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H6: updated health effect h6: updated investigation finding h6: updated type of investigation h6: updated investigation conclusions 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) 2007: (b)(6).Operative report.Preoperative diagnosis: multiple incarcerated ventral hernias with incarcerated umbilical hernia.Postoperative diagnosis: [blank].Repair of multiple incarcerated ventral huge hernias x 4 with permacol and prolene mesh.Omentectomy.Excision of umbilicus.Repair of incarcerated umbilical hernia with mesh.Surgeon (b)(6).Anesthesia: general.Estimated blood loss: [blank].Fluids: [blank].Complications: [blank].Findings: [blank].Operative technique and findings: ¿under satisfactory general anesthetic the patient consented to widely excising the umbilicus if it is involved and due to her weight of close to 300 pounds it was hard to tell how many hernias were involved, so using an elliptical incision in the umbilicus and mended superiorly and inferiorly we found 3 very huge incarcerated ventral hernias with bowels and omentum stuck in it.Another small hernia is on the lower end of the midline which was discovered later after we dissected the umbilicus which was also incarcerated.After the whole umbilicus was removed the incarcerated tissue of the omentum was reduced and we incorporated most of the holes into one, thereby creating almost a 10 x 12 cm opening.It took us a while to take everything out, but some bleeding was noted at the omentum so we decided to do an omentectomy by sequentially clamping it and dividing it and tying with heavy silk.Then after the whole 3 big ones in this large bowel and small bowel were all reduced.I put my finger down and discovered another small one about 3 x 4 cm on the lower end which was not obvious.This was then dissected out and reduced and closed with a small piece of prolene mesh in a running suture using 0 prolene.The bigger one because of the exposure to the bowel, we decided to use a permacol and the permacol was secured to surrounding fascia with 0 prolene in running stitches.After completion all sponge and instrument counts were correct and we decided to put an ng tube because there was too much manipulation of the small bowel.After satisfactory completion, irrigation of the whole wound which created a huge cavity with clindamycin antibiotic.Fluid suctioned out.Two jackson-pratts were left in place, one into the surrounding empty cavity of the abdominal wall, and the other one right on the mesh and secured to the skin with nylon 2-0.The subcutaneous tissue was then closed with interrupted chromic 1 and a threw in a couple 2-0 nylon stitches in n mattress fashion.The rest was closed with interrupted staples.The patient tolerated the procedure well and left the or in satisfactory condition.Blood loss minimal, no blood transfusion.¿ ¿ (b)(6) 2007: (b)(6).Pathology.Accession #: s07-44284.Clinical history: hernia sac ¿ umbilical.Pathologic diagnosis: a) skin and soft tissue, umbilical region, excision: fibromembranous tissue consistent with hernia sac.Portion of benign skin with focal mild chronic inflammation.Specimen received: hernia sac.Gross description: a) the specimen is designated ¿umbilical hernia sac¿ and consist of multiple portions of tan-yellow fibroadipose tissue that measure 16.5 x 12.5 x 5.8 cm in aggregate.Some of the portions of tissue have a sac-like configuration.Cut sections show no discrete lesions.Also submitted within the same container is an ellipse of tan skin, consistent with umbilicus, that measures 7.9 x 3.3 cm and is excised to a maximum depth of 2.5 cm.On cut sections, no discrete lesions are identified.Summary of cassettes: a1, soft tissue; a2, skin.¿ (b)(6) 2008: (b)(6).Operative report.Preoperative diagnosis: abdominal wall fluid, rule out old hematoma.Postoperative diagnosis: abdominal wall fluid, rule out old hematoma.Incision and drainage, and insertion of a drain.Assistant: (b)(6), crnfa.Anesthesia: general.Operative technique and findings: ¿under satisfactory general anesthetic, the operative site was painted with betadine aseptically and draped as usual.Using an 11 blade, the lower abdominal wall where the pocket is was entered.Hemostat was inserted.Cultures, aerobic and anaerobic, were taken.Suction recovered about close to 1 liter of old bloody fluid.A jackson pratt french 10 was inserted into the cavity and anchored to the skin with a heavy 2-0 nylon.The patient tolerated the procedure well and left the operating room in satisfactory condition.¿ blood loss: minimal.No blood transfusion.