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| Model Number 1DLMCP04 |
| Device Problems
No Apparent Adverse Event (3189); Insufficient Information (3190)
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| Patient Problems
Obstruction/Occlusion (2422); Not Applicable (3189); No Code Available (3191)
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| Event Date 03/27/2017 |
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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 incisional ventral hernia repair on (b)(6) 2010, whereby a gore dualmesh® plus biomaterial was implanted.The complaint alleges that on (b)(6) 2017, an additional procedure was performed whereby explant of the gore device was performed.It was reported the patient alleges the following injuries: additional surgery, bowel obstruction, mesh failure, mesh removal.Additional event specific information was not provided.
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Manufacturer Narrative
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Updated result code.Conclusion code remains unchanged.
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Manufacturer Narrative
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Other relevant history: 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 prior to (b)(6)2008 , including records for previous sigmoid colectomy were not provided.Records dated (b)(6)2008 indicate the patient was admitted to the hospital on (b)(6)2008 and discharged (b)(6)2008.Admitting diagnosis, appendicitis.Operative records dated (b)(6)2008 indicate the patient underwent exploratory laparotomy, lysis of adhesions, drainage of intraabdominal abscess, appendectomy.The patient ¿¿is a 50 year-old male who presented with severe lower abdominal pain mostly in the right side.Workup showed severe leukocytosis and cat scan of the abdomen and pelvis performed showed pneumoperitoneum with pericecal inflammatory process.¿ operative records dated (b)(6)2008 state: ¿a midline infraumbilical incision was then made using a #10 scalpel blade, cutting through skin.This was advanced subcutaneously with the bovie until the fascia was exposed.Hemostasis was established using electrocoagulation.The fascia was entered along the midline and the peritoneum was also entered under direct vision.Exposure was maintained using bookwalter retractor.Immediately encountered were mildly distended small bowel loops with purulent fluid and culture and sensitivity specimen was obtained.¿ the records dated (b)(6)2008 continue: ¿exploration performed revealed small bowel adhesions in the deep pelvis secondary to previous sigmoid colectomy.Lysis of adhesions was performed using metzenbaum scissors dissection.Further exploration then revealed a large inflammatory mass in the right lower quadrant with adherent small bowel that was causing partial small bowel obstruction.Small bowel was mobilized revealing a large abscess that was walled off by the small bowel and the small bowel mesentery.Lysis of adhesions was performed with metzenbaum scissors to completely mobilize the small bowel.¿ the operative records dated (b)(6)2008 state: ¿abscess was then drained by suctioning it with a yankauer.Further exploration revealed the inflammatory mass to be secondary to a perforated gangrenous appendicitis.Appendectomy was then performed.¿ ¿the wound was left open with staples fired along the mbilical area.The wound was then packed with 2-inch kerlix gauze moistened with saline followed by dry dressings.¿ pathology report dated (b)(6)2008 indicated final diagnosis: acute appendicitis with perforation.Operative records dated (b)(6)2008 indicate the patient underwent a procedure to control bleeding from an abdominal wound.¿the procedure was done emergently as the patient was bleeding extensively from the wound and had a pulsatile bleeder from the wound.A bleeder was ascertained and a suture ligature of 3-0 vicryl was used to create hemostasis.Bleeding was controlled the conclusion of the procedure and the wound was packed.Wound class type is clean contaminated as the wound was open to start with for the patient status post perforated appendicitis.¿ records dated between (b)(6)2008 and (b)(6)2010 were not provided.Operative records for surgical date(b)(6)2010 indicate the patient underwent laparoscopic extensive lysis of adhesions for approximately 1 to 1-1 /2 hours and laparoscopic incisional ventral hernia repair.The patient ¿¿is a 52-year-old male who presented to the emergency department complaining of abdominal pain, nausea, vomiting and constipation.He was found to have an incisional ventral hernia that was reduced on arrival.After reduction, the patient remained asymptomatic, and followup studies revealed resolution of obstruction.He did persist to have contents in the sac, however.¿ the operative records dated (b)(6)2010 state: ¿a 12 mm incision was made in the left upper quadrant, and dissection was taken down to the fascia using blunt dissection.The fascia was grasped on either side and incised with a scalpel.The posterior fascia was grasped, retracted into the wound and divided with metzenbaum scissors.A 12 mm trocar was then placed into the wound.The abdomen was insufflated to 15 mm hg.¿ the (b)(6)2010 records continue: ¿on inspection of the abdomen, there were several adhesions to the midline containing incarcerated contents of both omentum and small bowel.There were also adhesions in the right lower quadrant from his prior appendectomy.An area otherwise [sic] adhesions was identified in the right upper quadrant.¿ the (b)(6)2010 operative records state: ¿the adhesions in the right lower quadrant were then lysed using scissors, and an area of clear filmy adhesions.These adhesions were adherent to small bowel.Once these adhesions were lysed, this provided additional access to the right lower quadrant port.Dissection was then begun in the midline.The hernia contents were grasped and retracted into the abdomen.¿ records dated (b)(6)2010 continue: ¿there were dense adhesions.These were lysed both with sharp dissection and using.Endoshears and with the harmonic scalpel.With lysis of adhesions between the abdominal wall and the hernia contents, the hernia contents began to reduce.This was continued along the midline wound.There were several defects in the midline consistent with swiss cheese defect along the midline.This was continued both with harmonic scalpel and in the areas of omental adhesions and endoshears and areas of nearby small bowel.Of note, most of the small bowel was incarcerated in the lower hernia.