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| Model Number 1DLMCP203 |
| Device Problems
Contamination (1120); Insufficient Information (3190); Patient Device Interaction Problem (4001)
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| Patient Problems
Abscess (1690); Unspecified Infection (1930); Discharge (2225)
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| Event Date 03/03/2006 |
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Event Type
Injury
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Manufacturer Narrative
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(b)(6).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 addresses the following warning 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.¿.
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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) 2006, whereby a gore® dualmesh® plus biomaterial was implanted.The complaint alleges that on (b)(6) 2006, an additional procedure occurred whereby the gore device was explanted.It was reported the patient alleges the following injuries: infection of mesh, removal of mesh, abdominal wall abscess and drainage .Additional event specific information and medical records have been requested.
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Manufacturer Narrative
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Other relevant history: additional patient medical history.Conclusion code remains unchanged.Added medical record information.Additional details regarding the patient's clinical course were ascertained from a review of medical records and are as follows: records prior to on (b)(6) 2006, including records for past abdominal surgical procedures and prior hernia repair resulting in recurrence as noted in the on (b)(6) 2006 records, were not provided.History and physical records dated on (b)(6) 2006 indicate the patient was admitted with a chief complaint of abdominal pain.The records state: ¿the patient has a longstanding large ventral hernia and three days ago was in the emergency room with abdominal pain and was given a shot for it and permitted to go home.Since that time she has not gotten better and vomited several times and came back to the emergency room last night.She was found to have elevated blood pressure and admitted and seen in consultation by dr.(b)(6) and she is getting ready to go to surgery now.¿ the records state ¿the patient has had surgery for this hernia by dr.(b)(6) in the past.It recurred and he referred her to dr.(b)(6) at the university.Dr.(b)(6) wanted her to have a gastric bypass prior to trying to repair the hernia, however, her insurance wouldn¿t pay for the bypass.¿ records for the hernia surgery prior to on (b)(6) 2006 were not provided.The records dated on (b)(6) 2006 state: ¿review of systems: negative except for the abdominal pain and the hernia.The patient has always had morbid obesity.Past history: hysterectomy.¿ ¿physical examination, abdomen: diffusely tender and no masses are felt.¿ ¿impression: 1) incarcerated ventral hernia, 2) essential hypertension, 3) arthritis right ankle.¿ operative records dated on (b)(6) 2006 indicate the patient underwent ¿repair of incarcerated incisional hernia with bio mesh repair.¿ pre-operative/post-operative diagnosis: ¿incarcerated incisional hernia.¿ operative records dated on (b)(6) 2006 state: ¿incision was made in the area of the previous excision exposing multiple fascial defects with multiple hernias.These were all taken down.The complete edges of the small bowel were freed as was the fascial edges.Small bowel was run from the ligament of treitz to the ileocecal valve.There were no other abnormalities noted.I did not palpate anything abnormal in the abdomen except for some diverticular disease.I could not palpate any definite gallstones in the gallbladder.Nasogastric tube was positioned in the correct position in the stomach.I then decided to use a bio mesh type repair placing the slick side down and placing it subfascially and then tacking it into position.I then ran a stitch around this to keep it in position.Once the repair was done, we irrigated, placed the jackson-pratt, brought it out through a separate incision, sutured it into position.The subcutaneous was closed with vicryl, and the skin was closed with staples.Sterile dressing was applied.The patient tolerated the procedure satisfactorily.Post-operative physician progress notes dated on (b)(6) 2006 confirm a gore® dualmesh® plus biomaterial (1dlmcp203/03139583) was used during the procedure.History and physical records dated on (b)(6) 2006 state: ¿the patient is a 52-year-old female who presented to the emergency department with complaints of increasing drainage from her abdominal wall.The patient had been undergoing wound care and did not keep her friday appointment.She states that she had a copious amount of drainage while she was at church and it drained all over her clothes and she came to the emergency room.A ct scan of her abdomen showed a questionable abscess in the anterior wall.There was also quite a bit of postoperative changes from her recent hernia repair.