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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES GORE-TEX SOFT TISSUE PATCH; MESH, SURGICAL, POLYMERIC

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W.L. GORE & ASSOCIATES GORE-TEX SOFT TISSUE PATCH; MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number 1310015020
Device Problems Contamination (1120); Insufficient Information (3190); Patient Device Interaction Problem (4001)
Patient Problems Erosion (1750); Unspecified Infection (1930); Pain (1994); No Code Available (3191)
Event Date 09/23/2016
Event Type  Injury  
Manufacturer Narrative
(b)(4).(b)(6).Additional details regarding the patient's clinical course were ascertained from a review of medical records and are as follows: medical records dated (b)(6) 2011 indicate patient has ¿urinary tract infection, citrobacter¿.Record states patient urinalysis showed ¿too numerous to count white cells, 4 to 5 red cells, and many bacteria¿.Medical records dated (b)(6) 2011 states: ¿urostomy bag @ lower r abd.Site in tact.Draining cloudy w/ strings straw urine.Next to urostomy site is a quarter & ½ sized wound.¿ microbiology records dated (b)(6) 2011 indicates culture result of ¿nephrostomy urine¿ detects ¿enterococcus faecalis¿ and culture result of ¿urine¿ detects ¿citrobacter koseri (c.Diversus)¿.Microbiology record dated (b)(6) 2012 indicates culture result of ¿l urine from l nephroureterostomy & l kidney¿ detects ¿escherichia coli¿ and ¿citrobacter koseri (c.Diversus)¿.On (b)(6) 2012: (b)(6) health.(b)(6), md.Office note.Indwelling ureteral stent changed every 6 weeks.Incisional hernia has gotten bigger and bigger as time goes on and now is quite large, probably 10 cm at least in diameter, in the middle, is going to require mesh repair.Creates a problem because of potential contamination from ileal conduit.Will have to repair because it¿s causing a lot of pain and is getting larger rapidly.No sign of recurrent disease.Weight (b)(6), stable.Diabetes and blood pressure controlled.Has no allergies, takes lisinopril, metformin, aspirin.Has had back & bladder surgery.¿this man will have to have a drain, and i have explained to him there is at least a 20% chance of infection because it will require mesh.¿ history and physical records dated (b)(6) 2013 state the patient was seen for an enlarging ventral hernia with pain.¿this man is a (b)(6) hispanic male with diabetes and hypertension who had a bladder cancer requiring a total cystectomy and ileal conduit in 2010.¿ ¿he has a stenosis of one of his ureters at the anastomosis to the ileal conduit and has an indwelling stent, which is left in place and changed every six weeks.He had a ventral hernia that became apparent very quickly after he had his surgery, and it has become larger at times, now it has become difficult for this man to apply his appliance, and he is having pain in his midline wound.He has a large defect he describes.The patient has had no bowel obstruction and no previous abdominal surgery.¿ operative records dated (b)(6) 2013 indicate the patient underwent repair of a nonincarcerated ventral hernia with mesh.Findings from the procedure state: ¿approximately a 5 x 3 inch defect in the ventral abdominal wall from prior laparotomy incision.A single piece of mesh was used as an underlay with the edges rolled over on top of the fascia.¿ records detailing the prior laparotomy were not provided.The (b)(6) 2013 operative report states: ¿a #15 blade scalpel was then utilized to incise the skin and sharply dissect down through the old scar.The patient just had skin and subcutaneous tissue.The intestine was encountered and was inspected to ensure no damage had occurred.The skin incision was extended.Once opened the defect in the patient's anterior abdominal wall was approximately 5x4 inches.The patient's abdominal wall fascia had retracted laterally.So, bovie electrocautery was utilized to mobilize the fascia from the subcutaneous tissue.Adhesions below the fascia were taken down sharply with metzenbaum scissors.Some omental bleeding was controlled with a 2-0 silk ligature.Once all adhesions were free and the fascia had been mobilized, a piece of gore dual-sided mesh approximately 15 x 20 cm was placed into the abdomen.A single piece mesh was placed in combination underlay and overlay.The mesh was placed below the fascia with the external borders of the mesh wrapping around the fascial edge.¿ the (b)(6) 2013 records continue: ¿allis clamps were utilized to grab the fascia and mesh in a single bite and then a stitch of 0 prolene was used in a horizontal mattress fashion taking a bite of mesh and fascia.This was done in serial fashion.Each horizontal mattress was 1 cm apart.Circumferentially, the mesh was tightened to ensure appropriate tightness in all directions.Before completely sewing in the mesh, the abdominal cavity was inspected to ensure that no loops of intestine had been caught up in the suture line.The funnel stitches were secured in place.Normal saline was used to irrigate the mesh and the subcutaneous tissues.A 20-french blake drain was placed anterior to the mesh below the skin and subcutaneous tissues.This was sutured in place with an 0 prolene.The subcutaneous tissues were reapproximated using a running stitch of 3-0 vicryl.The skin was closed with staples.¿ the records confirm a gore dualmesh® biomaterial (1dlmc07/10485246) was implanted during the procedure.On (b)(6) 2013: progress record.Leaking ileal conduit by which saturated dressing.Dressing saturated w/ urine removed.Staples intact.Reapply urostomy bag, keep midline dry.On (b)(6) 2013: discharge summary.Final diagnoses: cystectomy and urinary conduit in 2010.Summary: this man had an enlarging, painful ventral hernia, directly in the midline just opposite his urostomy.No obstruction, just pain.Admitted, underwent a midline incision, dissection of a huge hernia sac and repair with a large piece of dualmesh.Because of the proximity to the urostomy, given levaquin preop and it was continued.The patient had a ureteral stent in place also through the urostomy, so we were not able to close it when we did the surgery.He had an uncomplicated repair.Warnings were given regarding constipation.On (b)(6) 2013: (b)(6) health.J.