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| Model Number 1DLMCP06 |
| Device Problems
No Apparent Adverse Event (3189); Insufficient Information (3190)
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| Patient Problems
Adhesion(s) (1695); Pain (1994); Hernia (2240); Not Applicable (3189)
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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® 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.¿.
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Event Description
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It was reported to gore that the patient underwent laparoscopic repair of an incisional hernia on (b)(6) 2003 whereby a gore dualmesh® plus biomaterial was implanted.The complaint alleges that an additional procedure was performed whereby revision of the gore device was performed.It was reported the patient alleges the following injuries: hernia recurrence, additional surgeries to revise the mesh, extensive fat necrosis, small bowel obstruction, small bowel resection, dense adhesions to small intestine, severe pain.Additional event specific information and medical records have been requested.
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Manufacturer Narrative
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Conclusion code remains unchanged.
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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 prior to (b)(6) 2003, including any abdominal incisions leading to the subsequent incisional hernia repair, were not provided.Operative records dated (b)(6) 2003 indicate the patient underwent laparoscopic repair of an incisional hernia with lysis of adhesions.The records state: ¿using blunt and sharp dissection, multiple adhesions were performed [sic] separating many adhesions from the anterior abdominal wall.There included some bowel and care was taken not to injure the bowel.It was inspected carefully.The adhesions were taken down from the abdominal from other adhesions and from the inside of the hernia sac.Also part of the falciform ligament was separated to allow better placement of the mesh.A piece of mesh was then cut to the appropriate length and stay sutures of gore-tex were placed in the apices.¿ the (b)(6) 2003 records state: ¿the passer was passed through this from the right side and the mesh was brought into the abdominal cavity.This was a dual mesh plus.Then the suture passer was used to grasp the sutures on the apices and bring them up into the abdominal wall and these were tied.This brought the mesh up to the abdominal wall and the patch appeared in good place.Some corkscrew tacks were then used to tack the very edge of the mesh circumferentially to the underlying fascia.Several spots of this was reinforced with further gore-tex suture passed with the passer.Upon completion of this the mesh patch seemed snug and tight enough.There was no evidence of active bleeding and no evidence of bowel injury.¿ the records confirm a gore dualmesh® plus biomaterial (1dlmcp06/02083712) was implanted during the procedure.Records between 6/30/2003 and 8/8/2006 were not provided to gore.Operative records dated (b)(6) 2006 indicate the patient underwent preperitoneal repair of incisional hernia with prolene mesh (non-gore device).The records state: ¿the upper portion of the old scar was excised and an incision was eventually made from the lower edge of the xiphoid down to below the umbilicus.The sac was identified and freed from the subcutaneous tissue.We decided to try to keep this extraperitoneal.The peritoneal margin was divided, keeping the peritoneum intact and circumferentially the fascial margin was defined, undermining it and pushing and separating the peritoneal surface below.There was some prolene mesh near the umbilicus and the tacks were seen.Eventually the entire length of the incision was palpated and showed no hernia lower, but basically the hernia went all the way up to the xiphoid.¿ the (b)(6)2006 records continue: ¿we decided to use prolene mesh.This was sutured with interrupted #1 prolene sutures a couple centimeters off the fascial edge and then the lower fascia could be closed with running #1 pds over the mesh, but from about the umbilicus up this could not be accomplished due to the fact that the hernia was too large.We had to take the hernia dissection laterally as there were some small defects lateral.The fascial edge was sutured to the mesh circumferentially in this area.¿ an intra-operative record indicates a bard mesh (non-gore device) was used during the procedure.There was no mention of infection and no mention of gore device removal.Operative records dated (b)(6) 2006 indicate the patient underwent debridement of the abdominal wall.Preoperative diagnosis states: ¿abdominal wall mass, status post extensive retrofascial hernia repair.¿ post-operative diagnosis states: ¿fat necrosis, abdominal wall.¿ the records state: ¿transverse incision was made over the lower edge of the nodule to the right of the midline, just above the umbilicus.Upon reaching this, there appeared to be fat necrosis which had never quite healed.It was a little grayish in its center and this whole nodule was removed including extension into the midline and below the midline scar and down around the little site that never quite closed over in the midline.This was all debrided and carried down to the fascia.The fascia appeared intact, but down in this area the tract headed down toward where there had been some exposed mesh graft.No obvious graft could be seen.There appeared to be a chronic cavity with some granulation.There were cauterized with a cautery and then curetted and it was decide[d] that hopefully the graft could be salvaged with antibiotics and allowing the wound to close then by granulation after this debridement had been accomplished.