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W. L. GORE & ASSOCIATES, INC. GORE® DUALMESH® PLUS BIOMATERIAL; MESH, SURGICAL, POLYMERIC
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Back to Search Results |
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| Model Number 1DLMCP04 |
| Device Problem
Insufficient Information (3190)
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| Patient Problems
Abscess (1690); Unspecified Infection (1930); Seroma (2069)
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| Event Date 01/09/2008 |
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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) 2007 whereby a gore® dualmesh® plus biomaterial was implanted.The complaint alleges that on (b)(6) 2008, (b)(6) 2008 and (b)(6) 2008, additional procedures occurred whereby the gore device was explanted.It was reported the patient alleges the following injuries: numerous seromas, numerous drainage of seromas, abscess, mesh infection, removal of infected mesh, recurrence, lysis of adhesions, dissection of liver, extended period with an open wound, excision of necrosis, numerous surgeries following excision to repair complex open wound, pain and suffering.Additional event specific information was not provided.
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Manufacturer Narrative
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B7: added medical history.H6: conclusion code remains unchanged.H10/11: added medical record information.Additional details regarding the patient's clinical course were ascertained from a review of medical records and are as follows: implant procedure: open repair of large ventral incisional hernia with extensive lysis of adhesions and implantation of mesh.Implant: gore® dualmesh® plus biomaterial [1dlmcp04/04896364, 15 x 19 cm].Implant date: on (b)(6) 2007.(hospitalization [ni]).On (b)(6) 2007: (b)(6), md.Operative report.Preoperative diagnosis: large incarcerated ventral incisional hernia.Postoperative diagnosis: large incarcerated ventral incisional hernia.Indications: the patient is a 61-year-old woman who underwent laparoscopic gastric bypass several years ago.She developed a perforated marginal ulcer and required exploratory laparotomy.Since that time, she has developed an increasingly uncomfortable and enlarging upper abdominal ventral incisional hernia.She had a preexisting incarcerated ventral incisional hernia just above the level of the umbilicus.Risks, benefits, and alternatives to the proposed surgery were explained in detail to the patient.She expresses understanding and would like to proceed.Description of procedure: ¿the patient was brought to the operating room and placed in a supine position.General anesthetic was administered and a foley catheter was placed.Her abdomen was prepped and draped in usual sterile fashion.An incision was made from xiphoid to umbilicus.The subcutaneous tissue were divided with electrocautery.The hernia sac was easily identified.It was dissected from the surrounding subcutaneous tissues down to the fascial defect.The hernia sac was entered.Using meticulous dissection, the hernia sac was dissected away from the intraabdominal contents.There was a large amount of adhesions from her prior surgeries.These adhesions were from transverse colon to hernia sac, as well as to the underside of the anterior abdominal wall laterally, superiorly, and inferiorly.It took an extended amount of time to completely dissect free these adhesions so that the hernia sac could be excised at its fascial edges.There was a large primary hernia defect which started approximately 3 cm below the xiphoid and extended to an area about 5 cm above the umbilicus.This measured approximately 18 cm x 14 cm wide.There was another fascial defect below this one and above the umbilicus which measured approximately 4 cm in transverse diameter.This had a very large hernia sac associated with it and incarcerated small intestinal contents.Again, this hernia sac was dissected away from its surrounding subcutaneous tissues down to the fascial edges after the small bowel was reduced back into the abdominal cavity.The entire area was fixed with one piece of mesh.A piece of dualmesh, 15 x 19 cm, was brought up into the field and placed over the defects.It was sewn in to incorporate both hernia defects.It was trimmed so that the final measurements of the mesh were about 18 cm long x 14 cm wide.A #7 jackson pratt drain was placed over the mesh and exited through a separate stab wound to the right of the incision.This was held to the skin with a nylon suture.The wound was generously irrigated.The wound was closed in layers with two layers of 3-0 vicryl and 4-0 vicryl.Clips were placed on the skin.Sterile dressings were applied.The patient tolerated the procedure well.She was withdrawn from general anesthesia, extubated and brought to recover.It should be noted that the mesh was sewn in with running #1 prolene.