¿ (b)(6) 2008: (b)(6).Operative report.Preoperative diagnosis: reaccumulated abdominal wall fluid, post hernia repair, and skin tag, abdominal wall.Postoperative diagnosis: reaccumulated abdominal wall fluid, post hernia repair, and skin tag, abdominal wall.Excision of skin tag of abdominal wall and drainage of a huge seroma of the anterior abdominal wall, with placement of two drains.Assistant: sherri mitchell, crnfa.Anesthesia: general.Operative technique and findings: ¿under satisfactory general anesthetic, the whole operative area was prepped with betadine aseptically and draped as usual.The patient is morbidly obese.The accumulation was discovered with an ultrasound of about 2 to 3 liters of fluid.She also wanted us to excise a skin tag over the anterior abdominal wall and this was elliptically excised.The base was cauterized.Then we concentrated on the seroma of the anterior abdominal wall.Two incisions were made on both sides of the midline and hemostat was used to puncture the pocket.The right side is a smaller pocket.We recovered quite a bit of old bloody fluid.The left side was loculated, so i had to make a bigger incision and try to break up the pocket, but we recovered more than 2 liters of brown fluid.After completion, two jackson-pratt drain french 10 were left in place and exited through the incision and anchored to the skin with nylon 2-0.The patient tolerated the procedure well and left the operating room is satisfactory condition.¿ ¿ (b)(6) 2008: the vascular lab.Alex juan, md.Ultrasound guided aspiration.History: recurrent seroma.Impression: (+) fluid collection/seroma visualized in the mid abdomen measuring 11.73 x 5.80 x 12.34 cm with an estimated fluid collection greater than 439 cc¿s by volume calculations.Amount of fluid aspirated: approximately 500cc¿s of fluid was aspirated successfully.¿ (b)(6) 2008: the vascular lab.(b)(6).Ultrasound guided aspiration.History: recurrent midline seroma.Impression: (+) fluid collection/seroma visualized in the midline abdomen measuring 10.39 x 2.97 x 6.55 cm with an estimated 105 cc¿s by volume calculations.Amount of fluid aspirated: approximately 180cc of fluid was aspirated successfully.¿ (b)(6) 2008: the vascular lab.(b)(6).Ultrasound guided aspiration.History: recurrent midline seroma.Impression: (+) fluid collection/seroma visualized in the midline abdomen measuring 13.61 x 5.59 x 11.43 cm with an estimated fluid collection greater than 450 cc¿s by volume calculations.Amount of fluid aspiration: approximately 200 cc¿s fluid was aspirated successfully.¿ (b)(6) 2008: (b)(6).Ultrasound guided aspiration.History: recurrent seroma.Impression: (+) fluid collection visualized in the midline abdomen/post -operative site measuring 12.31 x 4.86 x 10.32 cm with an estimated fluid collection greater than 323 cc¿s by volume calculations.Amount of fluid aspirated successfully: approximately 450 cc¿s of fluid was aspirated successfully.¿ (b)(6) 2009: (b)(6).Ultrasound guided aspiration.History: recurrent abdominal seroma.Impression: (+) fluid collection visualized in the lower abdomen/midline measuring 14.56 x 4.8 x 10.52 cm with an estimated 385 cc¿s by volume calculations.Amount of fluid aspirated successfully: approximately 380 cc¿s of fluid was aspirated successfully.¿ (b)(6) 2009: (b)(6).Ultrasound guided aspiration.History: recurrent abdominal swelling/seroma.Impression: (+) fluid collection/seroma visualized in the postoperative site of the abdomen measuring 11.89 x 2.29 x 11.47 cm with an estimated fluid volume of 209 cc¿s by volume calculations.Amount of fluid aspirated successfully: approximately 240 cc¿s of fluid was aspirated successfully.¿ (b)(6) 2009: (b)(6).Ultrasound guided aspiration.History: recurrent abdominal seroma.Impression: (+) fluid collection/seroma visualized in the postoperative site of the midline abdomen measuring 15.82 x 5.82 x 14.47 cm with an estimated fluid volume of 697 cc¿s by volume calculations.Amount of fluid aspirated successfully: approximately 470 cc¿s of fluid was aspirated successfully.¿ (b)(6) 2009: (b)(6) ultrasound guided aspiration.History: recurrent abdominal seroma.Impression: (+) fluid collection/seroma visualized in the postoperative site of the midline abdomen measuring 15.22 x 7.76 x 11.85 cm with an estimated fluid collection greater than 732 cc¿s by volume calculations.Amount of fluid aspirated successfully: approximately 760 cc¿s of fluid was aspirated successfully.¿ (b)(6) 2009: (b)(6).Ultrasound guided aspiration.History: recurrent abdominal seroma.Impression: (+) fluid collection/seroma visualized in the postoperative site of the midline abdomen measuring 15.34 x 13.62 x 8.66 cm with an estimated fluid collection greater than 947 cc¿s by volume calculations.Amount of fluid aspirated successfully: approximately 550 cc¿s of fluid was aspirated successfully.