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| Model Number FS0915 |
| Device Problems
No Apparent Adverse Event (3189); Insufficient Information (3190)
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| Patient Problems
Unspecified Infection (1930); Not Applicable (3189); No Clinical Signs, Symptoms or Conditions (4582)
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| Event Date 04/23/2013 |
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Event Type
Injury
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Manufacturer Narrative
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Added medical history.(b)(6).Additional details regarding the patient's clinical course were ascertained from a review of medical records and are as follows: records prior to (b)(6) 2013, including records for laparoscopic cholecystectomy and abdominal approach spinal surgery, were not provided.Discharge summary for inpatient admission dates of (b)(6) 2013 indicate patient admitted for abdominal pain, principal diagnosis incarcerated hernia.The patient ¿¿is a (b)(6) female who presented to the emergency department with complaints of severe abdominal pain.The patient underwent ct scan which revealed bowel obstruction from an incarcerated incisional hernia.The patient was admitted and taken to surgery.¿ the discharge summary for hospital admission (b)(6) 2013 states: ¿patient underwent a laparoscopic incarcerated incisional hernia repair with mesh as well as a small bowel resection.Following the procedure, the patient was transferred to the floor.She then had an episode of hypotension as well as some tachycardia.The patient experienced a decrease in hematocrit, ultimately requiring a blood transfusion secondary to a drop in hematocrit.¿ records for hospital admission (b)(6) 2013 continue: ¿the patient was returned to the operative theater on (b)(6) 2013 for diagnostic laparoscopy which did not reveal any source of bleeding.The patient returned to the floor following the procedure.She progressed without difficulty at this point.¿ operative records dated (b)(6) 2013 indicate the patient underwent laparoscopic incarcerated incisional hernia repair with mesh (synthetic biologic gore bio-a), and small bowel resection.The operative records dated (b)(6) 2013 state: ¿due to the patient's midline incision, decision made to enter the abdomen through the right upper quadrant.The abdomen was inspected.Dense adhesions were noted it the anterior abdominal wall.Lysis of adhesions was performed using blunt dissection, sharp dissection with scissors and sonosurg.¿ records dated (b)(6) 2013 continue: ¿dissection occurred down around the area of the incarcerated bowel.Large amount of omentum was noted in the hernia as well as a loop of small bowel using pressure from the outside as well as slight tugging from the inside.The hernia was ultimately able to be reduced.Once the bowel was reduced, it was noted to be severely compromised.There were areas that appeared to be necrotic with black necrosis.¿ operative records dated (b)(6) 2013 state: ¿time was allowed for the bowel to pink up.Several areas did pinken up; however, there were still some areas of significant concern.Decision was made that the patient would require a small bowel resection.The remaining part of the omentum was reduced out of the hernia.Endocatch bag was inserted and used to remove this compromised area of omentum.This was pulled out using the endocatch bag.¿ records dated (b)(6) 2013 continue: ¿decision was made due to the patient's place of the hernia that was slightly off the midline to perform an incision directly above the area of the hernia to tunnel down and place a wound protector to pull the small bowel for further resection.This was performed, the abdomen was opened just above the area of the hernia, slightly off the midline.A wound protector was placed, small bowel was pulled up.Gia stapled resection and side to side anastomosis was performed and the mesentery was closed using interrupted 3-0 vicryl stitching.¿ operative records dated (b)(6) 2013 continue: ¿the staple line of the small bowel was oversewn using running 3-0 vicryl stitch.Patent opening was noted and this returned into the abdominal cavity.At this point, a piece of gore bio-a 9 x 15 cm placed into the surgical field using #1 prolene stitches.This was sutured in an underlay fashion to the fascia through the opening.The mesh was then placed into the abdominal cavity.A running #1 vicryl stitch was used to close the fascia overlying the mesh; sutures were tied down.¿ records dated (b)(6) 2013 state: ¿re-insufflation of the abdomen was performed.Double crown of tacking was performed end to side on the mesh.Goad covering was noted.There was noted to be a small umbilical hernia as well.A stitch was placed through the hernia using carter thompson needle passer and used to close the defect through the incision that had already been made.Good repair was noted.Washout of the small incision on the anterior abdominal wall was washed out.Interrupted 3-0 vicryl was used to close the subcutaneous tissues and 4-0 monocryl was used to close all skin incisions.Sterile dressings applied.¿ the records confirm a gore® bio-a® tissue reinforcement (fs0915/10464804) was used during the procedure.Operative records dated (b)(6) 2013 indicate the patient underwent diagnostic laparoscopy with evacuation of hematoma.The records state: ¿the abdomen was entered, old blood was noted within the abdomen, mainly located in the left pericalic gutter.The anterior abdominal wall was inspected where the hernia repair was performed.There did not appear to be hematoma in this area.Adhesions were noted and taken down using sharp dissection with scissors and sonosurg,the small bowel was run.¿ the (b)(6) 2013 operative report continues: ¿the anastomosis was inspected.There did not appear to be any bleeding from the anastomotic site.The port sites were all inspected with no evidence of bleeding from the sites.The abdomen was explored.Old clot was evacuated; however, no areas of active bleeding could be identified.The area was inspected and watched for new blood.Evidence of bleeding was not identified.At this point,a decision was made to end the procedure.¿ radiology records for ct abdomen and pelvis dated (b)(6) 2013 states: ¿new bowel loop protruding through the anterior abdominal wall adjacent to the site of the hernia repair.Moderate small bowel distention.Partial obstruction is not excluded.¿ records for inpatient admission (b)(6) 2013 and discharge date of (b)(6) 2013 state: ¿patient was admitted (b)(6) 2013 with complaints of abdominal pain and hernia, ng tube decompression was performed.On (b)(6) 2013 the patient was taken to the operative theater where she underwent laparoscopic hernia repair with mesh.Following the procedure the patient was transferred to the floor where she progressed without significant complications.¿ history and physical records dated (b)(6) 2013 state: patient ¿¿is a (b)(6) female who underwent a repair of an incarcerated hernia by dr.(b)(6) approximately two weeks ago.She was discharged home and been having some nausea and vomiting for past 4 days, saw him in the office, and the hernia was reduced.She continued to have nausea and vomiting and presented to the er where ct showed what appeared to be another incarcerated hernia.She denies any fever, chills.No blood in her stool.She is passing gas.