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| Model Number 1DLMC07 |
| Device Problem
Insufficient Information (3190)
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| Patient Problems
Unspecified Infection (1930); No Clinical Signs, Symptoms or Conditions (4582)
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| Event Date 04/28/2009 |
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Event Type
Injury
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Manufacturer Narrative
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It should be noted that the gore® dualmesh® biomaterial instructions for use addresses the following adverse reactions among others: ¿possible adverse reactions with the use of any tissue deficiency prosthesis may include, but are not limited to, contamination, infection, inflammation, adhesion, fistula formation, seroma formation, hematoma, and recurrence." the gore® dualmesh® biomaterial instructions for use also states: ¿strict aseptic techniques should be followed.If an infection develops, it should be treated aggressively.An unresolved infection may require removal of the material.".
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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) 2009 whereby a gore® dualmesh® biomaterial was implanted.The complaint alleges that on (b)(6) 2009 and (b)(6) 2010, additional procedures occurred whereby the gore device was explanted.It was reported the patient alleges the following injuries: infection, mesh removal, adhesions, hernia recurrence, seroma.Additional event specific information was not provided.
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Manufacturer Narrative
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It should be noted that the gore® dualmesh® biomaterial instructions for use addresses the following adverse reactions among others: ¿possible adverse reactions with the use of any tissue deficiency prosthesis may include, but are not limited to, contamination, infection, inflammation, adhesion, fistula formation, seroma formation, hematoma, and recurrence." the gore® dualmesh® biomaterial instructions for use also states: ¿strict aseptic techniques should be followed.If an infection develops, it should be treated aggressively.An unresolved infection may require removal of the material.".
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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) 2009 whereby a gore® dualmesh® biomaterial was implanted.The complaint alleges that on (b)(6) 2009 and (b)(6) 2010, additional procedures occurred whereby the gore device was explanted.It was reported the patient alleges the following injuries: infection, mesh removal, adhesions, hernia recurrence, seroma.Additional event specific information was not provided.
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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: relevant medical information: ¿ (b)(6) 2008 ¿(b)(6) 2008: (b)(6) hospital.Inpatient hospitalization.¿ (b)(6) 2008: (b)(6) hospital.(b)(6), md.Operative report.Preoperative diagnosis: perforated viscus.Postoperative diagnosis: perforated anterior gastric wall.Procedure: exploratory laparotomy.Gastric ulcer biopsy.Primary repair and omental patch of perforated ulcer.Anesthesia: general.Estimated blood loss: less than 100 ml.Drains: blake drain.Jackson-pratt suction drain.Complications: none. indications: ¿this is a 61-year-old caucasian female who started having chest and epigastric pain approximately i week ago.She ignored it and thought that it was just some heartburn.The pain then increased in the last 3 days until the date of her admission when she states she had an acute increase in her pain in the left upper quadrant which made her short of breath.She was seen in the emergency department the morning of (b)(6) 2008 with shortness of breath.A chest x-ray was done and the patient was sent home.The patient was then recalled once the radiologist found that she had free air under the diaphragm.A decubitus x-ray was done on her second visit that day, which showed definite free air.I saw the patient in the emergency department and her abdominal examination and history were consistent with perforated viscus, either a duodenal source or epigastric due to her history of heartburn, her increase in ibuprofen due to the pain, as well as her prednisone which she had just stopped secondary to a flare-up of her ulcerative colitis.The procedures, alternatives, risks and questions were all discussed with the patient and her family.They all understood and wished to proceed.