¿ ¿physical examination, abdomen: obese, soft.She does have some purulent drainage from an open area in the inferior portion of the lungs.¿ ¿laboratory data: white count is elevated.It is 9000.¿ ¿the plan is to admit for incision and drainage of abdominal abscess.¿ operative records dated on (b)(6) 2006 indicate the patient underwent ¿incision, drainage and irrigation of abdominal wall abscess.¿ pre-operative/post-operative diagnosis: abdominal wall abscess.The records state: ¿the patient had a small draining area in the abdominal wall and this was opened a little larger and there was return of a small amount of purulent material.There was quite a bit of induration and infected-type tissue there but not a copious amount of pus drainage, it was more induration.The wound was irrigated with the stryker irrigation system and packed with betadine gauze.Estimated blood loss was minimal.The patient tolerated the procedure well.¿ operative records dated on (b)(6) 2006 indicate the patient underwent ¿exploration of wound with removal of mesh, packing and irrigation.¿ pre-operative diagnosis: ¿infected postsurgical wound from repair of incarcerated ventral hernia with mesh.¿ the records state: ¿we enlarged the incision, carried down and investigated all the pockets.Further evaluation revealed that at the mesh area there was considerable collection of purulent material and actually the edge of the mesh had started separating.L elected to go ahead and remove the mesh because i did not think this patient would get well unless i did so, realizing that she will develop another hernia and possibly even eviscerate.However, at this time, i do not think we have any choice, i removed the mesh, irrigated copiously with warm saline, then with a half mixture of betadine and saline.Once this was completed, i did not palpate any other pocket of purulent collections, packed it with kerlix, sterile dressing.Patient tolerated the procedure satisfactorily.¿ a pathology report for the explanted mesh and culture report for any swab specimens collected during the on (b)(6) 2006 procedure were not provided.Discharge summary dated on (b)(6) 2006 indicates the patient was admitted to the hospital on (b)(6) 2006.Admitting diagnosis: ¿infected mesh from previous incisional hernia repair.¿ ¿operative procedures: one incision and drainage.One incision and drainage with removal of mesh.¿ the record states: ¿this is a 52-year-old morbidly obese patient who had an infection.We tried to treat it conservatively.This did not work.We carried her to the operating room, removed the mesh, cleaned it out.The wound is granulating in.She can be managed on oral antibiotics and wound dressing changes at home.¿ records between on (b)(6) 2006 and on (b)(6) 2006 were not provided.History and physical records dated on (b)(6) 2006 indicate the patient was admitted for abdominal pain, nausea, and vomiting.The records state: ¿[the patient] had been seen in the emergency room the day before with nausea and vomiting and no definite signs.She was evaluated the next day because of persistence.Ct scan showed a large recurrent incisional hernia.Because of her cramping abdominal pain, nausea and vomiting, i thought that she probably had a partial obstruction and required surgical repair.The last surgery she had was at least two operations to remove mesh and clear up an infection.Therefore, i planned not to put the mesh in at that time.¿ physical examination, abdomen: ¿protuberant.Tenderness in the midright abdomen.Previous surgical scar well healed.Groin area was normal.¿ admitting impression: ¿recurrent incisional hernia.¿ records for the recent emergency room visit and ct scan were not provided.Operative records dated on (b)(6) 2006 indicate the patient underwent ¿repair of incarcerated recurrent incisional hernia.¿ pre-operative/post-operative diagnosis: ¿incarcerated recurrent incisional hernia.¿ the records state: ¿using part of the incision from prior surgery we went down through it, extended the incision to the right side laterally, found a hernia sac and entered the hernia sac.Incarcerated matted small bowel was present.We dissected all of the edges of the small bowel and then took down the adhesions of the small bowel in its entirety.From what l could palpate through the incision, i could not palpate anything wrong.I could palpate the nasogastric being in the proper position.Further evaluation revealed no other palpable lesions.