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| Model Number 1DLMC04 |
| 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 01/24/2020 |
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Event Type
Injury
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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: relevant medical information: on (b)(6) 2008: (b)(6) outpatient surgery clinics.(b)(6), md.History and physical.Morbidly obese lady presents with a several year history of recurrent incisional hernia.Had a tubal ligation through and umbilical port site in 1987, in 1994 developed a hernia in this area after a lot of lifting, which involved carrying firewood logs and she had that repaired and she reports that the repair was infected and it ¿busted¿ about a week later.Currently has a painful mass below this previous repair.History of gestational diabetes, depression.Surgical history of open cholecystectomy in 1991, tubal ligation in 1987, incisional hernia repair in 1994.Never smoked and does not drink.Weight (b)(6) pound, bmi 44.Exam: abdomen soft, nonreducible mass to the left side of the umbilicus.Impression: recurrent incisional hernia in a morbidly obese lady.Plan: best approached laparoscopically.I did discuss with her that this hernia repair may not be durable secondary to her morbid obesity and she understands.Implant procedure: [sic] laparoscopic repair of recurrent incisional hernia with mesh.Implant: gore® dualmesh® biomaterial [1dlmc04/05010697, 15 cm].Implant date: (b)(6) 2008 (hospitalization (b)(6) 2008).On (b)(6) 2008: the university hospital of (b)(6).(b)(6), md.Operative report.Preoperative diagnosis: recurrent incisional hernia.Postoperative diagnosis: recurrent incisional hernia.Assistant surgeon: dr.(b)(6).Anesthesia: general.Estimated blood loss: 10 ml.Complications: none.Preoperative note: ms.(b)(6) is a morbidly obese lady who had previously undergone a tubal ligation.She developed a hernia in her port site.Repair was attempted; however, that failed almost immediately, and she presented for a recurrent incisional hernia.Findings: 5 cm incisional hernia in the periumbilical area.Operative note: ¿after informed consent was obtained, she was taken to the operating room and general endotracheal anesthesia was induced.Foley catheter was placed, and her abdomen was prepped and draped in the standard sterile fashion.We accessed the abdomen with a standard technique using a visualizing trocar in the left upper quadrant without any injury to the underlying structures.A pneumoperitoneum was established, and 3 other ports were placed under direct visualization.We placed a 12 mm port in the left mid abdomen as far laterally as possible for our camera.We placed a left lower quadrant 5 mm port and a right mid quadrant 5 mm port as well.We began our dissection by reducing the hernia contents.The hernia was full of omentum, and this was reduced using sharp dissection and traction without any difficulty.The hernia defect was a round defect about 5 cm in diameter.We mapped this out and carefully measured it.We chose a 15 cm large piece of mesh such that we would have 5 cm overlapped on either side of the hernia.Stay sutures were placed in the mesh, and the abdomen was marked appropriately.The mesh was put in the abdomen, and the stay sutures were brought out through the anterior abdominal wall at the predetermined points.There were tied down to the fascia with the pneumoperitoneum let down.The pneumoperitoneum was then reestablished, and the remainder of the mesh was tacked in place with the tacking device.Our mesh was in excellent position at the end of the case.We removed all of our ports under direct visualization.We watched the mesh as the pneumoperitoneum was let down, and it was in excellent position.All the skin incisions were closed with running vicryl 4-0 subcuticular stitch.The patient tolerated the procedure well and was taken to recovery in stable condition.¿ on (b)(6) 2008: (b)(6) medical center.Implant sticker.Gore dualmesh® biomaterial.Ref catalogue number: 1dlmc04.Lot batch code: 05010697.W.L.Gore & associates.The records confirm a gore® dualmesh® biomaterial (1dlmc04/ 05010697) was implanted during the procedure.Relevant medical information: on (b)(6) 2008: (b)(6) medical center.(b)(6), md.Progress notes.Looks great.Home today.Instructions given.Explant procedure: removal of infected ventral hernia mesh with primary hernia repair.Explant date: (b)(6) 2020 (hospitalization (b)(6) 2020).On (b)(6) 2020: (b)(6) regional health system.