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| Model Number 1DLMC201 |
| Device Problems
No Apparent Adverse Event (3189); Insufficient Information (3190)
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| Patient Problems
Adhesion(s) (1695); Unspecified Infection (1930); Obstruction/Occlusion (2422); No Clinical Signs, Symptoms or Conditions (4582)
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| Event Date 10/27/2007 |
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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® biomaterial instructions for use addresses the following adverse reactions among others: ¿possible adverse reactions with the use of any tissue deficiency prosthesis may include, but are not limited to, contamination, infection, inflammation, adhesion, fistula formation, seroma formation, hematoma, and recurrence".The gore® dualmesh® biomaterial instructions for use 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) 2007 whereby a gore® dualmesh® biomaterial was implanted.The complaint alleges that on (b)(6) 2007, an additional procedure occurred whereby the gore device was explanted.It was reported the patient alleges the following injuries: removal of mesh, infection, lysis of adhesions, small bowel obstruction, additional surgery.Additional event specific information and medical records have been requested.
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Manufacturer Narrative
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B7: added medical history h6: updated results code.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: records prior to (b)(6) 2007 , including previous hernia repairs in 1989 and 1990 and additional abdominal procedures, were not provided.Operative records dated (b)(6) 2007 indicate the patient underwent cystoscopy for preoperative/postoperative diagnosis ¿status post implantation of artificial urinary sphincter with bladder neck cuff; mechanical failure of artificial sphincter; multiple urethral strictures.¿ operative records dated (b)(6) 2007 indicate the patient underwent explant artificial urinary sphincter pump; implant, artificial urinary sphincter with transcorporeal cuff approach.Preoperative/postoperative diagnosis ¿status post pelvic fracture; status post implantation of artificial urinary sphincter with bladder neck cuff; artificial urinary sphincter hydraulic leak, site unknown.¿ operative records dated (b)(6) 2007 indicate the patient underwent cystoscopy with direct vision placement of a glidewire and foley catheter for preoperative and postoperative diagnosis ¿incontinence with artificial urinary sphincter.¿ the records also state the patient underwent repair of recurrent ventral hernia with dualmesh.The records state preoperative diagnosis ¿recurrent right lower quadrant incisional hernia.¿ postoperative diagnosis ¿incarcerated right lower quadrant hernia.¿ operative records dated (b)(6) 2007 state: ¿the patient is a 53-year-old male with a remote history of a pelvic crush fracture.He has had multiple repairs of a right inguinal hernia in the past done by me in 1989 and 1990 using prolene mesh.In (b)(6)2006, he underwent a bilateral gluteal fasciocutaneous v-y advancement flaps for anorectal incontinence.In (b)(6)2006, he underwent a delorme anoplasty.In (b)(6) 2006, he was found to have a severe stricture at the site of his previous artificial sphincter.Also, in (b)(6) 2006, he underwent resection of a rectal prolapse.In (b)(6)2007, he had implantation of an artificial anorectal sphincter by dr.(b)(6) in (b)(6) clinic, (b)(6).In (b)(6) 2007, he was operated on by dr.(b)(6) who did a cystoscopy and noted numerous urethral strictures, and these were dilated.¿ operative records dated (b)(6) 2007 continue: ¿the patient thus at that point had an artificial urinary sphincter and an artificial anorectal sphincter.In (b)(6)2007, he underwent explantation of the artificial ureter sphincter because of a leak and then he had reactivation of the artificial urinary sphincter back in (b)(6)2007.The very first artificial sphincter was placed in the bulbus urethra and had eroded.The patient is also status post implantation of a penile prosthesis because the patient has had multiple previous operations in the perineum and pelvis.On examination in the office, he was found to have a bulge in the right lower quadrant extending just lateral to the midline, and, this bulge was not completely reducible.¿ ¿the previous mesh repairs that were done in 1986 and 1987 by me were difficult and required anchoring the prolene mesh down to coopers with the aid of a drill.