¿ operative records dated (b)(6)2010 state: ¿once all of the adhesions were lysed and the contents reduced, dissection was continued down along the inferior abdominal wall to provide clearing of the abdominal wall for mesh fixation.Once enough margin was created superiorly and inferiorly and additional adhesions lysed laterally, the hernia was measured.The hernia was measured to be approximately 12 mm long and 4 cm wide containing all of the defects.A mesh was chosen and cut to 19 x 10 cm for in order to create adequate overlap for the repair.Cv2 gore sutures were then chosen and placed at the superior, inferior and bilateral lateral edges of the oval mesh.This was a gore dualmesh.¿ the records dated (b)(6)2010 state: ¿the mesh was then rolled and brought into the abdomen through the 12 mm port.Intra-abdominally, the mesh was unraveled, and using a small stab incision, the gore sutures were brought out from intra to extracorporeally.This was done superiorly, inferiorly, and again right and left laterally.The mesh was inspected and noted to lie flush against the abdominal wall.The sutures were then tied.The mesh was then further secured to the abdominal wall using a protac device.This was done circumferentially around the mesh under direct visualization.Additional tacks were placed in the center of the mesh for added fixation and to reduce dead space.¿ operative records dated(b)(6)2010 continue: ¿once the tacks were placed and we were satisfied with the mesh placement, the 12 mm trocar was removed, and the wound was closed with a 0 vicryl on a carter-thomson endo closure device under direct visualization.Of note, a carter-thomson device was also used to bring out the sutures of the mesh.The remaining trocars were then removed under direct visualization.The insufflation was released from the abdomen.The skin was closed with running 4-0 monocryl subcuticular sutures.The stab wounds were closed with lndermil skin adhesive.¿ records confirm a gore dualmesh® plus biomaterial (1dlmcp04/06824597) was used during the procedure).Records between (b)(6)2010 and (b)(6)2017 were not provided.Operative records dated (b)(6)2017 indicate the patient underwent laparoscopic lysis of adhesions converted to an exploratory laparotomy, extensive enterolysis, explantation of previous mesh, recurrent incisional ventral hernia repair, strattice biological graft 20 x 10 cm, right and left rectus myofascial flap mobilization, excision of hypertrophic scar, scar revision.Postoperative diagnosis- high-grade small-bowel obstruction secondary to dense adhesions of the multiple loops of small bowel at the site of previous hernia repair with acute kinking, incarcerated omentum in the recurrent incisional hernia.The operative records dated (b)(6)2017 state: ¿patient had incarcerated omentum in the hernia that was superior to the previous hernia repair , but multiple loops of omentum with the small bowel were plastered to the abdominal wall that were causing acute kinking at multiple points with a high-grade small-bowel obstruction.Proximal small bowels were massively dilated and distal small bowels were completely collapsed.We proceeded by extensive enterolysis by freeing up all these adhesions with the help of endoshears and harmonic scalpel.¿ the records dated (b)(6)2017 continue: ¿we reduced the contents of the hernia sac and omentum was completely reduced and gradual enterolysis was performed laparoscopically with the help of endoshears.After significant time was spent to lyse the loops of bowel that were plastered to the previous mesh and tackers and abdominal wall, a limit was reached where we could not free up anymore without causing any enterotomy.At this point, decision was made to convert to a mini laparotomy.Patient had a previous hypertrophic scar at the site of previous appendectomy, that hypertrophic scar was excised and sent to pathology.¿ the (b)(6)2017 records state: ¿peritoneal cavity was entered through the hernial sac and gradually dissection was performed and these dense adhesions were gradually lysed down with the help of endoshears.Part of that during the process, we started to divide this previous gore dual plus mesh and lot of tackers were removed.After we completely opened the previous mesh and fascia in the midline, gradually we started to free up these multiple interloop adhesions of the small bowel that were causing bowel obstruction and there was a significant epithelialization of the previous gore dual plus mesh and that was completely plastering these loops of small bowel causing acute kinking.¿ the operative records dated (b)(6)2017 state: ¿after releasing the small bowel loops, gradually we freed the small bowel completely from the abdominal wall.We brought these loops through the midline and further any interloop adhesions or any kinking of the bowels were completely freed.After that we inspected the bowels and there was no evidence of any serosal tear, bowels were reduced back into peritoneal cavity.At this point, remaining tackers of the gore dual plus mesh were gradually removed and gore dual plus mesh was completely excised with the help of sharp dissection and also with the help of bovie cautery.¿ the records dated(b)(6)2017 continue: ¿ at this point, we were left with the hernial defect and a very weak fascia in the middle from the previous laparotomy, so we started to mobilize the myofascial flaps of the rectus muscle on both right and left side so we can primarily close it and reinforce with a strattice biological graft.So, first flap was raised on the right side and then on the left side.Part of the hernial sac was excised and sent to pathology.¿ operative records dated (b)(6)2017 state: ¿during the process, we also removed pieces of omentum.Those were also removed and sent to pathology.Omentum was brought in to cover the rest of the bowels.After the fascial flaps were raised in both sides, we used a strattice biological graft and it was tacked with multiple used pieces of #0 pds and #1 prolene to lateral edges of the fascia and all quadrants and to make sure there was no gap in between for any bowels to herniate.After all those stitches were placed, all the stitches were tied in the end and the fascia in the midline was closed with running #1 looped pds suture.¿ records confirm a strattice (non-gore device) was used during the procedure.Pathology report for (b)(6)2017 procedure states: ¿specimen source- omentum, mesh, hernia sac, scar abdomen tissue.Gross description: part a omentum: the specimen consists of a piece of fibrofatty tissue which measures 3 x 0.6 x 0.4 cm.Rep.Sections submitted in a single cassette.Part b.Mesh: the specimen consists of 2 pieces of plastic material the larger rneasuring 10 x 5 x 0.2 cm and the smaller 9 x 2.5 x 0.2 cm.There are several metallic structures present in the mesh.Gross diagnosis only.Part c: hernia sac: the specimen consists of a 2 pieces of grayish white tissue measuring in aggregate 3 x 1.5 x 0.8 cm.Rep.Sections of each pieces submitted in a single cassette.Part d scar tissue, abdomen: specimen consists of 2 linear pieces of skin measuring approximately 9 x.0.5 cm and 6 x 0.5 cm respectively.Fibrofatty tissue attached to the larger piece measures 7 x 3 x 0.8 cm rep.Sections submitted in a single cassette.