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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. GORE® SYNECOR® INTRAPERITONEAL BIOMATERIAL; MESH, SURGICAL, POLYMERIC

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W. L. GORE & ASSOCIATES, INC. GORE® SYNECOR® INTRAPERITONEAL BIOMATERIAL; MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number GKFR2030
Device Problem Insufficient Information (3190)
Patient Problems Unspecified Infection (1930); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/31/2017
Event Type  Injury  
Manufacturer Narrative
It should be noted that the gore® synecor® intraperitoneal 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® synecor® intraperitoneal 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.".
 
Event Description
It was reported to gore that the patient underwent laparoscopic incisional hernia repair on (b)(6), 2005 whereby a gore® dualmesh® plus biomaterial was implanted and on (b)(6), 2017 whereby a gore® synecor® intraperitoneal biomaterial was implanted.The complaint alleges that on (b)(6), 2016 an additional procedure occurred whereby a gore device was revised.The complaint alleges that on (b)(6), 2017 and (b)(6), 2018, additional procedures occurred whereby the gore devices were explanted.It was reported the patient alleges the following injuries: additional surgeries, pain, adhesions, revision, bowel resection, fistula, infection, wound vac, removal.Additional event specific information was not provided.
 
Manufacturer Narrative
Additional details regarding the patient's clinical course were ascertained from a review of medical records and are as follows: relevant medical information: (b)(6) 2004 ¿ (b)(6) 2004: fletcher allen health care [fahc].Inpatient hospitalization.(b)(6) 2004: (b)(6).Operative report.Assistant: (b)(6).Procedure: roux-en-y gastric bypass with cholecystectomy.Preoperative diagnoses: morbid obesity.Hypertension.Obstructive sleep apnea.Hypercholesterolemia.Postoperative diagnoses: morbid obesity.Hypertension.Obstructive sleep apnea.Hypercholesterolemia.Cholelithiasis.Anesthesia: general.Indications: ¿the patient is a 42-year-old man with a bmi of 65, who spent a year in the bariatric clinic preparing for gastric bypass surgery.¿ wound classification: not provided.Findings: ¿normal intraabdominal anatomy and gallbladder with cholelithiasis.¿ procedure: ¿the patient was prepped and draped sterilely over the abdomen after induction of general anesthesia in a supine position.An upper midline incision was made and carried down to the midline fascia.The abdomen was explored with the findings as above.The omni retractor was then positioned.The gastrohepatic ligament was opened to gain access to the lesser sac.The esophagus was surrounding at the level of eg [esophagogastric] junction with a penrose drain and used to pull the stomach anteriorly.The g [gastrostomy]-tube was removed, and a red rubber catheter was placed from the angle of his posterior to the stomach to the window along the lesser curvature between the first and second branches of the left gastric vein.This was used to guide tlh-60 stapler around the stomach and a 10-15 cc gastric pouch was created with a triple firing in a vertical orientation.The proximal jejunum was then identified by the ligament of treitz and divided about 15 cm distally.The tlc-55 stapler only fired partially across the diameter of the lumen, so this segment was removed by dividing it on either side with a new tlc-55 stapler.This, about 2 cm, segment was then resected.The mesentery was ligated with a 2-0 vicryl tie.The bypass limb was than measured at 50 cm.The stay sutures were used to attach the proximal jejunum to this point of the bypass limb.A retrocolic, antegastric tunnel was created, and a jejunojejunostomy was then performed in an end-to-side fashion with a tlc-55 stapler, closing the enterotomies with a tlh-60 stapler.The jejunal mesenteric defect was closed with running suture of 3-0 vicryl.The bypass limb was tacked down to the transverse colonic mesentery with a running suture of 3-0 vicryl.The jejunojejunostomy was inspected for hemostasis and integrity and this was found to be intact.At the corner of the staple line, there was a small serosal tear and this was inverted with a u-stitch of 3-0 silk.The gasirojejunostomy was performed in a handsewn fashion with an outer layer of 3-0 silk and an inner layer of 3-0 vicryl, around a 32-french