¿ there was no mention of infection and no mention of gore device removal.Surgical pathology records dated (b)(6) 2006 regarding a specimen collected (b)(6) 2006 state: ¿skin and subcutaneous tissue (abdominal wound tissue): acute and chronic inflammation with extensive necrosis.Granulation tissue and focal abscess formation.¿ operative records dated (b)(6) 2017 indicate the patient underwent a laparotomy with segmental resection of the small intestine.The report states: ¿68 -year-old man presented a couple of days ago with signs and symptoms of bowel obstruction.He had an initially high leukocytosis that went down to near normal levels and initially had what looked like a response with some bowel motions and decreased abdominal symptomatology.However, clamping the nasogastric tube yesterday resulted in very high ng outputs.The patient is now brought to the operating room for continued failure of conservative management of small bowel obstruction.¿ operative findings from the (b)(6) 2017 procedure state: grossly dilated small intestine with early signs of ischemia in the last 20-25 cm of bowel leading up to obstruction due to band adhesions.Some evidence of chronicity of the obstruction due to the dilation of the bowel proximal to the level of the anastomosis.Level of obstruction appeared to be proximal ileum.The (b)(6) 2017 procedure notes state: ¿i started making an incision around the area of the umbilicus and as expected from reviewing previous operative notes and the radiographic films, mesh was encountered.In the upper abdomen there appeared to be what looked like a marlex mesh and then underneath it was a gore ¿tex mesh.I cut through both of these.Minimal adhesions in the upper abdomen.In the mid abdomen there were some adhesions to the small intestine.Some of these were quite dense to the mesh and to some protruding tacks, so we took this down very sharply and very carefully to avoid injury to the bowel.Once this was removed outside of the immediate incision there was noted to be much less adhesions until we could adhesions circumferentially.¿ the (b)(6) 2017 records continue: ¿the grossly dilated bowel was seen with some purplish colorations as we got closer to the level of obstruction.I was able to deliver the small intestinal complement [sic] outside of the abdominal cavity.A wound protector was placed.The level of obstruction was realized and then fluid or bowel contents immediately flowed past the area of obstruction.After some time in a few minutes it looked like the bowel and the discoloration would resolve, but there were some splotchy dark purplish areas that looked ischemic and i made a decision to resect this area of bowel.The total length excised ended up being 40 cm and it was done to include the area where the band went around the intestine and proximally to about 40 cm.¿ we made an inspection in the bowel and some seromuscular defects were closed.No full - thickness defects were encountered.The bowel was irrigated until clear, and then finally closure was done with a #1 prolene.This was done to cover the mesh.The subcutaneous tissue was irrigated, closure done with staples.¿ there was no mention of infection and no mention of gore device removal.Surgical pathology report dated 5/24/2017 regarding a specimen collected 5/21/2017 states: ¿small bowel, segmental resection: portion of small bowel with vascular congestion, hemorrhage and mild ischemic-type changes.No malignancy identified.¿ 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 codes.H6: updated device codes.H6: updated conclusion codes.H6: 4316: appropriate term/code not available used for ¿withdrawn complaint.¿ this claim was withdrawn, and the alleged product complaint is no longer being pursued at this time.No further investigation is required at this time.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.Previous patient codes (2240, 1994, 1695, 2422, 1971) 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) 2003 through (b)(6) 2017 and not all records received in this time span are relevant to the gore-tex® dualmesh® plus biomaterial.Medical records from (b)(6) 2003 through (b)(6) 2006, and from (b)(6) 2006 through (b)(6) 2017 were not provided.Patient information: medical history: unknown; no prior records provided.Prior surgical procedures: unknown; no prior records provided.Implant preoperative complaints: unknown; no prior records provided.Implant procedure: laparoscopic repair of an incisional hernia with lysis of adhesions.Implant: gore-tex® dualmesh® plus biomaterial (1dlmcp06/02083712, 18cm x 24cm).Implant date: (b)(6) 2003 [hospitalization dates unknown].Description of hernia being treated: ¿using blunt and sharp dissection, multiple adhesions were performed [sic] separating many adhesions from the anterior abdominal wall.There included some bowel and care was taken not to injure the bowel.It was inspected carefully.The adhesions were taken down from the abdominal from other adhesions and from the inside of the hernia sac.Also part of the falciform ligament was separated to allow better placement of the mesh.