| Device Problems
No Apparent Adverse Event (3189); Insufficient Information (3190)
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| Patient Problems
Adhesion(s) (1695); Unspecified Infection (1930); Pain (1994); Not Applicable (3189)
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| Event Date 01/23/2012 |
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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 although the brand name and lot# of a gore device has not been provided, the instructions for use for the vast majority of gore¿s eptfe patch products that are indicated for the reconstruction of soft tissue deficiencies include the following warnings 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.¿ ¿possible 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 incisional hernia repair on (b)(6) 2000 whereby an alleged gore device was implanted.It was reported a second laparoscopic incisional hernia repair was performed on (b)(6) 2006 whereby two gore dualmesh® plus biomaterial devices were implanted.The complaint alleges that on (b)(6) 2012, an additional procedure was performed whereby the gore devices were explanted.It was reported the patient alleges the following injuries: abdominal pain, chronic nonhealing wound, adhesions to bowel, small bowel resection, chronic mesh infection, necrotic tissue, and mesh removal.Additional event specific information and medical records have been requested.
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Manufacturer Narrative
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Other relevant history: added patient medical history.Corrected conclusion code.Added medical record summary.Additional details regarding the patient¿s clinical course were ascertained from a review of medical records and are as follows: operative records dated (b)(6)2000 indicate the patient underwent laparoscopic repair of a lower midline incisional hernia.The records state: ¿in the left upper quadrant a number 10 port was placed using hasson method with development of a pneumoperitoneum.Identification showed an incisional hernia which was surrounding the umbilicus to almost down to the pelvis measuring approximately 15-20 cm in diameter.Within the hernia was a large amount of adhesions of omentum and bowel.All these were taken out of the hernia and the hernia reduced into the abdominal cavity with a combination of blunt and sharp dissection with scissors, being careful to obtain hemostasis.After identification of the hernia, a measurement of the hernia to include 3 cm in all directions was made.The mesh was fashioned in this size, rolled after four corners of prolene sutures were placed, and brought into the abdomen through the 10 mm port.The (b)(6)2000 records state: ¿three number 5's were placed, two in the anterior axillary line on the right side and a third in the anterior axillary line on the left.The mesh was brought into the abdominal cavity and oriented to cover the hole.The sutures were then brought back out onto the abdominal wall using a suture grasper.They were tied to the fascia.A hernia tacker was then used to tack the gore-tex to the abdominal wall in all directions at about a centimeter from the edge.Four other sutures were placed through the mesh and fascia to fix it to the fascia.These were all placed through separate stab wound incisions as were the previous sutures being brought through separate stab wound incisions.Exploration revealed hemostasis was intact.¿ product identification records for the alleged ¿gore-tex¿ device was not provided.Records between (b)(6)2000 and (b)(6)2006 were not provided to gore.Operative records dated (b)(6)2006 indicate the patient underwent laparoscopic repair of two incisional hernias.The records state: ¿videoscopic examination denoted the patient to have multiple adhesions to the posterior abdominal wall and to the previously placed gore-tex dual mesh.These were all taken down meticulously, adhesions including omentum and small bowel, as well as small bowel mesentery.These were all taken down meticulously.Care was taken to examine the bowel to rule out any type of enterotomy.None were found.The patient was noted to have a hernia which was above the previous repair just to the left of the midline.The patient also was noted to have a port site hernia on the left out lateral to the left upper quadrant port that was placed for this operation.