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W. L. GORE & ASSOCIATES, INC. GORE® DUALMESH® PLUS BIOMATERIAL; MESH, SURGICAL, POLYMERIC
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| Model Number 1DLMCP07 |
| 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 10/27/2010 |
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Event Type
Injury
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Manufacturer Narrative
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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)] additional details regarding the patient's clinical course were ascertained from a review of medical records and are as follows: relevant information: on (b)(6) 2005: (b)(6).(b)(6), md.Operative report.Preoperative diagnosis: ventral incisional hernia.Postoperative diagnosis: ventral incisional hernia.Anesthesia: general.Name of operation: open repair of ventral incisional hernia repair with mesh.[implant: kugel composix mesh].Findings: ¿this is about a 9 x 6 cm hernia defect in the lower midline.¿ procedure: ¿the patient was placed on the table in a supine position.After general anesthesia was induced, the lower abdomen was prepped with betadine scrub and solution and draped in the usual sterile fashion.The previous lower midline incision was reentered.The hernia sac was dissected out down to the fascia circumferentially.There is a good bit of small bowel adherent to the sac and to the peritoneum adjacent to the hernia defect.These adhesions were all taken down so that there would be room to place a mesh with good overlap.Once this was done, a kugel mesh of 11 x 14 cm was inserted intraperitoneally with the smooth gore-tex side facing internally and the marlex side facing externally.It was sutured in place with 0 ethibond stitches.Most of the hernia sac was trimmed but enough was left remaining to close over the mesh.The wound was irrigated.The subcutaneous tissue was approximated with 3-0 vicryl.The dermis was approximated with 3-0 vicryl and the skin was closed with skin staples.Sterile dressing was applied and all counts were reported as corrected.Wound classification: clean.¿ on (b)(6) 2005: (b)(6).Implant sticker: ¿bard composix kugel hernia patch.¿ on (b)(6) 2009: (b)(6).(b)(6), md.Operative report.Preoperative and postoperative diagnosis: infected ventral hernia mesh.Name of operation: removal of infected abdominal wall mesh with primary closure.Anesthesia: general endotracheal.Complications: small bowel enterotomy closed in two layers.Specimen removed: infected mesh.Estimated blood loss: less than 30 cc.Antibiotic prophylaxis: levaquin 500 mg was given intravenously (iv) on call to the operating room.Deep venous thrombosis (dvt) prophylaxis: the patient had ted/scd [thrombo-embolus deterrent/sequential compression device] hoses on both extremities during the operation for dvt prophylaxis.Brief history: ¿the patient is a (b)(6) while female that has had a prior lower midline incisional/ventral hernia repaired by dr.(b)(6) over a year ago with typical kugel patch.She presented to the hospital approximately six weeks ago with fevers, chills, and abdominal pain just below her umbilicus with the computer tomography (ct) scan showing infected mesh.We performed an i&d [incision and drainage] at the bedside and were able to get an extensive amount of pus drained.We have kept her on iv antibiotics for several days and then oral antibiotics over the last few weeks with her understanding there was a very high likelihood that this would fail.However, due to her extensive co-morbidities and pulmonary disease requiring home oxygen, we felt that we should at least give it a chance.It did fail and she presented back to the office the other day with fevers and beginning to have abdominal pain recurring in the lower abdomen with ct scan showing air pockets and what appeared to be continued infection.Therefore, we discussed with her proceeding to the operating room for removal of this mesh with possible placement of alloderm versus primary closure depending on what was found intraoperatively.She understood the risks including bleeding, infection, bowel injury, need for further surgery in the future, or possible recurrent hernia or persistent hernia.She understood we could not place another mesh due to this infected field and persistent infection.She also understood her increased risk from a pulmonary standpoint due to her respiratory disease and home oxygen.She understood these risks and desired to proceed with the operation.Informed consent: i have discussed risk, benefits, side effects and reasonable alternatives, including possible results of not receiving treatment, potential problems related to recuperation and the likelihood of achieving goals with the patient/caregivers.Informed consent was obtained.¿ findings: ¿kugel patch with approximately 30 cc of frank pus around the pocket.