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| Model Number 1DLMC04 |
| Device Problem
Insufficient Information (3190)
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| Patient Problems
Abscess (1690); Unspecified Infection (1930)
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| Event Date 08/07/2008 |
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Event Type
Injury
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Manufacturer Narrative
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It should be noted that the gore® dualmesh® biomaterial instructions for use addresses the following adverse reactions among others: ¿possible adverse reactions with the use of any tissue deficiency prosthesis may include, but are not limited to, contamination, infection, inflammation, adhesion, fistula formation, seroma formation, hematoma, and recurrence." the gore® dualmesh® biomaterial instructions for use also states: ¿strict aseptic techniques should be followed.If an infection develops, it should be treated aggressively.An unresolved infection may require removal of the material.".
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Event Description
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It was reported to gore that the patient underwent laparoscopic ventral hernia repair on (b)(6) 2007 whereby a gore® dualmesh® biomaterial was implanted.The complaint alleges that on (b)(6) 2008, an additional procedure occurred whereby the gore device was explanted.It was reported the patient alleges the following injuries: abscess, infected mesh, removal of mesh, drainage, debridement, and pain and suffering.Additional event specific information was not provided.
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Manufacturer Narrative
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Additional details regarding the patient's clinical course were ascertained from a review of medical records and are as follows: implant procedure: laparoscopic ventral hernia repair with mesh x 2 and lysis of adhesions.Implant: gore® dualmeshh® biomaterial [1dlmc04/04871269, 15 x 19 cm].Implant date: (b)(6) 2007 (hospitalization [ni]).(b)(6) 2007: new york-presbyterian the (b)(6).(b)(6).Operative report.Assistant: dr.(b)(6).Anesthesia: general.Preoperative diagnosis: ventral hernia, status post laparoscopic duodenal switch.Postoperative diagnosis: ventral hernia, status post laparoscopic duodenal switch.Indications: the patient underwent a laparoscopic removal of adjustable gastric band and removal of the port and tubing on (b)(6) 2005.Previously, the patient underwent a laparoscopic duodenal switch.Due to consistent weight loss, the patient started to develop a palpable periumbilical hernia.Cat scan was performed preoperatively which demonstrated and confirmed the presence of this hernia.The patient is to have concomitantly an abdominal panniculectomy by dr.(b)(6) which will be dictated by him in a separate operative report.Technique: ¿under general anesthesia, the abdomen was prepared with iodine.The patient was in supine position.Compressive devices were used in both legs to prevent deep vein thrombosis.Foley catheter was inserted to monitor urine output, inserted by the surgical team.The patient received antibiotics flagyl and ancef to avoid any abdominal wall infection.We started by making a supraumbilical incision and according to the lines of the plastic surgeon, we then went to the fascia and made an opening on the direct vision.A 10-mm re-usable trocar was inserted, and co2 was insufflated to 15 mmhg.We inserted a 10-mm laparoscope with a direct vision and inspected the abdominal cavity.There were multiple adhesions to the intraabdominal wall, mostly omental, and we had to insert three 5-mm trocar on the left paramedian area and lateral area.This with the sonosurg and combination of scissors, we were able to take down those adhesions to the intraabdominal wall to inspect the anterior abdominal wall completely.Using a 5-mm scope which we inserted in the left side, we inspected the periumbilical area.There, we found a hernia that was lower than the umbilicus.This measured about close to 2 cm in diameter and then of course the trocar site that we had just created superior to that.This will require a mesh that measured 10 x 10 cm gore-tex mesh ptfe dualmesh, one side that is rough and the other one is smooth.In the process of taking the adhesions in the left upper quadrant, we identified another hernia; this was close to the subcostal left area and in the midclavicular line.This may correspond to the port site or the tubing site of the band or trocar sites from the previous surgery.We decided to put a second mesh in this area about the same size; the hernia was the same size in diameter.There was no bowel incarcerated in any of those hernias.There was preperitoneal fat in the periumbilical hernia itself.We then after using a mesh of 15 x 19 cm, cut this in half in order to have 2 meshes roughly 10 x 10 cm.Cv2 gore-tex sutures were applied to each corner of these mesh, and then inserted inside the abdominal cavity through a 10-mm trocar.They were re-expanded