¿ the operative records dated on (b)(6) 2006 state: ¿there was actually minimal fascia that we could use for closure.There had been previous repair of mesh that had been infected and had been removed.There was also some mesh on the lateral aspect.I did not think putting mesh in was a wise thing to do so i freed up as much of the old scar and tissue as possible and used part of the fascia.Using #2 far-near, near-far internal retention sutures and #1 pds, we closed this defect transversely.Once i closed all of this, i then irrigated, closed the subcutaneous tissue with vicryl and closed the skin with staples.Again, i did not think placing mesh was a proper thing because of the infection possibility.¿ discharge summary dated on (b)(6) 2006 indicates the patient was admitted to the hospital on (b)(6) 2006.Diagnosis: ¿incarcerated, large, recurrent incisional hernia.¿ operative procedure: ¿exploratory laparotomy.Lysis of adhesions.Closure of defect.¿ the records state: ¿[the patient] had multiple large incisional hernias.She is morbidly obese and had recurrent hernias.She began having abdominal pain and vomiting, thought to have incarceration.She was carried to the operating room and underwent reduction and closure of the defect as best we could.We did not put any foreign material in because of the infection in the past.She has done well.She is eating.She is having bowel movements.We will discharge her home and return to the office a week from monday.Lorcet for pain.She will continue her other medications.¿ records between on (b)(6) 2006 and on (b)(6) 2007 were not provided.History and physical discharge summary record dated on (b)(6) 2007 indicated the patient was admitted to the hospital on (b)(6) 2007.Admitting/discharge diagnoses: ¿abdominal pain.Recurrent incisional hernia.Hypertension.Morbid obesity.Diabetes.¿ the record states: ¿the patient is a 54-year-old female who is followed by dr.(b)(6) where she presented to the emergency department with complaints of abdominal pain.As part of her workup in the emergency room, a ct scan of the abdomen was obtained.She did have a very large known ventral hernia that is recurrent.At the time that i saw her she was not experiencing any abdominal pain.Her diet was advanced.She was able to tolerate it and then a regular diet.She was discharged home, and she was to follow up with dr.(b)(6) in his office.¿ records for the recent emergency room visit and ct scan were not provided.History and physical records dated on (b)(6) 2007 indicate the patient was admitted for abdominal pain, nausea and vomiting.The records state: ¿[the patient] has had recurrent incisional hernias and had it repaired once with some infection of marlex and then go on back and have the marlex repaired.She has been experiencing some abdominal discomfort at home.She talked about possibly going to memphis to see a doctor up there.However, she got into problems with nausea, vomiting, and abdominal pain.She then came to the emergency room.On evaluation she was thought to have incarcerated small bowel with small bowel obstruction.She was admitted with plans to be explored.¿ physical examination, abdomen: ¿very pendulous with a hard place in the area of scarring with minimal tenderness.¿ ¿impression: incarcerated recurrent incisional hernia.¿ operative records dated on (b)(6) 2007 state the patient underwent ¿repair of incarcerated incisional hernia with lysis of adhesions, implementation of mesh.¿ pre-operative diagnosis: ¿incarcerated recurrent incisional hernia.¿ the records state: ¿transverse incision was made to reach the edge of the marlex mesh that had previously been implanted.Multiple defects were present as well as a large seroma.This was cultured.The edges of the marlex was trimmed back and then there were multiple fascial defects.There was no way that you could close the fascia primarily.Once i freed up all of the intestine edges and lysed the adhesions from the ligament of treitz to the ileocecal valve, i did not palpate or see anything abnormal or injuries to the intestines.I then placed a large sheet of marlex mesh inside the peritoneal cavity and ran the edges with prolene using some slack there.I then closed the previous marlex incision with double stranded #1 pds.We irrigated, the subcutaneous was closed, and the skin was closed with staples.¿ implant log record dated on (b)(6) 2007 indicates a non-gore manufactured polypropylene mesh was used during the procedure.A pathology and culture report for the ¿marlex¿ and swab specimens collected during the on (b)(6) 2007 procedure were not provided.Discharge summary records dated on (b)(6) 2007 indicated the patient was admitted to the hospital on (b)(6) 2007.Diagnoses: ¿incarcerated recurrent ventral hernias.Morbid obesity.¿ operative procedure: ¿exploratory laparotomy with repair of incarcerated ventral hernia with mesh.