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| Model Number 1DLMCP04 |
| Device Problems
No Apparent Adverse Event (3189); Insufficient Information (3190)
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| Patient Problems
Adhesion(s) (1695); Hernia (2240); Not Applicable (3189)
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Event Type
Injury
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Manufacturer Narrative
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(b)(6).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) 2005 whereby a gore dualmesh® plus biomaterial was implanted.It was reported the patient alleges the following injuries: adhesions, hernia recurrence, and additional surgery to repair hernia.Additional event specific information and medical records have been requested.
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Manufacturer Narrative
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Added medical history.Conclusion code remains unchanged.Added medical record information.Additional details regarding the patient's clinical course were ascertained from a review of medical records and are as follows: 03/23/15: centennial medical center.Discharge summary.Final dx: right colon polyp.Hospital course & treatment: pathology of r colon showed terminal ileum and portion of the right colon with 2.3 x 1.5 x 0.8 cm tubular adenoma in the r colon 12 cm from distal margin.No evidence of malignancy or high-grade dysplasia & no other lesions identified.16 pericolonic lymph nodes negative for malignancy or histopathological change.Postop period pt was afebrile w/ stable vs.Incisional wound area was c/d/i.Abdomen soft w/o distention.Upper mid abdominal incision developed sanguineous drainage upon palpation.3 staples removed to allow drainage & wound vac placed.No dehiscence noted.09/21/18: colonoscopy.Polyps of terminal ileum-no evidence of dysplasia or malignancy.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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Additional details regarding the patient¿s clinical course were ascertained from a review of medical records and are as follows: operative records dated 12/17/2015 indicate the patient underwent laparoscopic repair of incarcerated incisional hernias with mesh.Postoperative diagnoses state: ¿1.Incarcerated incisional hernia x 2.2.Morbid obesity.¿ the (b)(6) 2015 records state: ¿we then were able to visualize the patient's 2 incarcerated hernias.The inferior defect had incarcerated omentum.The superior defect had incarcerated omentum as well as the transverse colon within it.We then placed another 5 mm trocar into the right flank, another into the right lower quadrant.The patient was placed in the left airplane position in reverse trendelenburg.We then began with dissecting the colon and the omentum out of the superior defect.No cautery was used.Only cold scissors was used.After total lysis of adhesions time of 37 minutes, we were able to lyse all the adhesions between the omentum and the colon and released these from the superior defect.The inferior defect only had 3 bands of omentum incarcerated within it and these were lysed using the cautery scissors.We then inspected the abdomen for any further bleeding.None was identified.There was no bowel injury.¿ the (b)(6) 2015 records continue: ¿we then turned our attention to mesh placement.We then used spinal needles and placed these to the abdominal wall in order to visualize and calculate the total distance between the superior aspect of the most superior defect and the most inferior aspect of the most inferior defect.This measured 23 cm.We then measured the transverse dimensions of the hernia defects.The maximum width was 13 cm.Therefore, it was selected to use an 18 x 24 piece of gore -tex dualmesh.Gore -tex suture was placed at the superior and inferior margins of the mesh.This was then rolled and then placed through a 12 -mm trocar that was placed then in the left upper quadrant.Once the mesh was in the abdomen, it was unfurled and then once in a flattened position, we were able to use the pmi suture passer to retrieve the sutures through the abdominal wall 3 cm superior to our previously marked spinal needle and 3 cm inferior to the most inferior marked spinal needle.The mesh was laying very___ [sic] against the peritoneal cavity after these sutures were brought up.These were tied down.¿ the (b)(6) 2015 records state: ¿we then used the securestrap tacker to circumferentially affix the mesh to the peritoneal surface.We did use a double crown technique and then placed a second round of tacks more medially along the patient's hernia defect itself.We then were able to place transabdominal fixation sutures of 0 and #1 prolene suture 3 different points on the patient's right side as well as the left side.The sutures were then placed through the abdominal wall through the mesh, back up through the mesh and the abdominal wall.The mesh was then securely in position.We then inspected once again for any bowel injury.There was not identified [sic].