¿ the history and physical records dated (b)(6) 2013 continue: ¿radiographically she had a ct abdomen and pelvis which showed parasagittal supraumbilical incisional hernia with small bowel distention concerning for partial obstruction.¿ operative report dated (b)(6) 2013 indicates the patient underwent laparoscopic incarcerated incisional hernia repair with mesh.Operative findings revealed hernia medial to the previous repair, hernia within the midline from patient's previous open midline incision.The operative records dated (b)(6) 2013 state: ¿incision was made through the patient's previous right flank incisions.Adhesions were noted along the anterior abdominal wall along the patient's previous hernia repair.These were taken down with blunt dissection.The hernia was noted.It was lying in the midline from patient's previous midline incision.It did not involve the patient's previous hernia.A second defect was also noted further inferior.These had not been areas of incarcerated herniation of the patient's previous repair.¿ operative records dated (b)(6) 2013 continue: ¿once the anterior abdominal wall adhesions were taken down decision was made to perform a repair with gore dualmesh plus.The bowel was inspected, did not appear to be nonviable.At this point an 8 x 12 piece of gore dualmesh plus was placed into the field.Four corner stitches were placed with the gore-tex mesh.¿ records dated (b)(6) 2013 state: ¿the mesh was rolled and placed into the abdominal cavity using carter thompson needle passer the four corners were secured to the anterior abdominal wall, double layer of tacks was placed circumferentially around the mesh.There was some overlap with the previous repair.Once the mesh was secured, the abdomen was inspected and no bleeding was noted.¿ operative records dated (b)(6) 2013 continue: ¿a good repair was noted.No other hernia defects were noted.Ports were removed under direct visualization.Desufflation of the abdomen was performed.Twelve mm port site was closed using o vicryl stitch.All skin incisions closed using #4 monocryl stitch.Sterile dressing was applied.¿ records confirm a gore dualmesh®plus biomaterial (1dlmcp02/10414828) was used during the procedure.Interval history and physical records dated (b)(6) 2013 indicate three week follow up appointment.Patient ¿presents with chronic drainage from incision site.Patient having chronic inflammation at site of previous strangulated and ischemic bowel.¿ operative report dated (b)(6) 2013 indicates patient underwent debridement of anterior abdominal wall wound less than 20 cm.Findings: revealed necrotic tissue and fat necrosis.There is likely infection from patient's previous infarcted ischemic bowel within the area.The operative records dated (b)(6) 2013 state: ¿blunt dissection to the wound revealed some overlying healthy tissue with underlying necrotic tissue.Dissection occurred down to the fascial wall.All necrotic tissue was removed using combination of sharp dissection with scissors, curet to debride the walls, removal of prolene stitches was performed.¿ the records dated (b)(6) 2013 continue: ¿all tracking was checked and areas of fat necrosis opened, and debridement of all areas was performed.No hernia was noted.I did not see the mesh in the area.There did not appear to be compromise of the hernia repair.Washout was thoroughly performed with combination of saline and betadine.Once healthy tissue was noted in all areas the area was packed with iodoform.Sterile dressings applied.¿ radiology records for ct abdomen and pelvis (b)(6) 2013 findings: there is no free air or free fluid.There has been placement of mesh or sutures along the anterior abdominal wall at the site of previous hernia.No recurrent hernia is identified.There is no small bowel distention or obstruction.There is some stranding in the fat adjacent to the sutures or mass consistent with scar or edema.There is some minimal low density associated with the sutures which may also be postsurgical.History and physical record dated (b)(6) 2013 states: ¿patient presents to clinic with ongoing wound drainage.She has completed her course of bactrim with no improvement.She has undergone a ct scan.Abdomen: soft, non-distended, non-tender, pustular draining from the incision at strangulated hernia site, no erythema or cellulitis, no induration.Ct scan findings-postoperative changes, no abscess identified.Inpatient records dated (b)(6) 2013 state: ¿patient with infected mesh and previous incisional hernia repair and infarcted bowel.¿ the patient ¿is (b)(6) female who had undergone previous resection of small bowel for necrotic incarcerated hernia.The patient underwent repair at that time which ultimately resulted in mesh and wound infection.The patient continued to have a lot drainage from the abdominal area.Decision was made to perform mesh excision for likely mesh infection.This was performed without complication.The patient was placed on antibiotic therapy.The patient's postoperative course she did have wheezing following surgery which required respiratory consult and care.The patient also required iv antibiotics following her surgery due to the known infection.¿ operative report dated (b)(6) 2013 indicate the patient underwent diagnostic laparoscopy with lysis of adhesions along with drainage of intra-abdominal abscess for mesh infection, exploratory laparotomy with removal of infected mesh, repair of recurrent incisional hernia with mesh, xenograft graft 15 x 20 cm.The (b)(6) 2013 operative records state: ¿dense adhesions were noted in the anterior abdominal wall.A very prolonged lysis of adhesions was performed taking the small bowel off the anterior abdominal wall and no enterotomies were noted, after a very prolonged lysis of adhesions, the mesh was clearly identified.¿ the (b)(6) 2013 records state: ¿once the peritoneum was incised in this area, pus was drained.A large amount of pus was drained.After all the adhesions had been taken down with noted abscess and clear infection of the mesh, decision was made to perform exploratory laparotomy which would be required for removal of the mesh.¿ records dated (b)(6) 2013 continue: ¿a midline incision was made through the patient's previous midline incision.Dissection carried through subcutaneous tissues using cautery.The abdomen was entered.Tacks were taken down using ochsner clamp.The patient's previously placed gore-tex mesh was removed.After removal of the gore-tex mesh, attention was turned to removing the previous gore bio-a mesh.This was also removed.Once all mesh had been removed as well as visible tacks and prolene stitches as well as gore-tex stitches, decision was made to perform a xenograft placement with xenmatrix.¿ operative records dated (b)(6) 2013 state: ¿consideration was placed to a component separation without mesh.However, given the patient's abdominal girth, decision was made the patient would be at high risk for ischemia, therefore, a 15 x 20 piece of xenograft was placed onto the surgical field and was placed into the abdominal cavity.The fascia would have had to have been closed very tightly with an extremely high risk of recurrence without the xenograft.