W. L. GORE & ASSOCIATES, INC. GORE® DUALMESH® PLUS BIOMATERIAL; MESH, SURGICAL, POLYMERIC
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Model Number 1DLMCP03 |
Device Problem
Insufficient Information (3190)
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Patient Problems
Hernia (2240); No Code Available (3191); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/23/2014 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).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.".
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Event Description
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It was reported to gore that the patient underwent laparoscopic incisional hernia repair on (b)(6) 2014 whereby a gore® dualmesh® plus biomaterial was implanted.The complaint alleges that on (b)(6) 2014, an additional procedure occurred.It was reported the patient alleges the following injuries: hernia recurrence; chronic pain; seroma; mesh shrinkage.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 preoperative complaints: on (b)(6) 2014: (b)(6) , dr.(b)(6) , indications for surgery: ¿this is a 47-year-old with a history of umbilical hernia repaired with mesh at an outside hospital.He has had chronic pain at the site of the mesh and ct evidence of recurrent hernia.¿ implant procedure: exploratory laparoscopy, laparoscopic removal of abdominal wall mesh, placement on 10 x 15 cm ¿gore-tex mesh¿, laparoscopic incisional herniorrhaphy.Implant: gore® dualmesh® plus biomaterial (11603048/1dlmcp03) 10 x 15 cm.Implant date: february 13, 2014 [hospitalization dates unknown] (b)(6) , dr.(b)(6) , assistant: dr.(b)(6) , ms-3, anesthesia: general, preop diagnosis: recurrent incisional hernia, postop diagnosis: recurrent incisional hernia findings: ¿the ventralex mesh, which had been placed at his umbilicus was rolled and there was a recurrent hernia laterally.This mesh was removed and a 10 x 15 cm piece of gore dualmesh was placed.¿ operation: ¿a left upper quadrant incision was made and a veress needle as inserted.The abdomen was insufflated with carbon dioxide.A disposable 5 mm trocar was placed at this site and the intestines beneath examined and were free of injury.Three additional 5 mm ports were placed, 1 in the left lower quadrant and 2 on the right side of the abdomen, all under direct vision.There was omentum adherent to the mesh.The omentum was taken down sharply.Small bleeders were coagulated.The mesh was not affixed to the anterior abdominal wall and rolled easily.I then sharply excised the mesh and cut into 3 pieces and brought it out through the upsized 10 mm trocar site in the right upper quadrant.The falciform ligament was taken down and an endoloop was placed around it and the falciform was excised and passed off the field as a specimen.The medial umbilical ligaments were swept inferiorly to allow the mesh to adhere densely to the fascia.A 10 x 15 cm piece of dual gore-tex mesh was then prepared on the back table with 4 corner sutures of 2-0 gore-tex.The mesh was rolled, inserted into the abdomen and expanded.The mesh was brought to the anterior abdominal wall at 4 points using the laparoscopic suture passer.The sutures were cinched and endotacks were placed in between at the edge of the mesh all the way around.Four additional 2-0 gore-tex sutures were placed at each corner.This closed the defect nicely without tensions.The intestines and omentum were examined.There was no evidence of injury.The right upper quadrant 10mm trocar site was closed with a 0 vicryl suture using the laparoscopic suture passer.The incisions were then closed with 4-0 vicryl sutures.Mastisol, steri-strips and dry sterile dressings were applied.¿ relevant medical information: on (b)(6) 2014: (b)(6) , (b)(6) md, exploratory laparoscopy, removal of abdominal wall foreign body (clips and seroma cavity) assistant: (b)(6) md, anesthesia: general, preop diagnosis: abdominal pain, status post laparoscopic hernia repair, postop diagnosis: intra-abdominal adhesions and mesh seroma indications: ¿this is a 48-year-old 6 months status post a recurrent laparoscopic incisional hernia repair with gore-tex mesh.He has developed abdominal pain in the right upper quadrant consistent with [sic] pain.¿ findings: there was a dense seroma cavity on the undersurface of the gore-tex mesh.There were numerous clips that were horizontal and not vertical in the abdominal wall.These were removed.The seroma cavity was removed.The mesh was covering the original defect nicely, but at the edges, was somewhat shrunken.Photographs were taken.¿ aforementioned photographs were not provided. description of procedure: ¿the abdomen was entered with a veress needle in the left upper quadrant and once it was insufflated with carbon dioxide, a 5 mm disposable trocar was placed at this site.The intestines beneath were examined and were free of injury.A port was placed in the left lower quadrant under direct vision and in the low midline under direct vision.Using sharp dissection, the omentum was excised from the undersurface of the fascia.It was carefully examined.There was no evidence of intestinal damage.I removed a number of clips at the 9 o¿clock to 12 o¿clock position in the right upper quadrant aspect of the mesh.At one point, i got into a seroma cavity which was quite thickened.The seroma cavity was sharply excised and taken out in pieces through one of the 5 mm trocar sites.Multiple other clips were either sideways or just floating in the seroma fluid.These were removed one at a time.The mesh, however, appeared to be firmly affixed to the anterior abdominal wall.His mesh was completely covering the initial defect, although it was somewhat protracted at the edges.There were no additional clips.I carefully examined the omentum.There were no spilled clips.The mesh was irrigated and the trocars were removed under direct vision.The co2 was allowed to escape.The three 5 mm trocar sites were closed with interrupted 4-0 polysorb suture.Mastisol, steri-strips and dry sterile dressings were applied.¿ 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 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 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.".
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Manufacturer Narrative
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H6: updated health effect.H6: updated investigation finding.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.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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