(b)(6), md.Office note.3 weeks postop repair of large ventral hernia with a dual mesh.Large defect in the midline required dualmesh.My concern was infection because of chronic urinary instrumentation.Has an indwelling stent in conduit and ureteral anastomosis because of stricturing and has to be changed every few weeks.Was changed 2 weeks ago.So far, no sign of infection in area of incision.Drain was removed at 10 days postop and he did well.No leakage, swelling, redness or fever.Return in 3 months with no lifting until end of (b)(6).Wt (b)(6) [(b)(4)].On (b)(6) 2013: (b)(6) health.(b)(6), md.Office note.We are concerned about infection, but this man never really turned a hair with his healing.No sign of infection.Has a well-incorporated solid graft with no hernia now.Ureteral stent so far, has not infected mesh with manipulation of urinary tract.Wt (b)(6).On (b)(6) 2013: (b)(6) health.(b)(6), md.Office note.Has parastomal hernia around ileal conduit and wants it repaired.It¿s large and does need to be repaired.Will have him get back with dr.(b)(6) and consult with doctor who did surgery in (b)(6) and see if he has someone who repairs these and does a lot of it.If not, i will repair after that has been determined [(b)(4)].On (b)(6) 2013: (b)(6) health.(b)(6), md.Office note.Parastomal hernia is getting larger & causing pain now.It¿s twice the size of his stoma.Big ventral hernia from cystectomy was repaired with mesh and has remained well healed.He is very pleased with that.Will pursue repair through a lateral incision.May have to use mesh and the patient understands the risk of infection is my big concern.He understands that.Diabetes well controlled.Wt (b)(6).History and physical records dated (b)(6) 2013 state the patient was seen for an enlarging right parastomal hernia.¿this is a (b)(6) gentleman who i cared for in the past with a large ventral hernia who had a cystectomy and ileal conduit done in 2010 in (b)(6).He¿had a stenosis of his left ureteral conduit anastomosis.He had a large ventral hernia that became apparent quickly after he had his surgery and has gotten larger with time until it had to be repaired.We did that with mesh and he did very well and did not have any more problems, but began to develop some signs of parastomal hernia several months ago and it has gotten larger progressively and now is causing pain.His conduit still works.He still has to have his stents changed every 5 weeks and he has been doing well.¿ ¿he is a diabetic and takes januvia.¿ ¿his defect is reducible.¿ exam notes state: ¿he has a well-healed midline incision with no sign of recurrence of his hernia.He has a 4 cm parastomal hernia lateral to his stoma right lower quadrant of the abdomen.¿ operative records dated (b)(6) 2013 state the patient underwent primary repair of a right side parastomal hernia.The records state: ¿¿the patient's stoma was exposed.A pursestring of prolene was placed around the stoma to keep it from leaking during the procedure, and his stent was sutured to the skin off to the left side of the stoma.The patient had a betadine prep, drape, and t-shaped incision was made circumstoma laterally, and then extended laterally for about 3 inches.It was carried down through the skin and subcutaneous tissue.The hernia sac was exposed, was opened, and the hernia sac was excised from the lateral side of the ileal conduit.Once we had removed the hernia sac, we placed a stitch in the lateral aspect of the fascial defect and elevated it, and then using progressive medially marching sutures from lateral to medial we closed the defect of the hernia with prolene 0.I placed a 14 mm hegar dilator into the stoma and placed the last stitch to accommodate that size stoma and no larger.These were all tied, irrigated, cut, and the wound was then closed my running the subcutaneous tissue and the initial circumstomal incision first, and then the lateral incision was closed with subcu.The wound was then closed with a subcuticular of 3-0 vicryl in a similar fashion.¿ on (b)(6) 2013: pathology.Specimen received: ventral parastomal hernia repair.Clinical diagnosis: parastomal ventral hernia.Final pathological diagnosis: fibroadipose tissue, designated from ventral parastomal hernia, excision.Fibrotic and chronically inflamed hernia sac.Gross specimen: the specimen is received labeled ventral parastomal hernia sac and consists of three red-tan to gray fragments of soft tissue and fibroadipose tissue measuring 3 x 3 1 cm in aggregate.These are serially sectioned to reveal a yellowish homogenous cut surface.Sections are submitted in a single cassette.Microscopic: sections contain mesothelial-lined fibroadipose tissue with areas of dense fibrosis and foci of mid chronic inflammation.On (b)(6) 2013: discharge summary.This patient was admitted through day surgery for intervention for a parastomal hernia.The hernia repair was successfully performed, and the patient is dismissed from day surgery in good condition with follow up appointments and medications.On (b)(6) 2013: (b)(6) health.(b)(6), md.Office note.Has done great, wound is healed.Having no problems & pleased with surgical procedure.Wt (b)(6).On (b)(6) 2014: (b)(6) health.(b)(6), md.Office note.Parastomal hernia has recurred.This is going to be very complex and difficult to repair.He is having stents changed next week.Told him to wait a week after stents & let us know if he got any fever or other problems.It¿s going to require lateral abdominal incision, looking in the abdomen, and then repair with mesh from the inside.This is very complex and difficult.He understands complexity of this problem.Wt (b)(6).On (b)(6) 2014: operative report.Pre/postop diagnosis: recurrent parastomal hernia.Procedure: repair of recurrent parastomal hernia with mesh.Complications: none.Findings: a 4 x 6 cm fascial defect lateral to the stoma.The hernia was repaired primarily with gore-texas [sic] mesh onlay.Statement of medical necessity: ¿history of bladder cancer who was treated with a bladder resection and urinary reconstruction with an ileal conduit.He developed a midline ventral hernia in the past that was repaired with a large piece of mesh.The patient also developed a parastomal hernia which was repaired primarily in the past.He presented to the clinic with a recurrence of his parastomal hernia.The risks, benefits, and alternatives to repair of this recurrent parastomal hernia were thoroughly discussed with the patient.He elected to proceed.Description of procedure: the patient