MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES GORE DUALMESH BIOMATERIAL; MESH, SURGICAL, POLYMERIC

Catalog Number 1DLMC07

Device Problems No Apparent Adverse Event (3189); Insufficient Information (3190)

Patient Problems Adhesion(s) (1695); Nausea (1970); Pain (1994); Not Applicable (3189)

Event Date 08/31/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).Product identification records for the alleged gore device was not provided.Therefore, a review of the manufacturing records could not be performed.(b)(6).Product identification records for the alleged gore device was not provided.Therefore, a review of the manufacturing records could not be performed.It should be noted that the gore dualmesh® plus biomaterial instructions for use includes warnings and addresses the following adverse reactions among others: ¿strict aseptic techniques should be followed.If an infection develops, it should be treated aggressively.An unresolved infection may require removal of the material.¿ ¿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.¿.

Event Description

It was reported to gore that the patient underwent laparoscopic incisional hernia repair on (b)(6) 2006 whereby a gore dualmesh® plus biomaterial device was implanted.The complaint alleges that on (b)(6) 2015, the gore device was explanted.It was reported the patient alleges the following injuries: chronic abdominal pain, nausea, extensive dense abdominal adhesions, open abdominal wound, abscess, distended abdomen, small bowel resection, mesh infection, and mesh removal.Additional event specific information and medical records have been requested.

Manufacturer Narrative

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) 2009 indicate the patient was seen for routine follow up.¿he is here for a regular checkup.Overall doing well.Patient states still there are days when he has some discomfort in the abdomen, but no nausea, no vomiting.He is eating fine.Sleeping better.Patient also has off and on palpitation, but he says he is doing generally well.¿ medical records dated (b)(6) 2010 indicate the patient was seen for checkup.¿the patient is here for a checkup, missed previous appointment.Actually patient had an episode where he was having severe epistaxis.The patient even was seen in the jefferson emergency, was found to be in hemorrhagic shock.Blood pressure at the time was in the 80s.He states he is feeling much better.Later on he did have some cauterization by ent in the right nostril.Other than that, he himself still has complaints where he feels achy in the belly.¿ medical records dated (b)(6) 2010 state: ¿assessment: status post nissen fundoplication and redo with gastric bypass.Patient on further discussion states that he has some symptoms when he feels lightheaded and sweaty after eating sometimes.I feel that is more so symptoms related to the short gut syndrome/dumping syndrome.¿ medical records dated (b)(6) 2010 indicate patient was seen for check-up, flu shot.¿he continues to have some discomfort in abdomen and having some pain issues for which he is being followed by the cardiothoracic surgeon.He had another exploratory laparotomy with some lysis of adhesions recently on (b)(6) 2010, and (b)(6) 2010.Please refer to the note.He states he is feeling better, just feels sore from the surgery.¿ the records state: ¿physical examination: abdomen: protuberant.There is surgical scar midline as well as some scab formation on the right side of the belly.¿ ¿assessment and plan: status post multiple abdominal surgeries since 2002.¿ ¿.Including roux-en-y as well as fundoplication and recent exploratory laparotomy with lysis of adhesions.Patient otherwise will be seen in 4-5 months' time or as needed basis.¿ medical records dated (b)(6) 2011 indicate the patient was seen for checkup.¿the patient stated for the last 2 months he has noticed some occasional abdominal discomfort, more so on the right side and right lower quadrant area.However, he denies any nausea or any vomiting his appetite is good.His weight has been stable.Moving his bowels regularly no diarrhea or so,¿ the records state: ¿physical examination: abdomen soft.Mild discomfort in the right lower quadrant and flank area and mild discomfort in right upper quadrant area too, but no rigidity or rebound tenderness appreciated.I could not appreciate any definite masses.¿ medical records dated (b)(6) 2011 indicate the patient was seen for checkup.¿[patient] is here for a followup checkup from his previous appointment overall doing well.No specific complaints.Moving his bowels regularly.Occasionally, he feels little discomfort in the belly but according to him, nothing unusual.¿ ¿he received the mri of the abdomen which was unremarkable.¿ medical records dated (b)(6) 2012 indicate the patient was seen for routine follow-up.¿.A week ago, he had a surgery done by dr.Am, laparoscopic lysis of peritoneal adhesions.The patient recuperated from the surgery very well.He is overall doing very well now.No complaints of chest pain.No nausea.No vomiting.Moving his bowels regularly.¿ medical records dated (b)(6) 2012 indicate the patient was seen for checkup.¿a 49-year-old white male who is here for a regular checkup.The patient was seen by the foregut surgeon, dr.Luketich and patient is for another surgery for lysis of adhesion and possible some gastrectomy.¿ medical records dated (b)(6) 2012 indicate the patient was seen for hospital follow-up.¿patient is here for a followup checkup, recently hospitalized in the beginning of september for surgery for abdominal pain, found to have some bowel obstruction secondary to some adhesion, had a lysis of adhesion as well as hernia repair.The patient had a g-tube for some time.He recuperated from his surgery very well.He is here for a checkup.The patient complains of some pain at the surgical site or so, but no fever, no chills, no other complaints.¿ medical records dated (b)(6) 2012 state: ¿abdomen: soft and nontender.The patient has a midhne surgical scar and also on both sides of the abdomen, probably for laparoscopic hole.Nontender.¿ medical records dated (b)(6) 2013 indicate patient was seen for checkup.¿the patient stated that he had a small cyst and he went to dr.Alvi and he did care for it, on the abdominal wall.No complaint as such of chest pain.No complaints of nausea.No complaints of vomiting.Some nonspecific abdominal discomfort, he always has and feels it, which he related to previous multiple surgeries.¿ medical records dated (b)(6) 2014 indicate patient was seen for checkup.¿a very pleasant 51-year-old white male with multiple medical issues.¿ ¿he is also having some uncomfortable feeling in the abdomen where he had a previous surgery in the scar area.¿ medical records dated (b)(6) 2015 indicate the patient was seen for checkup visit.¿a very pleasant 52-year-old white male with a history of multiple medical issues, he is for followup of those.The patient has been in and out of the hospital because of the abdominal pain.Jt also radiates to the back.¿ ¿abdomen: protuberant.Mild discomfort all over.Multiple surgical scars from previous surgery.¿ medical records dated (b)(6) 2015 indicate the patient was seen for general surgery follow-up.¿a very pleasant 52-year-old white male, he is here for a checkup from the hospital, recently hospitalized because of a revision of roux-en¿y esophagojejunostomy.The patient had a very prolonged surgery according to him.Postop, he was on a vent, now he also has a peg tube.The patient is eating well.He has a considerable amount of pain in the abdomen.¿ ¿abdomen: protuberant, soft, nontender.Peg tube is in place.Midline surgical scar healing.¿ medical records dated (b)(6) 2015 indicate the patient was seen for pre-op exam.¿he is here for a checkup, basically for a preop clearance and history and physical for his upcoming surgery.The patient had a history of gero, nissen fundoplication going back almost 12 years ago, and since then the patient had multiple abdominal surgeries including foregut surgeries.The patient's last surgery was done in (b)(6) 2015, which was complicated with the infection, probably the mesh.He is here now for a preoperative clearance for exploratory laparotomy, lysis of adhesions, and removal of infected mesh.Other than that, he denies any specific complaint.The patient has a dressing on the abdominal wall area which the patient is quite concerned and he states this has changed his quality of life completely.¿ medical records dated (b)(6) 2015 indicate the patient was seen in for surgical followup.¿a very pleasant white male who is basically here for a followup from the hospital.He has "i cannot count how many" abdominal surgeries for hernias, for reflux, including nissan fundoplication.The patient is here for a checkup.He has surgery and removal of infected mesh.The patient has hernia and he is scheduled for another surgery sometime in a month or so.Overall, doing well.¿ ¿abdomen: soft.Well healed scar, midline.May be small hernia on the lower end of the incision.¿ medical records dated (b)(6) 2016 indicate the patient was seen for hospital follow-up.¿he has been in and out of the hospital multiple times because of his chronic abdominal pain, ventral vva!l hernia and recurrent infection with the abscess.The patient has been on prolonged course of antibiotic.He was already being seen and followed at jefferson infectious disease as well as by dr.Alvi.Overall, the patient states that he still has some discomfort and he has some leaky discharge from the abdominal wall.The patient does get a significant amount pain and also was followed by the pain specialist, somehow he could not keep his appointment and requesting a new pain specialist.¿ medical records dated (b)(6) 2016 state: ¿physical examination: abdomen: soft and nontender.However, mild discomfort all over.There is a dressing in the epigastric area.Multiple surgical scars.¿ a potential relationship, if any, between the alleged injuries or complications and the gore device is unclear from the provided information at this time.It should be noted that the gore® dualmesh® biomaterial instructions for use includes warnings and addresses the following adverse reactions among others: ¿strict aseptic techniques should be followed.If an infection develops, it should be treated aggressively.An unresolved infection may require removal of the material.¿ ¿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.¿ (b)(6) 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

Corrected device brand name.Added device lot#, catalog #, expiration date and udi.Added device manufacture date.Updated method/results codes.Conclusion code remains unchanged.

Manufacturer Narrative

Added method and result code 2 for sterilization evaluation.Conclusion code remains unchanged.

