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| Model Number 1DLMC07 |
| Device Problem
Insufficient Information (3190)
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| Patient Problems
Seroma (2069); No Clinical Signs, Symptoms or Conditions (4582)
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| Event Date 01/19/2012 |
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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.".
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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) 2008 whereby a gore® dualmesh® biomaterial was implanted.The complaint alleges that on (b)(6) 2012, an additional procedure occurred whereby the gore device was explanted.It was reported the patient alleges the following injuries: drainage of a preperitoneal seroma, extensive adhesiolysis, mesh migration.Additional event specific information was not provided.
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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.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.Based upon the information received, the device remains in the patient and was not available for evaluation.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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Manufacturer Narrative
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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.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.Based upon the information received, the device remains in the patient and was not available for evaluation.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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Manufacturer Narrative
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B7: added medical history.H6: conclusion code remains unchanged.H10/11: added medical record information.Additional details regarding the patient's clinical course were ascertained from a review of medical records and are as follows: implant #1 & #2 preoperative complaints: ¿ 1/9/08: university of missouri health care.(b)(6), md.Indications: ¿the patient is a very pleasant 45-year-old white male who had several previous hernias repairs.He has had 2 open ventral hernia repairs with mesh and had 5 small hernia repairs.The patient presents with recurring partial small bowel obstruction secondary to recurrent midline ventral hernia.The patient was recently admitted on (b)(6) 2007, with a partial small bowel obstruction that resolved with conservative management.The patient is interested in having a definitive repair of the ventral hernia.¿ implant #1 & #2 procedure: laparoscopic ventral hernia repair with mesh.Extensive lysis of adhesions.Implant: gore® dualmesh® biomaterial x2 [#1.1dlmc07/05279395, 20cm x 30 cm x 1 mm thick; #2.1dlmc07/05282338, 20cm x 30 cm x 1 mm thick] implant #1 & #2 date: (b)(6) 2008 (hospitalization (b)(6) 2008) ¿ 1/9/08: university of missouri health care.(b)(6), md.Operative report.Assistant: (b)(6), md.Preoperative and postoperative diagnosis: recurrent ventral hernia.Estimated blood loss: 50 ml.Anesthesia: general.¿ procedure: ¿after the benefits and risks were reexplained to the patient in the preoperative area, the patient signed a consent form and agreed to proceed with surgery.He was marked appropriately.His history and physical was updated.The patient was taken to the operating room, placed in the supine position, once general anesthesia was induced via the endotracheal tube.Prior to anesthesia, lovenox 40 mg sub q was given for dvt prophylaxis.The patient received a preoperative dose of antibiotics.Oral gastric tube was placed, as well as a foley catheter.The patient was prepped and draped in the usual sterile fashion.A left upper quadrant incision was made with a knife blade and a 12-mm visiport was used to access the intraabdominal cavity under direct visualization using a 0-degree, 10-mm scope.Co2 insufflation was began up to a maximum intraabdominal pressure of 15.The 30-degree scope was then used to inspect the intraabdominal cavity and no injury was noted.There was a fair amount of adhesions to the midline area of both omentum and the small bowel.Two left lateral 5-mm trocars were placed under direct visualization.Adhesiolysis was performed both bluntly, sharply, and with a harmonic scalpel.Two to 3 loops of small bowel were removed sharply without obvious enterotomy.Omentum and some of the falciform was taken down with the harmonic scalpel bluntly.There was previously placed mesh noted.Some of the edges were not peritonealized and these were removed sharply and removed from the abdomen.After complete adhesiolysis was performed, a 4th trocar was placed in the right lateral abdomen under direct visualization.At this time a small nubbin had been removed from the intraabdominal wall, it was carefully inspected and again