¿ records dated (b)(6) 2013 continue: ¿therefore, a #1 interrupted pds stitches were used to attach the xenograft into the anterior abdominal wall.There was 5 cm underlay in all areas.A good repair was noted.A thorough washout was performed with antibiotic irrigation.The fascia was closed over the mesh using running looped pds stitching.A 19-french blake drain was placed above the fascia, a running 2-0 vicryl stitch was used to close subcutaneous tissues.¿ operative records dated (b)(6) 2013 state: ¿a second was subcu layer was closed using interrupted 3-0 vicryl stitching.Loose staples were applied to the skin to allow for drainage.Multiple washouts were performed of each layer with bacitracin irrigation.The drain was secured using 2-0 nylon stitch.At this point, re-insufflation of the abdomen was performed.Visualization of the abdomen was performed.Layer of tacks was used circumferentially around the mesh to secure the 5 cm underlay.Good coverage was noted.No other hernias were noted within the abdomen.¿ records dated (b)(6) 2013 state: ¿there was good coverage of the anterior abdominal wall with the xenograft.Hemostasis was clearly observed.A 19-french blake drain was placed into the abdomioa1 cavity and pulled out through a port site.Desufflation of the abdomen was performed.Ports removed under visualization prior to desufflation.The 19-french blake drain in this area was secured using 2-0 nylon stitch.All skin incisions closed using staples.Some debridement of the previous wound site was performed.Packing was performed of this site as well as intermediate to the staples.Sterile dressing was applied.¿ records confirm a xenmatrix surgical graft was used during the procedure.Surgical pathology report dated (b)(6) 2013 indicates material submitted: 1.Mesh (gore), 2.Mesh (bio-a).Gross description: 1."mesh gore".Received is a pink-tan to gray segment of apparent gortex that is 10.1 x 6.5 x 0.2 cm in greatest dimension.There are multiple metallic spring-like pieces on the specimen.No tissue is noted on the specimen.2."mesh bio-a".Received are four pink to red-brown fragments of tissue that are 7 x 6.Z x 4.7 cm in greatest dimension.There are multiple metallic spring-like devices present embedded within the tissue.The specimen is serially sectioned.No masses, areas of abscess formation or purulent material is identified.Surgical pathology report dated (b)(6) 2013 continues: ¿microscopic description: 1.There are portions of foreign material consistent with gortex with adherent granulation tissue.There is foreign body reaction with giant cell formation.2.There are portions of fibrous tissue with marked foreign body reaction.There is polarizable foreign material which is surrounded by giant cells and inflammatory cells.Outpatient records dated (b)(6) 2013 ¿ct abdomen and pelvis- postoperative changes of the rectus sheath.No acute intra-abdominal or intrapelvic process identified.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® bio-a® tissue reinforcement instructions for use includes warnings and addresses the following adverse reactions among others: ¿possible adverse reactions with the use of any tissue deficiency prosthesis may include, but are not limited to, contamination, infection, inflammation, adhesion, fistula formation, seroma formation, hematoma, and recurrence.¿ the gore® bio-a® tissue reinforcement instructions for use also states: ¿the gore® bio-a® tissue reinforcement is used to reinforce soft tissue during the phases of wound healing by filling soft-tissue deficits.¿ ¿when used for hernia repair, it is recommended that gore® bio-a® tissue reinforcement be used as a suture-line reinforcement.¿.
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Event Description
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It was reported to gore that the patient underwent laparoscopic incisional hernia repair on (b)(6) 2013, whereby a gore dualmesh® plus biomaterial was implanted.The complaint alleges that on (b)(6) 2013, an additional procedure was performed whereby explant of the gore device was performed.It was reported the patient alleges the following injuries: additional surgery, infection, abdominal pain, debridement of wound, removal of mesh.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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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: history and physical records dated (b)(6) 2013 state: ¿the patient is a 50 year old female who presented to the emergency department today with complaints of sudden onset of abdominal pain.The patient had known incisional hernia.The patient was straining today when she began experiencing excruciating pain.This was followed by some nausea but no vomiting today.The patient has been having bowel movements; however, patient reports the pain is unrelenting and she has not been able to get relief.Workup in the emergency department revealed an incarcerated hernia confirmed by ct scan.¿ past medical history is noted as ¿significant for chronic pain and reflux.¿ surgical history states: ¿includes an abdominal approach for spinal surgery as well as several neck surgeries,¿and several other orthopedic procedures.The patient also had a laparoscopic cholecystectomy.¿ operative records dated (b)(6) 2013 indicate the patient underwent ¿1.Laparoscopic incarcerated incisional hernia repair with mesh (synthetic biologic gore bio-a).2.Small bowel resection.¿ finding state: ¿1.Incarcerated incisional hernia with omentum and bowel.2.Ischemic bowel, requiring resection.¿ operative records dated 1/16/2013 indicate the patient underwent diagnostic laparoscopy with evacuation of hematoma.Findings from the procedure state: ¿revealed old blood within the abdomen.No active bleeding found.¿ postoperative diagnosis states: ¿postoperative bleed.¿ the records state: ¿the abdomen was entered, old blood was noted within the abdomen, mainly located in the left pericolic gutter.The anterior abdominal wall was inspected where the hernia repair was performed.There did not appear to be hematoma in this area.Adhesions were noted and taken down using sharp dissection with scissors and sonosurg,the small bowel was run.¿ discharge summary dated (b)(6) 2013 states: ¿the patient is a 50-year-old female who presented to the emergency department with complaints of severe abdominal pain.The patient underwent ct scan which revealed bowel obstruction from an incarcerated incisional hernia.¿ ¿[on (b)(6) 2013] the patient underwent a laparoscopic incarcerated incisional hernia repair with mesh as well as a small bowel resection.Following the procedure, the patient was transferred to the floor.She then had an episode of hypotension as well as some tachycardia.The patient experienced a decrease in hematocrit, ultimately requiring a blood transfusion secondary to a drop in hematocrit.The patient was returned to the operative theater on (b)(6) 2013 for diagnostic laparoscopy which did not reveal any source of bleeding.The patient returned to the floor following the procedure.She progressed without difficulty at this point.¿ radiology records dated (b)(6) 2013 for a ct of the abdomen and pelvis states: ¿findings there is no free air.There has been a previous repair along the anterior abdominal wall at the site of the previously identified hernia.On today¿s exam there is a new bowel loop protruding through the anterior abdominal wall to the right of the sutures and/or mesh and slightly to the right of the umbilicus.This is at the site where there was a fat in the previous hernia.There is moderate small bowel distention in the upper abdomen.This can be followed to the level of the hernia.Distal to this the bowel is more normal in caliber.There is some fluid density seen in the subcutaneous fat superficial to the rectus sheath on the right.It is thought that this is not part of the bowel.There is some edema in the subcutaneous fat as well.There is a small amount of free pelvic fluid.