¿ operative records dated (b)(6) 2007 state: ¿urology team was called to place a foley catheter, which they were eventually able to do, although initially it was difficult due to the strictures and he required cystoscopy.The urethral device was inactivated.An incision was made along the lower midline and he was noted to have several reservoirs, one on either side of the midline and another, which was extending up inferior to the umbilicus.The hernia sac was identified coming through the floor at approximately the level of the external ring, although this appeared to be a direct defect.The sac was opened and the incarcerated small bowel was reduced.¿ operative records dated (b)(6)2007 state: ¿excess sac was amputated, and then, one of the sphincters, which was coming through the area, was partially mobilized.A piece of dualmesh (bard) was then placed into the defect.The mesh was sewn into the undersurface of the abdominal wall with great care taken to avoid the various sphincters and their tubes and reservoirs.As mentioned earlier, one reservoir was found on either side of the midline and there were multiple tubes coming through the area.¿ operative records dated (b)(6)2007 state: ¿the mesh was anchored to the pubic tubercle in the midline and then anchored to the rectus muscles on either side.The mesh was also overlapped over the femoral vessels so far as is possible.The mesh was sewn in with 0-ethibond sutures.The anterior rectus sheath was then approximated in the midline taking again care not to injure the variety of hardware in his abdominal wall.The rectus muscles were approximated with 0- pds.The skin was closed with 3-0 vicryl subcutaneous sutures and 4-0 monocryl running subcuticular stitches followed by dermabond.¿ the records confirm a gore® dualmesh®biomaterial (1dlmc201/05035084) was used during the procedure.Operative records dated (b)(6)2007 indicate the patient underwent exploratory laparotomy, lysis of adhesions, small bowel resection with anastomosis for incarcerated pelvic floor hernia, oversew enterotomy, repair of the ventral hernia with alloderrn, and removal of the old dualmesh.Preoperative and postoperative diagnosis ¿small bowel obstruction with incarcerated hernia.¿ the records also indicate the patient underwent cystoscopy with direct vision and placement of the glidewire and foley catheter for preoperative and postoperative diagnosis of ¿incontinence with artificial urinary sphincter.¿ the operative records dated (b)(6)2007 state: ¿the patient is a very complicated 53-year-old male with a remote history of a pelvic crush fracture.His most recent operation prior to this one was on (b)(6)2007, when i repaired a right lower quadrant inguinal hernia.His past history was significant for repairs of the right inguinal hernia in 1989 and 1990 using prolene mesh.Subsequently, he has had multiple procedures with artificial sphincters placed around the urethral sphincter and the anal sphincter as well as a penile prosthesis.He also had bilateral gluteal fasciocutaneous v-y advancement flaps in the past as well as a delorme anoplasty.His pelvis is deformed because of the prior fractures.¿ operative records dated (b)(6)2007 state: ¿the patient requires cystoscopy at the time of the operation on (b)(6)2007, because of a urethral stricture.He was discharged home following surgery but returned on the (b)(6) 2007, complaining of nausea and vomiting and at that time films suggested a possible bowel obstruction.We thought this was probably ileus and continued to observe him with a nasogastric tube.However, he failed to improve.A cat scan done late last night demonstrated postoperative fluid collection in the right inguinal area from the recent repair but there was concern for a small bowel loop incarcerated in the pelvis.He also had marked deformity of his pubic symphysis and changes in the pelvis consistent with his old fracture.¿ operative records dated (b)(6) 2007 state: ¿a midline incision was performed through the old midline scar.The patient has had multiple previous abdominal procedures including a prior ileostomy, taken down of ileostomy, and a small bowel anastomosis.The dense scar tissue in the midline was incised and then the fascia and peritoneum were carefully opened.The small bowel was densely adherent to the abdominal wall in taking down the small bowel, a small serosal tear was performed and this was oversewn with some 3-0 ethibond.Another area of adherence resulted in an enterotomy and this was oversewn also with 3-0 pds.The wound was carefully irrigated and the gloves of the operating team were changed.