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W. L. GORE & ASSOCIATES, INC. GORE® DUALMESH® PLUS BIOMATERIAL; MESH, SURGICAL, POLYMERIC
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| Model Number 1DLMCP04 |
| Device Problem
Insufficient Information (3190)
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| Patient Problems
Hernia (2240); No Clinical Signs, Symptoms or Conditions (4582)
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| Event Date 06/27/2008 |
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Event Type
Injury
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Manufacturer Narrative
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It should be noted that the gore® dualmesh® biomaterial instructions for use addresses the following adverse reactions among others: ¿possible adverse reactions with the use of any tissue deficiency prosthesis may include, but are not limited to, contamination, infection, inflammation, adhesion, fistula formation, seroma formation, hematoma, and recurrence." the gore® dualmesh® biomaterial instructions for use also 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.".
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Event Description
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It was reported to gore that the patient underwent open ventral hernia repair on (b)(6) 2006 whereby a gore® dualmesh® plus biomaterial was implanted.The complaint alleges that on (b)(6) 2008, an additional procedure occurred whereby the gore device was explanted.It was reported the patient alleges the following injuries: additional surgery, hernia recurrence, mesh migration or erosion, scar tissue sticking together, severe pain near hernia site.Additional event specific information was not provided.
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Manufacturer Narrative
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Additional details regarding the patient's clinical course were ascertained from a review of medical records and are as follows: implant procedure: repair: recurrent complex ventral abdominal incisional hernia, status post previous mesh hernia plasty complex ventral abdominal incision hernia.Implant: gore® dualmesh® plus biomaterial [1dlmcp03/03737668].Implant date: (b)(6) 2006 (hospitalization [ni]) on (b)(6) 2006: (b)(6) medical center.(b)(6) , md.Operative report.Preoperative diagnosis: recurrent complex ventral abdominal incisional hernia, status post previous mesh hernia plasty complex ventral abdominal incision hernia.Postoperative diagnosis: recurrent complex ventral abdominal incisional hernia, status post previous mesh hernia plasty complex ventral abdominal incision hernia.Assistant: rebecca l.Schindler, pa-c.Anesthesia: general anesthesia.Estimated blood loss: minimal.Complications: none.Specimens: none.Drains: 19 french blake drain in the subcutaneous tissue x1.Disposition: tolerated well, went to recovery room extubated in good condition.Description of procedure: ¿the patient¿s operative position was supine.Her abdomen was prepared with duraprep and disposable paper drapes.The patient had a long midline incision.Her previous hernia repair centered on the upper two-thirds of her previous midline incision.The new hernia was between the 6 o¿clock inferior portion of the previously placed mesh and the inferior suprapubic fascia.The hernia repair previously done in january was otherwise intact superiorly and on the right and left lateral sides.For that reason, i excised the bottom aspect of the previous excision and extended it down on the lower midline of the abdomen.I dissected straight vertically down through the subcutaneous tissue and through the hernia sac into the hernia space.I then resected the hernia sac circumferentially completely.I skeletonized the fascia identifying excellent fascia on the left lateral, right lateral and inferior sides.Superiorly i identified the inferior edge of the previously placed gore-tex mesh.I then performed adhesiolysis between the bowel and underlying fascial edges and completely cleared the abdominal wall.Superiorly there was a fibrous sheath of tissue up against the dual gore-tex mesh and this was dissected off the inferior surface, exposing the old mesh itself.I then brought in a new piece of dual gore-tex mesh, placing it 2 cm beyond the edge of the fascia on the left lateral, right lateral and inferior sides and 2 cm beyond the edge of the gore-tex above.I sutured it by placing a 0 prolene suture through the abdominal fascia down to the mesh, back up through the mesh and back up to the abdominal wall and tying them circumferentially.I did this with a parachute technique and did not tie any of the sutures until i had completely elevated the mesh against the abdominal wall.On the superior side obviously, i was sewing mesh to mesh.I then closed the overlying fascia with interrupted 0 prolene sutures.I then placed a deep drain through a separate stab incision.This was a 19 french drain device of a blake type and it was anchored to the skin with silk suture.The deep subcutaneous tissues were closed with interrupted 2-0 monocryl sutures.The dermis was closed with interrupted 3-0 monocryl sutures.The skin was closed with a running 4-0 monocryl.The skin was then sealed with indermil.Tegaderm and gauze dressing were placed at the drain site.The patient was taken to the recovery room in excellent condition, having tolerated the procedure well.