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| Model Number 1DLMC08 |
| Device Problems
No Apparent Adverse Event (3189); Insufficient Information (3190)
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| Patient Problems
Not Applicable (3189); No Information (3190)
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| Event Date 02/05/2014 |
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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® 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) 2013, whereby a gore dualmesh® biomaterial was implanted.The complaint alleges that on (b)(6) 2014, an additional procedure was performed whereby explant of the gore device was performed.It was reported the patient alleges the following injuries: mesh removal, additional surgery.
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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/revised details regarding the patient's clinical course were ascertained from a review of medical records and are as follows: discharge summary records dated (b)(6) 2012 indicate the patient has ¿¿a history of chronic kidney disease secondary to biopsy-proven focal segmental glomerulosclerosis.He was admitted (b)(6) 2012 to undergo a living related transplant from his father.Of note, the patient also underwent a bone marrow transplant for acute myeloblastic leukemia greater than 25 years ago, so this is an identical twin matched kidney from an hla standpoint.¿ the records indicate the patient underwent ¿hla identical kidney transplant from his father¿ on (b)(6) 2012.¿ operative records dated (b)(6) 2013 state the patient underwent laparoscopic incisional hernia repair with mesh, liver biopsy and excision of right lower extremity skin lesion.The ¿patient is a 36-year-old gentleman who had a living kidney transplant in (b)(6) 2012.The patient developed a large incisional hernia which he has been living with for quite some time.The patient feels that it is inhibiting his life due to swelling and occasional pain over the incision site, as well as it being unsightly.¿ the (b)(6) 2013 operative record states: ¿a supraumbilical, 1.5 cm, midline incision was made and taken through the fascia with the electrocautery.The peritoneum was entered under direct visualization.The abdomen was insufflated.At this point, two different 5 mm trocars were placed in the left flank under direct visualization.The incisional hernia was identified.It was measured to be greater than 10 cm in all directions.The hernia extended laterally to the level of the anterior superior iliac spine and almost medially to the level of the midline.¿ the operative records from (b)(6) 2013 also state: ¿the kidney was adherent to the lateral wall of the fascia.Electrocautery was used to mobilize the superior and lateral surfaces of the kidney off of the posterior surface of the lateral fascia to allow an area for the future mesh to be fixated laterally to the hernia defect.After the kidney was carefully mobilized with electrocautery, paying close attention to not enter the kidney parenchyma, this was continued inferiorly as the inferior surface of the kidney was adherent to the posterior area of the defect at its inferior border.¿ the (b)(6) 2013 operative records continue: ¿at this point, a dual-sided mesh was opened and cut to size, measuring 23 x 23 cm that was measured to be appropriate to cover this defect adequately.The measurements were performed by passing a spinal needle through the abdominal wall in all four quadrants.Gore sutures were placed in all four quadrants of the mesh and the mesh was marked appropriately.The mesh was then passed into the abdominal wall through the hasson trocar.The mesh was unraveled in the peritoneum appropriately.A gore suture passer device was placed in all four quadrants through the skin and fascia to allow transfascial suturing of the mesh in all four quadrants.¿ operative records from (b)(6) 2013 continue: ¿once this was completed, these sutures were tied down to the fascia.At this point, the remaining area of the mesh was tacked in place with a metallic tacker.This allowed complete covering of the defect in its entirety.There was a small amount of coverage laterally due to the fact that we were not able to extend the mesh any further due to the level of his pelvic brim; as well as the level of the kidney was at that level and felt to be unsafe to continue to mobilize the kidney down towards the hilum from its posterior view.¿ operative records from (b)(6) 2013 also state: ¿due to the fact that the liver appeared nodular for unknown reason, core needle biopsies times two were obtained of the left segment of the liver and sent to pathology.Hemostasis of the liver was obtained with electrocautery.At this point, all co2 gas was removed.The supraumbilical fascial defect was closed in o vicryl figure-of-eight suture times two and all skin incisions were closed with 4-0 pds in subcuticular fashion.