.Clinical signs, physical findings of cellulitis with history infected intraabdominal mesh.Abdomen: obese.Obvious area skin abscess with redness, erythema, tenderness just below belly button.Plan: will get intraoperative cultures.Mesh will need to come out.At this time, there is no absolute contraindication why this patient cannot undergo the mentioned surgery.On (b)(6) 2015: (b)(6) consultation.Indication: abdominal abscess, recurrent.Admitted for same problem 01/15, abscess cleaned out, mesh was retained.There was an effort to preserve the mesh.Immunosuppressive therapy withheld.After 6 weeks antibiotics, step down therapy.Abdominal abscess site turning red, inflamed with recurrence of signs infection.Abdomen: tenderness right periumbilical area, some cellulitis.Impression: recurrent abdominal abscess, infected mesh.Plan: antibiotics, surgical consult.On (b)(6) 2015: (b)(6) diology ¿ ct abdomen/pelvis.Indication: abdominal wall abscess follow up.Abdominal pain at site 5 days.History of infected mesh.Impression: abscess associated with mesh for repair of anterior abdominal wall hernia, measuring about 7.9 x 4.7 x 6.8 cm.An associated defect within the match [sic], and abscess/inflammatory change extends posterior to the mesh, abutting small bowel loops, which demonstrate mild reactive wall thickening.A knuckle of transverse colon is again noted passing through the anterior abdominal wall defect, near the superior margin of the hernia mesh.On (b)(6) 2015: (b)(6)egible].Progress notes.Feeling better, concerned about fever, has abd [abdominal] discomfort.Abd [abdomen]: mildly distended, mild generalized tenderness.Impression/plan: hospital day #6 diverticulitis [with] abscess.Surgery on tuesday.Atbx [antibiotics].On (b)(6) 2015: (b)(6) operative report.Preoperative diagnosis/diagnoses: recurrent abdominal wall abscess.Patient previously had seven abdominal laparotomy in the past including bowel resection, lysis of adhesions, repair of abdominal incisional hernia with mesh, abscess including the mesh and possibly there is a fistula between the mesh and the small bowel.Postoperative diagnosis/diagnoses: abdominal wall abscess.A fistula between the mesh and the small bowel.Extensive abdominal adhesions involving the whole abdomen.Procedure: laparotomy with lysis of extensive intraabdominal adhesions.Adhesions took three-quarter of the time of the operations.Removal of abdominal wall mesh.Debridement of abdominal wall including the skin and the muscle layers.The measurement of the debridement including 10 centimeters long by 10 centimeters wide.Small bowel resection with side-to-side anastomosis of two segments of small bowel.Placement of gastrostomy tube to help me with postoperative nutrition and gastrointestinal suction.Placement of large wound vac.The operation overall is extremely difficult and extremely tedious and it is not a routine operation.It took total of about 4 or 5 hours.Indications: ¿this is a 59-year-old female who had seven abdominal operations in the past and all for crohn disease and lysis of adhesions, bowel resection, and bowel obstruction in the past, incisional hernia repair with mesh.She had presented to the hospital some time in december this past year with abdominal wall abscess.At that time we were able to treat the abscess with percutaneous drainage and long-term iv [intravenous] antibiotic and had done very well for a few months.However, she comes back to the hospital with recurrent abdominal wall abscess.A decision was made to take her to surgery for removal of the mesh and also probably bowel resection.The patient understood the operation and she understood that it is going to be complicated and lengthy.She also understood that we are going to leave the incision open with a wound vac [vacuum assist closure].Intraoperatively i encountered abdominal wall abscess which involved encompassed gore-tex mesh which was placed in the abdominal wall and had to be removed completely.Also i believe there is a fistula between the mesh and the small bowel which has led to recurrence of this infection.The operation was very lengthy, tedious, and involved extensive intraabdominal adhesions but i was able to do it and did all adhesiolysis from ligament of treitz all the way to the ileocecal valve.I ended up removing two segments of small bowel with two anastomosis.The remaining small bowel is long enough to prevent small bowel short-bowel syndrome.A gastrostomy tube was placed.A large wound vac [vacuum assist closure] was placed in the incision.The patient has been on antibiotic preoperatively.Also she has been on lovenox as well as tpn [total parenteral nutrition].I did discuss the finding with the family post surgery.