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| Model Number 1DLMC07 |
| Device Problem
Insufficient Information (3190)
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| Patient Problems
Hernia (2240); No Clinical Signs, Symptoms or Conditions (4582)
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| Event Date 04/05/2018 |
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Event Type
Injury
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Event Description
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It was reported to gore that the patient underwent open ventral hernia repair on (b)(6)2007 whereby a gore® dualmesh® biomaterial was implanted.The complaint alleges that on (b)(6) 2018, an additional procedure occurred whereby the gore device was explanted.It was reported the patient alleges the following injuries: adhesions, hernia recurrence, and removal.Additional event specific information was not provided.
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Manufacturer Narrative
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It should be noted that the gore® dualmesh® biomaterial instructions for use addresses the following adverse reactions among others: ¿possible adverse reactions with the use of any tissue deficiency prosthesis may include, but are not limited to, contamination, infection, inflammation, adhesion, fistula formation, seroma formation, hematoma, and recurrence.".
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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: implant preoperative complaints: (b)(6) 2007: (b)(6) hospital.(b)(6).Indications: ¿the patient is a 36-year-old gentleman with a long history of crohn disease and multiple abdominal surgeries chronologically including partial colectomy, diverting loop ileostomy in the right lower quadrant, parastomal hernia repair of diverting loop ileostomy, total colectomy, takedown of right lower quadrant ileostomy and creation of a left lower quadrant ileostomy, abdomen and perineal resection.The patient presents with discomfort and a very large bulge in the region of the old right lower quadrant ileostomy.He has an obvious incarcerated ventral hernia at the site of his previous ileostomy site.He will require surgical repair of this hernia.The patient requests that every attempt be made to perform this laparoscopically prior to performing an open procedure.Therefore, he will undergo a laparoscopic ventral hernia repair.¿ implant procedure: extensive laparoscopic lysis of adhesions.Laparoscopic ventral herniorrhaphy with mesh.Takedown of falciform ligament.[implant: gore® dualmesh® biomaterial, 1dlmc07/04114007, 20cm x 30cm x 1mm thick].Implant date: (b)(6) 2007 [hospitalization dates unknown].(b)(6) 2007: (b)(6) hospital.(b)(6).Operative report.Assistants: (b)(6) and (b)(6).Pre and postoperative diagnosis: recurrent incarcerated ventral hernia.Crohn disease.Anesthesia: general.Estimated blood loss: 50 ml.Complications: none.Wound classification: ¿ii clean-contaminated wound." findings: ¿incarcerated small bowel and omentum in a fairly large defect in the right lower quadrant.The patient's abdominal wall defect was approximately 10 x 15 cm wide with an adjacent smaller defect just lateral to the large defect that was approximately 3 x 4 cm wide.The hernia defect was very close to the new ileostomy, therefore, care had to be taken to place the mesh next to the ileostomy but not involving any structures of the ileostomy." procedure: ¿the patient was taken to the operating room and placed supine on the operating table.After general endotracheal anesthesia was established, both of his arms were tucked at the sides, and the abdomen was shaved, and prepped and draped in a standard surgical fashion after a foley catheter was placed.The patient's defect was palpated to be in the right lower quadrant; therefore, three ports were placed in a triangulated fashion.The first port was 5-mm port placed in the anterior axillary line just below the costal margin on the left side of the patient.This was placed using the optiview method.The abdomen was entered successfully and was insufflated.Under direct visual guidance of the 5-mm 30-degree camera, two other ports were placed.A 10-mm port was placed also in the anterior axillary line but closer towards the patient's iliac crest more in the left lower quadrant region.A third port was a 5-mm port placed just left and lateral to the suprapubic region, therefore, the hernia defect was now triangulated.The hernia defect was seen, and as noted above it included small bowel and omentum.Carefully gentle traction was placed on the small bowel and omentum, and it was seen to be adherent to the anterior abdominal wall.Therefore, gently using cold laparoscopic scissors, the omentum and bowels were freed from the anterior abdominal wall and allowed to fall back down through the defect into the abdomen.This was done for a significant amount of time; approximately 45 minutes were spent in performing meticulous and extensive lysis of adhesions laparoscopically.Once the omentum and bowel fell back into the abdomen, the hernia defect was completely visualized and there was no remaining