no serosal injury and no enterotomy was noted.At this time the hernia was measured and was measured to be 24 x 22 cm.At this time it was decided to use a gore-tex dual mesh.Two 25/30 cm meshes were brought onto the field.They were cut, sewn together using 0-goretex suture to create a 34 x 32 cm size mesh.It was marked, 4 stay sutures were placed in the 12:00, 3:00, 6:00, and 9:00 position.The mesh was rolled and brought into the intraabdominal cavity, it was unrolled and properly oriented.This was performed after marking the abdomen appropriately.A transabdominal suture passer was then brought through each of the marked spots in the skin, at the 12:00, 3:00, 6:00, and 9:00 position, grasping the previously placed stay sutures and bringing them up through the fascia transabdominally leaving a small bridge of fascia gap.These were tied down.The mesh was noted to be taut in each direction.It was also noted that the hernia was adequately covered, at least 3-5 cm in each direction.The protac device was then used to place tacks starting in the right upper quadrant, between the 2 stay sutures, placing tacks approximately 1 cm apart.Tacks were then placed in the left lower quadrant between the 2 stay sutures, off the 1-cm part, repeating this in the right lower quadrant and then the left upper quadrant.We placed tacks around the entire circumference.Additional transfascial sutures were then placed, 2 between each suture for a total of 11 sutures.Small incisions were made in the skin with an 11-blade and suture passer was then grasped transabdominally, grasped inside the abdomen, and suture passer was again passed, grabbing a small bite of fascia, grabbing the other suture, and pulling it up.These sutures were tied.Again, the mesh was noted to be very taut.An adequate coverage was achieved.The abdomen was again inspected and hemostasis was assured.The abdomen was deflated.All instruments and trocars were removed.The skin was closed with subcuticular 4-0 monocryl sutures.A sterile dressing was applied.All sponge, sharp, and instrument counts were correct.Dr.Thaler was present for the entire procedure.He tolerated the procedure well, was extubated in the operating room, delivered to the recovery room awake and in stable condition ¿ 1/9/08: university of missouri health care.Implant log.#1.Description: ¿graft dual mesh 1mm thick 20cm x 30cm.¿ quantity: 1.Manufacturer: gore.Catalog number: 1dlmc07.Lot number: 05279395.Expiration date: 8/9/12.#2.Description: ¿graft dual mesh 1mm thick 20cm x 30cm.¿ quantity: 1.Manufacturer: gore.Catalog number: 1dlmc07.Lot number: 05282338.Expiration date: 8/9/12.Relevant medical information: ¿ unknown dates: unknown facility and provider.Interventional radiology.Failed drainage attempts x2 of recurrent seroma.[no procedure records provided.] revision preoperative complaints: ¿ 1/19/12: university of missouri health care.Arthur rawlings, md.Indications: ¿the patient is status post a laparoscopic ventral hernia repaired with mesh who was developed a recurrent seroma, failed interventional radiology drainage twice and with continued pain and concern for infection.He comes in for a laparoscopic drainage.¿ revision procedure: laparoscopic drainage of a preperitoneal seroma.Laparoscopic adhesiolysis 45 minutes.Revision date: (b)(6.) ¿ 1/19/12: university of missouri health care.(b)(6), md.Operative report.Assistant: (b)(6), md.Preoperative and postoperative diagnosis: mesh associated seroma with pneumoperitoneum.Anesthesia: general.¿ findings: ¿the patient had a very large seroma with a pneumoperitoneum beneath the seroma which was posterior to the mesh.This was opened and drained of approximately 2 liters of seroma fluid.Cultures were sent as well as pieces of the pneumoperitoneum for culture.¿ ¿ procedure: ¿informed consent was obtained.The patient was marked.History and physical was updated.He was taken to the operating room, laid supine on the table and general anesthesia was induced.His anterior abdomen was prepped and draped in usual sterile fashion after placement of bilateral scds.Time-out was performed and confirmed the identity of the patient, procedure to be performed and appropriate antibiotic coverage was given during within 30 min of incision time.Anterior abdomen was then prepped and draped in a sterile fashion.Veress needle was placed in the left upper quadrant and continued to the abdominal cavity.Test with a saline drop test and opening pressure of 8 mmhg.Pneumoperitoneum was created to a level of 15 mmhg was created and a total of three 5 mm trocars were placed along the patient's left abdominal wall lateral to the mesh.Lysis of adhesions for 45 minutes was performed until the majority were taken down from the center of the area of the pneumoperitoneum and the seroma.A defect was created in the pneumoperitoneum and 2 liters of fluid were irrigated free.Cultures were sent.Multiple large pieces of the pneumoperitoneum were excised to allow drainage as well as sent for culture.Hemostasis was achieved, trocars removed and skin was closed with subcuticular 4-0 vicryl suture.Benzoin, steri-strips, sterile occlusive dressings were applied.