¿ procedure: ¿in supine position, after induction of general endotracheal anesthesia without complication, the patient prepped and draped in usual manner.A midline incision through the old scar was made through the skin and subcutaneous tissue.Hemostasis achieved completely using cautery.The fascia was opened midline and then slowly i entered the abdominal cavity taking the adhesions down using sharp dissection.I continued to go down through the midline until i got into the abscess cavity, which is encompassed mesh.I continued to open abdominal wall.I removed the old mesh and then i started going laterally on taking down the adhesions cell by cell.It was a very tedious process.But i continued to do that completely both on the right side, as well as the left side.Then i left the midline alone in the middle and then i continued to do the dissection in lower pelvis until eventually i was able to separate the mid abdomen bowel which involved the mesh and the small bowel from the anterior abdominal wall.Then i spent significant amount of time, almost 2-1/2 to 3 hours, doing all lysis of adhesions.Also that allowed me to know the anatomy where the fistula is located.Once i was able to do that and i did that very carefully to prevent any damage to the intestine.I started resecting the bowel where the fistula is located using endo-gia to transect the bowel proximal to the fistula and distal to the fistula.Two segments of small bowel was removed and the segment in between those areas where viable.Then i went ahead and did two anastomosis side-to-side small bowel using endo-gia and ta55 4.8.The staple line was reinforced using 3-0 silk in interrupted fashion and the defect of the mesentery was closed using 3-0 vicryl continuous fashion.The same technique was followed to do the second anastomosis, side-to-side using endo-gia blue load, and ta55 to close the enterotomy.The staple line was reinforced with 3-0 silk interrupted fashion as well.The defect of the mesentery was closed using 0 vicryl in continuous fashion.After i performed that, i continued taking down all adhesions.The small bowel was stuck in the pelvis next to the colon.I was able to identify the left colon and also the sigmoid area and slowly dissecting the small bowel of the colon until i reached the ileocecal valve.Then after i performed that i ran the small bowel more than one time, at least three times to make sure there is no damage to the intestine, and no serosal tears and there was none.Then i decided to place a gastrostomy tube which will help me with postoperative management for nutrition and gastrointestinal suction as well.I passed a foley catheter through the abdominal wall.A pursestring suture of 3-0 silk was placed in the anterior wall of the stomach.The foley placed in the stomach and the stomach attached to the anterior abdominal wall using 3-0 silk interrupted fashion.The abdominal cavity was irrigated with antibiotic irrigation.No hemostatic agent was placed in the pelvis.It was oozing a little bit.Then i placed a drain, one in the pelvis coming out in the left lower quadrant, and one in the left gutter coming out on the left side, and one in right gutter coming out of the right side as well.Then i went ahead and debrided the abdominal wall where the mesh was removed and the abdominal wall was very thick and indurated and infected.I removed part of the fascia.I removed part of the skin.The segment that was removed was 10 x 10 centimeters and hemostasis achieved completely using cautery.Then a decision was made to close the abdominal wall primarily without adding any mesh and that was performed by approximating the midline using #1 looped pds in interrupted fashion.It came together without excessive tension.Once i closed the midline in the middle then i went ahead and ran the pds from the epigastric area all the way down to the pubic area using #1 looped pds as well.The subcutaneous tissue was left open, irrigated, and then i placed a large wound vac [vacuum assist closure].Then i attached all the drains and gastrostomy tube into the skin using 2-0 nylon.The patient tolerated the procedure well.Left the operating room intubated to the recovery room.I had discussed the details of the operation with the family and she had received about 4 units of blood and 2 units of ffp [fresh frozen plasma], and lost a total of 400 ml of blood.¿.