was brought to the operating room and placed supine.All pressure points were padded.General endotracheal anesthesia was administered, and preoperative antibiotics were given.The patient¿s abdomen including the stoma was prepped and draped sterilely.A time-out was performed.We started by creating a 10 cm transverse incision beginning at the lateral aspect of the stoma and extending laterally.The incision was also extended around the stoma superiorly and inferiorly.We carried the incision through the subcutaneous tissues using electrocautery.We dissected a rather large hernia sac.We entered the hernia sac and reduced a portion of colon and omentum.The hernia sac was excised at the level of the fascia.This revealed a 6 x 4 cm horizontally oriented elliptical fascial defect.We proceeded to close the fascia horizontally with interrupted 0 prolene figure-of-eight sutures.We then mobilized the tissue around the stoma conduit.This allowed us enough room to tuck mesh tails around the stoma.A segment of 2 mm in thickness gore-tex mesh was cut to fit the repaired fascia.The tails of the mesh were looped superiorly and inferiorly to the mesh which lied just lateral to the stoma.The mesh was secured in an onlay fashion to the anterior aspect just superficial to the fascia with interrupted 0 prolene suture.The mesh sat well at the completion of that maneuver.A 15-french jp drain was draped over the mesh and brought out superior to the incision.Scarpa¿s layer was closed with a running 3-0 vicryl suture.We achieved adequate hemostasis.We injected the skin and subcutaneous tissues with 10 ml of 0.25% marcaine.The skin was closed with a running 2-0 nylon suture.The drain was sutured in place using a single 0 prolene suture.A new stoma appliance was applied to the wound.The patient was awoken in the operating room and taken to the post anesthesia care unit in good condition.¿ the records confirm a gore-tex® soft-tissue patch (1310015020/7273905) was implanted during the procedure.On (b)(6) 2014: pathology.Specimen received: parastomal hernia.Clinical diagnosis: recurrent parastomal hernia.Final pathological diagnosis: fibroadipose tissue labeled parastomal hernia, excision.Tissue from hernia repair.Chronic inflammation.Gross specimen: the specimen is received labeled parastomal hernia and consists of purple to yellow soft tissue that appears to be fibroadipose tissue partially covered by membranous-type soft tissue.Sections are submitted in a single cassette.Microscopic: sections contain fibroadipose tissue with a mesothelial lining.Chronic inflammation is present.No other abnormalities are noted.On (b)(6) 2014: daily focus assessment report.Provider aware of leaking stoma.Per physician, stoma nurse needs to be consulted.10:42: abd.Dressing saturated with urine from urostomy.Wound care nurse called earlier for dressing change.16:51: eakins used as filler around sutured incision.On (b)(6) 2014: discharge summary.Admission/postop diagnoses: recurrent parastomal ventral hernia.Summary: developed a recurrence and had an enlarging ventral hernia lateral to this area.It was quite large, probably 6 cm in size.We repaired this on (b)(6) 2014, through a lateral approach with stomal revision.We had to mobilize the intra-sac adhesions, which included the cecum, as well as the small bowel and the ileal conduit itself.We repaired it with prolene suture and reinforced it with a u-shaped piece of gor-tex mesh 2 mm thickness, patch mesh and prolene sutures.Drained the subcutaneous area, closed the subcutaneous skin and restored the stoma.Kept overnight, because of the magnitude of his operation for pain control, but by the morning was comfortable, not taking any narcotics and was dismissed home in the care of his family.The stoma nurse will see him today for application of a new appliance to try to prevent leak, because of the ___ [sic] in place.Follow-up in the office 12 to 13 days for suture removal.On (b)(6) 2014: (b)(6) health.(b)(6), md.Office note.Lateral part of stoma necrosed.Sutures removed today, debrided.Seems to be draining well to be outside.Medial 2/3 of stoma is viable, will probably heal by itself.My concern is it will get an infection around the gore-tex mesh that he got in that area and it will have to come out and we will have a worsening problem.It could not be approached from midline because of previous surgery and a piece of mesh for a big midline hernia he had last year.Wt (b)(6).On (b)(6) 2014: (b)(6) health.(b)(6), md.Office note.Necrosis of stoma healing nicely.No obvious pus, no fever, no pain.Will have ureteral stent changed today over a wire.It looks like we are going to get this thing healed without a major complication.I am still concerned about potential for infection around gore-tex mesh that he has lying on top of the repair.Wt (b)(6).On (b)(6) 2014: (b)(6) health.(b)(6), md.Office note.Necrosis of bowel conduit healed up.Stent still in place.Draining well and having well-controlled drainage into bag.Should be no problem getting well now.On (b)(6) 2014: history & physical.Hpi: presented to er after having shaking chills during the day, fever, multiple episodes of vomiting as well as weakness.On (b)(6), the patient underwent a successful ureterostomy tube change.Symptoms started yesterday prior to presenting to the emergency department at which time it was noted that the patient had a fever of 102.6, heart rate of 109.Urinalysis in the ed showed large blood, positive nitrites, large leukocytes and many white blood cells.He was given a dose of levaquin in the ed.This morning, the patient states he is feeling better and is hungry.He has been on a clear liquid diet and is requesting regular food.Exam: does not appear toxic, just weak.T-max was recorded at 103 at midnight.Abdomen: soft, nontender, nondistended, with normoactive bowel sounds.Some blood in his urostomy bag.Foley is in place.Diagnostic studies: initial blood cultures gram-negative rods in 2 tubes.White blood cell count is 14.6 with 15% bands.White blood cell count yesterday 12.8.Impression: urinary tract infection.Sepsis secondary to #1.Acute kidney injury on chronic renal failure.On (b)(6) 2014: microbiology.Blood culture.Gram negative rod.Isolate (final) escherichia coli.On (b)(6) 2014: microbiology.Urine culture.Culture result (final) 10,000-50,000 cfu/ mi mixed gram negative rod.Isolate (final): proteus