¿ the (b)(6)2006 records continue: ¿the previously placed hernia patch was collapsed within the hernia that it was used to cover.Therefore, a large 20 x 20 cm graft was fashioned such to cover the previously placed graft as well as cover the new defect which was to the left of that and superior.This was put in through the left upper quadrant port, oriented, and it was pulled up to the abdominal wall using two stay sutures that had been placed prior to its placement into the abdominal cavity.It was brought up through the abdominal wall and tied thus orienting the graft over the defect.The graft was unrolled and then tacked in all directions with a spiral tacker and covering the previously placed graft as well as the new herniated area.Next, the port site was addressed.This was measured, found to be about 10 x 10; graft was placed into the abdomen and then tacked over it as well.The areas were copiously irrigated.Hemostasis was found to be intact.No evidence of a bowel injury was noted.¿ there was no mention of infection and no mention of gore device removal.An undated intraoperative record indicates two gore dualmesh® biomaterial devices (1dlmcp04/03839648, 1dlmcp08/03688516) were implanted during a laparoscopic repair of an incisional hernia.According to the initial information provided to gore, it was reported these devices were implanted during the 2/15/2006 procedure.Records between (b)(6)2006 and (b)(6)2011 were not provided to gore.Operative records dated (b)(6)2011 indicate the patient underwent debridement of an abdominal wound.Postoperative diagnosis states: ¿wound infection.¿ findings from the procedure state: ¿necrotic abdominal skin at the dependent portion of the pannus on the right oozing pus with defect tracking up almost the entire length of the previous skin incision.¿ the records indicate aerobic and anaerobic cultures and tissue samples were sent for cultures.The (b)(6)2011 records state: ¿a 40-year-old female who underwent a tahbso [total abdominal hysterectomy with bilateral salpingo-oophorectomy] on august 31, 2011, who was readmitted with a wound infection.The patient had tenderness, erythema and drainage oozing through the skin and the decision was made to take her to the operating room for debridement she was consented.¿ the (b)(6)2011 records continue: ¿the necrotic area of defect was excised and it was found that a large amount of pus came pouring from the incision.The defect was probed and the defect extended almost the entire length of her previous skin incision.The skin was opened up to the apex of the defect and cultures were obtained and tissue was obtained for culture as well.The necrotic tissue was debrided down to the bleeding edges and the irrigation device was used to further clean up the wound.Once this was done to satisfaction the wound was packed with dakin moistened kerlix x2.This was covered with abo pad and towel and abdominal binder and patient was awakened and transferred to the recovery area in stable condition.¿ operative records dated (b)(6)2012 indicate the patient underwent unilateral component separation done on the right, ventral hernia repair, and placement of strattice (non-gore device) as an abdominal wall implant.Postoperative diagnosis states: ¿suspected infected abdominal mesh.¿ findings from the procedure state: ¿thickened scarred mesh and old granulation tissue seen in the deep soft tissue consistent with a chronic wound and the bowel was stuck to the undersurface of the mesh and thus we called dr.Moore into the operating room to assist with dissection of the bowel off of the abdominal wall and the patient had a small bowel resection.¿ the (b)(6)2012 operative report states: ¿this is a 41-year-old woman who i was asked to see initially in the wound clinic for a chronic nonhealing wound after a total abdominal hysterectomy.The patient's past surgical history is significant for a prior laparoscopic hernia repair that resulted in recurrence and a repeat hernia repair done laparoscopically.She again developed a chronic wound after the hysterectomy.I initially planned to do a wound debridement and secondary closure.However, she was admitted to the hospital after i saw her in the wound clinic with abdominal pain and suspected mesh infection.She was treated with iv antibiotics and discharged.She is being brought back to the hospital for explantation of her suspected infected mesh, ventral hernia repair and component separation.The patient was seen initially in the preoperative area.I had a discussion with her about the plan and we discussed the use of strattice.We also discussed the possibility of bowel injury and the possibility of bowel resection and she consented to surgery.