¿ implant size and fixation: ¿a piece of mesh was then cut to the appropriate length and stay sutures of gore-tex were placed in the apices.The passer was passed through this from the right side and the mesh was brought into the abdominal cavity.This was a dual mesh plus.Then the suture passer was used to grasp the sutures on the apices and bring them up into the abdominal wall and these were tied.This brought the mesh up to the abdominal wall and the patch appeared in good place.Some corkscrew tacks were then used to tack the very edge of the mesh circumferentially to the underlying fascia.Several spots of this was reinforced with further gore-tex suture passed with the passer.Upon completion of this the mesh patch seemed snug and tight enough.There was no evidence of active bleeding and no evidence of bowel injury.¿ no post-operative information provided.Relevant medical information: (b)(6) 2006: preperitoneal repair of incisional hernia with prolene mesh (non-gore device).¿the upper portion of the old scar was excised and an incision was eventually made from the lower edge of the xiphoid down to below the umbilicus.The sac was identified and freed from the subcutaneous tissue.We decided to try to keep this extraperitoneal.The peritoneal margin was divided, keeping the peritoneum intact and circumferentially the fascial margin was defined, undermining it and pushing and separating the peritoneal surface below.There was some prolene mesh near the umbilicus and the tacks were seen.Eventually the entire length of the incision was palpated and showed no hernia lower, but basically the hernia went all the way up to the xiphoid.¿ ¿we decided to use prolene mesh.This was sutured with interrupted #1 prolene sutures a couple centimeters off the fascial edge and then the lower fascia could be closed with running #1 pds over the mesh, but from about the umbilicus up this could not be accomplished due to the fact that the hernia was too large.We had to take the hernia dissection laterally as there were some small defects lateral.The fascial edge was sutured to the mesh circumferentially in this area.¿ an intra-operative record indicates a bard mesh (non-gore device) was used during the procedure.There was no mention of infection and no mention of gore device removal.(b)(6) 2006: open debridement of the abdominal wall.¿abdominal wall mass, status post extensive retrofascial hernia repair.¿ post-operative diagnosis states: ¿fat necrosis, abdominal wall.¿ the records state: ¿transverse incision was made over the lower edge of the nodule to the right of the midline, just above the umbilicus.Upon reaching this, there appeared to be fat necrosis which had never quite healed.It was a little grayish in its center and this whole nodule was removed including extension into the midline and below the midline scar and down around the little site that never quite closed over in the midline.This was all debrided and carried down to the fascia.The fascia appeared intact, but down in this area the tract headed down toward where there had been some exposed mesh graft.No obvious graft could be seen.There appeared to be a chronic cavity with some granulation.There [sic] were cauterized with a cautery and then curetted and it was decided that hopefully the graft could be salvaged with antibiotics and allowing the wound to close then by granulation after this debridement had been accomplished.¿ surgical pathology: ¿skin and subcutaneous tissue (abdominal wound tissue): acute and chronic inflammation with extensive necrosis.Granulation tissue and focal abscess formation.¿ partial explant preoperative complaints: (b)(6) 2017: ¿presented a couple of days ago with signs and symptoms of bowel obstruction.He had an initially high leukocytosis that went down to near normal levels and initially had what looked like a response with some bowel motions and decreased abdominal symptomatology.However, clamping the nasogastric tube yesterday resulted in very high ng outputs.The patient is now brought to the operating room for continued failure of conservative management of small bowel obstruction.¿ partial explant procedure: laparotomy with segmental resection of the small intestine.Partial explant date: (b)(6) 2017 [hospitalization dates unknown].¿1.Grossly dilated small intestine with early signs of ischemia in the last 20-25 cm of bowel leading up to obstruction due to band adhesions.2.Some evidence of chronicity of the obstruction due to the dilation of the bowel proximal to the level of the anastomosis.3.Level of obstruction appeared to be proximal ileum.¿ ¿i started making an incision around the area of the umbilicus and as expected from reviewing previous operative notes and the radiographic films, mesh was encountered.In the upper abdomen there appeared to be what looked like a marlex mesh and then underneath it was a gore-tex mesh.I cut through both of these.Minimal adhesions in the upper abdomen.In the mid abdomen there were some adhesions to the small intestine.Some of these were quite dense to the mesh and to some protruding tacks, so we took this down very sharply and very carefully to avoid injury to the bowel.Once this was removed outside of the immediate incision there was noted to be much less adhesions until we could adhesions circumferentially.