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| Model Number 1DLMC03 |
| Device Problems
No Apparent Adverse Event (3189); Insufficient Information (3190)
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| Patient Problems
Adhesion(s) (1695); Pain (1994); Obstruction/Occlusion (2422); Not Applicable (3189)
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| Event Date 10/24/2006 |
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Event Type
Injury
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Manufacturer Narrative
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(b)(4).It should be noted that the gore dualmesh® biomaterial instructions for use includes warnings and addresses the following adverse reactions among others: ¿possible adverse reactions with the use of any tissue deficiency prosthesis may include, but are not limited to, contamination, infection, inflammation, adhesion, fistula formation, seroma formation, hematoma, and recurrence.¿.
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Event Description
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It was reported to gore that the patient underwent ventral incisional hernia repair on (b)(6) 2005, whereby a gore dualmesh® biomaterial was implanted.It was reported to gore that the patient underwent ventral incisional hernia repair on (b)(6) 2006, whereby a gore dualmesh® biomaterial was implanted.The complaint alleges that on (b)(6) 2006, an additional procedure was performed whereby explant of the gore device was performed.The complaint alleges that on (b)(6) 2011, an additional procedure was performed whereby explant of the gore device was performed.It was reported the patient alleges the following injuries: abdominal pain, difficulty eating, dense adhesions, multiple small bowel obstructions, hernia recurrence, mesh revision surgery, mesh removal surgeries.Additional event specific information was not provided.
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Manufacturer Narrative
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Pma/510k: corrected date.Updated results code.Conclusion code remains unchanged.
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Manufacturer Narrative
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A2: added date of birth.B7: added medical history.H6: conclusion code remains unchanged.Additional details regarding the patient's clinical course were ascertained from a review of medical records and are as follows: records prior to 2001, including records detailing the origin of the ¿right paramedial incision¿ noted in the (b)(6)2001 records, were not provided.Operative records dated (b)(6)2001 indicate the patient underwent ventral hernia repair and excision of an intramuscular lipoma of the right thigh.The records state: ¿the abdomen was exposed.The patient had a right paramedial incision through which a hernia could easily be palpated.The old scar was excised together with some of the fat tissue.The hernia sac was promptly visualized.The hernia sac was dissected and the contents were checked.No bowel was present.The hernia was easily reducible.We opened the abdominal cavity and evaluated the abdominal cavity.This patient had quite a few adhesions in the right upper quadrant and some in the right lower quadrant.Some were creating some potential for an internal hernia.These adhesions were easily dissected and removed.We also checked the right and left ovary, which appeared to be normal.We also checked the uterus, which was a normal size and had no signs of pathology whatsoever.The stomach was normal.The liver was normal.After all the adhesions were dissected the abdominal wall was closed in layers and this portion of the procedure was completed.¿ records between 2001 and 2004 were not provided.Operative records dated (b)(6)2004 state the patient underwent ventral hernia repair and excision of a lipoma of the abdominal wall.The records state: ¿a midline incision was done.This was medial to the lipoma, which was basically in the right upper quadrant just on top of the ventral hernia.The skin and subcutaneous tissues were incised and reaching the fascia we were able to see there were multiple small hernias through the midline and some of the incision had basically given away to the omentum, which was infiltrating those gaps.All these adhesions and omentum were dissected and the abdominal cavity was entered.Upon entering we were able to see that the hernia was continued down to under the umbilical area as well as superiorly.There were adhesions of the omentum throughout the entire abdominal wall and these adhesions were easily taken care of and dissected.Once the hernia was completely isolated we started dissecting the lipoma going subcutaneous just above the fascia from the right side and because we wanted to avoid a second incision we dissected pretty much about three inches toward the right side from the upper midline incision.Once the lipoma was excised small bleeders were cauterized and repair of the hernia was done with interrupted running sutures of prolene.This skin was then approximated with staples.¿ operative records dated (b)(6)2005 state the patient underwent recurrent incisional hernia repair with mesh.The records state: ¿there was a clear incisional hernia in the upper abdomen.Excision of the old scar was done with an elliptical incision.Evaluation of the defect was done.There were multiple defects within the midline through which one the colon was actually protruding, as well as omentum.The abdominal cavity was entered.We dissected all the adhesions with the anterior abdominal wall.We were able to see that part of the omentum was trapped and appeared to be chronically inflamed, so partial omentectomy was done of the omentum trapped.After we made sure there were no other defects repair of the hernia was done using a duo [sic] mesh.The mesh was fixed to the posterior aspect of the anterior abdominal wall with nurolon sutures.Once this was done the fascia itself was closed over the mesh with a running suture of prolene.The subcutaneous tissue was approximated with 3-0 vicryl.The skin was approximated with staples.