intraabdominal contents noted.Hemostasis was achieved with electrocautery.Adjacent to the large hernia defect, there was a 3 x 4 cm defect just lateral to the right of the large defect.This did not contain any abdominal contents.There was also some adhesiolysis performed adjacent to the ileostomy site to allow for better placement of the mesh.Next, the abdomen was allowed to desufflate to half of the pneumoperitoneum that was initially placed, and the defect was measured by using spinal needle to enter the abdomen in four quadrants around the hernia defect.It was measured to be approximately 10 x 15 cm, including adequate margins around the defect and also including the small defect adjacent to the large defect.The size of the mesh needed would have to be approximately 20 x 20 cm.Next, the mesh was opened up; it was a gore-tex dual mesh, rectangular shaped mesh that was approximately 20 x 30 cm.This was trimmed to be approximately 20 x 20 cm to allow for it to be fitted appropriately along the defect.Two stay sutures were placed in the mesh at the 12 o'clock and 6 o'clock position parallel to the border of the mesh, this was done with 0 pds suture.Following this, the mesh was then tightly rolled up, and attempted to be introduced through the 10 -mm port while visualizing with a 5-mm camera.After much coercion, the mesh would not fit through the port; therefore, the 10-mm port had to be removed from the patient.The mesh was just pushed through the incision that was created for the 10-mm port, and the mesh easily entered the abdomen.The 10-mm port was then replaced into the patient and carefully the mesh was opened up and flattened out.Next, carter-thompson needle was introduced at the previous 12 o'clock and 6 o'clock position that was marked on the patient.This was used to bring the pds suture that was on the mesh out of the patient.Once the sutures were out of the patient, they were used to grasp the mesh and help bring the mesh up against the patient's anterior abdominal wall.The sutures were not tied down immediately; they were just instead fastened using hemostats.Following this, laparoscopic spiral tacks were placed in a circumferential manner along the mesh.The first area we worked on was adjacent to the ileostomy to make sure that there would be adequate cover to the hernia defect but also there would be no encroachment upon the ileostomy or the structures involving the ileostomy.After we were satisfied with the placement of the mesh adjustment to the ileostomy and the tack placement, the rest of the mesh was tacked down also in a circumferential manner.Each tack was approximately 1 to 2 cm apart but not more than that.As we got closer towards the falciform ligament, it was noted that we would have to take down approximately 50% of the falciform ligament; therefore, cautery was used to take down the falciform ligament to allow for better placement of the mesh.Care was taken to make sure that the mesh did not hold upon itself, and there was not too much room between each tack.After this was performed, the mesh was inspected thoroughly and it was noted to be in place without any folds, and it did not appear to be loose or too tight.It seemed to have appropriate tension on it.Next, the abdomen was then inspected for any bleeding; none was seen.Under direct visual guidance, two ports were removed from the patient.Finally, the third port was removed from the patient.Please note that during the placement of the carter-thompson needle and around the lower edge of the hernia defect to pull the suture out of the patient, there was some bleeding encountered, this appeared to be arterial, therefore, the incision was opened up slightly more to about 1 cm and explored.The bleeding that was seen was localized and cauterized, and there was no more bleeding noted.After all totally desufflated, and a 10-mm port site was closed with 0 pds in interrupted fashion followed by reapproximation of the subcutaneous tissue with 3-0 vicryl in a running fashion followed by closure of all the skin incisions with 4-0 monocryl in a running subcuticular fashion.The incisions were then cleaned, dried, and sterile antimicrobial ointment was applied to the incisions and allowed to dry.The sponge, needle, and instrument counts were correct at the end of the case.The patient was awakened from anesthesia, and transferred to the recovery room in good condition.Dr.Haas was present and scrubbed throughout the entire care.¿ (b)(6) 2007: (b)(6) hospital.Implant record.¿dual mesh.Catalog #: 1dlmc07, lot #: 04114007.Size 20x30x1.Quantity: 1.Expiration date; 12/2010.Manufacturer: goretex [sic].¿ relevant medical information: (b)(6) 2017: (b)(6) hospital.(b)(6).Pathology.(b)(4).Source: ¿1.Hernia sac, 2.Ileostomy.