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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: please see the attached file for information ascertained from the medical records received on 1/10/20.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-tex® soft tissue patch 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.¿.The gore-tex® soft tissue patch instructions for use also states: ¿strict aseptic techniques should be followed.If an infection develops, it should be treated aggressively.An unresolved infection may require removal of the material.¿.W.L.Gore & associates, inc.(gore) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by gore, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Blank fields present on this report include required fields and fields determined to be not applicable.Blank required fields indicate that the information was not provided, was deemed unavailable or was not applicable.This report does not constitute an admission or a conclusion by fda, gore, or its associates that the device, gore or its associates caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects" or has "malfunctioned".These words are included in the report and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.
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Manufacturer Narrative
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H6: updated health effect- clinical code h6: updated investigation findings h6: updated investigation conclusion h6: health effect impact code: f26: no health consequences or impact previous patient codes (1802, 1930, 1994 and 3191 ¿ appropriate term/code not available used for "suffered serious bodily injuries, including infection, extreme pain, and ultimately death.¿) were reported based on the original complaint and are no longer applicable per gore¿s investigation.The gore-tex® soft tissue patch was utilized as product form initially based on the ambiguous wording of the original lawsuit complaint.Gore¿s investigation determined it was not a gore-tex® soft tissue patch.Therefore, no further investigation is required at this time.This event will be closed as no problem detected.Medical records: ¿ the known medical records span (b)(6), 1999 through (b)(6), 2016 and not all records received in this time span are relevant to the unknown gore® dualmesh® biomaterial.¿ the product identification for the gore® dualmesh® biomaterial that was implanted on (b)(6), 1999 was not provided.¿ there is no medical record documentation to indicate that a gore-tex® soft tissue patch was implanted or explanted at any time.Patient information: medical history: ¿ large incisional hernia in periumbilical and hypogastric area ¿ crohn¿s disease ¿ stress ulcer ¿ erosive gastritis ¿ gastroesophageal reflux disease [gerd] ¿ small hiatal hernia ¿ small ventral hernia ¿ diverticulosis ¿ chronic obstructive pulmonary disease [copd] ¿ chronic abdominal pain ¿ severe arthritis, prednisone dependent ¿ 6/96: small intestine rupture; diverticulitis with perforation [in mexico] ¿ diabetes mellitus - 1/16/06: requires insulin.¿ obesity - 3/4/99: 210 lbs., bmi 37.2.¿abdomen: large, obese and globular.¿ - 3/18/12: 188.6 lbs., bmi 33.4 - 6/10/14: 178.2 lbs., bmi 32.6 - 1/21/15: 171.4 lbs., bmi 30.37 ¿ smoking - 3/2/99: ¿does not smoke cigarettes.¿ - 4/5/00: ¿smokes occasional cigar.¿ - 9/29/11: ¿former use 1½ years ago.¿ - 6/9/13: ¿cigarette smoker, 40 pack year history, quit in 2010.¿ ¿ 5/29/13: suprapubic abscess ¿ 12/22/14: abdominal wall abscess ¿ 1/6/15: right abdominal and pelvic abscess with polymicrobial flora secondary to infected mesh.¿ 3/2/16: severe gi bleed, pouring blood from ileal stoma and orogastric tube.¿ 3/12/16: expired.Death certificate.Immediate cause: (a) ards [acute respiratory distress syndrome].Prior surgical procedures: ¿ 1982: cesarean section ¿ 1986: cesarean section ¿ unknown date: tubal ligation ¿ unknown date: fatty tumor removed in abdomen ¿ 1995: laparoscopic cholecystectomy ¿ 6/96: hemicolectomy - left colon resection and hartmann colostomy [in mexico] ¿ 11/96: takedown of hartmann colostomy, low anterior anastomosis.¿ unknown date: hysterectomy implant preoperative complaints: ¿ 3/2/99: periumbilical incisional hernia in left lower quadrant which developed secondary to colostomy.