¿ ¿the grossly dilated bowel was seen with some purplish colorations as we got closer to the level of obstruction.I was able to deliver the small intestinal complement [sic] outside of the abdominal cavity.A wound protector was placed.The level of obstruction was realized and then fluid or bowel contents immediately flowed past the area of obstruction.After some time in a few minutes it looked like the bowel and the discoloration would resolve, but there were some splotchy dark purplish areas that looked ischemic and i made a decision to resect this area of bowel.The total length excised ended up being 40 cm and it was done to include the area where the band went around the intestine and proximally to about 40 cm.¿ we made an inspection in the bowel and some seromuscular defects were closed.No full thickness defects were encountered.The bowel was irrigated until clear, and then finally closure was done with a #1 prolene.This was done to cover the mesh.The subcutaneous tissue was irrigated, closure done with staples.¿ there was no mention of infection of the prostheses and no details of which device(s) was/were removed.(b)(6) 2017: surgical pathology: ¿small bowel, segmental resection: portion of small bowel with vascular congestion, hemorrhage and mild ischemic-type changes.No malignancy identified.¿ conclusion: it should be noted that the gore-tex® 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-tex ® dualmesh® plus biomaterial instructions for use also states, ¿when using this device as a permanent implant and unintentional exposure occurs treat to avoid contamination or device removal may be necessary.¿ 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.Based upon the information received, status of the device is unable to be confirmed and therefore, not available for evaluation.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.Other code information: 1225: other code used for unsubstantiated/unable to confirm event (as investigated) is being used in conjunction with 1994-a: pain [chronic].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: 4316: appropriate term/code not available used for ¿withdrawn complaint.¿ this claim was withdrawn, and the alleged product complaint is no longer being pursued at this time.No further investigation is required at this time.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.Previous patient codes (2240, 1994, 1695, 2422, 1971) 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) 2003 through (b)(6) 2017 and not all records received in this time span are relevant to the gore-tex® dualmesh® plus biomaterial.Medical records from (b)(6) 2003 through (b)(6) 2006, and from (b)(6) 2006 through (b)(6) 2017 were not provided.Patient information: medical history: unknown; no prior records provided.Prior surgical procedures: unknown; no prior records provided.Implant preoperative complaints: unknown; no prior records provided.Implant procedure: laparoscopic repair of an incisional hernia with lysis of adhesions.Implant: gore-tex® dualmesh® plus biomaterial (1dlmcp06/02083712, 18cm x 24cm).Implant date: (b)(6) 2003 [hospitalization dates unknown].Description of hernia being treated: ¿using blunt and sharp dissection, multiple adhesions were performed [sic] separating many adhesions from the anterior abdominal wall.There included some bowel and care was taken not to injure the bowel.It was inspected carefully.The adhesions were taken down from the abdominal from other adhesions and from the inside of the hernia sac.Also part of the falciform ligament was separated to allow better placement of the mesh.¿ implant size and fixation: ¿a piece of mesh was then cut to the appropriate length and stay sutures of gore-tex were placed in the apices.The passer was passed through this from the right side and the mesh was brought into the abdominal cavity.This was a dual mesh plus.Then the suture passer was used to grasp the sutures on the apices and bring them up into the abdominal wall and these were tied.This brought the mesh up to the abdominal wall and the patch appeared in good place.Some corkscrew tacks were then used to tack the very edge of the mesh circumferentially to the underlying fascia.Several spots of this was reinforced with further gore-tex suture passed with the passer.Upon completion of this the mesh patch seemed snug and tight enough.There was no evidence of active bleeding and no evidence of bowel injury.¿ no post-operative information provided.Relevant medical information: (b)(6) 2006: preperitoneal repair of incisional hernia with prolene mesh (non-gore device).¿the upper portion of the old scar was excised and an incision was eventually made from the lower edge of the xiphoid down to below the umbilicus.The sac was identified and freed from the subcutaneous tissue.We decided to try to keep this extraperitoneal.The peritoneal margin was divided, keeping the peritoneum intact and circumferentially the fascial margin was defined, undermining it and pushing and separating the peritoneal surface below.There was some prolene mesh near the umbilicus and the tacks were seen.Eventually the entire length of the incision was palpated and showed no hernia lower, but basically the hernia went all the way up to the xiphoid.¿ ¿we decided to use prolene mesh.This was sutured with interrupted #1 prolene sutures a couple centimeters off the fascial edge and then the lower fascia could be closed with running #1 pds over the mesh, but from about the umbilicus up this could not be accomplished due to the fact that the hernia was too large.We had to take the hernia dissection laterally as there were some small defects lateral.The fascial edge was sutured to the mesh circumferentially in this area.