(b)(6), md.Operative report.Preoperative diagnosis: infected ventral hernia mesh.Postoperative diagnosis: infected ventral hernia mesh.History: a (b)(6)-year-old female with multiple surgical interventions with previous ventral hernias with mesh implanted.She has developed a chronic draining wound that has not healed despite antibiotic therapy with workup showing definitive evidence of mesh infection.She taken to the operating room for mesh removal.Risks including the high likelihood of recurrent ventral hernia development being explained to the patient.She has voiced understanding and given consent.Procedure note: ¿after the patient was identified and consented, transferred to the operating room and placed in the supine position where general endotracheal anesthesia was induced without complication.A foley catheter was placed.Scds were applied.Perioperative antibiotics were given.The draining wound was probed, tracks to a fairly posterior direction without significant undermining.An incision was created here.Subcutaneous tissues were opened down to the fascia.There were indurated areas on either side that were excised.Eventually this was taken down to ethibond suture that was identified and cut.Further dissection allowed for identification of the gore-tex mesh.The mesh was found to be secured in place both by ethibond suture as well as metal clips.The entire mesh eventually was removed.It approximated a 10 x 20 cm piece of mesh.There was some purulent material drainage surrounding this which also was removed.Once the entire mesh was removed i palpated being sure there was no other evidence of prosthetic material that was present.The wound was irrigated with hydrogen peroxide/normal saline solution.The fascia then was reapproximated with #1 pds in figure-of-eight fashion.The wound was packed open with acticoat dressing, fluff gauze and abd then was applied.The patient tolerated the procedure very well.She was awakened, extubated and transferred to the recovery room with plans for admission overnight for pain control.At the end of the procedure all sponge, needle, and instrument counts were correct and reported to me times two.I certify that i have explained the nature, purpose, benefits, complications from, risks of, alternatives (including no treatment and attendant risks), likelihood of achieving goals of care and potential problems that might occur during recuperation, to the proposed procedure/operation, have offered to answer any questions and have fully answered all such questions.I believe the patient/agent/relative/guardian fully understand what i have explained and answered.I certify that informed consent has been obtained prior to the operation/procedure listed on the consent form.¿ relevant medical information: on (b)(6) 2020: (b)(6) regional clinical laboratories.(b)(6), md.Pathology.Spec#: (b)(4).Final diagnosis: ¿abdominal mesh,¿ gross examination: synthetic mesh material.[second page missing].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.".
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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) 2008 whereby a gore® dualmesh® biomaterial was implanted.The complaint alleges that on (b)(6) 2020, an additional procedure occurred whereby the gore device was explanted.It was reported the patient alleges the following injuries: infection, chronic draining wound, explant.Additional event specific information was not provided.
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Manufacturer Narrative
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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: relevant medical information: ¿ (b)(6)2008: (b)(6)clinics.(b)(6), md.History and physical.Morbidly obese lady presents with a several year history of recurrent incisional hernia.Had a tubal ligation through and umbilical port site in 1987, in 1994 developed a hernia in this area after a lot of lifting, which involved carrying firewood logs and she had that repaired and she reports that the repair was infected and it ¿busted¿ about a week later.Currently has a painful mass below this previous repair.History of gestational diabetes, depression.Surgical history of open cholecystectomy in 1991, tubal ligation in 1987, incisional hernia repair in 1994.Never smoked and does not drink.Weight 265 pound, bmi 44.Exam: abdomen soft, nonreducible mass to the left side of the umbilicus.Impression: recurrent incisional hernia in a morbidly obese lady.Plan: best approached laparoscopically.I did discuss with her that this hernia repair may not be durable secondary to her morbid obesity and she understands.Implant procedure: ___[sic] laparoscopic repair of recurrent incisional hernia with mesh.Implant: gore® dualmesh® biomaterial [1dlmc04/05010697, 15 cm] implant date: (b)(6), 2008 (hospitalization (b)(6), 2008) ¿ (b)(6)2008: (b)(6).(b)(6), md.Operative report.Preoperative diagnosis: recurrent incisional hernia.Postoperative diagnosis: recurrent incisional hernia.Assistant surgeon: dr.(b)(6).Anesthesia: general.Estimated blood loss: 10 ml.Complications: none.Preoperative note: (b)(6) is a morbidly obese lady who had previously undergone a tubal ligation.She developed a hernia in her port site.Repair was attempted; however, that failed almost immediately, and she presented for a recurrent incisional hernia.Findings: 5 cm incisional hernia in the periumbilical area.Operative note: ¿after informed consent was obtained, she was taken to the operating room and general endotracheal anesthesia was induced.Foley catheter was placed, and her abdomen was prepped and draped in the standard sterile fashion.We accessed the abdomen with a standard technique using a visualizing trocar in the left upper quadrant without any injury to the underlying structures.A pneumoperitoneum was established, and 3 other ports were placed under direct visualization.We placed a 12 mm port in the left mid abdomen as far laterally as possible for our camera.We placed a