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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
Unspecified Infection (1930); No Clinical Signs, Symptoms or Conditions (4582)
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| Event Date 03/04/2011 |
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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 hernia repair on (b)(6)2010 and open recurrent incisional hernia repair on (b)(6) 2011 whereby gore® dualmesh® plus devices were implanted.The complaint alleges that on (b)(6) 2011, an additional procedure occurred whereby a gore device was explanted.It was reported the patient alleges the following injuries: no mesh removal, loss of anchorage., mesh infection, explant, uncertain if both were explanted.Additional event specific information was not provided.
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Manufacturer Narrative
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G3/g4: correcting date received by manufacturer for the initial mdr: the information needed to determine reportability was received on 4/22/21, not on 3/30/21.
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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 #1: redo laparotomy with ventral hernia repair with dual mesh.Implant: gore® dualmesh® plus [1dlmcp06/(b)(6), 18 cm x 24 cm].Implant date: (b)(6) 2010 (hospitalization [ni]) (b)(6) 2010: (b)(6) medical center [assigned].(b)(6) md.Operative report.Main diagnosis: ventral hernia.Postoperative diagnosis: ventral hernia.Assistant: (b)(6).Brief clinical note: (b)(6) is a 56-year-old woman who underwent redo laparotomy with lysis of adhesions, takedown of previous nissan, collis gastroplasty, and toupet fundoplication in (b)(6) 2009.At this time, she had a swiss cheese abdominal incision.This was closed primarily as the defects were tiny.She is brought to the or now after developing a larger ventral hernia.Brief description of procedure: ¿after informed consent was obtained, (b)(6) was brought to the operating room (or), placed supine on the operative table.General anesthesia was smoothly induced with a single-lumen endotracheal tube.Her abdomen was prepped and draped into a sterile field.Her previous laparotomy incision was made.Dissection was carried down into the peritoneal cavity using bovie electrocautery.Two large defects were noted, one superiorly and one inferiorly.These were connected in the midline.Approximately one hour of lysis of adhesions as well as cleaning off the anterior and posterior surfaces of the fascia was carried out.Following this, an 18 cm x 24 cm dual mesh was brought onto the field and multiple prolene sutures were used in interrupted fashion to sew the mesh to the defect.After this was performed, copious irrigation was performed with saline containing bacitracin.Following this, a 2-0 vicryl running layer was placed in the subcutaneous tissues followed by another 2-0 vicryl running layer, followed by staples in the skin.The patient tolerated the procedure well.After sterile dressings were applied, she was taken to the recovery room in stable condition.¿ (b)(6) 2010: (b)(6) medical center.Implant record.Material name: mesh, bio dualmesh+ oval.1 mm 18x24cm.1dlmcp06.Quantity: 1.Manufacturer: w.L.Gore & associates inc.Lot #: (b)(6).The records confirm a gore® dualmesh® plus biomaterial (1dlmcp06/(b)(6)) was implanted during the procedure.Implant procedure #2: repair of recurrent incisional hernia.Implant: gore® dualmesh® plus [1dlmcp06/(b)(6)].Implant date: (b)(6), 2011 (hospitalization [ni]) (b)(6) 2011: (b)(6) medical center [assigned].(b)(6) md.Operative report.Preoperative diagnosis: recurrent incisional hernia.Postoperative diagnosis: recurrent incisional hernia.Assistants: (b)(6) md.(b)(6) pac.Brief clinical note: (b)(6) is a 58-year-old woman, who had multiple abdominal operations.I did a redo collis nissen on her a couple years ago followed by a ventral hernia repair; however, the mesh has become detached on the right fascial side, and therefore, she is brought to the or for the above procedure.Brief description of procedure: ¿after informed was obtained, (b)(6) was brought to the or, placed supine on the operating table.General anesthesia was smoothly induced with a single-lumen endotracheal tube.Her abdomen was prepped and draped in a sterile field.Her previous laparotomy incision was made and the incision was carried inferiorly about another 3 cm.Dissection was carried through subcutaneous tissues very carefully.The hernia sac was identified and entered.Dissection was carried into the abdomen and lysis of adhesions was carried out of approximately ½ hour duration.The previous mesh was identified.This was attached like i said to the left fascia but had detached from the right-sided fashion.The fascia was feed up all around.The hernia sac was dissected free and sent for firm for permanent pathology.After fascial edges had been identified circumferentially, multiple 0 prolene sutures were used to sew a dual mesh into the defect.On the left side, the previous mesh was incorporated into the sutures, and large bites were taken 1 cm apart on the right side of the fascia.After these were all placed and tied, mesh was then irrigated with bacitracin-containing irrigation.Multiple layers of absorbable suture were placed over the mesh, and the subcutaneous tissues and staples were placed in the skin.Sterile dressings were applied.The patient tolerated procedure well and taken to recovery room stable condition.I was present for the entire procedure.¿ (b)(6) 2011: (b)(6) medical center.Implant sticker.Gore dualmesh® plus biomaterial.Ref catalogue number: 1dlmcp06.Lot batch code: (b)(6).W.L.Gore & associates.The records confirm a gore® dualmesh® plus biomaterial (1dlmcp06/ (b)(6)) was implanted during the procedure.Explant procedure: wound exploration with mesh removal.Explant date: (b)(6) 2011 (hospitalization [ni]) (b)(6) 2011: [facility ni].(b)(6) md.Operative report.Preoperative diagnosis: infected abdominal wound status post ventral hernia repair with mesh.Postoperative diagnosis: infected abdominal wound status post ventral hernia repair with mesh.Assistant: (b)(6) md.Brief clinical note: (b)(6) is a 58-year-old woman who previously had undergone 3 operations by me.The first was a redo nissen, the second was a ventral hernia repair, the third was a ventral hernia repair.Both of these included mesh.She now returns with fluid draining from her incision.Brief description of procedure: ¿informed consent was obtained.(b)(6) was brought to the or, placed supine on the operative table.General anesthesia was smoothly induced with a single-lumen endotracheal tube.Her abdomen was prepped and draped into a sterile field.The small defect in her abdomen was incised 2 cm superiorly and 2 cm inferiorly.Dissection was carried through subcutaneous tissues and the mesh was visible at the base of the wound.Therefore, her entire incision was opened and the mesh was identified all of the prolene¿s were taken down circumferentially.A nice inflammatory line was seen at the base of the incision such that no bowel was seen.A surgisis mesh was brought onto the field.Multiple 0-0 maxon sutures were used to sew this to the fascia.Multiple interrupted 0 vicryl sutures were then used to close a layer above this and a wound vac was placed over this.Please note that copious irrigation was performed at all levels with bacitracin-containing irrigation deeply and regular saline superficially.After the wound vac was placed.The patient was extubated and taken to the recovery room in stable condition.¿ 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 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.¿ the instructions for use further warn: ¿as with any implantable surgical device, strict aseptic techniques should be followed.If an infection develops, it should be treated aggressively.An unresolved infection may require removal of the material.¿ procedure and specific patient factors may contribute to or cause infection, leading to contamination, exposure, lack of incorporation and/or seeding of device.Procedure related factors may include adherence to clinical guidelines on infection risk management, contamination of device prior to or during implant, and post-operative persistent/symptomatic seroma and wound management.Patient risk factors may include diabetes, smoking, age, malnutrition, immunosuppressive therapy, post-operative instruction noncompliance, and hygiene.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 and sterilization 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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