¿ the records indicate a gore dualmesh® plus biomaterial (1dlmcp04/13792232) was used during the procedure.Records between 12/17/2015 and 4/27/2017 were not provided.Operative records dated (b)(6) 2017 indicate the patient underwent laparoscopic and open (hybrid) incisional hernia repair with mesh.Preoperative diagnoses state: ¿1.Incarcerated incisional hernia x 2.2.Morbid obesity.¿ the (b)(6) 2017 records state: ¿once this was achieved, a 5 mm trocar was inserted into the abdomen.Exploratory laparoscopy revealed some omental adhesions between the omentum and has previously placed gore -tex mesh in the upper abdomen.Another 5 mm trocar was placed in the left abdomen and then another in the left lower abdomen.We began by incising all the adhesions seen in the previously placed mesh and the omentum.We were then able to identify the recurrent hernia defect at the very inferior portion of the mesh at the patient's umbilicus.There was incarcerated small intestine within the hernia.After we lysed all the fatty adhesions, we were then able to carefully dissect the small intestine out of the hernia sac with cold scissors.After this was completed, we were able to assess the patient's hernia defect.It measured approximately 7 x 7 cm.We selected a piece of synecor mesh.This measured 20 x 25 cm due to the patient's morbid obesity, broad based mesh in order to prevent any eventration of the mesh.The (b)(6) 2017 records continue: ¿we placed a 12 -mm trocar right through the skin overlying the hernia defect then inserted with the aforementioned into the abdomen.We were able to retrieve the gore -tex sutures that have been placed at the superior and inferior portion of the 20 cm access so that this was centered over the patient's hernia defect.We then were able to use the securestrap tacker to circumferentially affix the mesh to the abdomen.We then placed 2 more 0 prolene sutures at the 3 and 9 o'clock positions of the mesh in order to ___.After inspected the abdomen for any other bleeding or bowel injury or none was identified, we were able to release the pneumoperitoneum, all the trocars removed.¿ the (b)(6) 2017 records state: ¿we then were able to turn our attention to closure of the patient's defect and removal of his hernia sac.We incised around the patient's previous incision around his umbilicus, we were able to open the patient's hernia sac using cautery.We were able to visualize our intraperitoneal mesh.This completely excised the hernia sac using cautery.We then used a 0 and #1 prolene suture to close the muscle on the anterior fascia of the rectus abdominis anteriorly.This was done in a running fashion.Finally, then we were able to closed the subcutaneous space.The umbilicus again was reimplanted using a 2-0 vicryl suture.We then closed the deep subcutaneous tissues using interrupted 2-0 vicryl.¿ the records indicate a gore® synecor® biomaterial was used during the (b)(6) 2017 procedure.There was no mention of infection of the gore dualmesh® biomaterial.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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A4: added patient weight 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: records dated (b)(6) 2015 indicate the patient was seen for colon mass.The [patient] ¿presents today with a large proximal transverse colon cancer.He is morbidly obese and this will certainly make the operation more complicated.¿ records dated (b)(6) 2015 indicate the patient was seen for surgical followup.The [patient] ¿presents today, doing relatively well.He had a wound vac, which i removed in the office today.Generally without complaints.His follow-up was benign.¿ records dated (b)(6) 2015 indicate the patient was seen for umbilical hernia.¿he has a ventral hernia with incarcerated omentum.He has some weakness and thinning at the upper abdomen hand port site.Ct scan to eval for any other port site hernias due to morbid obesity.If more than one is found they all can be repaired at the same time.If ventral hernia is the only one identified, i discussed lap incisional hernia.¿ records dated (b)(6) 2015 state: ¿obese abdomen.Well healed transverse incision upper abdomen.Diastasis recti around the upper hand port incision.He has a 6 cm umbilical hernia with incarcerated omentum.Thinning skin.He has 3 other well healed port sites in the lower abdomen.No hernias detected at these.¿ ct abdomen/pelvis dated (b)(6) 2015 states: ¿abdominal wall: there is a midline ventral supraumbilical hernia containing fat.This measures approximately 5.9 x 2.5 cm image 64 series 2.Also, there is a midline ventral periumbilical hernia containing noncompromised small bowel.The sac measures 8.1 x 7.6 cm, image 94; the neck measures 5.8 cm in transverse dimension.