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W. L. GORE & ASSOCIATES, INC. GORE® DUALMESH® PLUS BIOMATERIAL; MESH, SURGICAL, POLYMERIC
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| Model Number 1DLMCP06 |
| Device Problem
Insufficient Information (3190)
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| Patient Problems
Seroma (2069); No Clinical Signs, Symptoms or Conditions (4582)
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| Event Date 01/27/2017 |
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Event Type
Injury
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Event Description
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It was reported to gore that the patient underwent laparoscopic inguinal hernia repair on (b)(6) 2010 whereby a gore® dualmesh® plus biomaterial was implanted.The complaint alleges that on (b)(6) 2017, an additional procedure occurred whereby the gore device was explanted.It was reported the patient alleges the following injuries: adhesion, perforation, seroma, additional surgery, mesh removal, pain & suffering.Additional event specific information was not provided.
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Manufacturer Narrative
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The plus antimicrobial product coating contains silver carbonate [approximately 800 micrograms per cubic centimeter of product (g/cm3)], and chlorhexidine diacetate [approximately 1600 micrograms per cubic centimeter of product (g/cm3)].Additional details regarding the patient's clinical course were ascertained from a review of medical records and are as follows: implant procedure: laparoscopic bilateral inguinal hernia repair with mesh and laparoscopic repair of multiply recurrent ventral hernia with mesh.Implant: gore® dualmesh® plus biomaterial ref: 1dlmcp06; lot: 7003068.Implant date: (b)(6) 2010 [hospitalization (b)(6) 2010 ¿ discharge date unknown] on (b)(6) 2010: (b)(6) hospital.(b)(6) m.D.Operative report.Preoperative diagnosis: left inguinal scrotal hernia and multiply recurrent ventral hernia.Postoperative diagnosis: left inguinal scrotal hernia, indirect, and right indirect inguinal hernia with multiply recurrent upper midline hernia.Anesthesia: general.Estimated blood loss: none.Specimens: none.Indications: ¿mr.(b)(6) is a (b)(6) gentleman with a previous history of epigastric hernia repairs performed twice with phs mesh.They recurred and he also had what appeared to be a large left inguinal scrotal hernia.Ultrasound demonstrated a possible right inguinal hernia.The decision was made to proceed with laparoscopic repair of all the hernias and proper consent was obtained.¿ procedure: ¿¿a large loban dressing was placed over the entire abdominal wall.The abdomen was entered utilizing a 5-mm optical viewing trocar off the right hypochondrium.Upon safe entry into the abdomen, it was insufflated to 15 mmhg and then inspection of the abdomen was carried out.There were noted to be adhesions to the upper abdomen and the falciform ligament.Attention was turned to the pelvis where it was evident that the patient had a large inguinal scrotal hernia on the left with what appeared to be omentum and large bowel within it.On the right side, there was a smaller right indirect inguinal hernia.Under direct visualization, i placed a 5-mm left lateral trocar and a 10-mm umbilical trocar and the left side was operated on first.The peritoneum was incised horizontally below the level of the umbilicus out laterally.The preperitoneal space was developed down to the level of the indirect inguinal hernia sac which was meticulously and tediously dissected completely back into the abdominal cavity after reducing the large bowel and omentum by external manual pressure.The hernia sac was dissected back into the abdominal cavity.The vas deferens and spermatic vessels were identified and completely parietalized.The patient had a significant amount of fat in the preperitoneal space but we were able to completely de-peritonealize the lower abdomen and expose the psoas muscle out laterally and pubic bone medially.I then placed a 12 x 15 cm piece of soft pro midway to the polypropylene mesh so that it more than adequately overlapped the direct, indirect and femoral spaces.It was tacked to the posterior aspect of the pubic bone, cooper's ligament, superior medially into the posterior aspect of the rectus muscles, superior laterally all above the iliopubic tract.I then tacked the peritoneal flap back up against the anterior abdominal wall for complete closure of the peritoneum and no exposed mesh.Attention was turned to the right side where similarly the peritoneum was incised horizontally.Dissection was carried down to the preperitoneal space down to the level of the indirect inguinal hernia sac which was dissected back into the abdominal cavity completely parietalizing the vas deferens to the spermatic vessels.I completely uncovered the myopectineal orifice completely, uncovered the psoas muscle laterally, the pubic bone and cooper's ligament medially, and connected the dissection over to the left side.I then placed a 12 x 15-cm piece of soft pro midway to the polypropylene mesh so that it more than adequately covered the direct, indirect and femoral spaces.It covered the