¿ ¿impression: new bowel loop protruding through the anterior abdominal wall adjacent to the site of the hernia repair.Moderate small bowel distention.Partial obstruction is not excluded.¿ history and physical records dated (b)(6) 2013 state: patient ¿¿is a 50-year-old female who underwent a repair of an incarcerated hernia by dr.Gerth approximately two weeks ago.She was discharged home and been having some nausea and vomiting for past 4 days, saw him in the office, and the hernia was reduced.She continued to have nausea and vomiting and presented to the er where ct showed what appeared to be another incarcerated hernia.She denies any fever, chills.No blood in her stool.She is passing gas.¿ exam notes state: ¿abdomen: soft.She is tender at the prior small midline incision.There is a hematoma to the surrounding tissue.There is some ecchymosis down the lower pelvis.¿ the history and physical records dated (b)(6) 2013 continue: ¿radiographically she had a ct abdomen and pelvis which showed parasagittal supraumbilical incisional hernia with small bowel distention concerning for partial obstruction.¿ ¿impression: the patient with partial versus complete small-bowel obstruction.¿ ct records dated (b)(6) 2013 state: ¿findings: the previously identified incisional ventral hernia medial to the mesh repair is still present.There is some questionable wall thickening within the herniated loop of bowel on today¿s exam.Small bowel distention persists and is slightly more severe than on the previous exam.There is a transition zone to normal caliber loops of distal ileum on today¿s exam suggesting at least a partial obstruction.¿ discharge summary records dated (b)(6) 2013 state: ¿the patient was admitted (b)(6) 2013 with complaints of abdominal pain and hernia, ng tube decompression was performed.On (b)(6) 2013 the patient was taken to the operative theater where she underwent laparoscopic hernia repair with mesh.Following the procedure the patient was transferred to the floor where she progressed without significant complications.¿ interval history and physical records dated (b)(6) 2013 indicate three week follow up appointment.¿patient presents with chronic drainage from incision site.Patient having chronic inflammation at site of previous strangulated and ischemic bowel.¿ abdominal exam notes state: ¿soft, non-distended, there is chronic inflammatory tissue within patient¿s incision, and does not appear to be abscess or cellulitis.¿ ¿patient has nonhealing surgical wound from area of ischemic bowel.Plan for debridement¿¿ radiology records dated (b)(6) 2013 for a ct of the abdomen and pelvis state: ¿findings: there is no free air or free fluid.There has been placement of mesh or sutures along the anterior abdominal wall at the site of previous hernia.No recurrent hernia is identified.There is no small bowel distention or obstruction.There is some stranding in the fat adjacent to the sutures or mass consistent with scar or edema.There is some minimal low density associated with the sutures which may also be postsurgical.¿ ¿no acute intra-abdominal process.¿ operative report dated (b)(6) 2013 indicates the patient underwent: ¿1.Diagnostic laparoscopy with lysis of adhesions along with drainage of intra-abdominal abscess for mesh infection.2.Exploratory laparotomy with removal of infected mesh.3.Repair of recurrent incisional hernia with mesh.4.Xenograft 15 x 20 cm.¿ findings state: ¿revealed mesh infection.¿ postoperative diagnosis states: ¿mesh infection with abscess.¿ surgical pathology report dated (b)(6) 2013 indicates materials submitted: ¿1.Mesh (gore), 2.Mesh (bio-a).¿ gross description states: ¿1."mesh gore".Received is a pink-tan to gray segment of apparent gortex [sic] that is 10.1 x 6.5 x 0.2 cm in greatest dimension.There are multiple metallic spring-like pieces on the specimen.No tissue is noted on the specimen.2."mesh bio-a".Received are four pink to red-brown fragments of tissue that are 7 x 6.Z x 4.7 cm in greatest dimension.There are multiple metallic spring-like devices present embedded within the tissue.The specimen is serially sectioned.No masses, areas of abscess formation or purulent material is identified.¿ ¿final diagnosis: 1.Mesh gore: foreign material consistent with mesh with adherent granulation tissue and foreign body reaction.2.Mesh bio-a: fibrous tissue with polarizable foreign material and foreign body reaction.¿ consultation records dated (b)(6) 2013 state: ¿this 50-year-old white female began having some abdominal pain in january and was found to have an incarcerated ventral hernia.This required a short small bowel resection.Some repair was done with biomesh that became infected.This was removed and other mesh was tried.This was also infected.She is back now for her 5th operation to have all the mesh material removed and she has had a porcine prosthesis used now.She ordinarily does not have nausea, vomiting, or diarrhea, but has been having abdominal pain.She has lost some weight.She has been trying to lose some weight.¿ ¿she is otherwise fairly healthy.She smoked but quit 7 years ago.¿ records dated (b)(6) 2013 state a ct of the abdomen and pelvis was performed.¿postoperative changes of the rectus sheath.No acute intra-abdominal or intrapelvic process identified.Records dated (b)(6) 2013 state the patient was seen for abdominal pain.A ct performed states: ¿the patient status post previous anterior abdominal and pelvic wall surgery.There are no complications.Bowel is unremarkable there is no free fluid mass adenopathy bowel obstruction focal inflammation or other acute change.¿ records dated (b)(6) 2014 indicate the patient was seen for ¿local pain over the anterior abdominal wall, no acute injury.¿ ¿obese abdomen.Normoactive bowel sounds.Patient is tender over the left lower quadrant has the following scars ¿ has had multiple prior surgeries.¿ an abdominal ct performed the same day states: ¿there is a herniorrhaphy changes within the left anterior abdominal wall.No bowel distention.No free fluid.¿ 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® bio-a® tissue reinforcement instructions for use includes warnings and addresses the following adverse reactions among others: ¿possible adverse reactions with the use of any tissue deficiency prosthesis may include, but are not limited to, contamination, infection, inflammation, adhesion, fistula formation, seroma formation, hematoma, and recurrence.¿ the gore® bio-a® tissue reinforcement instructions for use also states: ¿the gore® bio-a® tissue reinforcement is used to reinforce soft tissue during the phases of wound healing by filling soft-tissue deficits.¿ ¿when used for hernia repair, it is recommended that gore® bio-a® tissue reinforcement be used as a suture-line reinforcement.¿ 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.H10/11: added medical record information.Additional details regarding the patient's clinical course were ascertained from a review of medical records and are as follows: records dated (b)(6) 2014 state: ¿abdominal pain ¿ she has had a month of abdominal pain in ruq, diarrhea, nausea and also some weight loss.She had labs and a ct done in the er.Then she had an egd and colonoscopy as well.