¿ the records confirm a gore dualmesh® biomaterial (1dlmc08/10683484) was used during the procedure.The records mention that a 23 x 23 cm mesh was implanted during the procedure; however, the 1dlmc08 measures 26 x 34 cm.Pathology records for the ¿core needle biopsies¿ obtained during the procedure were not provided.Records dated (b)(6) 2013 state a ct was performed.¿36-year-old man in postoperative day 3 status post renal transplant who presents with fever and right-sided incisional pain.¿ ¿there is a fluid collection between the right external and internal muscles over the patients ventral hernia repair, which measures 15.6 cm cc x 4.3 cm transverse x 3 cm ap.There is layering high attenuation and an internal hematocrit level within the collection.There is no surrounding stranding.¿ ¿impression: 1.Right abdominal wall fluid collection over the ventral hernia mesh repair, which contains high attenuation material and demonstrates an internal hematocrit level, consistent with acute hemorrhage.2.Multiple loops of mildly dilated small bowel in the right mid-abdomen, likely postoperative ileus.¿ records dated (b)(6) 2013 state the patient was seen for follow up regarding his kidney transplant.¿since his last visit, he has completely discontinued all immunosuppression.¿ ¿[the patient] was admitted on 4/26/13 to undergo an elective incisional hernia repair with dr.Wellen.¿ ¿postoperatively he was transferred¿in stable condition.He had a prolonged hospital stay secondary to development of a pneumonia and hypoxia with ambulation.He was initiated on iv anti-biotics and then was transitioned to po augmentin¿¿ blood culture results dated (b)(6) 2013 regarding a specimen collected (b)(6) 2013 states: ¿no growth.¿ records dated (b)(6) 2013 state: ¿the patient presents today with complaint of occasional upper gastric pain and chills which have resolved.¿ ¿the abdomen is soft with slight tenderness lateral to the incisions.Right flank/abdomen with edema with concern for seroma vs.Hematoma vs.Recurrent hernia.¿ ¿based on today¿s exam, the patient will undergo a noncontrast abdominal/pelvic ct for further evaluation.¿ ¿addendum: ct revealed no recurrent hernia, likely evolving postoperative hematoma or seroma along the right abdominal wall, and evolving ascites and intraperitoneal hematoma.A small amount of free fluid is again noted within the pelvis.There is a small hematocrit level with in the pelvis likely representing a small amount of resolving intraperitoneal hematoma.¿ ¿impression: 1.No recurrent hernia.2.Likely evolving postoperative hematoma or seroma along the right abdominal wall.3.Evolving ascites and intraperitoneal hematoma.¿ ct records dated (b)(6) 2013 state: ¿the intra-abdominal ascites has resolved.There his [sic] been interval right lateral abdominal wall ventral mesh hernia repair.There is a large subcutaneous fluid collection superficial to the mesh repair which measures 11.2 x 6.8 cm.This may represent an evolving postoperative hematoma or seroma.There is no residual hernia seen.¿ records dated (b)(6) 2013 state the patient was seen for follow up.¿the patient presents today as well as previous clinic where he feels well however the patient does have significant swelling over the graft and over the hernia position.The patient underwent a ct scan which revealed the swelling is just postoperative seroma and no evidence of recurrent hernia.¿ ¿abdomen: is thin, soft, nontender, no guarding, and no rebound.Swelling over right lower quadrant.¿ ¿after reviewing the ct scan with the patient and went over the images, i explained to the patient that i would rather not put a needle in the drain and it is currently sterile.Fluid collection i do not wish to seed it and potentially infect it.¿ records dated (b)(6) 2013 indicate the patient was seen for follow up on his hernia repair.¿the patient¿s postoperative course has been complicated by seroma/hematoma as well as ascites.The patient underwent ct on may 13 which revealed fluid collection but no recurrent hernia.The patient presents today with report that edema is improving however there is still a slightly noticeable protuberance over the right lower abdomen.¿ impression/plan states: ¿status post incisional hernia repair with resolving fluid collection.We again discuss aspiration of the remaining fluid.However we would prefer to continue to allow reabsorption of the fluid rather than risk infection in the operative bed/mesh.¿ records dated (b)(6) 2013 indicate a ct was performed for abnormal liver function tests.