¿ pathology report dated (b)(6)2017 continues: diagnosis- ¿part a.Omentum: fragments of fibro-adipose tissue with focal areas of dense fibrosis, vascular congestion and hemorrhage.Part b.Mesh: gross diagnosis only.Part c.Hernia sac: fragment of fibroadipose tissue and dense fibrous tissue consistent with contents of hernia sac.Part d, scar tissue: skin with dense fibrosis of dermis and scar formation.¿ 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: radiology records (b)(6) 2008 states: ¿successful, ct guided drainage of right lower quadrant fluid collection.¿ radiology records dated (b)(6) 2008 indicate patient underwent ct abdomen/pelvis with contrast.Impression: ¿the previous ct scan demonstrated a drain in the right lower quadrant.On the current examination, the drain has been removed.There is no obvious collection in the right lower quadrant.There is no evidence of fluid collections in the pelvis.¿ records dated between (b)(6) 2008 and (b)(6) 2010 were not provided.Radiology records dated (b)(6) 2010 indicate patient had a small bowel series.The records state: ¿examination shows small bowel to be of normal caliber.There is no evidence of any fixed loop or filling defect.There is normal coating of the small bowel.The terminal ileum is identified and is normal in appearance.¿ history and physical dated (b)(6) 2010 states: the patient ¿is a 52-year~old male who was complaining of abdominal pain, bloating and slight nausea, but no vomiting, with constipatlon.No fever.The patient claims that he is passing flatus.The patient has a hernia at the site of past surgery for a long time but the bulge is more prominent on standing, but it is reducible.¿ the history and physical records dated (b)(6) 2010 state: ¿ct scan showed mildly dilated bowel.There is an incisional hernia close to the umbilicus, containing a partial loop of bowel.¿ impression: ¿the patient with possible bowel obstruction, reducible incisional hernia.¿ pertinent records between (b)(6) 2010 and (b)(6) 2015 were not provided.Us abdomen dated (b)(6) 2015 states: impression: ¿cholelithiasis without biliary ductal dilatation.¿ ct abdomen/pelvis dated (b)(6) 2016 states: impression: ¿status post ventral abdominal hernia repair, evidence of small ventral umbilical hernia containing fat.¿ consultation records dated (b)(6) 2017 state: this patient ¿is a 59-year-old male who is well known to me, presented with severe lower groin, lower abdominal pain, associated with nausea and vomiting.The patient has no vomiting today, but has persistent nausea.He has no flatus today.The last bowel movement was yesterday.Patient also having some difficulty with urination, with frequency, he has seen by urologist as an outpatient, had an ultrasound and psa level, results are pending.The patient gained 45 pounds since his laparosc0pic ventral hernia repair.¿ the consultation records dated (b)(6) 2017 state: the patient ¿had ct scan of abdomen and pelvis that revealed mildly dilated small bowel loops with some loops of small bowel collapse especially around his mesh, patient has a herniated fat superior to the mesh around the umbilical region.¿ 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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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: radiology records (b)(6) 2008 states: ¿successful, ct guided drainage of right lower quadrant fluid collection.¿ radiology records dated (b)(6) 2008 indicate patient underwent ct abdomen/pelvis with contrast.Impression: ¿the previous ct scan demonstrated a drain in the right lower quadrant.On the current examination, the drain has been removed.There is no obvious collection in the right lower quadrant.There is no evidence of fluid collections in the pelvis.¿ records dated between (b)(6) 2008 and (b)(6) 2010 were not provided.Radiology records dated (b)(6) 2010 indicate patient had a small bowel series.The records state: ¿examination shows small bowel to be of normal caliber.There is no evidence of any fixed loop or filling defect.There is normal coating of the small bowel.The terminal ileum is identified and is normal in appearance.¿ history and physical dated (b)(6) 2010 states: the patient ¿is a 52-year~old male who was complaining of abdominal pain, bloating and slight nausea, but no vomiting, with constipatlon.No fever.The patient claims that he is passing flatus.The patient has a hernia at the site of past surgery for a long time but the bulge is more prominent on standing, but it is reducible.¿ the history and physical records dated (b)(6) 2010 state: ¿ct scan showed mildly dilated bowel.There is an incisional hernia close to the umbilicus, containing a partial loop of bowel.¿ impression: ¿the patient with possible bowel obstruction, reducible incisional hernia.¿ consultation records dated (b)(6) 2017 state: this patient ¿is a 59-year-old male who is well known to me, presented with severe lower groin, lower abdominal pain, associated with nausea and vomiting.The patient has no vomiting today, but has persistent nausea.He has no flatus today.The last bowel movement was yesterday.Patient also having some difficulty with urination, with frequency, he has seen by urologist as an outpatient, had an ultrasound and psa level, results are pending.The patient gained 45 pounds since his laparosc0pic ventral hernia repair.¿ the consultation records dated (b)(6) 2017 state: the patient ¿had ct scan of abdomen and pelvis that revealed mildly dilated small bowel loops with some loops of small bowel collapse especially around his mesh, patient has a herniated fat superior to the mesh around the umbilical region.¿ pathology report dated (b)(6) 2017 regarding a specimen collected (b)(6) 2017 states: ¿specimen source- omentum, mesh, hernia sac, scar abdomen tissue.Gross description: part a.Omentum: the specimen consists of a piece of fibrofatty tissue which measures 3 x 0.6 x 0.4 cm.Rep.Sections submitted in a single cassette.Part b.Mesh: the specimen consists of 2 pieces of plastic material the larger rneasuring 10 x 5 x 0.2 cm and the smaller 9 x 2.5 x 0.2 cm.There are several metallic structures present in the mesh.Gross diagnosis only.Part c: hernia sac: the specimen consists of a 2 pieces of grayish white tissue measuring in aggregate 3 x 1.5 x 0.8 cm.Rep.Sections of each pieces submitted in a single cassette.Part d scar tissue, abdomen: specimen consists of 2 linear pieces of skin measuring approximately 9 x.0.5 cm and 6 x 0.5 cm respectively.Fibrofatty tissue attached to the larger piece measures 7 x 3 x 0.8 cm rep.Sections submitted in a single cassette.