entire myopectineal orifice.It was tacked to the posterior aspect of the pubic bone superior medially and to the posterior aspect of the rectus muscle overlapping the mesh on the left side and the mesh was tacked to superior laterally all above the iliopubic tract.The mesh lay in good position with no inferior folding.I then placed the peritoneal flap back up against the anterior abdominal wall, tacked it in position and a small rent in the peritoneum inferiorly was suture reapproximated with a 3-0 vicryl suture utilizing intracorporeal suture technique.Attention was then turned to the upper abdomen where a 5-mm trocar was then placed in the right lateral abdomen to divide the falciform ligament superiorly up over the top of the liver.There was noted to be intraperitoneal polypropylene mesh consistent with a phs repair.Adhesions to this were sharply divided with good hemostasis.It was evident the patient had 2 hernia defects in close proximity to each other and the phs mesh was dissected off of the anterior abdominal wall using cautery and dropped down for later retrieval.The hernia defect in the upper abdomen was delineated with spinal needles at the extreme edges superiorly, inferiorly and laterally.The defect measured 8 cm horizontally x 8 cm vertically.This was measured intracorporeally with a metric ruler and the x and y coordinate grid was drawn in the anterior abdominal wall at the hernia defect area.A 12-mm trocar was placed in the left hypochondrium through which to later bring the mesh.I changed to a new set of sterile gloves.An 18 x 24-cm piece of dualmesh plus biomaterial was trimmed to 18 x 18.A gore cv- 0 suture was placed at each edge of the mesh and the mesh rolled tightly and brought in directly through the 12-mm trocar with no contact to the skin.The mesh was unfurled in the abdominal cavity and measuring a 5-cm overlap above the superior transabdominal needle, the superior transabdominal suture was retrieved along the y axis.Measuring a 5-cm overlap left lateral along the x axis, the left lateral transabdominal suture was retrieved.With these 2 sutures held taut, the inferior aspect of the mesh was stretched inferiorly into the lower abdomen and the inferior transabdominal suture retrieved along the y axis.With these 3 sutures held taut, the mesh was in good position and all 3 sutures were tied down.The right lateral aspect of the mesh was then stretched towards the right lateral abdomen along the right abdomen on the x axis.The right lateral transabdominal suture was retrieved and tied.Pneumoperitoneum was decided and then i tacked the mesh circumferentially around this entire perimeter approximately every 2 cm apart.I then placed a double crown second ring of sutures to the more medial aspect just lateral to the hernia defect edge circumferentially.I then placed additional #1 novafil sutures into each quadrant of the mesh for a total of 8 transabdominal fascial sutures and multiple protack fixation devices holding the mesh in position.The abdomen was inspected completely.There was good hemostasis of the operative field.I then completely removed the excised polypropylene mesh through the 12-mm trocar in the left hypochondrium.This was brought out completely after having to enlarge the fascia a bit.It was passed off the field.The abdomen was cleared.The umbilical trocar site defect was closed with #1 novafil suture on a suture passer using a figure-of-eight technique.The 12-mm trocar was removed from the right lateral abdomen and the abdomen was completely desufflated.The left lateral trocar incision from the 12 mm trocar rose up above the ribs and did not require fascial closure but nevertheless, i did place a figure-of-eight 0 vicryl suture simply to reapproximate the muscle which was dilated.I then closed the skin with 4-0 monocryl and dermabond skin glue.The patient tolerated the procedure well and was transferred to the recovery room in stable and satisfactory condition." on (b)(6) 2010: (b)(6).Implant sticker: gore® dualmesh® plus biomaterial ref: 1dlmcp06; lot: 7003068, w.L.Gore & associates.Size: 18 cm x 24 cm, expiration date: n/a, quantity: 1.On (b)(6) 2010: (b)(6).Implant sticker: ethicon prolene soft.Product code: 8pmh, lot: che449, size 6¿ x 6¿.Ethicon prolene soft.Product code: 8pmh, lot: che449, size 6¿ x 6¿.Quantity: 2.The records confirm gore® dualmesh® plus biomaterial (ref: 1dlmcp06; lot: 7003068) was implanted during the procedure.Relevant medical information: no interim medical records.Explant procedure: open recurrent incisional hernia repair.Bilateral rectus myofascial release.Removal of prior intraperitoneal mesh.Implantation of mesh.Scar revision 15 x 30 cm excision of skin.Explant date: (b)(6) 2017 [hospitalization: (b)(6) 2017].On (b)(6) 2017: (b)(6) hospital.(b)(6) m.D.Operative report.Pre- and postoperative diagnosis: recurrent incisional hernia.Anesthesia: general and postoperative pain block.Estimated blood loss: 250 ml.Specimens: mesh from abdomen.Drains: 19 fr.Blake drain in the retromuscular position.19 fr.Blake drain in the subcutaneous position.Indications: ¿multiply recurrent incisional hernia with loss of abdominal domain and prior intraperitoneal mesh.Underwent progressive preoperative pneumoperitoneum.