Manufacturer Narrative

H6: corrected conclusion code.H10/11: added medical record summary.Additional details regarding the patient's clinical course were ascertained from a review of medical records and are as follows: records prior to (b)(6)2006 , including prior abdominal procedures, were not provided.Operative records dated(b)(6)2006indicate the patient underwent ¿laparoscopic repair of anterior abdominal wall hiatal hernia with gore-tex dual plus mesh using 20 x 20 centimeter mesh, laparoscopic lysis of adhesions, and laproscopic takedown of g-tube.¿ postoperative diagnosis states: ¿anterior abdominal wall incisional hernia.¿ the (b)(6)2006operative report states: ¿extensive amount of intra-abdominal adhesions.Prior g-tube, which was anchored to the abdominal wall and 12 x 12 cm anterior abdominal wall incisional hernia.We entered the abdomen via open technique in the right mid abdomen.I placed a 12 mm blunt port there.I established pneumoperitoneum to 15 mmhg.The abdomen was insufflated uneventfully.On initial inspection there was no injury noted to any bowel.We placed additional ports on the lateral abdominal wall on left and right side, placed strategically and started our dissection with the ultrasonic shears.We dissected the adhesions to the abdominal wall sharply with the ultrasonic shears.After about one hour of adhesion lysis, we were able to clear the abdominal wall and recognize the dominant incisional hernia in the upper abdominal wall.¿ the (b)(6)2006 operative records continue: ¿during our dissection, we also noted that the patient had the fundus of the stomach anchored to the abdominal wall from the prior g-tube.We dissected this stomach from the abdominal wall meticulously with the ultrasonic shears and stapled off the g-tube site with endo-gia to blue load with multiple fires.Following that we performed further adenolysis to clear up some adhesions on the anterior abdominal wall in proximity of the liver to free up further any adhesions to get adequate margins circumferentially with the mesh deployment.Once all the adenolysis was performed we marked the abdominal wall appropriately with a skin marker to identify the incisional hernia defect.Then we removed the carbon dioxide from the abdomen and measured it on the abdomen with a ruler and we determined the defect was 12 x 12 cm in dimension.¿ the (b)(6)2006 operative report states: ¿we fashioned a gore-tex dual plus mesh externally to 20 x 20 cm and we placed four anchoring sutures on the corners of the mesh on the left side of the mesh.These sutures were placed with 0 gore.The mesh was rolled until it was within the abdomen.With appropriate orientation, with the rough side placed only in the abdominal wall and the smooth side towards the peritoneal surface.The four transfixing sutures were delivered abdominally, after a small incision was made using carter-thomason device.These sutures were delivered with the appropriate marks on the skin, where the abdomen was removed of carbon dioxide.These transfixing sutures were tied to anchor the mesh in the abdominal wall, and the remaining repair was done with the tacker.Tacks were placed on the edge of the mesh and another roll about a centimeter medial from the edge.Once the repair was completed, it was examined.It was nice and snug on the abdominal wall.There was no bulge noted on the repair, and it was anchored at all points.The abdomen was examined for new injuries.There were no enterotomies or gastrotomies noted.The staple line of the g-tube site was intact.There was no leaking identified.The blunt port fascia was also incorporated within the repair with the mesh.We also closed the blunt port fascia, the anterior fascia with vicryl sutures.The remaining part of the skin was closed with vicryl in interrupted fashion.¿ product identification records for the alleged gore device were not provided.Operative reports dated (b)(6)2007 indicate the patient underwent ¿diagnostic laparoscopy with laparoscopic lysis of extensive adhesions.¿ postoperative diagnosis states: ¿abdominal pain with extensive amount of anterior abdominal adhesions.¿ the (b)(6)2007 operative records state: ¿the patient is a 44-year-old male who had a history of prior nissen, which was converted to a roux-en-y for recurrent reflux.He also following that had an abdominal wall hernia repair with mesh, and for the past 5 months, complains of left upper abdominal pain.His workup revealed a normal cat scan with no recurrent abdominal wall hernia.An upper gi follow through shows no bowel obstruction.The entry site was via open technique on the right mid abdomen, placed a 12-mm blunt port and established pneumoperitoneum to 15 mmhg.We placed additional two 5-mm ports on the left side, and 2 additional 5-mm ports on the right side under direct visualization.There was extensive amount of abdominal wall adhesions.They were taken down meticulously with the ultrasonics.The capsule over the mesh was noted and was entered sharply with the ultrasonics.The mesh was completely exposed.All of the edges of the mesh were exposed and the prior tacks were identified.There was no recurrent abdominal wall hernia noted.It took a total of about 2 hours and 20 minutes to do extensive lysis of adhesions to clear the abdominal wall of all anterior abdominal wall adhesions.¿ the (b)(6)2007 operative report continues: ¿a prior g-tube site was identified, was mobilized, and the stomach was left intact to the abdominal wall.After complete adenolysis was performed, the area of the abdominal wall was then inspected.There was no recurrent hernia.There were no noted enterotomies.There was no bile thinning, no bleeding noted.On the left upper quadrant adjacent to the mesh, there was dense scar and adhesions and the part of the greater curvature of the stomach was adherent to the mesh.It was taken down sharply with the ultrasonics.This took another additional 20 minutes.Once the operation was completed, we again examined thoroughly the abdominal wall.There was no recurrent hernia, and we terminated the operation at that time.Hemostasis was adequate and complete.Again, there was no noted enterotomies.There was no bile staining, and perhaps the patient¿s symptoms were attributed to dense adhesions on the abdominal wall in the left upper quadrant.The opening of the blunt port fascia was closed with carter thomason and 0 vicryl.¿ records between 2007 and 2012 were not provided.Operative records dated(b)(6)2012 indicate the patient underwent ¿esophagogastroduodenoscopy, diagnostic laparoscopy, extensive laparoscopic lysis of adhesions of over 2 hours, small bowel resection, laparotomy, reduction of internal hernia, closure of mesenteric defect and gastrostomy tube placement.¿ the (b)(6)2012 operative records state: ¿mr.Seman is a 49-year-old male known to our clinic for complaints of right upper quadrant abdominal pain.The pain is 6 on a scale of 1-10 and is experienced on a day to day basis.He complains also of nausea on a daily basis with or without meals.He has had an extensive history of gastroesophageal reflux disease for which he underwent a nissen fundoplication back in 2002 following which he did well for several years until recurrence of symptoms prompted conversion from nissen to a roux-en-y esophagojejunostomy by dr.Luketich in 2005.Following that procedure, he did well and again until he started having on and off cramping abdominal pains for which he has undergone multiple lysis of adhesions in his abdomen from 2008 to 2010 from multiple surgeons including dr.Awais and dr.Shende from our department.The latest one was in february 2012, performed in mckeesport.He comes to us with continuing symptoms and he had a barium swallow with an upper gi follow through that shows a possible low-grade small-bowel obstruction noted on his right upper quadrant near the area where he complains of the pain, which seems to be close to the jejunojejunal anastomosis.¿ the (b)(6)2012 operative procedure record states: ¿cut-down technique was performed using scalpel blade for the skin and s retractors as well as electrocautery and metzenbaum scissors and tonsils to elevate the fascial lining at the right upper quadrant.The incision was taken down to the fascial lining which is elevated and divided and incised and access is gained to the peritoneal lining , which was also incised and elevated, gaining access to the peritoneal cavity without injury to any structures.A blunt hasson port is placed and insufflation of pneumoperitoneum is insufflated to 15mmhg on high-flow.It is tolerated well by the patient.A 30-degree 10-mm scope was then introduced in the cavity and inspection of the cavity reveals a considerable amount of adhesions to the abdominal wall from the abdominal content.The gastric remnant is densely adhesed to the anterior abdominal wall.The falciform and the left lobe of the liver.¿ the (b)(6)2012 records state: ¿our ports were then placed under direct visualization including a 5-11 port in the left upper quadrant, another 5-mm port in the left costal margin and another 5-mm port in the right upper quadrant near the costal margin.Lysis of adhesions was undertaken with autosonic scalpel, mobilizing the gastric conduit from the anterior abdominal wall from the falciform as well as from the left lobe of the liver and from its caudad lobe attachments.This was mobilized all the way away from the hiatus as well and the greater curve arcade was clearly identified and kept out of harm s way at all times.Adhesions were lysed also at the right upper quadrant, mobilizing the right lobe of the liver and also on the left upper quadrant.Lysis of adhesions was extensive in excess of 2 hours.The attention was then transferred to the right flank were another 5-mm port was placed for a liver retractor.Liver retractor was then placed to retract up the left lobe of the liver, which was also in dense connection to the spleen.These divisions were not undertaken and only with the elevation of the liver it was sufficient to expose the area of the hiatus.Extensive lysis of adhesions was then performed, identifying our roux-en-y and its roux limb ascending up to the esophageal anastomosis.High mediastinal dissection with reduction of hiatal hernia of the roux limb was performed.Circumferential of the roux was obtained, keeping the mesentery of harm¿s way.¿ the (b)(6)2012 records continue: ¿this one was carried out, in all ports high into the mediastinum to the level of the pulmonary veins.A considerable blind loop portion of the roux limb was dissected and this one was divided with a linear cutting purple load stapler, after passing the endoscope into the roux limb to avoid stricturing of its lumen.This was done with picture-in-picture having endoscopic and laparoscopic identification.This specimen was sent over for pathologic analysis.Once this was completed and the recurrent hiatal hernia had been reduced, a simple single braided suture stitch was placed with #0 suture using the endostitch device to approximate the posterior right and left diaphragmatic crus reducing the access hiatal opening.Once this had been completed, the procedure was then converted to an open procedure performing a midline laparotomy extending from the area of the umbilicus to the subxiphoid area.This one was taken down to fascia lining with electrocautery and access was gained to the peritoneal cavity without injury to any underlying structures.¿ the(b)(6)2012 records state: ¿retractor was placed to maintain the abdomen open and an extensive lysis of adhesions was undertaken to identify the anatomy.The transverse colon and mesocolon was clearly identified as well as the roux which was in a retrocolic position.Once the superior portion of the abdomen had been dissected, attention was then transferred to the inferior portion to the mesocolon, where extensive lysis of adhesions was then undertaken.The ligament of treitz was clearly identified as well as the roux coming through the mesocolon.In this area corresponding to the petersen¿s defect area, a large internal hernia was identified.On this one both the roux limb, including the jejunostomy anastomosis had herniated through it into the right upper quadrant area of the patient.This one was containing a cocoon of adhesions which was lysed without injuries to the bowel and reduced.The bowel was then run all the way distally to the ileocecal valve performing lysis of adhesions along its way without any injuries or enterotomies.¿ the (b)(6)2012 records continue: ¿the attention was then transferred to the mesenteric defect where the hernia had been identified and this one was closed using 2-0 silk stitches and 3-0 silk stitches.They were performed interrupted to avoid cinching and purse stringing the mesentery.Once this was completed, the bowel was then run again all the way distally to the colon and back again proximally to the ligament of treitz.The jejunojejunostomy was patent with good lumen and it lied nicely without any kinks.At this point, the mesocolon was then displaced inferiorly and excess defect for the passage of our roux was then closed at the level of the mesentery.A #3 tikosyn 3-0 silk stitches were also placed to maintain the roux in a straight fashion and keeping it from re-herniating into the superior portion of the abdomen.Once this was completed, the abdomen was copiously irrigated and aspirated with antibiotic solution.Attention was then transferred to our gastric remnant where 2 pursestring sutures were placed.The first one was a #2-0 vicryl and the second one with #2-0 silk.The center of this pursestring was entered with the autosonic device and area on the left upper quadrant of the abdomen was chosen for stab incision for placement of our gastrostomy.Of note, our gastrostomy did not go through the mesh of the previous hernia repair of the patient.¿ the (b)(6)2012 records continue: ¿a #18 french mic gastrostomy tube was then placed through the entrance point, and introduced into our gastrostomy and our pursestrings were cinched down.The stomach was then pexied to the abdominal wall at the entry site of the gastrostomy tube using multiple 2-0 silk stitches in an interrupted fashion and inflating our balloon.The seal was nice and it was away from the most lateral left side border of the previously placed mesh and anterior procedure of the patient.Copious irrigation was performed again and aspirated.Hemostasis was satisfactory.Retractors were removed.All counts were complete at this point in the case and the bowel lay nicely without any kinks or tears.It was proceeded to close the abdomen using first a #o vicryl interrupted suture stitches on our hasson port from the inside and then a single stranded #2 pds suture line was placed at the level of the fascia and the mesh for caudally to proximally and then proximal to caudally and tying in the middle.Another suture line was then placed and approximated the anterior rectus fascia in the same manner.The wound was then irrigated again and the skin was then approximated with staples.All of our other port sites had been removed under direct visualization before closing the laparotomy, and they were closed at the level of the skin after irrigating the wounds using multiple 0-silk sutures were placed to secure the mic g-tube in place and this one was capped.¿ records dated (b)(6)2012 continue: ¿at the procedure of esophagogastroduodenoscopy was performed on the table before starting the laparoscopic portion of the case.The endoscope was advanced all the way down to the small gastric pouch remnant and the esophagus lay straight and without any lesions.The z-line was found at 41 cm and the crural pinch was found at 43 cm compatible with a small hiatal hernia.¿ records between 2012 and 2015 were not provided.Operative report dated 2/25/2015 indicate the patient underwent ¿esophagogastrojejunoscopy, laparoscopic lysis of adhesions, laparotomy, repair of hiatal hernia, small bowel resection, small bowel anastomoses x2, and placement of gastrostomy feeding tube.¿ postoperative diagnosis states: ¿dysphagia, chronic partial small bowel obstruction, h/o roux-en-y near esophagojejunostomy.¿ the (b)(6)2015 records state: ¿mr.Shaw is a 52 y.O.Male with complex past surgical history, nissen fundoplication in 2002, conversion to roux-en-y near esophagojejunostomy in 2005, multiple additional surgicalinterventions for small bowel obstruction and ventral hernia with the use of mesh.Due to worsening symptoms, cramping pain, poor po tolerance and vomiting with radiologic evidence of delayed intestinal transit and chronic partial obstruction decision was made to proceed with surgical revision of roux-en-y.¿then we proceeded to perform an upper gl endoscopy.The adult gastroscope was introduced through the mouth and passed posterior to the arytenoid cartilages into the esophagus.The esophagogastric junction was at 42 cm , gastrojejunal anastomosis was at 46 cm, it was patent, very tortuous roux limb, i was unable to advance the endoscope pass [.Cm] given tortuosity.The gastroscope was withdrawn.¿ the (b)(6)2015 records continue: ¿an incision for a 12 mm laparoscopic port was performed in the right paraumbilical area, using direct fascial cut down technique the peritoneal cavity was entered, port was inserted and c02 pneumoperitoneum established at 15 mmhg.There were abundant dense adhesions between bowel loops and between bowel and abdominal wall.Two additional ports were placed in right and left flanks.Tedious and meticulous lysis of adhesions was started switching between endoshears and harmonic device, it took at least 120 minutes of lysis of adhesions to be able to have better understanding of the anatomy, severe dense adhesions were found at the diaphragmatic hiatus area, the decision was made to convert to laparotomy.Midline supraumbilical incision was performed and carried down into the peritoneal cavity, the bookwalter was placed and abdominal cavity exposed.We proceeded to continue with lysis of adhesions, at the level of the jejuno-jejunal anastomosis there was moderate bowel dilation, we were able to release small bowel from treitz to right colon.¿ the (b)(6)2015 records state: ¿next we dedicated our attention to the gastrojejunostomy, there was severe dense adhesions at this level, with the spleen retracted to the diaphragmatic hiatus.After long and careful dissection we were able to expose the crura and release the esophagus circumferentially, an intraoperative esophagogastroscopy was performed and area of kinking was identified at the crural pinch, it was the right crus impinging into the esophagus, we partially divided the right crus relieving the kinking.The near esophagojejunal anastomosis was patent, therefore no intervention was made at this level.Silk stitches were placed between the esophagus and the diaphragm to prevent herniation.Next, the jejuno-jejunal anastomosis was resected given tortuosity and dilation.In order to increase the length of the roux limb, we performed an end to end jejuno -jejuna l anastomosis one layer with interrupted 3-0 silk stitches.Next, we selected the site for the roux limb-biliopancreatic limb anastomosis, it was 150 cm from the esophagojejunostomy.¿ the (b)(6)2015 records continue: ¿a side to side anastomosis was performed with vascular load 60 mm and entrance points were closed with connell-mayo suture with silk.Mesenteric defect was closed with silk interrupted stitches.The peterson defect was closed with interrupted silk stitches between mesocolon and bowel serosa.A stamm gastrostomy was placed bringing the gastric remnant lateral to the right flank in an area without mesh, stomach secured to abdominal wall with 6 2-0 silk stitches.A 21fr mic g-tube was inserted, and secured to the skin with silk stitches, it was at 8 cm at the skin.Abdominal cavity was irrigated and hemostasis verified.Given the presence of a mesh (prosthesis) in the abdominal wall from previous ventral hernia repair, intraoperative consult was called to plastic surgery, dr.Russavage scrubbed in, and performed closure of the abdominal wall, this procedure will be dictated in a different operative note by dr russavage.¿ additional operative records dated 2/25/2015 indicate the patient underwent ¿fascial closure 27cm abdomen 3-layer plastic closure and abdominal incision 27cm.Postoperative diagnosis states:¿ open abdominal wound, personal history of multiple prior abdominal operations, personal history of mesh placement.¿ the (b)(6)2015 records state: ¿[the patient] is a 52-year-old gentleman status post multiple prior interventions after having a prior esophagojejunostomy had difficulty with abdominal pain and distention.Dr.Luketich today had revised his abdomen through both the laparoscopic and open approach.We had initially agreed that he had a well incorporated mesh and that for this lengthy operation, which was clean, a removal of this mesh and subsequent mesh replacement could be devastating to his abdominal wall so we mutually agreed that primarily closing the mesh today was in the patient¿s best interest.¿ the (b)(6)2015 records continue: ¿after dr.Luketich had completed his portion of the operation, attention was then turned to the fascial edges, which the edges were advanced under no tension.Peak inspiratory pressures were at 23-24 during the majority of the case and had clearly no domain issues.The fascial edges were repaired with #1 prolene.Wounds were irrigated with copious amounts of bacitracin-impregnated solution.A 15-french round channel drain was placed over the fascial closure and a 3-layer plastic closure was then accomplished of the skin.¿ operative report dated (b)(6)2015 indicate the patient underwent ¿remove 3 prolene sutures.¿ the records state: ¿[the patient] is a 52-year-old gentleman status post open abdominal operations with prior hernia repairs, presents with 2 open areas for removal of sutures.¿ operative report states: ¿prolene sutures were removed.Hemostasis maintained with meticulous electrocautery.The wound was packed open.¿ operative report dated (b)(6)2015 indicate the patient underwent ¿exploratory laparotomy, lysis of adhesions, excision of 30 x 30 cm infected mesh, drainage abscess, and debridement of abdominal wall.¿ postoperative diagnosis states: ¿infected abdominal wall mesh.¿ the records dated (b)(6)2015 state: ¿an elliptical incision was made incorporating his draining sinus tract.We entered the peritoneal cavity caudal to the palpable mesh and safely entered the peritoneal cavity.We then began lysing adhesions, taking the omentum and bowel off the back of the mesh.We proceeded in a cephalad direction and essentially splitting the mesh in half until the upper end at the xiphoid.We then fully excised all mesh, tacks and sutures from the mesh on the left and right abdominal wall.We protected the posterior rectus sheath as we did so.After the mesh was fully excised we then excised 3 cm of the inflammatory tissue on either side of the midline to get back to good healthy tissue.Cultures were sent from the abscess cavity.The bowel was inspected and protected throughout.Of note, he had had a previous gastrostomy, which we left tacked to the abdominal wall.The abdomen was irrigated copiously with antibiotic solution.We then performed a skin only closure.One layer of subcutaneous tissue was closed with 3-0 polysorb sutures.The skin was closed with a running 0 surgipro suture starting at either end and tying in the midline.¿ a potential relationship, if any, between the alleged injuries or complications and the gore device is unclear from the provided information at this time.It should be noted that the gore dualmesh® plus biomaterial instructions for use includes warnings and addresses the following adverse reactions among others: ¿strict aseptic techniques should be followed.If an infection develops, it should be treated aggressively.An unresolved infection may require removal of the material.¿ ¿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.¿ 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

