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| Model Number 1DLMC04 |
| Device Problem
Insufficient Information (3190)
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| Patient Problems
No Code Available (3191); No Clinical Signs, Symptoms or Conditions (4582)
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| Event Date 01/31/2019 |
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Event Type
Injury
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Manufacturer Narrative
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(b)(4).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.".
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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) 2006 whereby a gore® dualmesh® biomaterial was implanted.The complaint alleges that on (b)(6) 2019, an additional procedure occurred whereby the gore device was explanted.It was reported the patient alleges the following injuries: small bowel resection, recurrent incisional hernia repair, extensive adhesiolysis, near complete omentectomy, removal of old mesh.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: relevant medical information: (b)(6) 2006: (b)(6) md.Operative report.Preoperative and postoperative diagnosis: umbilical hernia.Procedure: umbilical hernia repair.Anesthesia: general.Procedure: ¿after satisfactory general anesthesia had been obtained, the patient's abdomen was prepped and draped in usual sterile fashion.A small incision was made below the umbilicus after first instilling a few milliliter of 0.25% marcaine.The umbilical skin was lifted off the umbilical defect.The defect was then closed with running o prolene suture, it was about 2 cm in length.A 3-0 vicryl was then used to approximate the subcutaneous tissue and the skin closed with 4-0 vicryl subcuticular stitch.Steri-strips and bandage were applied.The patient tolerated well.Prognosis for recovery is good.¿ (b)(6) 2006: (b)(6) md.Operative report.Preoperative and postoperative diagnosis: recurrent umbilical hernia.Procedure: repair of recurrent umbilical hernia.Anesthesia: general.Procedure: ¿after satisfactory general endotracheal anesthesia had been obtained, the patient's abdomen was prepped and draped in the usual sterile fashion.Previously, the incision was excised and lengthened.The umbilical skin was lifted off the defect.The defect edges were freed up.It was quite a small defect admitting about 2 fingers.We placed #1 prolene as internal retention sutures with bites away back from the edges and then ran a #1 looped pds as primary closure.Retention sutures were then tied.There appeared to be a very satisfactory repair.The 3-0 vicryl was used to approximate the subcutaneous tissue and skin was closed with skin staples.The patient tolerated the procedure well.Prognosis for recovery is reasonably good.¿ implant preoperative complaints: no information.Implant procedure: repair of recurrent umbilical hernia.Implant: gore® dualmesh® biomaterial [1dlmc04/04481353].Implant date: (b)(6) 2006 (hospitalization dates unknown).(b)(6) 2006: (b)(6) md.Operative report.Preoperative and postoperative diagnosis: recurrent umbilical hernia.Procedure: ¿after satisfactory prepping and draping in the usual sterile fashion, the umbilicus was excised using a transverse incision.The defect was clearly encountered and was freed.The edges were freed up.We started using the [dual layer] mesh.We put a piece of dual layer mesh and sutured it to the back wall of the fascia using 0 prolene.Once this was completed, the fascia was closed back over the mesh using a pds and subcutaneous tissue approximated with 3-0 vicryl and marcaine instilled.The skin was closed with skin staples.Bandage applied.The patient tolerated the procedure reasonably well.Prognosis is good.Estimated blood loss around 25 cc.¿ (b)(6) 2006: (b)(6) facility.Implant sticker.¿gore dualmesh® biomaterial.¿ ref catalogue number: 1dlmc04.Lot batch code: 04481353.Expiration 7/10/11.W.L.Gore and associates.Relevant medical information: explant preoperative complaints: (b)(6) 2019: (b)(6) md.Indications: ¿the patient is a 65-year-old male who presented to the emergency room overnight.He reported feeling a pop during the day yesterday and had severe abdominal pain since then.The patient reported having had multiple hernias repaired at the umbilicus in the past.Physical exam showed 2 large bulges on either side of the midline in the central abdomen.A transverse incision was well healed.The umbilicus was surgically missing.A ct scan showed an incarcerated incisional hernia with multiple complex chambers to the hernia.There was bowel within the hernia and dilatation of proximal small bowel.There was a free-floating piece of mesh from a previous repair in the subcutaneous space without apparent attachment to the abdominal fascia proper.¿ explant procedure: small bowel resection.Recurrent incisional hernia repair.Extensive adhesiolysis.Near-complete omentectomy.Explant date: (b)(6) 2019 (hospitalization dates unknown).(b)(6) 2019: (b)(6) md.Operative report.Preoperative diagnosis: incarcerated recurrent incisional hernia.Postoperative diagnosis: strangulated recurrent incisional hernia.Procedure: ¿there were 2 obvious bulges containing incarcerated hernia.The long axis was transverse, and the previous incision was transverse.During the dissection, the scar tissue and hernia sac in between were excised, which resulted in a single the previous transverse incision was opened with a scalpel and extended on both sides.A very tedious dissection was required to dissect a very complex multilobulated hernia sac from surrounding subcutaneous structures.There was considerable attachment of the omentum within the multiple hernia pockets.This required a very extensive adhesiolysis and ultimately excision of most of the omentum.There were 2 fascial defects, 1 on each side of the midline fascial defect 16 cm in diameter.The previous gore-tex mesh, which was incorporated into scar tissue, was excised.A single loop of small bowel had been incarcerated in the left-sided fascial defect.The antimesenteric border of the small bowel was ischemic in appearance, even though peristalsis of the entire bowel wall in that area was noted.The 2 limbs of small bowel associated with this small area of necrosis were brought alongside each other and attached with interrupted 3-0 silk sutures.An opening was made in the bend which resulted.Both limbs of the small bowel were decompressed with a pool sucker.A side-to-side stapled anastomosis was then made with 75 mm linear cutter staplers and reloads, effectively excising the ischemic bowel and forming the anastomosis.The mesentery of the excluded bowel was divided between clamps and ligated with vicryl suture.The staple lines were inspected and found to be intact.The entire transverse staple line was imbricated with 3-0 silk lembert sutures.The rent in the mesentery was closed with interrupted 3-0 vicryl suture.Considerable oozing had occurred throughout the surgery from the subcutaneous tissues where the hernia sac had been excised.There was also considerable oozing from fascial edges and from the omentum.Several parts of the omentum which had previously been ligated with vicryl suture required repeat ligation to promote hemostasis.The peritoneal cavity was then irrigated with warm saline solution.The bowel was returned to the peritoneal cavity in a natural position.All instruments and packs were removed.The fascial defect was closed along the midline with running #1 prolene suture.Even though this was a multiply recurrent hernia, mesh was not used for reinforcement due to the bowel resection.A 7- french jackson-pratt drain was placed in the subcutaneous space and brought out through a separate stab incision.The adipose tissue at the skin incision was reapproximated with interrupted 3-0 vicryl suture.The skin was closed with staples.A dressing was applied.The patient tolerated the procedure well.All counts were correct.The estimated blood loss was 200 ml.A single drain was placed.The specimen consisted of a small bowel loop, most of the omentum, and the excised gore-tex mesh.The patient was transported to the paco in good condition.¿ 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.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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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 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.Previous patient codes were reported based on the original complaint and are no longer applicable and/or not reportable per gore¿s investigation.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.¿ 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 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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