¿ pathology report dated (b)(6) 2017 continues: diagnosis- ¿part a.Omentum: fragments of fibro-adipose tissue with focal areas of dense fibrosis, vascular congestion and hemorrhage.Part b.Mesh: gross diagnosis only.Part c.Hernia sac: fragment of fibroadipose tissue and dense fibrous tissue consistent with contents of hernia sac.Part d, scar tissue: skin with dense fibrosis of dermis and scar formation.¿ 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: conclusion code remains unchanged.Additional details regarding the patient's clinical course were ascertained from a review of medical records and are as follows: (b)(6) 2008: (b)(6) medical center.(b)(6), md.Emergency room notes.Diagnosis: acute abdomen-perforated appendix-for operating room.History of diverticulitis.Reports vomiting, abdominal pain; notes for past 3 days nausea, vomiting, constipation, then noted some blood in urine today-some fever, chills.Pain now worse on left flank, left lower quadrant, midl [sic] pain on right; more constant, worse with range of motion.Some loss of appetite.Diverticulitis; surgery 7 months ago in (b)(6), no primary medical doctor in this area now.Social history: no smoking, denies alcohol.Exam: abdomen; soft, no distention, positive tenderness, no rebound, positive guarding bilateral lower quadrants, right possible left [sic] left flank pains, no palpable masses, positive flank tenderness.Ct abdomen/pelvis: free intra-peritonela [sic] air, medial to cecum, with inflammatory changes, possible small extravasation of contrast, cevcal [sic] wall thickened, free fluid in pelvis; findings concerning for perforated appendix.Plan: admitted to service of dr.Yrad; condition stable.(b)(6) 2008: nighthawk pros.(b)(6) md.Radiology ¿ ct abdomen/pelvis.Preliminary interpretation.Impression: free intra-peritoneal air within the mid pelvis medial to the cecum and marked mesenteric inflammatory changes.Possible small amount of extravasated oral contrast medial to cecum versus small amount of contrast within the proximal appendix.Cecal wall thickened.Small amount of free fluid within pelvis; concerning for perforated appendicitis.No focal abscesses.Mildly distended oral contrast filled loops of small bowel within pelvis measuring 3.3 cm in greatest diameter.Remainder of small bowel loops normal in caliber.Possible early small bowel obstruction.(b)(6) 2008: (b)(6) ct abdomen/pelvis with contrast.Indication: abdominal pain.Impression: marked wall thickening and inflammatory changes involving the cecum and right lower quadrant mesentery.Extraluminal mesenteric gas and contrast medial to the cecum; differential diagnostic considerations include perforated appendicitis, diverticulitis and tumor.Small amount of ascites.Moderately dilated loops of distal small bowel likely on the [illegible] of ileus.Findings discussed with emergency room physician by dr.Novell.On (b)(6) 2008: (b)(6) md.History & physical.Complaining of lower abdominal pain; started 3 to 4 days ago, localized to right lower quadrant area; few episodes of nausea/vomiting/diarrhea.Since 2 days ago, however, feeling constipated.Developed fever.Increasing severity of pain prompted consultation in emergency room; workup significant for findings of pneumoperitoneum with severe peri-cecal inflammatory process noted and free air.Surgical consultation then called.Past medical history: perforated sigmoid diverticulitis (b)(6) 2007; laparoscopic sigmoid colectomy.Seasonal asthma.Exam: abdomen; mildly obese.On palpation, abdomen soft with prominent tenderness in bilateral lower quadrant area most pronounced in right lower quadrant with some guarding and rebound tenderness.Impression: acute abdomen with perforated viscus.Plan: schedule emergency exploration.(b)(6) 2008: (b)(6).[illegible].Operative note.Preop diagnosis: acute abdomen/perforated viscus.Postop diagnosis: perforated gangrenous appendicitis, intra-abdominal abscess, partial small bowel obstruction.Procedure: exploratory laparotomy, lysis of adhesions, drainage of intra-abdominal abscess, appendectomy.Specimen: appendix.Assistant: dr.Bhandari.Drains: jp (#10).Blood: 100 cc.Condition to recovery room: stable.(b)(6) 2008: (b)(6).Reason: medical management; seeing for postoperative care.Exam: mildly obese.Abdomen: (b)(6) drain in inferior portion of wound, abdomen draped with bandages.Plan: follow up with postoperative care, blood pressure and labs.(b)(6) 2008: community medical center.Steven priolo, md.Operative report.Preoperative diagnosis: bleeding abdominal wound.Postoperative diagnosis: bleeding abdominal wound.Procedure: control of bleeding form an abdominal wound.Procedure in detail: ¿the patient was put on the spinal table.The area was prepped and draped in a sterile fashion.This procedure was done emergently as the patient was bleeding extensively from the wound and had a pulsatile bleeder from the wound.It was prepped and draped and infiltrated with lidocaine.A bleeder was ascertained and a suture ligature of 3-0 vicryl was used to create hemostasis.Bleeding was controlled [sic] the conclusion of the procedure and the wound was packed by the nurse.The patient tolerated the procedure well.Wound class type is clean contaminated as the wound was open to start with for the patient status post perforated appendicitis.¿ (b)(6) 2008: (b)(6).Radiology ¿ ct abdomen/pelvis.Indication: abdominal pain, evaluate for abscess.Comparison: (b)(6) 2008.Impression: enhancing fluid collection within right lower quadrant measuring 4.8 cm, most consistent with abscess collection.Small amount of subcapsular ascites, adjacent to the liver.Small right pleural effusion.(b)(6) 2008: (b)(6).[illegible].Progress notes.Ct; positive abscess collection, right lower quadrant peri-cecal.Vital signs stable, afebrile.Abdomen soft, positive right lower quadrant/[illegible].Wound clean, granulated with [illegible].Pod [postop day] #9 status post exploratory laparotomy appendectomy.For ct guided drainage right lower quadrant abscess.Discharge plan in morning with home antibiotics.(b)(6) 2008: (b)(6).Radiology ¿ ct pelvis.Comparison: (b)(6) 2008.Impression: no significant residual collection, right lower quadrant.Enlarged peri sigmoid lymph node of indeterminate clinical significance.Follow up colonoscopy suggested.Records dated (b)(6) 2008 indicate the patient was admitted to the hospital on (b)(6) 2008 and discharged (b)(6) 2008.Admitting diagnosis, appendicitis.(b)(6) 2008: (b)(6) medical center.(b)(6)], md.Radiology ¿ ct abdomen/pelvis with contrast.Indication: abdominal pain.Impression: no evidence for residual abscess in the right lower quadrant.The drain in right lower quadrant has been removed.No fluid collections at the pelvis.Status post laparotomy.Mild fatty changes of the liver.Otherwise unremarkable.(b)(6) 2008: (b)(6) medical center.