¿ (b)(6) 2009: (b)(6).Ultrasound guided aspiration.History: recurrent abdominal seroma.Impression: (+) fluid collection/seroma visualized in the postoperative site of the midline abdomen measuring 13.14 x 12.87 x 9.01 cm with an estimated fluid collection greater than 797 cc¿s by volume calculations.Amount of fluid aspirated successfully: approximately 750 cc¿s of fluid was aspirated successfully.¿ (b)(6) 2009: (b)(6).Ultrasound guided aspiration.History: recurrent seroma in postoperative site of abdomen.Impression: (+) fluid collection/seroma visualized in the postoperative site of the midline abdomen measuring 13.24 x 14.24 x 9.44 cm with an estimated fluid collection greater than 931 cc¿s by volume calculations.Amount of fluid aspirated successfully: approximately 675 cc¿s of fluid was aspirated successfully.¿ (b)(6) 2009: (b)(6).Ultrasound guided aspiration.History: recurrent abdominal seroma.Impression: (+) fluid collection/seroma visualized in the postoperative site of the midline abdomen.Amount of fluid aspirated successfully: approximately 600 cc of fluid was aspirated successfully.¿ (b)(6) 2009: (b)(6) ultrasound guided aspiration.History: recurrent abdominal seroma.Impression: (+) fluid collection/seroma visualized in the postoperative site of the abdomen measuring 15.08 x 7.79 x 15.85 cm with an estimated 1000 cc¿s by volume calculations.Amount of fluid aspirated successfully: approximately 350 cc of fluid was aspirated successfully.¿ (b)(6) 2010: (b)(6).(b)(6).Ultrasound guided aspiration.History: recurrent abdominal seroma.Impression: (+) fluid collection/seroma visualized in the postoperative site midline abdomen measuring 12.43 x 12.02 x 6.70 cm with estimated fluid collection greater than 524 cc¿s by volume calculations.Amount of fluid aspirated successfully: approximately 75 cc of fluid was aspirated successfully.¿ (b)(6) 2010: (b)(6).Operative report.Preoperative diagnosis: recurrent seroma of anterior abdominal wall post incisional repair with mesh.Postoperative diagnosis: recurrent seroma of anterior abdominal wall post incisional repair with mesh.Exploration of abdominal wall, marsupialization of the cavity and debridement of the abdominal wall.Assistant: (b)(6), crnfa.Anesthesia: general.Operative technique and findings: ¿the patient was given 2 g of ancef one hour prior to the procedure.The patient¿s medical record, name and site were all identified with a time-out technique.The patient was prepped and draped under general anesthetic.She is morbidly obese with a huge seroma that has been aspirated for several months post repair of a huge incisional hernia with mesh.The patient understood that this required a more extensive debridement of the anterior abdominal wall in order to obliterate the cavity.So, after prepping and draping, an elliptical incision was made on the old scar and this was carried down and went into a very thick cavity, which almost measured at least 10 cm x 15 cm in diameter.The mesh is still intact, but the cavity is probably 0.5 cm thick had to be excised to unroof the entire cavity.We have recovered almost another 100 cc seroma and a lot of necrotic tissue that has to be debrided.After completely unroofing the entire cavity wall, we decided to leave this open and utilize a wound vac for postoperative care.Irrigation of the cavity with antibiotic and the wound was left opened intact and then dressing applied.The patient tolerated the procedure well and left the operating room in satisfactory condition.¿ ¿ (b)(6) 2010: (b)(6).Operative report.Preoperative diagnosis: abdominal wall abscess.Postoperative diagnosis: abdominal wall abscess.Bedside incision and drainage of abdominal wall abscess.Anesthesia: none.Complications: none.Estimated blood loss: the patient remained stable.Brief history and consent: the patient is a 50-year-old female with multiple ventral hernia repairs with mesh who was complicated by recurrent seroma.She is currently being treated with a wound vac and presents with abdominal pain and fever.Ct scan shows evidence of an abdominal wall abscess.All risks, benefits, possible complications and alternatives of this procedure were explained to the patient.All of her questions were answered to her satisfaction and she decided to proceed.A signed consent was obtained.This patient is a patient of dr.Juan.This procedure was done on his behalf.Description of operation: ¿the patient was taken to the operating room and placed on the table in the supine position.A time-out was performed such that the patient¿s name, site, diagnosis and procedure were all confirmed.The patient was prepped and draped in standard sterile fashion.An ultrasound was done at the bedside to locate the cavity.Plans were made to perform ultrasound-guided drain placement, however, with minimal manipulation or removal of the wound vac material, the abscess cavity was