W. L. GORE & ASSOCIATES, INC. GORE® DUALMESH® PLUS BIOMATERIAL; MESH, SURGICAL, POLYMERIC
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Model Number 1DLMCP04 |
Device Problem
Insufficient Information (3190)
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Patient Problems
Erosion (1750); Unspecified Infection (1930); Inflammation (1932)
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Event Date 10/08/2021 |
Event Type
Injury
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Manufacturer Narrative
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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)].It should be noted that the gore® dualmesh® plus biomaterial 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." the gore® dualmesh® plus biomaterial 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.".
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Event Description
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It was reported to gore that the patient underwent laparoscopic parastomal hernia repair on (b)(6) 2013 whereby a gore® dualmesh® plus biomaterial was implanted.The complaint alleges that on [(b)(6) 2014 an additional procedure occurred whereby the gore device was explanted.It was reported the patient alleges the following injuries: urinoma around the mesh, adhesions to small intestine, foreign body giant cell reaction, adhesions, partial mesh removal, mesh erosion into small bowel causing enterotomy, inflammation, infection, mesh erosion into ileal conduit causing an opening in the urostomy, bowel resection.Additional event specific information was not provided.
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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: relevant medical information: on (b)(6) 2013: (b)(6).(b)(6) , md; (b)(6) , md.Office notes.61-year-old status post cystectomy and ileal conduit formation for bladder cancer in 1995.Presented for parastomal hernia; says always reducible.Does not cause any pain.However, is inhibiting his lifestyle; unable to wear clothes that do not fit around the hernia and has difficulty with ostomy bags.Medical history: hypertension, diabetes, hypercholesterolemia, neuropathy, bladder cancer.Surgical history: cystectomy with ileal conduit formation, incisional hernia repair 1997.Medications: baclofen, celebrex, norco, ciprofloxacin, citalopram, cymbalta, hydrochlorothiazide, lisinopril, metformin, niacin, ropinirole.Social: does not smoke; smoked 2-3 packs/day for 40 years, quit 5 years ago.Abdomen: ileal conduit right lower quadrant with large reducible parastomal hernia.Nontender.Impression: parastomal hernia, diabetes mellitus, hypertension.Plan: risks, benefits, alternative of procedure explained.Would like to proceed; scheduled for january 17.On (b)(6) 2013: (b)(6).(b)(6) , md; (b)(6) , md.Operative report.Resident surgeon: (b)(6) , md.(b)(6) , md.Name of operation/procedure: laparoscopic lysis of adhesions x2 hours.Reduction of incarcerated parastomal hernia and placement of parietex parastomal mesh ¿ modified sugarbaker technique.Preoperative diagnosis: right lower quadrant ileal conduit incarcerated parastomal hernia.Postoperative diagnosis: right lower quadrant ileal conduit incarcerated parastomal hernia.Two fascial defects in mid abdomen less than 1 cm dia each.Indications for procedure: jerry ramsey is a 61-year-old former smoker with a history of bladder cancer who underwent total cystectomy and ileal conduit creation who developed a parastomal hernia around his ileal conduit in the right lower quadrant.He was seen and evaluated in the general surgery clinic an elected to undergo laparoscopic parastomal hernia repair with mesh.Anesthesia: general endotracheal.Operative findings: he was found to have significant adhesions throughout his entire abdomen.The majority of the case involved tedious lysis of adhesions, ultimately he was found to have multiple loops of small bowel incarcerated within the parastomal defect.All incarcerated loops were able to be reduced laparoscopically.He was also found to have 2 small 1-cm fascial defects superiorly near the midline.A 20-cm circular parietex mesh was placed without complication.Description of procedure: ¿after informed consent was obtained, the patient was transported to the operative theater where he was placed in the supine position and appropriate monitoring devices were affixed.A time out was performed confirming his allergy to penicillin and he received 600 mg of preoperative clindamycin antibiotic.General anesthesia was then induced.His ileal conduit appliance was removed.The stoma and surrounding areas were prepped with a betadine solution