(b)(6), md.Emergency room notes.Complains of abdominal pain described as periumbilical, nausea/vomiting.Had ruptured appendix a year ago; prior abdominal surgery.Developed chest pain 2 hours ago.Past medical history: diverticulitis, ruptured appendix, acid reflux.Exam: abdomen; positive distention.Bowel sounds active, some tenderness in periumbilical area; no guarding, rebound, palpable masses, or costovertebral angle tenderness.Ct scan abdomen/pelvis; 2-3 small fat containing ventral wall hernias, no bowel obstruction.Impression/plan: feeling better; does not need observation for abdominal complaints.Repeat ekg normal, repeat enzymes negative.Diagnosis: chest pain, ventral hernias.Advised to follow up with dr.Morelos.(b)(6) 2008: (b)(6) medical center.(b)(6) md.Radiology ¿ ct abdomen/pelvis without contrast.Indication: abdominal pain.Impression: no evidence of acute abdominal or pelvic abnormalities.Several small umbilical and periumbilical fat containing hernias.Follow up imaging as clinically needed.(b)(6) 2010: (b)(6) medical center.(b)(6), md.Emergency room notes.Complains of abdominal pain starting 4 days ago, over incisional hernia in the middle of abdomen; constant, aching; gets worse intermittently with nausea, no vomiting, mild constipation.Prior abdominal surgery.Medical history: appendectomy for perforated appendix; incisional hernia close to umbilicus, left inguinal hernia repair twice decades ago.Social history: no smoking, alcohol socially.Exam: abdomen; no distention, bowel sounds active, mild tenderness in ventral hernia close umbilicus; reducible.No guarding, rebound, palpable masses, costovertebral angle tenderness, hepatosplenomegaly, or bruits.Impression: acute periumbilical abdominal pain, reducible ventral hernia, ileus.Plan: admitted to service of (b)(6).(b)(6) 2010: nighthawk pros.(b)(6), md.Radiology ¿ ct abdomen/pelvis.Preliminary interpretation.Indications: abdominal pain rule out obstruction.Impression: ventral wall hernia containing a portion of small bowel.The small bowel loop just proximal to the hernia sac is distended measuring 3.3 cm in diameter.Possible incarcerated ventral wall hernia versus focal ileus.The remainder of the small bowel loops are normal in caliber.There is a second more superior ventral wall hernia containing mesenteric fat.Umbilical hernia containing non-distended loop of small bowel.(b)(6) 2010: (b)(6) medical center.[illegible].Radiology ¿ ct abdomen/pelvis with contrast.Indication: abdominal pain.Comparison: (b)(6) 2008.Impression: anterior abdominal wall hernia which is complex with multiple defects.The largest defect does contain a partially herniated loop of bowel and there is mild dilatation just proximal to loop which may represent a component of partial obstruction and some adhesive changes of this loop to this area.Evaluation is limited due to lack of oral contrast.(b)(6) 2010: (b)(6) medical center.(b)(6), md.Operative note.Preoperative diagnosis: incisional ventral hernia.Postoperative diagnosis: incisional ventral hernia.Procedure: laparoscopic extensive lysis of adhesions, laparoscopic incisional ventral hernia repair.Specimen: none.Assistant: (b)(6).Anesthesia type: general endotracheal anesthesia.Drains: none.Findings: 217919.Complications: none.Condition to pacu [post anesthesia care unit]: stable.(b)(6) 2010: (b)(6) medical center.[illegible].Operative implant record.Implant label.Gore® dualmesh® plus biomaterial.Ref catalogue number: 1dlmcp04.Lot batch code: 06824597.W.L.Gore & associates.(b)(6) 2010: (b)(6) medical center.[illegible].Discharge summary.Feels much better, tolerating clears, no recent nausea/vomiting, positive bowel movement, vital signs stable, afebrile.Abdomen soft, wounds clean/dry/intact.Impression/plan: status post laparoscopic lysis of adhesions, repair of incisional hernia.Ileus resolved.Regular diet.Discharge home.(b)(6) 2010: (b)(6) medical center.[illegible].Discharge summary addendum.Had some nausea yesterday.Tolerated regular diet, now feeling much better.Afebrile.Abdomen soft, nontender, nondistended, wounds clean/dry/intact.Plan: discharge home today.(b)(6) 2010: (b)(6) medical center.[illegible].Discharge instructions.Activity: progress as tolerated.Diet: regular.Follow up with (b)(6).Restrictions: avoid heavy lifting (over 10 pounds), straining and bending.Avoid driving.(b)(6) 2012: (b)(6) medical center.(b)(6), md.Emergency room notes.Complains of abdominal pain, moderate to severe left lower quadrant pain for past 4 or more days; associated nausea/vomiting.Exam: abdomen; no distention, bowel sounds active, mild to moderate tenderness in left lower quadrant; no guarding, rebound, palpable masses, or costovertebral angle tenderness.Ct abdomen/pelvis: small ventral abdominal wall hernia status post surgery with omental fat in hernia sac identified in midline; no acute intra-abdominal process.Impression/plan: abdominal pain.Follow up with (b)(6).Discharged.(b)(6) 2012: (b)(6) medical center.(b)(6)], md.Radiology ¿ abdomen x-ray.Indication: left sided abdominal pain.Impression: nonspecific bowel gas pattern with post-surgical changes.(b)(6) 2012: (b)(6) medical center.(b)(6) md.Radiology ¿ ct abdomen/pelvis without contrast.Indication: left sided abdominal pain.Impression: small ventral abdominal wall hernia status post surgery with omental fat in the hernia sac identified in the midline.Without contrast material, no acute intra-abdominal process noted.(b)(6) 2015: (b)(6) medical center.(b)(6) md.Emergency room notes.Rectal bleeding; told to meet (b)(6) [sic] for colonoscopy at 5 pm.Weight 103.63 kg, bmi 32.78.Experiencing bright red blood per rectum past 2 days.Routine colonoscopy on monday, 2 polyps removed, next day developed rectal bleeding.Complains of some left lower quadrant pain; chronic, has been fully worked up in past, no different today.Exam: abdomen; soft, no distention, tenderness, rebound, guarding, or palpable mass.Remained stable during emergency room course.Had colonoscopy at 5 pm with (b)(6) ; reports colon full of blood from previous bleeding, will pass, stable to discharge home and will follow up as outpatient.(b)(6) 2016: (b)(6) medical center.(b)(6), md.Emergency room notes.For past year has had intermittent episodes of mild to moderate, dull, left sided lower back and flank pain associated with radiation to left lower quadrant of abdomen.States in past year has had endoscopies/colonoscopies to determine source of pain with no findings; pain worse recently, tonight more severe and constant.Exam: abdomen; not distended, bowel sounds present, no tenderness, costovertebral angle tenderness, guarding, rebound, mass, or palpable pulsatile mass.Weight 112 kg, bmi 35.35.Impression: left flank pain.Admit.(b)(6) 2016: (b)(6) medical center.(b)(6), np; catherine a.Hanlon, md.Rapid diagnostic unit notes.From emergency department for evaluation of left side/flank pain that radiates to left lower quadrant; pain intermittently over 1 year, worsening over last 3 weeks.Social: no smoking, alcohol daily.Drug detoxification (b)(6) 2014.Impression/plan: degenerative joint disease, back spasms; no acute abdomen.Stable for discharge.Discharge with follow up.