¿ operative records dated (b)(6) 2007 continue: ¿after much dissection, it became apparent that there was a loop of ileum, which was stuck down into the pelvis and this was difficult to access because of the hardware in place from his various sphincters.The incision was extended over to the right side through the old groin incision again taking care not to injure the variety of tubes that were coming through the abdominal wall.The dual mesh that had been placed 10 days ago was removed.A hernia tape was placed on the proximal small bowel in order to prevent small bowel contents from coming into the obstructed loop and the small bowel was brought up out of the pelvis.This required a great deal of dissection and took over an hour to free.¿ operative records dated (b)(6) 2007 state: ¿despite this, a hole in the small bowel was observed as the bowel was brought out.The bowel appeared to be stuck on some old mesh that had been present from the one of the prior repairs.The area of the traumatized bowel was then resected using gia 60 autosuture instruments on either side and a side-side to functional end anastomosis was performed with another gia 60 cartridge and the insertion sites were closed with a tia 30.The mesentery of the small bowel was divided between clamps and tied with ties of 0 vicryl and then the resected specimen tape was taken off the table and submitted to pathology.¿ operative records dated (b)(6) 2007 state: ¿because of the contamination, i did not want to use any synthetic mesh.Three pieces of 8 x 10 alloderm were hydrated and were used to close the defects.In order to do this, the prevesical space was dissected and the mesh was placed into the prevesical space and anchored down to the pubic ramus.The alloderm mesh was then brought over to close off the femoral canal.Again, it was very difficult to visualize the cooper ligament because of the hardware.However, it was felt that the mesh was anchored into cooper ligament and on the anterior wall, there was a hole measuring about 2 x 2 cm lateral to the rectus muscle and there was hardware in this area.¿ operative records dated (b)(6) 2007 state: ¿there was also a large reservoir in the preperitoneal space along the anterior abdominal wall where normally we would have anchored some sutures.The right colon and ilium were completely freed from the pelvis and the ureters were traced down to the bladder.The properitoneal space was closed off with alloderm mesh, sewn in with 0-prolene sutures and some 3-0 pds sutures.Finally, the defect in the rectus and anterior abdominal wall was also closed with a piece of alloderm.The abdomen was irrigated with saline and also with dilute betadine and then the bowel contents were reduced back into the abdominal cavity with aid of the moist towel.The urine had some mild blood tinge during the sewing in of the alloderm.However, this cleared and there was no evidence of any ureteral or bladder injury during the operation.¿ operative records dated (b)(6) 2007 state: ¿the abdominal wall musculature was sewn together with a 1 pds figure of 8 sutures in the lower portion of the midline and the rest of the wound was closed with loop #1 pds after mobilizing the skin and subcutaneous fascia off the abdominal wall for a distance of approximately 6 cm on either side of the abdominal wall in the upper portion of the abdomen.Mobilization was limited in the lower part because of the sphincters.The subcutaneous tissues were closed over a 7-mm jp drain, brought out through the upper abdomen and then the incision was closed with 3-0 vicryl interrupted sutures and staples.Dry sterile dressings were applied.¿ pathology records for the(b)(6) 2007 procedure were not provided.There is no mention of infection of the gore® dualmesh®biomaterial.Operative records dated (b)(6) 2007 indicate the patient underwent wound exploration for preoperative diagnosis ¿possible enteric fistula.¿ postoperative diagnosis ¿superficial wound infection and ¿frozen abdomen.¿ the records state ¿the patient is a 53-year-old male with a remote history of a pelvic crush fracture and 2 right groin hernia repairs in the 1980's.He also has a history of an artificial anal sphincter and artificial ureteral sphincter and a penile implant.On (b)(6) 2007 he underwent a repair of an anterior abdominal wall hernia with gore-tex mesh and another defect was felt around the femoral canal.The gore-tex was placed so as to cover both areas.¿ operative records dated (b)(6) 2007 state: ¿he was readmitted on (b)(6) 2007 , with abdominal pain and small bowel distention.He was treated with ng suction and then because he failed to improve, he was re-explored on (b)(6) 2007.At that time, he was found to have an incarcerated loop of small bowel in the pelvis and a femoral defect.He underwent a bowel resection with a side-to-side anastomosis and oversew of an enterotomy.The abdominal defect was closed off with alloderm and several sheets of alloderm were placed down in the pelvis and along the lower portion of the abdominal wall where the gore-tex was removed.