¿ the (b)(6)2012records state: ¿she had an old incision that we excised.We extended the incision superiorly.We dissected down to the level of the fascia and elevated the fascia above the area of the mesh into the abdomen and there were extensive adhesions of the omentum and small bowel to the undersurface of the old mesh.We were able to free up some of the fascia from the mesh enough such that we could began the dissection of the omentum and small bowel off of the undersurface of the mesh.During that dissection she was noted to have bowel adherent to the undersurface of the mesh.There was some bleeding of the serosa with blunt dissection of the bowel off of the undersurface of the mesh.At that point, we asked dr.Moore to come into the operating room.He was on-call for general surgery and he graciously agreed and came and dissected the bowel off of the mesh.The patient ultimately did have a small bowel resection.Please see dr.Moore's note for that dictation and dr.Moore also assisted in dissecting some of the soft tissue off of the undersurface of the fascia as well.¿ the (b)(6)2012 records continue: ¿once the mesh was explanted and of note we did see protak and one of the protak was imbedded in an area just adjacent to the bowel, but once we excised all of the mesh and the protak we were able to begin the abdominal wall reconstruction.She had a large defect and we were able to use the doppler to identify the perforators of the abdominal wall on the right side.We then dissected out laterally past the midline, preserving two perforators that we identified both percutaneously and with direct doppler testing of those vessels and they were found to have a pulsatile flow.Once we were past the semilunar line we incised the external oblique fascia and carried that fascial incision superiorly and inferiorly.¿ the (b)(6)2012 records continue: ¿at that point we medialized the right muscle and fascial layer toward the left that we did not perform a component separation for and once we felt we could adequately close the defect we took a 20 x 16 piece of strattice [non-gore device] and placed it as an underlay under the fascia.That was sewn in place with interrupted #1 pds suture.We also used some running pds suture as well.Of note, prior to handling the strattice we did prep the skin and change our gloves.Once the strattice was sewn in place, we placed a drain in between the strattice and the fascia and we were able to close the fascia over the strattice and the drain and that was also with #1 pds suture and both running and interrupted sutures were used.At that point, we irrigated the soft tissues.Hemostasis was achieved throughout the case with mostly electrocautery.¿ dr.Moore¿s records detailing the enterolysis and small bowel resection with primary anastomosis portion of the (b)(6)2012 procedure state: ¿this is a 41-year-old female with chronic mesh infection and she was actually brought in by dr.Andrews for an elective mesh removal and repair.Dr.Andrews got about two-thirds of the mesh out by the time i came down and i encountered some bowel that was stuck to the mesh, so he called me in to assist.¿ the (b)(6)2012 enterolysis and small bowel resection records continue: ¿when i got there a loop of bowel that was stuck to the mesh that we took down with scissors.The integrity of the wall was intact throughout, but then just below that was another loop and when we looked there was actually a hole.It was sort of a crumpled up piece of mesh and right where it crumpled it was stuck into the bowel.We actually got that piece of bowel out and it had a 1.5 cm defect on the mesenteric side of the small bowel.We then finished taking down the rest of that loop and a couple loops from the mesh and then removed the mesh from the abdominal cavity.We then freed up the proximal and distal end of that piece of bowel and did a side-to-side functional end-to-end primary anastomosis and we went through the mesentery on either side of the bowel and truncated the bowel with the gia and then we went across the mesentery with gia as well.We sutured the two pieces of bowel together and there was a proximal and distal end and then used the gia two white loads to make our anastomosis.Once done, we closed the hole in the side wall with a gia-60.We then put a couple lembert in to stop the oozing from the suture line and then closed the mesenteric defect with 3-0 silk.Once we finished that, we did some more enterolysis freeing up some of the bowel from the abdominal wall.There was another piece of mesh that was removed by dr.Andrews and that terminated my portion of the procedure.