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W. L. GORE & ASSOCIATES, INC. GORE® DUALMESH® PLUS BIOMATERIAL; MESH, SURGICAL, POLYMERIC
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| Model Number 1DLMCP05 |
| Device Problem
Insufficient Information (3190)
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| Patient Problem
Obstruction/Occlusion (2422)
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| Event Date 09/08/2011 |
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Event Type
Injury
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Manufacturer Narrative
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The plus antimicrobial product coating contains silver carbonate [approximately 800 micrograms per cubic centimeter of product (g/cm3)], and chlorhexidine diacetate [approximately 1600 micrograms per cubic centimeter of product (g/cm3)].It should be noted that the gore dualmesh plus biomaterial instructions for use addresses the following adverse reactions among others: ¿possible adverse reactions with the use of any tissue deficiency prosthesis may include, but are not limited to, contamination, infection, inflammation, adhesion, fistula formation, seroma formation, hematoma, and recurrence." the gore dualmesh plus biomaterial instructions for use also states: ¿strict aseptic techniques should be followed.If an infection develops, it should be treated aggressively.An unresolved infection may require removal of the material.".
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Event Description
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It was reported to gore that the patient underwent open incisional hernia repair on (b)(6), 2005 whereby a gore dualmesh plus biomaterial was implanted.The complaint alleges that on (b)(6), 2011, an additional procedure occurred whereby the gore device was explanted.It was reported the patient alleges the following injuries: small bowel obstruction; small bowel resection; removal of mesh; adhesions; pain.Additional event specific information was not provided.
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Manufacturer Narrative
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B7: added medical history.H6: conclusion code remains unchanged.H10/11: added medical record information.Additional details regarding the patient's clinical course were ascertained from a review of medical records and are as follows: implant procedure: repair incisional hernia with mesh.Implant: gore® dualmesh® plus biomaterial [1dlmcp05, 03287753].Implant date: (b)(6) 2005 (hospitalization [ni]) (b)(6) 2005: (b)(6).[illegible].Operative note.[handwritten].Preoperative diagnosis: incisional hernia.Postoperative diagnosis: same.[missing full operative report].The records confirm a gore® dualmesh® plus biomaterial (1dlmcp05, 03287753) was implanted during the procedure.Explant procedure: laparoscopic cholecystectomy.Open lysis of adhesions.Small bowel resection and anastomosis.Liver biopsy.Explanation of previously placed mesh.Explant date: (b)(6), 2011 (hospitalization [ni]) (b)(6) 2011: (b)(6) hospital.(b)(6), md.Operative report.Preoperative diagnosis: small bowel obstruction.Chronic cholelithiasis and cholelithiasis.Postoperative diagnosis: small bowel obstruction.Chronic cholelithiasis and cholelithiasis.Nodule on the liver.Surgeon: dr.(b)(6).Assistant: dr.(b)(6).Anesthesia: general endotracheal anesthesia.Anesthesiologist: dr.(b)(6).Indications: the patient is a 62-year-old lady who was admitted 4 days ago with abdominal pain.She was diagnosed with small bowel obstruction.She also had gallstones in her gallbladder.Since conservative management did not resolve her bowel obstruction, she was taken to the operating room for an exploration along with possible laparoscopic cholecystectomy.Description of the procedure: ¿after taking an informed consent, the patient was taken to the operating room, where she was placed supine on the table.She had sequential compression devices placed on her legs.She was given iv antibiotics prior to surgery.The abdomen was prepped and draped in the usual sterile fashion.She had a foley catheter placed prior to surgery.She had a nasogastric tube already in place.The abdomen was prepped and draped in the usual sterile fashion.A longitudinal incision was made in the previous midline scar.This was carefully opened under direct vision to avoid any enterotomies.The abdominal cavity was easily entered.A 12 mm trocar was introduced and pneumoperitoneum was achieved.There were omental adhesions to the right side, some of which were taken down from the xiphoid area, and a 5 mm port was placed