dilator.The g-tube was positioned through the anastomosis and methylene blue was insufflated under pressure.No leak was identified.A small serosal tear from the 3-0 silk was inverted with another 3-0 silk in a seromuscular layer in the stomach.The area was irrigated with normal saline.Hemostasis was found to be intact.The gallbladder was then removed in a retrograde fashion down to the level of the cystic artery and duct which were ligated with 2-0 vicryl ties.The area was irrigated with normal saline.Hemostasis was found to be intact.After a correct sponge and instrument count, the fascia was closed with running suture of double-stranded 1 pds.The subcutaneous tissue was irrigated and the skin was closed with staples.Sterile dressing was applied and the patient was brought to the recovery room in good condition.¿ (b)(6) 2004: (b)(6).Operative report.Assistant: (b)(6).Procedure: exploratory laparotomy, repair of leak, placement of drains, and gastrostomy.Implant: surgisis.Preoperative diagnosis: anastomotic leak.Postoperative diagnosis: anastomotic leak.Anesthesia: general.Indications: ¿the patient is a 42-year-old male, who is one day status post roux-en-y gastric bypass, who developed tachycardia, tachypnea, high white count, and was brought to the operating room to rule out anastomotic leak.¿ wound classification: not provided.Findings: ¿there was a pinhole leak of the left lateral aspect of the anastomosis.¿ procedure: ¿the patient was prepped and draped sterilely over the abdomen after induction of general anesthesia.His skin staples and fascial sutures were removed.The omni retractor was positioned.There was about 100 cc of cloudy fluid around the area of the gastrojejunostomy.The g-tube was guided into through the anastomosis and a penrose drain was placed around the esophagus.On insufflation with methylene blue under significant pressure, a pinhole leak could be seen in the left lateral aspect of the anastomosis.This was reinforced with a vertical mattress seromuscular bite of 3-0 silk between the stomach and the jejunum.No leak could be identified under pressure after this repair.At this point, the upper abdomen was irrigated copiously with 18 liters of warm normal saline.A gastrostomy was performed and brought out through the right upper quadrant, securing it with a 20-french foley with 10 cc in a 30 cc balloon.This was secured in place with two pursestrings of 2-0 silk, tacking the antrum to the anterior abdominal wall.The axiom sump and sheath drains were placed in the lesser sac and the left subphrenic space.To minimize the chance of acute compartment syndrome, an approximately 4 x 6-inch ellipse of surgisis was sutured in place circumferentially with prolene suture.A wound vac was then placed in the subcutaneous tissue.The patient was then brought to the surgical intensive care unit [sicu] in improved condition on the ventilator.¿ (b)(6) 2004: (b)(6).Discharge summary.Final diagnosis: morbid obesity status post gastric bypass and chole [cholecystectomy].Chief complaint: obesity.Hospital course: ¿this patient was seen and evaluated in the clinic.He was admitted on (b)(6) and was taken to the operating room where a roux en y gastric bypass and cholecystectomy was performed.There were no complications.He was recovered and brought to the floor.Soon after he became tachycardic and febrile.An abdominal ct was obtained and revealed extraluminal contrast suggestive of leek.An ex [exploratory] lap [laparotomy] was performed, finding a pinhole leak at the lateral anastamosis.The leak was repaired, and axiom drains placed in the left subphrenic space and morrisson¿s pouch.A g [gastric] tube was placed following irrigation.Patient was transferred to the sicu [surgical intensive care unit] for observation.He did well.He was extubated and made slow steady improvement.He was transferred back to the floor on (b)(6).Methylene blue study and ct were both negative for leak.His ng [nasogastric] was removed and his diet was advanced.Physical therapy was consulted for assistance with ambulation.His drains were backed out.Arrangements were made for a home wound vac.He is discharged to home and will follow up in the clinic.