¿ operative records dated (b)(6) 2007 state: ¿over the past 12 days, the patient has not had any flatus per rectum, but continued to have bowel sounds.Several studies were performed this week, however, none was conclusive for complete bowel obstruction.Today, the incision area appeared reddened.He also began draining some green, foul smelling fluid out of his subcutaneous drain.Despite the fact that he did not have any significant leukocytosis we elected to take him to the operating room for exploration.Operative records dated (b)(6) 2007 state: ¿the patient was given general anesthesia and the staples and sutures in the midline wound were removed.The groin staples were left intact.In the lower portion of the midline incision, there was an area that had been opened, drained, and then re-closed several days ago.On opening this area, we encountered creamy thick pus and a cavity that did not communicate with the groin wound.The pus was sent for culture and sensitivity and aerobic and anaerobic cultures.The remaining midline staples were removed, and the wound was irrigated.No enteric contents were seen.The fascia was incised and the old fascial suture was removed.¿ operative records dated (b)(6) 2007 state: ¿there were dense adhesions present to the fascia, and the peritoneum could not be safely opened.At this point, i elected not to proceed with a full abdominal exploration since i thought it would be terribly hazardous and carried the potential for major bowel injury.The patient had no evidence of free air preoperatively and there was no suggestion of any current bowel leak.The fascia was re-closed with double #1 running pds suture, and the wound was packed open with gauze.The plan will be to keep the patient on tpn until either the bowel obstruction resolves or until the adhesions become softer and it is safer to reexplore him.¿ discharge summary dated (b)(6) 2007 indicates the patient was admitted to the hospital on (b)(6) 2007 for admitting diagnosis ¿small bowel obstruction.¿ the records state: ¿the patient is a 53-year-old male who has a remote history of a pelvic crush fracture and 2 right groin hernia repairs in 1980s who presented on (b)(6) 2007 , for repair of an anterior abdominal wall hernia.This reportedly was uneventful, and the patient was discharged home but was readmitted on (b)(6) with abdominal distention and pain as well as nausea and vomiting and was diagnosed with a small bowel obstruction.¿ discharge summary dated (b)(6) 2007 states: ¿hospital course: he was treated initially with conservative measures including ng-tube suction and iv fluids.When he failed to improve with no return of bowel function and continued to have nausea, vomiting, and abdominal distention, he was taken to the operating room and re-explored on (b)(6) 2007.Discharge summary dated (b)(6) 2007 continues: ¿the patient was also placed on tpn on day 2 due to the fact that he already been n.P.O.For an extended period of time and it was anticipated he would have a delayed return of bowel function.The patient remained distended after surgery and serial kubs as well as physical exam were consistent with the postop ileus.The patient was kept n.P.O.And on tpn.He remained afebrile with a soft abdomen that was distended.The patient continued to have large amounts of ng-tube drainage consistent with his postopileus though as this ileus persisted the possibility of a recurrent small bowel obstruction was considered.¿ discharge summary dated (b)(6) 2007 states: ¿on (b)(6) , the patient was noted to have fluid bilious and somewhat purulent fluid coming from a subcutaneous drain and due to fear that he had an enterocutaneous fistula given the intra-abdominal hardware he was again taken back· to the operating room what was initially thought to be an enterocutaneous fistula, however, at the time of the operation it was found to be a superficial wound infection, this was debrided and drained.The patient was returned to the floor in stable condition and was kept on iv antibiotics.He then developed right upper quadrant pain and had ultrasound findings consistent with acute cholecystitis.Given the patient's multiple recent abdominal surgeries and fact that any definitive operative intervention for the acute cholecystitis would be exceptionally difficult and dangerous, the patient was advised to undergo percutaneous placement of cholecystostomy tube and he agreed and this was performed on (b)(6) 2007.Discharge summary dated (b)(6) 2007 states: ¿the patient's ileus appeared to resolve.He began passing flatus and was passing stool with diminishing abdominal distention and his diet was slowly advanced such that he was tolerating a regular diet on the day of the