¿ findings: hernia location: subxiphoid epigastric.Hernia size: 13 x 13 cm.Mesh size & type: 27 x 28 cm atrium vitamesh (mid-weight, wide-pore polypropylene).Mesh position: retromuscular.Myofascial releases: bilateral rectus myofascial release (rives-stoppa).Procedure: "¿a midline incision was made and dissection was carried down through subcutaneous tissue.The abdomen was entered safely.There were multiple omental adhesions.Her right colon and the terminal ileum was reduced from the subcutaneous hernia sac in the right abdomen.A meticulous and tedious sharp lysis of adhesions was carried out and the herniated viscera were all delivered back into the native peritoneal cavity.This was completed with no injury to the viscera.After the anterior abdominal wall was cleared off of all adhesions, a large safety towel was placed over the viscera to protect them.The prior intraperitoneal gore dualmesh was identified.It was intact and adherent to the left lateral abdomen but unattached from the right lateral abdomen.There was a large seroma on the underside of the mesh.Seroma cavity was entered.It had particulate matter as a well as straw-colored fluid.This was aspirated dry.The mesh was subsequently excised off the abdominal wall utilizing out cautery removing all of the transabdominal fascial sutures of gore-tex as well as polypropylene.All of the visible protack fixation points were also removed.She was passed off the field.The hernia defect was located in the subxiphoid, epigastric regions.The total hernia defect area was measured as 13 cm horizontal and 13 cm vertical.A rectus myofascial release (rives-stoppa) was performed on the left side.The posterior rectus sheath was incised just lateral to the hernia edge.This incision in the posterior rectus sheath was extended both cephalad and caudal to the hernia defect.Superiorly, the dissection was carried up into the retro-xiphoid space and under the costal margin.Dissection was carried out laterally in the retromuscular plane to the edge of the rectus sheath peeling away the posterior rectus sheath from the underside of the rectus muscle.The segmental innervation to the rectus muscle was preserved.The rectus myofascial release accomplished medialization of the posterior rectus sheath towards the midline and release of the rectus muscle from its encasement in the rectus sheath, allowing for widening of the rectus muscle and advancement towards the midline.A rectus myofascial release (rives-stoppa) was performed on the right side.The posterior rectus sheath was incised just lateral to the hernia edge.This incision in the posterior rectus sheath was extended both cephalad and caudal to the hernia defect.Superiorly, the dissection was carried up into the retro-xiphoid space and under the costal margin.Dissection was carried out laterally in the retromuscular plane to the edge of the rectus sheath peeling away the posterior rectus sheath from the underside the rectus muscle.The segmental innervation to the rectus muscle was preserved.The rectus myofascial release accomplished medialization of the posterior rectus sheath towards the midline and release of the rectus muscle from its encasement in the rectus sheath, allowing for widening of the rectus muscle and advancement towards the midline.The towel was removed and the posterior fascia was reapproximated in the midline with a continuous 2-0 pds suture.The retromuscular plane was copiously irrigated with warm normal saline.There was good hemostasis of the operative field.A new set of sterile gloves were used prior to handling the mesh.A piece of atrium vitamesh wide pore polypropylene mesh was brought into the operative field and sized to 27 x 28 cm.The mesh was fixated superiorly, to the posterior aspect of the xiphoid process with 2-0 prolene suture.The upper lateral aspects of the mesh were sutured along the costal margin with 2-0 prolene suture.The inferior aspect of the mesh was fixated in the inferior abdomen at its corners utilizing 2-0 pds suture, full -thickness through the abdominal, utilizing the reverdin needle.Laterally, the mesh was fixated with 2-0 pds suture to the lateral abdominal wall.The mesh space was irrigated with a clindamycin/gentamicin irrigation solution.A single 19 french blake drain was placed in the retromuscular position.The rectus muscles were re-approximated in the midline utilizing a continuous #1, looped pds suture taking 5 mm bites of the fascia with 5 mm advancement.The fascia came together well.The subcutaneous tissue was irrigated with the antibiotic irrigation solution.The hernia sac was excised with cautery from the subcutaneous cutaneous tissue on the left.A massive hernia sac was excised from the right lateral abdomen with cautery as well.The hernia sac on the right extended to the anterior superior iliac spine.Due to the redundancy of the skin in the right abdomen it was excised.A portion of skin measuring 15 cm wide by 30 cm in vertical dimension was sharply excised to healthy bleeding edges.A single 19 french blake drain was placed in the subcutaneous position¿" on (b)(6) 2017: (b)(6).Implant information: 27 x 28 cm atrium vitamesh (mid-weight, wide-pore polypropylene).On (b)(6) 2017: (b)(6) hospital.