¿ surgical pathology records dated (b)(6)2012 regarding a specimen collected (b)(6)2012 state as the final diagnosis: ¿a.Small bowel, resection: portion of small bowel with dense serosal adhesions containing lymphocytes and plasma cells, focal foreign body giant cell reaction, and mild acute serositis.Edema and hemorrhage is also noted.Grossly a transmural defect is noted.B.Abdominal mesh, excision: foreign body device consistent mesh material.Fibroadipose tissue with fibrosis, foreign-body giant cell reaction and chronic inflammation.C.Skin, abdominal scar, excision: skin with dense fibrosis and lymphocytes and plasma cells.See comment.Comment: due to the numerous plasma cells, a kappa/lambda stain was performed; however it is noncontributory due to high background staining.Given the clinical background, these plasma cells are most likely reactive; however suggest serum protein electrophoresis.¿ operative records dated (b)(6)2012 indicate the patient underwent debridement of skin, subcutaneous tissue, muscle and fascia of abdominal wall, and application of a wound vac.Postoperative diagnosis is noted as: ¿infected abdominal wound and necrotic and infected fascia.¿ findings from the procedure state: ¿necrotic fascia and it was debrided.There is now exposed strattice.The strattice appeared to be healthy.It was bleeding.¿ the (b)(6)2012 records state: ¿this is a 40-year-old woman with a history of diabetes and elevated bmi, who is status post a unilateral component separation abdominal wall reconstruction with strattice.That procedure was done on february 13, 2012.She developed a postoperative wound infection for which she was admitted to the hospital and we performed a bedside debridement, but i determined that bedside debridement was likely inadequate and we did obtain a ct scan which showed extensive inflammatory changes in the abdominal wall.The patient was consented for a wound debridement and possible laparotomy.¿ the (b)(6)2012 records state: ¿we began the procedure by opening the entire midline incision.There was a large amount of devitalized soft tissue, mostly on the left side with some on the right as well and this is to the right and left of the midline incision.There was obviously necrotic and likely infected fascia and thus we had to open the fascia to debride and excise the infected fascia.We sent the old eschar and wound for path.We also sent the fascia for pathology and culture.We then irrigated the wound with pulse lavage saline containing bacitracin 1 l.We then placed a silver foam wound v.A.C.In the wound.Of note, there were bleeders that were controlled with 3-0 vicryl stick ties.Of note, the strattice was noted to have revascularized and was actually bleeding.There were pds sutures that were removed with the debridement.There was rectus muscle identified and some of the rectus muscle did contract with electrocautery.Once the debridement was found to be complete we then placed the v.A.C.Foam and then the v.A.C.Drape and placed it at 150 mmhg suction pressure.¿ surgical pathology records dated 2/16/2012 regarding a specimen collected (b)(6)2012 states as a final diagnosis: ¿a.Soft tissue, abdomen, excision: fibroadipose tissue showing acute and chronic inflammation, fibrosis, and fat necrosis.B.Abdominal fascia, excision: fibroadipose tissue and skeletal muscle showing acute and chronic inflammation and fat necrosis.¿ operative records dated (b)(6)2012 indicate the patient underwent ¿debridement of skin, subcutaneous tissue, in preparation for subsequent closure, about 15 cm2 was the size of the debridement, application of wound vac to wound that measured at least 400 cm2.¿ postoperative diagnosis states: ¿open infected abdominal wound.¿ findings from the procedure state: ¿some devitalized tissue.It was debrided with electrocautery.There was exposed strattice.There was no frank pus.¿ the (b)(6)2012 records state: ¿this is a 41-year-old woman who had a component separation and reconstruction of her abdominal wall after she had an infected mesh removed.She developed postoperative soft tissue infection.Of note, she did require a bowel resection during that initial operation because of bowel that was stuck to the undersurface of the old gore-tex mesh.In the postoperative period, as mentioned, she developed soft tissue necrosis and infection.She was brought to the operating room on (b)(6)2012, for wound debridement.At that time she was found to not only have soft tissue skin and subcutaneous tissue infected and necrotic, she also had necrotic and infected fascia.That fascia was debrided at that time.She is being brought back for essentially a second look and to replace the wound vac.¿ the (b)(6)2012 records continue: ¿we began the procedure by inspecting the wound.We saw some devitalized tissue superiorly under a flap.It had a little purulent appearance to it.It was an excisional debridement done with cautery and then pickups.Several areas were done.She also had a debridement of some areas on the sidewalls.Again, that was done with electrocautery.We then irrigated with 3 l of pulsed lavage saline containing bacitracin, achieved hemostasis with electrocautery.We then cut down some vac foam.There were three large pieces that were essentially used.One of them was cut in half, thus there were four pieces of vac foam in the wound.We placed the vac drape and then placed it to the wound vac.A binder was placed.