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Catalog Number 1DLMCP03 |
Device Problems
No Apparent Adverse Event (3189); Insufficient Information (3190)
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Patient Problems
Adhesion(s) (1695); Pain (1994); Hernia (2240); Not Applicable (3189)
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Event Date 05/13/2013 |
Event Type
Injury
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Manufacturer Narrative
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(b)(6).(b)(4).It should be noted that the gore dualmesh® plus biomaterial instructions for use includes 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.¿.
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Event Description
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It was reported to gore that the patient underwent laparoscopic incisional hernia repair on (b)(6) 2011 whereby a gore dualmesh® plus biomaterial device was implanted.The complaint alleges that on (b)(6) 2013, the gore devices was explanted.It was reported the patient alleges the following injuries: pain, hernia recurrence, adhesions, and mesh removal.Additional event specific information and medical records have been requested.
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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: records prior to 8/30/2001, including previous abdominal procedures, were not provided.Operative records dated 8/30/2011 indicate the patient underwent laparoscopic cholecystectomy and laparoscopic incisional hernia repair (reducible).Indications for the procedure state: ¿biliary dyskinesia and incisional hernia from a previous partial nephrectomy.¿ the (b)(6) 2011 procedure notes state: ¿a 12-mm port was placed through the hernia defect.The patient was placed in reverse trendelenburg.Adhesions were taken down and then the cystic duct and artery were dissected out, clipped, and divided.The gallbladder was removed from the liver bed with the bovie electrocautery, placed in an endocatch bag, and removed from the abdomen.It was inspected on the back table and the clips were in good position.The abdomen was reinsufflated.At this point the 12-mm port was removed.The fascia was closed with a 0 vicryl suture with a suture passer.I then used the bovie scissors to take down all the adhesions to this epigastric hernia and then the defect was closed primarily with 0 vicryl sutures with a suture passer.I then chose a 10 x 15 cm piece of physiomesh and then the mesh was rolled up and placed in the abdomen.It was pulled up through the repair defect with a suture passer, tacked to the chest wall in 1-cm increments with a securestrap, and then four transfascial sutures were passed with a suture passer and 0 ethibond sutures.At this point the repair was in good position.The patient was hemostatic.All ports were removed.¿ the operative report indicates a ¿physiomesh¿ (non-gore device) was used.However, a procedure implant report dated (b)(6) 2011 indicates a gore dualmesh® biomaterial (1dlmcp03) was used during the procedure.Lot number for the alleged gore device was not provided.Records between 8/30/2011 and 5/13/2013 were not provided.Operative records dated (b)(6) 2013 indicate the patient underwent laparoscopic recurrent ventral hernia repair.The records state: ¿two additional 5-mm ports were placed, one in the lower midline and one in the left lower quadrant.I took down all of the adhesions with the bovie scissors and bluntly.I used the scissors to remove the mesh.After i removed the mesh, i removed it out through the 5-mm port site.I then used #0 ethibond sutures to primarily close the defect.I measured the defect.It was 6 cm in diameter.After it was closed, i placed an 11 x 14 piece cm piece of ventrio mesh.A single transfascial suture was placed.The mesh was rolled up and placed in the abdomen.It was pulled into place.Four additional transfascial sutures were placed in all four quadrants of the mesh.The mesh was.Then tacked in 1-cm increments with the securestrap device.Then, after that was performed, the repair was inspected and in good position.The abdomen was irrigated out with saline.Some saline was left in the abdomen.The lower 5-mrn port site was closed with a #0 ethibond suture at the level of the fascia where the mesh was placed through, then the skin incisions were closed with 4-0 monocryl subcuticular suture and infiltrated with exparel.¿ the records indicate a non-gore device was used during the procedure.There was no mention of infection in the medical records.A potential relationship, if any, between the alleged injuries or complications and the gore device is unclear from the provided information at this time.It should be noted that the gore dualmesh® plus biomaterial instructions for use includes 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.¿ 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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Added medical history.Conclusion code remains unchanged.Added medical record information.Additional/revised details regarding the patient's clinical course were ascertained from a review of medical records and are as follows: records dated 11/29/2010 indicate the patient underwent ¿hand-assisted laparoscopic left partial nephrectomy, cystoscopy, and dilatation of urethral stricture.