and a 20-french foley catheter was inserted and the balloon was inflated.The catheter and surrounding skin was reprepped with chlorhexidine and 2 large tegaderms were used to cover the ostomy and catheter.The abdomen was then completely prepped with a chlorhexidine solution and he was draped in the standard sterile fashion followed by application of an ioban drape.A veress needle was then inserted in the midclavicular line, inferior to the left costal margin.An audible click was heard.No gastric or enteric contents were aspirated.Saline flowed easily through the needle and the water drop test was normal.The opening pressure was 7mmhg and the abdomen was insufflated to a total pressure of 15 mmhg.A 5-mm port was then placed laterally in the left lower quadrant with a visiport technique.Initial survey of the abdomen revealed significant adhesions to the majority of the anterior abdominal wall.Two additional 5-mm ports were placed under direct visualization, more superiorly in the left lateral abdomen, and one 5-mm port was placed in the superior lateral right abdomen following necessary lysis of adhesions.Tedious lysis of adhesions accounted for the majority of the operation, this was performed sharply with great care taken to avoid injury to any bowel.Once the abdominal wall was sufficiently cleared to allow for mesh placement, incarcerated fat from the 2 small hernia defects was reduced and finally multiple loops of small bowel were reduced from the parastomal defect.Using a spinal needle to gauge location and size of the hernia defects, a 20-cm circular parietex mesh was selected.The parastomal hernia measured 6 cm in diameter.Two ethibond sutures were placed approximately 6 cm apart on the lateral circumference of the mesh, and a third suture secured on the opposite end of the mesh to form an isosceles triangle.The mesh was then moistened with sterile saline, rolled tightly and pulled through the left upper 5-mm trocar with a long grasper placed through the right port site.The mesh was then oriented and the 2 inferior sutures were secured transfascially at 2 areas lateral to the parastomal defect to allow for adequate closure of the hernia, yet not compress the ileal conduit.The third suture was secured more superiorly, allowing for flat placement of the mesh and adequate coverage of the other 2 hernias, as well.With traction applied to the suture tails externally, the mesh formed the expected triangular shape without significant tension on the overlying fascia and he was found to have no significant tension on the overlying fascia and he was found to have no significant tension compressing his ileal conduit.The sutures were then tied securing the mesh to the ventral abdominal wall.A sure-strap tacking device was then used to secure the entire circumference of the mesh with tacks placed no greater than 1 cm apart.Additional tacks were placed near the transfascial sutures and additional tacks were placed circumferentially more medially on the mesh.The mesh was then reexamined and found to lay completely flat without undue tension.The remainder of the abdomen was surveyed and complete hemostasis had been achieved.No succus or other sign of injury was observed.The abdomen was then irrigated with suction irrigator device.Final survey of the abdomen revealed complete hemostasis.Three 5-mm ports were removed under direct visualization.The final port remained in place to allow for abdominal desufflation, the final port was then removed.The 5-mm trocar sites were then cauterized, benzoin and steri-strips were then used to close all 5-mm trocar sites and band-aids were placed over the veress needle insertion site, as well as the 3 transfascial suture sites.The remaining ioban drape was then removed.The foley catheter removed from the ileal conduit and an ostomy appliance applied.The patient was then awakened from general anesthesia and transported to the recovery unit for further assessment and monitoring.Specimens obtained: none.Implants: a 20-cm circular parietex mesh.Estimated blood loss: 15 ml.Complications: none.Attending surgeon dr.(b)(6) was present for the entire operation.¿ ¿i was present and scrubbed for the entire procedure.¿ (b)(6).On (b)(6) 2013: university hospital.Implant record.Parietex parastomal mesh.Manufacturer: covidien.On (b)(6) 2013: (b)(6).(b)(6) , md; (b)(6) , md.Discharge summary.Diagnosis: parastomal hernia.Tolerated surgery well, transferred to floor where pain controlled on oral medications.Put on clear liquid diet; waited for return of bowel function; began having bowel movements (b)(6) 2013.Tolerated advancing to regular diet.Did have some electrolyte abnormalities and hyperglycemia; corrected with replacement and restarting home metformin and sitagliptin, as well as sliding scale insulin.Developed seroma of parastomal hernia sac; although no signs of recurrence of hernia.Continued to have good output from ileal conduit.Follow up with dr.