¿ instructions: ¿no heavy lifting or strenuous activity for 6 weeks.No driving.Shower only.Okay to get wound wet, but pat dry.Do not rub the wound area.Wound vac [vacuum assisted closure] change every 2-3 days by the vna [visiting nurse association].Wound vac therapy to be set at 125mmhg continuous.If wound vac fails may try wet to dry dressing changes bid [twice a day].For rash around wound use nystatin powder and cover with duoderm.See dr.Racine as needed.Please call for an appointment.See dr.Spaulding in 1 week.Please call for an appointment.¿ implant #1 preoperative complaints: (b)(6) 2005: fahc.(b)(6).Indications.¿this is a 43-year-old man who underwent a gastric bypass procedure last year who had a postoperative leak and subsequent reexploration with placement of a surgisis mesh due to compartment syndrome.He had an open wound, which healed, but he then developed a bulge in the upper abdomen consistent with an incisional hernia.He was seen in the office and offered a laparoscopic approach to repair this incisional hernia.¿ implant #1 procedure: laparoscopic incisional hernia repair.[implant: gore® dualmesh® plus biomaterial, 1dlmcp08/2738354, 26cm x 34cm x 1cm thick, oval.] implant #1 date: (b)(6) 2005 [hospitalization dates (b)(6) 2005].(b)(6) 2005: fahc.(b)(6).Operative report.Assistants: (b)(6).(b)(6).Preoperative diagnosis: incisional hernia.Postoperative diagnosis: incisional hernia.Anesthesia: general and local.Estimated blood loss: minimal.Complications: none.Wound classification: not provided.Findings: ¿defect measuring 19 x 16 cm in the upper abdomen.A gore-tex dualmesh plus measuring 31 x 26 cm, was used to bridge the fascial gap, with at least 5 cm overlap.Tisseel glue was placed under the uppermost portion of the mesh against the pericardium.¿ procedure: ¿the patient was taken to the operating room and placed supine on the operating table, and identified as (see above).After induction of general anesthesia, the abdomen was prepped and draped in the usual sterile fashion along with an ioban drape.An incision was made in the right mid abdomen, which was 5 mm long, and a veress needle was used to access the peritoneal cavity, which was insufflated to 14 mmhg using carbon dioxide.A 5-mm port was placed in this location, followed by a 5-mm 0-degree scope, which was used to examine the abdomen.There were adhesions to the anterior abdominal wall and the defect could be seen.Another 5-mm port was placed superior to the port on the left, and a 5-mm port was placed in the right mid abdomen, and a 10-mm port was placed in the right upper quadrant.A combination of blunt and sharp dissection, along with a harmonic scalpel, was used to take the adhesions down from the anterior abdominal wall.This was done by alternating between sides.There was transverse colon stuck inside the hernia sac, as was omentum.There was liver stuck to the edge of the defect.The adhesiolysis was lengthy due to his morbid obesity; indeed, the patient was 5 foot 8, and weighted [sic] 340 pounds.This added significantly to the length of the surgery, which took over four hours to complete.After the adhesions were completely taken off the abdominal wall, the liver was dissected off of its attachments to the anterior abdominal wall, as well.The defect could be seen and was marked on the loban on the anterior abdominal wall.It measured 19 x 16 cm.Using atleast a 5cm overlap with a superior extension, the mesh was then cut to size.It was a gore-tex dualmesh plus measuring 31 x 26 cm, and 13 anchoring sutures were placed at the periphery at 6 cm intervals.Corresponding locations on the anterior abdominal wall were then marked and stab incisions were made in the skin in these locations.The mesh was then rolled.The12mm port was removed.Alcohol was placed in this location and the mesh was passed through the abdominal wall into the abdomen.The mesh was then unrolled and the anchoring sutures were pulled through the abdominal wall and tied down.The mesh was then tacked at 1 cm intervals around its periphery with the protacker device.Care was taken to avoid injury to the pericardium superiorly.The mesh was tacked around the pericardium.Tisseel glue was then placed in the superior aspect under the pericardium and the mesh was allowed to stick to the tisseel glue to prevent unrolling.This would later allow for adhesions to help this stick in this location.Another anchoring suture was placed inferior to the pericardium through the mesh.This was a 1 prolene suture and it was tied down.The omentum was then laid over the bowels.The bowels were inspected.There was no enterotomy seen.There was no further bleeding.The fascia at the 12-mm port site was closed with a figure-of-eight stitch using the endoclose device with 0 vicryl suture.The fascia was infiltrated with 0.5% marcaine in this location.The skirt at each port site was closed with subcuticular stitch of 4-0 monocryl and the stab incisions were closed with steri-strips.Band-aids were applied over steri-strips to the trocar sites.The sponge, needle, and instrument counts were correct at the end of the case.The pneumoperitoneum had been released before the ports were removed.The patient was awoken from anesthesia, extubated, and taken to the recovery room in stable condition.