¿ on (b)(6) 2007: (b)(6) center.Implant sticker: gore dualmesh® plus biomaterial.Ref catalog number: 1dlmcp04.Lot: 04896364.Exp.11/2009.Abdomen.The records confirm a gore® dualmesh® plus biomaterial (1dlmcp04/04896364) was implanted during the procedure.Relevant medical information: on (b)(6) 2008: (b)(6), md.Operative report.Preoperative diagnosis: abdominal wall seroma.Postoperative diagnosis: abdominal wall seroma.Operation: incision and drainage of abdominal wall seroma.Indication: the patient is a 62-year-old woman who underwent an open repair of a large abdominal hernia with mesh implantation several months ago.She has developed a chronic large seroma which has not resolved despite multiple aspirations.The risks, benefits, and alternative to the proposed surgery were explained in detail.She expresses understanding and would like to proceed.Description of procedure: the patient was brought to the operating table and placed in supine position and iv sedation was utilized.Her abdomen was prepped and draped in the usual sterile fashion.1% lidocaine was used throughout the procedure for local anesthesia.A 3 cm incision was made just above and to the left of the umbilicus.The subcutaneous tissues were divided with electrocautery down to the seroma cavity.The cavity was incised.A large amount of serous fluid came out.A 10-mm jackson pratt drain was placed within the seroma cavity, but the catheter was met with resistance.Therefore, i increased the size of the opening to the seroma and stuck a finger in to break up any loculations.The mesh and sutures were palpable.The loculations were broken up with my finger.The jp drain was then replaced into the seroma cavity.It was tunneled subcutaneously to an exit site in the left lower quadrant.It was secured to this site with nylon suture.Subcutaneous tissues from the incision were closed with vicryl.A running nylon suture was placed in the incision and sterile dressing were applied.The patient tolerated the procedure well.The jp drain was placed to a grenade.Approximately 450 ml of serous fluid was returned immediately.She was taken to recovery in good condition.¿ on (b)(6) 2008: (b)(6), md.Operative report.First assistant: (b)(6), md/hs.Preoperative diagnosis: persistent large abdominal wall seroma.Postoperative diagnosis: persistent large abdominal wall seroma.Procedure: excision of abdominal wall seroma with placement of drains.Indications: the patient is a 62-year-old woman who underwent an open abdominal wall hernia approximately nine months ago with mesh implantation.She has had persistent seroma which has not responded to multiple aspirations as well as placement of a drainage catheter.She presents now for complete excision of this large abdominal wall seroma.The risks, benefits and alternatives were explained in detail to the patient.She expressed understanding and would like to proceed.Description of procedure: ¿the patient was brought to the operating room and placed in a supine position.General anesthetic was administered.Her abdomen was prepped and draped in the usual sterile fashion.A 10-12 cm incision was made in the midline just above the umbilicus over the main portion of the abdominal wall seroma.Cautery was used for the dissection.The wall of the seroma was identified and was separated away from its surrounding subcutaneous tissues down to the fascial level.The base of the seroma was approximately 15 cm in diameter and was the same size as the piece of dualmesh which was used at the prior hernia repair.At the base of the seroma, at the fascial level, cautery was used to divide the seroma wall which was quite thick.It was anywhere from 5-10 mm in thickness.The seroma was then completely excised at the level of the fascia.There was a large amount of straw-colored thin fluid within the seroma.This did not look infected.Nevertheless a sample was sent for culture.There was some chronic mucoid granulation tissue at the most inferior aspect of the seroma which although did not look actively infected, it may have represented an old abscess in the past or some fat necrosis.The prolene suture in this location was a little loose.I placed another 0 prolene suture and then tightened the existing prolene by tying them together.The wound was generously irrigated out.Two 10 mm jp drains were placed, one exiting on the left side and one exiting in the right side of the lower aspect of the abdomen.These were sutured into place with a 2-0 nylon.The ends were cut so that it fit nicely across the mesh.The subcutaneous tissues laterally were then sewn down to the lateral aspect of the mesh repair bilaterally.The subcutaneous tissues were then closed again in the midline and tacked down to the hernia mesh to obliterate any free space.Clips were then placed in the skin.A sterile dressing was applied.The patient tolerated the procedure well.She was withdrawn from general anesthesia, extubated and brought to the recovery in good condition.¿ explant procedure: exploratory laparotomy, lysis of adhesions, removal of infected mesh.Explant date: on (b)(6) 2008 (hospitalization [ni]).On (b)(6) 2008: (b)(6), md.Operative report.Preoperative diagnosis: recurrent ventral incisional hernia with mesh infection.Postoperative diagnosis: recurrent ventral incisional hernia with mesh infection.Assistant: (b)(6), md/hs.Indications: the patient is a 62-year-old woman who underwent a large ventral incisional hernia repair nearly one year ago.She developed a persistent seroma which required reoperation, drainage, and drain placement.Since that operation, she has had continued drainage through her umbilicus, as well as through the jackson-pratt sites in the right and left lower quadrant.Most recently she has developed additional wound just below the xiphoid, all consistent with persistent mesh infection.The risks, benefits, and alternative to the proposed surgery were explained in detail to the patient.She expressed understanding and would like to proceed.Description of procedure: ¿the patient was brought to the operating room and placed in supine position.A general anesthetic was administered.A foley catheter was placed.Her abdomen was prepped and draped in the usual sterile fashion.This is a two-part operation, the first of which was performed by myself and the second part which will be dictated separately was performed by dr.