¿ gross description: ¿the specimen is received in two parts each labeled with the patient¿s name and medical record number.Part 1 received in formalin and labeled hernia sac is a pink-tan membranous saccular portion of fibrofatty tissue measuring 11.5 x 3.5 x 2.0 cm.The tissue is serially cross sectioned to reveal tan-pink membranous cut surfaces with adherent golden yellow lobulated adipose tissue.Representative cross sections are submitted in cassette 1a.Part 2 received in formalin and labeled ileostomy is a tan-white 2.5 x 2.0 cm skin ellipse with a central protuberant mucosal lumen measuring 2.3 x 1.9 cm.The mucosal lumen extends into a length of small bowel measuring 2.5 cm in length up to 1.3 cm in diameter.The surgical margin is stapled and the staples are removed.The specimen is opened to reveal tan-pink glistening mucosal folds with no gross lesions.Representative sections are submitted in cassette 2a to include margin and ostomy site.¿ microscopic description: ¿microscopic examination performed, findings, are incorporated into the diagnostic section.¿ explant preoperative complaints: (b)(6) 2018: (b)(6) hospital.(b)(6).Indications: ¿(b)(6) is a 47yo [year old] m [male] with history of crohn's disease s/p [status post] colectomy who presents for scheduled surgery.He had a right ileostomy for two years which he then had relocated to the left side due to a parastomal hernia on the right.He also had a prior in situ repair, but it was not successful.He now has an expanding left parastomal hernia for which he seeks surgical management.Patient also has an incisional hernia on his right abdominal wall from previous ostomy site.¿ explant procedure: exploratory laparotomy.Extensive lysis of adhesions.Explantation of mesh.Small bowel resection.Creation of end ileostomy.Explant date: (b)(6) 2018 [hospitalization dates (b)(6) 2018]: (b)(6) 2018: (b)(6) hospital.(b)(6).Operative report.[surgery prior to explant procedure].Assistant: (b)(6).Preoperative diagnosis: parastomal hernia.Postoperative diagnosis: parastomal hernia.Incisional ventral hernia.Extensive adhesions to old mesh.Anesthesia: general.Estimated blood loss: 30ml.Specimens: explanted mesh, ileostomy.Complications: none. findings: ¿the patient is a 47-year-old male with history of total colectomy for crohn's and end ileostomy.The patient has a history of parastomal hernias and presents for component separation and repair of the parastomal mesh by plastics.That portion of the procedure is dictated separately by dr.Dinh.A portion of procedure was to gain access to the abdomen free of abdominal adhesions, take down the ileostomy and reformed it at the end of the case.We entered into the abdomen through the patient's prior incision in the midline.Immediately upon entry into the abdomen, we found extensive adhesions to the abdominal wall, mostly involving the small bowel and the mesentery of the small bowel.There is old mesh on the right side with those with metal tacks causing much of the adhesions.First, we focused on the left side with parastomal hernia.Using a combination of sharp dissection and cautery, we slowly took down adhesions between the rest of the small bowel and the abdominal wall, freeing up the ileostomy around the hernia site.With the adhesions freed up on the left side, we then sterilely covered with midline incision and took down the ileostomy from above.We used cautery circular lateral in the ileostomy and slowly took this down using cautery and freed up the subcutaneous tissue.Once the ileostomy was freed up, we took an echelon 60 stapler with blue load and fired across it.We then irrigated out the area and freed up the rest of the ileostomy site.With this done, we next addressed the right side.We found metal tacks and the old mesh, and we began to remove these.We then proceeded to explant the entire mass, which was secured with metal tacks and slowly freed up all the bowel off it.After we did this, we were able to run the bowel looking for an enterotomy but there was none.After this, dr.Dinh took over to begin his hernia repair.This is dictated separately.When he finished with this, we were called back in to recreate our ileostomy.We oriented the small bowel, brought it up through the ileostomy site, secured it to his mesh with a couple of 3-0 vicryl stitches and then removed the staple line after freshening it up and proceeded with the ileostomy.Ostomy appliance was placed.Dr.Dinh then finished the rest of the case is dictated separately.The patient tolerated procedure well with no complications.I was present for all portions of the procedure.Dr.Bobby johnson was present and necessary for surgical first assist.¿ procedure: ¿the patient was placed supine on the operating table under general anesthesia and prepped and draped in a sterile manner.Using a 10 blade, a midline incision was made in the prior scar.We dissected through subcutaneous tissue with bovie cautery and entered the abdomen by picking up on the fascia and peritoneum with clamps and cut in between.We extended the incision for the length of the scar.We immediately began to encounter some adhesions.We took these down with a combination of sharp dissection with metzenbaum scissors and cautery with the omentum was involved.We focused on the left side, first clearing off the abdominal wall adhesions.We freed up the underside of the ileostomy from abdominal adhesions.We then sterilely covered the midline wound and began to take down the ileostomy from above.We used cautery to make a circular incision around the ileostomy then began to use cautery and sharp dissection to dissect the ileostomy out the subcutaneous