¿ ¿the plan at this point will be to continue dressing changes until the wound is sufficiently clean and the infection is well controlled.At that point the plan will be to attempt to close the wound at least partially.¿ operative records dated 4/27/2012 indicate a split-thickness skin graft was placed to an open abdominal wound.Findings from the procedure state: ¿open abdominal wound with good granulation.There was some undermining superiorly.¿ the (b)(6)2012 records state: ¿this is a 48-year-old woman who had a component separation and ventral hernia repair.She developed soft tissue and fascial necrosis requiring debridement and we treated her as an outpatient with both v.A.C.And then with dakin dressing changes.She returned to the operating room today for grafting of her abdominal wound.¿ the (b)(6)2012 records continue: ¿we began the procedure by curetting and performing an excisional debridement of the wound with a curette and that was both the exposed wound and the undermined area.We then irrigated with 3 l of pulse lavage saline.We then placed a drain under the undermined area and harvested skin from the left thigh at 0.012 of an inch and sutured it in place to the wound with a 4-0 chromic suture.Once that was done, the xeroform was placed on the wound, v.A.C.Foam and then the v.A.C.Sticky drape.For the donor site the plan was antibiotic ointment on the wound, benzoin around and a tegaderm.¿ 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 although the brand name and lot# of a gore device has not been provided, the instructions for use for the vast majority of gore¿s eptfe patch products that are indicated for the reconstruction of soft tissue deficiencies include the following warnings 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.¿ ¿possible 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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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: records between (b)(6) 2006 and (b)(6) 2011; including total abdominal hysterectomy with bilateral salpingo-oophorectomy on (b)(6) 2011 were not provided to gore.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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Previous patient codes (1971, 1695, 1930, 1994, 3190 used for "chronic non-healing wound") were reported based on the original complaint and are no longer applicable per gore¿s investigation.H6: updated device codes, h6: updated conclusion codes, h6: updated patient codes.In the absence of additional information or medical records from the complainant, this event file will be closed with the information provided.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.The following information was determined from the medical records.Medical records: the known medical records span august 31, 2000 through september 27, 2011, not all records received in this time span are relevant to three devices: #1 -unknown gore device, #2 -gore® dualmesh® plus biomaterial and #3 - gore® dualmesh® plus biomaterial.Records from february 15, 2006 through september 27, 2011; including total abdominal hysterectomy with bilateral salpingo-oophorectomy on (b)(6) 2011 were not provided.Patient information: medical history: on (b)(6) 2000: lower midline incisional hernia, on (b)(6) 2006: incisional hernia x 2, on (b)(6) 2011: wound infection, on (b)(6) 2012: suspected infected abdominal mesh, on (b)(6) 2012: history of diabetes and elevated bmi, on (b)(6) 2012: open infected abdominal wound.Prior surgical procedures: on (b)(6) 2000: laparoscopic repair of incisional hernia, on (b)(6) 2006: laparoscopic repair of incisional hernia x2, on (b)(6) 2011: total abdominal hysterectomy with bilateral salpingo-oophorectomy, on (b)(6) 2011: debridement of abdominal wound, on (b)(6) 2012: unilateral component separation done on the right, ventral hernia repair, placement of strattice which is dermis as an abdominal wall implant 320 cm2, enterolysis, small bowel resection with primary anastomosis.On (b)(6) 2012: debridement of skin, subcutaneous tissue, muscle and fascia of abdominal wall 378 cm about, application of wound vac greater than 50 cm2 measured 378 cm on (b)(6) 2012: debridement of skin, subcutaneous tissue, in preparation of subsequent closure, about 15 cm2 the size of the debridement, application of wound vac to wound that measured at least 400 cm2.On (b)(6) 2012: split-thickness skin graft to open abdominal wound 120 cm2 implant #1 preoperative complaints: preoperative records were not provided.Implant #1 procedure: laparoscopic repair of incisional hernia.