mirabilis, escherichia coli.On (b)(6) 2014: loopogram.Reason for exam: right renal damage.Impression: findings worrisome for a fistula between the ileal conduit in the sigmoid colon.On (b)(6) 2014: loopogram.Reason for exam: urinary tract infection, renal failure.Impression: the right upper collecting system and ureter are patent and communicate with the ileal conduit without obstruction.Fistula between the ileal conduit and the sigmoid colon.On (b)(6) 2014: ct abdomen/ pelvis w/o contrast.Reason for exam: renal failure, urinary tract infection.Impression: fistula with communication between the ileal conduit and sigmoid colon possibly through a diverticulum.On (b)(6) 2014: colon barium enema.Reason for exam: fistula.Impression: fistula from the sigmoid colon to the ileal conduit could not be demonstrated from this direction.On (b)(6) 2014: discharge summary.Hospital course: stable throughout hospital stay.Urine culture revealed proteus and escherichia coli.Found to have a fistula from his ileal conduit to his colon.It was felt that general surgery consultation would be needed in the future to consider repair of that, although that was going to be a large surgery.He feels good, is afebrile, wants to go home.Discharge diagnoses: sepsis secondary to urinary tract infection.Urinary tract infection with escherichia coli and proteus grown out of cultures.Acute kidney injury superimposed on chronic renal insufficiency.Fistula from the ileal conduit to the colon.Discharge medications: keflex 500 mg daily for now.On (b)(6) 2014: (b)(6) health.(b)(6), md.Office note.4 ½ months postop repair of recurrent parastomal hernia with a piece of goretex mesh.Had infection which started in this area 2 weeks ago.Was seen and evaluated by dr.(b)(6), placed on antibiotics, and then came back to see her late last week with an area of extrusion or infection, she probed, cleaned and referred him back here.He has extruded his goretex mesh.Today, under topical anesthesia, i excised the mesh completely, incising the sutures in a circumferential area, and removed the entire piece of mesh from the area.I debrided all of the chronic inflammatory tissue, packed the wound, and we will start home nurse dressing changes and pack it and change it every day.He¿s going to have recurrent hernia and i think the only option would be to have the conduit redone, probably in (b)(6), where he had his original cystectomy and ileoconduit.Had a leak between ileoconduit and sigmoid colon on x-ray, but because of lack of infection and need for catheter stent, it was felt to leave it in place.On (b)(6) 2014: (b)(6) health.(b)(6), md.Office note.Defect is about 3 cm x 3 cm, flat-based, clean and doing well now.It should heal over without problems.Recommend dr.(b)(6) refer him back to (b)(6) to fix complex parastomal hernia.It could be repaired from the inside once it has healed through a right upper quadrant incision and approach from that direction.Wt (b)(6).On (b)(6) 2014: (b)(6) health.(b)(6), md.Office note.Wound is clean and almost completely closed.On (b)(6) 2015: (b)(6) health.(b)(6), md.Office note.Wound closed by itself.Loop of small bowel which is part of the ileal conduit was up against the skin, eroded through skin, developed a leak seen by urologist.Had left ureteral tube changed recently put through new pseudostoma into the conduit.Basically has a stoma medial to this open area.His concern is little prolapse of mucosa there.It is prolapsing mucosa.Along with the conduit it does internally intussuscept and come out.He should have no problem with this.Looks like a double barrel stoma.Told him repairing will be somewhat difficult because it¿s inside the intestine not at the end that is causing this area.To resect the other and do an end stoma could be done but would be with some obvious chance of injury to bowel below or to conduit which would be even worse.With lack of conduit he would have to have urostomy tubes which i think he would like to have.Right now this only herniates about 1.5 cm above the skin and is functioning quite well.I would leave it alone.See him back in 2 months and if this is starting to do something bad like intussusception i would not want to repair this if at all possible.On (b)(6) 2015: (b)(6) health.(b)(6), md.Office note.No worse than 2 months ago.Not causing pain.Repair would be somewhat arduous.Can be done, would shorten ileal loop.Wt (b)(6).No sign of recurrence of hernia.Recommend observation.On (b)(6) 2016: wound care clinic progress note.Hpi: patient comes in now with a 1-1/2 inch opening on the medial side of urostomy with extruding mesh.Approximately 1 inch x ¾ inch of this was excised.The rest of it was still fairly deep within the abdominal wall and therefore i felt that dr.(b)(6) should evaluate this for removal.Diagnosis: infected abdominal wall hernia mesh.On (b)(6) 2016: missing operative report from abdominal wall mesh excision.Pathology.Procedure: abdominal wall mesh excision.Specimen received: abdominal wall mesh.Clinical diagnosis: abdominal wall mesh.Final pathological diagnosis: abdominal wall mesh.Gross specimen: the specimen is labeled abdominal wall mesh and consists of a membranous portion of stiff material which measures 2.9 x 1.89 cm with a thickness of 0.1 cm.It has minimal portions of what appear to be blood clots.There is no gross evidence of exudate.No sections are submitted.On (b)(6) 2016: emergency record.Hpi: abdominal pain.This is a chronic problem at site of his urostomy where there is a small ulceration.Exam: abdomen: soft and nontender.Small ulceration noted to lateral aspect of urostomy.No active bleeding or infection noted.Disposition: discharged.On (b)(6) 2016: (b)(6) health.(b)(6), md.Office note.Seen by dr.