¿ the records indicate a ¿a 7-cm midline incision was made just above the umbilicus.¿ records dated 8/8/2011 state the patient was seen ¿¿after noticing some abdominal pain after heavy lifting.She had a benign tumor excised from her left kidney laparoscopically in november.The patient in her initial evaluation also complained of some bloating.¿ ¿assessment/plan: incisional reducible hernia.Plan is to proceed with a laparoscopic hernia repair.¿ records between 8/30/2011 and 4/29/2013 were not provided.Records dated (b)(6) 2013 state: ¿39 year old here after a ventral hernia repair 2 years ago.She has had progressive constipation and increased pain.The pain is with straining and with activity.No urinary symptoms.She does have nausea, but no emesis.She has severe pain occasionally but when it reduces she feels better.The pain gets intense and is 8/10 when it is stuck out.The pain is sharp and worse when bending over.¿ abdominal exam notes state: ¿abdomen is soft and nondistended but there is a large 6 cm incisional hernia.The defect is superior to the old repair and i suspect the superior portion of the old repair tore loose.¿ the (b)(6) 2013 records continue: ¿¿6 month history of abdominal bulge and worsening constipation.She states that her nausea and emesis are gradually worsening and her pain at times can get intense when she is sitting.She has to get up, walk around and rub it back down.I suspect this is when it is intermittently incarcerating.We will schedule a laparoscopic incisional hernia repair.We will possibly do mesh removal and replacement.¿ operative records dated 5/13/2013 indicate the patient underwent laparoscopic recurrent ventral hernia repair with mesh removal.The records state: ¿two additional 5-mm ports were placed, one in the lower midline and one in the left lower quadrant.I took down all of the adhesions with the bovie scissors and bluntly.I used the scissors to remove the mesh.After i removed the mesh, i removed it out through the 5-mm port site.I then used #0 ethibond sutures to primarily close the defect.I measured the defect.It was 6 cm in diameter.After it was closed, i placed an 11 x 14 piece cm piece of ventrio mesh.A single transfascial suture was placed.The mesh was rolled up and placed in the abdomen.It was pulled into place.Four additional transfascial sutures were placed in all four quadrants of the mesh.The mesh was then tacked in 1-cm increments with the securestrap device.Then, after that was performed, the repair was inspected and in good position.The abdomen was irrigated out with saline.Some saline was left in the abdomen.The lower 5-mrn port site was closed with a #0 ethibond suture at the level of the fascia where the mesh was placed through, then the skin incisions were closed with 4-0 monocryl subcuticular suture and infiltrated with exparel.¿ the records indicate a non-gore device was used during the procedure.There was no mention of infection in the medical records.Records dated (b)(6) 2013 state the patient was seen for abdominal pain.¿this is a 39-year-old female, status post lap ventral hernia with mesh by dr.Hutchinson in may of 2013.She had been doing well, except for the past week she has not had a bowel movement.Over the past 3 days, she has had increased pain, nausea and vomiting.Eventually had to present to an outside hospital.A cat scan was done, which showed possible mesh infection and the patient was transferred here.¿ ¿cat scan of the abdomen pelvic shows an 8 x 3 cm fluid collection, along with superficial and peritoneal mass consistent with a possible abscess.The patient also has some free fluid consistent with hemorrhage.¿ a nasal mrsa swab dated 5/20/2013 states: ¿no growth¿¿ discharge summary records dated 5/21/2013 state: ¿this patient underwent a laparoscopic ventral hernia repair.She did not have a bowel movement for a week and then went to the emergency room.Imaging demonstrated fluid around the mesh, which did not appear infectious in origin.She was empirically covered with the antibiotics and started on bowel stimulation.Her symptoms improved after she had multiple bowel movements, and she was then discharged the next day with relief of her symptoms, normal white count, no evidence of infection¿.¿ a potential relationship, if any, between the alleged injuries or complications and the gore device is unclear from the provided information at this time.It should be noted that the gore dualmesh® plus biomaterial instructions for use includes 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.