[product identification records for the alleged ¿gore-tex mesh¿ were not provided.] implant date: #1.On (b)(6) 2000.[hospitalization unknown.] description of hernia being treated: ¿in the left upper quadrant a number 10 port was placed using hasson method with development of a pneumoperitoneum.Identification showed an incisional hernia which was surrounding the umbilicus to almost down to the pelvis measuring approximately 15-20 cm in diameter.Within the hernia was a large amount of adhesions of omentum and bowel.All these were taken out of the hernia and the hernia reduced into the abdominal cavity with a combination of blunt and sharp dissection with scissors, being careful to obtain hemostasis." implant size and fixation: ¿after identification of the hernia, a measurement of the hernia to include 3 cm in all directions was made.The mesh was fashioned in this size, rolled after four corners of prolene sutures were placed, and brought into the abdomen through the 10 mm port.Three number 5¿s were place, two in the anterior axillary line on the right side and a third in the anterior axillary line on the left.The mesh was brought into the abdominal cavity and oriented to cover the hole.The sutures were then brought back out onto the abdominal wall using a suture grasper.They were tied to the fascia.A hernia tacker was then used to tack gore-tex to the abdominal wall in all directions at about a centimeter from the edge.Four other sutures were placed through the mesh and fascia to fix it to the fascia.These were all placed through separate stab wound incisions as were the previous sutures being brought through separate stable wound incisions.Exploration revealed hemostasis was intact.All ports were removed under direct vision.All the stab wound including port sites were closed with 4-0 vicryl in subcuticular fashion.The left upper quadrant 10 mm port site fascia was closed with 0 vicryl in an interrupted fashion.¿ no post-operative medical records were provided.Implant #2 / #3 preoperative complaints: preoperative records were not provided.Implant #2 / #3 procedure: laparoscopic repair of incisional hernia x2.[two devices] gore® dualmesh® plus biomaterial [03839648/1dlmcp04, 15cm x 19cm] and gore® dulamesh® plus biomaterial [03688516/1dlmcp08, 26cm x 34cm].Implant #2 / #3 date: on (b)(6) 2006 [hospitalization unknown.] description of hernia being treated: ¿a pneumoperitoneum was made by using a veress needle in the left upper quadrant after which a #10 was placed in the left upper quadrant and the three 5¿s, one placed in the right upper quadrant, one in the right lower quadrant, and one in the left lower quadrant.Videoscopic examination denoted the patient to have multiple adhesions to the posterior abdominal wall and to the previously placed gore-tex dual mesh.These were all taken down meticulously, adhesions including omentum and small bowel, as well as small bowel mesentery.These were all taken down meticulously.Care was taken to examine the bowel to rule out any type of enterotomy.None were found.The patient was noted to have a hernia which was above the previous repair just to the left of the midline.The patient also was noted to have a port site hernia on the left out lateral to the left upper quadrant port that was placed for this operation.The previously placed hernia patch was collapsed within the hernia that it was used to cover.¿ implant size and fixation: ¿therefore, a large 20 x 20 cm graft was fashioned such to cover the previously placed graft as well as cover the new defect which was to the left of that and superior.This was put in through the left upper quadrant port, oriented, and it was pulled up to the abdominal wall using two stay sutures that had been placed prior to its placement into the abdominal cavity.It was brought up through the abdominal wall and tied thus orienting the graft over the defect.Next, the port site was addressed.This was measured, found to be about 10 x 10; graft was placed into the abdomen and then tacked over it as well.The areas were copiously irrigated.Hemostasis was found to be intact.No evidence of a bowel injury was noted.All ports were removed under videoscopic guidance.The skin of all ports was closed with 4-0 vicryl in a subcuticular fashion with steri-strips and a pressure dressing.