¿ procedure: ¿the patient was taken to the operating room and general endotracheal anesthesia was performed.The patient's abdomen was prepped and draped in normal sterile fashion.A midline longitudinal incision 1 cm above the umbilicus down to approximately 3 cm above the pubic symphysis was made through the old scar.Electrocautery was used to transect through the subcutaneous tissue.We were able to dissect out this kugel mesh patch with an extensive amount of purulence surrounding the patch.We had two loops of small bowel really stuck to the mesh.We freed these with metzenbaum scissors; however, we did have one enterotomy that we had to close with 3-0 chromic in an interlocking running fashion followed by a second layer of interrupted 3-0 silk sutures.We had very little succus spillage, simply this interactome noted and the frank pus.We did take cultures.We also sent the mesh for cultures.After thoroughly irrigating the subcutaneous tissue and abdomen and freeing all the adhesions that were surrounding this area and returning the abdominal contents to their appropriate position, we were able to get a tongue of omentum down over this area.The actual fascia defect was minimal.Given there was an extensive amount of scarring with thick scar tissue in this area that we felt would not allow us to proceed with primary closure with loop pds sutures, we considered alloderm mesh placement.But again, because there was no tension on the incision and there was very little fascia defect, we thought it would simply be best to proceed with the primary closure; therefore, we used running loop pds from above and below in the middle.We then thoroughly irrigated the wound again and suctioned it dry period we approximated the subcutaneous tissue with 3-0 vicryl and re approximated the skin with widely spaced staples in case infection occurred and would easily drain.A sterile dressing was applied prior to leaving the operating room period sponge, needle, and lap counts were reported correct at the end of the operation.The patient tolerated the entire procedure well and was transferred to the post-anesthesia care unit (pacu) in stable condition.¿ implant preoperative complaints: on (b)(6) 2010: (b)(6).(b)(6).Brief history: ¿the patient is a (b)(6) white female, who had a prior incisional hernia repair by dr.(b)(6) approximately a year ago that subsequently got infected and had to remove the mesh.We kept her on iv antibiotics for several days and subsequently oral antibiotics, which completely cleared her mesh infection, and she has continued to do well for over a year now with no residual infection at all.She has this hernia that has continued to develop at the prior hernia site and has gotten large enough that it is very disabling to her and very painful.There is small bowel incarcerated in the hernia itself even though it is fairly large, measuring approximately 18 cm in size.We discussed with her hernia repair.She understood the possibility of infection, bleeding, recurrence of the hernia, bowel injury, and possible need for multiple operations.She also understood her risk from a cardiac and respiratory standpoint, especially with her requiring home oxygen and history or pulmonary problems.Given these risks and benefits, she desired to proceed with the operation.¿ implant procedure: incisional hernia repair with mesh.[implant: gore® dualmesh® plus biomaterial, 1dlmcp07/6935930 , 20 cm x 30 cm x 1mm thick] implant date: (b)(6), 2010 [hospitalization dates unknown] wound classification: ¿clean-contaminated.¿ on (b)(6) 2010: (b)(6).(b)(6).First assistant: (b)(6), md.Operative report.Preoperative and postoperative diagnosis: incisional hernia.Anesthesia: general.Complications: none.Specimen removed: hernia sac.Estimated blood loss: 50 cc.Antibiotic prophylaxis: levaquin was given intravenously (iv) on call to the operating room.Deep venous thrombosis (dvt) prophylaxis: the patient had ted/scd hoses were used also on call to the operating room.Informed consent: i have discussed risk, benefits, side effects and reasonable alternatives, including possible results of not receiving treatment, potential problems related to recuperation and the likelihood of achieving goals with the patient/caregivers.Informed consent was obtained.Findings: ¿large abdominal hernia associated with rectal diastasis and partial loss of domain.¿ procedure: ¿the patient was taken to the operating room and general endotracheal anesthesia was performed.The patient's abdomen was prepped and draped in normal sterile fashion.A midline laparotomy incision was made, approximately 10 cm to 12 cm in length at the prior repair site, and we were able to dissect out the hernia sac from the subcutaneous tissue, and we were able to reduce the hernia contents back into the abdominal cavity.She had an extensive amount of intra-abdominal adhesions that we took down also to make sure we had plenty of underlay with the mesh.Once we had all these adhesions appropriately freed up, we then used a 30 x 20-cm piece of dualmesh for repair period we placed a 2-0 prolene sutures on the mesh in caudal direction, followed by approximately four more sutures between these prior sutures, and then we marked on the abdominal wall to use the suture passer and pull these sutures up through the fascia splaying out the mesh underlay pattern on the anterior abdominal wall completely covering the area of hernia defect.We tie these sutures down in standard fashion.We then thoroughly irrigated the abdomen and suctioned it dry.We could not reapproximate the fascia over the mesh due to the large amount of defect, but we were able to reapproximate the subcutaneous tissue in two layers, followed by reapproximation of the skin with 4-0 monocryl in a running fashion.We did not place (b)(6) (jp) drains due to possible risk of infection, especially with her history of infection approximately a year ago.Sponge, needle, and lab counts were reported correct at the end of the operation.She was transferred to the post-anesthesia care unit (pacu) in stable condition.