discharge.His tpn was slowly weaned to off on november 18.He remained afebrile with a soft abdomen and a clean, dry, and intact incision.The cholecystostomy tube was clamped and he was able to tolerate this without any abdominal pain.The dressing around it remained clean and the cholecystostomy tube site remained clean, dry, and intact without any evidence of infection.He had persistent copious amounts of diarrhea and sample was sent for c.Diff and this was negative.Therefore, on (b)(6), the patient was tolerating regular diet, ambulating independently, had good pain control with oral oxycodone elixir and had diminishing stool output, however, continued to have some diarrhea that was c.Diff negative and was deemed stable for discharge home.¿ operative records dated (b)(6) 2008 indicate the patient underwent laparotomy and cholecystectomy.Preoperative and postoperative diagnosis ¿chronic cholecystitis, history of multiple prior operations.¿ there is no mention of a gore device in the operative procedure notes.Operative records dated (b)(6) 2008 indicate the patient underwent revision of artificial urinary sphincter for preoperative/postoperative diagnosis ¿recurrent urinary incontinence; status post artificial urinary sphincter implantation; cuff induced urethral atrophy.A potential relationship, if any, between the alleged injuries or complications and the gore device is unclear from the provided information at this time.It should be noted that the gore® dualmesh® biomaterial instructions for use addresses the following adverse reactions among others: ¿possible adverse reactions with the use of any tissue deficiency prosthesis may include, but are not limited to, contamination, infection, inflammation, adhesion, fistula formation, seroma formation, hematoma, and recurrence.¿ the gore® dualmesh® biomaterial instructions for use 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: updated health effect- clinical code.H6: updated investigation findings.H6: updated investigation conclusions.H6: health effect impact code: f26: no health consequences or impact.Previous patient codes (1695, 1930, 2422) were reported based on the original complaint and are no longer applicable per gore¿s investigation.The investigation has been completed.Based upon gore¿s investigation there is no available information that reasonably suggests that a gore device may have caused or contributed to death, serious injury or reportable malfunction, and is no longer considered reportable.This event will be closed as no problem detected.Medical records: the known medical records span (b)(6) 2007 through (b)(6) 2008 and not all records received in this time span are relevant to the gore® dualmesh® biomaterial.Patient information: medical history: pelvic crush fracture.Inguinal hernia.Prior surgical procedures: 1989, 1990: hernia repair.2006: resection of rectal prolapse.2006: bilateral gluteal fasciocutaneous v-y advancement flaps.2006: delorme anoplasty.2007: implantation of artificial anorectal sphincter.2007: artificial ureter sphincter.Ileostomy with subsequent ileostomy takedown [unknown date].Implant preoperative complaints: (b)(6) 2007: ¿the patient is a 53-year-old male with a remote history of a pelvic crush fracture.He has had multiple repairs of a right inguinal hernia in the past done by me in 1989 and 1990 using prolene mesh.In (b)(6) 2006, he underwent a bilateral gluteal fasciocutaneous v-y advancement flaps for anorectal incontinence.In (b)(6) 2006, he underwent a delorme anoplasty.In (b)(6) 2006, he was found to have a severe stricture at the site of his previous artificial sphincter.Also, in (b)(6) 2006, he underwent resection of a rectal prolapse.In (b)(6) 2007, he had implantation of an artificial anorectal sphincter by dr.(b)(6) in (b)(6) clinic, (b)(6).In (b)(6) 2007, he was operated on by dr.(b)(6) who did a cystoscopy and noted numerous urethral strictures, and these were dilated.The patient thus at that point had an artificial urinary sphincter and an artificial anorectal sphincter.In (b)(6) 2007, he underwent explantation of the artificial ureter sphincter because of a leak and then he had reactivation of the artificial urinary sphincter back in (b)(6) 2007.The very first artificial sphincter was placed in the bulbus urethra and had eroded.The patient is also status post implantation of a penile prosthesis because the patient has had multiple previous operations in the perineum and pelvis.On examination in the office, he was found to have a bulge in the right lower quadrant extending just lateral to the midline, and, this bulge was not completely reducible.¿ ¿the previous mesh repairs that were done in 1989 and 1990 by me were difficult and required anchoring the prolene mesh down to coopers with the aid of a drill.