¿ the operative records state the patient ¿was found to have incarcerated ventral hernia.She had multiple defects.We freed all this area up, placed mesh inside.Postoperatively the patient is doing well.She is eating.Her incision looks good.She will be discharged home to return to the office next week.Lorcet for pain.¿ 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 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 addresses the following warning 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.¿ 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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Updated results code.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: (b)(6) 2006: (b)(6).[ni].Office note.Every other staple removed.Still having drainage.Jackson pratt, leave it and return in 7-10 days.(b)(6) 2006: (b)(6).[ni].Office note.Remaining staples removed, jackson pratt came out at home.(b)(6) 2006: (b)(6).[ni].Office note.Had some drainage out of jackson pratt hole, cleaned with q-tip and peroxide.Has a little pocket there.If this does not correct may need to open up and drain wider.Put on keflex.(b)(6) 2006: (b)(6).[ni].Office note.After xylocaine, opened area.Cleaned out with peroxide, should continue to get well slowly.(b)(6) 2006: (b)(6).[ni].Office note.Wound probed, cleaned, much better.(b)(6) 2006: (b)(6).[ni].Office note.Wound probed, filing in, no evidence of active infection.(b)(6) 2006: (b)(6).[ni].Office note.Wound cleaned up well, dressing changed.(b)(6) 2006: (b)(6).[ni].Office note.Continues to heal, granulating in, nothing else needs to be done other than continuing as is.(b)(6) 2006: (b)(6).[ni].Office note.Wound granulating in nice and clean.Continue as is.(b)(6) 2006: (b)(6).[ni].Office note.Wound almost completely healed, healing up from bottom.[missing records: records for the ct scan showing large recurrent incisional hernia were not provided.] (b)(6) 2006: (b)(6).[ni].Office note.Removed part of the staples, healing alright.(b)(6) 2006: (b)(6).[ni].Office note.Remaining staples out, wound healing.(b)(6) 2006: (b)(6).[ni].Office note.Wound well healed.(b)(6) 2007: (b)(6).[ni].Office note.Has recurrent incisional hernia, had some nausea but is gone.I have explained that it is very difficult to repair this where it will not come back.She understands, i recommend massive weight loss.(b)(6) 2007: (b)(6).[ni].Office note.Recurrent incisional hernia, no nausea or vomiting.C/o pain, i think going to have repaired.I explained that we probably can not repair, is going to stay permanent.Try to get referred to larger center where they may be able to work something else different out.They will try to get an apt to the surgery clinic.[missing records: records for ¿recurrent incisional hernias and had it repaired once with some infection of marlex and then go on back and have the marlex repaired¿ were not provided.] (b)(6) 2007: (b)(6).[ni].Office note.Healing well, every other staple out.(b)(6) 2007: (b)(6).[ni].Office note.Remaining staples out.Wound healing well.No lifting and straining for at least 3 to 4 weeks.(b)(6) 2007: (b)(6).[ni].Office note.Wound well healed.(b)(6) 2010: (b)(6).[ni].Office note.Recurrent incisional hernia.Explained the possibility of fixing this is almost impossible.In process of maybe having gastric bypass.Told her best thing to do was have the bypass and then have the hernia fixed after substantial weight loss.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 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 addresses the following warning 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.¿ 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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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) 2006: (b)(6) center.(b)(6), md.Operative report.Pre/postop diagnosis: incarcerated incisional hernia.Operative procedure: repair of incarcerated incisional hernia with bio mesh repair.03/11/06: (b)(6) center.(b)(6), md.Discharge summary.Diagnosis: infected mesh from previous incisional hernia repair.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 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 addresses the following warning 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.