(b)(6) in 2 weeks.Shower only, may lift no more than 10 pounds.Instructions given on how to keep wound cleaned.Discharged in good condition.On (b)(6) 2013: (b)(6) hospital.(b)(6) , md.Emergency department visit.Brought to emergency department by family with complaint of being unable to have bowel movement for past 5 days, vomiting past 2 days.Has taken milk of magnesium and a suppository with no relief.States admitted to hospital in springfield for small bowel obstruction friday and was discharged yesterday; did not have improvement prior to being discharged.History of 2 small bowel obstructions.Abdomen: hyperactive bowel sounds, mildly distended, mild right lower quadrant tenderness with no guarding or rebound.Urostomy right lower quadrant draining yellow urine.Spoke with dr.(b)(6) ; agrees with plan, accepting patient under his care.Impression: small bowel obstruction.Acute pancreatitis.Hypokalemia.Plan: admitted.On (b)(6) 2013: (b)(6).(b)(6) , md.Radiology ¿ abdominal x-ray.Indication: small bowel obstruction.Impression: at least moderate small bowel obstruction suspected.No free air.On (b)(6) 2013: (b)(6) hospital.(b)(6) , md.Radiology ¿ ct abdomen/pelvis.Indication: nausea/vomiting, abdominal pain.Findings: small bowel markedly dilated with air-fluid levels.Small bowel dilated into a peristomal hernia in right lower quadrant.Small bowel exiting hernia is decompressed suggesting incarceration of the bowel within the hernia sac.Some fluid in hernia sac and infiltrative density in subcutaneous tissues adjacent to the hernia compatible with incarceration.Impression: high-grade small bowel obstruction secondary to an incarcerated peristomal hernia with fluid in the hernia sac and the adjacent subcutaneous soft tissues and infiltration compatible with incarceration.Aortoiliac and coronary atherosclerosis.Mild fatty infiltration of the liver.On (b)(6) 2013: (b)(6).(b)(6) , md.Radiology ¿ abdominal ultrasound.Indication: elevated lipase and amylase.Bowel obstruction.Impression: gallstone lodged in gallbladder neck.Fatty infiltration of liver.Poor visualization of the pancreas and retroperitoneal structures due to bowel obstruction and large amount of bowel gas.On (b)(6) 2013: (b)(6).(b)(6) , md.Radiology ¿ abdominal x-ray.Indication: follow up small bowel obstruction.Impression: persistent small bowel obstruction with decrease in the number of dilated small bowel loops in the midabdomen possibly indicating some improvement.No definite free intraperitoneal air.On (b)(6) 2013: (b)(6).(b)(6).Radiology ¿ abdominal x-ray.Impression: persistent dilated small bowel loop in right midabdomen with air-fluid levels.Unchanged compared with (b)(6) 2013.On (b)(6) 2013: (b)(6) hospital.[signature illegible].Pre-anesthesia evaluation.Weight: 265 lbs.Obesity.Diabetes mellitus.Asa: 3.Implant #1 and #2 procedure: laparoscopic gore-tex patch repair of the parastomal hernia.Laparoscopic cholecystectomy.Central venous line placement.Implant: gore® dualmesh® plus biomaterial [1dlmcp04/9214322, 15 cm x 19 cm x 1mm] and gore® dualmesh® plus biomaterial [1dlmcp08/[illegible], 26 cm x 34 cm x 1 mm] implant #1 and #2 date: (b)(6) 2013 (hospitalization (b)(6) 2013).On (b)(6) 2013: (b)(6).(b)(6) , md.Operative report.Preoperative diagnosis: small bowel obstruction.Recurrent incarcerated parastomal hernia.Cholelithiasis.Postoperative diagnosis: small bowel obstruction.Recurrent incarcerated parastomal hernia.Cholelithiasis.Informed consent: patient and surgical site were identified, and informed consent was obtained.Description of procedure: ¿patient was brought to the operating room and placed on the operating table in supine position.Intravenous antibiotic was given preoperatively.General endotracheal anesthesia was induced.First, using full sterile barrier, seldinger technique, the left subclavian vein was cannulated with triple lumen central venous line.All 3 lumens were aspirated with unobstructed venous blood flow and flushed with normal saline.Line was secured using silk sutures and covered with sterile dressing.Next, foley catheter was inserted through the right lower quadrant stoma which is a urostomy, and the balloon was inflated.Good seal was obtained, and the flow of urine in the catheter was noted.Abdomen was then prepped and draped in a sterile fashion.Haropin 0.5% was injected at the incision sites.First, the 5-mm trocar was inserted through a right upper