tissue.After we had freed up some of it, we took down the mesentery and used a blue load and echelon 60 across it and removed the ileostomy, sent it for specimen.We then irrigated out the wound and proceeded to take down the rest of the adhesions at the ostomy site using sharp dissection and cautery.With this done, we next addressed the right side of the abdomen where the mesh was.There were extensive adhesions here.Overall, adhesiolysis took over an hour and a half of surgical time.We slowly took down the small bowel off the mesh removing metal tacks as we went.We removed the metal tacks using kocher clamps and cautery to explant the mesh off the abdominal wall.It had poorly integrated into the abdominal wall to help facilitate this and avoid too much unnecessary injury to the fascia.We removed it at that point, this was sent for specimen.We then ran the small bowel from the ileostomy site back, was looking for any injury.No enterotomies were visualized.There were some signs of creeping fat near the ileostomy consistent with the patient's history of crohn's disease, but no narrowing or stricture was felt.Dr.Dinh next began his portion of the case, this is dictated separately.At the end the case, after we did place the mesh, we were called back in to do the ileostomy.It was oriented and pulled up to make sure the mesentery was not twisted and pulled up through the parastomal site.Two 2-0 vicryl stitches were intact between the small bowel and mesh to help keep the small bowel in place.We then freshened up the distal portion of the ileum removing some of the mesenteric fat later at the staple line then removed the staple line using cautery and used 3-0 vicryl stitches to close the ileostomy.An ostomy appliance was placed.Dr.Dinh then finished his portion of the case, which was dictated separately.The patient was successfully extubated and transferred to pacu.¿ (b)(6) 2018: (b)(6) hospital.(b)(6).Operative note.Assistant: (b)(6) and (b)(6).Pre and post-operative diagnosis: parastomal hernia without obstruction or gangrene.Recurrent incisional hernia.Procedure: repair of left lower quadrant parastomal hernia with silo technique using biologic mesh.Primary repair of a right incisional abdominal wall hernia with reinforcement with an underlay biologic mesh.Anesthesia: general.Estimated blood loss; 100 ml.Specimen: parastomal hernia sac.Implant: matrix tissue strattice.Complications: none. wound classification: ¿clean-contaminated." findings: ¿right abdominal incisional hernia at previous ileostomy stie, measuring 6x6xm [sic]; hernia repaired primarily and strattice mesh placed as underlay.Left parastomal hernia measuring 8x8cm, repaired with silo technique using strattice mesh." procedure: ¿after informed consent was obtained from the patient, he was brought into the operating room and placed under general anesthesia.The patient's entire abdominal wall was prepped and draped in the usual fashion.Dr.Stephens of colorectal surgery then proceeded to perform a midline laparotomy.Through this approach, he was able to perform significant lysis of adhesions.He also detached and temporarily closed the ileostomy in preparation for the silo technique of parastomal hernia repair.During this dissection, dr.Stephens also saw a loosely hanging old piece of synthetic mesh on the abdominal wall.He removed this mesh completely.This will be dictated separately.Afterwards, plastic surgery then entered the operating room.The patient already is under anesthesia with an open laparotomy wound.With the bowel protected, a decision was made to repair the incisional hernia in the right midquadrant first.Therefore, with the bowel retracted out of the way, the edges of the fascia and the right rectus muscle were found.It was repaired with multiple interrupted figure-of-eight #1 pds sutures in a primary fashion.After this was done, the incisional hernia on the right abdominal wall was closed.This was then reinforced with placement of underlay biologic mesh (strattice) measuring approximately 8 cm x 4 cm.A piece of biologic mesh was placed underneath and secured in place using multiple 0 pds sutures.After this was done, the right abdominal wall incisional hernia was repaired and reenforced with the mesh.Attention was then turned to the left quadrant parastomal hernia.With the bowel protected, the skin above the left rectus muscle was elevated past the lateral border of the hernia.It was found that the hernia opening itself is large through the rectus muscle.There is a large sac within the subcutaneous space and this was removed carefully.With the bowel protected, a portion of the opening through the rectus muscle was closed using figure-of-eight 0 prolene sutures to reduce the size of the large defect through the rectus muscle until it is approximately 3 cm in diameter.Next, on a side table, a silo utilizing strattice biologic mesh was created.Two squares of biologic mesh, each measuring 8 cm x 8 cm were cut out.Within the center of each of the squares, a circle of 3 cm in diameter was marked.The circles were placed so that they will overlap each other when one mesh is placed on top the other.Within each circle, a cross was cut.The crosses were designed