¿ an intra-operative record indicates a bard mesh (non-gore device) was used during the procedure.There was no mention of infection and no mention of gore device removal.(b)(6) 2006: open debridement of the abdominal wall.¿abdominal wall mass, status post extensive retrofascial hernia repair.¿ post-operative diagnosis states: ¿fat necrosis, abdominal wall.¿ the records state: ¿transverse incision was made over the lower edge of the nodule to the right of the midline, just above the umbilicus.Upon reaching this, there appeared to be fat necrosis which had never quite healed.It was a little grayish in its center and this whole nodule was removed including extension into the midline and below the midline scar and down around the little site that never quite closed over in the midline.This was all debrided and carried down to the fascia.The fascia appeared intact, but down in this area the tract headed down toward where there had been some exposed mesh graft.No obvious graft could be seen.There appeared to be a chronic cavity with some granulation.There [sic] were cauterized with a cautery and then curetted and it was decided that hopefully the graft could be salvaged with antibiotics and allowing the wound to close then by granulation after this debridement had been accomplished.¿ surgical pathology: ¿skin and subcutaneous tissue (abdominal wound tissue): acute and chronic inflammation with extensive necrosis.Granulation tissue and focal abscess formation.¿ partial explant preoperative complaints: (b)(6) 2017: ¿presented a couple of days ago with signs and symptoms of bowel obstruction.He had an initially high leukocytosis that went down to near normal levels and initially had what looked like a response with some bowel motions and decreased abdominal symptomatology.However, clamping the nasogastric tube yesterday resulted in very high ng outputs.The patient is now brought to the operating room for continued failure of conservative management of small bowel obstruction.¿ partial explant procedure: laparotomy with segmental resection of the small intestine.Partial explant date: (b)(6) 2017 [hospitalization dates unknown].¿1.Grossly dilated small intestine with early signs of ischemia in the last 20-25 cm of bowel leading up to obstruction due to band adhesions.2.Some evidence of chronicity of the obstruction due to the dilation of the bowel proximal to the level of the anastomosis.3.Level of obstruction appeared to be proximal ileum.¿ ¿i started making an incision around the area of the umbilicus and as expected from reviewing previous operative notes and the radiographic films, mesh was encountered.In the upper abdomen there appeared to be what looked like a marlex mesh and then underneath it was a gore-tex mesh.I cut through both of these.Minimal adhesions in the upper abdomen.In the mid abdomen there were some adhesions to the small intestine.Some of these were quite dense to the mesh and to some protruding tacks, so we took this down very sharply and very carefully to avoid injury to the bowel.Once this was removed outside of the immediate incision there was noted to be much less adhesions until we could adhesions circumferentially.¿ ¿the grossly dilated bowel was seen with some purplish colorations as we got closer to the level of obstruction.I was able to deliver the small intestinal complement [sic] outside of the abdominal cavity.A wound protector was placed.The level of obstruction was realized and then fluid or bowel contents immediately flowed past the area of obstruction.After some time in a few minutes it looked like the bowel and the discoloration would resolve, but there were some splotchy dark purplish areas that looked ischemic and i made a decision to resect this area of bowel.The total length excised ended up being 40 cm and it was done to include the area where the band went around the intestine and proximally to about 40 cm.¿ we made an inspection in the bowel and some seromuscular defects were closed.No full thickness defects were encountered.The bowel was irrigated until clear, and then finally closure was done with a #1 prolene.This was done to cover the mesh.The subcutaneous tissue was irrigated, closure done with staples.¿ there was no mention of infection of the prostheses and no details of which device(s) was/were removed.(b)(6) 2017: surgical pathology: ¿small bowel, segmental resection: portion of small bowel with vascular congestion, hemorrhage and mild ischemic-type changes.No malignancy identified.¿ conclusion: it should be noted that the gore-tex® 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-tex ® dualmesh® plus biomaterial instructions for use also states, ¿when using this device as a permanent implant and unintentional exposure occurs treat to avoid contamination or device removal may be necessary.¿ 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.Based upon the information received, status of the device is unable to be confirmed and therefore, not available for evaluation.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.Section c1: name: plus antimicrobial product coating manufacturer/compounder: w.L.Gore & associates, inc.Lot number 02083712.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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