¿ 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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Based upon gore¿s investigation 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.Previous patient codes (1695, 1994, 2240) were reported based on the original complaint and are no longer applicable and/or not reportable per gore¿s investigation.The following information was determined from the medical records.Medical records: the known medical records span (b)(6) 2010 through (b)(6) 2013 and not all records received in this time span are relevant to the gore® dualmesh® plus biomaterial.Records from (b)(6) 2011 through (b)(6) 2013 were not provided.Patient information: medical history: hypertension.Prior surgical procedures: (b)(6) 2010: partial left nephrectomy.Back surgery [unknown date].Implant preoperative complaints: on (b)(6) 2011: [the patient] ¿is a 37-year-old female who is here after noticing some abdominal pain after heavy lifting.She had a benign tumor excised from her left kidney laparoscopically in (b)(6).The patient in her initial evaluation also complained of some bloating.¿ ¿incisional reducible hernia.Plan is to proceed with a laparoscopic hernia repair.¿ implant procedure: laparoscopic cholecystectomy and laparoscopic incisional hernia repair (reducible).Implant: gore® dualmesh® plus biomaterial (unk/1dlcmp03, 10 cm x 15 cm).Implant date: (b)(6) 2011 [hospitalization dates unknown].Description of hernia being treated: ¿the abdomen was reinsufflated.At this point the 12-mm port was removed.The fascia was closed with a 0 vicryl suture with a suture passer.I then used the bovie scissors to take down all the adhesions to this epigastric hernia and then the defect was closed primarily with 0 vicryl sutures with a suture passer.¿ implant size and fixation: ¿i then chose a 10 x 15 cm piece of physiomesh and then the mesh was rolled up and placed in the abdomen.It was pulled up through the repair defect with a suture passer, tacked to the chest wall [sic] in 1-cm increments with a securestrap, and then four transfascial sutures were passed with a suture passer and 0 ethibond sutures.At this point the repair was in good position.The patient was hemostatic.All ports were removed.¿ no post-operative records were provided.Explant preoperative complaints: on (b)(6) 2013: ¿39 year old here after a ventral hernia repair 2 years ago.She has had progressive constipation and increased pain.The pain is with straining and with activity.No urinary symptoms.She does have nausea, but no emesis.She has severe pain occasionally but when it reduces she feels better.The pain gets intense and is 8/10 when it is stuck out.The pain is sharp and worse when bending over.¿ ¿abdomen is soft and nondistended but there is a large 6 cm incisional hernia.The defect is superior to the old repair and i suspect the superior portion of the old repair tore loose.¿ explant procedure: laparoscopic recurrent ventral hernia repair with mesh removal.Explant date: (b)(6) 2013.¿two additional 5-mm ports were placed, one in the lower midline and one in the left lower quadrant.I took down all of the adhesions with the bovie scissors and bluntly.I used the scissors to remove the mesh.After i removed the mesh, i removed it out through the 5-mm port site.I then used #0 ethibond sutures to primarily close the defect.I measured the defect.It was 6 cm in diameter.After it was closed, i placed an 11 x 14 piece cm piece of ventrio mesh.A single transfascial suture was placed.The mesh was rolled up and placed in the abdomen.It was pulled into place.Four additional transfascial sutures were placed in all four quadrants of the mesh.The mesh was then tacked in 1-cm increments with the securestrap device.Then, after that was performed, the repair was inspected and in good position.The abdomen was irrigated out with saline.Some saline was left in the abdomen.The lower 5-mm port site was closed with a #0 ethibond suture at the level of the fascia where the mesh was placed through, then the skin incisions were closed with 4-0 monocryl subcuticular suture and infiltrated with exparel.¿ records indicate that a non-gore device was implanted during the (b)(6) 2013 procedure.Conclusion: it should be noted that the gore® dualmesh® plus biomaterial instructions for use includes 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, dysphagia, erosion or extrusion and related harms, exposure or protrusion and related harms, fever, fistula, gerd recurrence, recurrence, ileus, increased procedure time and related harms, irritation or inflammation, infection, pain, paresthesia, perforation, revision / re-intervention, seroma or hematoma and related harms, wound complications and wound dehiscence.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.After multiple requests, product identification information was not provided for this device and thus it could not be confirmed to be a gore hernia device.Review of the manufacturing and sterilization records could not be performed as a valid lot number was not provided.In an abundance of caution for product surveillance tracking and trending purposes only, this event has been analyzed, coded and reported as necessary assuming it is a gore hernia device.All available information has been placed on file for use in product surveillance tracking, trending and follow-up.Name: plus antimicrobial product coating.Manufacturer/compounder: w.L.Gore & associates, inc.Lot number unk.Additional manufacturer narrative: 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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