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: (b)(6) 2010: ¿ct abdomen with contrast.¿clinical history: ge reflux, abdominal pain.There has been esophagojejunostomy, proximal gastrectomy and cholecystectomy.The esophagojejunal anastomosis is patent and there is no evidence of significant stasis in the distal esophagus.The gastric remnant is mildly distended with fluid and contains a small amount of air.There is no hydronephrosis, biliary dilatation, free air, ascites, adenopathy, bowel dilatation, or focal inflammation.Mesh in the anterior abdominal wall is intact; there is no evidence of recurrent hernia.Impression: no acute intraabdominal abnormality.Mild fluid distention of the gastric remnant.Intact ventral hernia repair.¿ (b)(6) 2010: operative report.¿preoperative diagnosis: upper abdominal pain.History of multiple abdominal operations and closing the ventral hernia repair with mesh.Postoperative diagnosis: upper abdominal pain.History of multiple abdominal operations and closing the ventral hernia repair with mesh.Extensive abdominal wall adhesions above the liver and the gastric remnant to the abdominal wall.Procedures: diagnostic laparoscopy with laparoscopic extensive lysis of adhesions.Total time: 2 hours.Takedown of a g-tube.Esophagogastroduodenoscopy, diagnostic.¿ ¿the patient was recently seen in my office as a follow up with upper abdominal pain, especially postprandially.He had a cat scan performed, which revealed dilated gastric remnant tethered to the liver and the abdominal wall possibly causing his abdominal pain.We attribute this to a scar tissue.He was taken to the or for diagnostic laparoscopy and examination and possible lysis of adhesions and take-down of the g-tube.¿ description of procedure: ¿once the patient was asleep, we proceeded on to do a diagnostic endoscopy, which revealed the cricopharyngeus at 14 cm; the proximal and mid esophagus were non diseased.The distal esophagus revealed the z line and an esophagojejunal anastomosis at about 40 cm with no recurrent hiatal hernia.The small bowel was nonischemic.Anastomosis was patent with no stricture.The blind limb was short.The roux limb was examined to 80 cm with no undue evidence of any ischemia or lesions.Again, the esophagus appeared to be nondiseased and no mucosal lesions or esophagitis.The esophagus was suctioned.The scope was removed.The abdomen was prepped and draped in the usual sterile fashion.Safe entry of the abdomen was achieved via a 1 cm cutdown.Blunt port was placed in the right mid abdomen, established pneumoperitoneum to 15 mmhg.Three additional ports were placed.They were all versastep ports under direct visualization.We started our diagnostic laparoscopy, which revealed obvious adhesions to the upper abdominal wall.The stomach and the liver was plastered to the abdominal wall, which may be causing this patient some pain postprandially.We started the dissection by doing lysis of adhesions with the autosonix sharply.We lysed the adhesions from the abdominal wall with the autosonix.This took about an hour of operative time.Hemostasis was adequate and complete.We then did additional lysis of adhesions from the abdominal wall, which took another hour of operative time, sharply with the autosonix and taken down the liver and the g-tube from the abdominal wall safely.After this was all completed, we assessed for abdominal wall.The mesh repair was intact and complete with no recurrence.We were able to mobilize the gastric remnant away from the colon and the liver to get further mobilization of this area with the autosonix.There was no evidence of any lesions or pathology other than extensive scarring from the liver and the gastric remnant to the abdominal wall and the gastric remnant to the colon and to the liver.Again, after all of this was taken down, the scar was excised with the autosonix.We assessed for hemostasis; it was adequate and complete.We did infiltrate in the upper abdomen then the liver with some seprafilm slurry.We proceeded on to complete the operation.Closure of the blunt port was approximated with 0 vicryl suture.The ports were removed.The carbon dioxide was removed and the wounds were dressed with steri-strips and opsite dressing.¿ there is no mention of gore device removal in the records.A potential relationship, if any, between the alleged injuries or complications and the gore device is unclear from the provided information at this time.It should be noted that the gore® dualmesh® biomaterial instructions for use includes warnings and addresses the following adverse reactions among others: ¿strict aseptic techniques should be followed.If an infection develops, it should be treated aggressively.An unresolved infection may require removal of the material.¿ ¿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.¿ 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