¿healed transverse incision in left flank consistent with colostomy site with hernia protruding from the periumbilical area on the right side and also the left colostomy incision site.No incarceration of hernia appreciated.¿ ¿ 3/4/99: ¿has large bulging mass through lower abdomen.(b)(6) 1998 presented a bulging mass in two different places around umbilicus and in lower third of the wound of the scar.¿ ¿midline scar from the hernia around the umbilicus and also in mid infraumbilical area with protrusion of soft reducible nontender mass.No obvious evidence of incarceration, no organomegaly.¿ implant procedure: incisional hernia repair, lysis of multiple small bowel adhesions, insertion of a ¿gore-tex dual mesh¿, panniculectomy of the mid abdomen.Implant: gore® dualmesh® biomaterial (unk/unk).Implant date: (b)(6), 1999 (hospitalization (b)(6), 1999) ¿ description of hernia being treated: ¿the incision was deepened down to the anterior rectus sheath and the fascia of the external oblique and the rectus muscle were identified.All the redundant panniculus was then removed using a low current bovie.The patient was found to have a large defect which was completely replacing the mid abdomen from the supraumbilical area to almost the pubic symphysis.In addition, there were two or three areas of weakness and herniation almost all the way up to the xiphoid process.In view of that finding, i decided to open the sac, remove all the redundant sac which was done without to [sic] much difficulty and then try to dissect enough wall of the abdomen laterally, medially, superiorly and inferiorly which proved to be quite difficult due the presence of dense multiple small bowel adhesions.The small bowel was ¿cemented¿, so to speak against the posterior abdominal wall and those bowel loops were painstakingly taken down one by one with sharp dissection.Once this was done and all the dense adhesions had been taken down, decent fascia was then detected lateral and medially.As was stated, the fascia was extremely attenuated and thin and weak in the upper abdomen and subxiphoid area and also in the suprapubic area.¿ ¿ implant size and fixation: ¿due to the large defect present, i decided to use a 10 x 9 cm in size dual mesh gore-tex graft with the smooth edge toward the peritoneum and the rough edge outside so as to avoid any adhesions from the bowel to the gore-tex mesh.This gore-tex mesh was then attached to the undersurface of the posterior abdominal wall using a running stitch of 0-0 gore-tex.This was done all around the defect with care being taken to overlap the anterior aspect of the fascia so as to re-enforce [sic] the posterior gore-tex.This was done with relative ease.Once this was accomplished, i was able to reapproximate the edges of the fascia side to side on top of the dual mesh using interrupted stitches of 0-0 ethibond.The subcutaneous tissue was reapproximate [sic] with interrupted stitches of 3-0 vicryl and dermal stitches of 4-0 vicryl were then applied to the dermis.¿ ¿ post-operative period: [4 days] o 3/9/99: discharge summary: ¿postoperatively did develop low grade fever; placed on augmentin.Discharged on fourth postoperative day without any complication.Developed anemia postoperative.Home on ferrous sulfate.¿ ¿ post-operative period: [1-2 weeks] o 3/12/99 ¿ 3/19/99: hospitalization: upper abdominal pain, nausea and vomiting.¿well-healing transverse incision with no signs of secondary infection.Bowel sounds reduced, tenderness primarily in left upper quadrant.Abdominal series shows dilated loops of small bowel and some air-fluid levels consistent with either ileus or partial small bowel obstruction.Impression: acute abdominal pain.Partial small bowel obstruction.¿ o 3/19/99: discharge summary.Final diagnosis: partial small bowel obstruction, adynamic ileus status post incisional hernia repair.Relevant medical information: ¿ 4/5/00: acute abdominal pain.Ct abdomen shows small bowel obstruction.Conservative treatment.¿ 1/2/02: abdominal pain.¿ 1/2/02 ct abdomen: ¿evidence of prior repair of midline anterior abdominal wall hernia with presence of mesh or other reinforcer.Inflammatory standing in peritoneum subjacent to reinforcing mesh.Distended bowel loops in this region.¿ ¿ 1/7/02: ct abdomen: ¿suggests pattern of partial small bowel obstruction likely due to adhesions.Severity improved.¿ ¿ 1/15/06: chronic abdominal pain.