at 45-degree offset of each other.After the crosses were cut within the circles, they created 4 triangular flaps within each circle.With the mesh one on top of the other and the circles overlapping, the triangular flaps were pulled toward each other.The 8 triangular flaps then formed the wall of the silo.The triangular flaps were then sutured together with 3-0 monocryl sutures at the edges of the flaps to create the sidewall of the silo.After this was done, the silo was completed with an onlay and an underlay mesh protecting the silo with the side wall around its opening.This silo biologic mesh was then pulled through the remaining opening on the left rectus muscle and secured in place with multiple 0 pds sutures.This was performed to secure the mesh both on top of the rectus muscle and below the rectus muscle (as an onlay and an underlay).After this was done, the opening through the rectus muscle was protected with the new silo.At this time, dr.Stephens then returned to the operating room and pulled the ileostomy stoma through the new rectus opening (which is reenforced with the silo biologic mesh) through the rectus muscle and through the opening on the skin.The ileostomy was temporarily secured to the skin.The ileostomy segment was sutured to the wall of the silo with several 4-0 monocryl sutures.Next, the midline abdominal incision was closed.After counting of all the equipment to be correct, closure of the midline laparotomy incision started with reapproximation of the fascia layer.The rectus fascia was closed with multiple figure-of-eight #1 prolene sutures.After this was done, a drain was placed to drain the subcutaneous space.The skin was closed in layers with 2-0 pds suture for the deep or scarpa's fascia layer, 3-0 monocryl suture for the dermal layer, and 4-0 monocryl suture for the skin.Afterwards, the ileostomy stoma was then matured on the abdominal wall and an appliance was placed.The closed midline abdominal incision was further protected with dermabond and a dressing.The patient was then awakened, extubated, and transferred to the recovery room in stable condition.There was no complication.Estimated blood loss for the plastic surgery portion of procedure was 100 ml.¿ (b)(6) 2018: (b)(6) hospital.Implant.¿matrix tiss strattice 20x20cm." (b)(6) 2018: (b)(6) hospital.(b)(6).Pathology: (b)(4).Material: ¿a.Abdominal wall mass, b.Hernia sac left.C.Ileostomy.¿ gross: ¿specimen is received in three parts.Received in formalin labeled abdominal wall mesh is a tan-pink irregular portion of synthetic material (14.0 x 12.0 x 0.6 cm} entirely submitted in toto for identification only.Received in formalin labeled hernia sac left are multiple pieces of yellow-white adipose tissue lined by tan-pink membranes (10.0.X 7.0 x 2.5 cm in aggregate).Specimen is serially sectioned.Cut surface is yellow-tan to tan-pink and rubbery.No gross lesions is noted.Representative sections in b1-2.Received in formalin labeled ileostomy is a segment of bowel (3.0 cm in length x 1.0 cm in diameter).An ostomy site is present (2.0 cm in diameter).No skin grossly surrounds the ostomy.Serosa is a tan-pink smooth; mucosa is tan-pink with normal folds.Specimen is serially sectioned.Cut surface is tan-pink rubbery.No gross lesion noted.Entirely submitted in c1-4.¿ microscopic: not performed.Sections of the hernia sac show fibroadipose tissue with scattered iymphocytic inflammatory infiltrate.A small focus of foreign-body giant cell reaction is seen.No definitive mesothelial lining is seen.No malignancy is identified.C.Sections of the ileostomy show small bowel mucosa with mucosal erosion and associated lymphoplasmacytic inflammatory infiltrate.Areas of foreign-body giant cell reaction are seen.No malignancy is identified.¿ a potential relationship, if any, between the alleged injuries or complications and the gore device has not been established at this time based on available information.It should be noted that the gore® dualmesh® biomaterial instructions for use addresses the following adverse reactions among others: ¿possible adverse reactions with the use of any tissue deficiency prosthesis may include, but are not limited to, contamination, infection, inflammation, adhesion, fistula formation, seroma formation, hematoma, and recurrence.The gore® dualmesh® biomaterial instructions for use also states: ¿strict aseptic techniques should be followed.If an infection develops, it should be treated aggressively.An unresolved infection may require removal of the material.W.L.Gore & associates, inc.(gore) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by gore, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Blank fields present on this report include required fields and fields determined to be not applicable.Blank required fields indicate that the information was not provided, was deemed unavailable or was not applicable.This report does not constitute an admission or a conclusion by fda, gore, or its associates that the device, gore or its associates caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects" or has "malfunctioned".These words are included in the report and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.