under direct vision just to the left of the falciform ligament without any difficulty.Using a dissector form this port, some of the flimsy omental adhesions were taken down form the abdominal cavity, and the liver was freed.The anterior abdominal wall was freed on the right side, and 2 more ports were placed under direct vision.The liver was lifted up.The gallbladder was found underneath it covered with omental adhesions.The fundus was grasped with a grasper from the lateral most port and the right upper quadrant.Medial grasper grasped the omental adhesions, and these were taken down with coagulation diathermy.Since the gallbladder was fully visible, medial grasper now grasped the hartmann pouch lifting it inferolaterally.The patient was in right side of and head up position at this time.The cystic duct came into view.It was quite short but normal in caliber.It was dissected up to the body of the gallbladder.The cystic artery was superior and posterior to the cystic duct.This too was circumferentially dissected up to the body of the gallbladder.Cystic duct was clipped 3 times proximally, once distally, and divided.The posterior branch was also clipped twice proximally, once distally, and divided.The gallbladder was dissected free from the liver bed using hook coagulation diathermy.Once it was removed, it was placed in an endobag and retrieved from the umbilical port.Of note was the fact that before dissection, the gallbladder was tensely distended and had to be aspirated with a long needle to allow it to be grasped with a grasper from the medial port.The right upper quadrant was irrigated with saline.Hemostasis was secured with coagulation diathermy.2 white nodules were seen in the liver on the left lobe.One of them looked umbilicated; the other one had a bulging appearance.Once was right at the liver edge.The second one, which was bulging in appearance and white in color, was further cephalad close to the diaphragm on the left lobe.The lower one was easily amenable to biopsy.A tru-cut biopsy was performed on the lower liver lesion.2 passes were made, and 2 pieces of tissue were removed, sent for histopathology.Hemostasis was secured with coagulation diathermy.Now attention was directed to the rest of the abdominal cavity.There was dense adhesion just below the midline trocar and to the right, which had small bowel adherent to it.There were considerable adhesions all around.Hence, it was felt that it would be safer to open up and perform the rest of the procedure in an open fashion.The midline incision was extended to make it into formal laparotomy.There was small bowel adherent to the midline and to the right of midline to a previously placed mesh, and there were dense adhesions to this mesh.Trying to separate the bowel from the mesh caused a couple of enterotomies, and there was some spillage in the peritoneal cavity.The enterotomy was quickly sutured close with 3-0 silk stitches.The dissection was continued.This was the site of the obstruction.There were dense adhesions here, and 1 limb of the small bowel was caught in the tissues causing a complete obstruction.Distally, the small bowel appeared decompressed.Proximally, the small bowel was quite dilated.The entire small bowel was freed and run from the ligament of treitz down to the ileocecal valve.The portion, which was obstructed where there were the 2 enterotomies and where there was some compressing band causing possible ischemia, the entire portion was excised.This was mid ileum level, and about 15 inches of the small bowel was removed.Using gia stapler, a side-to-side anastomosis was performed using a gia 75 and a blue load.The resultant defect was closed with a ta60 stapler, again using a blue load.The entire anastomosis line was closed with 3-0 silk interrupted lembert sutures.The mesenteric defect was closed with 2-0 vicryl continuous running stitch.The bowel was replaced back in the peritoneal cavity, and the entire peritoneal cavity was copiously irrigated with more than 4 l of saline.There was no omentum.Hence, 2 seprafilms were placed in the abdominal cavity to prevent adhesions.The mesh, which probably had been placed at the time of her first hernia surgery, was an intraperitoneal mesh which looked like ptfe and the bowel was adherent to this mesh.It was felt that this mesh could probably cause more problems in the future.Hence, it was completely removed.The mesh that was placed during the second surgery was an overlay mesh.Hence, as it was completely incorporated in the patient¿s body, it was left alone.The abdominal cavity was closed with #1 prolene continuous running stitch.The subcutaneous tissues were irrigated with more saline, then closed with staples.The 3-port site in the subxiphoid and the right upper quadrant regions were also closed with staples.The incision was instilled with 20 ml of 0.5 marcaine with epinephrine for local anesthesia.A dry dressing was applied.An abdominal binder was placed over everything.The patient tolerated the procedure well.She was extubated and brought to the recovery room in a stable condition.Needles, swabs, and instruments were counted correct at the end of the case.Blood loss was estimated at 150 cc.Total urine output for the duration of the case was 220 cc.