¿ records dated (b)(6) 2015 state: ¿she is worked in today for worsening of her ruq pain that she has had for over a year.She has gi appt tomorrow.She is not sure when she had a ct done but has had one.¿ records dated (b)(6) 2015 state: ¿she is still having ruq pain and her pain doctor wonders if it is from her back and requests an mri.Gerd-ok recently.¿ records dated (b)(6) 2016 state: ¿she has had decreased appetite and weight loss for several months.¿ records dated (b)(6) 2018 state the patient was seen for a small bowel obstruction.¿this patient is a 55-year-old female with a past surgical history significant for multiple abdominal surgeries.Initially in (b)(6) 2013 patient had incision and hernia repair with small bowel resection due to incarcerated small bowel few days after this on the 16th she was taken back to the or for a postoperative bleed.On (b)(6) 2013 she was found to have an intra-abdominal abscess with mesh infection she underwent exploratory laparotomy with mesh removal and replacement with xenograft.On (b)(6) 2013 patient went back to the or again for yet another laparoscopic repair of an incarcerated incisional hernia.¿ the (b)(6) 2018 records state: ¿patient was most recently seen in our office on (b)(6) 2016 to discuss undergoing surgery for lysis of adhesions because she was having some gi symptoms however at that time a decision was made not to undergo any diagnostic laparoscopy.Patient presents to the er currently with complaints of severe mid abdominal pain and vomiting since last night.¿ records dated (b)(6) 2016 state the patient was seen for abdominal adhesions.¿she has been evaluated and had extensive workup by dr.(b)(6) for recurrent abdominal pain to no avail.Dr.(b)(6) believes she may need a lysis of adhesions.She has bad reflux and takes medications that seems to help.She is complaining of when she eats it makes the pain worse and she feels bloated.¿ 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® bio-a® tissue reinforcement instructions for use includes warnings and addresses the following adverse reactions among others: ¿possible adverse reactions with the use of any tissue deficiency prosthesis may include, but are not limited to, contamination, infection, inflammation, adhesion, fistula formation, seroma formation, hematoma, and recurrence.¿ the gore® bio-a® tissue reinforcement instructions for use also states: ¿the gore® bio-a® tissue reinforcement is used to reinforce soft tissue during the phases of wound healing by filling soft-tissue deficits.¿ ¿when used for hernia repair, it is recommended that gore® bio-a® tissue reinforcement be used as a suture-line reinforcement.¿ 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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Previous patient code (1930) was 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), 2013 through (b)(6), 2016, and not all records received in this time span are relevant to gore® dualmesh® plus biomaterial and gore® bio-a® tissue reinforcement.Patient information: medical history: hypertension.Morbid obesity.(b)(6) 2013: 230 lbs., bmi 37.12.(b)(6) 2016: ¿lost 50 lbs.In past year.¿ (b)(6) 2016: 191 lbs., bmi 30.8.(b)(6) 2018: 187 lbs., bmi 30.2.Chronic pain.Gastroesophageal reflux disease [gerd].Barretts esophagus.Hyperlipidemia.Chronic anxiety.Fibromyalgia.Smoker [¿less than 100 in lifetime¿].(b)(6) 2013: quit 7 years ago.Prior surgical procedures: unknown date: laparoscopic cholecystectomy.Unknown date: abdominal approach spinal surgery.Implant #1 preoperative complaints: (b)(6) 2013: ¿presented to the emergency department today with complaints of sudden onset of abdominal pain.The patient had known incisional hernia.The patient was straining today when she began experiencing excruciating pain.This was followed by some nausea but no vomiting today.The patient has been having bowel movements; however, patient reports the pain is unrelenting and she has not been able to get relief.Workup in the emergency department revealed an incarcerated hernia confirmed by ct scan.¿ implant #1 procedure: laparoscopic incarcerated incisional hernia repair with mesh ¿synthetic biologic gore bio-a¿ and small bowel resection.Implant: gore® bio-a® tissue reinforcement (fs0915/10464804, 9cm x 15cm).Implant #1 date: (b)(6), 2013 [hospitalization (b)(6), 2013] description of hernia being treated: ¿dense adhesions were noted it [sic] the anterior abdominal wall.Lysis of adhesions was performed using blunt dissection, sharp dissection with scissors and sonosurg.¿ ¿dissection occurred down around the area of the incarcerated bowel.Large amount of omentum was noted in the hernia as well as a loop of small bowel using pressure from the outside as well as slight tugging from the inside.The hernia was ultimately able to be reduced.Once the bowel was reduced, it was noted to be severely compromised.There were areas that appeared to be necrotic with black necrosis.¿ ¿decision was made due to the patient's place of the hernia that was slightly off the midline to perform an incision directly above the area of the hernia to tunnel down and place a wound protector to pull the small bowel for further resection.This was performed, the abdomen was opened just above the area of the hernia, slightly off the midline.A wound protector was placed, small bowel was pulled up.¿ implant size and fixation: ¿the staple line of the small bowel was oversewn using running 3-0 vicryl stitch.Patent opening was noted and this returned into the abdominal cavity.At this point, a piece of gore bio-a 9 x 15 cm placed into the surgical field using #1 prolene stitches.This was sutured in an underlay fashion to the fascia through the opening.The mesh was then placed into the abdominal cavity.A running #1 vicryl stitch was used to close the fascia overlying the mesh; sutures were tied down.¿ ¿re-insufflation of the abdomen was performed.Double crown of tacking was performed end to side on the mesh.Goad [sic] covering was noted.There was noted to be a small umbilical hernia as well.A stitch was placed through the hernia using carter thompson needle passer and used to close the defect through the incision that had already been made.Good repair was noted.Washout of the small incision on the anterior abdominal wall was washed out.Interrupted 3-0 vicryl was used to close the subcutaneous tissues and 4-0 monocryl was used to close all skin incisions.¿ (b)(6) 2013: diagnostic laparoscopy with evacuation of hematoma.¿the anterior abdominal wall was inspected where the hernia repair was performed.There did not appear to be hematoma in this area.Adhesions were noted and taken down using sharp dissection with scissors and sonosurg, the small bowel was run.¿ ¿old clot was evacuated; no areas of active bleeding could be identified.¿ (b)(6) 2013: discharge summary: ¿following the procedure [(b)(6) 2013], the patient was transferred to the floor.She then had an episode of hypotension as well as some tachycardia.The patient experienced a decrease in hematocrit, ultimately requiring a blood transfusion secondary to a drop in hematocrit.The patient was returned to the operative theater on (b)(6) 2013 for diagnostic laparoscopy which did not reveal any source of bleeding.The patient returned to the floor following the procedure.She progressed without difficulty at this point.