¿ procedure: ¿the patient was taken to the operating room and placed in the supine position.She was placed under general anesthesia and intubated.Her abdomen was prepped and draped in a sterile surgical fashion.A midline incision was made from just below the umbilicus to the xiphoid process.Dissection was taken down using cautery down to the fascia.The fascia was opened at the linea alba and the abdomen was entered.There was a small amount of fluid identified but no succuss.The omni retractor was assembled and her abdominal wall was retracted for better visualization.The abdomen was then systematically explored lifting the omentum up revealing the transverse colon.The large bowel was followed from the cecum all the way to the sigmoid colon.No perforations were identified.There was no grouping fat at the small bowel and no perforations were identified.The small bowel was then followed from the ligament of treitz all the way to the ileocecal valve.Again the small bowel was normal without any grouping fat and no perforation.At this point, the stomach was explored.No perforations were noted at the antrum.The lesser sac was entered and there were no perforations posteriorly.The duodenum was deflected medially and again no perforations were identified in the duodenum either anteriorly or posteriorly.At this point the cardia was explored and it was noted to be stuck to the spleen.There was quite a bit of inflammatory exudate.This was carefully removed and the cardia was carefully dissected away from the spleen making sure not to injure the spleen.At the greater curvature approximately 1 inch or 1.5 inches distal to the esophagogastric junction, a small pinhole was finally identified.Due to the unusual location of this ulcer, the area was biopsied and the edges of the ulceration were cleaned up.The specimen was sent to pathology to rule out any malignancy.The ulceration was then closed in 2 layers using 3-0 silk popoff as well as 3-0 vicryl.An omental tongue was then dissected and flipped over the perforation and held in place using 3-0 vicryl sutures.The rest of the omentum was draped back over the small bowel and large bowel.The abdomen was irrigated with warm normal saline.A nasogastric tube [ng] was placed into the antrum of the stomach.A small incision in the left upper quadrant was then made and a blake drain was placed in the left upper quadrant and secured in place with 2-0 prolene suture.At this point, the abdomen was closed using #1 vicryl, two sutures, one coming from superiorly towards the umbilicus and one coming from the distal incision toward the umbilicus.Once the peritoneum was closed, the fascia was again irrigated and 3-0 vicryl was used to approximate the skin.The skin was closed using dissolvable staples.The area was then cleaned, dried and mastisol and steri-strips were applied to the incision, as well as dry island dressings.The jackson-pratt [jp] tube was dressed using 4 x 4 gauze and it was attached to a jp bulb for drainage.At this point, the patient was woken up, extubated and taken back to the recovery room in good condition.¿ on (b)(6) 2008: (b)(6) medical center.(b)(6), md.Pathology report.Specimen received: ¿stomach ulcer, biopsy.¿ final diagnosis: ¿stomach, partial excision: acute ulceration with perforation.¿ gross description: ¿received in a container of formalin labeled ¿hart, kathryn¿ only and ¿biopsy of stomach ulcer¿ on the requisition is a portion of bowel with tan-pink granular mucosa measuring 1.2 x 1 x 0.4 cm.The apparent surgical margin is inked blue, the specimen is serially sectioned and entirely submitted in cassettes a and b.¿ microscopic description: ¿sections reveal fragments of gastric mucosa which is ulcerated with marked acute inflammation and necrosis of the underlying tissues.This appears to extend through the wall of the stomach into the serosal tissue.There is no evidence of malignancy.¿ on (b)(6) 2008: (b)(6) hospital.(b)(6), md.Discharge instructions: ¿follow up with me in one week.Patient was discharged by dr.(b)(6).¿ implant #1 preoperative complaints: ¿ on (b)(6) 2009: (b)(6) hospital.(b)(6), md.Indications: ¿kathryn is a 61-year-old female whom, approximately a year ago, underwent emergency exploratory laparotomy for a perforated gastric ulcer, which i repaired primarily with an omental flap.Unfortunately the patient then developed a large incisional hernia approximately 6 months later.Risks, benefits and complications of the procedure were discussed with (b)(6) in the office.Complications include but are not limited to infection, bleeding, injury to the bowel, inability to do it laparoscopically and having to open and adverse reaction to anesthesia.All her questions were answered and (b)(6) wished to proceed.¿ implant#1 procedure: laparoscopic lysis of adhesions and incisional hernia repair with mesh.[implant: gore® dualmesh® biomaterial, 1dlmc07/05060461, 20cm x 30cm x 1mm thick] implant #1 date: (b)(6) 2009 [hospitalization dates unknown].¿ on (b)(6) 2009: (b)(6) hospital.(b)(6), md.Operative report.Pre and postoperative diagnosis: incisional hernia.Anesthesia: general.Estimated blood loss: less than 100 ml.Complications: none.¿ wound classification: not provided.¿ findings: ¿one large hernia measuring 10 x 15 cm and 4 small ones at the distal end of the old incision.