¿there are postoperative changes of prior incisional hernia repair using mesh, a small residual hernia is noted which contains peritoneal fat, the aperture measures 1.4 cm.There is a small residual right lower quadrant subcutaneous fluid collection with mild rim enhancement measuring 1.0 cm in thickness.¿ ¿small rim-enhancing subcutaneous post-operative fluid collection, substantially decreased in size since most recent prior ct.¿ records dated (b)(6) 2013 indicate the patient was seen for follow up on his hernia repair.¿the patient¿s postoperative course has been complicated by seroma/hematoma as well as ascites.The patient underwent mri on 7/23/13 which revealed postoperative changes of right lower quadrant incisional hernia repair with mesh with residual 1.4 cm hernia along the lateral aspect of the repair containing peritoneal fat, and a small rim-enhancing subcutaneous postoperative fluid collection which was decreased in size in comparison with the previous ct.However, the pelvis was not fully examined on this study.The patient presents today with complaint that area of laxity/bulging has increased in size.The area is nontender but well pronounced when in the upright position.¿ impression/plan states: ¿esrd s/p transplant with subsequent incisional hernia and resolving fluid collection.We would like the patient to get an updated abdominal/pelvic ct to evaluate fluid for possible drainage.¿ an addendum to the (b)(6) 2013 records state: ¿abdominal pelvic ct performed 9/30/13 revealed interval development of a new abdominal wall hernia lateral to the mesh repair containing colon and the terminal ileum.No evidence of bowel obstruction.¿ ct records dated (b)(6) 2013 state: ¿there is a trace amount [of] fluid in the pelvis, decreased from the prior study.No free intraperitoneal air.Again seen are postoperative changes of a right lateral abdominal wall ventral hernia repair with mesh.There has been development of new abdominal wall hernia lateral to the mesh with a mouth measuring 5 cm in transverse dimension and 11 cm in craniocaudal dimension.The hernia contains normal appearing colon and terminal ileum without evidence of obstruction.A large fluid collection superficial to the mesh repair has decreased in size, consistent with resolving postoperative hematoma or seroma.Stomach, small bowel, and colon are otherwise normal in caliber without evidence of obstruction.¿ records dated (b)(6) 2013 state the patient was seen for follow up ¿status post kidney, incisional hernia and immunosuppression management.¿ ¿he denies abdominal pain associated with the hernia but states that the bulge is bothersome.¿ ¿abdomen: soft, nontender there is a large bulge in the right lower quadrant which is reducible.Incision is well healed and there is no renal graft tenderness.¿ consultation records dated (b)(6) 2013 state: ¿36-year-old patient¿referred in consultation for a recurrent pseudohernia.[the patient] had a renal transplant in (b)(6) 2012 and subsequently developed an incisional hernia which was repaired laparoscopically with mesh in (b)(6) 2013.He developed a seroma afterwards and then began developing some increase in bulging and laxity and was found to have a recurrent hernia.He is also seen on a ct scan done on september 30th and has colon and internal ileum in it.He is bothered by the appearance and has some discomfort from it and it has gotten a little bigger.¿ the (b)(6) 2013 records state: ¿abdomen: soft with a hockey stick incision in his right lower abdomen.His abdomen is a little protuberant.He has a lateral bulging consistent with an incisional hernia that is most likely reducible with some bowel in it.It is nontender.No other findings.¿ ¿[the patient] has a recurrent incisional hernia and i would recommend repairing this open given his failure with the laparoscopic repair and the appearance on the ct with a lot of mesh medially to the hernia.I also think we might be able to get some primary tissue coverage and therefore get him a better contour if we do it open.There is a small chance i might need to task some of the mesh laparoscopically.¿ operative records dated (b)(6) 2014 state the patient underwent ¿difficult open repair of recurrent right flank hernia with 20 x 15 cm lipid barrier coated c-qur mesh, adhesiolysis.¿ the ¿patient is a 36-year-old male who has a living-related kidney transplant in the right iliac fossa.He developed an incisional hernia there and had a laparoscopic incisional hernia repair with gore-tex dual mesh in (b)(6) 2013.He has recurred laterally and comes now for open repair.¿ implant records from the (b)(6) 2013 procedure state that after placement of the gore device: ¿there was a small amount of coverage laterally due to the fact that we were not able to extend the mesh any further due to the level of his pelvic brim; as well as the level of the kidney was at that level and felt to be unsafe to continue to mobilize the kidney down towards the hilum from its posterior view.