¿ relevant medical information: (b)(6) 2013: ct abdomen: ¿new bowel loop protruding through the anterior abdominal wall adjacent to the site of the hernia repair.Moderate small bowel distention.Partial obstruction is not excluded.¿ implant #2 preoperative complaints: (b)(6) 2013: ¿she was discharged home and been having some nausea and vomiting for past 4 days, saw him in the office, and the hernia was reduced.She continued to have nausea and vomiting and presented to the er where ct showed what appeared to be another incarcerated hernia.She denies any fever, chills.No blood in her stool.She is passing gas.¿ ¿abdomen: soft.She is tender at the prior small midline incision.There is a hematoma to the surrounding tissue.There is some ecchymosis down the lower pelvis.¿ (b)(6) 2013: ct abdomen: ¿the previously identified incisional ventral hernia medial to the mesh repair is still present.There is some questionable wall thickening within the herniated loop of bowel on today¿s exam.Small bowel distention persists and is slightly more severe than on the previous exam.There is a transition zone to normal caliber loops of distal ileum on today¿s exam suggesting at least a partial obstruction.¿ implant #2 procedure: laparoscopic incarcerated incisional hernia repair with mesh.Implant: gore® dualmesh® plus biomaterial (1dlmcp02/10414828, 8cm x 12cm).Implant #2 date: (b)(6), 2013 [hospitalization (b)(6) 2013] description of hernia being treated: ¿¿incision was made through the patient's previous right flank incisions.Adhesions were noted along the anterior abdominal wall along the patient's previous hernia repair.These were taken down with blunt dissection.The hernia was noted.It was lying in the midline from patient's previous midline incision.It did not involve the patient's previous hernia.A second defect was also noted further inferior.These had not been areas of incarcerated herniation of the patient's previous repair.¿ implant size and fixation: ¿once the anterior abdominal wall adhesions were taken down decision was made to perform a repair with gore dualmesh plus.The bowel was inspected, did not appear to be nonviable.At this point an 8 x 12 piece of gore dualmesh plus was placed into the field.Four corner stitches were placed with the gore-tex mesh.¿ ¿the mesh was rolled and placed into the abdominal cavity using carter thompson [carter thomason] needle passer the four corners were secured to the anterior abdominal wall, double layer of tacks was placed circumferentially around the mesh.There was some overlap with the previous repair.Once the mesh was secured, the abdomen was inspected and no bleeding was noted.¿ ¿a good repair was noted.No other hernia defects were noted.¿ (b)(6) 2013: discharge summary: ¿following the procedure the patient was transferred to the floor where she progressed without significant complications.¿ relevant medical information: (b)(6) 2013: ¿patient presents with chronic drainage from incision site.Patient having chronic inflammation at site of previous strangulated and ischemic bowel.¿ abdominal exam notes state: ¿soft, non-distended, there is chronic inflammatory tissue within patient¿s incision, and does not appear to be abscess or cellulitis.¿ ¿patient has nonhealing surgical wound from area of ischemic bowel.Plan for debridement¿¿ (b)(6) 2013: debridement of anterior abdominal wall wound less than 20 cm.¿revealed necrotic tissue and fat necrosis.There is likely infection from patient's previous infarcted ischemic bowel within the area.¿ ¿all necrotic tissue was removed using combination of sharp dissection with scissors, curet to debride the walls, removal of prolene stitches was performed.¿ ¿all tracking was checked and areas of fat necrosis opened, and debridement of all areas was performed.No hernia was noted.I did not see the mesh in the area.There did not appear to be compromise of the hernia repair.Washout was thoroughly performed with combination of saline and betadine.Once healthy tissue was noted in all areas the area was packed with iodoform.Sterile dressings applied.¿ (b)(6) 2013: ct abdomen: ¿there has been placement of mesh or sutures along the anterior abdominal wall at the site of previous hernia.No recurrent hernia is identified.There is no small bowel distention or obstruction.There is some stranding in the fat adjacent to the sutures or mass consistent with scar or edema.There is some minimal low density associated with the sutures which may also be postsurgical.¿ explant #1 & #2 preoperative complaints: (b)(6) 2013: ¿patient presents to clinic with ongoing wound drainage.She has completed her course of bactrim with no improvement.She has undergone a ct scan.¿ ¿abdomen: soft, non-distended, non-tender, pustular draining from the incision at strangulated hernia site, no erythema or cellulitis, no induration.¿ ¿ct scan findings-postoperative changes, no abscess identified.¿ (b)(6) 2013: ¿.Who had undergone previous resection of small bowel for necrotic incarcerated hernia.The patient underwent repair at that time which ultimately resulted in mesh and wound infection.The patient continued to have a lot drainage from the abdominal area.Decision was made to perform mesh excision for likely mesh infection.¿ explant #1 & #2 procedure: diagnostic laparoscopy with lysis of adhesions along with drainage of intra-abdominal abscess for mesh infection.Exploratory laparotomy with removal of infected mesh.Repair of recurrent incisional hernia with mesh.¿xenograft 15 x 20 cm.¿ explant #1 & #2 date: (b)(6), 2013 [hospitalization dates unknown] ¿dense adhesions were noted in the anterior abdominal wall.A very prolonged lysis of adhesions was performed taking the small bowel off the anterior abdominal wall and no enterotomies were noted, after a very prolonged lysis of adhesions, the mesh was clearly identified.Once the peritoneum was incised in this area, pus was drained.A large amount of pus was drained.After all the adhesions had been taken down with noted abscess and clear infection of the mesh , decision was made to perform exploratory laparotomy which would be required for removal of the mesh¿ ¿the abdomen was entered.Tacks were taken down using ochsner clamp.The patient's previously placed gore-tex mesh was removed.After removal of the gore-tex mesh, attention was turned to removing the previous gore bio-a mesh.This was also removed.Once all mesh had been removed as well as visible tacks and prolene stitches as well as gore-tex stitches, decision was made to perform a xenograft placement with xenmatrix.¿ ¿consideration was placed to a component separation without mesh.However, given the patient's abdominal girth, decision was made the patient would be at high risk for ischemia, therefore, a 15 x 20 piece of xenograft was placed onto the surgical field and was placed into the abdominal cavity.The fascia would have had to have been closed very tightly with an extremely high risk of recurrence without the xenograft.¿ ¿therefore, a #1 interrupted pds stitches were used to attach the xenograft into the anterior abdominal wall.There was 5 cm underlay in all areas.A good repair was noted.A thorough washout was performed with antibiotic irrigation.The fascia was closed over the mesh using running looped pds stitching.A 19-french blake drain was placed above the fascia, a running 2-0 vicryl stitch was used to close subcutaneous tissues.