(b)(6) 2005: fahc.Implant sticker.¿gore dualmesh® plus biomaterial.¿ catalogue number: 1dlmcp08.Lot #: 2738354.Manufacturer: w.L.Gore & associates.(b)(6) 2005: fahc.(b)(6).Discharge instructions.¿he was dc¿d [discharged] home with instructions to follow up w/dr.Borrazzo in 2 weeks.No heavy lifting or strenuous activity for 6 weeks.Shower only, do not soak incisions.Okay to get wound wet, but pat dry.Do not rub the wound area.Band aids may be removed 4/9; steri strips fall off on their own in 2 wks [weeks].See dr.Borrazzo in 2 weeks.Please call for an appointment.See dr.Racine as needed.Please call for an appointment.¿ relevant medical information: (b)(6) 2005.Fahc.Inpatient hospitalization.(b)(6) 2005: (b)(6).History and physical examination.¿the patient is a 43-year-old gentleman status post ventral hernia repair with abdominal pain and distension and nausea.The patient underwent gastric bypass (b)(6) 2004 complicated by leak requiring reoperation.The patient underwent laparoscopic ventral hernia repair (b)(6) 2005.The patient complains at worsening abdominal pain and no bowel movement since (b)(6) 2005.The patient has had some flatus, last was the day prior to admission.The patient describes constant pain, worse on the left side, worse with motion.He has had nausea.He has had no vomiting.The patient was seen by his nurse practitioner today, who obtained an abdominal series which revealed air fluid levels throughout the small and large bowel.The patient was referred to the emergency room for further evaluation and treatment.¿ physical examination: ¿the patient is in no acute distress, complaining of abdominal pain.Abdomen is obese, it is soft.There is a well-healed midline scar.There are multiple surgical scars from the tack sites from the ventral hernia repair.There is tenderness along the left side of the tack line.There is no erythema, there is no mass.The abdomen is slightly distended.¿ impression: ¿ileus, less likely large bowel obstruction, perhaps exacerbated by narcotics.We will plan nasogastric decompression, observation, enemas.Less likely is mechanical complications related to hernia repair.If there are signs or symptoms of infection, we will consider further evaluation, potentially cat scan of the abdomen.At this time, observation with nasogastric tube drainage will be the plan.¿ (b)(6) 2005: (b)(6).Discharge summary.Final diagnosis: sbo [small bowel obstruction].Chief complaint: abdominal pain w/nausea and vomiting.Hospital course: ¿this patient is 4 days after a ventral hernia repair and presents with nausea, abdominal pain and no bowel movement since surgery.He was admitted for hydration, ng decompression and serial exams.He was given an enema on 4/13 and had a large bowel movement and felt much better.His ng was clamped and he tolerated it well.It was removed and his diet was advanced.He did well.He is discharged to home and will follow up in the clinic.¿ activities: ¿no restrictions.Shower only.Okay to get wound wet, but pat dry.Do not rub the wound area.¿ symptoms to call your doctor about: ¿increased pain.Nausea or vomiting.¿ appointments: ¿see dr.Levin as needed.Please call for an appointment.Follow up with dr.Borrazzo as scheduled.¿ revision preoperative complaints: (b)(6) 2016: (b)(6) medical center [uvmc].(b)(6).Indications.¿this gentleman is 54 years old with a past medical history significant for morbid obesity, status post open roux-en-y gastric bypass in 2004 by dr.Spaulding complicated by leak on post op day # 1, ventral hernia repair with mesh by dr.Borrazzo, gore-tex mesh 26 x 31, open cholecystectomy, hypertension, hyperlipidemia, dilated cardiomyopathy, supraventricular tachycardia and atrial flutter/fibrillation on xarelto.This patient underwent laparoscopic revision of his roux-en-y gastric bypass due to gastrogastric fistula at saranac lake by dr.