(b)(6) about a month ago and had some piece of mesh removed in his office.He was worried about a little bleeding.I saw him months ago and thought he might well need revision of his loop at that point in time.Surgery was done elsewhere.Creatinine clearance is dropping.Has to have a stent placed in 1 of the ureters because of stenosis at end of the loop.This is being changed.He is doing well otherwise and was concerned about the need for having the mesh removed.I think this gentleman needs to have his loop revised.Send him back to original surgical intervention site to have uro-loop revised.They can repair inside of abdominal wall hernia area at that time.No mesh extruding now.Wt (b)(6).On (b)(6) 2016: radiology report.Exam: exchange of left nephron-ureterostomy catheter.Examination was not performed.Patient has a peristomal hernia with associated infection.Due to the active inflammatory changes at the ileal conduit stoma with inflammatory fluid present at this site, the catheter exchange was not performed.Patient was presently not on antibiotic therapy.Patient was given prescription for cipro 500 mg p.O.B.I.D.X 10 days.On (b)(6) 2016: microbiology.Blood culture.Source: blood, peripheral blood draw.Culture blood aerobic: final (b)(6) 2016 no growth.Culture blood anaerobic: final (b)(6) 2016 no growth.Hospital admission records dated (b)(6) 2016 state: ¿this is a (b)(6) male who presents for evaluation of recurrent parastomal hernia.The patient originally had cystectomy in 2011 with ileal conduit, had 2 times parastomal hernia repairs at san angelo, had recurrent parastomal hernia which has been getting worse since (b)(6).Endorses nausea, vomiting, intermittent fever, endorses purulent drainage from the stoma site.Also complains of burning pain, 8/10 at its peak around the stoma site.Pain aggravated by pressure and alleviated by nothing.Symptoms have been getting worse since (b)(6).¿ ¿per urology note, also now with ileal conduit stoma stenosis and left ureteral stricture.He was seen¿this afternoon and it was deemed necessary to admit this patient for iv antibiotics and fluid resuscitation.¿ ¿¿status post cystectomy and ileal conduit, multiple parastomal hernia repair's with mesh, now parastomal hernia mesh infection and open wound.We are consulted by urology for repair of parastomal hernia.It appears the patient has severe mesh infection.He will need explantation of the mesh during his revision of his ileal conduit.¿ records detailing a parastomal mesh implantation, including identity, and subsequent parastomal hernia mesh infection as stated in medical records dated (b)(6) 2016 were not provided.
 
Event Description
It was reported to gore that the patient underwent open ventral hernia repair on (b)(6) 2013 whereby a gore dualmesh® biomaterial was implanted.The complaint alleges that on (b)(6) 2016, an additional procedure was performed whereby explant of the gore device was performed.It was reported the patient alleges the following injuries: abdominal pain, infected mesh, revision surgery, and loss of consortium.Additional event specific information was not provided.
 
Manufacturer Narrative
H6: updated results code.Conclusion code remains unchanged.
 
Manufacturer Narrative
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 the information ascertained from the medical records received on 10/04/19.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.
 
Manufacturer Narrative
Previous patient codes ( 1994, 3191 code used for "loss of consortium¿) were reported based on the original complaint and is no longer applicable and/or not reportable per gore¿s investigation.The investigation has been completed.In the absence of additional information or medical records from the complainant, this event file will be closed with the information provided.The following information was determined from the medical records.Medical records: the known medical records span april 21, 2011 through december 20, 2017, and not all records received in this time span are relevant to gore-tex® soft tissue patch, and gore® dualmesh® biomaterial.Patient information: medical history: smoking 1980: quit smoking (b)(6) 2016: smokeless tobacco: ¿former user, quit 36 years ago.¿ (b)(6) 2016: ¿former smoker, quit 36 years ago, 1 pack per week from ages 16 to 41.¿ diverticulosis.Drug induced diabetes mellitus with diabetic nephropathy.(b)(6) 2012: metformin chronic renal insufficiency bladder cancer hypertension (b)(6) 2012: lisinopril prior surgical procedures: 2007: photo-selective vaporization of the prostate 2010: total cystectomy and ileal conduit secondary to bladder cancer (b)(6) 2011: robotic radical cystoprostatectomy with ileal conduit (b)(6) 2011: nephrostomy tube and stent placement; ¿he has a stenosis of one of his ureters at the anastomosis to the ileal conduit and has an indwelling stent, which is left in place and changed every six weeks.¿ implant #1 preoperative complaints: (b)(6) 2012: microbiology: ¿culture result of ¿l urine from l nephropyelostomy & l kidney¿ detects ¿escherichia coli¿ and ¿citrobacter koseri (c.Diversus).¿ (b)(6) 2012: ¿incisional hernia has gotten bigger and bigger as time goes on and now is quite large, probably 10 cm at least in diameter, in the middle, is going to require mesh repair.Creates a problem because of potential contamination from ileal conduit.Will have to repair because it¿s causing a lot of pain and is getting larger rapidly.¿ ¿this man will have to have a drain, and i have explained to him there is at least a 20% chance of infection because it will require mesh.¿ (b)(6) 2013: history and physical: ¿ventral hernia that became apparent very quickly after his surgery, has become larger at times, now difficult to apply his appliance, pain in midline wound.Abdomen: soft.Right lower quadrant urastoma with indwelling stent, large 10 cm ventral hernia, reducible but very tender.Impression: enlarging, painful ventral hernia without incarceration.¿ implant #1 procedure: ventral hernia repair with gore dual mesh and jackson-pratt drain placement.Implant gore® dualmesh® biomaterial (1dlmc07/10485246, 20cm x 30 cm).Implant #1 date: (b)(6) 2013 [hospitalization (b)(6) 2013] description of hernia being treated: ¿a #15 blade scalpel was then utilized to incise the skin and sharply dissect down through the old scar.The patient just had skin and ___ [sic] subcutaneous tissue.The intestine was encountered and ___ [sic] was inspected to ensure no damage had occurred.The skin incision was extended.Once opened, the defect in the patient¿s anterior abdominal wall was approximately 5 x 4 inches.The patient¿s abdominal wall fascia had retracted laterally.So, bovie electrocautery was utilized to mobilize the fascia from the subcutaneous tissue.Adhesions below the fascia were taken down sharply with metzenbaum scissors.Some omental bleeding was controlled with a 2-0 silk ligature.