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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 preoperative complaints: none.Implant procedure: laparoscopy with lysis of adhesions and conversion to open ventral hernia repair with ¿gore-tex dualmesh patch¿ [implant: gore® dualmesh® biomaterial, 1dlmc04/(b)(4), 15cm x 19cm x 1mm thick, oval].Implant date: on (b)(6) 2006 (hospitalization unknown).(b)(6).Preoperative diagnosis: ventral incisional hernia.Postoperative diagnosis: large multifocal ventral incisional hernia.Assistant: (b)(6).Procedure: with the patient in supine position, the abdomen was prepped and draped in normal fashion for exploratory surgery.A transverse incision was made in the left upper quadrant and deepened through the subcutaneous tissue.The fascia was incised and then using a combination of blunt and sharp dissection, the peritoneal cavity was entered.The hasson trocar was inserted and pneumoperitoneum was obtained to 10mmhg pressure with carbon dioxide.The laparoscope was inserted and with the angled laparoscope, it was possible to visualize the extensive adhesions of the omentum to the anterior abdominal wall.These adhesions were gradually taken down after first placing two 10 mm ports in the lateral and inferior aspects of the left lower quadrant.The patient should be noted had a foley catheter in place.With gradual combination of sharp and blunt dissection, it was possible to free up the adhesions from the anterior abdominal wall and identified the hernia defects.It actually proved to be a multiloculated hernia extending from just below the umbilicus to the midepigastrium.When the area of the defects was measured and it appeared that we would not have a large enough patch to get adequate coverage laparoscopically, and therefore, a decision was made to convert to an open procedure.Therefore, the laparoscope was removed and a midline incision was made in the skin deepening though the subcutaneous tissue including removing the skin of the umbilicus and opening up through the hernia sac.Multiple hernia defects were interconnected, and at this point, it appeared that a 19x15 cm piece of gore-tex patch would actually fit this defect quite well.Therefore, the gore-tex was put in place.This was a dualmesh patch, so that the rough surface was placed towards the fascia and the smooth surface was towards the bowel.Individual horizontal mattress sutures of 0 prolene were placed starting at the 12 o¿clock position and going around the edges of the fascia to the 6 o¿clock position through nine.These sutures were all tied and then likewise, multiple sutures were placed extending from 12 o¿clock-6 o¿clock through the 3 o¿clock position again placing them all individually and then tying them all at the end.Once this was done, it appeared that the gore-tex patch was in a good position to heal and close over the defect.The fascial edges were then approximated with interrupted sutures of 0 prolene to create a second layer of the mesh.It should be noted that in one area inferiorly where there was a suture placed through the fascia, a whitish discharge was noted.This fluid was sent for stat gram stain which showed no evidence of bacteria and no cells.This probably represents old fat necrosis from previous surgery.In any event, the gore-tex was in place, and the fascia was sewn over that with interrupted 0 prolene sutures.The subcutaneous tissue was approximated with 3.0 vicryl and then the skin staples were used to close the skin wound.The left upper quadrant transverse incision was closed with a figure-of-eight suture of #2 dexon and then stay sutures were tied over that.Skin staples were used to close all the skin wounds.The patient tolerated the procedure well.All counts were correct at the end of the procedure.Estimated blood loss less than 100cc.The records confirm a gore® dualmesh® biomaterial (1dlmc04/(b)(4)) was implanted during the procedure.Explant preoperative complaints: none.Explant procedure: wound exploration with explantation of gore-tex patch.Explant date: date on (b)(6) 2008 (hospitalization on (b)(6) 2008).(b)(6).Preoperative diagnosis: chronic draining wound lower abdomen, question infected gore-tex patch.Postoperative diagnosis: chronic draining wound lower abdomen, question infected gore-tex patch.Assistant: (b)(6).Procedure: with the patient in the supine position under general endotracheal anesthesia, the abdomen was prepped and draped in a normal fashion for wound exploration.The patient had a sinus tract in the lower part of her midline incision below the umbilicus.The was probed with a kelly clamp and it extended deep and superior to that point.Incision was made around the tract, removing the entire tract and its associated skin.This was deepened down into the subcutaneous tissue.At the depths of the tract several prolene sutures and the superficial surface of the mesh were encountered.There was some fibrinous material around the mesh itself.Therefore, it appears that the mesh was contaminated.Circumferential dissection of the mesh, removing the mesh and cutting out all the sutures that could be visualized was carried out.The mesh was removed and cultured.The patient had received cefoxitin preoperatively as she had staph aureus that was sensitive to cefoxitin.In any event, after removing the gore-tex patch by circumferential dissection and removing the sutures, the wound was inspected.It was irrigated out and the wound was closed by first approximating the fascia with figure-o-eight sutures of 0 prolene.The subcutaneous tissue was then irrigated, some marcaine was infiltrated into the subcutaneous tissue and the skin wound was then closed with skin staples after first placing a penrose drain in the depts of the subcutaneous tissue.The patient tolerated this very well.A dry sterile compression dressing and abdominal binder were applied.I think it is highly unlikely that this patient will develop any dehiscence because the tissue looked pretty strong that the sutures were placed in and there did not appear to be any free peritoneal cavity underneath the gore-tex patch.The patient tolerated everything very well and was taken to the recovery area in satisfactory condition.Due the extensiveness of the surgery, she will be kept in the hospital as an observation patient overnight to observe for signs of bleeding, etc.Relevant medical information: none.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® 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: ¿strict aseptic techniques should be followed.If an infection develops, it should be treated aggressively.An unresolved infection may require removal of the material.¿ the instructions for use also warn: ¿when using this device as a permanent implant and exposure occurs, treat to avoid contamination, or device removal may be necessary.¿ 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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