¿ 1/15/06: ct abdomen: ¿high-grade bowel obstruction with multiple bowel loops adhesed to the anterior abdominal wall.Some interloop mesenteric fluid noted, possibility of internal hernia cannot be excluded.¿ ¿ 1/19/06: ct abdomen: ¿improvement with resolving small bowel obstruction.¿ conservative treatment.¿ 8/23/06: recurrent abdominal pain.Diverticulosis per colonoscopy.Revision preoperative complaints: ¿ 3/31/07: ¿lot of pain for past couple days and getting worse; describes pain all over abdominal area.¿ impression: small bowel obstruction.Revision procedure: laparotomy, lysis of extensive intraabdominal adhesions took more than half of the time of the operation.The operation took almost 4 hours.It was very tedious difficult work.Small bowel resection with side-to-side anastomosis.Revision date: (b)(6), 2007 (hospitalization (b)(6), 2007 through (b)(6), 2007) o findings: ¿she had extensive intraabdominal adhesions that go from the ligament of treitz all the way to the ileocecal valve.The bowel looks like spaghetti.It took me a long time to lyse all of the adhesions.I was able to do this successfully.¿ ¿ ¿she does have a gore-tex mesh in the midline from previous hernia repair.She had a midline incision and transverse abdominal incision previously.I had to cut through the mesh to enter the abdominal cavity.¿ o procedure: ¿i spent at least 2-1/2 hours taking all of the adhesions down which i was able to do without damaging the bowel.I did that from the ligament of treitz all the way to the ileocecal valve using sharp dissection.Once that was accomplished i decided that the middle part of the intestine has chronic obstruction and is all kinked, and is not going to work on this patient.I elected to remove that.Maybe she had some kind of bezoar in it where she has thick small bowel content.Gia was used proximal and distal to that segment and then gia was also used to transect the mesentery of the small bowel.Then side-to-side anastomosis was carried out using gia and a ta-55 4.8.Before doing the anastomosis the proximal part of the small bowel was evacuated which resulted in thick material, for which probably was good to retrieve it because it probably would cause further obstruction like a bezoar.Then closure of the abdominal cavity was achieved by approximating the fascia using #2 nylon in a continuous fashion.Addendum: ¿i did perform an appendectomy because it was kinked and the tip appeared inflamed.¿ o 3/31/07: pathology for appendix and small bowel.No mention of mesh.O 4/18/07: discharge summary: ¿postoperatively developed complications.Started on total parenteral nutrition and recovery was very slow.Gradually, recovered and started tolerating oral diet.Staples were removed.¿ relevant medical information: ¿ 4/18/11: generalized abdominal pain for 2-3 years.Ct abdomen: ¿small ventral hernia containing anterior wall of transverse colon without evidence of obstruction.¿ ¿ 1/25/12: ct abdomen: ¿surgical material is noted in anterior abdominal wall.Stable appearing abdominal wall hernia containing anterior wall of transverse colon.¿ ¿ 12/22/14: ct abdomen: ¿subcutaneous abscess involving right paracentral abdominal wall which closely abuts a probable dehisced surgical site.Small midline abdominal wall hernia superior to the fluid collection containing fat and transverse colon.¿ ¿ 12/25/14: ct abdomen: ¿stable percutaneous abscess drain with significant decrease size of anterior wall abscess.Some residual purulence at level of umbilicus.Soft tissue gas is noted in adjacent abdominal wall defect with subtle findings suspicious for enteric fistula with an immediately adjacent loop of small bowel.¿ culture positive for escherichia coli.Abscessogram: no intra-abdominal extension.Explant preoperative complaints: ¿ 3/9/15: ¿had abdominal wall abscess, has mesh in.Drainage done, antibiotics.Impression/plan: abdominal abscess.The patient has clearly shown that this mesh is infected and antibiotics, drainage are not going to be working for her.Abdomen: marked edema, recurrent abscess in abdominal wall.¿ ¿ 3/10/15: ct abdomen/pelvis: ¿abscess associated with mesh for repair of anterior abdominal wall hernia, measuring about 7.9 x 4.7 x 6.8 cm.An associated defect within the match [sic], and abscess/inflammatory change extends posterior to the mesh, abutting small bowel loops, which demonstrate mild reactive wall thickening.A knuckle of transverse colon is again noted passing through the anterior abdominal wall defect, near the superior margin of the hernia mesh.