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: (b)(6) 15: [missing records: ct of abdomen and pelvis used for comparison for ct done (b)(6) 15 was not provided.(b)(6) 15: plastic & reconstructive surgery ¿ (b)(6) clinic.(b)(6).Office notes.Follow up after abdominal closure all incisions are healing and no complaints related nausea vomiting alternating constipation or diarrhea states bowel function was normal.Does have complaints related to mid abdominal pain around gastrostomy tube and incision line but there is no erythema no fluid collection no evidence of any hernia.Remaining staples removed today and instructions given further activity and will follow up in 4-6 weeks.No lifting, pushing, nor pulling greater than 5 lbs.(gallon of milk weigh 8 lbs.) for a total of one month from date of surgery; no greater than 10 lbs.Up to 3 months after date of surgery; with a final increase to 25 lbs lasting for 6 months after surgery.Has life-time lifting restriction of 50 lbs.(b)(6) 15: plastic & reconstructive surgery ¿ (b)(6) clinic.(b)(6).Office notes.Postoperative follow up for operation done 02/25/15.Presents today reporting small area draining along abdominal incision with focal pain.No diarrhea or constipation, but occasional dysphagia and vomiting.Incision is well-healed with exception of 1cm area centrally where has scant serosanguineous [sic] drainage and shallow tract which was probed and cultured.Abdominal wall intact to palpation and valsalva without evidence of hernia recurrence.Advised to initiated [sic] ¼¿ nugauze packing to wound.Started on 10-day course of bactrim ds and will return in 2 weeks unless symptoms worsen.Lifting and activity restrictions reviewed.[brenda s.Bellissimo, pa-c notes] complain of leakage started saturday, still leaking clear fluid.Complain of some time when eating food feels like its [sic] stuck.Complain of abdominal pain, chills, nausea, vomiting.Denies fevers.Weight 205 lb.0.4 oz, bmi 28.60.(b)(6) 15: plastic & reconstructive surgery ¿ (b)(6) clinic.(b)(6).Office notes.Postoperative follow up, some pain to abdomen.Small pinpoint open area that he covers with a band-aid.Denies recent drainage or redness.Incision is well coapted and well healed.One pinpoint area that is not quite healed.No drainage, erythema, edema, or signs of infection.Minimal pain with palpation to abdomen.Continue to dress small open area with band-aid.Given prescription for vicodin.This is to be last narcotic prescription.Weight 205 lb.4 oz, bmi 28.63.(b)(6) 15: plastic & reconstructive surgery ¿ (b)(6) clinic.(b)(6).Office notes.Postoperative, states has been ¿horrible¿, abdomen draining and smelling.Has been changing dressing 5 times a day.Getting chills at night and having diarrhea.Abdominal incision well coapted, well healed.One area not healed, is now packed.No drainage.No erythema, edema, or signs of infection.Minimal pain with palpation to abdomen.Wound measures 0.5x0.7x2cm in depth.Will order ct for evaluation.Discussed possible vac application.Continue to dress open area with packing and primapore.Will be consented for irrigation and debridement of abdomen with possible delayed closure with vac application.(b)(6) 15: mckeesport radiology.(b)(6).Radiology-ct abdomen/pelvis without contrast.Clinical history: abdominal pain.Findings: please note that evaluation of the abdominal viscera is suboptimal given lack of iv contrast.Stable postsurgical changes of stomach and small bowel dictated.Prior ventral hernia mesh repair is noted.New superficial open wound is demonstrated overlying hernia repair.Small bowel is unremarkable without evidence of obstruction.Colon is grossly unremarkable.No pelvic free fluid seen.No pelvic or inguinal lymphadenopathy.Impression: stable postsurgical changes of prior ventral hernia mesh repair.New superficial open wound is demonstrated overlying the repair.No evidence of acute inflammatory process within abdomen or pelvis within the constraints of a noncontrast examination.(b)(6) 15: plastic & reconstructive surgery ¿ (b)(6) clinic.(b)(6).Office notes.Status post suture abscess irrigation and debridement on 06/17.Been changing dressing twice a day with wet to dry dressing.Wound is 90% granular.Measuring 8cm x 5cm by 3cm in depth.Mild amount of drainage.No signs of infection.No erythema.Continue wet to dry dressing changes twice a day at this time.Will discuss with dr.Peitzman on when we will remove infected mesh and then repair.Can send wound vac back to texas [sic] as he does not need it at this time.It was forgone in his care to avoid fistulization.Weight 199 lb.15.3 oz, bmi 27.89.(b)(6) 15: plastic & reconstructive surgery ¿ (b)(6) clinic.(b)(6).Office notes.Complains of constant abdominal pain.Continued wet-to-dry dressings twice a day with smaller size of wound.Wound is clean and well-granulated measuring 7 cm by 3 cm.Mild amount of purulence from center of wound.Otherwise no evidence of cellulitis.Continue wet-to-dry dressing changes twice daily-with dry dressing as needed depending on amount of purulent drainage.Weight 205 lb.11oz, bmi 28.69.(b)(6) 15: plastic & reconstructive surgery ¿ (b)(6) clinic.(b)(6).Office notes.Postoperative day number 54.Frustrated with draining wound, with the pain (has an appointment with pain clinic at montefiore today for regional blocks.) on exam has copious thick drainage from base of 10 cm x 4 cm wound with 1 cm of proud flesh.Treated today with silver nitrate.Has contact dermatitis along the inferior border of taped wound for bacterial colonization.Slated for a september mesh removal coordinated with peitzman and russavage and abdominal wall reconstruction.Has colonized indwelling mesh.Discussed finding of chronic open hypergranular wound of colonized mesh of abdomen.Mr.Seman is interested in undergoing definitive repair of open draining wound of abdomen.Obtained informed consent.Patient instructed to shower with baby shampoo and cleanse the wound.[notes of lucas a.Dvoracek, md (resident)]: wound has been draining green-yellow material.Changes dressing 2 times per day.Patient does have fevers, nausea, vomiting, diarrhea, constipation.Complains of constant abdominal pain that is approximately 8/10 controlled on percocet.Abdomen has minor area of dermatitis inferior to draining incision.Weight 204 lb, bmi 28.45.(b)(6)16: plastic monroeville office.Brenda s.Bellissimo, pa-c; james m.Russavage, md.Office notes.In clinic regarding upcoming mesh removal of his abdomen as it is colonized.History of debridement abdominal wound and abdominal wall reconstruction 06/17/15.In 08/15 pietzman removed his mesh.Has had mesh repair after this at jefferson.It has become infected and is on a continual antibiotic suppression.Taking keflex.Review of systems positive for: fever, chills, weight gain, malaise/fatigue, weakness, decreased appetite, shortness of breath, nausea, abdominal pain, diarrhea, back pain, joint pain, neck pain, cold intolerance, numbness/tingling, mood changes.Examination abdomen: abdominal wall is not intact to valsalva maneuver and palpation.Appreciable hernias nor fascial defects to palpation.No active redness nor cellulitis.Assessment/plan: counselled that we will help dr.Sanchez with an abdominal wall reconstruction.This will not be a separation of component parts as he is currently colonized with his mesh and that separation of component parts would ultimately put his repair at risk of failure.Weight 215 lb, bmi 29.99.04/09/18: plastic & reconstructive surgery ¿ falk clinic.Joanna hoi yeun ng-glazier, md; james m.Russavage, md.Office notes.Abdominal wall hernia.Currently with flatus and bowel movements.Denies fever or chills.Examination abdomen; soft, non-distended, non-tender, midline abdominal scar, laparotomy scars, right lower quadrant ostomy scar well-healed with evidence for thinning/striae, positive palpable and reducible hernia right lower quadrant, fascial defect approximately 6x6cm, positive rectus diastasis, muscle is fairly lateral.Assessment/plan: ct abdomen/pelvis with oral contrast only to re-evaluate abdominal wall.Weight loss encouraged.04/10/18: mckeesport imaging.Srinivas iyer.Radiology-ct abdomen/pelvis with contrast.Clinical history: history of multiple abdominal surgeries, infected hernia mesh, and small bowel obstruction; evaluate for obstruction prior to a repeat hernia repair/component separation.Findings: status post gastric bypass surgery.Bowel loops are of normal caliber.An abdominal wall mesh, which is somewhat bowing anteriorly.A few of the small bowel loops are seen extending to and interposed between the mesh and the adjacent anterior abdominal wall musculature.No inflammatory changes in the abdomen or pelvis.No free fluid in the abdomen or pelvis.Impression: no bowel obstruction.04/23/18: plastic & reconstructive surgery ¿ falk clinic.Sophia m.Moses, pa-c; james m.Russavage, md.Office notes.Seen earlier this month, here to follow-up ct.Denies nausea, vomiting, diarrhea, constipation, fever and chills.Abdomen: soft, non-tender, non-distended, midline abdominal scar, laparotomy scars, right lower quadrant scar well healed, reducible hernia right lower quadrant 6x6cm.Assessment/plan: presents for evaluation of abdominal hernia and mesh.Ct reviewed without evidence of dilated bowel.Abdominal mesh will most likely need to be removed and replaced.10/01/18: plastic & reconstructive surgery ¿ falk clinic.James m.Russavage, md.Office notes.2 weeks out from ventral hernia repair, separation of parts.Presents without abdominal binder but relates he wears it all the time usually.Been tracking drains, does not have log today, relates the medial and lateral jackson-pratts have minimal output.No other complaints, denies pain.Ventral hernia incision well approximated with staples.Peri-incisional erythema <2cm, no drainage, no purulence.Jackson-pratt sites x 3 with mild purulence, mild erythema.No palpable hernia present.Weight 214 lb.Assessment/plan: progressing well postoperatively, but importance of wearing abdominal binder, and diligently recording jackson-pratt output was stressed.Given another abdominal binder.Everyother [sic] staple was removed.Given prescription for bactrim.Bmi 30.27.10/05/18: isaly aesthetic center.Sophia m.Moses, pa-c, james m.Russavage, md.Office notes.Postoperative follow up.Has 110 cc¿s from jackson-pratt drain yesterday.Denies fever, chills, nausea/vomiting/diarrhea, constipation.Incision clean/dry/intact with staples intact.Midline drain intact to suction with ss [serosanguinous] drainage.Assessment/plan: staples removed.Jackson-pratt seems to be getting clogged.Will have him return monday to strip it.Weight 214 lb, bmi 30.27.10/08/18: plastic & reconstructive surgery ¿ falk clinic.Sophia m.Moses, pa-c; james m.Russavage, md.Office notes.States drain fell out yesterday am.Denies fever, chills, nausea/vomiting/diarrhea, constipation.Incision clean/dry/intact.No erythema or signs of infection.No fluid collection appreciated.Assessment/plan: local wound care to jackson-pratt site.No lifting greater than 5 pounds.11/05/18: plastic & reconstructive surgery ¿ falk clinic.Jennifer lynn anderson, md, phd (resident); james m.Russavage, md.Office notes.Pain improving, has chronic pain from multiple surgeries (greater than 20), sees pcp [primary care provider] once a month for refills for pain medications.Wearing abdominal binder, not lifted anything greater than 5 pounds.Denies fever, chills, nausea/vomiting, diarrhea, constipation.Incision clean/dry/intact.No erythema or signs of infection.Small fluid collection appreciated.Jackson-pratt sites healing, no drainage or surrounding erythema.Abdomen soft, non-distended, mild tender to palpation in right upper quadrant.Assessment/plan: continue to wear abdominal binder to assist with resolution of fluid collection.No lifting greater than 5 pounds.Weight 204 lb.Bmi 29.27.A potential relationship, if any, between the alleged injuries or complications and the gore device is unclear from the provided information at this time.It should be noted that the gore® dualmesh® 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® 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.