quadrant incision under camera guidance.Pneumoperitoneum was induced with carbon dioxide.Pressure was maintained and tolerated well at 15 mmhg.There was a 3-part endocavity in the right upper quadrant allowing for placement of 2 more trocars under direct vision in standard fashion.Fundus of the gallbladder was grasped and retracted in cephalad direction.Adhesions between gallbladder body and omentum were taken down easily using harmonic instrument.Gallbladder neck was exposed and retracted.The junction with the cystic duct was dissected.The cystic duct was occluded with clips distally and proximally and divided without bile leaks.The cystic artery was dissected, occluded with clips and divided without bleeding.Gallbladder was then detached from the liver bed using harmonic instrument.Care was taken not to violate the gallbladder wall and spill any bile.The gallbladder was placed in the endopouch and removed in its entirety through a subxiphoid trocar site.The right upper quadrant was irrigated with neosporin solution and cautery was used to complete hemostasis in the gallbladder fossa.No bile leaks were seen.Next, 3 trocars were placed in the right flank area under direct vision.There were extensive adhesions between the omentum in loops of small bowel and the anterior abdominal wall, starting in the supraumbilical area and spanning all the way down to the pelvis.Therefore, sharp dissection using scissors was initiated to lyse the adhesions.As more visibility was obtained, 3 trocars were placed in the left flank area under direct vision.Dissection switched from side to side.Eventually edge of what appears to be a prolene mesh that was placed to repair parastomal hernia was reached.Adhesions became more advanced in this area, and careful sharp dissection continued to free the adhesions.Loops of small bowel were then reduced out of a parastomal hernia.The segment of ileum that was used to create the urostomy was then dissected and isolated from all its attachments and the lateral abdominal wall.Previously placed prolene mesh does not appear to go around the stoma, it only covers the medial part of the defect.Dissection was continued until all adhesions were lysed and the entire abdominal wall was freed.Cautery was used very sparingly to maintain good hemostasis.Next, the extent of the defect and anticipated repair were marked on the anterior abdominal wall using transabdominally placed spinal needles.Appropriate size dual mesh gore-tex patch was selected for the repair.Patch was trimmed to appropriate size and shape, and a small hole was created to allow passage of the segment of ileum that serves as urostomy.A slit was then tented in the patch to allow placement of the patch around the stoma.Patch was marked for proper orientation and then cardinal sutures of gore-tex were patch.Patch was rolled and inserted into the peritoneum through the 10-mm trocar site.Patch was unrolled intraperitoneally, placed around the urostomy, and then cardinal sutures were pulled through a small abdominal stab incision using suture.Care was taken to stretch the patch lightly against the inner surface of the abdominal wall.When this was ensured, cardinal sutures were tied, and knots were buried subcutaneously.Next, the edge of the patch was secured to the peritoneum using a titanium tacks at 1-cm intervals around the perimeter of the patch.Four transabdominal sutures of gore-tex were placed in order to secure the patch.The patch was then inspected.There was still a small gap between the edge of the patch and the urostomy in the medial aspect.Also, the slit created in the patch that was used to place the patch around the urostomy was not completely approximated due to overall tightness of the patch.Decision was made to place the second patch to cover the central portion of the first patch and complete closure of the hernia defect.This was again done with gore-tex patch that was measured and shaped appropriately, and cardinal sutures of gore-tex were placed.Patch was then rolled and inserted into the peritoneal cavity.Patch was positioned appropriately and tightened against the inner surface of the abdominal wall, and cardinal sutures were pulled through the abdominal wall using small stab incisions and suture passer.Sutures were tied, and knots were buried subcutaneously.After that the patch was secured using titanium tacks.Peritoneum was irrigated with neosporin solution.No enteric content leaks were seen.Both patches closed the defect securely with only a small opening allowing for the urostomy to pass through.Vicryl #0 was placed through the fascia at both 10-mm trocar sites using endoclosure instrument.All trocars were removed under direct vision, and no bleeding was noted.Pneumoperitoneum was deflated and vicryl was tied to contain secure fascia closure.Skin was closed using staples.Foley catheter was then removed from the urostomy, and urostomy appliance was secured.Sterile dressings and abdominal binder were placed.Patient was awakened and extubated in the operating room.He was taken to recovery room in satisfactory condition, having tolerated the procedure well.