¿ the (b)(6) 2014 operative findings states: ¿there was a very attenuated external oblique that was intact but underneath this was a hernia recurrence at the lateral aspect of the old mesh.There were quite a few adhesions, and we were able to sweep these off the gore-tex mesh on the underside pretty well.However, the kidney was fairly densely stuck to the posterior aspect of the lateral abdominal wall musculature and, therefore, to help take this down, we brought dr.Jason wellen in.We placed a 20 x 15 cm lipid barrier coated mesh, and the defect was about 10 x 14 cm.So, we had at least 3 to 4 cm overlap all the way around.We removed most of the old gore-tex dual mesh leaving only a little bit of a rim around the medial, superior, and inferior aspects where it was tacked and very difficult to get off there.Note the operative time was 3 hrs 20 minutes reflecting the level of difficulty of this case.¿ the (b)(6) 2014 operative records continue: ¿we made a transverse right flank incision centered over the area where the hernia bulge was and extended across his right-sided hockey stick incision.We deepened this down to the subcutaneous and down to this attenuated tissue layer.We actually opened this up and divided it and then that took us down to the old mesh medially and where the hernia defect was on the lateral aspect.We took adhesions down to the mesh superiorly and then got down onto the transplant kidney.We very carefully took down adhesions releasing that from the posterolateral abdominal wall.¿ the (b)(6) 2014 operative records also state: ¿as we got more inferiorly, we felt that it would be best to have one of the transplant surgeons assist with that, and so dr.Jason wellen was called into the room, and he helped get down the inferior part of the kidney.We appeared to take things down as far as the inferior epigastric vessels and never got close to anything that looked like ureter.Once this was adequately off the posterior abdominal wall, we had enough room to put our mesh in.¿ the operative records from (b)(6) 2014 state: ¿we then began taking out most of the old gore-tex mesh and excised it sharply, and we took out some tex [sic] but most around the inferomedial and superior side we left.We then took a 20 x 15 cm lipid barrier coated mesh, which we dipped in antibiotic, and we sutured it as an underlay using a mattress and #1 prolene's interrupted.On the inferior side, we used a reverdin needle, and we brought the suture up through a small puncture wound in the skin.So, we had avoided dissecting a big flap out down there.¿ operative records from (b)(6) 2014 continue: ¿once we put that row across that inferior and a little bit lateral margin, we then were able to put the rest in, in a standard fashion full thickness fascia in and out mesh and back up.We did this circumferentially, and a total of 28 sutures were used.We had good fixation all the way around, and there was no laxity in the mesh at all.We irrigated with antibiotic solution, and there was good hemostasis.We then put a large blake drain via a stab incision in the right lower abdomen and put it into the space sitting on top of the mesh.¿ the (b)(6) 2014 operative records also state: ¿we then closed over that with first a couple of interrupted figure-of-8 #1 pds sutures and then running o pds suture so that laterally and medially we had a couple of interrupted figure-of-b's that were full thickness and then we simply closed this attenuated external oblique over that.The drain, therefore, resided in that deep space.We then placed another drain via a stab incision in the right mid abdomen and brought that onto lie on top of the external oblique closure.We irrigated both times with antibiotic solution and obtained final hemostasis.We then closed the deep subcutaneous with a running 2-0 vicryl and the skin with a stapler.Both drains were secured with 3-0 nylon sutures.Dressings were applied.¿ there was no mention of infection in the records.Additionally, there are no pathology reports describing analysis of the explanted gore device.Records dated (b)(6) 2014 state the patient ¿¿is now about seven weeks out from his right flank incisional hernia repair.He is doing well.He really has no complaint except an occasional discomfort at about the 1:00 or 2:00 position.This most likely is from where the mesh is anchored with a suture.On exam, he looks really good.His incision is completely healed.Everything feels firm and solid across the flank incision.