¿ the records indicate a gore dualmesh® biomaterial (1dlmc03/03996764) was implanted during the procedure.Operative records dated (b)(6)2006 indicate the patient underwent recurrent hernia repair with mesh.The records state: ¿the abdomen was exposed.An upper midline incision was present from previous scar from previous hernia repair.We could easily see the hernia and was also seen on ct scan.The old scar was removed.The skin and subcutaneous tissue were incised.As we reached the mesh itself we were able to see that in the lower portion the hernia had pulled away from the tissue creating herniation.We had to dissect the mesh away to reach fresh, new margins.We evaluated the new hernia defect.We definitely need a larger piece of mesh, which was used to do the repair.This mesh was fixed with interrupted suture of surgilon and then a running suture of prolene to obtain a good firmer repair.After this was done the wound was irrigated with antibiotic solution.The subcutaneous tissue was reapproximated with vicryl.The skin was approximated with staples.¿ the records indicate a gore dualmesh® biomaterial (1dlmc03/04380836) was used during the procedure.There was no mention of infection and no mention of gore device removal in the records.Records between 2006 and 2009 were not provided.Operative records dated(b)(6)2009 indicate the patient underwent laparotomy, lysis of adhesions, ventral hernia repair, and excision of a 4 cm tumor of the right ankle.Post operative diagnoses state: ¿1.Partial small bowel obstruction secondary to adhesions.2.Ventral hernia.3.Tumor of the right ankle ¿ 4 cm.¿ the (b)(6)2009 operative report states: ¿the abdomen was exposed.A midline incision was done through the old scar.We were able to enter the cavity.This patient had a previously gore-tex mesh.However, very few adhesions were in the mesh itself but there was herniation at the edge of the lower edge of the mesh where some of the bowels were trapped and kinked.The bowels had to be dissected and the adhesions were completely removed.After that we were able to dissect completely the other adhesions from the abdominal wall which included omentum and small bowel.Once all of the adhesions were completely dissected we checked the bowels.They appeared to be kinked but there was no distention of the bowels proximally to that.So, we started the repair and basically we closed the hernia defect with a running suture of prolene.The mesh which had been cut in the middle was reapproximated again using prolene sutures.Once this was done, the wound was irrigated with antibiotic solution and the skin was closed with staples.¿ there was no mention of infection or removal of the gore device in the records.Records between 2009 and 2011 were not provided.Operative records dated (b)(6)2011 indicate the patient underwent ventral hernia repair with mesh and lysis of adhesions.The records state: ¿an incision was carried out to excise the old scar where the hernia was also present.This was thought to facilitate the healing because we got good healthy tissue.This patient was quite obese, so that took quite some time until we reached the fascia and the edge of the mesh.The patient had previously inserted mesh, so we tried to remove the old mesh as well.As this was done, we entered the abdominal cavity and we were able to see indeed there were multiple adhesions between the omentum and the mesh itself, as well as the small bowel and the mesh.So this had to be painstakingly dissected until we were able to completely remove the old mesh and leave the defect.¿ the (b)(6)2011 operative report states: ¿the defect was about 20 centimeters wide x 25 centimeters long and definitely there was no way we could put it together without mesh.So dissection of the subcutaneous tissue was done to facilitate also the overlapping of the subcutaneous tissue over the mesh.Once this was done, small bleeders were cauterized.The wound was irrigated.The mesh was fixed with interrupted sutures of braylon and we used parietex dual-type of mesh with the smooth side toward the bowels.Also to facilitate the connection between the mesh and the wall we used to protack with absorbable tacks so we did not have to have any gap between the stitches.Once this was done, some retention sutures were used to approximate the full thickness dissected subcutaneous tissue and then subcutaneous stitches interrupted were used for the edges of the subcuticular closure and the skin was then approximated with staples.¿ the records indicate a non-gore device was used during the procedure.There was no mention of infection.Additionally, it is unclear from the medical records if both implanted gore dualmesh® biomaterial devices were removed during this procedure.Operative records dated (b)(6)2011 state the patient underwent release of a small bowel obstruction.The records state: ¿the abdomen was exposed.Patient had staples from a recent surgery for ventral hernia repair with mesh.The staples and some retention sutures were removed and we were able to basically divide the skin and subcutaneous tissue.As soon as we did that we realized in the lower portion of the incision there were small bowel loops which were trapped there.As we dissected small bowel loops from the surrounding tissue and some actually were adherent to the mesh on the outside, we realized that all these small bowel loops were coming out from a disruption of the repair between the mesh and the lower aspect of the incision.There was no new herniation.So we dissected all the bowels and we were able to push back into the abdominal cavity.We freed up the edges and then re-approximation of the mesh to the edges of the tissue, which was healthy was done with interrupted suture with nylon.Once this was done the subcutaneous tissue was irrigated with antibiotics solution.A jackson-pratt was left in place and then the skin was approximated with interrupted suture of 0-prolene and staples.