¿ estimated blood loss: 150 ml.Specimen: gallbladder.On (b)(6) 2013: (b)(6) hospital.Implant sticker.Gore® dualmesh® plus biomaterial.Ref catalogue number: 1dlmcp04.Lot batch code: 9214322.W.L.Gore and associates.[handwritten] 15cm x 19 cm x 1 mm.Implant sticker.Gore® dualmesh® plus biomaterial.Ref catalogue number: 1dlmcp08.Lot batch code: [illegible].W.L.Gore and associates.[handwritten] 26.0 cm x 34.0 cm x 1 mm.[handwritten] expiration 2015-10.The records confirm two gore® dualmesh® plus biomaterial (1dlmcp04/9214322) and (1dlmcp08/[illegible]) were implanted during the procedure.Relevant medical information: on (b)(6) 2013: (b)(6).(b)(6) , md.Pathology report.Accession number: (b)(4).Diagnosis: gallbladder, cholecystectomy: chronic cholecystitis, cholelithiasis, cholesterolosis.Specimen type: a: gallbladder.Clinical impression and history: cholelithiasis.Gross description: received in a single container of formalin labeled ¿ramsey, jerry¿ and ¿gallbladder¿ is an intact gallbladder measuring 11.2 x 5.5 x 4 cm.The serosal surface is yellow green in appearance.Opening the gallbladder reveals a velvety green mucosa remarkable for a light diffuse yellow streaking.The gallbladder wall measures up to 0.2 cm in greatest thickness and is remarkable for a green viscous bile with a single crystalline calculus that measures 1.4 cm in greatest dimension.Representative sections from the neck, body, and fundus are submitted in cassette a1.Microscopic description: microscopic examination supports the above captioned diagnosis.On (b)(6) 2013: (b)(6).[signature illegible].Progress notes.Postoperative day 4.Without complaints.Seroma in hernia sac.On (b)(6) 2013: (b)(6).(b)(6) , md.Discharge summary.Diagnosis: small bowel obstruction secondary to recurrent, incarcerated parastomal hernia.Cholelithiasis.Procedure during hospitalization: laparoscopic gore-tex patch repair of the parastomal hernia and cholecystectomy, with central venous line placement.Admitted, nasogastric tube inserted for suctioning.Intravenous hydration provided.Treatment continued until small bowel dilatation resolved both clinically and radiographically.Patient then taken for laparoscopic cholecystectomy and gore-tex patch repair of parastomal hernia.Tolerated procedure well.Postoperative course significant for a period of ileus requiring continuation of intravenous hydration and bowel rest.Bowel function gradually returned, allowing for resumption of oral intake.Wounds were healing well, without signs of infection.Urostomy was viable, functional.Oral intake advanced, tolerated well.Discharge home on postoperative day 5; follow up care arranged for him.On (b)(6) 2014: (b)(6).(b)(6) , md; (b)(6) , md.History and physical.Known to general surgery service after laparoscopic parastomal hernia repair with modified sugarbaker technique using parietex mesh (b)(6) 2013.Transferred from mercy hospital with concerns of a fistulous connection between the ileal conduit and the abdominal wall.Initially presented to west plains hospital (b)(6) 2014 with nausea, vomiting and acute renal failure.Transferred to mercy hospital for further evaluation and management.Ct abdomen/pelvis obtained on admission showed large fluid collection of anterior abdominal wall posterior to the mesh lying extraperitoneally.Lab values on admission showed leukocytosis of 15.6, creatinine 5.8.On (b)(6) 2014, underwent percutaneous pigtail catheter placement and fluid sent for culture.Final cultures returned enterococcus sensitive to ampicillin, gentamicin and vancomycin as well as coag-negative staphylococcus sensitive to vancomycin only.Started on intravenous vancomycin, cefepime and ciprofloxacin for antimicrobial coverage.Output from pigtail catheter concerning for urine; repeat ct showed no obvious leak from ileal conduit to subcutaneous space.Given pyridium; noted to change ileal conduit output to orange color and pigtail drain output turned this orange color.On (b)(6) 2014, a loopogram was attempted at the outside facility; not successful as catheter unable to be placed into urostomy.Acute renal failure has resolved.Leukocytosis also resolved.Tolerating regular diet; denies nausea/emesis or abdominal pain.States approximately 8 