¿ implant size and fixation: ¿once all adhesions were free and the fascia had been mobilized, a piece of gore dual-sided mesh approximately 15 x 20 cm was placed into the abdomen.A single piece mesh was placed in combination underlay and overlay.The mesh was placed below the fascia with the external borders of the mesh wrapping around the fascial edge.Allis clamps were utilized to grab the fascia and mesh in a single bite and then a stitch of 0 prolene was used in a horizontal mattress fashion taking a bit of mesh and fascia.This was done in serial fashion.Each horizontal mattress was 1 cm apart.Circumferentially, the mesh was tightened to ensure appropriate tightness in all directions.Before completely sewing in the mesh, the abdominal cavity was inspected to ensure that no loops of intestine had been caught up in the suture line.The funnel stitches were secured in place.Normal saline was used to irrigate the mesh and the subcutaneous tissues.A 20-french blake drain was placed anterior to the mesh below the skin and subcutaneous tissues.This was sutured in place with an 0 prolene.The subcutaneous tissues were reapproximated using a running stitch of 3-0 vicryl.¿ findings: ¿approximately a 5 x 3 inch defect in the ventral abdominal wall from prior laparotomy incision.A single piece of mesh was used as an underlay with the edges rolled over on top of the fascia.¿ (b)(6) 2013: discharge summary: ¿underwent a midline incision, dissection of a huge hernia sac and repair with a large piece of dualmesh.Because of the proximity to the urostomy, given levaquin preop and it was continued.The patient had a ureteral stent in place also through the urostomy, so we were not able to close it when we did the surgery.He had an uncomplicated repair.¿ relevant medical information: (b)(6) 2013: ¿has an indwelling stent in conduit and ureteral anastomosis because of stricturing and has to be changed every few weeks.Was changed 2 weeks ago.So far, no sign of infection in area of incision.Drain was removed at 10 days postop and he did well.¿ (b)(6) 2013: ¿has a well-incorporated solid graft with no hernia now.Ureteral stent so far, has not infected mesh with manipulation of urinary tract.¿ (b)(6) 2013: ¿has parastomal hernia around ileal conduit and wants it repaired.It¿s large and does need to be repaired.¿ (b)(6) 2013: repair of parastomal hernia with primary repair.¿.We closed the defect of the hernia with prolene 0.¿ (b)(6) 2013: ¿has done great, wound is healed.Having no problems and pleased with surgical procedure.¿ implant #2 preoperative complaints: (b)(6) 2014: ¿parastomal hernia has recurred.This is going to be very complex and difficult to repair.He is having stents changed next week.Told him to wait a week after stents and let us know if he got any fever or other problems.It¿s going to require lateral abdominal incision, looking in the abdomen, and then repair with mesh from the inside.This is very complex and difficult.He understands complexity of this problem.Wt 193.¿ (b)(6) 2014: ¿history of bladder cancer who was treated with a bladder resection and urinary reconstruction with an ileal conduit.He developed a midline ventral hernia in the past that was repaired with a large piece of mesh.The patient also developed a parastomal hernia which was repaired primarily in the past.He presented to the clinic with a recurrence of his parastomal hernia.¿ implant #2 procedure: repair of recurrent parastomal hernia with mesh.Implant: gore-tex® soft tissue patch (1310015020/7273905) 10 cm x 15 cm, 2 mm thick.Implant #2 date: (b)(6) 2014 [hospitalization (b)(6) 2014] description of hernia being treated: ¿we started by creating a 10 cm transverse incision beginning at the lateral aspect of the stoma and extending laterally.The incision was also extended around the stoma superiorly and inferiorly.We carried the incision through the subcutaneous tissues using electrocautery.We dissected a rather large hernia sac.We entered the hernia sac and reduced a portion of colon and omentum.The hernia sac was excised at the level of the fascia.This revealed a 6 x 4 cm horizontally oriented elliptical fascial defect.We proceeded to close the fascia horizontally with interrupted 0 prolene figure-of-eight sutures.¿ implant size and fixation: ¿we then mobilized the tissue around the stoma conduit.This allowed us enough room to tuck mesh tails around the stoma.A segment of 2 mm in thickness gore-tex mesh was cut to fit the repaired fascia.The tails of the mesh were looped superiorly and inferiorly to the mesh which lied just lateral to the stoma.The mesh was secured in an onlay fashion to the anterior aspect just superficial to the fascia with interrupted 0 prolene suture.The mesh sat well at the completion of that maneuver.A 15-french jp drain was draped over the mesh and brought out superior to the incision.Scarpa¿s layer was closed with a running 3-0 vicryl suture.We achieved adequate hemostasis.¿ (b)(6) 2014: discharge summary: ¿kept overnight, because of the magnitude of his operation for pain control, but by the morning was comfortable, not taking any narcotics and was dismissed home in the care of his family.The stoma nurse will see him today for application of a new appliance to try to prevent leak, because of the _ [sic] in place.¿ relevant medical information: (b)(6) 2014: ¿lateral part of stoma necrosed.My concern is it will get an infection around the gore-tex mesh that he got in that area and it will have to come out and we will have a worsening problem.It could not be approached from midline because of previous surgery and a piece of mesh for a big midline hernia he had last year.Wt 183.¿ (b)(6) 2014: ¿necrosis of stoma healing nicely.No obvious pus, no fever, no pain.Will have ureteral stent changed today over a wire.It looks like we are going to get this thing healed without a major complication.I am still concerned about potential for infection around gore-tex mesh that he has lying on top of the repair.¿ (b)(6) 2014: ¿necrosis of bowel conduit healed up.¿ (b)(6) 2014: hospitalization (b)(6) 2014.(b)(6) 2014: ct abdomen: ¿fistula with communication between the ileal conduit and sigmoid colon possibly through a diverticulum.¿ (b)(6) 2014: discharge summary: ¿sepsis secondary to urinary tract infection with e.Coli and proteus.Acute kidney injury superimposed on chronic renal insufficiency.Fistula from the ileal conduit to the colon.Keflex daily.