¿ relevant medical information: (b)(6) 2013: pathology report: ¿1.Mesh (gore), 2.Mesh (bio-a).¿ gross description states: ¿1."mesh gore".Received is a pink-tan to gray segment of apparent gortex [sic] that is 10.1 x 6.5 x 0.2 cm in greatest dimension.There are multiple metallic spring-like pieces on the specimen.No tissue is noted on the specimen.2."mesh bio-a".Received are four pink to red-brown fragments of tissue that are 7 x 6.2 x 4.7 cm in greatest dimension.There are multiple metallic spring-like devices present embedded within the tissue.The specimen is serially sectioned.No masses, areas of abscess formation or purulent material is identified.¿ microscopic: ¿1.There are portions of foreign material consistent with gortex with adherent granulation tissue.There is foreign body reaction with giant cell formation.2.There are portions of fibrous tissue with marked foreign body reaction.There is polarizable foreign material which is surrounded by giant cells and inflammatory cells.¿ it should be noted that the gore® bio-a® tissue reinforcement 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.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- clinical code.H6: updated investigation findings.H6: updated investigation conclusion.H6: health effect impact code: f26: no health consequences or impact.Previous patient code (1930) was 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) 2013 through (b)(6) 2016, and not all records received in this time span are relevant to gore® dualmesh® plus biomaterial and gore® bio-a® tissue reinforcement.Patient information: medical history: hypertension / morbid obesity / (b)(6) 2013: 230 lbs., bmi 37.12 / (b)(6) 2016: ¿lost 50 lbs.In past year.¿ / (b)(6) 2016: 191 lbs., bmi 30.8 / (b)(6) 2018: 187 lbs., bmi 30.2 / chronic pain / gastroesophageal reflux disease [gerd] / barretts esophagus / hyperlipidemia / chronic anxiety / fibromyalgia / smoker [¿less than 100 in lifetime¿] / (b)(6) 2013: quit 7 years ago.Prior surgical procedures: unknown date: laparoscopic cholecystectomy.Unknown date: abdominal approach spinal surgery.Implant #1 preoperative complaints: (b)(6) 2013: ¿presented to the emergency department today with complaints of sudden onset of abdominal pain.The patient had known incisional hernia.The patient was straining today when she began experiencing excruciating pain.This was followed by some nausea but no vomiting today.The patient has been having bowel movements; however, patient reports the pain is unrelenting and she has not been able to get relief.Workup in the emergency department revealed an incarcerated hernia confirmed by ct scan.¿ implant #1 procedure: laparoscopic incarcerated incisional hernia repair with mesh ¿synthetic biologic gore bio-a¿ and small bowel resection.Implant: gore® bio-a® tissue reinforcement (fs0915/10464804, 9cm x 15cm).Implant #1 date: (b)(6) 2013 [hospitalization (b)(6) 2013] description of hernia being treated: ¿dense adhesions were noted it [sic] the anterior abdominal wall.Lysis of adhesions was performed using blunt dissection, sharp dissection with scissors and sonosurg.¿ ¿dissection occurred down around the area of the incarcerated bowel.Large amount of omentum was noted in the hernia as well as a loop of small bowel using pressure from the outside as well as slight tugging from the inside.The hernia was ultimately able to be reduced.Once the bowel was reduced, it was noted to be severely compromised.There were areas that appeared to be necrotic with black necrosis.¿ ¿decision was made due to the patient's place of the hernia that was slightly off the midline to perform an incision directly above the area of the hernia to tunnel down and place a wound protector to pull the small bowel for further resection.This was performed, the abdomen was opened just above the area of the hernia, slightly off the midline.A wound protector was placed, small bowel was pulled up.¿ implant size and fixation: ¿the staple line of the small bowel was oversewn using running 3-0 vicryl stitch.Patent opening was noted and this returned into the abdominal cavity.At this point, a piece of gore bio-a 9 x 15 cm placed into the surgical field using #1 prolene stitches.This was sutured in an underlay fashion to the fascia through the opening.The mesh was then placed into the abdominal cavity.A running #1 vicryl stitch was used to close the fascia overlying the mesh; sutures were tied down.¿ ¿re-insufflation of the abdomen was performed.Double crown of tacking was performed end to side on the mesh.Goad [sic] covering was noted.There was noted to be a small umbilical hernia as well.A stitch was placed through the hernia using carter thompson needle passer and used to close the defect through the incision that had already been made.Good repair was noted.Washout of the small incision on the anterior abdominal wall was washed out.Interrupted 3-0 vicryl was used to close the subcutaneous tissues and 4-0 monocryl was used to close all skin incisions.¿ (b)(6) 2013: diagnostic laparoscopy with evacuation of hematoma.¿the anterior abdominal wall was inspected where the hernia repair was performed.There did not appear to be hematoma in this area.Adhesions were noted and taken down using sharp dissection with scissors and sonosurg, the small bowel was run.¿ ¿old clot was evacuated; no areas of active bleeding could be identified.¿ (b)(6) 2013: discharge summary: ¿following the procedure [(b)(6) 2013], the patient was transferred to the floor.She then had an episode of hypotension as well as some tachycardia.The patient experienced a decrease in hematocrit, ultimately requiring a blood transfusion secondary to a drop in hematocrit.The patient was returned to the operative theater on (b)(6) 2013 for diagnostic laparoscopy which did not reveal any source of bleeding.The patient returned to the floor following the procedure.She progressed without difficulty at this point.¿ relevant medical information: (b)(6) 2013: ct abdomen: ¿new bowel loop protruding through the anterior abdominal wall adjacent to the site of the hernia repair.Moderate small bowel distention.Partial obstruction is not excluded.¿ implant #2 preoperative complaints: (b)(6) 2013: ¿she was discharged home and been having some nausea and vomiting for past 4 days, saw him in the office, and the hernia was reduced.She continued to have nausea and vomiting and presented to the er where ct showed what appeared to be another incarcerated hernia.She denies any fever, chills.No blood in her stool.She is passing gas.¿ ¿abdomen: soft.She is tender at the prior small midline incision.There is a hematoma to the surrounding tissue.There is some ecchymosis down the lower pelvis.¿ (b)(6) 2013: ct abdomen: ¿the previously identified incisional ventral hernia medial to the mesh repair is still present.There is some questionable wall thickening within the herniated loop of bowel on today¿s exam.Small bowel distention persists and is slightly more severe than on the previous exam.There is a transition zone to normal caliber loops of distal ileum on today¿s exam suggesting at least a partial obstruction.