¿ 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: health effect impact code: f1903: device explantation.Previous patient codes (1690, 2225) were reported based on the original complaint and are no longer applicable per gore¿s investigation.The investigation has been completed.In the absence of additional information or medical records from the complainant, this event file will be closed with the information provided.Medical records: the known medical records span january 6, 2006 through october 13, 2010, and not all records received in this time span are relevant to gore® dualmesh® plus biomaterial.Patient information: medical history: diverticulitis.Obesity.On (b)(6) 2013: 334lbs.; bmi 63.1.On (b)(6) 2015: 377lbs.; bmi 71.2.On (b)(6) 2017: 366lbs.; bmi 69.2.On (b)(6) 2018: 359lbs.; bmi 67.8.On (b)(6) 2019: 320lbs.; bmi 60.1.Diabetes mellitus.Neuropathy.Prior surgical procedures: hysterectomy [unknown date].Implant preoperative complaints: on (b)(6) 2006: ¿the patient has a longstanding large ventral hernia and three days ago was in the emergency room with abdominal pain and was given a shot for it and permitted to go home.Since that time she has not gotten better and vomited several times and came back to the emergency room last night.She was found to have elevated blood pressure and admitted and seen in consultation by dr.(b)(6) and she is getting ready to go to surgery now.¿ ¿the patient has had surgery for this hernia by dr.(b)(6) in the past.It recurred and he referred her to dr.(b)(6) at the university.Dr.(b)(6) wanted her to have a gastric bypass prior to trying to repair the hernia, however, her insurance wouldn¿t pay for the bypass.¿ implant procedure: repair of incarcerated incisional hernia with ¿bio mesh¿ repair.Implant: gore® dualmesh® plus biomaterial (03139583/1dlmcp203) 20cm x 30cm x 2mm.Implant date: (b)(6) 2006.Description of hernia being treated: ¿incision was made in the area of the previous excision exposing multiple fascial defects with multiple hernias.These were all taken down.The complete edges of the small bowel were freed as was the fascial edges.Small bowel was run from the ligament of treitz to the ileocecal valve.There were no other abnormalities noted.I did not palpate anything abnormal in the abdomen except for some diverticular disease.I could not palpate any definite gallstones in the gallbladder.¿ implant size and fixation: ¿then decided to use a bio mesh type repair placing the slick side down and placing it subfascially and then tacking it into position.I then ran a stitch around this to keep it in position.¿ post-operative period: [two month].On (b)(6) 2006: ¿every other staple removed.Still having drainage.Jackson pratt, leave it and return in 7-10 days.¿ on (b)(6) 2006: ¿remaining staples removed, jackson pratt came out at home.¿ on (b)(6) 2006: ¿had some drainage out of jackson pratt hole, cleaned with q-tip and peroxide.Has a little pocket there.If this does not correct may need to open up and drain wider.Put on keflex.¿ on (b)(6) 2006: ¿after xylocaine, opened area.Cleaned out with peroxide, should continue to get well slowly.¿ on (b)(6) 2006: ¿wound probed, cleaned, much better.¿ on (b)(6) 2006: ¿wound probed, filing [sic] in, no evidence of active infection.¿ explant preoperative complaints: on (b)(6) 2006: [the patient] ¿presented to the emergency department with complaints of increasing drainage from her abdominal wall.The patient had been undergoing wound care and did not keep her friday appointment.She states that she had a copious amount of drainage while she was at church and it drained all over her clothes and she came to the emergency room.A ct scan of her abdomen showed a questionable abscess in the anterior wall.There was also quite a bit of postoperative changes from her recent hernia repair.¿ on (b)(6) 2006: incision, drainage and irrigation of abdominal wall abscess ¿the patient had a small draining area in the abdominal wall and this was opened a little larger and there was return of a small amount of purulent material.There was quite a bit of induration and infected-type tissue there but not a copious amount of pus drainage, it was more induration.The wound was irrigated with the stryker irrigation system and packed with betadine gauze.¿ explant procedure: exploration of wound with removal of mesh, packing and irrigation explant date: (b)(6) 2006 [hospitalized (b)(6) 2006].¿we enlarged the incision, carried down and investigated all the pockets.Further evaluation revealed that at the mesh area there was considerable collection of purulent material and actually the edge of the mesh had started separating.I elected to go ahead and remove the mesh because i did not think this patient would get well unless i did so, realizing that she will develop another hernia and possibly even eviscerate.However, at this time, i do not think we have any choice, i removed the mesh, irrigated copiously with warm saline, then with a half mixture of betadine and saline.Once this was completed, i did not palpate any other pocket of purulent collections, packed it with kerlix, sterile dressing.¿ relevant medical information: on (b)(6) 2006: ¿morbidly obese patient who had an infection.We tried to treat it conservatively.This did not work.We carried her to the operating room, removed the mesh, cleaned it out.The wound is granulating in.She can be managed on oral antibiotics and wound dressing changes at home.