(b)(6) 2017: (b)(6) medical center.(b)(6), md.Emergency room notes.59-year-old male reports onset this afternoon of diffuse lower abdominal pain; radiates into groin associated with nausea, non-bloody vomiting, and rectal pain that per patient is consistent with prior history of diverticulitis.Recent history of urinary retention and frequency; voiding small amounts; followed up urologist.History of prior abdominal surgery; recent colonoscopy, polyps removed.Exam: abdomen; obese, lower mid abdominal scar.Bowel sounds active, mild generalized tenderness, mild guarding all 4 quadrants.No rebound, palpable masses, costovertebral angle tenderness.Social history: alcohol 1-2 x/week, denies tobacco.Weight 112 kg, bmi 35.35.Emergency department course/treatment: ct abdomen; partial small bowel obstruction; nothing by mouth order.Discussed with (b)(6) covering for (b)(6); admit, consult surgeon dr.(b)(6).Impression/plan: partial small bowel obstruction.Abdominal pain.Stable; admit to inpatient unit.(b)(6) 2017: advanced radiology solutions.(b)(6), md.Radiology ¿ ct abdomen/pelvis.Preliminary report.Indication: lower abdominal/pelvic pain.Comparison: no pertinent prior imaging studies available.Impression: dilated focal small bowel loop in the anterior abdomen abutting the anterior abdominal wall mesh suggesting partial obstruction, possibly related to adhesions.Superior to mesh there is a fat-containing ventral hernia.(b)(6) 2017: (b)(6) medical center.(b)(6), md.Radiology ¿ ct abdomen/pelvis with contrast.Indication: abdominal pain.Comparison: prior study dated 07/26/16 and 04/10/12.Impression: postsurgical changes in the abdominal wall with surgical mesh, related to prior hernia repair.Superior to surgical site in the abdominal wall there is a small ventral hernia containing omental fat, stable.Mildly dilated few loops of small bowel, abutting on the anterior abdominal wall at the level of the cervical spine, suspicious for partial obstruction secondary to adhesion.No evidence for abscess formation or free intraperitoneal air.(b)(6) 2017: (b)(6) medical center.(b)(6), md.History & physical.Complaining of progressive abdominal pain past 1-2 weeks.Ventral hernia repair 7-8 years ago; pain kept getting worse, having vomiting, likely bile past 1-2 days.No fever/blood in stool.Exam: abdomen; diminished bowel sounds, distention, tenderness to palpate mid abdomen to lower abdomen bilaterally, no guarding.Impression: acute small bowel partial obstruction, obesity, abdominal pain secondary to obstruction.Plan: consult gastroenterology, surgery.Iv [intravenous] fluids, nothing by mouth, needs nasogastric tube.(b)(6 )2017: (b)(6) medical center.(b)(6), md.Consultation report.Reason: bowel obstruction.History of present illness: in usual state of health until wednesday; noticed decrease in appetite, worsening lower abdominal pain that has been present for some time.Began having emesis, presented to emergency room last night.We know him in office due to prior surveillance colonoscopies.Has had tubular adenomas on every colonoscopy; (b)(6).Last colonoscopy complicated by post-polypectomy bleeding necessitating urgent colonoscopy w/ clipping of post-polypectomy ulcer; have not seen him since 07/2015.Social: drinks alcohol regularly; does relay he drinks more than he should.Review of systems: [included] chronic sharp pains suprapubic region, bilateral groins, radiating into legs; intermittent spasm pains in rectum.Groin pain worse when lays supine.Has frequent reflux.Exam: abdomen; soft, mildly distended, no tenderness, active bowel sounds, no organomegaly or ascites.Laboratory data: ct reviewed by myself; there are prominent small bowel loops within the small bowel tacked to the internal aspects of ventral hernia repair with mesh.Small bowel appears more dilated proximal to this and decompressed distally.Liver mildly enlarged, somewhat fatty.Gallstones noted.Plan: nothing by mouth, iv [intravenous] fluids, ambulate, outpatient discussion regarding upper endoscopy.(b)(6) 2017: (b)(6) medical center.Felix [illegible], md.Radiology ¿ abdomen x-ray.Indication: partial small bowel obstruction, abdominal pain.Impression: no evidence of bowel obstruction.Residual contrast within large bowel.(b)(6) 2017: (b)(6) medical center.Felix [illegible], md.Radiology ¿ abdomen x-ray.Indication: abdominal pain.Comparison: (b)(6) 2017.Impression: no evidence of bowel obstruction.Residual contrast within large bowel.(b)(6) 2017: (b)(6) medical center.(b)(6), do.Progress notes.Still pain; not too bad, had flatus, ambulatory.Small bowel series: impression: no evidence of bowel obstruction.Impression/plan: abdominal pain, obesity, ventral hernia.Would like surgery now, not later.(b)(6) 2017: (b)(6) medical center.(b)(6), md.Progress notes.Impression/plan: partial small bowel obstruction resolved.Recurrent ventral hernia containing omentum/fat.Laparoscopic ventral hernia repair with mesh, possible open.Procedure with risks of pneumonia, deep vein thrombosis, pulmonary embolism, bleeding, infection, mesh infection, visceral injury, recurrent hernia explained.Advised to loose [sic] weight.(b)(6) 2017: (b)(6) medical center.(b)(6), md.Operative note.Assistant: dr.(b)(6).Preoperative diagnosis: partial small bowel obstruction, incarcerated recurrent ventral hernia.Postoperative diagnosis: high-grade small bowel obstruction, dense adhesions, incarcerated recurrent incisional ventral hernia.Sedation anesthesia: geta [general endotracheal anesthesia].Procedures: laparoscopic lysis of adhesions, converted to exploratory laparotomy, extensive lysis of adhesions, explantation of previous mesh, recurrent incisional ventral hernia repair, strattice biological graft, right and left rectus myo-fascial flap mobilization excision of hypertrophic scar and scar revision.Post-procedure high risk for bleeding: yes.Estimated blood loss: 150 ml.Complications: none.Condition: stable.Specimen: omentum, scar, hernia sac, mesh.Drain: one jp.(b)(6) 2017: (b)(6) medical center.(b)(6), md.Progress notes.No overnight events, denies nausea/vomiting, pain adequately controlled.Exam: abdomen soft, dressing clean, jp-serosanguineous.Impression/plan: status post laparoscopic lysis of adhesions, exploratory laparotomy, extensive lysis of adhesions, ventral hernia repair, myofascial flap, biological graft, removal of previous mesh, high grade small bowel obstruction from very dense adhesions.Nothing by mouth, nasogastric tube, iv [intravenous] fluids.Abdominal binder, out of bed.(b)(6) 2017: (b)(6) medical center.