¿ records dated (b)(6) 2016 indicate the patient was seen for a three week surgical followup.¿[patient] returns to the office 3 weeks lap ventral hernia repair with mesh.They report that their pain is better.They deny any drainage from their wound.They deny fevers and chills.They are eating well and moving their bowels.They have been wearing their abdominal binder daily.¿ general examination: ¿abdomen is soft.Incision is pink and healing well.No drainage.Appropriately tender.Repair intact.¿ records dated (b)(6) 2016 indicate the patient was seen for six week surgical followup.¿[patient] report that their pain is better and tolerable.They deny any drainage from their wound.They deny fevers and chills.They are eating well and moving their bowels.They have been wearing their abdominal binder daily.They report they are gradually getting back to normal activities.¿ general examination: ¿abdomen is soft.Incision is pink and healing well.No drainage.Appropriately tender.Repair intact.¿ records dated (b)(6) 2017 indicate the patient was seen for possible hernia.¿the patient has a large incisional hernia.It is currently reducible.¿ abdomen: ¿obese abdomen.Several well healed scars over abdomen.About 10 cm around the umbilicus there is an incompletely reducible hernia defect, minimally tender.¿ records dated (b)(6) 2017 indicate the patient was seen for surgical followup.¿[patient] returns to the office 4 weeks s/p laparoscopic incisonal [sic] hernia repair.They report that their pain is mainly in the right lower abdomen.They deny any drainage from their wound.They deny fevers and chills.They are eating well and moving their bowels.They have been wearing their abdominal binder daily.¿ general examination: ¿abdomen is soft.Incision is pink and healing well.No drainage.Appropriately tender.Repair intact.¿ ct abdomen/pelvis dated (b)(6) 2017 states: ¿there is a moderate ventral hernia, the defect in the abdominal wall measuring approximately 4.5 cm, unchanged from prior.It contains loops of small bowel that are normal caliber.It is unchanged from the prior examination.There is no abnormal stranding present.There appears to be interval placement of a surgical mass which projects superior to the hernia.There has been repair of a fat-containing superior ventral hernia which had stranding which is now resolved.¿ 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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H6: updated patient codes.H6: updated device codes.H6: updated conclusion codes.The investigation has been completed.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.This event will be closed as no problem detected.Previous patient codes (1695, 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) 2015 through (b)(6) 2018 and not all records received in this time span are relevant to the gore® dualmesh® plus biomaterial.Records from (b)(6) 2016 through (b)(6) 2017 were not provided.Patient information: medical history: colon cancer.Obesity. (b)(6) 2015: 346 lbs; bmi 48.2. (b)(6) 2015: 348 lbs; bmi 48.6. (b)(6) 2017: 360 lbs; bmi 50.2. (b)(6) 2017: 364 lbs; bmi 50.8.Hypertension.Chronic obstructive pulmonary disease.Prior surgical procedures: (b)(6) 2015: laparoscopic colectomy.Implant preoperative complaints: (b)(6) 2015: ct abdomen/pelvis: ¿there is a midline ventral supraumbilical hernia containing fat.This measures approximately 5.9 x 2.5 cm image 64 series 2.Also, there is a midline ventral periumbilical hernia containing noncompromised small bowel.The sac measures 8.1 x 7.6 cm, image 94; the neck measures 5.8 cm in transverse dimension.¿ implant procedure: laparoscopic repair of incarcerated incisional hernias with mesh.Implant: gore® dualmesh® plus biomaterial (13792232/1dlmcp04) 15cm x 19cm.Implant date: (b)(6) 2015 [hospitalization dates unknown].Description of hernia being treated: ¿once in the peritoneal cavity, carbon dioxide insufflation was begun and continued to achieve a pressure of 15mmhg.We had poor visualization at this insufflation pressure and therefore, it was increased to 18 mmhg.The patient's peak airway pressures were only 28 and he tolerated this well.We then were able to visualize the patient's 2 incarcerated hernias.The inferior defect had incarcerated omentum.The superior defect had incarcerated omentum as well as the transverse colon within it.We then placed another 5 mm trocar into the right flank, another into the right lower quadrant.The patient was placed in the left airplane position in reverse trendelenburg.We then began with dissecting the colon and the omentum out of the superior defect.No cautery was used.Only cold scissors was used.After total lysis of adhesions time of 37 minutes, we were able to lyse all the adhesions between the omentum and the colon and released these from the superior defect.The inferior defect only had 3 bands of omentum incarcerated within it and these were lysed using the cautery scissors.We then inspected the abdomen for any further bleeding.None was identified.There was no bowel injury.