¿ records dated (b)(6) 2014 state the patent ¿¿called today to discuss his pain now 2 mo s/p flank hernia repair.They say he is very active and almost daily complains at some point about intermittent pain with getting up/down and twisting/bending.He is out and about quite a bit and is able to complete his normal daily activities.They do notice sometimes though that he will slump his shoulder down b/c if he stretches out he will feel the pain.The pain comes as a sharp burning at the same location that was discussed with dr.Brunt at his recent appt.Once he moves about a bit and changes position the pain subsides.No bulges to the area, inflammation or drainage.Afebrile.No gi complaints.He tried wearing his binder for a short time but didn¿t think it did much b/c the area was just below the binder.He has not been icing.They asked about whether to give him narcotics for the pain and advised that they do not do that since he is very active and is currently able to function without narcotics.Did strongly advise that he start icing bid and avoid exacerbating movements and perhaps slow his activity level down somewhat.¿ records dated (b)(6) 2018 indicates the patient was seen for a renal follow up.The following is noted in a ¿problem list¿: ¿right lower quadrant incisional hernia treated with a mesh by dr.Jason wellen in (b)(6) 2013.This was complicated by postoperative fluid collection which has decreased in size based on his last ct scan from (b)(6) 2013, but it also shows evidence of a new abdominal wall hernia lateral to the mesh repair containing colon and terminal ileum with no evidence of bowel obstruction.The patient underwent repeat hernia repair, now open under dr.Michael brunt(b)(6) 2014.¿ 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® 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 result code.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 prior to (b)(6) 2013, including records for any prior abdominal procedures, were not provided.Additionally, records detailing the source of the incisional hernia noted in the (b)(6) 2013 records were not provided.Operative records dated (b)(6) 2013 state the patient underwent laparoscopic incisional hernia repair with mesh, liver biopsy and excision of right lower extremity skin lesion.The ¿patient is a 36-year-old gentleman who had a living kidney transplant in may 2012.The patient developed a large incisional hernia which he has been living with for quite some time.The patient feels that it is inhibiting his life due to swelling and occasional pain over the incision site, as well as it being unsightly.¿ the (b)(6) 2013 operative record states: ¿a supraumbilical, 1.5 cm, midline incision was made and taken through the fascia with the electrocautery.The peritoneum was entered under direct visualization.The abdomen was insufflated.At this point, two different 5 mm trocars were placed in the left flank under direct visualization.The incisional hernia was identified.It was measured to be greater than 10 cm in all directions.The hernia extended laterally to the level of the anterior superior iliac spine and almost medially to the level of the midline.¿ the operative records from (b)(6) 2013 also state: ¿the kidney was adherent to the lateral wall of the fascia.Electrocautery was used to mobilize the superior and lateral surfaces of the kidney off of the posterior surface of the lateral fascia to allow an area for the future mesh to be fixated laterally to the hernia defect.After the kidney was carefully mobilized with electrocautery, paying close attention to not enter the kidney parenchyma, this was continued inferiorly as the inferior surface of the kidney was adherent to the posterior area of the defect at its inferior border.¿ the (b)(6) 2013 operative records continue: ¿at this point, a dual-sided mesh was opened and cut to size, measuring 23 x 23 cm that was measured to be appropriate to cover this defect adequately.The measurements were performed by passing a spinal needle through the abdominal wall in all four quadrants.Gore sutures were placed in all four quadrants of the mesh and the mesh was marked appropriately.The mesh was then passed into the abdominal wall through the hasson trocar.The mesh was unraveled in the peritoneum appropriately.A gore suture passer device was placed in all four quadrants through the skin and fascia to allow transfascial suturing of the mesh in all four quadrants.