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| Model Number 1DLMC06 |
| Device Problem
Insufficient Information (3190)
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| Patient Problems
Unspecified Infection (1930); Seroma (2069)
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| Event Date 11/09/2007 |
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Event Type
Injury
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Manufacturer Narrative
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It should be noted that the gore® dualmesh® 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® 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.".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 a legal admission by anyone that the product described in this report has any defects or has malfunctioned, as defined from a legal standpoint.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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Event Description
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It was reported to gore that the patient underwent open ventral and incisional hernia repair on (b)(6) 2007 whereby a gore® dualmesh® biomaterial was implanted.The complaint alleges that on (b)(6) 2007, an additional procedure occurred whereby the gore device was explanted.It was reported the patient alleges the following injuries: additional surgeries, adhesions, omentectomy, mesh removal, infected mesh, seroma, obstruction, recurrence, pain & 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: exploratory laparotomy.Lysis of intraabdominal adhesions.Repair of ventral/incisional hernia using a gore-tex dual mesh.Omentectomy.Implant: gore® dualmesh® biomaterial; ref: (b)(4); lot: 04410947.Implant date: (b)(6) 2007 [hospitalization (b)(6) 2007 ¿ unknown discharge].(b)(6) 2007: (b)(6) hospital.(b)(6).(b)(6).Operative report.Pre- and postoperative diagnosis: incarcerated ventral / incisional hernia.Anesthesia: general.Estimated blood loss: minimal.Specimen: omentum.Complications: none.Indications: the patient is a 72-year-old white male who underwent splenectomy emergently several years ago, according to the patient in 1958 for traumatic splenic injury.Since then he has done well, but started developing a ventral abdominal hernia with also an umbilical hernia.He complains of intermittent pain and wanted to have this repaired.Findings: the patient had significant adhesions to the posterior abdominal wall from previous surgical scar.Procedure: ¿¿through a standard midline incision, a skin incision was made.The skin incision was carried down through the subcutaneous tissue down through fascia until the abdominal cavity was entered.Upon entering the abdominal cavity, omentum was adherent to the posterior abdominal wall at the previous left upper median incision.These adhesions were carefully lysed and a small section of the omentum was excised and tied off.After careful mobilization of the omentum and making sure there were no other abnormalities noted.I then proceeded to insert a gore-tex dual mesh.This was sutured to the abdominal wall insertion using 0 prolene suture continuous.This was done circumferentially.After of the mesh, a jackson-pratt drain was then placed on top of the mesh and brought out through a separate stab wound, it was secured with 2-0 silk suture.I then proceeded to approximate the subcutaneous tissue using 2-0 vicryl.Following that, the skin was then closed using 2-0 nylon running suture.The jackson-pratt drain was secured with 2-0 silk suture.The patient tolerated the procedure well.¿ (b)(6) 2007: (b)(6) hospital.(b)(6).Implant information: gore® dualmesh® biomaterial; ref: (b)(4); lot: 04410947; size 18 x 24 cm x 1 mm.Qty: 1.The records confirm a gore® dualmesh® biomaterial (ref: (b)(4); lot: 04410947) was implanted during the procedure.Relevant medical information: no interim medical records.Explant procedure: exploratory laparotomy.Lysis of adhesions.Omentectomy.Removal of infected gore-tex mesh.Insertion of micromesh.Explant date: (b)(6) 2007 [hospitalization: (b)(6) 2007 ¿ unknown discharge].(b)(6) 2007: (b)(6) hospital.(b)(6).Operative report.Pre- and postoperative diagnosis: infected ventral abdominal gore-tex mesh.Anesthesia: general.Estimated blood loss: minimal.Indications: ¿the patient is a 72-year-old white male who underwent ventral abdominal hernia repair.He is known to have rectus abdominus muscle diastasis and at that time the ventral hernia was repaired.The patient however continued to have redness along the wound with drainage.The wound was also non healing.Following this the patient was therefore scheduled for removal of the infected mesh." findings: ¿the patient had mildly infected gore-tex mesh.On balloon exploration of the abdomen there was notable what appears to be an festerous spleen arising from the omentum.¿ procedure: ¿the previous sutures were removed and the skin was opened through the previous midline incision.Then blunt dissection was performed until the gore-tex was exposed.The prolene holding the gore-tex to the abdominal wall was removed.The gore-tex was removed intact.Note that culture of this was obtained and the gore-tex was also sent for culture.Following this there was a pseudo membrane formed by the omentum just directly underneath the gore-tex.This was excised and sent for pathological culture.This, was considered the omentectomy.After this was done because now the abdominal cavity was entered i carefully explored the abdominal cavity.Upon exploring the abdominal cavity, what appeared to be an accessory spleen was noted.It should be noted that the patient had previous splenectomy.He also was noted to have diverticula arising in the large colon mainly the sigmoid.There is no evidence of infection.After brief exploration the gallbladder was also noted to be intact and non-distended.I then irrigated the abdominal cavity carefully and suctioned it out.Because the patient has significant laxity of the rectus abdominus muscle, i felt that some form of closure was needed.I had preoperatively explained to the patient that may have to use a vicryl mesh.The vicryl mesh 30 centimeters by 30 centimeters was then folded and cut to the size of the ventral wall defect.I then used 0 vicryl to suture the vicryl mesh in the posterior abdominal wall carefully.This was done circumferentially.After this was completed i then inserted a flat jackson-pratt drain directly over the mesh and secured with 2-0 silk suture in the inferior portion of the wound through a separate stab wound.After this was done then i proceeded to close the subcutaneous tissue now over the mesh using 0 vicryl continuous suture.Following this i then excised the skin edge from the previous incision circumferentially.After this and after adequate hemostasis was achieved 1 then proceeded to close the wound using 2-0 nylon running continuous.The patient tolerated the procedure well." (b)(6) 2007: wound cultures, omentum and gore-tex infected graft were sent to microbiology and pathology.(b)(6) 2007: implant: 12¿ x 12¿ vicryl mesh.Ethicon.Catalog: vkml.Lot: tg2697; qty: 1.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® 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® 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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It should be noted that the gore® dualmesh® 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® 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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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® 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.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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