with maryland dissectors; and then we started with the superior left one.After making some markings on the skin, we were able to make a stab wound with an 11 blade and pass through the suture passer to grasp each corner of this gore-tex sutures.These were tied in the subcutaneous tissue, and then we added about 2 sutures between each quadrant, so a total of 12 sutures were used to secure the mesh to the intraabdominal wall and avoiding the use of tacks, this creates adhesions, and adhesions to the small bowel is potentially concerned later.So, after completing all these mesh securing to the abdominal wall, a last inspection to the abdominal cavity demonstrated some adhesions to the small bowel itself.But none causing kinking or causing partial small bowel obstruction, especially near the y connection of the duodenal switch.The rest of the abdomen did not demonstrate abnormalities.Liver appeared normal and was not cirrhotic.Other small bowel loops appeared normal, some segments of the colon appeared normal as well.The rest of the anterior abdominal wall did not demonstrate inguinal or femoral hernias.There was a small hematoma on the right inferior side from one of the suture that may have hit the small branch of the epigastric artery.This hematoma was stable and relatively small perhaps about 3 x 3 cm in size.We had left the sutures out completely off gore-tex after we tied the knot so that dr.(b)(6) can identify them during his abdominal panniculectomy and circumferential subcutaneous dissection.We pulled the skin, though, from the scarpa to avoid any puckering at each of the small sides.With this in mind, we stopped our procedures and put a sterile green towel on top to remove all the drapes and laparoscopic instruments, and dr.Schwartz team is then taking over.The instrument, sponge counts, and needle counts at the end of our procedure was correct.The estimated blood loss was negligible, and the patient did tolerate well that part of the procedure.The pneumoperitoneum had been evacuated, and all the 5-mm wounds were left open and as well as the 10-mm wound in the superior umbilical area.Dr.(b)(6) is going to proceed with panniculectomy and close these wounds.¿ (b)(6) 2007: new york-presbyterian the (b)(6).Implant sticker: gore dualmeshh® biomaterial.Ref catalogue number: 1dlmc04.Lot batch code: 04871269.W.L.Gore & associates.The records confirm a gore dualmeshh® biomaterial (1dlmc04/04871269) was implanted during the procedure.Explant procedure: wound debridement, removal of infected sutures and mesh.Explant date: (b)(6) 2008 (hospitalization [ni]).(b)(6) 2008: [facility ni].(b)(6).Operative report.Preoperative diagnosis: wound infection (infected mesh).Postoperative diagnosis: same.Assistant surgeon: (b)(6), (b)(6).The patient is a 50 year old gentleman with a complex history of weight loss surgery, an incisional hernia repaired with goretex mesh, abdominoplasty.And a chronic, infected, draining sinus.Pre-operative consent was obtained for wound debridement; the patient understands that this surgery as a significant risk of recurrence of the infection (the gore mesh is infected) and will likely require further surgery.Procedure: ¿the patient entered the operating room.Following appropriate identification, he was placed in supine position on the operating table.Venodyne boots were applied.Full general anesthesia was induced with orotracheal intubation.The patient was prepped and draped in a semi lithotomy position.Appropriate antibiotics were given intravenously.An elliptical incision was carried down over the draining sinus after having injected methylene blue to delineate the tract.Several (> 4) ethibond, prolene and gore sutures were removed and then part of the gore mesh (4 x 10 cm) was also removed.A small sinus in the luq was also debrided.The operative site was examined and hemostasis was verified.The wound was irrigated copiously with peroxide.With this being satisfactory, sterile "cling" dressings were applied (inserted into the wound).Anesthesia was well tolerated, however a significant rash/erythema was noted on tile thighs and trunk on completion of the procedure.The patient was extubated on the table and accompanied by the surgical team to the recovery room.Estimated blood loss was approximately 50 cc.Sponge, needle and instrument counts were reported correct to the surgeon.¿ 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.In the absence of additional information or medical records from the complainant, this event file will be closed with the information provided.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® 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.¿ 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.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.The explanted portion of the device was not able to be returned to gore for evaluation; therefore, a direct product analysis could not be conducted.Based upon the information received, part of the device remains in the patient and was not available for evaluation.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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