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| Model Number 1DLMCP04 |
| Device Problems
No Apparent Adverse Event (3189); Insufficient Information (3190)
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| Patient Problems
Pain (1994); Hernia (2240); Not Applicable (3189); No Code Available (3191)
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Event Type
Injury
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Manufacturer Narrative
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(b)(4).(b)(6).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.¿.
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Event Description
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It was reported to gore that the patient underwent open incisional and umbilical hernia repair on (b)(6) 2011, whereby a gore dualmesh® biomaterial was implanted.It was reported the patient alleges the following injuries: abdominal pain, large abdominal bulge, weight loss, mesh revision, recurrent hernia.Additional event specific information was not provided.
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Manufacturer Narrative
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Additional details regarding the patient's clinical course were ascertained from a review of medical records and are as follows: records dated (b)(6) 2009 indicate surgical history of four c-sections.Records continue and state: ¿she had no problem with her c-sections, except adhesions.¿ discharge records dated (b)(6) 2009 indicate the patient was seen in the emergency room for abdominal pain.The records state: ¿this is a 40-year-old female who presented with the onset of sharp epigastric pain that moved into the right lower quadrant.The pain began two days prior to admission but has been getting progressively worse.She has some nausea but no vomiting.No change in her bowel habits or blood in her stools.No history of colonoscopy.She, of note, has a daughter with a history of crohn's disease.She developed fever then progressing pain on the day of admission.¿ the (b)(6) 2009 discharge summary states: ¿the patient was admitted with the diagnosis of a perforated appendicitis, possible perforated cecal tumor with generalized peritonitis and cholelithiasis.She was resuscitated, iv antibiotics were started, and she was taken to the operating room where she had an exploratory laparotomy with findings of a perforated, gangrenous appendix with generalized peritonitis.This was treated with appendectomy and washing out of the entire abdomen due to her gallstones.She had a cholecystectomy done at the same setting.¿ final diagnosis is noted as perforated appendicitis/cholelithiasis with a cholecystectomy and appendectomy performed on (b)(6) 2009.Operative records dated (b)(6) 2011 indicate the patient underwent repair of incisional and umbilical hernias with mesh.Findings from the procedure state: ¿an 8 cm incisional hernia defect.¿ the records state: ¿we explored the hernia through her previous midline incision, opening this up with a scalpel and then using a blunt dissection of the cautery to identify the fascia.We found a large defect mostly to the right of the midline approximately 8 cm in size.We identified the fascia circumferentially and created flaps back such that we could repair the hernia with a few u-stitches of prolene.¿ the (b)(6) 2011 operative report continues: ¿inferiorly, there was a small umbilical hernia with a piece of preperitoneal fat in it.We opened this through the fascia to connect it to the incisional hernia.There was only approximately a half centimeter of tissue between the two hernia defects.Once this was opened, a 15 x 19 cm piece of dual mesh, hernia mesh was selected.We then began on the right side and using interrupted u-stitches of o prolene, sutured back 3 to 4 cm from the fascial edge going around circumferentially and back medially excising a small portion of the mesh to have it more readily fit into place.We were able to do this circumferentially with a nice tension-free repair of the mesh placed posterior to the fascia.We then had loose, weaker tissue still in the space anterior to the mesh.This was then reapproximated with interrupted o nurolon to close over the mesh.The subcutaneous tissue was then reapproximated with 3-0 vicryl suture and the umbilical skin tacked down to the fascia using 3-0 vicryl suture.The skin was closed with staples.¿ the records confirm a gore dualmesh® plus biomaterial (1dlmcp04/6996160) was implanted during the procedure.Records between 2/8/2011 and 12/18/2012 were not provided.Records dated (b)(6) 2012 indicate the patient was seen for an incisional hernia.The records state: ¿the patient is a 44-year-old female who is status post incisional hernia repair with mesh.She had some pain in the left upper quadrant which resolved but then she developed a large bulge in that area.She has lost 20 pounds.She was started on metformin diet control for insulin resistance.The bulge has always been reducible and is worse with activity.¿ medical history is noted as remarkable for insulin resistance, c-sections, orthopedic surgeries, cholecystectomy, smoking, and ruptured appendix.Abdominal exam notes state: ¿well healed surgical scar.Left sided hernia which is reducible on exam.¿ operative records dated (b)(6) 2012 indicate the patient underwent repair of a recurrent incisional hernia with mesh.Findings from the procedure state: ¿left side of her mesh had pulled away at the fascia with a result in hernia.¿ the operative notes state: ¿her hernia had been previously marked.It was above the umbilicus.We went down through her previous incision, carried this down to the fascia and using sharp and cautery dissection, dissected back to her mesh and then followed this down to the fascia, freeing up the fascia and the mesh circumferentially.We could see that the mesh had pulled away.¿ the (b)(6) 2012 operative report continues: ¿the running suture coming through the fascia on her left side.We were able to lay the mesh back down posteriorly and sutured this in place along the entire left side approximately every centimeter with a u stitch of o prolene suture going through the fascia and into the mesh.I then was able to reapproximate the fascia in the midline again using o prolene suture, mattress sutures through the fascia and then reinforced this anteriorly with a piece of soft polypropylene mesh.We used a 3 x 5 inch piece, placed it over the fascia and sutured it in place circumferentially again with u stitches of o prolene and then trimmed the edges back.The wound was injected with marcaine.The subcutaneous tissue reapproximated with 3-0 vicryl.The skin closed with staples.¿ the records indicate a non-gore device was used during the procedure.There is no mention of infection and 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: ¿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.