¿ implant procedure: ¿repair of recurrent ventral hernia with dualmesh¿ implant: gore® dualmesh® biomaterial (05035084/1dlmc201) 15 x 19 cm, 2 mm thick.Implant date: (b)(6) 2007.Description of hernia being treated: ¿an incision was made along the lower midline and he was noted to have several reservoirs, one on either side of the midline and another, which was extending up inferior to the umbilicus.The hernia sac was identified coming through the floor at approximately the level of the external ring, although this appeared to be a direct defect.The sac was opened and the incarcerated small bowel was reduced.Excess sac was amputated, and then, one of the sphincters, which was coming through the area, was partially mobilized.¿ implant size and fixation: ¿a piece of dualmesh (bard) [sic, reference to bard incorrect] was then placed into the defect.The mesh was sewn into the undersurface of the abdominal wall with great care taken to avoid the various sphincters and their tubes and reservoirs.As mentioned earlier, one reservoir was found on either side of the midline and there were multiple tubes coming through the area.The mesh was anchored to the pubic tubercle in the midline and then anchored to the rectus muscles on either side.The mesh was also overlapped over the femoral vessels so far as is possible.The mesh was sewn in with 0-ethibond sutures.The anterior rectus sheath was then approximated in the midline taking again care not to injure the variety of hardware in his abdominal wall.The rectus muscles were approximated with 0- pds.The skin was closed with 3-0 vicryl subcutaneous sutures and 4-0 monocryl running subcuticular stitches followed by dermabond.¿ no post-operative records were provided.Explant preoperative complaints: (b)(6) 2007: ¿the patient is a very complicated 53-year-old male with a remote history of a pelvic crush fracture.His most recent operation prior to this one was on (b)(6) 2007, when i repaired a right lower quadrant inguinal hernia.His past history was significant for repairs of the right inguinal hernia in 1989 and 1990 using prolene mesh.Subsequently, he has had multiple procedures with artificial sphincters placed around the urethral sphincter and the anal sphincter as well as a penile prosthesis.He also had bilateral gluteal fasciocutaneous v-y advancement flaps in the past as well as a delorme anoplasty.His pelvis is deformed because of the prior fractures.The patient requires cystoscopy at the time of the operation on (b)(6) 2007, because of a urethral stricture.He was discharged home following surgery but returned on the (b)(6) 2007, complaining of nausea and vomiting and at that time films suggested a possible bowel obstruction.We thought this was probably ileus and continued to observe him with a nasogastric tube.However, he failed to improve.A cat scan done late last night demonstrated postoperative fluid collection in the right inguinal area from the recent repair but there was concern for a small bowel loop incarcerated in the pelvis.He also had marked deformity of his pubic symphysis and changes in the pelvis consistent with his old fracture.¿ explant procedure: exploratory laparotomy, lysis of adhesions, small bowel resection with anastomosis for incarcerated pelvic floor hernia, oversew enterotomy, repair of the ventral hernia with alloderm, and removal of the old dualmesh.Explant date: (b)(6) 2007.¿a midline incision was performed through the old midline scar.The patient has had multiple previous abdominal procedures including a prior ileostomy, taken down of ileostomy, and a small bowel anastomosis.The dense scar tissue in the midline was incised and then the fascia and peritoneum were carefully opened.The small bowel was densely adherent to the abdominal wall in taking down the small bowel, a small serosal tear was performed and this was oversewn with some 3-0 ethibond.Another area of adherence resulted in an enterotomy and this was oversewn also with 3-0 pds.The wound was carefully irrigated and the gloves of the operating team were changed.After much dissection, it became apparent that there was a loop of ileum, which was stuck down into the pelvis and this was difficult to access because of the hardware in place from his various sphincters.The incision was extended over to the right side through the old groin incision again taking care not to injure the variety of tubes that were coming through the abdominal wall.The dual mesh that had been placed 10 days ago was removed.A hernia tape was placed on the proximal small bowel in order to prevent small bowel contents from coming into the obstructed loop and the small bowel was brought up out of the pelvis.This required a great deal of