¿ operative records from (b)(6) 2013 continue: ¿once this was completed, these sutures were tied down to the fascia.At this point, the remaining area of the mesh was tacked in place with a metallic tacker.This allowed complete covering of the defect in its entirety.There was a small amount of coverage laterally due to the fact that we were not able to extend the mesh any further due to the level of his pelvic brim; as well as the level of the kidney was at that level and felt to be unsafe to continue to mobilize the kidney down towards the hilum from its posterior view." operative records from (b)(6) 2013 also state: ¿due to the fact that the liver appeared nodular for unknown reason, core needle biopsies times two were obtained of the left segment of the liver and sent to pathology.Hemostasis of the liver was obtained with electrocautery.At this point, all co2 gas was removed.The supraumbilical fascial defect was closed in o vicryl figure-of-eight suture times two and all skin incisions were closed with 4-0 pds in subcuticular fashion.¿ the records confirm a gore dualmesh® biomaterial (1dlmc08/10683484) was used during the procedure.The records mention that a 23 x 23 cm mesh was implanted during the procedure; however, the 1dlmc08 measures 26 x 34 cm.Pathology records for the ¿core needle biopsies¿ obtained during the procedure were not provided.Operative records dated (b)(6) 2014 state the patient underwent ¿difficult open repair of recurrent right flank hernia with 20 x 15 cm lipid barrier coated c-qur mesh, adhesiolysis.¿ the ¿patient is a 36-year-old male who has a living-related kidney transplant in the right iliac fossa.He developed an incisional hernia there and had a laparoscopic incisional hernia repair with gore-tex dual mesh in (b)(6) 2013.He has recurred laterally and comes now for open repair.¿ implant records from the (b)(6) 2013 procedure state that after placement of the gore device: ¿there was a small amount of coverage laterally due to the fact that we were not able to extend the mesh any further due to the level of his pelvic brim¿¿ the (b)(6) 2014 operative findings states: ¿there was a very attenuated external oblique that was intact but underneath this was a hernia recurrence at the lateral aspect of the old mesh.There were quite a few adhesions, and we were able to sweep these off the gore-tex mesh on the underside pretty well.However, the kidney was fairly densely stuck to the posterior aspect of the lateral abdominal wall musculature and, therefore, to help take this down, we brought dr.(b)(6).We placed a 20 x 15 cm lipid barrier coated mesh, and the defect was about 10 x 14 cm.So, we had at least 3 to 4 cm overlap all the way around.We removed most of the old gore-tex dual mesh leaving only a little bit of a rim around the medial, superior, and inferior aspects where it was tacked and very difficult to get off there.Note the operative time was 3 hrs 20 minutes reflecting the level of difficulty of this case.¿ the (b)(6) 2014operative records continue: ¿we made a transverse right flank incision centered over the area where the hernia bulge was and extended across his right-sided hockey stick incision.We deepened this down to the subcutaneous and down to this attenuated tissue layer.We actually opened this up and divided it and then that took us down to the old mesh medially and where the hernia defect was on the lateral aspect.We took adhesions down to the mesh superiorly and then got down onto the transplant kidney.We very carefully took down adhesions releasing that from the posterolateral abdominal wall.¿ the (b)(6) 2014 operative records also state: ¿as we got more inferiorly, we felt that it would be best to have one of the transplant surgeons assist with that, and so dr.(b)(6) was called into the room, and he helped get down the inferior part of the kidney.We appeared to take things down as far as the inferior epigastric vessels and never got close to anything that looked like ureter.Once this was adequately off the posterior abdominal wall, we had enough room to put our mesh in.¿ the operative records from (b)(6) 2014 state: ¿we then began taking out most of the old gore-tex mesh and excised it sharply, and we took out some tex [sic] but most around the inferomedial and superior side we left.We then took a 20 x 15 cm lipid barrier coated mesh, which we dipped in antibiotic, and we sutured it as an underlay using a mattress and #1 prolene's interrupted.On the inferior side, we used a reverdin needle, and we brought the suture up through a small puncture wound in the skin.So, we had avoided dissecting a big flap out down there.¿ operative records from (b)(6) 2014 continue: ¿once we put that row across that inferior and a little bit lateral margin, we then were able to put the rest in, in a standard fashion full thickness fascia in and out mesh and back up.We did this circumferentially, and a total of 28 sutures were used.We had good fixation all the way around, and there was no laxity in the mesh at all.We irrigated with antibiotic solution, and there was good hemostasis.We then put a large blake drain via a stab incision in the right lower abdomen and put it into the space sitting on top of the mesh.