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Event Description
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Product description correction: it was reported to gore that the patient underwent open incisional and umbilical hernia repair on (b)(6) 2011, whereby a gore dualmesh® plus biomaterial was implanted.
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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: operative records dated (b)(6) 2008 indicate the patient underwent repeat low transverse cesarean section.Postoperative diagnosis: ¿39 1/7 weeks intrauterine pregnancy, history of cesarean section x3.¿ medical records dated (b)(6) 2009 for emergency room visit for ¿drainage from abd[ominal] incision.¿ the records state: ¿the patient is 40 years old.She had surgery and was discharged on (b)(6) 2009, two days ago.She had an appendectomy and cholecystectomy, and has had some drainage from her incision.She had the surgery here with dr.(b)(6).She has not had any fever or other symptoms.The drainage has been clearish-red, and there has not been any pain, but the patient has noted some erythema around the wound.She saw dr.(b)(6) after the operation, and two of the staples were removed lower down, where she was also having some drainage.She has had some drainage since then in the area just above the umbilicus.¿ medical records dated (b)(6) 2009 state: ¿physical examination: ¿abdomen: soft, with a healing surgical incision noted; there is some erythema around the incision which is vertical, both above and below the umbilicus.There is no induration or tenderness on palpation.There is an area which appears to be draining, and after discussing the patient with dr.Marley, we removed one of the staples and found that there was more drainage noted in this area.That area was red, both the umbilicus, and drained some brownish-red, clear to cloudy material, which was not foul-smelling.Approximately 10 cc was drained, and there was a small amount of oozing afterward.¿ medical records dated (b)(6) 2009 state: ¿diagnosis: status post surgery with drainage from the surgical wound.¿ ¿plan: we will have the patient follow up with dr.Marley with her outpatient appointment, and she is to continue taking her antibiotics.If she develops any more pain she may come back to the emergency department, likewise if she develops further erythema or fever.She is discharged at this time.¿ records between 2/8/2011 and 12/12/2012 were not provided.Ct abdomen records dated (b)(6) 2012 state: ¿findings: there is a ventral or incisonal hernia slightly to the left of midline in the mid-abdomen, measuiring about 2 x 8.2 x 8.7 cm.The hernia is to the left of mesh in the abdominal wall from earlier hernia repair.The hernia contains fat, as vell as a knuckle of transverse colon.There is no associated intestinal obstruction.The unenhanced liver and spleen are nonmal in size and configuration.There has been a cholecystectomy and appendectomy.The pancreas, adrenals and kidneys appear normal.There is no periaortic adenopathy.¿ 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: ¿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.