dissection and took over an hour to free.Despite this, a hole in the small bowel was observed as the bowel was brought out.The bowel appeared to be stuck on some old mesh that had been present from the one of the prior repairs.The area of the traumatized bowel was then resected using gia 60 autosuture instruments on either side and a side-side to functional end anastomosis was performed with another gia 60 cartridge and the insertion sites were closed with a tia 30.The mesentery of the small bowel was divided between clamps and tied with ties of 0 vicryl and then the resected specimen tape was taken off the table and submitted to pathology.Because of the contamination, i did not want to use any synthetic mesh.Three pieces of 8 x 10 alloderm were hydrated and were used to close the defects.In order to do this, the prevesical space was dissected and the mesh was placed into the prevesical space and anchored down to the pubic ramus.The alloderm mesh was then brought over to close off the femoral canal.Again, it was very difficult to visualize the cooper ligament because of the hardware.However, it was felt that the mesh was anchored into cooper ligament and on the anterior wall, there was a hole measuring about 2 x 2 cm lateral to the rectus muscle and there was hardware in this area.There was also a large reservoir in the preperitoneal space along the anterior abdominal wall where normally we would have anchored some sutures.The right colon and ilium were completely freed from the pelvis and the ureters were traced down to the bladder.The properitoneal space was closed off with alloderm mesh, sewn in with 0-prolene sutures and some 3-0 pds sutures.Finally, the defect in the rectus and anterior abdominal wall was also closed with a piece of alloderm.The abdomen was irrigated with saline and also with dilute betadine and then the bowel contents were reduced back into the abdominal cavity with aid of the moist towel.The urine had some mild blood tinge during the sewing in of the alloderm.However, this cleared and there was no evidence of any ureteral or bladder injury during the operation.The abdominal wall musculature was sewn together with a 1 pds figure of 8 sutures in the lower portion of the midline and the rest of the wound was closed with loop #1 pds after mobilizing the skin and subcutaneous fascia off the abdominal wall for a distance of approximately 6 cm on either side of the abdominal wall in the upper portion of the abdomen.Mobilization was limited in the lower part because of the sphincters.The subcutaneous tissues were closed over a 7-mm jp drain, brought out through the upper abdomen and then the incision was closed with 3-0 vicryl interrupted sutures and staples.Dry sterile dressings were applied.¿ pathology for the explanted gore device were not provided.Conclusions: it should be noted that the gore® dualmesh® biomaterial instructions for use include warnings and addresses the following adverse reactions among others: ¿possible adverse reactions with the use of any tissue deficiency prosthesis may include, but are not limited to, contamination, infection, inflammation, adhesion, fistula formation, seroma formation, hematoma, and recurrence.¿ the instructions for use further state: ¿when using this device as a permanent implant and exposure occurs, treat to avoid contamination, or device removal may be necessary.¿ the ifu recommends that ¿for best results, use monofilament sutures.Suture size should be determined by surgeon preference and the nature of the reconstruction.¿ as with any surgical procedure, there are always risks of complications for surgical repair of hernias and soft tissue deficiencies, with or without mesh.These may include but are not limited to, adhesions and related harms, bleeding, bowel obstruction, dysphagia, erosion or extrusion and related harms, exposure or protrusion and related harms, fever, fistula, gerd recurrence, recurrence, ileus, increased procedure time and related harms, irritation or inflammation, infection, pain, paresthesia, perforation, revision / re-intervention, seroma or hematoma and related harms, wound complications and wound dehiscence.Many of the potential complications are associated with the patient¿s underlying disease progression, co-morbidities, additional medical history and/or other surgical procedures.The above inherent risks are typically detailed in standard informed consent documents.The device was not able to be returned to gore for evaluation; therefore, a direct product analysis could not be conducted.Review of the manufacturing records verified that the lot met all pre-release specifications.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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