Manufacturer Narrative

Additional details regarding the patient's clinical course were ascertained from a review of medical records and are as follows: (b)(6) 2003: [missing records: an operative report for incisional hernia repair was not provided.] (b)(6) 2004: [missing records: an operative report for incisional hernia repair was not provided.] (b)(6) 2005: (b)(6).Office notes.Presents with postprandial abdominal pain, dysphagia, diarrhea.Occasional regurgitation small amounts of oral intake.Does continue to gain weight, has gained 60 pounds in last 2 years.Abdomen: upper midline incision well healed.Impression/plan: underwent complicated nissen fundoplication, patient reports took nearly 9 hours.I believe his wrap is around proximal stomach interfering with esophageal peristalsis, emptying of proximal stomach.Scheduled for redo nissen fundoplication.We did discuss the benefits of all a roux-en-y esophagojejunostomy potentially should his anatomy not be amendable to surgical correction.Agreeable to proceed.(b)(6) 2005: (b)(6).Discharge summary.Admit date: (b)(6) 2005.Procedure: laparoscopic revision of nissen fundoplication converted to open roux-en-y gastrojejunostomy.Has jp [jackson-pratt] to suction, midline incision which will have homecare assist him with.(b)(6) 2005: (b)(6).Office notes.Abdomen: well-healed large midline incision.(b)(6) 2006: (b)(6).Lap inc [incisional] hernia repair 20 x 30 cm dual mesh.(b)(6) 2006: (b)(6).Implant record.Dual mesh, gortex.20cmx30cm.Lot number: 03757290.Manufacturer: gortex.Expiration date: 2010-11-21.Site: abdomen.The records confirm a gore® dualmesh® biomaterial (ni/03757290) was implanted during the procedure.(b)(6) 2006: (b)(6).Discharge summary.Admit date: (b)(6) 2006.Discharge diagnosis: status post laparoscopic repair of incisional hernia.History present illness: following his open fundoplication, he required 2 attempts at open ventral hernia repair, both of which resulted in failure.Does report bulging of abdomen which has always reduced when he lies, relaxes.Occasional constipation.Complains of worsening of pain with exercise, strain.Hospital course: underwent laparoscopic repair of incisional hernia with dual mesh.Discharge instructions: may shower today.Instructed to wear abdominal binder for at least 2 weeks until seen in clinic.Condition on discharge: stable.Abdominal incisions dry, intact.(b)(6) 2006: [missing records: an operative report for laparoscopic ventral hernia repair with mesh was not provided.] (b)(6) 2006: (b)(6).Office notes.3 months abdominal pain, increasing in nature with time.Month and half of dysphagia, also increasing.Does maintain stable weight.Abdomen: mildly tender diffusely to palpation.Skin: multiple well healed incisions from both ports sites, vertical midline incision.Impression/plan: ct abdomen, pelvis.(b)(6) 2007: (b)(6).[illegible].Office notes.Ventral hernia repair [with] mesh 11/[illegible].Still c/o [complains of] epigastric and l [left] subcostal pain.Pt [patient] with l [left] sided abd [abdomen] pain.Ct [negative] for hernia recurrence.Impression/plan: chronic abd [abdominal] pain, [no] obvious occurrence of hernia.(b)(6) 08 - (b)(6) 2010: [missing records: operative reports for multiple lysis of adhesions in his abdomen were not provided.] (b)(6) 2012: [missing records: an operative report for loa [lysis of adhesions] was not provided.] (b)(6) 2012: (b)(6).Radiology ¿ upper gi series with small bowel follow through.Indication: abdominal pain, nausea, dyphagia [sic], loss of appetite.Findings: post surgical changes including surgical clips and surgical anastomosis along with mesh hernia repair tacks.At 1 hour, contrast is seen within colon, within normal limits.There was inadequate contrast to evaluate terminal ileum, however the patient was unwilling to remain for further contrast to pass through this region.Impression: redemonstrated cluster small bowel in right upper quadrant in region of patient¿s pain, with new area of associated dilated small bowel, may represent a low grade partial small bowel obstruction secondary to adhesions versus a jejuno-jejunal anastomotic dilation.(b)(6) 2012: (b)(6).[illegible].Office notes.Abdominal pain, ruq [right upper quadrant].Impression/plan: [mostly illegible] obs [observation] and symptom care until sbo [small bowel obstruction] seen.(b)(6) 2012: (b)(6).Progress notes.Gi: s/p [status post] hiatal hernia repair.G tube placed on suction this am after pt [patient] had bilious emesis.(b)(6) 2012: (b)(6).Discharge summary.Admit date: (b)(6) 2012.Discharged to home.Incisions dry, intact, staples intact.(b)(6) 2014: (b)(6).Discharge summary.Admit date: (b)(6) 2014.2-month worsening gerd [gastroesophageal reflux disease] increasingly more uncomfortable last 2 weeks.He reported he came to ed [emergency department] because he didn¿t want to wait for appointment, wanted an expedited workup.Underwent baswa [unknown abbreviation], found herniated e-j.Underwent egd with dilation.Plan was to repeat baswa [unknown abbreviation], f/u [follow up] in clinic 2 weeks to discuss possible repair.Pt [patient] insisted he did not want to leave without having another repair surgery.Despite explaining that this was not possible at this time, pt [patient] continued to insist, stating if he didn¿t get operated on this time, he was ¿never going to come back here.¿ then demanded his discharge paperwork, was discharged home with instructions to f/u [follow up] in clinic should he choose to do so.(b)(6) 2015: (b)(6).Radiology ¿ upper gi series with small bowel follow through.Indication: abd [abdominal], midsternal pain.Findings: anastomotic staple lines noted in right and left upper quadrants.Mesh anchors noted overlying mid abdomen.Surgical clips noted mid abdomen.Impression: mild incomplete stripping wave a small amount proximal escape and reflux.Clustered segment small bowel in right upper quadrant probably corresponding to an anastomotic site which is dilated and fixed up palpation.Proximal to the anastomosis is a short segment of small bowel, slightly dilated indicating low-grade partial obstructive pattern.(b)(6) 2015: (b)(6).Office notes.Worsening chronic abdominal pain, he refers being in constant pain with exacerbations after meals, mild dysphagia, vomiting 2-3 times weekly, ¿acid reflux¿ when lying supine.Impression: given worsening of symptoms, persistent pain, mild dysphagia, chronic vomiting, after a long discussion held with patient it was considered that findings of partial small bowel obstruction at the jejuno-jejunostomy might be playing a role.I did explain to patient the high risk associated to abdominal surgery on him given the multiple interventions has had in past.I explained risks and possible complications associated with such complex procedure given his challenging clinical condition, (b)(6) understood and agreed to proceed with surgical revision.Plan: schedule for redo roux-en-y esophago-jejunostomy, abdominal wall reconstruction.(b)(6) from plastics to be contacted to assist in this likely complex abdominal wall closure given history of multiple ventral hernia repairs with mesh.(b)(6) 2015: (b)(6).Progress notes.S/p [status post] primary myofascial closure with prior mesh.Dressing c/d/i [clean, dry, intact] with minimal bloody strikethrough.(b)(6) 2015: (b)(6).Radiology ¿ upper gi series with small bowel follow through.Indication: status post roux-en-y revision, evaluate for leak.Findings: suture material from multiple anastomotic sites noted.Mesh anchors noted overlying abdomen.Impression: no evidence of leak or obstruction.(b)(6) 2015: (b)(6).Discharge summary.Admit date: (b)(6) 2015.Due to worsening symptoms, cramping pain, poor po [by mouth] tolerance, vomiting, with radiologic evidence of delayed intestinal transit and chronic partial obstruction decision was made to proceed with surgical revision of roux-en-y.There were no postoperative complications.Discharged to home.Condition: good.Incisions dry, intact, staples intact.Patient education: increase activity as tolerated.Do not lift anything heavier than 10 pounds until seen by physician.Do not drive car until cleared by physician.No tub baths 4 weeks.May shower after discharge.Wash incisions with mild soap, water, pat dry with clean towel.(b)(6) 2015: (b)(6).Microbiology.Deep wound culture.Wound abd [abdomen] sinus tract.Gram stain: moderate wbcs [white blood cells] present few gram-positive cocci in pairs and clusters.Culture: moderate staphylococcus aureus.(b)(6) 2015: (b)(6).[illegible].History and physical.Open wound abdominal wall with retained suture, c/o [complain of] drainage, aroma, pain.Skin: non-healing wound abdomen 5 x 7 x 2 cm.Impression/plan: ct.Continue to dress open area with primapore.Consented for i&d [irrigation and debridement] of abdomen.(b)(6) 2015: (b)(6).Operative report.Preoperative diagnoses: suture abscess, abdomen; personal history of mesh placement.The records state: ¿[the patient] is a 52-year-old gentleman status post open abdominal operations with prior hernia repairs, presents with 2 open areas for removal of sutures.¿ operative report states: ¿prolene sutures were removed.Hemostasis maintained with meticulous electrocautery.The wound was packed open.¿ (b)(6) 2015: (b)(6).Pathology report.Accession #: (b)(6).Final diagnosis: skin, soft tissue, open wound debridement: skin with ulcer and granulation tissue, abscess in dermis and subcutaneous tissue.Gross description: the specimen is received in formalin labeled with the patient¿s name, initials wjs, medical record number and ¿1.Open wound abdomen¿.It consists of a 8.2 x 1.3 x 2.2 cm un-oriented elliptical excision of tan skin, excised to a depth of 2.0 cm.There is a 2.0 x 1.0 x 2.0 cm well tan-pink to white open area which is 0.2 cm away from the nearest margin.The deep margin is inked black, and the specimen is serially sectioned to reveal yellow lobulated fatty tissue, and pink soft tissue.The specimen is representatively submitted in cassettes a & b.Formalin exposure time: 28 hours.Microscopic: microscopic examination substantiates the diagnosis indicated above.Patient history: chief complaint/surgery pre-op [operative] diagnosis: abdominal wound.Surgery post-op [operative] diagnosis: abdominal wound.Surgical procedure: irrigation and debridement of wound.Histo tissue summary/slides reviewed: part 1: open wound abdomen.Taken: (b)(6) 2015 14:22.Received: (b)(6) 2015 15:11.Stain/cnt h & e x1 block a.Stain/cnt h & e x 1 block b.(b)(6) 2015: (b)(6).Microbiology.Deep wound culture: gram stain: moderate wbcs [white blood cells] present, rare gram-positive cocci in pairs.Culture: moderate staphylococcus aureus.(b)(6) 2015: (b)(6).Progress notes.Wet to dry dressing removed, no bowel tissue present, base of wound granular.(b)(6) 2015: (b)(6).Discharge summary.Admit date: (b)(6) 2015.Hospital course: multiple surgical interventions for small bowel obstruction, ventral hernia repair with use of mesh.S/p [status post] abdominal i&d [irrigation and debridement].Discharge to home.No strenuous activities.(b)(6) 2015: (b)(6).History and physical.He has had multiple operations for incisional hernias as well as placement of multiple pieces of mesh.Has had a chronic mesh infection with open abdominal wound drainage, pain.Exam: long midline incision.10 x 3 cm open, granulating wound with purulent material.Mesh is palpable deep to his abdominal wall measuring 15x 20 cm.Most recent ct shows what appears to be laparoscopic mesh with tacks corresponding with what i felt on exam.I will plan exploratory laparotomy, lysis of adhesions, excision of mesh and foreign material as his first of 2 operations.Following this, we will plan his second procedure as separation of parts.(b)(6) 2015: missing records: records for the ct scan showing ¿what appears to be laparoscopic mesh with tacks¿ was not provided.] (b)(6) 2015: (b)(6).History and physical.Has had chronic draining wound from midline incision.Has been on multiple antibiotics, it has been drained several times without healing.Presents today for elective exploratory laparotomy with excision of the infected mesh.Gastrointestinal: open wound in midline incision with proud flesh.Impression/plan: infected mesh.