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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: records dated 6/8/2009 indicate surgical history of four c-sections.Records continue and state: ¿she had no problem with her c-sections, except adhesions.¿ ct abdomen/pelvis for right lower quadrant pain, nausea dated (b)(6) 2009 states: ¿the examination was performed with iv contrast enhancement.The liver, spleen, pancreas, both adrenal glands and kidneys are unremarkable.No hydronephrosis is seen on either side.Calcified gallstone is noted.No gallbladder wall thickening is seen.There is thickening of the gastric wall, the finding is nonspecific due to incomplete distention of the structure.Clinical correlation is suggested to exclude and underlying inflammatory or neoplastic process.¿ ct pelvis dated (b)(6) 2009 states: ¿mild dilatation of the small bowel loops is seen.No evidence of small bowel inflammatory change is identified.There is a lobulated soft tissue mass, measuring approximately 4cm in diameter.Extensive pericecal fat tissue stranding is also noted.The findings could be suggestive of acute appendicitis with a pericecal abscess.The possibility of a cecal tumor is also consideration.No free fluid in the pelvis or free air in the peritoneum is identified.¿ operative report dated (b)(6) 2009 indicates the patient underwent appendectomy, cholecystectomy.Postoperative diagnosis: perforated gangrenous appendicitis, cholelithiasis, peritoneal abscess.The (b)(6) 2009 operative report states: ¿the abdomen was then scored through a midline incision.We easily accessed the peritoneal cavity.However, there were dense adhesions between the omentum, the uterus, and the lower abdominal wall, lncision was carried down to just above the uterus.It was fixed there and it was left attached to the wall.The omentum on the uterus was divided using cautery.We were able to expose the right lower quadrant.Rolling this anteriorly, we came into a very loose abscess cavity which was primarily formed by a phlegmon of small bowel and the omentum.¿ operative records dated 6/8/2009 state: ¿this was suctioned off easily.The area was irrigated.There was no further purulent material and it did not appear to be purulent material across the abdominal cavity.There was a lot of fibrinous debris in the area on the small and large bowel, as well as the omentum.The cecum was mobilized by taking down the peritoneal reflection.We were able to bring the cecum, appendix, and terminal ileum into the operative field.It was quite evident that she had a gangrenous perforated appendicitis.¿ operative records dated 6/8/2009 continue: ¿there were several small pieces of stool at the base of the appendix that had extravasated.These were removed.This was followed back to the base of the appendix where it was clamped, and the appendix excised.A 0 chromic tie was placed around the stump of the appendix and then this was dunked using a z stitch of 3-0 vicryl suture.A local piece of fat was then tacked down over the appendiceal repair using a 3-0 vicryl.¿ the operative records dated 6/8/2009 also state: ¿the area was then copiously irrigated.There appeared to be good hemostasis.Attention was then directed to the gallbladder.It was grasped and using cautery, we opened the peritoneum along the liver edge and were able to use the right angle to dissect down to the infundibulum of the appendix where it started to form the cystic duct.A clamp was placed across this.A second clamp was placed more proximally on the gallbladder, and this was divided.¿ operative records dated 6/8/2009 state: ¿the cystic duct was then ligated using a 3-0 silk stick tie.There is good hemostasis in the base.No evidence of a bile teak.We could pihpate her large gallstone in the gallbladder.The abdomen was then copiously irrigated especially into the pelvis and right lower quadrant.The fluid return was clear.There appeared to be good hemostasis.Sponge and needle counts were correct.The fascia was then reapproximated using running loop pedia suture.The subcutaneous tissue was irrigated.Marcaine injected into the fascia and the skin closed with staples.Sterile dressing was applied and the patient was sent in stable condition to recovery, after extubation in the operating room.¿ a gram stain report dated 6/15/2009 regarding a specimen collected 6/14/2009 from an abdominal wound states: ¿no organisms seen, white blood cells-none seen.¿ a wound culture report dated 6/17/2009 regarding a specimen collected 6/14/2009 from an abdominal wound states: ¿moderate growth normal skin flora, organism 1-escherichia coli, scant growth.¿ progress note dated 1/15/2011 states ¿¿c/o lump on top on incision site where she had her appendix removed in june 2009.Concerned [with] hernia.¿ records also state ¿¿abd[omen] + [positive] vertical scar, mild bulging on r [right], soft.¿ 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: ¿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.
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Manufacturer Narrative
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H6: updated patient code.H6: updated device code.H6: updated conclusion code.The investigation has been completed.Based on 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, 2240, 3191 other code for "large abdominal bulge" and "weight loss") 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 (b)(6) 2008 through (b)(6) 2012, and not all records received in this time span are relevant to the gore® dualmesh® plus biomaterial.Medical records from (b)(6) 2009 through (b)(6) 2011 were not provided.Patient information: medical history: smoking.Insulin resistant diabetes.(b)(6) 2012: metformin.Prior surgical procedures: unknown dates: cesarean section x 3.On (b)(6) 2008: repeat low transverse cesarean section.On (b)(6) 2009: open exploratory laparotomy, appendectomy for perforated gangrenous appendicitis, peritoneal abscess, and cholecystectomy for cholelithiasis.Dense adhesions encountered.Implant preoperative complaints: (b)(6) 2011: ¿¿complained of lump on top on incision site where she had her appendix removed in (b)(6) 2009.Concerned [with] hernia.