¿ the (b)(6) 2014operative records also state: ¿we then closed over that with first a couple of interrupted figure-of-8 #1 pds sutures and then running o pds suture so that laterally and medially we had a couple of interrupted figure-of-b's that were full thickness and then we simply closed this attenuated external oblique over that.The drain, therefore, resided in that deep space.We then placed another drain via a stab incision in the right mid abdomen and brought that onto lie on top of the external oblique closure.We irrigated both times with antibiotic solution and obtained final hemostasis.We then closed the deep subcutaneous with a running 2-0 vicryl and the skin with a stapler.Both drains were secured with 3-0 nylon sutures.Dressings were applied.¿ there was no mention of infection in the records.Additionally, there are no pathology reports describing analysis of the explanted gore device.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® 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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The investigation has been complete.This event will be closed based upon currently available information.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 (3190) 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 may 7, 2012 through january 31, 2018, and not all records received in this time span are relevant to gore® dualmesh® biomaterial.Patient information: medical history: chronic kidney disease.Focal segmentation glomerulosclerosis.Acute myeologenous leukemia.Gout.Prior surgical procedures: (b)(6) 2012: kidney transplant.Bone marrow transplant.Implant preoperative complaints: (b)(6) 2013: ¿the patient developed a large incisional hernia which he has been living with for quite some time.The patient feels that it is inhibiting his life due to swelling and occasional pain over the incision site, as well as it being unsightly.¿ implant procedure: laparoscopic incisional hernia repair with mesh, liver biopsy, and excision of right lower extremity skin lesion.Implant: gore® dualmesh® biomaterial (10683484/1dlmc08) 26cm x 34cm, oval.Implant date: (b)(6) 2013 [hospitalization dates unknown].Description of hernia being treated: ¿the incisional hernia was identified.It was measured to be greater than 10 cm in all directions.The hernia extended laterally to the level of the anterior superior iliac spine and almost medially to the level of the midline.¿ implant size and fixation: ¿at this point, a dual-sided mesh was opened and cut to size, measuring 23 x 23 cm that was measured to be appropriate to cover this defect adequately.The measurements were performed by passing a spinal needle through the abdominal wall in all four quadrants.Gore sutures were placed in all four quadrants of the mesh and the mesh was marked appropriately.The mesh was then passed into the abdominal wall through the hasson trocar.The mesh was unraveled in the peritoneum appropriately.A gore suture passer device was placed in all four quadrants through the skin and fascia to allow transfascial suturing of the mesh in all four quadrants.Once this was completed, these sutures were tied down to the fascia.At this point, the remaining area of the mesh was tacked in place with a metallic tacker.This allowed complete covering of the defect in its entirety.There was a small amount of coverage laterally due to the fact that we were not able to extend the mesh any further due to the level of his pelvic brim; as well as the level of the kidney was at that level and felt to be unsafe to continue to mobilize the kidney down towards the hilum from its posterior view.¿ post-operative period: [one week].(b)(6) 2013: ct abdomen: ¿impression: 1.Right abdominal wall fluid collection over the ventral hernia mesh repair, which contains high attenuation material and demonstrates an internal hematocrit level, consistent with acute hemorrhage.2.Multiple loops of mildly dilated small bowel in the right mid-abdomen, likely postoperative ileus.¿ (b)(6) 2013: ¿since his last visit, he has completely discontinued all immunosuppression.¿ ¿postoperatively he was transferred in stable condition.He had a prolonged hospital stay secondary to development of a pneumonia and hypoxia with ambulation.He was initiated on iv anti-biotics and then was transitioned to po augmentin.¿ relevant medical information: (b)(6) 2013: ¿the abdomen is soft with slight tenderness lateral to the incisions.Right flank/abdomen with edema with concern for seroma vs.Hematoma vs.Recurrent hernia.¿ (b)(6) 2013: ct abdomen/pelvis: ¿impression: 1.No recurrent hernia.2.Likely evolving postoperative hematoma or seroma along the right abdominal wall.3.Evolving ascites and intraperitoneal hematoma.¿ (b)(6) 2013: ¿the patient underwent a ct scan which revealed the swelling is just postoperative seroma and no evidence of recurrent hernia.