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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 Problem
Unspecified Infection (1930)
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| Event Date 06/01/2016 |
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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 incisional hernia repair on (b)(6) 2010 whereby a gore® dualmesh® plus biomaterial was implanted.The complaint alleges that on (b)(6) 2016, an additional procedure occurred whereby the gore device was explanted.It was reported the patient alleges the following injuries: infection.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 preoperative complaints: ¿ 10/18/10: (b)(6).Indications: ¿patient is a 59-year-old gentleman status post repair of a colovesical fistula.He developed a postoperative incisional hernia.Patient agreed undergo surgical repair.He understood risks and benefits, gave informed consent.¿ implant procedure: repair of incisional hernia with dualmesh.[implant: gore® dualmesh® plus biomaterial, 1dlmcp03/7308381, 10 cm x 15 cm x 1 mm, oval] implant date: (b)(6) 2010 [hospitalization dates unknown] ¿ 10/18/10: (b)(6).Operative report.Pre- and postoperative diagnosis: incisional hernia.Anesthesia: general.Estimated blood loss: 20 ml.Specimens: none.Complications: none.¿ wound classification: [not provided] ¿ findings: ¿repair [with] mesh¿ ¿ procedure: ¿the patient was brought to the operating room after receiving preoperative iv antibiotics and dvt [deep vein thrombosis] prophylaxis on his lower extremities.He was placed under general endotracheal anesthesia.His abdomen was prepped and draped in standard fashion.Midline abdominal incision was made excising the incisional scar, primarily a couple of centimeters above and below the umbilicus.Underlying soft tissues was (sic) divided with electrocautery the abdomen was entered through the hernia sac.The hernia sac was then removed from the soft tissue and the fascial edges cleared of any adherent tissue on the anterior and superior aspects.This allowed at least a 2 cm depth of fascia for the closure.Next, a piece of gore-tex with dualmesh was placed with textured side facing up towards the fascia.It was sutured and the 12, 3, 6 and 9 o'clock positions with interrupted 0 gore-tex suture to the undersurface of the fascia.Next 0 gore-tex suture was used in a running fashion circumferentially around the repair adhering the mesh to the under surface of the fascia.Once the continuous suture was tied and the sutures and quadrants were tied as well.Next, the fascial defect was closed with a running 0 gore-tex suture.The wound was then thoroughly irrigated.The soft tissue of the wound was then closed in a running fashion and also incorporated to the fascial layer with a running 2-0 vicryl suture.Skin edges were closed with 3-0 monocryl in a subcuticular fashion and dressed with surgical tape.Local anesthetic was injected at the surgical sites.Patient was awakened and extubated, brought to the recovery in stable condition, doing well without any complications and also an abdominal binder was placed on the patient¿s abdomen as well.¿ ¿ 10/18/10: (b)(6).Implant sticker: ¿gore dualmesh® plus biomaterial.Ref catalogue number: 1dlmcp03.Lot batch code: 7308361.W.L.Gore & associates.¿ explant preoperative complaints: ¿ 6/1/16: (b)(6).Indications: ¿the patient is a 65-year-old man who underwent a ventral incisional hernia repair with mesh implantation several years ago.He developed discomfort near his umbilicus last november and underwent a ct scan which revealed a fluid collection near his mesh.Several months later he began to have intermittent drainage of fluid over the area and this has persisted despite antibiotic treatment.He has a wound just below his umbilicus.The risks, benefits and alternatives to the proposed surgery were explained in detail to the patient.He expresses understanding and would like to proceed.¿ explant procedure: open debridement of necrotizing abdominal wound and removal of infected mesh explant date: (b)(6) 2016 [hospitalization dates unknown] ¿ 6/1/16: (b)(6).Assistant #1: (b)(6).Operative report.Pre- and postoperative diagnosis: necrotizing abdominal wall infection and infected mesh.Anesthesia.General.¿ wound classification: [not provided] ¿ findings: [not provided] ¿ procedure: ¿the patient was brought to the operating room, placed in a supine position and a general anesthetic was administered.His abdomen was prepped and draped in the usual sterile fashion.An elliptical incision was made over the wound which was located just below his umbilicus.There was a tract that went deep and superior to a fluid collection with purulent material within.The tract and the walls of this fluid collection were all excised and this led further superior to a cavity which had an obviously infected piece of dual mesh which was still being held into position with multiple running and interrupted gore-tex sutures.The incision was carried further cephalad to get to the mesh.A kocher was placed on the mesh and it was gradually dissected away from this infected cavity.All of the visualized gore-tex sutures were removed.The cavity was debrided extensively from its necrotic material.In getting to this infected mesh, the abdominal cavity was entered.A limited lysis of adhesions was performed so that the infected mesh cavity was open to the abdominal cavity.This allowed closure of the fascia over this area and this was performed with interrupted figure-of-eight 0 nurolon sutures.Some of the attenuated fascia inferior to that was imbricated with figure-of-eight vicryl sutures as well.The prosthetic mesh to support the attenuated tissue was not used because of the infected field.The wound was generously irrigated.Staples were placed in the skin.A sterile dressing was applied.The patient tolerated the procedure well.He was brought to recovery in good 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 investigation findings code.Conclusion code remains unchanged.H6: updated health effect - impact code.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.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.There is insufficient information available for gore to reasonably draw conclusions related to aspects of the event, therefore conclusion code ¿d15: cause not established¿ is being used.Insufficient information may include limited or missing relevant medical records, involvement of multiple implanted devices (including non-gore devices) in the field of treatment, patient non-compliance, and/or a general lack of available detail or specificity related to an adverse event and/or device.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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