left lower quadrant 5 mm port and a right mid quadrant 5 mm port as well.We began our dissection by reducing the hernia contents.The hernia was full of omentum, and this was reduced using sharp dissection and traction without any difficulty.The hernia defect was a round defect about 5 cm in diameter.We mapped this out and carefully measured it.We chose a 15 cm large piece of mesh such that we would have 5 cm overlapped on either side of the hernia.Stay sutures were placed in the mesh, and the abdomen was marked appropriately.The mesh was put in the abdomen, and the stay sutures were brought out through the anterior abdominal wall at the predetermined points.There were tied down to the fascia with the pneumoperitoneum let down.The pneumoperitoneum was then reestablished, and the remainder of the mesh was tacked in place with the tacking device.Our mesh was in excellent position at the end of the case.We removed all of our ports under direct visualization.We watched the mesh as the pneumoperitoneum was let down, and it was in excellent position.All the skin incisions were closed with running vicryl 4-0 subcuticular stitch.The patient tolerated the procedure well and was taken to recovery in stable condition.¿ ¿ (b)(6)2008: (b)(6) medical center.Implant sticker.Gore dualmesh® biomaterial.Ref catalogue number: (b)(4).Lot batch code: 05010697.W.L.Gore & associates.¿ the records confirm a gore® dualmesh® biomaterial (1dlmc04/ 05010697) was implanted during the procedure.Relevant medical information: ¿ (b)(6)2008: (b)(6)medical center.(b)(6), md.Progress notes.Looks great.Home today.Instructions given.Explant procedure: removal of infected ventral hernia mesh with primary hernia repair.Explant date: (b)(6), 2020 (hospitalization (b)(6), 2020) ¿ (b)(6)2020: (b)(6)health system.(b)(6), md.Operative report.Preoperative diagnosis: infected ventral hernia mesh.Postoperative diagnosis: infected ventral hernia mesh.History: a 61-year-old female with multiple surgical interventions with previous ventral hernias with mesh implanted.She has developed a chronic draining wound that has not healed despite antibiotic therapy with workup showing definitive evidence of mesh infection.She taken to the operating room for mesh removal.Risks including the high likelihood of recurrent ventral hernia development being explained to the patient.She has voiced understanding and given consent.Procedure note: ¿after the patient was identified and consented, transferred to the operating room and placed in the supine position where general endotracheal anesthesia was induced without complication.A foley catheter was placed.Scds were applied.Perioperative antibiotics were given.The draining wound was probed, tracks to a fairly posterior direction without significant undermining.An incision was created here.Subcutaneous tissues were opened down to the fascia.There were indurated areas on either side that were excised.Eventually this was taken down to ethibond suture that was identified and cut.Further dissection allowed for identification of the gore-tex mesh.The mesh was found to be secured in place both by ethibond suture as well as metal clips.The entire mesh eventually was removed.It approximated a 10 x 20 cm piece of mesh.There was some purulent material drainage surrounding this which also was removed.Once the entire mesh was removed i palpated being sure there was no other evidence of prosthetic material that was present.The wound was irrigated with hydrogen peroxide/normal saline solution.The fascia then was reapproximated with #1 pds in figure-of-eight fashion.The wound was packed open with acticoat dressing, fluff gauze and abd then was applied.The patient tolerated the procedure very well.She was awakened, extubated and transferred to the recovery room with plans for admission overnight for pain control.At the end of the procedure all sponge, needle, and instrument counts were correct and reported to me times two.I certify that i have explained the nature, purpose, benefits, complications from, risks of, alternatives (including no treatment and attendant risks), likelihood of achieving goals of care and potential problems that might occur during recuperation, to the proposed procedure/operation, have offered to answer any questions and have fully answered all such questions.I believe the patient/agent/relative/guardian fully understand what i have explained and answered.I certify that informed consent has been obtained prior to the operation/procedure listed on the consent form.¿ relevant medical information: ¿ (b)(6)2020: (b)(6)clinical laboratories.(b)(6), md.Pathology.Mc:458:20.Final diagnosis: ¿abdominal mesh,¿ gross examination: synthetic mesh material.[second page missing].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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H6: updated results code.Conclusion code remains unchanged.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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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.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 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.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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