¿ relevant medical information: on (b)(6) 2011: ¿wound clinic for a chronic nonhealing wound after a total abdominal hysterectomy.The patient¿s past surgical history is significant for a prior laparoscopic hernia repair that resulted in recurrence and a repeat hernia repair that resulted in recurrence and a repeat hernia repair done laparoscopically.She again developed a chronic wound after the hysterectomy.I initially planned to do a wound debridement and secondary closure.However, she was admitted to the hospital after i saw her in the wound clinic with abdominal pain and suspected mesh infection.She was treated with iv antibiotics and discharge.¿ on (b)(6) 2011: debridement of abdominal wound.¿the necrotic area of defect was excised and it was found that a large amount of pus came pouring from the incision.The defect was probed and the defect extended almost the entire length of her previous skin incision.The skin was opened up to the apex of the defect and cultures were obtained and tissue was obtained for culture as well.The necrotic tissue was debrided down to the bleeding edges and the irrigation device was used to further clean up the wound.¿ explant preoperative complaints: preoperative records were not provided.Explant procedure: unilateral component separation done on the right.Ventral hernia repair.Placement of strattice which is dermis as an abdominal wall implant 320 cm2.Explant date: on (b)(6) 2012.(b)(6), md¿s report: ¿thickened scarred mesh and old granulation tissue seen in the deep soft tissue consistent with a chronic wound and the bowel was stuck to the undersurface of the mesh and thus we called dr.(b)(6) into the operating room to assist with dissection of the bowel off of the abdominal wall and the patient had a small bowel resection.¿ ¿she had an old incision that we excised.We extended the incision superiorly.We dissected down to the level of the fascia and elevated the fascia above the area of the mesh into the abdomen and there were extensive adhesions of the omentum and small bowel to the undersurface of the old mesh.We were able to free up some of the fascia from the mesh enough such that we could began the dissection of the omentum and small bowel off of the undersurface of the mesh.During that dissection she was noted to have bowel adherent to the undersurface of the mesh.There was some bleeding of the serosa with blunt dissection of the bowel off of the undersurface of the mesh.At that point, we asked dr.(b)(6) to come into the operating room.He was on-call for general surgery and he graciously agreed and came and dissected the bowel off of the mesh.The patient ultimately did have a small bowel resection.Please see dr.(b)(6) note for that dictation and dr.(b)(6) also assisted in dissecting some of the soft tissue off of the undersurface of the fascia as well.¿ ¿once the mesh was explanted and of note we did see protak and one of the protak was imbedded in an area just adjacent to the bowel, but once we excised all of the mesh and the protak we were able to begin the abdominal wall reconstruction.She had a large defect and we were able to use the doppler to identify the perforators of the abdominal wall on the right side.We then dissected out laterally past the midline, preserving two perforators that we identified both percutaneously and with direct doppler testing of those vessels and they were found to have a pulsatile flow.Once we were past the semilunar line we incised the external oblique fascia and carried that fascial incision superiorly and inferiorly.At that point we medialized the right muscle and fascial layer toward the left that we did not perform a component separation for and once we felt we could adequately close the defect we took a 20 x 16 piece of strattice and placed it as an underlay under the fascia.That was sewn in placed with interrupted #1 pds suture.We also used some running pds suture as well.Of note, prior to handling the strattice we did prep the skin and change our gloves.Once the strattice was sewn in place, we placed a drain in between the strattice and the fascia and we were able to close the fascia over the strattice and the drain and that was also with #1 pds suture and both running and interrupted sutures were used.At that point, we irrigated the soft tissues.Hemostasis was achieved throughout the case with mostly electrocautery.We placed again a drain in between the strattice and the fascia and then two subcutaneous drains and we did design a vertical panniculectomy on the right side only and excised that skin and subcutaneous tissue and then prepared to close.We closed with 0 vicryl in the scarpa¿s layer with 2-0 vicryl in the deep dermis and subcutaneous layer and then closed the skin with a 2-0 monoderm.¿ (b)(6), md¿s report: ¿dr.