¿ there was no mention of infection or device removal in the records.Records between 2011 and 2016 were not provided.Operative records dated (b)(6)2016 state the patient underwent ¿laparotomy and massive lysis of adhesions¿ for a diagnosis of ¿abdominal pain secondary to adhesions, massive adhesions.¿ the records state: ¿the abdomen was exposed.There was an upper midline incision, which basically old scar was removed, also a transverse incision, which had been removed of the umbilicus done at a different institution, so were knew [sic] we were ready for lots of adhesions.Skin and subcutaneous tissues were cut and then the fascia area was replaced by this thick fascia, which we had to dissect.As we dissected the thick fascia, we expected to find the preperitoneal fat.A second mesh there was found.This was adherent to the bowels, so we had to pay attention to dissect the bowels and the omentum away from the second layers, the inner layer of mesh.Once we did all this, finally we entered the abdominal cavity.We opened up the incision up and down.All the adhesions between the omentum and the anterior abdominal wall, as well as small bowel and anterior abdominal wall, were done.We starting [sic] running the small bowel.¿ the (b)(6)2016 records continue: ¿we were able to see some area of small bowels really twisted to itself.Basically what happened, i guess during the last surgery, she did have part of the mesh removed and some of the mesh was left onto the intestinal wall creating a lot of adhesions which were quite tenacious, not enough to block her, but i am sure responsible for her pain.So what we did was just dissect as much as we could.We ran from the treitz to the ileocecal area, and once this was completely released, finally we were able to reapproximate the incision with a running suture of prolene.Multiple running sutures of prolene 1 were used to approximate the skin edges.Subcutaneous tissue was approximately [sic] with vicryl and the skin was approximated with staples.¿ there are no records detailing the patient¿s complaints of abdominal pain and difficulty eating.A potential relationship, if any, between the alleged injuries or complications and the gore device is unclear from the provided information at this time.It should be noted that the gore dualmesh® biomaterial instructions for use includes warnings and addresses the following adverse reactions among others: ¿possible adverse reactions with the use of any tissue deficiency prosthesis may include, but are not limited to, contamination, infection, inflammation, adhesion, fistula formation, seroma formation, hematoma, and recurrence.W.L.Gore & associates, inc.(gore) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by gore, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Blank fields present on this report include required fields and fields determined to be not applicable.Blank required fields indicate that the information was not provided, was deemed unavailable or was not applicable.This report does not constitute an admission or a conclusion by fda, gore, or its associates that the device, gore or its associates caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ""defects"" or has ""malfunctioned"".These words are included in the report and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.".
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Manufacturer Narrative
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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.Previous patient codes (1695, 1994, 2240, 2422, 3191 used for ¿difficulty eating¿) were reported based on the original complaint and are no longer applicable and/or not reportable per gore¿s investigation.The following information was determined from the medical records.Medical records: ¿ the known medical records span november 12, 2001 through august 1, 2016 and not all records received in this time span are relevant to the gore® dualmesh® biomaterial.¿ records from november 13, 2001 through august 16, 2004; from october 24, 2006 through september 11, 2009; from september 11, 2009 through june 14, 2011 were not provided.Prior surgical procedures: ¿ (b)(6) 2001: ventral hernia repair and excision of intramuscular lipoma of right thigh ¿ (b)(6) 2004: ventral hernia repair and excision of a lipoma of the abdominal wall implant #1 procedure: recurrent incisional hernia repair with mesh.Implant: gore® dualmesh® biomaterial ((b)(6)/1dlmc03) 10cm x 15cm, oval.Implant #1 date: (b)(6) 2005 [hospitalization dates unknown] ¿ description of hernia being treated: ¿¿there was a clear incisional hernia in the upper abdomen.Excision of the old scar was done with an elliptical incision.Evaluation of the defect was done.There were multiple defects within the midline through which one the colon was actually protruding, as well as omentum.The abdominal cavity was entered.We dissected all the adhesions with the anterior abdominal wall.We were able to see that part of the omentum was trapped and appeared to be chronically inflamed, so partial omentectomy was done of the omentum trapped.After we made sure there were no other defects repair of the hernia was done using a duo [sic] mesh.¿ ¿ implant size and fixation: ¿the mesh was fixed to the posterior aspect of the anterior abdominal wall with nurolon sutures.Once this was done the fascia itself was closed over the mesh with a running suture of prolene.The subcutaneous tissue was approximated with 3-0 vicryl.The skin was approximated with staples.