(b)(6) 2015: (b)(6).Intraoperative record.Pathology specimens: infected mesh.To specimen refrigerator.(b)(6) 2015: (b)(6).Pathology report.Accession #: (b)(6).Final diagnosis: infected mesh, excision: skin and subcutaneous tissue with ulceration, fibrosis, chronic inflammation, and foreign body giant cell reaction.Adjoining mesh material.Gross description: the specimen is received fresh labeled with the patient¿s name, initials wjs and ¿infected mesh¿.It consists of an elliptical portion of tan-pink wrinkled skin, which is 12.0 x 1.5 cm and has been excised to a depth of 7.5 cm.The skin surface displays a poorly healed incision with exposed partially necrotic subcutaneous tissue.The subcutaneous tissue displays an 18.0 x 7.0 x 1.5 cm portion of synthetic mesh material with adherent necrotic and ischemic soft tissue and multiple metallic tacks.No discrete lesions are identified grossly.Representative sections are submitted in one cassette labeled as a.Formalin exposure time: 6 hours.Microscopic: microscopic examination substantiates the diagnosis indicated above.Patient history: chief complaint/surgery pre-op [operative] diagnosis: incisional hernia: infected mesh (with tacks).Surgery post-op [operative] diagnosis: incisional hernia: infected mesh (with tacks).Surgical procedure: lysis adhesions.Surgical procedure: laparotomy exploratory.Histo tissue summary/slides reviewed: part 1: 1.Infected mesh.Taken: (b)(6) 2015 12:11.Received: (b)(6) 2015 13:08.Stain/cnt h & e x 1.Block a.(b)(6) 2015: (b)(6).Progress notes.Gastrointestinal: mildly ttp [tender to palpation] around incision.Dressing c/d/i [clean, dry, intact], slight shadowing on underside of dressing.(b)(6) 2015: (b)(6).Discharge summary.Admit date: (b)(6) 2015.Incisional hernia, infected mesh.Gastrointestinal: binder intact, mildly ttp [tender to palpation] around incision site, sutures intact.Discharge to home.Activity: no driving while taking pain medication, do not return to work until follow-up, may shower, no tub baths, do not soak incisions, no sex until cleared by physician, no lifting greater than 10 pounds, no bending or twisting at the waist, no sitting for extended periods of time.(b)(6) 2015: [missing records: an operative report for ex laparotomy, ventral hernia repair with mesh and bilateral rectal muscle advancement flap was not provided.] (b)(6) 2016: [missing records: an operative report for diagnostic laparoscopic, loa [lysis of adhesions] was not provided.] (b)(6) 2016: (b)(6).Consultation.Right lower quadrant pain and bulge.In (b)(6) 2015, patient was frustrated with pain in his ventral hernia, saw a surgeon in (b)(6) who repaired his ventral hernia with mesh.In (b)(6) 2015, incision opened with copious purulent drainage.Maintained on [antibiotics], wound healed.He notices a tender bulge in rlq [right lower quadrant] that gets larger with valsalva or standing.Ct at mckeesport shows some dense fluid around mesh and rlq [right lower quadrant] ventral hernia.Gi: mild tenderness of rlq [right lower quadrant], hernia defect at site of tenderness, bulge with valsalva.Impression/plan: mesh infection, ventral hernia.No indication for surgical admission.(b)(6) 2016: (b)(6).Radiology ¿ upper gi series with small bowel follow through.Indication: abd [abdominal] pain/heartburn/hx [history] revision of rny [roux-en-y]/hx [history] multiple hernia repairs.Findings: surgical staple lines, mesh anchors.Fewer mesh anchors are present compared to previous examination consistent with history of partial mesh removal.Impression: small herniation esophagogastric jejunal anastomosis above the diaphragm with a small amount of spontaneous gastroesophageal reflux.2 possible small herniations or eventrations of the small bowel are seen along the anterior right abdomen.(b)(6) 2018: (b)(6).Radiology ¿ upper gi series with small bowel follow through.Indication: dysphagia, abdominal pain, dumping syndrome, hx [history] rny [roux-en-y], evaluate for obstruction down low and stricture up high, postgastric surgery syndromes, bariatric surgery status.Impression: possible small herniation of esophagogastric jejunal anastomosis above diaphragm.Contrast did not reach distal small bowel before the patient left the department.(b)(6) 2018: (b)(6).Office notes.Abdominal pain, dysphagia.Complaining of recurrent purulent drainage from upper part of wound, worsening abdominal pain, right lower quadrant abdominal mass.Right lower quadrant pain is constant pressure, increases with bowel movements.Has had this pain for years.Plan: discussed with patient that additional surgical intervention may not relieve current pain as he has had multiple procedures to address same pain that have been unsuccessful.He is also at risk for additional complications given his extensive surgical history.Will continue to monitor at this time.Bmi 32, recommend healthy life style changes.Weight loss may also assist with abdominal pain symptoms.Egd/possible dilation.(b)(6) 2018: (b)(6).History and physical.Recurrent abd [abdominal] wall hernia.Abdomen: midline [and] rlq [right lower quadrant] [illegible] large hernia.(b)(6) 2018: (b)(6).Operative report.Operation: exploratory laparotomy, lysis of adhesions, excision of infected mesh and infected abdominal wall.Assistant: (b)(6).¿no resident was available to assist me.¿ preoperative diagnoses: chronic abdominal wall infection and incisional hernia.Postoperative diagnoses: chronic abdominal wall infection and incisional hernia.Procedure: ¿after successful induction of general anesthesia, the patient received intravenous vancomycin on the operating table.Gastric and bladder catheters were place.The abdomen was prepped with chlorhexidine solution and draped in a sterile fashion.A midline incision was made.We were able to safely enter the peritoneal cavity cephalad to his incisional hernia.We began our dissection laterally on the left and right around the chronic abdominal wall infection.We identified the mesh.We did not encounter pus as we dissected the chronic infection.The mesh was widely excised as we carefully took small bowel adhesions off the anterior abdominal wall.The mesh and chronic infection were sent en bloc to pathology.There were several other areas of chronic infection along the edges of the rectus, which were excised.We took the rectus bilaterally.Caudally, we dissected the space of retzius to ensure that the bladder would not be an issue for (b)(6).We began dissecting subcutaneous tissue off the anterior rectus sheath.The hernia sac was completely excised.We ran the small bowel several times to be certain as there was no injury and no evidence of internal hernia.(b)(6) then scrubbed for his portion of the case.I personally performed the general surgical portion of the case.¿ (b)(6) 2018: (b)(6).Operative report.Preoperative diagnoses: personal history of multiple prior abdominal operations, personal history of mesh infection, midline abdominal wall defect.Operation: right rectus abdominus myocutaneous perforator sparing advancement flap and left rectus abdominis myocutaneous perforator sparing advancement for abdominal closure with 38 cm plastic closure of incision.Indication: (b)(6) is a 56-year-old gentleman status post multiple prior operations, multiple hernia failures were included multiple bouts of infected mesh.(b)(6) and i agree that we would make an attempt of flap closure of the abdomen with no mesh based on his prior complications of mesh in the past.(b)(6) understood the risks of infection, bleeding, recurrent hernia, consent had been obtained by me.Procedure: ¿after (b)(6) had completed his portion of the operation, for details, please refer to his operative report, attention was then turned first to the right rectus abdominis muscle where dissection was carried out above the level of the ribcage releasing the lateral portion of the rectus muscle maintaining blood supply in the superior and inferior epigastric arteries and releasing the external oblique from above the level of the ribcage to the anterior superior iliac spine on the right hand side and the blood supply was left, both on the superior and inferior epigastric and the intercostal perforators.Muscle flap was advanced to the midline with no tension.Attention was then turned to the patient¿s left side where dissection was carried out, releasing the lateral portion of the rectus muscle and the external oblique from above the level of the ribcage to the anterior superior iliac spine and to the midaxillary line.This mobilized the left rectus muscle, which was based on the superior and inferior epigastric arteries and veins as well as the perforating vessel from these intercostals.The muscle flaps were advanced with minimal tension to the midline where they were inset with #1 prolene.Wounds were irrigated with copious amounts of normal saline solution.Three 15-french round channel drains were placed.The prior scar hernia sac, foreign bodies were all excised along the skin for 3-layer plastic closure of 38 cm.The patient tolerated the procedure well.There were no intraoperative or immediate postoperative complications.I, (b)(6), was physically performed the critical portion of the operation, guided the residents through the noncritical portion of the operation.(b)(6) was immediately available wheels in to wheels out.¿ (b)(6) 2018: (b)(6).Intraoperative record.Pathology specimens: old mesh.To specimen refrigerator.(b)(6) 2018: upmc presbyterian.(b)(6).Pathology report.Accession #: (b)(6).Final diagnosis: synthetic mesh and soft tissue, incisional hernia repair: synthetic mesh and attached fibroadipose tissue with chronic inflammation and foreign body giant cell reaction.Gross description: the specimen is received unfixed labeled with the patient¿s name, initials ws and ¿old mesh¿.The specimen consists of multiple tan-pink, soft, focally hemorrhagic and roughened portions of fibromembranous tissue with adherent yellow lobular adipose tissue intermixed with dense fibrous tissue and suture material with potential synthetic mesh measuring 20.0 x 15.0 x 2.5 cm in aggregate.The specimen is serially cross-sectioned and representative cross-sections are submitted in cassette labeled a.Formalin exposure time: 8 hours.Microscopic: microscopic examination substantiates the diagnosis indicated above.Patient history: chief complaint/surgery pre-op [operative] diagnosis: incisional hernia.Surgery post-op [operative] diagnosis: incisional hernia.Surgical procedure: repair incisional hernia.Surgical procedure: separation of parts.Surgical procedure: lysis adhesions.Histo tissue summary/slides reviewed: part 1: 1-old mesh.Taken: (b)(6) 2018 12:46.Received: (b)(6) 2018 15:17.Stain/cnt h&e x 1.Block a.(b)(6) 2018: (b)(6).Discharge summary.Admit date: (b)(6) 2018.Incisional hernia without, obstruction or gangrene.Elective incisional hernia repair with separation of parts.Postoperative course uncomplicated, jps [jackson-pratt] with serous bloody drainage.Midline incision dressed, c/d/i [clean, dry, intact], jp [jackson-pratt] x 3.Discharge to home.Activity: do not drive until follow-up visit, do not return to work until follow up, may shower, no tub baths, do not soak incisions, no lifting greater than 5 pounds.Abdominal binder at all times.Empty jp [jackson-pratt] and record 2-3 times a day.Wound care: wash with soap and water daily, pat dry.(b)(6) 2018: (b)(6).Phone call.(b)(6) a (lateral, subcutaneous) had fallen out.(b)(6) a (lateral, subcutaneous) was, per patient, putting out low volume serosanguinous.Recommendations: dress with dry gauze dressing, keep clean.Also reiterated clinic recommendations to use his abdominal binder and drain log.A potential relationship, if any, between the alleged injuries or complications and the gore device is unclear from the provided information at this time.It should be noted that the gore® dualmesh® biomaterial instructions for use includes warnings and addresses the following adverse reactions among others: ¿strict aseptic techniques should be followed.If an infection develops, it should be treated aggressively.An unresolved infection may require removal of the material.¿ ¿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.¿ 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