¿ on (b)(6) 2006: (b)(6) medical center.Implant sticker.Gore® dualmesh® plus biomaterial.Ref catalogue number: 1dlmcp03.Lot batch code: 03737668.W.L.Gore & associates.The records confirm a gore® dualmesh® plus biomaterial (1dlmcp03/03737668) was implanted during the procedure.Explant procedure: lysis of adhesions, 150 minutes.Removal of implanted mesh.Repair of recurrent incarcerated incisional hernia.Implantation of mesh.Explant date: (b)(6) 2008 (hospitalization [ni]).On (b)(6) 2008: (b)(6) hospitals.(b)(6) , md.Operative report.Preoperative diagnosis: recurrent incarcerated incisional hernia.Postoperative diagnosis: recurrent incarcerated incisional hernia.Teaching surgeon: (b)(6) , md.Resident surgeon: (b)(6) , md.Assistants: none.Anesthesia: general anesthesia, plus epidural.Specimens: explant mesh.Estimated blood loss: 400 ml.Indications for surgery: the patient has a highly symptomatic recurrence of a previously repaired incisional hernia.She has diastasis recti in her upper abdominal scar, a large hernia bulge and visible and ct scan-document detachment of the previously implanted mesh in the lower abdomen.Operative findings: 1) recurrent incisional hernia with incarceration of small bowel (4 herniation sites); 2) partially detached mesh with minimal residual fixation to midline fascia; 3) intact upper midline fascia.Procedure: ¿the patient undergoes placement of an epidural catheter preoperatively.She then undergoes general anesthesia without difficulties.She has received antibiotics, prophylactic heparin.She is sensitive to latex.Therefore, latex-free operating room equipment is used.After induction of general anesthesia, a foley catheter is placed.The patient is prepped and draped in the usual sterile fashion.The old midline scar is opened.The umbilicus can be left intact.The abdomen is entered at the site of a superior herniation site.The previously implanted mesh can be easily identified.It is wrinkled up substantially in its upper and lower portions.Within these mesh wrinkles, small intestine is incarcerated.With meticulous lysis of adhesions (150 minutes), the bowel can be freed from the abdominal wall and the overlying mesh.The mesh prosthesis is then removed.This can be achieved without tissue loss and without bleeding.The hernia sacs are excised from the subcutaneous tissue.Once hemostasis is complete, the small bowel loops are placed back into the abdomen and the omentum is carefully draped on top of it.Both rectus sheaths are then opened above the umbilicus.The rectus muscles are identified.The posterior rectus sheath is dissected free and the muscles are elevated gently.The epigastric vessels are identified and protected throughout.This is achieved on both sides all the way to the lateral end of the rectus sheath.The dissection extends 5 cm above the uppermost hernia site.Dissection is carried out into the preperitoneal space.The pubic ramus is identified as well as cooper¿s ligaments.The preperitoneal tissue is separate to allow retraction of the peritoneum and full exposure of the iliac vessels.The left round ligament is identified and divided.The right round ligament is not identified.With optimal relaxation, it is possible to close the posterior rectus sheath and the transversalis fascia and peritoneum with a running #1 pds suture.The operative site is then carefully irrigated.Four 0 prolene sutures are placed on cooper¿s ligament, two on each side.The preperitoneal area is then measured for an optimal sized mesh implant.A 16 x 24 cm piece of ultra pro mesh is armed with 14 gore-tex sutures, six on each long side, two superiorly.The mesh is then introduced into the preperitoneal space.The sutures are carefully passed through the abdominal wall well lateral to the rectus muscle.The reverdin needle is used.The sutures are then tightened in a preliminary fashion.It confirms optimal mesh size and placement.The inferior lateral sutures are then tied, the superior sutures subsequently.The previously placed prolene sutures to cooper¿s ligament are then threaded through the mesh.They are tied down to cooper¿s ligament.Careful inspection reveals accurate placement of the mesh well behind the symphysis pubis and to the iliac vessels.The remaining sutures are then tied.The mesh bed is then carefully irrigated again.Hemostasis is in good order.The anterior midline fascia is closed with a running #1 pds.The wound is again irrigated and staples closed.The stab incisions for the gore-tex sutures are staples as well.Gauze and tegaderm are applied.The patient has tolerated the procedure well.She breathes comfortably and is pain-free.She is brought to the recovery room.¿ on (b)(6) 2008: (b)(6) hospitals.(b)(6) , md.Brief operative note.[handwritten].Postop diagnosis: recurrent incarcerated incisional hernia.Procedures: loa 150 min.Removal of implanted mesh.Repair of hernia.Implantation of mesh.Attending surgeon: (b)(6) , md.Resident: (b)(6) , md.Findings: 16 x 10 cm hernia.16 x 24 cm mesh.14 [illegible].4 prolene.Specimens: mesh.Estimated blood loss: 400 ml.On (b)(6) 2008: (b)(6) hospitals.Implant sticker.Ultrapro mesh.Lot: zm9dstm0.Exp: nov.2012.30 x 30 cm (12 x 12 in.).Uml1.Ethicon.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.The gore® dualmesh® plus biomaterial instructions for use also 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.