¿ ¿after reviewing the ct scan with the patient and went over the images, i explained to the patient that i would rather not put a needle in the drain and it is currently sterile.Fluid collection i do not wish to seed it and potentially infect it.¿ (b)(6) 2013: ¿status post incisional hernia repair with resolving fluid collection.We again discuss aspiration of the remaining fluid.However we would prefer to continue to allow reabsorption of the fluid rather than risk infection in the operative bed/mesh.¿ (b)(6) 2013: ct abdomen/pelvis: ¿there are postoperative changes of prior incisional hernia repair using mesh, a small residual hernia is noted which contains peritoneal fat, the aperture measures 1.4 cm.There is a small residual right lower quadrant subcutaneous fluid collection with mild rim enhancement measuring 1.0 cm in thickness.¿ (b)(6) 2013: ct abdomen/pelvis: ¿there has been development of new abdominal wall hernia lateral to the mesh with a mouth measuring 5 cm in transverse dimension and 11 cm in craniocaudal dimension.The hernia contains normal appearing colon and terminal ileum without evidence of obstruction.A large fluid collection superficial to the mesh repair has decreased in size, consistent with resolving postoperative hematoma or seroma.¿ explant preoperative complaints: (b)(6) 2013: [the patient] ¿has a recurrent incisional hernia and i would recommend repairing this open given his failure with the laparoscopic repair and the appearance on the ct with a lot of mesh medially to the hernia.I also think we might be able to get some primary tissue coverage and therefore get him a better contour if we do it open.There is a small chance i might need to task some of the mesh laparoscopically.¿ explant procedure: ¿difficult open repair of recurrent right flank hernia with 20 x 15 cm lipid barrier coated c-qur mesh, adhesiolysis.¿ explant date: (b)(6) 2014 [hospitalization dates unknown].¿we made a transverse right flank incision centered over the area where the hernia bulge was and extended across his right-sided hockey stick incision.We deepened this down to the subcutaneous and down to this attenuated tissue layer.We actually opened this up and divided it and then that took us down to the old mesh medially and where the hernia defect was on the lateral aspect.We took adhesions down to the mesh superiorly and then got down onto the transplant kidney.We very carefully took down adhesions releasing that from the posterolateral abdominal wall.¿ ¿we then began taking out most of the old gore-tex mesh and excised it sharply, and we took out some tex [sic] but most around the inferomedial and superior side we left.We then took a 20 x 15 cm lipid barrier coated mesh, which we dipped in antibiotic, and we sutured it as an underlay using a mattress and #1 prolene's interrupted.On the inferior side, we used a reverdin needle, and we brought the suture up through a small puncture wound in the skin.So, we had avoided dissecting a big flap out down there.¿ relevant medical information: (b)(6) 2014: ¿seven weeks out from his right flank incisional hernia repair.He is doing well.He really has no complaint except an occasional discomfort at about the 1:00 or 2:00 position.This most likely is from where the mesh is anchored with a suture.On exam, he looks really good.His incision is completely healed.Everything feels firm and solid across the flank incision.¿ (b)(6) 2014: ¿almost daily complains at some point about intermittent pain with getting up/down and twisting/bending.He is out and about quite a bit and is able to complete his normal daily activities.They do notice sometimes though that he will slump his shoulder down b/c if he stretches out he will feel the pain.The pain comes as a sharp burning at the same location that was discussed with dr.Brunt at his recent appt.Once he moves about a bit and changes position the pain subsides.No bulges to the area, inflammation or drainage.¿ ¿he has not been icing.They asked about whether to give him narcotics for the pain and advised that they do not do that since he is very active and is currently able to function without narcotics.Did strongly advise that he start icing bid [twice a day] and avoid exacerbating movements and perhaps slow his activity level down somewhat.¿ conclusion: it should be noted that the gore® dualmesh® 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® biomaterial instructions for use also states, ¿if gore® dualmesh® 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 device was not able to be returned 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.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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