The investigation has been completed.Based upon gore¿s investigation there is no available information that reasonably suggests that a gore device may have caused or contributed to death, serious injury or reportable malfunction, and is no longer considered reportable.This event will be closed as no problem detected.Previous patient codes (1994, 1970, 1695, 1690, 1930, 3160, 3191 used for ¿open abdominal wound¿) were reported based on the original complaint and are no longer applicable and/or not reportable per gore¿s investigation.The following information was determined from the medical records.Medical records: the known medical records span april 5, 2005 through september 22, 2018, and not all records received in this time span are relevant gore® dualmesh® biomaterial.Patient information: medical history: smoker ¿ 2 packs/day x 10 years; essential hypertension; anxiety; anemia; chronic gastritis; chronic duodenitis; gastroesophageal reflux disease; hiatal hernia; hepatitis a; obesity.­(b)(6)2005: 255 lbs.; bmi 35.6, ­(b)(6)2005: 262 lbs.; bmi 36.5, ­(b)(6)2006: 223 lbs.; bmi 31.1, ­(b)(6)2015: 218 lbs.; bmi 30.42, ­(b)(6)2018: 216 lbs.; bmi 30.2.Prior surgical procedures: [dates unknown for following surgeries] cholecystectomy, nissen fundoplication, incisional hernia repair x2, roux-en-y esophagojejunostomy with takedown of nissen fundoplication, lysis of adhesions, small bowel resection, placement of gastrostomy tube.Implant preoperative complaints: on (b)(6)2006: ¿extensive amount of intra-abdominal adhesions.Prior g-tube, which was anchored to the abdominal wall and 12 x 12 cm anterior abdominal wall incisional hernia.¿ implant procedure: laparoscopic repair of anterior abdominal wall hiatal hernia ¿with gore-tex dual plus mesh using 20 x 20 centimeter mesh¿, laparoscopic lysis of adhesions, and laparoscopic takedown of g-tube.Implant: gore® dualmesh® biomaterial (03757290/1dlmc07) 20cm x 30cm.Implant date: (b)(6) 2006 [hospitalized (b)(6)2006] description of hernia being treated: ¿once all the adhesiolysis was performed we marked the abdominal wall appropriately with a skin marker to identify the incisional hernia defect.Then we removed the carbon dioxide from the abdomen and measured it on the abdomen with a ruler and we determined the defect was 12 x 12 cm in dimension.¿ implant size and fixation: ¿we fashioned a gore-tex dual plus mesh externally to 20 x 20 cm and we placed four anchoring sutures on the corners of the mesh on the left side of the mesh.These sutures were placed with 0 gore.The mesh was rolled until it was within the abdomen.With appropriate orientation, with the rough side placed only in the abdominal wall and the smooth side towards the peritoneal surface.The four transfixing sutures were delivered abdominally, after a small incision was made using carter-thomason device.These sutures were delivered with the appropriate marks on the skin, where the abdomen was removed of carbon dioxide.These transfixing sutures were tied to anchor the mesh in the abdominal wall, and the remaining repair was done with the tacker.Tacks were placed on the edge of the mesh and another roll about a centimeter medial from the edge.¿ post-operative period: [two days] on (b)(6)2006: ¿abdominal incisions dry, intact.¿ relevant medical information: on (b)(6)2007: ¿still c/o [complains of] epigastric and l [left] subcostal pain.Pt [patient] with l [left] sided abd [abdomen] pain.Ct [negative] for hernia recurrence.¿ ¿chronic abd [abdominal] pain, [no] obvious occurrence of hernia.¿ on (b)(6)2007: ¿diagnostic laparoscopy with laparoscopic lysis of extensive adhesions¿ ¿the capsule over the mesh was noted and was entered sharply with the ultrasonics.The mesh was completely exposed.All of the edges of the mesh were exposed and the prior tacks were identified.There was no recurrent abdominal wall hernia noted.It took a total of about 2 hours and 20 minutes to do extensive lysis of adhesions to clear the abdominal wall of all anterior abdominal wall adhesions.¿ ¿a prior g-tube site was identified, was mobilized, and the stomach was left intact to the abdominal wall.After complete adhesiolysis was performed, the area of the abdominal wall was then inspected.There was no recurrent hernia.There were no noted enterotomies.There was no bile thinning, no bleeding noted.On the left upper quadrant adjacent to the mesh, there was dense scar and adhesions and the part of the greater curvature of the stomach was adherent to the mesh.It was taken down sharply with the ultrasonics.This took another additional 20 minutes.Once the operation was completed, we again examined thoroughly the abdominal wall.There was no recurrent hernia, and we terminated the operation at that time.¿ on (b)(6)2010: ct abdomen: ¿intact ventral hernia repair.¿ on (b)(6)2010: ¿diagnostic laparoscopy with laparoscopic extensive lysis of adhesions.Takedown of a g-tube.Esophagogastroduodenoscopy, diagnostic.¿ ¿the stomach and the liver was plastered to the abdominal wall, which may be causing this patient some pain postprandially.¿ ¿the mesh repair was intact and complete with no recurrence.¿ on (b)(6)2011: ¿occasionally, he feels little discomfort in the belly but according to him, nothing unusual.¿ ¿mri of the abdomen which was unremarkable.¿ on (b)(6)2012: ¿.A week ago, he had a surgery done by dr.(b)(6), laparoscopic lysis of peritoneal adhesions.The patient recuperated from the surgery very well.He is overall doing very well now.No complaints of chest pain.No nausea.No vomiting.Moving his bowels regularly.¿ (b)(6)2012: [missing records: an operative report for loa [lysis of adhesions] was not provided.] on (b)(6)2012: upper gi series with small bowel follow through.¿redemonstrated cluster small bowel in right upper quadrant in region of patient¿s pain, with new area of associated dilated small bowel, may represent a low grade partial small bowel obstruction secondary to adhesions versus a jejuno-jejunal anastomotic dilation.¿ on (b)(6)2012: ¿esophagogastroduodenoscopy, diagnostic laparoscopy, extensive laparoscopic lysis of adhesions, small bowel resection, laparotomy, reduction of internal hernia, closure of mesenteric defect and gastrostomy tube placement.¿ ¿of note, our gastrostomy did not go through the mesh of the previous hernia repair of the patient.¿ ¿the seal was nice and it was away from the most lateral left side border of the previously placed mesh and anterior procedure of the patient.¿ on (b)(6)2014: ¿he is also having some uncomfortable feeling in the abdomen where he had a previous surgery in the scar area.¿ on (b)(6)2014: ¿underwent baswa [unknown abbreviation], found herniated e-j.Underwent egd with dilation.Pt [patient] insisted he did not want to leave without having another repair surgery.Despite explaining that this was not possible at this time, pt continued to insist, stating if he didn¿t get operated on this time, he was ¿never going to come back here.¿ then demanded his discharge paperwork, was discharged home with instructions to f/u in clinic should he choose to do so.¿ on (b)(6)2015: upper gi series with small bowel follow through.¿clustered segment small bowel in right upper quadrant probably corresponding to an anastomotic site which is dilated and fixed up palpation.Proximal to the anastomosis is a short segment of small bowel, slightly dilated indicating low-grade partial obstructive pattern.¿ on (b)(6)2015: ¿given worsening of symptoms, persistent pain, mild dysphagia, chronic vomiting, after a long discussion held with patient it was considered that findings of partial small bowel obstruction at the jejuno-jejunostomy might be playing a role.I did explain to patient the high risk associated to abdominal surgery on him given the multiple interventions has had in past.I explained risks and possible complications associated with such complex procedure given his challenging clinical condition¿ ¿schedule for redo roux-en-y esophago-jejunostomy, abdominal wall reconstruction.Dr.(b)(6) from plastics to be contacted to assist in this likely complex abdominal wall closure given history of multiple ventral hernia repairs with mesh.¿ on (b)(6)2015: ¿esophagogastrojejunoscopy, laparoscopic lysis of adhesions, laparotomy, repair of hiatal hernia, small bowel resection, small bowel anastomoses x2, and placement of gastrostomy feeding tube.¿ ¿tedious and meticulous lysis of adhesions was started switching between endoshears and harmonic device, it took at least 120 minutes of lysis of adhesions to be able to have better understanding of the anatomy, severe dense adhesions were found at the diaphragmatic hiatus area, the decision was made to convert to laparotomy.¿ ¿in order to increase the length of the roux limb, we performed an end to end jejuno -jejunal anastomosis one layer with interrupted 3-0 silk stitches.¿ ¿given the presence of a mesh (prosthesis) in the abdominal wall from previous ventral hernia repair, intraoperative consult was called to plastic surgery, dr.(b)(6) scrubbed in, and performed closure of the abdominal wall, this procedure will be dictated in a different operative note by dr (b)(6).¿ ¿we had initially agreed that he had a well incorporated mesh and that for this lengthy operation, which was clean, a removal of this mesh and subsequent mesh replacement could be devastating to his abdominal wall so we mutually agreed that primarily closing the mesh today was in the patient¿s best interest.¿ on (b)(6)15: ¿the patient had a very prolonged surgery according to him.Postop, he was on a vent, now he also has a peg tube.The patient is eating well.He has a considerable amount of pain in the abdomen.¿ ¿midline surgical scar healing.¿ appear to be missing a record between 3/25/15 and 4/13/15 indicating reason for wound culture.On (b)(6)2015: microbiology: deep wound culture of abdomen sinus tract; ¿culture: moderate staphylococcus aureus¿.On (b)(6)2015: ¿open wound abdominal wall with retained suture, c/o [complain of] drainage, aroma, pain.¿ on (b)(6)2015: operative report.Preoperative diagnoses: suture abscess, abdomen; personal history of mesh placement.The records state: ¿[the patient] is a 52-year-old gentleman status post open abdominal operations with prior hernia repairs, presents with 2 open areas for removal of sutures.¿ operative report states: ¿prolene sutures were removed.Hemostasis maintained with meticulous electrocautery.The wound was packed open.¿ on (b)(6)2015: microbiology.¿deep wound culture: gram stain: moderate wbcs [white blood cells] present, rare gram-positive cocci in pairs.Culture: moderate staphylococcus aureus.¿ on (b)(6)2015: ¿he has had multiple operations for incisional hernias as well as placement of multiple pieces of mesh.¿ no records were provided to support multiple pieces of mesh.¿has had a chronic mesh infection with open abdominal wound drainage, pain.¿ ¿10 x 3 cm open, granulating wound with purulent material.Mesh is palpable deep to his abdominal wall measuring 15x 20 cm.¿ on (b)(6)2015: ¿the patient's last surgery was done in (b)(6) 2015, which was complicated with the infection, probably the mesh.He is here now for a preoperative clearance for exploratory laparotomy, lysis of adhesions, and removal of infected mesh.¿ explant preoperative complaints: on (b)(6)2015: ¿has had chronic draining wound from midline incision.Has been on multiple antibiotics, it has been drained several times without healing.Presents today for elective exploratory laparotomy with excision of the infected mesh.¿ explant procedure: exploratory laparotomy, lysis of adhesions, excision of 30 x 30 cm ¿infected mesh,¿ drainage abscess, and debridement of abdominal wall.Explant date: (b)(6)2015 [hospitalized (b)(6) 2015].¿an elliptical incision was made incorporating his draining sinus tract.We entered the peritoneal cavity caudal to the palpable mesh and safely entered the peritoneal cavity.We then began lysing adhesions, taking the omentum and bowel off the back of the mesh.We proceeded in a cephalad direction and essentially splitting the mesh in half until the upper end at the xiphoid.We then fully excised all mesh, tacks and sutures from the mesh on the left and right abdominal wall.We protected the posterior rectus sheath as we did so.After the mesh was fully excised we then excised 3 cm of the inflammatory tissue on either side of the midline to get back to good healthy tissue.Cultures were sent from the abscess cavity.The bowel was inspected and protected throughout.Of note, he had had a previous gastrostomy, which we left tacked to the abdominal wall.The abdomen was irrigated copiously with antibiotic solution.We then performed a skin only closure.One layer of subcutaneous tissue was closed with 3-0 polysorb sutures.The skin was closed with a running 0 surgipro suture starting at either end and tying in the midline.¿ relevant medical information: on (b)(6)2015: pathology report: ¿it consists of an elliptical portion of tan-pink wrinkled skin, which is 12.0 x 1.5 cm and has been excised to a depth of 7.5 cm.The skin surface displays a poorly healed incision with exposed partially necrotic subcutaneous tissue.The subcutaneous tissue displays an 18.0 x 7.0 x 1.5 cm portion of synthetic mesh material with adherent necrotic and ischemic soft tissue and multiple metallic tacks.No discrete lesions are identified grossly.¿ on (b)(6)2015: ¿the patient has hernia and he is scheduled for another surgery sometime in a month or so.Overall, doing well.Conclusion: it should be noted that the gore® dualmesh® biomaterial 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® dualmesh® 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.¿ the instructions for use further state: ¿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.Individual medical decisions, if inconsistent and/or non-conforming to the device manufacturer¿s recommendations, ifu, or recognized best practices, may result in or contribute to an adverse event.As with any surgical procedure, there are always risks of complications for surgical repair of hernias and soft tissue deficiencies, with or without mesh.These may include but are not limited to, adhesions and related harms, bleeding, bowel obstruction, 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 above inherent risks are typically detailed in standard informed consent documents.The device was not able to be returned for evaluation; therefore, a direct product analysis could not be conducted.Review of the manufacturing records verified that the lot met all pre-release specifications.All available information has been placed on file for use in product surveillance, 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.