(b)(6) from plastic surgery.A midline incision was made from the xiphoid to umbilicus.The ulcers at the epigastric area were ellipsed out.Subcutaneous tissues were dived with electrocautery down to the dualmesh.There was no seroma noted at this time and the mesh was fairly well incorporated at tis central portion.There were multiple drainage sites, including the right and left lower quadrant and the umbilicus, as described above.These all tracked down to prolene suture knots around the mesh.Also, the epigastric track was followed down to infected prolene sutures.The prolene sutures were all removed.The dual mesh was separated from its attachments laterally.There was a large amount of fibrous tissue around the edges from the prior hernia sac, as well as from more scar tissue formation.A lysis of adhesions was performed intraabdominally to free up the adhesions from the prior operations from the anterior abdominal wall.This was performed laterally with metzenbaum scissors, as well as up underneath the xiphoid.The liver was dissected off the underside of the xiphoid and superiorly as well.Flaps were then created by dissecting off the subcutaneous tissues from the hernia sac.Fibrous tissue, and finally the anterior abdominal wall which included the anterior rectus sheath.There were recurrent hernias both laterally from suture holed, as well as inferiorly just under the umbilicus.The redundant tissue was all removed back to the recuts fascia using cautery.Again, flaps were created on both sides, dissecting subcutaneous tissues of the anterior rectus sheath.At this point, dr.(b)(6) took over and proceeded with the separation of parts, closure of the hernias, and placement of alloderm, and this will be dictated separately.¿ on (b)(6) 2008: (b)(6), md.Operative report.Preoperative diagnosis: recurrent internal/incisional hernia with complex wound of abdominal wall.Postoperative diagnosis: recurrent internal/incisional hernia with complex wound of abdominal wall.Procedure: 1) right and left components separation with rectus abdominis myocutaneous flap reconstruction of abdominal wall and closure.2) closure of hernia and repair of hernia with flaps in addition to a 16 x 20 piece of extra thick alloderm abdominal dermis.3) excision of a large amount of subcutaneous tissue and skin of abdominal wall with reconstruction of the skin and subcutaneous tissue with adjacent tissue arrangement.Assistant: (b)(6), do/hs.Indications for procedure: the patient is a 62-year-old female who has had a hernia repair with recurrent seroma leading to wounds.I saw the patient at the request of dr.Harris for assistance with reconstruction.The details of the procedure, realistic outcome, hopeful recovery, expected post-operative course, major risks and complications.All of her questions were invited and answered and consent obtained.Description of procedure: ¿the patient was correctly identified in the preoperative holding area and brought back to the operating suite where she was prepped and draped in the usual sterile fashion.After dr.(b)(6) had finished his portion harvesting the component separation portion an incision was made out laterally and the fascia allowed to mobilize the rectus abdominis and rotate that into the midline.Once this had been done on both the right and left side it was felt that they would be able to be closed and they were closed with multiple horizontal mattress pds sutures.After this had been carried out attention was taken to alloderm and a 16 x 20 cm piece of alloderm was placed and secured under tension with again multiple interrupted pds sutures using figure of eight and horizontal mattress and finally a running pds was used to secure that.Mattress sutures were placed just to the right and left of the midline overlying the recuts muscles.Finally the excess skin with the ulcers was excised and the remaining soft tissue was them rotated in to place in order to facilitate closure.This was closed in multi-layer fashion with absorbable sutures, insorb stapler and a running 4-0 monocryl.Ethibond was then placed over the incision, it should be noted that two blake drains were placed.The patient tolerated the procedure and was taken to the post anesthesia care unit in stable condition.