¿ on (b)(6) 2010: (b)(6).Implant sticker: ¿gore dualmesh® plus biomaterial.¿ ref catalogue number: 1dlmcp07.Lot batch code: 6935930.W.L.Gore & associates.Explant preoperative complaints: on (b)(6) 2010: (b)(6).(b)(6).Brief history: ¿the patient is a (b)(6) obese white female who had prior ventral hernia over a year ago that had infected mesh that had to be removed.She persisted with her hernia over the last year with total resolution of her infection.We felt we should proceed with placing a repeat mesh and repair of her hernia.However, postoperatively, she had failed to heal in this area.She has chronic respiratory issues and chronic nutritional issues, again morbidly obese.She had an extensive amount of serous drainage.It was felt unsure if this mesh was actually infected or simply just would not heal, but over a month treatment with iv antibiotics and given the chronicity of the wound, the patient as well as myself felt that removal of the mesh and simply primary closure of the abdomen was appropriate and the patient would just simply have this moderate size ventral hernia if we could get this wound to heal.She understood the risks and benefits including bleeding, infection, bowel injury, possible dehiscence, need for further surgery on her abdominal wall, and possible need for wound vac placement.She understood these risks and desired to proceed.¿ explant procedure: removal of gore-tex mesh with primary closure of the abdomen with nylon suture far-near and near-far.Explant date: (b)(6), 2010 [hospitalization dates unknown].On (b)(6) 2010: (b)(6).(b)(6).Assistant: (b)(6), md.Operative report.Preoperative and postoperative diagnosis: non-healing abdominal wound.Prior ventral hernia repair.Anesthesia: general.Complications: none.Specimen removed: gore-tex mesh.Drains: jp drain was placed to bulb suction.Estimated blood loss: less than 30 cc.Informed consent: i have discussed risk, benefits, side effects and reasonable alternatives, including possible results of not receiving treatment, potential problems related to recuperation and the likelihood of achieving goals with the patient/caregivers.Informed consent was obtained.Findings: ¿large ventral hernia.¿ procedure: ¿the patient was taken to the operating room and general endotracheal anesthesia was performed.The patient's abdomen was prepped and draped in the normal sterile fashion.The prior laparotomy incision was opened another 3 cm proximal and there was already an approximately 2 x 2 cm opening in the mid of the prior incision.The distal end of the incision had healed.We were able to remove the mesh, large sheet, through this area of opening.There was noted to be an extensive amount of serous drainage but no frank push [sic].We thoroughly irrigated the abdomen and suctioned it dry.There was an extensive amount of inflammation in the abdominal cavity from multiple surgeries and essentially a frozen abdomen of the abdominal contents.We therefore felt it was safest for this patient simply to close her skin and subcutaneous tissue primarily.Therefore, we proceeded with closure of nylon sutures far-near and near-far x4 sutures and between these placed a vertical mattress suture of 0 nylon.The patient tolerated the procedure well and was transferred to the pacu in stable condition.Sponge, needle, and lap counts were reported as correct at the end of the operation.¿ on (b)(6) 2010: (b)(6).(b)(6), md.Pathology report: pre-op diagnosis: non-healing abdominal wound.Date of specimen: (b)(6) 2010.Anatomic source: a.Infected mesh abdominal wound.Gross description: ¿a.Infected mesh abdominal wound is received in formalin and consists of a square of yellow-tan plastic mesh measuring 20 x 15 x less than 0.2 cm.There are blue plastic sutures securely attached.There does not appear to be any identifying numbers on the specimen.There are numerous irregular fragments of fibrofatty soft tissue present measuring in aggregate 1 x 1 x 0.2 cm.There are submitted a1-n.¿ final diagnosis: ¿a.Granulation tissue and fibrinopurulent exudate attached to synthetic mesh consistent with infected mesh; refer to cultures for identification of infectious agent.¿ 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.
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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 whereby a gore® dualmesh® plus biomaterial was implanted.The complaint alleges that on (b)(6), 2010, an additional procedure occurred whereby the gore device was explanted.It was reported the patient alleges the following injuries: mesh removal, infection, seroma, abscess, pain and suffering.Additional event specific information was not provided.
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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.This claim was withdrawn, and the alleged product complaint is no longer being pursued at this time.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.No further investigation is required at this time.Based upon gore¿s investigation 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 and "withdrawn." 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.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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