Manufacturer Narrative

H6: updated patient codes.H6: updated device codes.H6: updated conclusion codes.The investigation has been completed.Based upon gore¿s investigation there is no available information that reasonably suggests that a gore device may have caused or contributed to death, serious injury or reportable malfunction, and is no longer considered reportable.This event will be closed as no problem detected.Previous patient codes (1994, 1970, 1695, 1690, 1930, 3160, 3191 used for ¿open abdominal wound¿) were reported based on the original complaint and are no longer applicable and/or not reportable per gore¿s investigation.The following information was determined from the medical records.Medical records: the known medical records span april 5, 2005 through september 22, 2018, and not all records received in this time span are relevant gore® dualmesh® biomaterial.Patient information: medical history: smoker ¿ 2 packs/day x 10 years, essential hypertension, anxiety, anemia, chronic gastritis, chronic duodenitis, gastroesophageal reflux disease, hiatal hernia, hepatitis a, obesity, on ­ (b)(6) 2005: 255 lbs.; bmi 35.6, ­on (b)(6) 2005: 262 lbs.; bmi 36.5, ­ on (b)(6) 2006: 223 lbs.; bmi 31.1, on­ (b)(6) 2015: 218 lbs.; bmi 30.42, ­ on (b)(6) 2018: 216 lbs.; bmi 30.2.Prior surgical procedures: [dates unknown for following surgeries].Cholecystectomy, nissen fundoplication, incisional hernia repair x2, roux-en-y esophagojejunostomy with takedown of nissen fundoplication, lysis of adhesions, small bowel resection, placement of gastrostomy tube.Implant preoperative complaints: on (b)(6) 2006: ¿extensive amount of intra-abdominal adhesions.Prior g-tube, which was anchored to the abdominal wall and 12 x 12 cm anterior abdominal wall incisional hernia.¿ implant procedure: laparoscopic repair of anterior abdominal wall hiatal hernia ¿with gore-tex dual plus mesh using 20 x 20 centimeter mesh¿, laparoscopic lysis of adhesions, and laparoscopic takedown of g-tube.Implant: gore® dualmesh® biomaterial (03757290 / 1dlmc07) 20cm x 30cm.Implant date: on (b)(6) 2006 [hospitalized on (b)(6) 2006].Description of hernia being treated: ¿once all the adhesiolysis was performed we marked the abdominal wall appropriately with a skin marker to identify the incisional hernia defect.Then we removed the carbon dioxide from the abdomen and measured it on the abdomen with a ruler and we determined the defect was 12 x 12 cm in dimension.¿ implant size and fixation: ¿we fashioned a gore-tex dual plus mesh externally to 20 x 20 cm and we placed four anchoring sutures on the corners of the mesh on the left side of the mesh.These sutures were placed with 0 gore.The mesh was rolled until it was within the abdomen.With appropriate orientation, with the rough side placed only in the abdominal wall and the smooth side towards the peritoneal surface.The four transfixing sutures were delivered abdominally, after a small incision was made using carter-thomason device.These sutures were delivered with the appropriate marks on the skin, where the abdomen was removed of carbon dioxide.These transfixing sutures were tied to anchor the mesh in the abdominal wall, and the remaining repair was done with the tacker.Tacks were placed on the edge of the mesh and another roll about a centimeter medial from the edge.¿ post-operative period: [two days].On (b)(6) 2006: ¿abdominal incisions dry, intact.¿ relevant medical information: on (b)(6) 2007: ¿still c/o [complains of] epigastric and l [left] subcostal pain.Pt [patient] with l [left] sided abd [abdomen] pain.Ct [negative] for hernia recurrence.¿ ¿chronic abd [abdominal] pain, [no] obvious occurrence of hernia.¿ on (b)(6) 2007: ¿diagnostic laparoscopy with laparoscopic lysis of extensive adhesions.¿ ¿the capsule over the mesh was noted and was entered sharply with the ultrasonics.The mesh was completely exposed.All of the edges of the mesh were exposed and the prior tacks were identified.There was no recurrent abdominal wall hernia noted.It took a total of about 2 hours and 20 minutes to do extensive lysis of adhesions to clear the abdominal wall of all anterior abdominal wall adhesions.¿ ¿a prior g-tube site was identified, was mobilized, and the stomach was left intact to the abdominal wall.After complete adhesiolysis was performed, the area of the abdominal wall was then inspected.There was no recurrent hernia.There were no noted enterotomies.There was no bile thinning, no bleeding noted.On the left upper quadrant adjacent to the mesh, there was dense scar and adhesions and the part of the greater curvature of the stomach was adherent to the mesh.It was taken down sharply with the ultrasonics.This took another additional 20 minutes.Once the operation was completed, we again examined thoroughly the abdominal wall.There was no recurrent hernia, and we terminated the operation at that time.¿ on (b)(6) 2010: ct abdomen: ¿intact ventral hernia repair.¿ on (b)(6) 2010: ¿diagnostic laparoscopy with laparoscopic extensive lysis of adhesions.Takedown of a g-tube.Esophagogastroduodenoscopy, diagnostic.¿ ¿the stomach and the liver was plastered to the abdominal wall, which may be causing this patient some pain postprandially.¿ ¿the mesh repair was intact and complete with no recurrence.¿ on (b)(6) 2011: ¿occasionally, he feels little discomfort in the belly but according to him, nothing unusual.¿ ¿mri of the abdomen which was unremarkable.¿ on (b)(6) 2012: ¿a week ago, he had a surgery done by dr.(b)(6), laparoscopic lysis of peritoneal adhesions.The patient recuperated from the surgery very well.He is overall doing very well now.No complaints of chest pain.No nausea.No vomiting.Moving his bowels regularly.¿ on (b)(6) 2012: [missing records: an operative report for loa [lysis of adhesions] was not provided.] on (b)(6) 2012: upper gi series with small bowel follow through ¿redemonstrated cluster small bowel in right upper quadrant in region of patient¿s pain, with new area of associated dilated small bowel, may represent a low grade partial small bowel obstruction secondary to adhesions versus a jejuno-jejunal anastomotic dilation.¿ on (b)(6) 2012: ¿esophagogastroduodenoscopy, diagnostic laparoscopy, extensive laparoscopic lysis of adhesions, small bowel resection, laparotomy, reduction of internal hernia, closure of mesenteric defect and gastrostomy tube placement.¿ ¿of note, our gastrostomy did not go through the mesh of the previous hernia repair of the patient.¿ ¿the seal was nice and it was away from the most lateral left side border of the previously placed mesh and anterior procedure of the patient.¿ on (b)(6) 2014: ¿he is also having some uncomfortable feeling in the abdomen where he had a previous surgery in the scar area.¿ on (b)(6) 2014: ¿underwent baswa [unknown abbreviation], found herniated e-j.Underwent egd with dilation.Pt [patient] insisted he did not want to leave without having another repair surgery.Despite explaining that this was not possible at this time, pt continued to insist, stating if he didn't get operated on this time, he was ¿never going to come back here.¿ then demanded his discharge paperwork, was discharged home with instructions to f/u in clinic should he choose to do so.¿ on (b)(6) 2015: upper gi series with small bowel follow through ¿clustered segment small bowel in right upper quadrant probably corresponding to an anastomotic site which is dilated and fixed up palpation.Proximal to the anastomosis is a short segment of small bowel, slightly dilated indicating low-grade partial obstructive pattern.¿ on (b)(6) 2015: ¿given worsening of symptoms, persistent pain, mild dysphagia, chronic vomiting, after a long discussion held with patient it was considered that findings of partial small bowel obstruction at the jejuno-jejunostomy might be playing a role.I did explain to patient the high risk associated to abdominal surgery on him given the multiple interventions has had in past.I explained risks and possible complications associated with such complex procedure given his challenging clinical condition¿ ¿schedule for redo roux-en-y esophago-jejunostomy, abdominal wall reconstruction.Dr.Russavage from plastics to be contacted to assist in this likely complex abdominal wall closure given history of multiple ventral hernia repairs with mesh.¿ on (b)(6) 2015: ¿esophagogastrojejunoscopy, laparoscopic lysis of adhesions, laparotomy, repair of hiatal hernia, small bowel resection, small bowel anastomoses x2, and placement of gastrostomy feeding tube.¿ ¿tedious and meticulous lysis of adhesions was started switching between endoshears and harmonic device, it took at least 120 minutes of lysis of adhesions to be able to have better understanding of the anatomy, severe dense adhesions were found at the diaphragmatic hiatus area, the decision was made to convert to laparotomy.¿ ¿in order to increase the length of the roux limb, we performed an end to end jejuno -jejunal anastomosis one layer with interrupted 3-0 silk stitches.¿ ¿given the presence of a mesh (prosthesis) in the abdominal wall from previous ventral hernia repair, intraoperative consult was called to plastic surgery, dr.(b)(6) scrubbed in, and performed closure of the abdominal wall, this procedure will be dictated in a different operative note by dr.(b)(6).¿ ¿we had initially agreed that he had a well incorporated mesh and that for this lengthy operation, which was clean, a removal of this mesh and subsequent mesh replacement could be devastating to his abdominal wall so we mutually agreed that primarily closing the mesh today was in the patient¿s best interest.¿ on (b)(6) 2015: ¿the patient had a very prolonged surgery according to him.Postop, he was on a vent, now he also has a peg tube.The patient is eating well.He has a considerable amount of pain in the abdomen.¿ ¿midline surgical scar healing.¿ appear to be missing a record between on (b)(6) 2015 indicating reason for wound culture.On (b)(6) 2015: microbiology: deep wound culture of abdomen sinus tract; ¿culture: moderate staphylococcus aureus¿ on (b)(6) 2015: ¿open wound abdominal wall with retained suture, c/o [complain of] drainage, aroma, pain.¿ on (b)(6) 2015: operative report.Preoperative diagnoses: suture abscess, abdomen; personal history of mesh placement.The records state: ¿[the patient] is a 52-year-old gentleman status post open abdominal operations with prior hernia repairs, presents with 2 open areas for removal of sutures.¿ operative report states: ¿prolene sutures were removed.Hemostasis maintained with meticulous electrocautery.The wound was packed open.¿ on (b)(6) 2015: microbiology.¿deep wound culture: gram stain: moderate wbcs [white blood cells] present, rare gram-positive cocci in pairs.Culture: moderate staphylococcus aureus.¿ on (b)(6) 2015: ¿he has had multiple operations for incisional hernias as well as placement of multiple pieces of mesh.¿ no records were provided to support multiple pieces of mesh.¿has had a chronic mesh infection with open abdominal wound drainage, pain.¿ ¿10 x 3 cm open, granulating wound with purulent material.Mesh is palpable deep to his abdominal wall measuring 15x 20 cm.¿ on (b)(6) 2015: ¿the patient's last surgery was done on (b)(6) 2015, which was complicated with the infection, probably the mesh.He is here now for a preoperative clearance for exploratory laparotomy, lysis of adhesions, and removal of infected mesh.¿ explant preoperative complaints: on (b)(6) 2015: ¿has had chronic draining wound from midline incision.Has been on multiple antibiotics, it has been drained several times without healing.Presents today for elective exploratory laparotomy with excision of the infected mesh.¿ explant procedure: exploratory laparotomy, lysis of adhesions, excision of 30 x 30 cm ¿infected mesh,¿ drainage abscess, and debridement of abdominal wall.Explant date: on (b)(6) 2015 [hospitalized on (b)(6) 2015].¿an elliptical incision was made incorporating his draining sinus tract.We entered the peritoneal cavity caudal to the palpable mesh and safely entered the peritoneal cavity.We then began lysing adhesions, taking the omentum and bowel off the back of the mesh.We proceeded in a cephalad direction and essentially splitting the mesh in half until the upper end at the xiphoid.We then fully excised all mesh, tacks and sutures from the mesh on the left and right abdominal wall.We protected the posterior rectus sheath as we did so.After the mesh was fully excised we then excised 3 cm of the inflammatory tissue on either side of the midline to get back to good healthy tissue.Cultures were sent from the abscess cavity.The bowel was inspected and protected throughout.Of note, he had a previous gastrostomy, which we left tacked to the abdominal wall.The abdomen was irrigated copiously with antibiotic solution.We then performed a skin only closure.One layer of subcutaneous tissue was closed with 3-0 polysorb sutures.The skin was closed with a running 0 surgipro suture starting at either end and tying in the midline.¿ relevant medical information: on (b)(6) 2015: pathology report: ¿it consists of an elliptical portion of tan-pink wrinkled skin, which is 12.0 x 1.5 cm and has been excised to a depth of 7.5 cm.The skin surface displays a poorly healed incision with exposed partially necrotic subcutaneous tissue.The subcutaneous tissue displays an 18.0 x 7.0 x 1.5 cm portion of synthetic mesh material with adherent necrotic and ischemic soft tissue and multiple metallic tacks.No discrete lesions are identified grossly.¿ on (b)(6) 2015: ¿the patient has hernia and he is scheduled for another surgery sometime in a month or so.Overall, doing well.Conclusion: it should be noted that the gore® dualmesh® biomaterial 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® dualmesh® 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.¿ the instructions for use further state: ¿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.Individual medical decisions, if inconsistent and/or non-conforming to the device manufacturer¿s recommendations, ifu, or recognized best practices, may result in or contribute to an adverse event.As with any surgical procedure, there are always risks of complications for surgical repair of hernias and soft tissue deficiencies, with or without mesh.These may include but are not limited to, adhesions and related harms, bleeding, bowel obstruction, 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 above inherent risks are typically detailed in standard informed consent documents.The device was not able to be returned for evaluation; therefore, a direct product analysis could not be conducted.Review of the manufacturing records verified that the lot met all pre-release specifications.All available information has been placed on file for use in product surveillance, 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.

• Brand Name: GORE DUALMESH BIOMATERIAL
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 7640886
• MDR Text Key: 112414837
• Report Number: 2017233-2018-00340
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• PMA/PMN Number: K063435
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 09/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/17/2010
• Device Catalogue Number: 1DLMC07
• Device Lot Number: 03757290
• 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 Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 52 YR
• Patient Weight: 99