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Manufacturer Narrative
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H6: updated investigation findings code.Conclusion remains unchanged.It should be noted that the gore® dualmesh® biomaterial instructions for use addresses the following adverse reactions among others: ¿possible adverse reactions with the use of any tissue deficiency prosthesis may include, but are not limited to, contamination, infection, inflammation, adhesion, fistula formation, seroma formation, hematoma, and recurrence.The gore® dualmesh® biomaterial instructions for use also states: ¿strict aseptic techniques should be followed.If an infection develops, it should be treated aggressively.An unresolved infection may require removal of the material.W.L.Gore & associates, inc.(gore) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by gore, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Blank fields present on this report include required fields and fields determined to be not applicable.Blank required fields indicate that the information was not provided, was deemed unavailable or was not applicable.This report does not constitute an admission or a conclusion by fda, gore, or its associates that the device, gore or its associates caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects" or has "malfunctioned".These words are included in the report and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.
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Manufacturer Narrative
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H6: updated health effect.H6: updated investigation finding.H6: updated type of investigation.H6: updated investigation conclusions.The investigation has been completed.Based upon the totality of the information received over the course of the investigation and reported by gore in the previously submitted medical record narratives the following conclusions have been reached.As previously reported, all pertinent medical records requested may not have been received.Through gore's investigation and based on the available information there is no available information that reasonably suggests that a gore device may have caused or contributed to death, serious injury or reportable malfunction, and is no longer considered reportable.Therefore, this event is being coded as no clinical signs, symptoms or conditions, no health consequences or impact and will be closed as no problem detected.Previous patient codes were reported based on the original complaint and are no longer applicable and/or not reportable per gore¿s investigation.Following gore¿s investigation, the previously submitted annex f code has been updated to reflect gore¿s final conclusion.It should be noted that the gore® dualmesh® biomaterial instructions for use include warnings and addresses the following adverse reactions among others: "possible adverse reactions with the use of any tissue deficiency prosthesis may include, but are not limited to, contamination, infection, inflammation, adhesion, fistula formation, seroma formation, hematoma, and recurrence." medical records that indicate mesh "movement" or that the device led to a recurrence may reflect a recurrence as a function of a patient¿s poor tissue quality leading to fascial dehiscence or loss of anchorage of fixation, or may be related to the hernia type, individual patient comorbidities, and technical and procedural aspects of the repair.These factors include but are not limited to, fixation type, mesh shape/sizing used, and defect closure decisions.Additionally, a new, unrelated hernia can occur but may be referred to as a recurrent hernia.As with any surgical procedure, there are always risks of complications for surgical repair of hernias and soft tissue deficiencies, with or without mesh.These may include but are not limited to, adhesions and related harms, bleeding, bowel obstruction, compromised device biocompatibility, contamination which may lead to patient harms, device damage, dysphagia, erosion or extrusion and related harms, exposure or protrusion and related harms, fever, fistula, gerd recurrence, defect recurrence and related harms, ileus, increased procedure time and related harms, irritation or inflammation, infection, mesh migration, mesh contraction, pain, paresthesia, perforation, revision/re-intervention, seroma or hematoma and related harms, tissue ischemia, wound complications and wound dehiscence and additional intervention including surgery.Many of the potential complications are associated with the patient¿s underlying disease progression, co-morbidities, additional medical history and/or other surgical procedures.The above inherent risks are typically detailed in standard informed consent documents.The device was not able to be returned to gore for evaluation; therefore, a direct product analysis could not be conducted.Review of the manufacturing records verified that the lot met all pre-release specifications.W.L.Gore & associates, inc.(gore) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by gore, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Blank fields present on this report include required fields and fields determined to be not applicable.Blank required fields indicate that the information was not provided, was deemed unavailable or was not applicable.This report does not constitute an admission or a conclusion by fda, gore, or its associates that the device, gore or its associates caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects" or has "malfunctioned".These words are included in the report and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.
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