¿ ¿¿ abdomen positive vertical scar, mild bulging on right, soft.¿ implant procedure: open repair of incisional and umbilical hernias with mesh.The records confirm a gore® dualmesh® plus biomaterial (1dlmcp04/6996160, 15cm x 19cm) was implanted during the procedure.Implant date: on (b)(6) 2011 [hospitalization dates unknown] description of hernia being treated: findings: ¿an 8 cm incisional hernia defect.¿ procedure: ¿we explored the hernia through her previous midline incision, opening this up with a scalpel and then using a blunt dissection of the cautery to identify the fascia.We found a large defect mostly to the right of the midline approximately 8 cm in size.We identified the fascia circumferentially and created flaps back such that we could repair the hernia with a few u-stitches of prolene.Inferiorly, there was a small umbilical hernia with a piece of preperitoneal fat in it.We opened this through the fascia to connect it to the incisional hernia.There was only approximately a half centimeter of tissue between the two hernia defects.¿ implant size and fixation: ¿once this was opened, a 15 x 19 cm piece of dual mesh, hernia mesh was selected.We then began on the right side and using interrupted u-stitches of o prolene, sutured back 3 to 4 cm from the fascial edge going around circumferentially and back medially excising a small portion of the mesh to have it more readily fit into place.We were able to do this circumferentially with a nice tension-free repair of the mesh placed posterior to the fascia.We then had loose, weaker tissue still in the space anterior to the mesh.This was then reapproximated with interrupted o nurolon to close over the mesh.The subcutaneous tissue was then reapproximated with 3-0 vicryl suture and the umbilical skin tacked down to the fascia using 3-0 vicryl suture.¿ relevant medical information: on (b)(6) 2012: ct abdomen: ¿there is a ventral or incisional hernia slightly to the left of midline in the mid-abdomen, measuring about 2 x 8.2 x 8.7 cm.The hernia is to the left of mesh in the abdominal wall from earlier hernia repair.The hernia contains fat, as well as a knuckle of transverse colon.There is no associated intestinal obstruction.¿ revision preoperative complaints: on (b)(6) 2012: ¿.Who is status post incisional hernia repair with mesh.She had some pain in the left upper quadrant which resolved but then she developed a large bulge in that area.She has lost 20 pounds.She was started on metformin diet control for insulin resistance.The bulge has always been reducible and is worse with activity.¿ medical history is noted as remarkable for insulin resistance, c-sections, orthopedic surgeries, cholecystectomy, smoking, and ruptured appendix.Abdominal exam notes state: ¿well healed surgical scar.Left sided hernia which is reducible on exam.¿ revision procedure: repair of a recurrent incisional hernia with mesh.Revision date: (b)(6) 2012 [hospitalization dates unknown] findings: ¿left side of her mesh had pulled away at the fascia with a result in hernia.¿ procedure: ¿her hernia had been previously marked.It was above the umbilicus.We went down through her previous incision, carried this down to the fascia and using sharp and cautery dissection, dissected back to her mesh and then followed this down to the fascia, freeing up the fascia and the mesh circumferentially.We could see that the mesh had pulled away.¿ ¿the running suture coming through the fascia on her left side.We were able to lay the mesh back down posteriorly and sutured this in place along the entire left side approximately every centimeter with a u stitch of o prolene suture going through the fascia and into the mesh.I then was able to reapproximate the fascia in the midline again using o prolene suture, mattress sutures through the fascia and then reinforced this anteriorly with a piece of soft polypropylene mesh.We used a 3 x 5 inch piece, placed it over the fascia and sutured it in place circumferentially again with u stitches of o prolene and then trimmed the edges back.The wound was injected with marcaine.The subcutaneous tissue reapproximated with 3-0 vicryl.The skin closed with staples.¿ conclusion: it should be noted that the gore® dualmesh® plus 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® plus biomaterial instructions for use also states, ¿cutting gore® dualmesh® plus biomaterial to the proper size is essential.Use sharp surgical instruments to trim the mesh.If gore® dualmesh® plus biomaterial is cut too small, excessive tension may be placed on the suture line, which may result in recurrence of the original, or development of an adjacent, tissue defect.¿ medical records that indicate mesh ¿movement¿ or that the device led to a recurrence may reflect a recurrence as a function of a patient¿s poor tissue quality leading to fascial dehiscence or loss of anchorage of fixation, or may be related to the hernia type, individual patient comorbidities, and technical and procedural aspects of the repair.These factors include but are not limited to, fixation type, mesh shape/sizing used, and defect closure decisions.Additionally, a new, unrelated hernia can occur but may be referred to as a recurrent hernia.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.Based upon the information received, the device remains in the patient and was not available for evaluation.Review of the manufacturing records verified that the lot met all pre-release specifications.The investigation concluded that there is no relationship between the dhr findings and the event.All available information has been placed on file for use in product surveillance tracking, trending and follow-up.Section c1: name: plus antimicrobial product coating.Manufacturer/compounder: w.L.Gore & associates, inc.Lot number 6996160.Additional manufacturer narrative: 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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Search Alerts/Recalls
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