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W. L. GORE & ASSOCIATES, INC. GORE® DUALMESH® PLUS BIOMATERIAL; MESH, SURGICAL, POLYMERIC
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| Model Number 1DLMCP08 |
| Device Problem
Insufficient Information (3190)
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| Patient Problems
Obstruction/Occlusion (2422); No Clinical Signs, Symptoms or Conditions (4582)
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| Event Date 04/30/2014 |
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Event Type
Injury
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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)].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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Event Description
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It was reported to gore that the patient underwent open ventral incisional hernia repair on (b)(6) 2003 whereby a gore® dualmesh® plus biomaterial was implanted.The complaint alleges that on (b)(6) 2014, an additional procedure occurred whereby the gore device was explanted.It was reported the patient alleges the following injuries: dense adhesions, bowel obstruction, recurrence, pain and suffering.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: laparoscopic adhesiolysis (70 minutes).Attempted laparoscopic ventral hernia repair.Open ventral hernia repair with mesh.Implant: gore® dualmesh® plus biomaterial [1dlmcp08/01547087, 26 cm x 34 cm x 1 mm] implant date: (b)(6) 2003 (hospitalization [ni]).(b)(6) 2003: (b)(6).(b)(6), md.Operative report.Preoperative diagnosis: ventral incisional hernia times one status post abdominal surgery.Postoperative diagnosis: ventral incisional hernia times nine status post abdominal surgery.Anesthesia: general.Complications: none.Condition: stable.Procedure: ¿this is a 49-year-old white female who presented to my office with complaints of pain along the mid aspect of her prior abdominal incision.Her primary physician had requested a ct scan and this revealed the possibility of a ventral incisional hernia, above the level of the umbilicus.The patient was then offered surgical repair and she agreed to proceed, understanding the risks and benefits of the procedure which included infection, bleeding, the possibility of bowel or bladder injury, the possibility of recurrence, possibility of postoperative abdominal wall pain, and the possibility of conversion of the surgery to an open approach.Once appropriate consents were obtained the patient was taken to the operating room and placed in the supine position.After adequate anesthesia induction she was orotracheally intubated and general anesthesia was applied.The abdomen was prepped and draped in a standard sterile fashion from the nipples down to the pubis.Next, through a left flank, left upper quadrant approach, an open cannulation of the abdominal cavity was performed and the 5-mm trocar placed and the video camera introduced.The patient had dense abdominal adhesions, tenting up not only the omentum but also the small bowel to the anterior abdominal wall.This extended from flank to flank, as well as from pubis all the way up to the area of the subxiphoid apace.A small place in the left lower quadrant was then cleared up and i was able to place a second 5-mm trocar.Tediously, adhesiolysis was performed (70 minutes).In doing so, i identified eight different fascial defects between the subxiphoid area and the umbilicus and then there were two more, approximately an inch and a half below the umbilicus.By this time, a third and fourth 5-mm trocars had been placed in the right upper as well as right lower quadrant.A 35 by 16-cm mesh was chosen for repair after the defects were measured externally with approximately an inch and a half of normal abdominal wall past each margin of the defect, extending to the defect found below the umbilicus.The mesh was placed within the abdomen through the left upper quadrant trocar.Two horizontal mattress sutures of 0-ethibond had been placed at the inferior and superior margins of the mesh and these retrieved with a suture passer instrument at the above mentioned areas through separate stab incisions.I was able to place one suture on the right lateral side of the mesh but then despite tedious maneuvering and changing positions with the trocars i could not adequately place the mesh despite attempts at securing each corner of the mesh with the 5-mm protack.After several failed attempts i decided to abort the laparoscopic approach and perform it open.Therefore, the prior midline incision was opened from the midepigastric area to below the umbilicus and dissection was deepened all the way down to the fascia and the peritoneal cavity was opened.Old fascial defeats were interconnected with the incision.The abdomen was copiously irrigated with sterile water and suctioned dry.Hemostasis was obtained.Next, by using the same dual meshpro which was initially placed laparoscopically, and after the protacks were removed from the anterior abdominal wall as well as the sutures, the mesh was fashioned to cover the defect and sutured to the edges of the defect with interrupted 0-ethibond in a horizontal mattress fashion.The