¿we then turned our attention to mesh placement.We then used spinal needles and placed these to the abdominal wall in order to visualize and calculate the total distance between the superior aspect of the most superior defect and the most inferior aspect of the most inferior defect.This measured 23 cm.We then measured the transverse dimensions of the hernia defects.The maximum width was 13 cm.¿ implant size and fixation: ¿therefore, it was selected to use an 18 x 24 piece of gore-tex dualmesh.Gore-tex suture was placed at the superior and inferior margins of the mesh.This was then rolled and then placed through a 12 -mm trocar that was placed then in the left upper quadrant.Once the mesh was in the abdomen, it was unfurled and then once in a flattened position, we were able to use the pmi suture passer to retrieve the sutures through the abdominal wall 3 cm superior to our previously marked spinal needle and 3 cm inferior to the most inferior marked spinal needle.The mesh was laying very against the peritoneal cavity after these sutures were brought up.These were tied down.We then used the securestrap tacker to circumferentially affix the mesh to the peritoneal surface.We did use a double crown technique and then placed a second round of tacks more medially along the patient's hernia defect itself.We then were able to place transabdominal fixation sutures of 0 and #1 prolene suture 3 different points on the patient's right side as well as the left side.The sutures were then placed through the abdominal wall through the mesh, back up through the mesh and the abdominal wall.The mesh was then securely in position.We then inspected once again for any bowel injury.There was not identified [sic].The pneumoperitoneum was released.We were then able to close the left upper quadrant 12 mm trocar site with a 0 vicryl suture.This was done at the fascial level.The skin was then closed using a 4-0 monocryl.Dermabond was applied to all these incisions.¿ no post-operative records were provided.Relevant medical information: (b)(6) 2016: ¿abdomen is soft.Incision is pink and healing well.No drainage.Appropriately tender.Repair intact.¿ (b)(6) 2016: ¿repair intact.¿ (b)(6) 2017: ¿obese abdomen.Several well healed scars over abdomen.About 10 cm around the umbilicus there is an incompletely reducible hernia defect, minimally tender.¿ (b)(6) 2017: ct abdomen/pelvis: ¿there is a moderate ventral hernia, the defect in the abdominal wall measuring approximately 4.5 cm, unchanged from prior.It contains loops of small bowel that are normal caliber.It is unchanged from the prior examination.There is no abnormal stranding present.There appears to be interval placement of a surgical mass which projects superior to the hernia.There has been repair of a fat containing superior ventral hernia which had stranding which is now resolved.¿ (b)(6) 2017: laparoscopic and open incisional hernia repair with mesh exploratory laparoscopy revealed some omental adhesions between the omentum and has previously placed gore-tex mesh in the upper abdomen.Another 5 mm trocar was placed in the left abdomen and then another in the left lower abdomen.We began by incising all the adhesions seen in the previously placed mesh and the omentum.We were then able to identify the recurrent hernia defect at the very inferior portion of the mesh at the patient's umbilicus.There was incarcerated small intestine within the hernia.After we lysed all the fatty adhesions, we were then able to carefully dissect the small intestine out of the hernia sac with cold scissors.After this was completed, we were able to assess the patient's hernia defect.It measured approximately 7 x 7 cm.We selected apiece of synecor mesh.This measured 20 x 25 cm due to the patient's morbid obesity, broad based mesh in order to prevent any eventration of the mesh.We placed a 12 -mm trocar right through the skin overlying the hernia defect then inserted with the aforementioned into the abdomen.We were able to retrieve the gore-tex sutures that have been placed at the superior and inferior portion of the 20 cm access so that this was centered over the patient's hernia defect.We then were able to use the securestrap tacker to circumferentially affix the mesh to the abdomen.We then placed 2 more 0 prolene sutures at the 3 and 9 o'clock positions of the mesh in order to.After inspected the abdomen for any other bleeding or bowel injury or none was identified, we were able to release the pneumoperitoneum, all the trocars removed.We then were able to turn our attention to closure of the patient's defect and removal of his hernia sac.We incised around the patient's previous incision around his umbilicus, we were able to open the patient's hernia sac using cautery.We were able to visualize our intraperitoneal mesh.This completely excised the hernia sac using cautery.We then used a 0 and #1 prolene suture to close the muscle on the anterior fascia of the rectus abdominis anteriorly.This was done in a running fashion.Finally, then we were able to closed the subcutaneous space.The umbilicus again was reimplanted using a 2-0 vicryl suture.We then closed the deep subcutaneous tissues using interrupted 2-0 vicryl.