¿ relevant medical information: (b)(6) 2011: (b)(6) hospital.(b)(6) md.Pathology.Clinical information: small bowel obstruction; chronic cholecystitis.Specimen source: a) gallbladder.B) liver needle biopsy.C) sm bowel resect.D) foreign body.Gross description: a) labeled ¿knaack, charlene; gallbladder¿ is a 7.3 x 3.2 x 1.5 cm disrupted gallbladder with patent cystic duct.The serosa is purple and smooth with adipose tissue.The lumen contains green viscid bile with no calculi present.The mucosa is green brown and velvety to trabecular.The wall is up to 0.4 cm.B) labeled ¿knaack, charlene; left lobe liver biopsy¿ are two tan cores, 0.9 x 0.1 cm and 0.7 x 0.1 cm.C) labeled ¿knaack, charlene; small bowel¿ is an unoriented segment of small bowel, 29.5 cm in length and ranges in diameter from 2.1 cm to 3.2 cm.The peritoneum is dull gray purple with adhesions.One end of the bowel has a 0.7 cm in length area of structure that corresponds to the decrease in diameter.The stricture is 5.2 cm from the margin.The mucosa corresponding to the stricture is unremarkable.The mucosa of the mid portion of the bowel has a 1.1 x 0.7 cm red firm raised area of discoloration that upon sectioning reveals multiple black sutures.The corresponding peritoneum is inked black and is suggestive of previous perforation, 10.1 cm from the closer margin and 11.8 cm form the stricture.The remaining mucosa is tan pink to green and diffusely granular.Sections of the mesentery reveal multiple thrombosed vessels.Summary: c1 margin closest to stricture; c2 margin closest to sutured area; c3-c4 stricture; c5-7 area with suture; c8 peritoneal adhesions; c9 mesentery.Gross description: d) labeled ¿knaack charlene; mesh¿ is a 6.7 x 5.2 x 2.1 cm circular portion of mesh material.One surface is tan and smooth and the opposing surface has adherent gray fibromembranous tissue, grossly viable.Microscopic description: microscopic examination performed all specimens.Comment: part b.This specimen was seen in consultation with dr.(b)(6) who agrees with the diagnosis.It should be noted that the gore® dualmesh® plus biomaterial instructions for use addresses the following adverse reactions among others: ¿possible adverse reactions with the use of any tissue deficiency prosthesis may include, but are not limited to, contamination, infection, inflammation, adhesion, fistula formation, seroma formation, hematoma, and recurrence." the gore® dualmesh® plus biomaterial instructions for use also states: ¿strict aseptic techniques should be followed.If an infection develops, it should be treated aggressively.An unresolved infection may require removal of the material.".
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Manufacturer Narrative
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It should be noted that the gore® dualmesh® plus biomaterial instructions for use addresses the following adverse reactions among others: ¿possible adverse reactions with the use of any tissue deficiency prosthesis may include, but are not limited to, contamination, infection, inflammation, adhesion, fistula formation, seroma formation, hematoma, and recurrence.The gore® dualmesh® plus biomaterial instructions for use also states: ¿strict aseptic techniques should be followed.If an infection develops, it should be treated aggressively.An unresolved infection may require removal of the material.W.L.Gore & associates, inc.(gore) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by gore, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Blank fields present on this report include required fields and fields determined to be not applicable.Blank required fields indicate that the information was not provided, was deemed unavailable or was not applicable.This report does not constitute an admission or a conclusion by fda, gore, or its associates that the device, gore or its associates caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects" or has "malfunctioned".These words are included in the report and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.