(b)(6) on (b)(6) 2016.He was discharged and started having respiratory distress and altered mental status.He presented to cvph [(b)(6) hospital] with rapid afib where cardioversion was initiated in the emergency room.He was intubated due to hemodynamic instability unresponsiveness and respiratory distress.His chest x-ray showed massive amount of air under right hemidiaphragm.He had leukocytosis 21, lactate 2.4.Inr 3.5.He received vanco [vancomycin] and cipro [ciprofloxacin] before he was accepted by acute care surgery service.Dr.(b)(6) team contacted me as the patient has a history of a roux-en-y gastric bypass and recent revision 4 days ago.The patient was seen in the er [emergency room] intubated on pressor and in septic shock.The patient received ivf [intravenous fluid]/ ffp [fresh frozen plasma].¿ revision procedure: exploratory laparotomy.Small-bowel resection with primary stapled end-to-end functional side to side anastomosis.Upper endoscopy.Abdominal washout.Drain placement.Revision date: (b)(6) 2016 [hospitalization dates (b)(6) 2016 ¿ (b)(6) 2016].(b)(6) 2016: uvmc.(b)(6).Operative report.Assistants: (b)(6).For endoscopy, (b)(6).Preoperative diagnosis: septic shock due to leak versus enterotomy with respiratory distress (intubated).Postoperative diagnosis: septic shock due to small-bowel (jejunum) perforation x2, enteric contents with peritonitis.Anesthesia: general.Estimated blood loss: less than 200.Specimens: portion of small bowel.Complications: none.Wound classification: not provided.Findings: ¿a gush of air upon entry in the abdominal cavity, about 1.5 l [liters] of intraperitoneal fluid with intestinal contents; two perforations in the jejunum about 2 cm apart, one full thickness about 3 cm wide and the other about 1 cm and collection with fibrin tissue in the area; upper endoscopy showed no anastomotic leak and the anastomosis was patent without bleeding.¿ procedure: ¿the patient was brought to the operating room on a stretcher then moved to operating room in supine position.He was strapped to the table.An extra dose of antibiotic prophylaxis was given.For dvt [deep vein thrombosis] prophylaxis, sequential compression devices were applied to both lower extremities.The patient's abdomen was prepped and draped in usual sterile surgical fashion.The foley catheter was placed to gravity.The ng tube was placed to suction.Who [world health organization] comprehensive checklist was completed.Everybody in the room introduced him/herself.A time-out was completed.The patient was identified by the name, medical record number and date of birth.Plan for procedure was confirmed.Consent form was checked.Instruments and equipment were checked and everything we needed was available in the room.We started our procedure by making a supraumbilical midline incision from the xiphoid process to the supraumbilical area over the old scar that was subsequently extended to just above the umbilicus.The wound was deepened in layers, skin, subcutaneous tissue until we reached the fascia.Then we dissected the subcutaneous tissue of the fascia.The fascia as well as the fibrous tissue was grasped with 2 kocher clamps and was opened with metzenbaum scissors.We encountered the previously placed gore-tex mesh.We opened the gore-tex mesh under direct vision and after we accessed the peritoneal cavity, the mesh as well as the posterior sheath were opened with electrocautery.Upon entering the peritoneal cavity, a gush of air coming as well as about 1.5 [sic] turbid fluid with intestinal contents identified and suctioned from the right subhepatic area.The abdominal cavity was irrigated with plenty of warm normal saline and suctioned.For better exposure the bookwalter retractor was placed.At this point, the upper endoscopy was performed by dr.Malhotra that passed through the gastrojejunal anastomosis and the gastrostomy that showed no stricture, stenosis or bleeding.At this point, we emerged [sic] the upper abdominal area with normal saline and air leak test was performed, which showed no air leak in this area.Then, our attention was drawn to eviscerate the small bowel.In the right upper quadrant, the small bowel was adherent to the anterior abdominal wall with fibrous tissue.With gentle manipulation, we were able to eviscerate the small bowel.The transverse colon was identified and the roux limb which was placed retrocolic was followed caudally.2 full thickness perforations were encountered 2 cm apart, (3x2 cm and 1x1 