months ago, underwent an additional revision of his parastomal hernia which sounds like it was laparoscopic and the mesh was adjusted.Has not had issues with stoma since that time.Recently admitted to outside facility with pneumonia; recovered without issues.Surgical history: ventral incisional hernia repair with mesh placement in 1997.Laparoscopic parastomal hernia repair approximately december 2013.Abdomen: soft, nondistended.Well-healed vertical midline incision.Ileal conduit right lower quadrant with clear yellow urine in appliance.Soft parastomal hernia.Just superior to the urostomy is 10-french pigtail catheter draining clear yellow urine.No surrounding erythema.Impression/plan: developed an infected abdominal wall urinoma after abdominal wall mesh likely eroded into the ileal conduit.Has since recovered from acute renal failure and systemic inflammatory response syndrome.Loopogram not successful; however, laboratory testing indicated abdominal wall fluid collection was indeed urine.Will be admitted to surgical ward.Antibiotics deescalated to intravenous vancomycin only, as cultures are finalized.Will attempt repeat loopogram in the morning to identify area of the fistulous tract.Will be given sliding scale insulin for glycemic control.Addendum: admitted to outside hospital for sepsis; found to have a large fluid collection between the two meshes.Drainage of fluid showed infected urine concerning for fistula with the ileal conduit.Admit for antibiotics, drain management, urology consult.On (b)(6) 2014: university hospital.(b)(6) , md; (b)(6) , md.Urology consultation.Dr.(b)(6) performed a laparoscopic hernia repair with parietex mesh placement (b)(6).Did not follow up with dr.(b)(6) after his 2-week postoperative check; however, had apparent recurrence of parastomal hernia and had revision by a surgeon in (b)(6) around (b)(6).About 7-10 days ago, worsening malaise, nausea/vomiting; found to have acute renal failure.Ct showed large fluid collection of anterior abdominal wall likely between 2 layers of mesh.Weight: (b)(6) 2014: 108.2 kg, bmi 32.Abdomen: soft, nontender, nondistended, right urostomy pink, patent, with clear yellow urine in bag.Truclose drain above urostomy with copious clear yellow fluid (urine), slight sediment.Attempted to pass a 14 and 16-french foley into conduit; was able to easily pass the catheters into conduit distal to fascia, however catheter would not pass below fascia.Conduit probed digitally, fascia and mesh were felt as well a likely stenotic fascial orifice.Patient experienced pain on digital exam.Impression/plan: parastomal hernia repair with mesh with subsequent revision likely with additional mesh placement.Now with recent infected urinoma status post drainage.Likely mesh erosion as etiology of urine leak.Foley unable to be placed below fascia in conduit.Will add on for looposcopy, loopogram, indicated procedures.On (b)(6) 2014: university hospital.(b)(6) , md; (b)(6) , md.Operative report.Resident: (b)(6) md, (b)(6).Service: urology.Procedure performed: looposcopy.Loopogram with interpretation independent of radiology.Foley catheter placement in ileostomy.Description of procedure: ¿after consent was obtained, the patient was taken to the operating room and placed on the table in the supine position.General anesthesia was induced and a timeout was performed.The patient had already received a dose of iv vancomycin this morning and thus, no additional antibiotics were administered.Patient was then prepped and draped in standard fashion.A flexible cystoscope was introduced into the ileostomy loop and a 0.035 sensor wire was advanced through the scope.A stenotic region was present just beyond the parastomal mesh.This area of stenosis was proximal enough to the ileostomy opening to be easily palpated.An area of compromised tissue was palpated just posterior to the mesh.The flexible cystoscope was then removed.A council tip foley catheter was then advanced over the wire, past the stenotic region.10cc sterile water was injected into the foley balloon.Contrast was then injected through the catheter and fluoroscopic images were obtained.Contrast was visualized within the loop with extention [sic] into the previously existing drain tubing.The procedure was then completed, and the patient was awakened from anesthesia and was transferred to recovery in stable condition.¿ preoperative diagnosis: infected urinoma.Postoperative diagnosis: infected urinoma.Anesthesia: general.Condition: good.Estimated blood loss: minimal.Fluid replacement: crystalloid.Complications: none.Drains: foley in ileostomy, 10ccs in balloon.Specimen: none.Attending physician present for entire procedure.Disposition: pacu, floor.Addendum by (b)(6) md, (b)(6) on (b)(6) 2014 06:12: ¿i was present for the entire procedure.