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Manufacturer Narrative
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Additional details regarding the patient's clinical course were ascertained from a review of medical records and are as follows: implant procedure: [implant: gore® dualmesh® plus biomaterial, 1dlmcp05/03287753, 7.5cm x 10cm x 1mm thick].Implant date: (b)(6) 2005: banner good samaritan surgicenter.Implant sticker.¿dualmesh plus antimicrobial.Lot #:03287753.Item #: 1dlmcp05.¿ a potential relationship, if any, between the alleged injuries or complications and the gore device has not been established at this time based on available information.It should be noted that the gore® dualmesh® plus biomaterial instructions for use addresses the following adverse reactions among others: ¿possible adverse reactions with the use of any tissue deficiency prosthesis may include, but are not limited to, contamination, infection, inflammation, adhesion, fistula formation, seroma formation, hematoma, and recurrence.The gore® dualmesh® plus biomaterial instructions for use also states: ¿strict aseptic techniques should be followed.If an infection develops, it should be treated aggressively.An unresolved infection may require removal of the material.W.L.Gore & associates, inc.(gore) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by gore, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Blank fields present on this report include required fields and fields determined to be not applicable.Blank required fields indicate that the information was not provided, was deemed unavailable or was not applicable.This report does not constitute an admission or a conclusion by fda, gore, or its associates that the device, gore or its associates caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects" or has "malfunctioned".These words are included in the report and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.
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Manufacturer Narrative
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H6: updated health effect.H6: updated investigation finding.H6: updated type of investigation.H6: updated investigation conclusions.The investigation has been completed.Based upon the totality of the information received over the course of the investigation and reported by gore in the previously submitted medical record narratives the following conclusions have been reached.As previously reported, all pertinent medical records requested may not have been received.In the absence of additional information or medical records from the complainant, this event file will be closed with the information provided.Following gore¿s investigation, the previously submitted annex f code has been updated to reflect gore¿s final conclusion.It should be noted that the gore® dualmesh® plus biomaterial instructions for use include warnings and addresses the following adverse reactions among others: ¿possible adverse reactions with the use of any tissue deficiency prosthesis may include, but are not limited to, contamination, infection, inflammation, adhesion, fistula formation, seroma formation, hematoma, and recurrence.¿ as with any surgical procedure, there are always risks of complications for surgical repair of hernias and soft tissue deficiencies, with or without mesh.These may include but are not limited to, adhesions and related harms, bleeding, bowel obstruction, compromised device biocompatibility, contamination which may lead to patient harms, device damage, dysphagia, erosion or extrusion and related harms, exposure or protrusion and related harms, fever, fistula, gerd recurrence, defect recurrence and related harms, ileus, increased procedure time and related harms, irritation or inflammation, infection, mesh migration, mesh contraction, pain, paresthesia, perforation, revision/re-intervention, seroma or hematoma and related harms, tissue ischemia, wound complications and wound dehiscence and additional intervention including surgery.Many of the potential complications are associated with the patient¿s underlying disease progression, co-morbidities, additional medical history and/or other surgical procedures.The above inherent risks are typically detailed in standard informed consent documents.The device was not able to be returned to gore for evaluation; therefore, a direct product analysis could not be conducted.Review of the manufacturing records verified that the lot met all pre-release specifications.C1: the plus antimicrobial product coating contains silver carbonate [approximately 800 micrograms per cubic centimeter of product (g/cm3)], and chlorhexidine diacetate [approximately 1600 micrograms per cubic centimeter of product (g/cm3)].W.L.Gore & associates, inc.(gore) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by gore, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Blank fields present on this report include required fields and fields determined to be not applicable.Blank required fields indicate that the information was not provided, was deemed unavailable or was not applicable.This report does not constitute an admission or a conclusion by fda, gore, or its associates that the device, gore or its associates caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects" or has "malfunctioned".These words are included in the report and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.
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