respectively) that were closed full thickness in continues manner to control continuous spillage.The abdominal cavity again was irrigated with plenty of normal saline and suctioned.The decision was made to resect this portion of bowel 8 cm in length.Before proceeding with the resection, several moist laparotomy pads were placed to isolate the length of the small bowel and also to prevent inadvertent intraabdominal contamination.The site of proximal and distal small-bowel transection was selected.From these sites, the peritoneum covering on both sides of the mesentery was incised with electrocautery.By lifting the small bowel, we used transillumination to review the vascular arcade.A small window was created in the mesenteric border proximally and distally, through which is 60 mm endo-gia loaded with white cartridge was introduced and the small piece of the bowel was transected.The vessels were controlled with kelly clamp and secured with a running 2-0 vicryl suture.The specimen was divided from the rest of the bowel and then was passed off the table.A non-crushing grasper was placed proximal to the anastomosis.The bowel was then reanastomosed in the usual side-to-side functional end-to-end anastomosis.The 2 loops of the bowel were aligned and secured with 2 stay silk suture [sic].An enterotomy in the antimesenteric border was performed by using the electrocautery.The gia loaded with the white cartridge 30 stapler was introduced in the lumen of the proximal and distal portion of the bowel, secured, checked and fired.Hemostasis was checked.The staple line showed no bleeding.Another 2 firings with 60 mm was performed to make sure this anastomosis was wide enough.The enterotomy was closed hand sewn in 2 layers using vicryl 2-0.The staple line was then oversewn with interrupted lembert suture.The mesenteric defect was closed with a running silk 2-0.The integrity of the anastomosis was checked and confirmed to be patent and water airtight.It was widely open with no signs of leak.Again, the small bowel was eviscerated and run from the anastomosis toward the ligament of treitz towards the opening of the mesocolon.No other points of obstruction or perforation identified.Again, the abdominal cavity was irrigated with plenty of normal saline until the effluent ran clear.Two 19-french blake drains were placed, one in the right lower quadrant placed in the right paracolic gutter and in the walled off cavity underneath the right side of the liver toward the gastrojejunal anastomosis.The other 19-french blake drain was placed in the left lower quadrant and placed in the left paracolic gutter to the left hernidiaphragm.Both were secured with 2-0 nylon x2.The fascia was closed with ethibond 0 on ct-1 needle in running fashion and we placed 5 interrupted figure-of-eight of the same suture.The subcutaneous tissue was approximated using vicryl 2-0 on sh needle.The skin was closed by using skin stapler.At the end of the procedure, all sponge, needle and instrument counts were correct x2.The patient remained unstable with 2 pressor, remained intubated and transferred to recovery room in critical condition.¿ implant #2 and explant #1 preoperative complaints: (b)(6) 2017: (b)(6) hospital [amch].(b)(6).Indications.¿the patient is a man who has had enterocutaneous fistula, who has had inability to manage this as an outpatient.He has been admitted to the hospitalist service.He was transferred from champlain valley regional hospital for ongoing management for this.He has had discussions regarding the increased risks and complications associated with previous operations and infected mesh about completion of the procedure as well as risks of long-term including bleeding, infection, and recurrent enterocutaneous fistula.After detailed discussions were made, he was interested in proceeding ahead with surgical treatment.¿ implant #2 and explant #1 procedure: exploratory laparotomy, resection of enterocutaneous fistula, removal of mesh, segmental bowel resection, repair of incisional hernia with mesh.[implant: gore® synecor biomaterial, gkfr2030/15563036, 20cm x 30cm, rectangle.] implant #2 and explant #1 date: (b)(6) 2017 [hospitalization (b)(6) 2017 ¿ (b)(6) 2017].(b)(6) 2017: amch.(b)(6).Operative report.Assistants: (b)(6).Dr.