¿ on (b)(6) 2014: university hospital.(b)(6) , md; (b)(6) , md.Discharge summary.Presented from outside hospital with ct showing large fluid collection in anterior abdominal wall.Parastomal hernia repair revision (b)(6) 2014.On (b)(6) 2014, had percutaneous pigtail catheter placed; cultures showed sensitivity to vancomycin.Admitted and placed on vancomycin.Urology consulted to complete a loopogram to evaluate for a fistula.Looposcopy and loopogram did show a leak from the ileal conduit to the fluid cavity previously seen on ct.Advanced to diabetic diet, had no issues overnight, was ambulating, good urine output.Drain output did change to a milky consistency overnight.Continued to be afebrile with decreasing leukocytosis.To follow-up with general surgery to discuss planning with urology for mesh, excision peristomal hernia repair and ileal conduit reconstruction.Addendum: history of cystectomy, ileoconduit, parastomal hernia repair with mesh, ventral/recurrent parastomal hernia repair with additional mesh.Transferred with infected urinoma between the mesh secondary to new fistula from ileoconduit to abdominal wall.Has been on 2 weeks of vancomycin.Due to no systemic disease, normal wbc, adequately drained infection, antibiotics discontinued.Follow up in 3-4 weeks with dr.(b)(6) and urology for surgical planning.On (b)(6) 2014: university hospital.(b)(6) , md; (b)(6) , md.History and physical.Foul-smelling drainage from ileal conduit and abdominal drain.History of ileal conduit and multiple parastomal hernia repairs with mesh.Recently evaluated with looposcopy which demonstrated communication between his ileal conduit and abdominal wall mesh resulting in a urinoma with infected mesh.Foley catheter placed in the ostomy; maintained since hospital discharge.Also has abdominal drain in place.Is scheduled for mesh explantation and relocation of ostomy at end of this week.Two days ago, noticed increased cloudiness of abdominal drain fluid, then urine draining from conduit became cloudy as well.Today noticed foul smelling drainage from both sites.Had some emesis this morning followed by a large bowel movement, then one additional episode of emesis.No fevers, chills or abdominal pain.Presented to ozarks medical center.Blood and urine cultures drawn.Ciprofloxacin and metronidazole were administered.Ct scan obtained with large fluid/air collection in the abdomen measuring 4.7 x 25 x 16 cm.Transferred to umh for further care.On admission, afebrile, tachycardic to 118.Medical history: gastroesophageal reflux disease.Gastrointestinal: soft, hypoactive bowel sounds.Drain bag and ileal conduit draining foul-smelling yellow fluid with yellow strands that look like stool.Impression/plan: abdominal abscess, hyponatremia, infected abdominal mesh, leukocytosis, acute kidney injury, hyper glycemia.Admit for intravenous fluids, intravenous antibiotics and analgesia.Keep nothing by mouth.Likely will need interventional radiology versus operative drainage of abscess.Home medications resumed.Started sliding scale insulin.Discuss with general surgery in morning.
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Manufacturer Narrative
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H6: updated results code.Conclusion code remains unchanged it should be noted that the gore® dualmesh® plus biomaterial 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.The gore® dualmesh® plus biomaterial 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.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.Following gore¿s investigation, the previously submitted annex f code has been updated to reflect gore¿s final conclusion.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.¿ the instructions for use further warn: ¿as with any implantable surgical device, strict aseptic techniques should be followed.If an infection develops, it should be treated aggressively.An unresolved infection may require removal of the device.¿ 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.The instructions for use further warn: ¿when using this device as a permanent implant and exposure occurs, treat to avoid contamination, or device removal may be necessary.¿ 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.Medical records that indicate mesh ¿movement¿ or that the device lost anchorage may be 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." 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 and sterilization 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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