¿ explant procedure: laparotomy with lysis of extensive intraabdominal adhesions.Adhesions took three-quarter of the time of the operations.Removal of abdominal wall mesh.Debridement of abdominal wall including the skin and the muscle layers.The measurement of the debridement including 10 centimeters long by 10 centimeters wide.Small bowel resection with side-to-side anastomosis of two segments of small bowel.Placement of gastrostomy tube to help me with postoperative nutrition and gastrointestinal suction.Placement of large wound vac.Explant date: (b)(6), 2015: [hospitalization (b)(6), 2015 through(b)(6), 2015] ¿ findings: ¿intraoperatively i encountered abdominal wall abscess which involved encompassed gore-tex mesh which was placed in the abdominal wall and had to be removed completely.Also i believe there is a fistula between the mesh and the small bowel which has led to recurrence of this infection.The operation was very lengthy, tedious, and involved extensive intraabdominal adhesions but i was able to do it and did all adhesiolysis from ligament of treitz all the way to the ileocecal valve.I ended up removing two segments of small bowel with two anastomosis.The remaining small bowel is long enough to prevent small bowel short-bowel syndrome.¿ ¿ procedure: ¿a midline incision through the old scar was made through the skin and subcutaneous tissue.Hemostasis achieved completely using cautery.The fascia was opened midline and then slowly i entered the abdominal cavity taking the adhesions down using sharp dissection.I continued to go down through the midline until i got into the abscess cavity, which is encompassed mesh.I continued to open abdominal wall.I removed the old mesh and then i started going laterally on taking down the adhesions cell by cell.It was a very tedious process.But i continued to do that completely both on the right side, as well as the left side.Then i left the midline alone in the middle and then i continued to do the dissection in lower pelvis until eventually i was able to separate the mid abdomen bowel which involved the mesh and the small bowel from the anterior abdominal wall.Then i spent significant amount of time, almost 2-1/2 to 3 hours, doing all lysis of adhesions.Also that allowed me to know the anatomy where the fistula is located.Once i was able to do that and i did that very carefully to prevent any damage to the intestine.I started resecting the bowel where the fistula is located using endo-gia to transect the bowel proximal to the fistula and distal to the fistula.Two segments of small bowel was removed and the segment in between those areas where [sic] viable.Then i went ahead and did two anastomosis side-to-side small bowel using endo-gia and ta55 4.8.The staple line was reinforced using 3-0 silk in interrupted fashion and the defect of the mesentery was closed using 3-0 vicryl continuous fashion.The same technique was followed to do the second anastomosis, side-to-side using endo-gia blue load, and ta55 to close the enterotomy.The staple line was reinforced with 3-0 silk interrupted fashion as well.The defect of the mesentery was closed using 0 vicryl in continuous fashion.After i performed that, i continued taking down all adhesions.The small bowel was stuck in the pelvis next to the colon.I was able to identify the left colon and also the sigmoid area and slowly dissecting the small bowel of the colon until i reached the ileocecal valve.Then after i performed that i ran the small bowel more than one time, at least three times to make sure there is no damage to the intestine, and no serosal tears and there was none.Then i decided to place a gastrostomy tube which will help me with postoperative management for nutrition and gastrointestinal suction as well.I passed a foley catheter through the abdominal wall.A pursestring suture of 3-0 silk was placed in the anterior wall of the stomach.The foley placed in the stomach and the stomach attached to the anterior abdominal wall using 3-0 silk interrupted fashion.The abdominal cavity was irrigated with antibiotic irrigation.No hemostatic agent was placed in the pelvis.It was oozing a little bit.Then i placed a drain, one in the pelvis coming out in the left lower quadrant, and one in the left gutter coming out on the left side, and one in right gutter coming out of the right side as well.Then i went ahead and debrided the abdominal wall where the mesh was removed and the abdominal wall was very thick and indurated and infected.I removed part of the fascia.I removed part of the skin.The segment that was removed was 10 x 10 centimeters and hemostasis achieved completely using cautery.Then a decision was made to close the abdominal wall primarily without adding any mesh and that was performed by approximating the midline using #1 looped pds in interrupted fashion.It came together without excessive tension.