¿ ¿ specimens: ¿fluid as well as peritoneum for culture and sensitivities.¿ ¿ plan: ¿if the mesh does come back to be with infected seroma, a consideration for mesh removal will be discussed with the patient.¿ ¿ [no pathology report provided.] relevant medical information: ¿ 4/15/13 ¿ 4/17/13: (b)(6) hospital.Inpatient admission.- 4/15/13: (b)(6), md.Operative report.Assistant (b)(6), md.Preoperative and postoperative diagnoses: morbid obesity with a bmi of 56, hyperlipidemia, hypertension, gastroesophageal reflux disease, ventral hernia, and osteoarthritis.Procedure: laparoscopic roux y gastric bypass with 150 cm roux limb complicated by multiple adhesions requiring extensive lysis of adhesions.Anesthesia: general.Estimated blood loss: 75 ml.- indications: ¿this is a 51-year-old, white male with a history of morbid obesity.The patient has failed medical weight loss, therefore was thought to be a candidate for bariatric surgery.He was worked up and appropriately consented.He was thought to be a reasonable candidate for bariatric surgery.¿ - procedure: ¿a small incision was made to the left of the umbilicus.A 12 mm optical trocar was inserted through the fascia into the peritoneum.Once confirmed to be intraperitoneal, co2 insufflation was used to get an adequate pneumoperitoneum.Two trocars were placed in the patient's left upper quadrant and 2 in the patient's right upper quadrant through small stab incisions under direct visualization.Please note, there was a 12 mm and 5 mm on each side.There were extensive adhesions.This required very extensive lysis of adhesions throughout the entire abdomen.Eventually we were able to identify what appeared to be the ligament of treitz.During the lysis of adhesions the omentum basically had become divided down to the transverse colon.We identified the ligament of treitz and marked off 50 cm distal to the ligament of treitz.The small bowel was divided here with the white load laparoscopic stapler.We next marked off a 150 cm roux limb.The roux limb was joined to the biliary limb with 3-0 silk suture.Next, 2 enterotomies were made, 1 in the roux limb and 1 in the biliary limb.Using a white load laparoscopic stapler, a jj anastomosis was then created.The common enterotomy was closed with a running 3-0 silk suture.The mesenteric defect was closed with running 3-0 silk suture.The patient was then placed in a steep reverse trendelenburg position.A small stab incision was made in the mid epigastrium and a clinch liver retractor was inserted and secured to the right crus of the diaphragm.The angle of his was identified.It was dissected free from its peritoneal attachments.Next, a 25 circular anvil was inserted through the left upper quadrant incision.A gastrotomy was made with a harmonic scalpel.Using a rubio clamp, the 25 circular anvil was inserted through the gastrotomy and brought out high on the lesser curve of the stomach.The gastrotomy was closed with a running 3-0 silk suture.Next, we created a window in the gastrohepatic ligament.We created a small narrow tubular gastric pouch using several blue loads on the laparoscopic stapler.We completed this dissection at the angle of his.We ensured that they were completely divided across the stomach.The roux limb was then brought up into the foregut of the abdomen.A large enterotomy was made and a 25 circular stapler was inserted into the small bowel.The stapler was eventually joined to the anvil and a gastrojejunostomy was then created.The excess roux limb was taken off with the harmonic scalpel at the mesentery followed by a white load laparoscopic stapler.The specimen was removed through the left upper quadrant incision.Several clips were placed on the raw edge of the roux limb.Next, an endoscope was passed through the esophagus into the gastric pouch.A leak insufflation test was performed.There was no evidence of leak.No evidence of major bleeding.Several clips were applied to ensure adequate hemostasis at the raw edge of the roux limb.There was also some bleeding.A 3-0 silk suture was placed to secure this.Once we had adequate hemostasis, the abdomen was explored 1 more time.There was no evidence of major problems.The liver retractor was then removed.The left upper quadrant incision was closed with a large vicryl tie and a grainy needle in a transfascial fashion.The rest of the trocars were taken out under visualization.The abdomen was deinsufflated and the skin was closed with skin clips.The patient tolerated the procedure well.¿ 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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