¿ ¿ no post-operative records were provided.Explant #1/implant #2 procedure: recurrent hernia repair with mesh.Implant: gore® dualmesh® biomaterial ((b)(6)/1dlmc03) 10cm x 15cm, oval.Explant #1/implant #2 date: (b)(6) 2006 [hospitalization dates unknown] ¿ ¿the abdomen was exposed.An upper midline incision was present from previous scar from previous hernia repair.We could easily see the hernia and was also seen on ct scan.The old scar was removed.The skin and subcutaneous tissue were incised.As we reached the mesh itself we were able to see that in the lower portion the hernia had pulled away from the tissue creating herniation.We had to dissect the mesh away to reach fresh, new margins.We evaluated the new hernia defect.We definitely need a larger piece of mesh, which was used to do the repair.This mesh was fixed with interrupted suture of surgilon and then a running suture of prolene to obtain a good firmer repair.After this was done the wound was irrigated with antibiotic solution.The subcutaneous tissue was reapproximated with vicryl.The skin was approximated with staples.¿ ¿ no post-operative records were provided.Relevant medical information: ¿ (b)(6) 2009: laparotomy, lysis of adhesions, ventral hernia repair, and excision of a 4 cm tumor of the right ankle ¿a midline incision was done through the old scar.We were able to enter the cavity.This patient had a previously gore-tex mesh.However, very few adhesions were in the mesh itself but there was herniation at the edge of the lower edge of the mesh where some of the bowels were trapped and kinked.The bowels had to be dissected and the adhesions were completely removed.After that we were able to dissect completely the other adhesions from the abdominal wall which included omentum and small bowel.Once all of the adhesions were completely dissected we checked the bowels.They appeared to be kinked but there was no distention of the bowels proximally to that.So, we started the repair and basically we closed the hernia defect with a running suture of prolene.The mesh which had been cut in the middle was reapproximated again using prolene sutures.Once this was done, the wound was irrigated with antibiotic solution and the skin was closed with staples.¿ explant #2 procedure: ventral hernia repair with mesh and lysis of adhesions explant #2 date: (b)(6) 2011 [hospitalization dates unknown] ¿ ¿an incision was carried out to excise the old scar where the hernia was also present.This was thought to facilitate the healing because we got good healthy tissue.This patient was quite obese, so that took quite some time until we reached the fascia and the edge of the mesh.The patient had previously inserted mesh, so we tried to remove the old mesh as well.As this was done, we entered the abdominal cavity and we were able to see indeed there were multiple adhesions between the omentum and the mesh itself, as well as the small bowel and the mesh.So this had to be painstakingly dissected until we were able to completely remove the old mesh and leave the defect.The defect was about 20 centimeters wide x 25 centimeters long and definitely there was no way we could put it together without mesh.So dissection of the subcutaneous tissue was done to facilitate also the overlapping of the subcutaneous tissue over the mesh.Once this was done, small bleeders were cauterized.The wound was irrigated.The mesh was fixed with interrupted sutures of braylon and we used parietex dual-type of mesh with the smooth side toward the bowels.Also to facilitate the connection between the mesh and the wall we used to protack with absorbable tacks so we did not have to have any gap between the stitches.Once this was done, some retention sutures were used to approximate the full thickness dissected subcutaneous tissue and then subcutaneous stitches interrupted were used for the edges of the subcuticular closure and the skin was then approximated with staples.¿ ¿ records indicate a non-gore device was implanted during the (b)(6) 2011 procedure.Relevant medical information: ¿ (b)(6) 2011: release of a small bowel obstruction ¿patient had staples from a recent surgery for ventral hernia repair with mesh.The staples and some retention sutures were removed and we were able to basically divide the skin and subcutaneous tissue.As soon as we did that we realized in the lower portion of the incision there were small bowel loops which were trapped there.As we dissected small bowel loops from the surrounding tissue and some actually were adherent to the mesh on the outside, we realized that all these small bowel loops were coming out from a disruption of the repair between the mesh and the lower aspect of the incision.There was no new herniation.So we dissected all the bowels and we were able to push back into the abdominal cavity.We freed up the edges and then re-approximation of the mesh to the edges of the tissue, which was healthy was done with interrupted suture with nylon.¿ conclusion: it should be noted that the gore® dualmesh® biomaterial instructions for use includes warnings and addresses the following adverse reactions among others: ¿possible adverse reactions with the use of any tissue deficiency prosthesis may include, but are not limited to, contamination, infection, inflammation, adhesion, fistula formation, seroma formation, hematoma, and recurrence.¿ the instructions for use further state: ¿use only nonabsorbable sutures, such as gore-tex® suture, with a noncutting needle (such as taper or piercing point) of appropriate size to anchor the device.The use of absorbable sutures may lead to inadequate anchoring of gore® dualmesh® plus biomaterial to the host tissue and necessitate reoperation.For best results, use monofilament sutures.Suture size should be determined by surgeon preference and the nature of the reconstruction.¿ 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.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 above inherent risks are typically detailed in standard informed consent documents.The devices were 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 lots met all pre-release specifications.All available information has been placed on file for use in product surveillance tracking, trending and follow-up.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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