easily accessed.It was drained easily and adequately at the bedside.Purulent fluid was obtained.There was no bleeding.I repeated an ultrasound at bedside showed that cavity to decrease substantially.I then went ahead and sent the patient for repeat ct scan without oral or iv contrast and demonstrated that the cavity had decreased substantially in size and there was obvious communication now with the outside environment.Therefore, the recommendation was reapply the wound vac for suction evacuation of the rest of the abscess contents and promote healing.My findings and results were communicated to the primary surgeon (b)(6).Implant procedure: exploratory laparotomy, lysis of dense adhesion, repair of multiple incarcerated recurrent incisional hernia x6 with dualmesh.Partial omentectomy.Implant: gore® dualmesh® plus biomaterial [1dlmcp04/11263274, 15cm x19cm x1mm, oval].Implant date: (b)(6) 2013 (hospitalization (b)(6) (b)(6).Operative report.Preoperative diagnosis: multiple recurrent incarcerated incisional hernia x6.Morbid obesity.Postoperative diagnosis: multiple recurrent incarcerated incisional hernia x6.Morbid obesity.Assistant: (b)(6), crnfa.¿ procedure: ¿after prepping and draping, we decided since this is a recurrent problem from multiple repairs in the past and recently being seen at the outside hospital emergency room for incarcerated bowel.The patient was then referred to me for urgent surgical intervention.After preop workup, the patient was deemed to be healthy enough to have this repaired.The patient was given antibiotic an hour prior to procedure.Patient¿s name, medical record, and site were all identified with a time-out technique.After prepping and draping, we decided to go through midtransverse to the right from a previous midline to avoid going thru the huge scar with a very thick scar tissue.Going through the transfers after reviewing the cat scan it indicated that most of the incarcerated bowels were to the right of the midline.So, after dissecting down to the subcutaneous tissue consisting of small and large bowel.Ranging from 1-2 cm, about two of them, and the rest were huge, measured at least 8 x 10 cm, allowing the small bowel, large bowel incarceration.So, it took us some time to almost basically explore all the opening and excise the sac and reduce everything and eventually join a couple of big ones into 1 big one for easier repair, converting into a 12 x 14 size opening.In the midst of doing that, we had explored the entire bowel and taken out some of the very thick adherent small bowel into the anterior abdominal wall.After freeing, it took us almost 30-45 minutes just to free the small bowel, large bowel, until we can make sense out of it, we also had to resect part of an infarcted omentum.We also discovered there are little hernia to the left of the midline which i could not reach and i do not want extend the incision.And since no bowels are caught in it except omental tissues, i decided to left it in place and closed the midline anterior scar tissue to the fascia on the lower end toward the midline to obliterate the space away from the repair to the right.This was done with 0 prolene in running stitch.Then the opening to the right of the midline which measured at least 12 x 15 was joined by a couple of hernias, was then covered with dualmesh.This was secured with 0 prolene in running stich and multiple angle stitch applied.Other small ones were approached with primary repair with 0 prolene.There is a big space noted after the repair which require drainage, irrigation done.Sponge and instrument count correct.Two jackson-pratt drains, french 10, were left in the area because of the size of the wound and the cavity and exited through a different stab wound and anchored to skin with nylon 2-0.Satisfactory sponge and instrument count correct.Hemostasis done.The wound was then closed with interrupted chromic.The skin was closed, skin staples.We added a couple of retention stitches in place.The patient left the or in satisfactory condition.¿ blood loss: minimal.No blood transfusion.¿ (b)(6) 2013: (b)(6).Implant sticker.Gore dualmesh® plus biomaterial.Ref catalogue number: 1dlmcp04.Lot batch code: 11263274.W.L.Gore & associates.¿ (b)(6) 2013: (b)(6).Implant record.Inventory item: mesh dual plus.15x19x1mm.Manufacturer: old w.L.Gore.Model/cat number: 1dlmcp04.Lot number: 11263274.¿ (b)(6) 2013: osu east.(b)(6) md.Brief op-note.Preoperative diagnosis: incisional hernia without mention of obstruction or gangrene.Postoperative diagnosis: incisional hernia without mention of obstruction or gangrene.Procedure performed: repair incisional/ventral open with mesh.Implantation mesh for open incisional/ventral hernia repair or debridement.Intraoperative findings: no significant abnormalities.Anesthesiologist: charles l.Hamilton, iii, md.Surgical staff: circulator: cathy sowers, rn.Complications: none.Estimated blood loss: minimal.Specimens: no specimen sent.