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Manufacturer Narrative
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It should be noted that the gore® dualmesh® plus biomaterial instructions for use addresses the following adverse reactions among others: ¿possible adverse reactions with the use of any tissue deficiency prosthesis may include, but are not limited to, contamination, infection, inflammation, adhesion, fistula formation, seroma formation, hematoma, and recurrence.The gore® dualmesh® plus biomaterial instructions for use also 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.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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Additional details regarding the patient's clinical course were ascertained from a review of medical records and are as follows: implant #1 preoperative complaints: (b)(6) 2006: (b)(6) medical center [nhrmc].(b)(6).Preoperative diagnosis: multifocal, complex, massive, recurrent, ventral, symptomatic incisional hernia (multi-fenestrated).Implant #1 procedure: complex repair as above with dual gortex mesh.[implant: gore® dualmesh® plus biomaterial, 1dlmcp04/03820777, 15cm x 19cm x 1mm thick, oval.] implant #1 date: (b)(6) 2006 [hospitalization dates not provided].(b)(6) 2006: nhrmc.(b)(6).Operative report.Assistant: (b)(6).Postoperative diagnosis: multifocal, complex, massive, recurrent, ventral, symptomatic incisional hernia (multi-fenestrated).Anesthesia: general.Estimated blood loss: less than 100 ml.Specimens: none.Complications: none.Wound classification: not provided.Procedure: ¿the previous midline incision was excised away and disguarded [sic] to new cutaneous edges.The peritoneal cavity was safely entered and the central abdominal fascia was extremely attenuated with multiple crater-like swiss cheese, full-thickness, fascial defects.The entire central abdominal fascia was sharply trimmed back to clean edges.Extensive lysis of adhesions was carried out to separate the visceral contents from points of adhesions inside the hernia sacs and to the anterior abdominal wall.This allowed for a completely free abdominal wall.At this point i dissected the anterior fascial surface with bowie cautery and this created a large subcutaneous dead space.I used an underlay technique placing a dual gortex mesh underneath the fascial edge on either side and suturing full thickness with #0 prolene, superficial to deep, through the abdominal wall and then through the mesh back up through the abdominal wall and tied in knots on top of the fascia.I did this at one cm.Intervals along the circumference and the mesh fit perfectly.Care was taken not to entrap any visceral contents in placing the sutures or tying them.The free fascial edges i sutured so that the knots were about 2.5 to 3 cm.Inside the fascial edge circumferentially.The free fascial edges were then closed with interrupted #0 prolene sutures over the mesh to try to avoid any direct communication between the subcutaneous space that would have fluid and the mesh itself.This patient is at risk for wound infection based on obesity, age, nutritional status and diabetes.The drains were brought through two separate stab incisions, one on the right and one on the left, and fixed to the skin with nylon sutures.#19- french blake drains were utilized.The deep subcutaneous tissues were closed with 2-0 monocryl sutures.The dermis was closed with multiple interrupted 3-0 monocryl sutures.The skin was approximated with a finishing 4-0 monocryl subcuticular suture.The wound was sealed with dermabond to provide an ultimate biologic barrier.Sterile dressings, were placed as drain exit sites.The patient was taken to the recovery room in excellent condition having tolerated the procedure well.¿ (b)(6) 2006: nhrmc.Implant sticker.¿gore dualmesh® plus biomaterial.¿ site: ¿open ventral hernia repair.¿ catalogue #: 1dlmcp04.Lot #: 03820777.Size: 15cm x 19cm x 1mm.Expiration date: 7/24/2007.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.The gore® dualmesh® plus biomaterial instructions for use also 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.W.L.Gore & associates, inc.(gore) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by gore, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Blank fields present on this report include required fields and fields determined to be not applicable.Blank required fields indicate that the information was not provided, was deemed unavailable or was not applicable.This report does not constitute an admission or a conclusion by fda, gore, or its associates that the device, gore or its associates caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects" or has "malfunctioned".These words are included in the report and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.
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Manufacturer Narrative
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H6: updated health effect.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.¿ 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.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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