¿ implant #2 procedure: laparoscopic incarcerated incisional hernia repair with mesh.Implant: gore® dualmesh® plus biomaterial (1dlmcp02/10414828, 8cm x 12cm).Implant #2 date: (b)(6) 2013 [hospitalization (b)(6) 2013] description of hernia being treated: ¿¿incision was made through the patient's previous right flank incisions.Adhesions were noted along the anterior abdominal wall along the patient's previous hernia repair.These were taken down with blunt dissection.The hernia was noted.It was lying in the midline from patient's previous midline incision.It did not involve the patient's previous hernia.A second defect was also noted further inferior.These had not been areas of incarcerated herniation of the patient's previous repair.¿ implant size and fixation: ¿once the anterior abdominal wall adhesions were taken down decision was made to perform a repair with gore dualmesh plus.The bowel was inspected, did not appear to be nonviable.At this point an 8 x 12 piece of gore dualmesh plus was placed into the field.Four corner stitches were placed with the gore-tex mesh.¿ ¿the mesh was rolled and placed into the abdominal cavity using carter thompson [carter thomason] needle passer the four corners were secured to the anterior abdominal wall, double layer of tacks was placed circumferentially around the mesh.There was some overlap with the previous repair.Once the mesh was secured, the abdomen was inspected and no bleeding was noted.¿ ¿a good repair was noted.No other hernia defects were noted.¿ (b)(6) 2013: discharge summary: ¿following the procedure the patient was transferred to the floor where she progressed without significant complications.¿ relevant medical information: (b)(6) 2013: ¿patient presents with chronic drainage from incision site.Patient having chronic inflammation at site of previous strangulated and ischemic bowel.¿ abdominal exam notes state: ¿soft, non-distended, there is chronic inflammatory tissue within patient¿s incision, and does not appear to be abscess or cellulitis.¿ ¿patient has nonhealing surgical wound from area of ischemic bowel.Plan for debridement¿¿ (b)(6) 2013: debridement of anterior abdominal wall wound less than 20 cm.¿revealed necrotic tissue and fat necrosis.There is likely infection from patient's previous infarcted ischemic bowel within the area.¿ ¿all necrotic tissue was removed using combination of sharp dissection with scissors, curet to debride the walls, removal of prolene stitches was performed.¿ ¿all tracking was checked and areas of fat necrosis opened, and debridement of all areas was performed.No hernia was noted.I did not see the mesh in the area.There did not appear to be compromise of the hernia repair.Washout was thoroughly performed with combination of saline and betadine.Once healthy tissue was noted in all areas the area was packed with iodoform.Sterile dressings applied.¿ (b)(6) 2013: ct abdomen: ¿there has been placement of mesh or sutures along the anterior abdominal wall at the site of previous hernia.No recurrent hernia is identified.There is no small bowel distention or obstruction.There is some stranding in the fat adjacent to the sutures or mass consistent with scar or edema.There is some minimal low density associated with the sutures which may also be postsurgical.¿ explant #1 & #2 preoperative complaints: (b)(6) 2013: ¿patient presents to clinic with ongoing wound drainage.She has completed her course of bactrim with no improvement.She has undergone a ct scan.¿ ¿abdomen: soft, non-distended, non-tender, pustular draining from the incision at strangulated hernia site, no erythema or cellulitis, no induration.¿ ¿ct scan findings-postoperative changes, no abscess identified.¿ (b)(6) 2013: ¿.Who had undergone previous resection of small bowel for necrotic incarcerated hernia.The patient underwent repair at that time which ultimately resulted in mesh and wound infection.The patient continued to have a lot drainage from the abdominal area.Decision was made to perform mesh excision for likely mesh infection.¿ explant #1 & #2 procedure: diagnostic laparoscopy with lysis of adhesions along with drainage of intra-abdominal abscess for mesh infection.Exploratory laparotomy with removal of infected mesh.Repair of recurrent incisional hernia with mesh.¿xenograft 15 x 20 cm.¿ explant #1 & #2 date: (b)(6) 2013 ¿dense adhesions were noted in the anterior abdominal wall.A very prolonged lysis of adhesions was performed taking the small bowel off the anterior abdominal wall and no enterotomies were noted, after a very prolonged lysis of adhesions, the mesh was clearly identified.Once the peritoneum was incised in this area, pus was drained.A large amount of pus was drained.After all the adhesions had been taken down with noted abscess and clear infection of the mesh , decision was made to perform exploratory laparotomy which would be required for removal of the mesh¿ ¿the abdomen was entered.Tacks were taken down using ochsner clamp.The patient's previously placed gore-tex mesh was removed.After removal of the gore-tex mesh, attention was turned to removing the previous gore bio-a mesh.This was also removed.Once all mesh had been removed as well as visible tacks and prolene stitches as well as gore-tex stitches, decision was made to perform a xenograft placement with xenmatrix.¿ ¿consideration was placed to a component separation without mesh.However, given the patient's abdominal girth, decision was made the patient would be at high risk for ischemia, therefore, a 15 x 20 piece of xenograft was placed onto the surgical field and was placed into the abdominal cavity.The fascia would have had to have been closed very tightly with an extremely high risk of recurrence without the xenograft.¿ ¿therefore, a #1 interrupted pds stitches were used to attach the xenograft into the anterior abdominal wall.There was 5 cm underlay in all areas.A good repair was noted.A thorough washout was performed with antibiotic irrigation.The fascia was closed over the mesh using running looped pds stitching.A 19-french blake drain was placed above the fascia, a running 2-0 vicryl stitch was used to close subcutaneous tissues.¿ relevant medical information: (b)(6) 2013: pathology report: ¿1.Mesh (gore), 2.Mesh (bio-a).¿ gross description states: ¿1."mesh gore".Received is a pink-tan to gray segment of apparent gortex [sic] that is 10.1 x 6.5 x 0.2 cm in greatest dimension.There are multiple metallic spring-like pieces on the specimen.No tissue is noted on the specimen.2."mesh bio-a".Received are four pink to red-brown fragments of tissue that are 7 x 6.2 x 4.7 cm in greatest dimension.There are multiple metallic spring-like devices present embedded within the tissue.The specimen is serially sectioned.No masses, areas of abscess formation or purulent material is identified.¿ microscopic: ¿1.There are portions of foreign material consistent with gortex with adherent granulation tissue.There is foreign body reaction with giant cell formation.2.There are portions of fibrous tissue with marked foreign body reaction.There is polarizable foreign material which is surrounded by giant cells and inflammatory cells.¿ conclusion: gore® bio-a® tissue reinforcement (10464804/fs0915).It should be noted that the gore® bio-a® tissue reinforcement 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 and sterilization 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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Search Alerts/Recalls
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