fascial edges had been freed up for an approximate distance of 2 inches from the defect on each side prior to doing this.The mesh was trimmed to fit the defect and appeared to lay down appropriately without tension.The edges of the fascia were then also approximated with running 0-ethibond suture.A #7 jackson-pratt drain was placed in the dead space and brought out through a separate stab incision in the right lower quadrant.The subcutaneous layer was, closed with a running 2-0 vicryl suture as well as a running 3-0 vicryl suture.The skin edges were approximated with skin staples.Each layer was irrigated after closure.All other trocar incisions were closed with staples as well.The patient tolerated the procedure with no complications.General anesthesia was reversed.The patient was extubated in the operating room and then transferred to the recovery room in stable condition.¿ (b)(6) 2003: (b)(6).Implant sticker.Dualmesh corduroy antimicrobial.Item #: 1dlmcp08.Lot #: 01547087.[handwritten]: manufacturer: gore-tex dual mesh plus.Size: 26 cm x 34 cm x 1 mm.Exp: 7/13/04.The records confirm a gore® dualmesh® plus biomaterial (1dlmcp08/01547087) was implanted during the procedure.Relevant medical information: (b)(6) 2014: (b)(6).(b)(6), md.Operative report.Preoperative diagnosis: adult-onset diabetes mellitus.Incisional hernia.Morbid obesity.Postoperative diagnosis: adult-onset diabetes mellitus.Incisional hernia.Morbid obesity.Hiatal hernia.Laparoscopic sleeve gastrectomy (36 bougie #1, #2 hiatal hernia repair).Findings: she had a massive omental adhesion to her previously placed mesh for her midline incisional hernia, which made our access extremely difficult and causes much more time and effort to do this procedure.Therefore, difficulty modifier will be added to this case.Her initial attempted access was unsuccessful in the right subcostal anterior axillary line area, so we moved to the epigastrium just below the xiphoid and were able to gain access with a veress needle, and after achieving pneumoperitoneum, a 5 mm trocar was placed.We then chose a site in the left upper abdomen laterally for a 5 mm working trocar and cleared the epigastrium in the omentum with the ligasure until our other trocars could be placed under direct vision.The omentum was plastered to the posterior abdominal wall and the stomach was tented with the distal greater curvature.This also made mobilization of the stomach difficult.After much effort and changing the trocar sites, we finally cleared the area more laterally than usual for camera port, which was placed under direct vision, and then we proceeded with other port placements in the subxiphoid area in right upper abdomen in order to accomplish our sleeve gastrectomy.Assistant: (b)(6), md.Anesthesia: general.Specimen: none.Estimated blood loss: 50 ml.Condition: stable.Description of the procedure: ¿after finally gaining access, the left lobe of the liver was elevated.The patient was placed in the extreme reverse trendelenburg position.She had a moderate-sized hiatal hernia.Right left crus were carefully identified, then the repair was accomplished anterior with a figure-of-eight 0 surgidac utilizing endo stitch.The repair was accomplished over the 36 bougie.The initial short dissection was accomplished after taking down the peritoneum overlying the left crus.Attention was then turned to the greater curvature and approximately 10 cm proximal to the pylorus.The greater curvature was taken down with a ligasure bck to the original dissection.Having mobilized the proximal stomach from the left crus, a bougie was placed and sequential firings of purple load 60 endo-gia with seamguards accomplished our sleeve gastrectomy staying close to her 36 bougie after we passed the incisura.The leak test was performed and was normal.Hemostasis was assured.The procedure was terminated.An area to the fight and slightly inferior to her umbilicus was inspected and a small ventral hernia was present.The omentum was to this area as well as her transverse colon, so we chose to forego this hernia repair since i seen there was no danger for incarceration of small bowel obstruction.The 12 mm port site was closed with a carter-thomason closure device after extracting the fundus with an endopouch.The skin was closed interrupted 4-0 monocryl in a subcuticular fashion op-site dressing was applied.The patient was awakened and returned to the recovery room in stable condition having tolerated the procedure well.Sponge and needle count correct x2.¿ (b)(6) 2014: (b)(6).[signature illegible].Anesthesia record.Weight 102.45 kg.Bmi 37.5.Asa 2.Former smoker, quit >1 year ago.Surgical history: hysterectomy (b)(6) 2002.Hernia repair 2003, 2005.Lipoma removed abdomen area 2005.Appendectomy.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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H6: updated results 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.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.¿ 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.Based upon the information received, the device remains in the patient and was not available for evaluation.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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