(b)(6), do.Discharge note.Postoperative day 6.Wound inspected, drain in place.Admitted with increasing abdominal pain; found to have small bowel obstruction secondary to dense adhesions from previous surgery requiring lysis of adhesions by dr.Bhandari.Remainder of his stay was waiting for return of bowel function.To be discharged today.Return to work 6 weeks from operation, may 1.Follow up tuesday with (b)(6) for removal of jp drain, follow up with me in 5 weeks to return to work.(b)(6) 2018: associates in gastroenterology, pc.Sarah [illegible], pa/eric eschinger, md.History & physical.Presents for clearance of gastric sleeve with (b)(6).Reports gerd [gastroesophageal reflux disease] every other day; takes tums [antacid].Exam: gastrointestinal; soft, nontender, nondistended, normal bowel sounds, no organomegaly.Impression/plan: diverticulosis, colon polyps, hemorrhoids.Recommend esophagogastroduodenoscopy for clearance for gastric sleeve.Discussed need for daily proton pump inhibitor; refuses.Colonoscopy 2020.03/??/18: [missing records: records including operative report for gastric sleeve were not provided.] 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 code.H6: updated conclusion codes.Previous patient codes (2422 and 3191: appropriate term/code not available for ¿mesh failure¿) were reported based on the original complaint and are no longer applicable per gore¿s investigation.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.Medical records: the known medical records span (b)(6) 2008 through (b)(6) 2018 and not all records received in this time span are relevant to gore® dualmesh® plus biomaterial.Records from (b)(6) 2010 through (b)(6) 2012; and from (b)(6) 2012 through (b)(6) 2015 were not provided.Patient information: medical history: 2007: perforated sigmoid colon.(b)(6) 2008: perforated appendicitis.Obesity. (b)(6) 2008: bmi 34. (b)(6) 2015: bmi 33. (b)(6) 2015: bmi 35. (b)(6) 2017: bmi 39.(b)(6) 2014: drug detoxification, alcohol.(b)(6) 2015: recreational opioids/alcohol.Smoker. (b)(6) 2015: ½ pack per day x28 years.Prior surgical procedures: left inguinal hernia repair x2.2007: laparoscopic sigmoid colectomy.(b)(6) 2008: appendectomy.(b)(6) 2008: ct guided abscess drainage in right lower abdomen.Implant preoperative complaints: (b)(6) 2010: ¿complains of abdominal pain starting 4 days ago, over incisional hernia in the middle of abdomen; constant, aching; gets worse intermittently with nausea, no vomiting, mild constipation.¿ ¿acute periumbilical abdominal pain, reducible ventral hernia, ileus.¿ (b)(6) 2010: ct abdomen/pelvis: ¿ventral wall hernia containing a portion of small bowel.The small bowel loop just proximal to the hernia sac is distended measuring 3.3 cm in diameter.Possible incarcerated ventral wall hernia versus focal ileus.The remainder of the small bowel loops are normal in caliber.There is a second more superior ventral wall hernia containing mesenteric fat.Umbilical hernia containing non-distended loop of small bowel.¿ (b)(6) 2010: ct abdomen/pelvis with contrast: ¿anterior abdominal wall hernia which is complex with multiple defects.The largest defect does contain a partially herniated loop of bowel and there is mild dilatation just proximal to loop which may represent a component of partial obstruction and some adhesive changes of this loop to this area.¿ implant procedure: laparoscopic extensive lysis of adhesions for approximately 1 to 1 ½ hours and laparoscopic incisional ventral hernia repair.Implant: gore® dualmesh® plus biomaterial (06824597/1dlmcp04, 15 cm x 19 cm, oval).Implant date: (b)(6) 2010; hospitalized (b)(6) 2010.Description of hernia being treated: ¿on inspection of the abdomen, there were several adhesions to the midline containing incarcerated contents of both omentum and small bowel.There were also adhesions in the right lower quadrant from his prior appendectomy.An area otherwise [sic] adhesions was identified in the right upper quadrant.The adhesions in the right lower quadrant were then lysed using scissors, and an area of clear filmy adhesions.These adhesions were adherent to small bowel.Once these adhesions were lysed, this provided additional access to the right lower quadrant port.Dissection was then begun in the midline.The hernia contents were grasped and retracted into the abdomen.There were dense adhesions.These were lysed both with sharp dissection and using.Endoshears and with the harmonic scalpel.With lysis of adhesions between the abdominal wall and the hernia contents, the hernia contents began to reduce.This was continued along the midline wound.There were several defects in the midline consistent with swiss cheese defect along the midline.This was continued both with harmonic scalpel and in the areas of omental adhesions and endoshears and areas of nearby small bowel.Of note, most of the small bowel was incarcerated in the lower hernia.Once all of the adhesions were lysed and the contents reduced, dissection was continued down along the inferior abdominal wall to provide clearing of the abdominal wall for mesh fixation.Once enough margin was created superiorly and inferiorly and additional adhesions lysed laterally, the hernia was measured.The hernia was measured to be approximately 12 mm long and 4 cm wide containing all of the defects.¿ implant size and fixation: ¿a mesh was chosen and cut to 19 x 10 cm for in order to create adequate overlap for the repair.Cv2 gore sutures were then chosen and placed at the superior, inferior and bilateral lateral edges of the oval mesh.This was a gore dualmesh.The mesh was then rolled and brought into the abdomen through the 12 mm port.Intra-abdominally, the mesh was unraveled, and using a small stab incision, the gore sutures were brought out from intra to extracorporeally.This was done superiorly, inferiorly, and again right and left laterally.The mesh was inspected and noted to lie flush against the abdominal wall.The sutures were then tied.The mesh was then further secured to the abdominal wall using a protac device.This was done circumferentially around the mesh under direct visualization.Additional tacks were placed in the center of the mesh for added fixation and to reduce dead space.Once the tacks were placed and we were satisfied with the mesh placement, the 12 mm trocar was removed, and the wound was closed with a 0 vicryl on a carter-thomson [carter-thomason] endo closure device under direct visualization.Of note, a carter-thomson [carter-thomason] device was also used to bring out the sutures of the mesh.¿ post-operative period: [four days]. (b)(6) 2010: ¿status post laparoscopic lysis of adhesions, repair of incisional hernia.Ileus resolved.Regular diet.Discharge home.¿ (b)(6) 2010: ¿had some nausea yesterday.Tolerated regular diet, now feeling much better.Afebrile.Abdomen soft, nontender, nondistended, wounds clean/dry/intact.Discharge home today.