¿ explant #1 preoperative complaints: (b)(6) 2014: ¿4½ months postop repair of recurrent parastomal hernia with a piece of goretex mesh.Had infection which started in this area 2 weeks ago.Was seen and evaluated by dr.Cerna, placed on antibiotics, and then came back to see her late last week with an area of extrusion or infection, she probed, cleaned and referred him back here.He has extruded his goretex mesh.¿ explant #1 procedure: excision of mesh [gore-tex® soft-tissue patch] explant #1 date: (b)(6) 2014 [office procedure] ¿today, under topical anesthesia, i excised the mesh completely, incising the sutures in a circumferential area, and removed the entire piece of mesh from the area.I debrided all of the chronic inflammatory tissue , packed the wound, and we will start home nurse dressing changes and pack it and change it every day.He¿s going to have recurrent hernia and i think the only option would be to have the conduit redone, probably in san antonio, where he had his original cystectomy and ileoconduit.Had a leak between ileoconduit and sigmoid colon on x-ray, but because of lack of infection and need for catheter stent, it was felt to leave it in place.¿ relevant medical information: (b)(6) 2014: ¿defect is about 3 cm x 3 cm, flat-based, clean and doing well now.It should heal over without problems.¿ (b)(6) 2014: ¿wound is clean and almost completely closed.¿ (b)(6) 2015: ¿wound closed by itself.Loop of small bowel which is part of the ileal conduit was up against the skin, eroded through skin, developed a leak seen by urologist.Had left ureteral tube changed recently put through new pseudostoma into the conduit.Basically has a stoma medial to this open area.His concern is little prolapse of mucosa there.It is prolapsing mucosa.Along with the conduit it does internally intussuscept and come out.He should have no problem with this.Looks like a double barrel stoma.Told him repairing will be somewhat difficult because it¿s inside the intestine not at the end that is causing this area.To resect the other and do an end stoma could be done but would be with some obvious chance of injury to bowel below or to conduit which would be even worse.With lack of conduit he would have to have urostomy tubes which i think he would like to have.Right now this only herniates about 1.5 cm above the skin and is functioning quite well.I would leave it alone.See him back in 2 months and if this is starting to do something bad like intussusception i would not want to repair this if at all possible.¿ (b)(6) 2015: ¿no sign of recurrence of hernia.¿ (b)(6) 2016: wound care clinic: ¿patient comes in now with a 1½ inch opening on the medial side of urostomy with extruding mesh.Approximately 1 inch x ¾ inch of this was excised.The rest of it was still fairly deep within the abdominal wall and therefore i felt that dr.Cornell should evaluate this for removal.Diagnosis: infected abdominal wall hernia mesh.¿ pathology: ¿abdominal wall mesh: the specimen is labeled abdominal wall mesh and consists of a membranous portion of stiff material which measures 2.9 x 1.89 cm with a thickness of 0.1 cm.It has minimal portions of what appear to be blood clots.There is no gross evidence of exudate.No sections are submitted.¿ (b)(6) 2016: ed visit: ¿abdominal pain.This is a chronic problem at site of his urostomy where there is a small ulceration.Abdomen: soft and nontender.Small ulceration noted to lateral aspect of urostomy.No active bleeding or infection noted.¿ (b)(6) 2016: ¿no mesh extruding now.¿ explant #2 preoperative complaints: (b)(6)2016: ct abdomen: ¿mild hydroureteronephrosis of right kidney, 3 nonobstructing stones.Status post ventral hernia mesh repair, with crumpled appearance of the mesh and protrusion of the right lateral mesh and exposure to the cutaneous surface via cutaneous wound.¿ (b)(6) 2016: history and physical: ¿evaluation of recurrent parastomal hernia.Nausea, vomiting, intermittent fever, purulent drainage from stoma site.Burning pain, 8/10 at its peak around the stoma site.Symptoms have been getting worse since august.Per urology note, also now with ileal conduit stoma stenosis and left ureteral stricture.Abdomen: soft, tender to palpation around ostomy site.There is a protruding ileal conduit stent in the ileal conduit stoma.Medial to the conduit was a 3.2 cm open wound with protruding mesh material and granulation.The wound appears and smelled infected.Plan: parastomal hernia mesh infection and open wound.It appears the patient has severe mesh infection.He will need explantation of the mesh during his revision of his ileal conduit.¿ (b)(6) 2016: microbiology: ¿incision site.Gram stain wound: final (b)(6) 2016 direct smear: few polymorphonuclear leukocytes/ oif.No organisms seen.Culture wound aerobic: final (b)(6) 2016 organism 1: streptococcus group f.Quantity: light growth.¿ (b)(6) 2016: ¿history of a prior cystectomy and ileal conduit who has developed both parastomal and ventral incisional hernias of abdominal wall and at some point, in the remote past underwent a mesh repair of his ventral and parastomal hernias with an onlay gore-tex mesh.He presented to our outpatient surgery clinic approximately 2 days ago with infected mesh eroding through his skin, a septic abdominal wall with severe tenderness along his entire abdominal wall and purulence draining both around some skin ulceration with extruded mesh and pus draining around his ileal conduit site.He was in significant discomfort, and he was admitted directly from the clinic to christus santa rosa and has been on fluid rehydration and antibiotics for the past 48 hours, and he presents at this time for definitive operative therapy.