¿ (b)(6) 2017: ¿abdomen is soft.Incision is pink and healing well.No drainage.Appropriately tender.Repair intact.¿ 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.¿ the gore dualmesh plus biomaterial ifu also states, ¿cutting gore® dualmesh® plus biomaterial to the proper size is essential.Use sharp surgical instruments to trim the device.If gore® dualmesh® plus biomaterial is cut too small, excessive tension may be placed on the suture line, which may result in recurrence of the original, or development of an adjacent, tissue defect.¿ 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.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.All available information has been placed on file for use in product surveillance tracking, trending and follow-up.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 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.This event will be closed as no problem detected.Previous patient codes (1695, 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 march 9, 2015 through september 21, 2018 and not all records received in this time span are relevant to the gore® dualmesh® plus biomaterial.Records from january 26, 2016 through march 3, 2017 were not provided.Patient information: medical history: colon cancer.Obesity. (b)(6) 2015: 346 lbs; bmi 48.2. (b)(6) 2015: 348 lbs; bmi 48.6. (b)(6) 2017: 360 lbs; bmi 50.2. (b)(6) 2017: 364 lbs; bmi 50.8.Hypertension.Chronic obstructive pulmonary disease.Prior surgical procedures: (b)(6) 2015: laparoscopic colectomy.Implant preoperative complaints: (b)(6) 2015: ct abdomen/pelvis: ¿there is a midline ventral supraumbilical hernia containing fat.This measures approximately 5.9 x 2.5 cm image 64 series 2.Also, there is a midline ventral periumbilical hernia containing noncompromised small bowel.The sac measures 8.1 x 7.6 cm, image 94; the neck measures 5.8 cm in transverse dimension.¿.Implant procedure: laparoscopic repair of incarcerated incisional hernias with mesh.Implant: gore® dualmesh® plus biomaterial (13792232/1dlmcp04) 15cm x 19cm.Implant date: (b)(6) 2015 [hospitalization dates unknown].Description of hernia being treated: ¿once in the peritoneal cavity, carbon dioxide insufflation was begun and continued to achieve a pressure of 15mmhg.We had poor visualization at this insufflation pressure and therefore, it was increased to 18 mmhg.The patient's peak airway pressures were only 28 and he tolerated this well.We then were able to visualize the patient's 2 incarcerated hernias.The inferior defect had incarcerated omentum.The superior defect had incarcerated omentum as well as the transverse colon within it.We then placed another 5 mm trocar into the right flank, another into the right lower quadrant.The patient was placed in the left airplane position in reverse trendelenburg.We then began with dissecting the colon and the omentum out of the superior defect.No cautery was used.Only cold scissors was used.After total lysis of adhesions time of 37 minutes, we were able to lyse all the adhesions between the omentum and the colon and released these from the superior defect.The inferior defect only had 3 bands of omentum incarcerated within it and these were lysed using the cautery scissors.We then inspected the abdomen for any further bleeding.None was identified.There was no bowel injury.¿we then turned our attention to mesh placement.We then used spinal needles and placed these to the abdominal wall in order to visualize and calculate the total distance between the superior aspect of the most superior defect and the most inferior aspect of the most inferior defect.This measured 23 cm.We then measured the transverse dimensions of the hernia defects.The maximum width was 13 cm.¿.Implant size and fixation: ¿therefore, it was selected to use an 18 x 24 piece of gore-tex dualmesh.Gore-tex suture was placed at the superior and inferior margins of the mesh.This was then rolled and then placed through a 12 -mm trocar that was placed then in the left upper quadrant.Once the mesh was in the abdomen, it was unfurled and then once in a flattened position, we were able to use the pmi suture passer to retrieve the sutures through the abdominal wall 3 cm superior to our previously marked spinal needle and 3 cm inferior to the most inferior marked spinal needle.The mesh was laying very against the peritoneal cavity after these sutures were brought up.These were tied down.We then used the securestrap tacker to circumferentially affix the mesh to the peritoneal surface.We did use a double crown technique and then placed a second round of tacks more medially along the patient's hernia defect itself.We then were able to place transabdominal fixation sutures of 0 and #1 prolene suture 3 different points on the patient's right side as well as the left side.The sutures were then placed through the abdominal wall through the mesh, back up through the mesh and the abdominal wall.The mesh was then securely in position.We then inspected once again for any bowel injury.There was not identified [sic].The pneumoperitoneum was released.We were then able to close the left upper quadrant 12 mm trocar site with a 0 vicryl suture.This was done at the fascial level.The skin was then closed using a 4-0 monocryl.Dermabond was applied to all these incisions.