(b)(6).Preoperative diagnosis: enterocutaneous fistula, infected mesh.Postoperative diagnosis: enterocutaneous fistula, infected mesh.Anesthesia: general.Estimated blood loss: as per anesthesia.Specimens: mesh to pathology, skin to pathology.Wound classification: not provided.Findings: ¿previously placed mesh removed in total with evidence of enterocutaneous fistula.Exploratory laparotomy with segmental bowel resection with re-anastomosis.Normal anatomy status post gastric bypass, otherwise.No complication noted at the termination of procedure.¿ procedure: ¿after informed consent was obtained, patient was placed on the or [operating room] table in a standard supine manner.General endotracheal anesthesia was administered.Foley catheter was placed at this point.Chloraprep of the abdomen was performed and a sterile surgical field was created.Surgical timeout was then done.The skin was opened sharply inferiorly to the previous enterocutaneous fistula site.The previous site was dissected free from surrounding tissues and was then dissected free from small bowel sharply.Entry was made in the peritoneum in the inferior aspect.The skin was opened sharply as was the fascia.Sequential ligation of adhesions was done as entry was made into the abdomen.After complete lysis to the right abdominal wall done similarly dissection was done to the left abdominal wall.The full small bowel was mobilized into midline without difficulty.At this point, the area over the enterocutaneous fistula, which have been controlled by silk stitch.At this time, this was then dissected free from surrounding tissue.A small bowel was lysed free and segmental resection was accomplished with side-to-side anastomosis.Using endogla stapler, a good lumen size and good vascularity was noted.The mesentery was closed, to decrease the chance for internal herniation.At this point, the small bowel was returned to the abdomen.Copious irrigation was done in the abdomen using 6 l of irrigant.The fluid was noted to be clear without any concerns.At this point, decision made for primary closure of the inferior portion of the wound started closing this with #1 pds.At this point, there was inadequate tissue coverage.Decision was made to use a synecor mesh from gore-tex to allow closure of this midline.In a [sic] interposition fashion, the synecor mesh was then brought into reapproximation using a #1 pds to reapproximate the entire defect of the midline.The closure of the abdominal wall was noted.At this point, skin was elliptically incised around the edges that were adherent to the enterocutaneous fistula and then was brought together using nylon suture.Copious irrigation of the skin was done with prevena device.This was then placed to allow drainage from the site.The patient was then awakened, extubated, taken to the pacu [post anesthesia care unit] in good condition after all sponge and instrument counts were noted to be correct." (b)(6) 2017: amch.Implant sticker.¿gore® synecor biomaterial.¿ ref #: (b)(4).Lot #: 15563036.Expiration date: 2019-9-26.See attachment for h10/11 continuation.
 
Manufacturer Narrative
H6: updated results code and component code.Conclusion code remains unchanged.It should be noted that the gore® synecor® intraperitoneal 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® synecor® intraperitoneal 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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Brand Name
GORE® SYNECOR® INTRAPERITONEAL BIOMATERIAL
Type of Device
MESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
W. L. GORE & ASSOCIATES, INC.
1505 n. fourth street
flagstaff AZ 86004
Manufacturer (Section G)
MPD APC B/P
p.o. box 1408
elkton MD 21922 1408
Manufacturer Contact
vanessa rodriguez
1505 n. fourth street
flagstaff, AZ 86004
9285263030
MDR Report Key13653564
MDR Text Key288675988
Report Number3003910212-2022-01341
Device Sequence Number1
Product Code FTL
UDI-Device Identifier00733132635368
UDI-Public00733132635368
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K152609
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup,Followup,Followup
Report Date 01/26/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/02/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date09/26/2019
Device Model NumberGKFR2030
Device Catalogue NumberGKFR2030
Was Device Available for Evaluation? No
Date Manufacturer Received04/21/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/26/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention; Hospitalization;
Patient Age60 YR
Patient SexMale
Patient Weight147 KG
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