¿ explant #2 procedure: exploratory laparotomy.Explantation of infected mesh [gore® dualmesh® biomaterial].Irrigation and debridement of abdominal wall fascia, superficial and deep.Placement of vicryl mesh.Explant #2 date: (b)(6) 2016 [hospitalization (b)(6) 2016] ¿¿ his previous midline laparotomy incision was opened.He had gross purulence spilling out through his skin incision and through and ulcer of his abdominal skin from the eroded mesh, and this abscess cavity was cultured with a culture swab and sent for gram stains and sensitivities.Once the midline was opened, the subcutaneous tissues were dissected out with cautery.The infected gore-tex mesh was easily identified , grasped and simply explanted by avulsing it from his anterior sheath; cutting sutures were necessary and debriding subcutaneous tissues and fascia along with it.The gore-tex mesh was explanted as an entire specimen leaving approximately about a 10 x 10 sized fascial defect in the midline.We carefully explored his abdominal cavity.His abdominal cavity was actually clean.There was no infection deep into his intra-abdominal space, and the mesh was abutting but not eroding into his ileal conduit and stoma site.After careful exploration, we further debrided any necrotic debris including skin, subcutaneous fat and fascia and muscle all the way down to the posterior sheath when necessary.Once the debridement was completed, hemostasis was achieved with cautery, and then the entire field was lavaged with the pulsavac device with at least 4 l of antibiotic saline.For temporary fascial closure, skin flaps were created to the subcutaneous tissues to the point where reasonable fascia could be encountered.It was approximately a 10 x 10 cm defect that was closed.We then repaired the defect with multiple figure-of-eight interrupted sutures of pds, and then we quilted a small piece of vicryl mesh onto his anterior rectus sheath for reinforcement to prevent evisceration.The vicryl mesh was quilted both to the anterior rectus sheath and to his skin, again to prevent dehiscence.: (b)(6) 2016: microbiology.¿acid fast cultures.Source: abscess/pus wound, abdominal region.Afb smear, concentrated final (b)(6) 2016: no acid-fast bacilli seen.Culture afb, concentrated final (b)(6) 2016: 6 week report: no acid-fast bacilli recovered.Fungal cultures.Source: abscess/pus wound.Fungal smear final (b)(6) 2016: no yeast or fungal elements seen.Culture fungus final (b)(6) 2016: 1 month report: no fungus recovered.Source: abdomen.Gram stain surgery final: (b)(6) 2016 direct smear: many polymorphonuclear leukocytes/ oif; few gram positive cocci/ oif; few gram negative bacilli/ oif.Culture surgery aerobic final (b)(6) 2016: organism 1 escherichia coli, light growth.Organism 2 streptococcus group f, light growth.Source: other.Culture anaerobic final (b)(6) 2016: organism 1 bacteroides ovtaus, light growth, beta lactamase positive.¿ (b)(6) 2016: pathology: ¿explanted mesh.Specimen, labeled ¿explanted mesh¿, and consists of an artificial structure resembling mesh material.It is somewhat crinkled , but measures approximately 9.4 x 12.8 cm.A small amount of attached tissue is present.¿ (b)(6) 2016: discharge summary: ¿¿ admitted from clinic on sept.21 with evidence of infected mesh for iv antibiotics and fluid resuscitation.On the 23rd he was brought to the or where we did mesh explantation, some closure of his fascia and placement of vicryl mesh for retention.Patient recovered well, was tolerating diet, ambulating, making urine out of his ileal conduit.On day of discharge, pain was well-controlled.Wound vac was successfully placed.Patient will be going home on augmentin 875 twice a day for 30 days.¿ relevant medical information: (b)(6) 2016: ¿wound improved.¿ (b)(6) 2016: ct abdomen: ¿ileal conduit appears patent with left nephroureteral stent in place.Soft tissue thickening of stoma.¿ (b)(6) 2016: ¿surgical abdominal wall wound with dehiscence secondary to infected mesh.¿ (b)(6) 2017: bilateral myofascial release with posterior components separation.Ventral incisional hernia repair with mesh.Parastomal hernia repair with mesh.Complex abdominal wound closure and negative pressure wound therapy.Conclusion: it should be noted that the gore-tex® soft-tissue patch instructions for use includes warnings and addresses the following adverse reactions among others: ¿possible adverse reactions with the use of any tissue deficiency prosthesis may include, but are not limited to, contamination, infection, inflammation, adhesion, fistula formation, seroma formation, hematoma, and recurrence.¿ the gore-tex® soft-tissue patch instructions for use states, ¿exposure of the gore-tex® soft tissue patch to the external environment during healing should be avoided.If the gore-tex® soft tissue patch should become exposed during healing, treat to avoid contamination and allow for secondary healing with tissue flap coverage, if possible.¿ the gore-tex® soft-tissue patch instructions for use warns, ¿strict aseptic techniques should be followed.If an infection develops, it should be treated aggressively.An unresolved infection may require removal of the material.¿ the gore-tex® soft-tissue patch instructions for use also warns, ¿when using this device as a permanent implant and exposure occurs, treat to avoid contamination, or device removal may be necessary.¿ 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 wound management.Patient risk factors may include diabetes, smoking, age, malnutrition, immunosuppressive therapy, post-operative instruction noncompliance, and hygiene.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, dysphagia, erosion or extrusion and related harms, exposure or protrusion and related harms, fever, fistula, gerd recurrence, recurrence, ileus, increased procedure time and related harms, irritation or inflammation, infection, pain, paresthesia, perforation, revision / re-intervention, seroma or hematoma and related harms, wound complications and wound dehiscence.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 device was not returned 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.All available information has been placed on file for use in tracking, trending and follow-up.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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Brand Name
GORE-TEX SOFT TISSUE PATCH
Type of Device
MESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
W.L. GORE & ASSOCIATES
flagstaff AZ
MDR Report Key8665921
MDR Text Key146917044
Report Number3003910212-2019-00159
Device Sequence Number1
Product Code FTL
UDI-Device Identifier00733132600519
UDI-Public00733132600519
Combination Product (y/n)N
PMA/PMN Number
K963619
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Type of Report Initial,Followup,Followup,Followup
Report Date 10/22/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/04/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date11/17/2014
Device Model Number1310015020
Device Catalogue Number1310015020
Device Lot Number7273905
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age75 YR
Patient Weight89
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