(b)(6) got about two-thirds of the mesh out by the time i came down and i encountered some bowel that was stuck to the mesh, so he called me in to assist.When i got there a loop of bowel that was stuck to the mesh that we took down with scissors.The integrity of the wall was intact throughout, but then just below that was another loop and when we looked there was actually a hole.It was sort of a crumpled up piece of mesh and right where it crumpled it was stuck into the bowel.We actually got that piece of bowel out and it had a 1.5 cm defect on the mesenteric side of the small bowel.We then finished taking down the rest of that loop and a couple from the mesh and then removed the mesh from the abdominal cavity.We then freed up the proximal and distal end of that piece of bowel and did a side-to-side functional end-to-end primary anastomosis and we went through the mesentery on either side of the bowel and truncated the bowel with the gia and then we went across the mesentery with gia as well.We sutured the two pieces of bowel together and there was a proximal and distal end and then used the gia two white loads to make our anastomosis.Once done, we closed the hole in the side wall with a gia-60.We then put a couple lembert in to stop the oozing from the suture line and then closed the mesenteric defect with 3-0 silk.Once we finished that, we did some more enterolysis freeing up some of the bowel from the abdominal wall.There was another piece of mesh that was removed by dr.(b)(6) and that terminated my portion of the procedure.¿ relevant information: on (b)(6) 2012: pathology report.Final diagnosis: a) small bowel, resection: portion of small bowel with dense serosal adhesions containing lymphocytes and plasma cells, focal foreign body giant cell reaction and mild acute serositis.Edema and hemorrhage is also noted.Grossly a transmural defect is noted.B) abdominal mesh, excision: foreign body device consistent mesh material.Fibroadipose tissue with fibrosis, foreign-body giant cell reaction and chronic inflammation.C) skin, abdominal scar, excision: skin with dense fibrosis and lymphocytes and plasma cells.On (b)(6) 2012: debridement of skin, subcutaneous tissue, muscle and fascia of abdominal wall 378 cm about.Application of wound v.A.C.Greater than 50 cm2 measured 378 cm.On (b)(6) 2012: debridement of skin, subcutaneous tissue, in preparation for subsequent closure, about 15 cm2 the size of the debridement, application of wound vac to wound that measured at least 400 cm2.On (b)(6) 2012: pathology: ¿a.Soft tissue, abdomen, excision: fibroadipose tissue showing acute and chronic inflammation, fibrosis, and fat necrosis.B.Abdominal fascia, excision: fibroadipose tissue and skeletal muscle showing acute and chronic inflammation and fat necrosis.¿ on (b)(6) 2012: split-thickness skin graft to open abdominal wound 120 cm2.The alleged ¿gore-tex¿ mesh is being captured as gore-tex® soft tissue patch for product surveillance purposes.It should be noted that the instructions for gore-tex® soft tissue patch 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® soft tissue patch is provided sterile.Procedure and specific patient factors may contribute to or cause infection, leading to contamination or infection of the mesh material.The instructions for use further states ¿strict aseptic techniques should be followed.If an infection develops, it should be treated aggressively.An unresolved infection may require removal of the material.¿ 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.Medical records that indicate mesh ¿movement¿ or that the device led to a recurrence may reflect a recurrence as a function of a patient¿s poor tissue quality leading to fascial dehiscence or loss of anchorage of fixation, or may be related to the hernia type, individual patient comorbidities, and technical and procedural aspects of the repair.These factors include but are not limited to, fixation type, mesh shape / sizing used, and defect closure decisions.Additionally, a new, unrelated hernia can occur but may be referred to as a recurrent hernia.The device was not able to be returned to gore for evaluation; therefore, direct product analyses could not be conducted.After multiple requests, product identification information was not provided for device #1 [unknown ¿gore-tex¿] and thus it could not be confirmed to be a gore hernia device.Review of the manufacturing and sterilization records could not be performed as a valid lot number was not provided.In an abundance of caution for product surveillance tracking and trending purposes only, this event has been analyzed, coded and reported as necessary assuming it is a gore hernia device.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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