¿ relevant medical information: (b)(6) 2012: ¿complains of abdominal pain, moderate to severe left lower quadrant pain for past 4 or more days; associated nausea/vomiting.¿ (b)(6) 2012: ct abdomen/pelvis: ¿small ventral abdominal wall hernia status post surgery with omental fat in the hernia sac identified in the midline.¿ (b)(6) 2015: ¿for past year has had intermittent episodes of mild to moderate, dull, left sided lower back and flank pain associated with radiation to left lower quadrant of abdomen.States in past year has had endoscopies/colonoscopies to determine source of pain with no findings; pain worse recently, tonight more severe and constant.¿ (b)(6) 2016: ct abdomen/pelvis: ¿status post ventral abdominal hernia repair, evidence of small ventral umbilical hernia containing fat.¿ explant preoperative complaints: (b)(6) 2017: emergency room: ¿partial small bowel obstruction.Abdominal pain.Stable; admit to inpatient unit.¿ (b)(6) 2017: ct abdomen/pelvis: ¿dilated focal small bowel loop in the anterior abdomen abutting the anterior abdominal wall mesh suggesting partial obstruction, possibly related to adhesions.Superior to mesh there is a fat-containing ventral hernia.¿ (b)(6) 2017: history and physical: ¿complaining of progressive abdominal pain past 1-2 weeks.Ventral hernia repair 7-8 years ago; pain kept getting worse, having vomiting, likely bile past 1-2 days.No fever/blood in stool.¿ ¿acute small bowel partial obstruction, obesity, abdominal pain secondary to obstruction.¿ (b)(6) 2017: surgical consultation: [the patient] ¿presented with severe lower groin, lower abdominal pain, associated with nausea and vomiting.The patient has no vomiting today, but has persistent nausea.He has no flatus today.The last bowel movement was yesterday.¿ ¿the patient gained 45 pounds since his laparoscopic ventral hernia repair.¿ (b)(6) 2017: gastroenterology consultation: ¿ct reviewed by myself; there are prominent small bowel loops within the small bowel tacked to the internal aspects of ventral hernia repair with mesh.Small bowel appears more dilated proximal to this and decompressed distally.¿ (b)(6) 2017: x-ray abdomen: ¿no evidence of bowel obstruction.Residual contrast within large bowel.¿ (b)(6) 2017: x-ray abdomen: ¿no evidence of bowel obstruction.Residual contrast within large bowel.¿ (b)(6) 2017: ¿partial small bowel obstruction resolved.Recurrent ventral hernia containing omentum/fat.Laparoscopic ventral hernia repair with mesh, possible open.Procedure with risks of pneumonia, deep vein thrombosis, pulmonary embolism, bleeding, infection, mesh infection, visceral injury, recurrent hernia explained.Advised to loose [sic] weight.¿ explant procedure: laparoscopic lysis of adhesions converted to an exploratory laparotomy, extensive enterolysis, explantation of previous mesh, recurrent incisional ventral hernia repair, strattice biological graft 20 x 10 cm, right and left rectus myofascial flap mobilization, excision of hypertrophic scar, scar revision.Explant date: (b)(6) 2017.¿patient had incarcerated omentum in the hernia that was superior to the previous hernia repair, but multiple loops of omentum with the small bowel were plastered to the abdominal wall that were causing acute kinking at multiple points with a high-grade small-bowel obstruction.Proximal small bowels were massively dilated and distal small bowels were completely collapsed.We proceeded by extensive enterolysis by freeing up all these adhesions with the help of endoshears and harmonic scalpel.We reduced the contents of the hernia sac and omentum was completely reduced and gradual enterolysis was performed laparoscopically with the help of endoshears.After significant time was spent to lyse the loops of bowel that were plastered to the previous mesh and tackers and abdominal wall, a limit was reached where we could not free up anymore without causing any enterotomy.At this point, decision was made to convert to a mini laparotomy.Patient had a previous hypertrophic scar at the site of previous appendectomy, that hypertrophic scar was excised and sent to pathology.Peritoneal cavity was entered through the hernial sac and gradually dissection was performed and these dense adhesions were gradually lysed down with the help of endoshears.Part of that during the process, we started to divide this previous gore dual plus mesh and lot of tackers were removed.After we completely opened the previous mesh and fascia in the midline, gradually we started to free up these multiple interloop adhesions of the small bowel that were causing bowel obstruction and there was a significant epithelialization of the previous gore dual plus mesh and that was completely plastering these loops of small bowel causing acute kinking.After releasing the small bowel loops, gradually we freed the small bowel completely from the abdominal wall.We brought these loops through the midline and further any interloop adhesions or any kinking of the bowels were completely freed.After that we inspected the bowels and there was no evidence of any serosal tear, bowels were reduced back into peritoneal cavity.At this point, remaining tackers of the gore dual plus mesh were gradually removed and gore dual plus mesh was completely excised with the help of sharp dissection and also with the help of bovie cautery.At this point, we were left with the hernial defect and a very weak fascia in the middle from the previous laparotomy, so we started to mobilize the myofascial flaps of the rectus muscle on both right and left side so we can primarily close it and reinforce with a strattice biological graft.So, first flap was raised on the right side and then on the left side.Part of the hernial sac was excised and sent to pathology.During the process, we also removed pieces of omentum.Those were also removed and sent to pathology.Omentum was brought in to cover the rest of the bowels.After the fascial flaps were raised in both sides, we used a strattice biological graft and it was tacked with multiple used pieces of #0 pds and #1prolene to lateral edges of the fascia and all quadrants and to make sure there was no gap in between for any bowels to herniate.After all those stitches were placed, all the stitches were tied in the end and the fascia in the midline was closed with running #1 looped pds suture.¿ records indicate a non-gore device was implanted during the (b)(6) 2017 procedure.Relevant medical information: (b)(6) 2017: ¿no overnight events, denies nausea/vomiting, pain adequately controlled.¿ 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.¿ 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 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.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: 06824597.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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Search Alerts/Recalls
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