¿ on (b)(6) 2006: ¿continues to heal, granulating in, nothing else needs to be done other than continuing as is.¿ on (b)(6) 2006: [the patient] ¿had been seen in the emergency room the day before with nausea and vomiting and no definite signs.She was evaluated the next day because of persistence.Ct scan showed a large recurrent incisional hernia.Because of her cramping abdominal pain, nausea and vomiting, i thought that she probably had a partial obstruction and required surgical repair.The last surgery she had was at least two operations to remove mesh and clear up an infection.Therefore, i planned not to put the mesh in at that time.¿ on (b)(6) 2006: repair of incarcerated recurrent incisional hernia [hospitalized (b)(6) 2006] ¿using part of the incision from prior surgery we went down through it, extended the incision to the right side laterally, found a hernia sac and entered the hernia sac.Incarcerated matted small bowel was present.We dissected all of the edges of the small bowel and then took down the adhesions of the small bowel in its entirety.From what l could palpate through the incision, i could not palpate anything wrong.¿ ¿there was actually minimal fascia that we could use for closure.There had been previous repair of mesh that had been infected and had been removed.There was also some mesh on the lateral aspect.I did not think putting mesh in was a wise thing to do so i freed up as much of the old scar and tissue as possible and used part of the fascia.Using #2 far-near, near-far internal retention sutures and #1 pds, we closed this defect transversely.¿ on (b)(6) 2006: [the patient] ¿had multiple large incisional hernias.She is morbidly obese and had recurrent hernias.She began having abdominal pain and vomiting, thought to have incarceration.She was carried to the operating room and underwent reduction and closure of the defect as best we could.We did not put any foreign material in because of the infection in the past.¿ on (b)(6) 2007: ¿has recurrent incisional hernia, had some nausea but is gone.I have explained that it is very difficult to repair this where it will not come back.She understands, i recommend massive weight loss.¿ on (b)(6) 2007: ¿recurrent incisional hernia, no nausea or vomiting.C/o pain, i think going to have repaired.I explained that we probably can not repair, is going to stay permanent.Try to get referred to larger center where they may be able to work something else different out.¿ on (b)(6) 2007: repair of incarcerated incisional hernia with lysis of adhesions, implementation of mesh [hospitalized (b)(6) 2007].¿transverse incision was made to reach the edge of the marlex mesh that had previously been implanted.Multiple defects were present as well as a large seroma.This was cultured.The edges of the marlex was trimmed back and then there were multiple fascial defects.There was no way that you could close the fascia primarily.Once i freed up all of the intestine edges and lysed the adhesions from the ligament of treitz to the ileocecal valve, i did not palpate or see anything abnormal or injuries to the intestines.I then placed a large sheet of marlex mesh inside the peritoneal cavity and ran the edges with prolene using some slack there.I then closed the previous marlex incision with double stranded #1 pds.¿ records indicate a non-gore device was implanted during the (b)(6) 2007 procedure.On (b)(6) 2007: [the patient] ¿was found to have incarcerated ventral hernia.She had multiple defects.We freed all this area up, placed mesh inside.Postoperatively the patient is doing well.She is eating.Her incision looks good.¿ on (b)(6) 2010: ¿recurrent incisional hernia.Explained the possibility of fixing this is almost impossible.In process of maybe having gastric bypass.Told her best thing to do was have the bypass and then have the hernia fixed after substantial weight loss.¿ 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 warn, ¿as with any implantable surgical device, strict aseptic techniques should be followed.If an infection develops, it should be treated aggressively.An unresolved infection may require removal of the device.¿ the gore® dualmesh® plus biomaterial instructions for use also warn, ¿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 device was not able to be returned to gore for evaluation; therefore, a direct product analysis could not be conducted.Review of the manufacturing and sterilization records verified that the lot met all pre-release specifications.The investigation concluded that there is no relationship between the device history record findings and the event.Section c1: name: plus antimicrobial product coating.Manufacturer/compounder: w.L.Gore & associates, inc.Lot number: 03139583.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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