¿ ¿ 3/17/15: pathology.A) mesh: ¿consists of portions of grayish white to pink-tan mesh with attached fibrotic soft tissue, 15 x 7 x 4 cm in aggregate.Suture noted.One bowel segment contains a full-thickness wall defect with hemorrhagic, indurated edges, approximately 1 cm.This area grossly consistent with fistula tract.Gross/microscopic diagnosis: a) mesh: fragments of mesh.Adjacent soft tissues with inflammation, degenerative change, and focal foreign body granulomas, benign.B) sections of small bowel: area of full-thickness bowel defect consistent with fistula tract.¿ ¿ 3/26/15: ct abdomen: ¿resolution of previous anterior abdominal wall abscess.Removal previous anterior abdominal wall hernia mesh.Questionable peritoneal hematomas in left mid and central abdomen.¿ ¿ 4/7/15: ct abdomen: ¿previously seen large multilocular mid abdominal mesenteric hematoma has evolved into irregular multilocular fluid collection.Abscess cannot be excluded.Several additional smaller mesenteric fluid collections.Scattered colonic diverticulosis.¿ ¿ 4/9/15: hematoma drained, gram stain negative for bacteria.Clinical improvement.¿ 4/12/15: ct abdomen: ¿interval mild decrease in size of complex mid abdominal fluid collection.Pigtail drainage catheter visualized, good position.No new fluid collections visualized.¿ 4/15/15: discharge summary.Cultures have shown patient growing enterococcus anginosis [sic] e.Coli, some form of choreiform bacteria.Transferred to st.Catherine¿s.Relevant medical information: ¿ 2/28/16 - 3/12/16: 3/1/16: massive gi bleed.Emergency colonoscopy: blood throughout colon, fresh, diverticular bleed.Indication: ¿.Massive lower gastrointestinal bleed.No upper gastrointestinal source noted.No visualized bleeding on angiography in the catheterization laboratory.She returned hypotensive to the icu and went into asystole.Standard acls [advanced cardiac life support] procedures were initiated.With chest compressions as well as with iv [intravenous] access and blood products infusing, cpr, and multiple rounds of epinephrine we were able to get a heart beat, pulses and a pressure.¿ o 3/1/16: emergent laparotomy.Total colectomy with end ileostomy.Extensive lysis of adhesions taking greater than 90% of the time of the procedure.Small bowel resection with primary anastomosis.Excision of 7 different small bowel diverticula.Repair of multiple serosal tears, at least 7-8 different areas of small bowel.Placement of gastrostomy tube.¿¿ ; appeared to be multiple pieces of old mesh and adherent pieces of intestine to this.After a long tedious dissection, i had all the colon freed out from the terminal ileum.It appeared she had some sort of a colon resection with the splenic flexure essentially taken down in the past.¿ ¿ ¿when i started looking at the small bowel more closely there were multiple diverticula that started from the ligament of treitz.Most of them were localized within the jejunum and i started by freeing up the diverticula which were all present on the mesenteric border of the small intestine.There was 1 segment of small intestine that had multiple mesenteric defects and also had diverticula within them as well and, therefore, elected to do a small bowel resection of this area.¿ o pathology.Diverticulum proximal jejunum, diverticulum proximal small bowel and small bowel, and total colectomy: diverticulitis and diverticulosis.[no reference to mesh being present.] ¿ 3/12/16: death certificate.Immediate cause: (a) ards [acute respiratory distress syndrome].Due to or as a consequence of: (b) pneumonia.Due to or as a consequence of: (c) sepsis.Due to or as a consequence of: (d) gi bleed; angiodysplasia.Conclusions gore-tex® soft tissue patch (unk/unk) the gore-tex® soft tissue patch was utilized as product form initially based on the ambiguous wording of the original lawsuit complaint.Gore¿s investigation determined it was not a gore-tex® soft tissue patch.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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