¿.No post-operative records were provided.Relevant medical information: (b)(6) 2016: ¿abdomen is soft.Incision is pink and healing well.No drainage.Appropriately tender.Repair intact.¿.(b)(6) 2016: ¿repair intact.¿.(b)(6) 2017: ¿obese abdomen.Several well healed scars over abdomen.About 10 cm around the umbilicus there is an incompletely reducible hernia defect, minimally tender.¿.(b)(6) 2017: ct abdomen/pelvis: ¿there is a moderate ventral hernia, the defect in the abdominal wall measuring approximately 4.5 cm, unchanged from prior.It contains loops of small bowel that are normal caliber.It is unchanged from the prior examination.There is no abnormal stranding present.There appears to be interval placement of a surgical mass which projects superior to the hernia.There has been repair of a fat-containing superior ventral hernia which had stranding which is now resolved.¿.(b)(6) 2017: laparoscopic and open incisional hernia repair with mesh exploratory laparoscopy revealed some omental adhesions between the omentum and has previously placed gore-tex mesh in the upper abdomen.Another 5 mm trocar was placed in the left abdomen and then another in the left lower abdomen.We began by incising all the adhesions seen in the previously placed mesh and the omentum.We were then able to identify the recurrent hernia defect at the very inferior portion of the mesh at the patient's umbilicus.There was incarcerated small intestine within the hernia.After we lysed all the fatty adhesions, we were then able to carefully dissect the small intestine out of the hernia sac with cold scissors.After this was completed, we were able to assess the patient's hernia defect.It measured approximately 7 x 7 cm.We selected apiece of synecor mesh.This measured 20 x 25 cm due to the patient's morbid obesity, broad based mesh in order to prevent any eventration of the mesh.We placed a 12 -mm trocar right through the skin overlying the hernia defect then inserted with the aforementioned into the abdomen.We were able to retrieve the gore-tex sutures that have been placed at the superior and inferior portion of the 20 cm access so that this was centered over the patient's hernia defect.We then were able to use the securestrap tacker to circumferentially affix the mesh to the abdomen.We then placed 2 more 0 prolene sutures at the 3 and 9 o'clock positions of the mesh in order to ___.After inspected the abdomen for any other bleeding or bowel injury or none was identified, we were able to release the pneumoperitoneum, all the trocars removed.We then were able to turn our attention to closure of the patient's defect and removal of his hernia sac.We incised around the patient's previous incision around his umbilicus, we were able to open the patient's hernia sac using cautery.We were able to visualize our intraperitoneal mesh.This completely excised the hernia sac using cautery.We then used a 0 and #1 prolene suture to close the muscle on the anterior fascia of the rectus abdominis anteriorly.This was done in a running fashion.Finally, then we were able to closed the subcutaneous space.The umbilicus again was reimplanted using a 2-0 vicryl suture.We then closed the deep subcutaneous tissues using interrupted 2-0 vicryl.¿ (b)(6) 2017: ¿abdomen is soft.Incision is pink and healing well.No drainage.Appropriately tender.Repair intact.¿.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.¿.The gore dualmesh plus biomaterial ifu also states, ¿cutting gore® dualmesh® plus biomaterial to the proper size is essential.Use sharp surgical instruments to trim the device.If gore® dualmesh® plus biomaterial is cut too small, excessive tension may be placed on the suture line, which may result in recurrence of the original, or development of an adjacent, tissue defect.¿.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.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.All available information has been placed on file for use in product surveillance tracking, trending and follow-up.Section c1: name: plus antimicrobial product coating.Manufacturer/compounder: w.L.Gore & associates, inc.Lot number 13792232.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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