¿ on (b)(6) 2008: (b)(6) center.Operative record.Implant sticker: alloderm regenerative tissue matrix; 16 x 20.Relevant medical information: on (b)(6) 2008: (b)(6), md.Operative report.Preoperative diagnosis: complex wound in abdomen.Postoperative diagnosis: complex wound in abdomen.Procedure: debridement of complex wound in abdomen.Anesthesia: general.Indications: the patient is a 62-year-old female who has had multiple problems with abdominal hernia wound.She now presents with what appears to be some ischemic changes at her abdominal wound.I had a long discussion with her about the details of excision and the use of dressing changes, possible a vac postoperatively to try to control the wound.Consent: after going over the details of the procedure and the major risks, complications, and recovery, all of her questions were answered, and consent was obtained.Description of procedure: ¿the patient was correctly identified in the preoperative holding area and brought to the operative suite where she was prepped and draped in the usual sterile fashion.After the induction of general anesthesia, an operative skin bite [sic] was sharply excised in the skin and subcutaneous tissue.There was a moderate amount of fat necrosis.This was excised out.The wound was irrigated and there was no evidence of purulence.Four retaining-type sutures were placed in order to prevent the wound from pulling apart, and it was packed with a wet-to-dry dressing.We will admit her to the hospital and have her set up for a vac.¿ on (b)(6) 2010: (b)(6), md.Operative report.Preoperative diagnosis: complex wound of the abdomen.Postoperative diagnosis: complex wound of the abdomen.Operation/procedure: 1) debridement of complex wound of the abdomen.2) rearrangement of tissues in order to fill in the defect and close wound.Anesthesia: general.Indications: the patient is a 64-year-old female who has had a very complex wound of her abdomen.Had a long discussion about the details of the wound and the need for closure.We have been treating it with dressing changes for sometime without any forward progress.All of her questions were invited and answered.Consent was obtained.Description of procedure: ¿the patient was correctly identified in the preoperative holding area and brought to the operating suite, prepped and draped in the usual sterile fashion.After administration of anesthesia, the operation began by making an incision in the wound.There was a large cavity underneath the subcutaneous tissue that had not healed.That was adequately excised out.After that was adequately excised out, cautery was used to help secure hemostasis and then wound was irrigated.This did leave a significant defect for the soft tissues which undermining was carried out and the tissue was then rotated into place to help facilitate closure.Several mattress-type sutures were placed in order to help the superior portion to stick down to the inferior portion.In addition, floseal was used in order to help facilitate this.A #7 jackson-pratt drain was placed.And the wound was closed in multiple layer fashion with 3-0 and 4-0 monocryl as well as skin staples.The patient tolerated the procedure well and was taken to the post anesthesia care unit in stable condition.¿ on (b)(6) 2010: (b)(6), md.Operative report.Preoperative diagnosis: complex open wound, abdomen.Postoperative diagnosis: complex open wound, abdomen.Procedure: debridement of complex open wound, abdomen, with complex closure.Anesthesia: general.Indications: the patient is a 64-year-old female who has had a longstanding problem with a complex wound of her abdomen.I had a long discussion with her about the details of the surgery, the challenges we face, the hopeful outcome, and the major risks and complications and expected recovery.All of her questions provided were answered and consent was obtained.Description of procedure: ¿the patient was correctly identified in the preoperative holding area, prepped and draped in the usual sterile fashion.After the administration of anesthesia, the operation began by debriding out the wound.A large transverse incision was made in order to completely excise out the wound as well as the pseudo-capsule that was formed around the wound inside.Once that had been completely excised, the incision was closed by mobilizing a lot of the abdominal pannus from below and rotating it superiorly as well as mobilizing the superior portion of the excessive abdominal tissue and rotating inferiorly.Mattress type sutures were placed in order to discourage any dead space and multiple 2-0 and 3-0 absorbable sutures were placed in the deep, mid portion, and subcuticular area in order to reapproximate the tissue edges.A running 4-0 subcuticular suture was used to reapproximate the skin as well as skin staples.One large drain was placed.A dressing was applied.A small portion of the tissue excised was sent for culture, and she was allowed to be recovered from her anesthesia and taken to the post anesthesia care unit 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.In the absence of additional information or medical records from the complainant, this event file will be closed with the information provided.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 device.¿ 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.Individual medical decisions and/or actions of healthcare professional or device user, if inconsistent and/or non-conforming to the device manufacturer¿s recommendations, ifu, or recognized best practices, may result in or contribute to an adverse event.The instructions for use further state: ¿cutting gore® dualmesh® plus biomaterial to the proper size is essential.Use sharp surgical instruments to trim the mesh.If gore® dualmesh® plus biomaterial is cut too small, excessive tension may be placed on the suture line, which may result in recurrence of the original, or development of an adjacent, tissue defect.¿ the instructions for use further includes a precaution which states, ¿ensure the size of the device is adequate for the intended repair.¿ 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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