(b)(6) m.D.Pathology report.Specimen: a.Mesh from abdomen.Final diagnosis: mesh from abdomen: benign fibroadipose tissue with hyalinization, foreign body giant cells with intracellular polarizable debris, hemosiderin, and adherent fibrin mesh (gross diagnosis).Gross description: mesh from abdomen: received fresh and placed in formalin, labeled as "mesh from abdomen.(b)(6)", is a 15 x 12 x 2.5 cm portion of pink-yellow, membranous soft tissue that is received in a saccular configuration.A mild amount of tan-yellow; serous fluid is identified within the saccular component as well as a pink-tan, fibrinous tissue.Multiple areas of silver, metallic wiring and tan-white, mesh-iike material are identified throughout the soft tissue.No distinct nodules or masses are grossly identified throughout the specimen.Multiple representatives of the specimen are submitted in block a1.Microscopic description: this is a benign fibrotic soft tissue with areas of hyalinization, patchy chronic inflammation and adherent fibrin.In addition, there are detached portions of fibrin and hemorrhage.Synthetic material along the surface is noted.Scant mature adipose tissue is also present.Negative for malignancy.A potential relationship, if any, between the alleged injuries or complications and the gore device has not been established at this time based on available information.It should be noted that the gore® dualmesh® plus biomaterial instructions for use addresses the following adverse reactions among others: ¿possible adverse reactions with the use of any tissue deficiency prosthesis may include, but are not limited to, contamination, infection, inflammation, adhesion, fistula formation, seroma formation, hematoma, and recurrence.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 a legal admission by anyone that the product described in this report has any defects or has malfunctioned, as defined from a legal standpoint.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 investigation findings code.Conclusion code remains unchanged.It should be noted that the gore® dualmesh® plus biomaterial instructions for use addresses the following adverse reactions among others: ¿possible adverse reactions with the use of any tissue deficiency prosthesis may include, but are not limited to, contamination, infection, inflammation, adhesion, fistula formation, seroma formation, hematoma, and recurrence.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.H6: corrected health effect - impact code.
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Manufacturer Narrative
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H6: updated health effect h6: updated investigation finding h6: updated type of investigation h6: updated investigation conclusions.The investigation has been completed.Based upon the totality of the information received over the course of the investigation and reported by gore in the previously submitted medical record narratives the following conclusions have been reached.As previously reported, all pertinent medical records requested may not have been received.Through gore's investigation and based on the available information 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.Therefore, this event is being coded as no clinical signs, symptoms or conditions, no health consequences or impact and will be closed as no problem detected.Previous patient codes were reported based on the original complaint and are no longer applicable and/or not reportable per gore¿s investigation.Following gore¿s investigation, the previously submitted annex f code has been updated to reflect gore¿s final conclusion.It should be noted that the gore® dualmesh® plus 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.¿ 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, compromised device biocompatibility, contamination which may lead to patient harms, device damage, dysphagia, erosion or extrusion and related harms, exposure or protrusion and related harms, fever, fistula, gerd recurrence, defect recurrence and related harms, ileus, increased procedure time and related harms, irritation or inflammation, infection, mesh migration, mesh contraction, pain, paresthesia, perforation, revision/re-intervention, seroma or hematoma and related harms, tissue ischemia, wound complications and wound dehiscence and additional intervention including surgery.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.C1: the plus antimicrobial product coating contains silver carbonate [approximately 800 micrograms per cubic centimeter of product (g/cm3)], and chlorhexidine diacetate [approximately 1600 micrograms per cubic centimeter of product (g/cm3)].W.L.Gore & associates, inc.(gore) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by gore, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Blank fields present on this report include required fields and fields determined to be not applicable.Blank required fields indicate that the information was not provided, was deemed unavailable or was not applicable.This report does not constitute an admission or a conclusion by fda, gore, or its associates that the device, gore or its associates caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects" or has "malfunctioned".These words are included in the report and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.
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