¿ (b)(6) 2013: (b)(6).(b)(6) md.Pathology.Clinical history: incisional hernia without mention of obstruction or gangrene.Pathologic diagnosis: a) abdominal soft tissue, excision: fibroadipose with reactive fibrosis, partially covered by an attenuated to reactive mesothelium, consistent with hernia sac.Focal acellular eosinophilic material consistent with biologic mesh with associated multinucleated giant cell foreign body resection.Specimen received: hernia sac/hydrocele/seroma.Hei x 1, hei x1.Gross description: the specimen is received in one properly labeled container with the patient¿s name and accession number.A) the specimen is designated ¿hernia sac¿ and consist of four irregular portions of tan-pink to yellow-gray soft tissue that are 12.4 x 8.3 x 2.3 cm in aggregate.The largest portion of tissue is a saccular.Each portion of tissue contains a moderate amount of attached yellow lobulated adipose tissue.One of the portions of tissue contains attached blue sutures and a 1.4 x 0.9 x 0.6 cm firm nodular area.Cut sections through this firm area reveal gray-tan finely granular surfaces.The remaining cut surfaces are pink-tan to gray, fibrous, focally hemorrhagic and smooth.Relevant medical information: ¿ (b)(6) 2013: [facility (b)(6)].(b)(6).Operative report.Preoperative diagnosis: abscess, abdominal wall.Postoperative diagnosis: abscess, abdominal wall.Incision and drainage of abscess, abdominal wall.Incision and drainage of abscess, abdominal wall.Assistant: (b)(6), crnfa.Anesthesia: general.Operative technique and findings: ¿the patient was given antibiotic an hour prior to procedure.The patient's name, medical record, and site were all identified with a time-out technique.After prepping and draping the previous incisional hernia repair site where the infection was pretty progressive.This patient was brought in after several tapping in the office, did not clear the fluid, and finally got to low infected, so we decided to drain this in the operating room.After prepping and draping, the 11-blade was used to enter the cavity.Culture aerobic and anaerobic was taken and jackson pratt drain was left in placed and anchored which skin with nylon 2-0.The patient tolerated the procedure well and left the or in satisfactory condition.Blood loss was minimal.No blood transfusion.¿ explant procedure: debridement of anterior abdominal wound.Excision of fistula.Excision of infected gore-tex mesh.Explant date: (b)(6) 2014 (hospitalization (b)(6) ¿ (b)(6) 2014: [facility ni].(b)(6).Operative report.Preoperative diagnosis: chronic nonhealing abdominal wound, also with fistula.Postoperative diagnosis: chronic nonhealing abdominal wound, also with fistula.Assistant: sherri mitchell, rnfa.Anesthesia: general.¿ procedure: ¿the patient was given antibiotic an hour prior to procedure.Patient¿s name, medical record, and site were all identified with a time-out technique.After prepping and draping, the fistula is right in the middle of the incision from the previous repair of hernia, and this has never healed and was treated at a wound clinic outside of our facility.Because of the chronic drainage, cat scan indicated more fistula, so the patient was referred back for debridement of that and possibly excision of the mesh.After prepping and draping, a transverse incision was approached in the same fashion, including the fistula opening.Cultures, aerobic and anaerobic, were taken.This was carried down through a very thick abdominal wall, and a fistula directing into a huge cavity that measured about 7 x 10 cm in diameter.This was full of necrotic tissues.After debridement the gore-tex mesh was then taken out completely.All stitches were removed.More debridement was done and sent for pathologic confirmation.The wound now measures at least 5 x 8 cm in opening, so after full irrigation and more debridement and packing, wet packing was then left in place.Patient is going to have a wound vac placed the following day.This well be treated aggressively with long-term iv antibiotics and wound vac treatment.The patient tolerated procedure well and left the or in satisfactory condition.¿ blood loss: minimal.No blood transfusion.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.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.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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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.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.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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