¿ ¿ procedure: ¿patient was taken to the operating room, placed in a supine position.She was placed under general anesthesia and intubated.A foley was placed.Her abdomen was prepped and draped in a sterile surgical fashion and once this was done a timeout was called.At the timeout, patient's name, birth date, procedure and site were reviewed and agreed upon by the operating room team.At this point a mixture of 1% lidocaine and 0.5% marcaine was injected in the left flank.A small 5-mm incision was made and a visiport was placed into the abdomen without difficulty.Adhesions were identified up to the large hernia.Once the abdomen was insufflated to a pressure of 15 three more ports were placed: two 5 mm and one 12.Dissection was then done of the adhesions using a harmonic scalpel, being careful not to injure any of the bowel that was adhered to the hernia.Once all the adhesions were removed 1 large hernia was identified and 4 small ones the length of the entire incision.At this point, with the light showing through the patient's abdomen, marks were placed on the abdominal skin for the size of the mesh.A 20 x 30 cm mesh was asked for.The abdomen was then reinflated and the mesh was placed through the 12-mm port into the abdomen.Once in the abdomen it was unrolled.The right upper corner was tacked to the abdominal wall and then the right lower corner was tacked.The mesh was stretched and the left upper and left lower corners were then tacked and then all the way around the mesh more tacks were placed to secure the mesh.Once the mesh was completely secured the ports were removed, the abdomen was deflated and the small incisions were closed using 4-0 vicryl.The abdomen was then cleaned, dried and mastisol and steri-strips were applied as well as dry dressings.The foley was removed and the patient was woken up and taken to the recovery room in stable condition.¿ ¿ on (b)(6) 2008: (b)(6) hospital.Implant sticker: ¿gore dualmesh biomaterial.Ref #: 1dlmc07.Lot #: 05060461.W.L.Gore & associates.¿ explant #1 preoperative complaints: ¿ on (b)(6) 2009: (b)(6) hospital.(b)(6), md.Indications: ¿ms.(b)(6) is a 62 -year-old caucasian female who in (b)(6) of last year was taken to the operating room for a gastric ulcer perforation on the greater curvature, which was repaired primarily, and an omental patch was also placed.She then underwent a laparoscopic hernia repair in (b)(6) of this year and today returned to the emergency department with left flank and left shoulder pain.A ct scan showed free air and fluid around the stomach.A recurrent perforation was suspected and therefore recommendation was made to the patient to take her to the operating room for an exploration and repair of the ulcer with possible resection of that part of the stomach.The risks, benefits and complications were discussed with her.Her questions were answered and she wished to proceed.¿ explant #1 procedure: exploratory laparotomy with resection of small part of stomach at its greater curvature.Removal of old mesh.Explant #1 date: (b)(6) 2009 [hospitalization dates (b)(6) 2009] ¿ on (b)(6) 2009: (b)(6) hospital.(b)(6), md.Operative report.Preoperative diagnosis: free air.Postoperative diagnosis: recurrent perforated gastric ulcer.Anesthesia: general.Estimated blood loss: 150 ml.Complications: none.¿ wound classification: not provided.¿ procedure: ¿patient was taken to the operating room, placed in a supine position.She was placed under general anesthesia and intubated under rapid sequence.A foley was placed as well as a nasogastric tube [ng].Her abdomen was prepped and draped in a sterile surgical fashion.At this point a timeout was called.The patient's name, date of birth, allergies, surgery type and procedure were discussed with the team.At this point the superior aspect of her old scar was removed and dissection was taken down to the fascia using cautery.Once the fascia was identified it was opened using scissors.Once in the abdomen a small amount of green fluid was identified and this was suctioned out.The previously placed mesh was dissected away from the fascia completely and removed due to the increased risk of infection.The mesh was able to get peeled off of the fascia without much difficulty.The tacks were removed with hemostats.Once the mesh was removed the abdominal wall was retracted as well as the liver.The transverse colon was identified an inspected.No perforation was identified.The omentum was opened into the lesser sac and posterior aspect of the stomach was inspected.No gastric fluid was noted and no perforations were identified.At the greater curvature at the junction of the cardia and fundus the old omental patch was identified and slowly removed.The gastric ulcer was noted in the same place.There was edema in the stomach wall.At this point the decision was made to take this part of the stomach with a stapler.The short gastrics were clamped, cut and ligated along the greater curvature for approximately 10-15 cm, the greater curvature was then clamped with a 75 straight linear stapler and once the edema was removed from the stomach the stapler was fired and the stomach and ulceration were removed from the operating table and sent to pathology.Next a running 3-0 vicryl was used to do a running lambert to imbricate the staple line.Once this was done the abdomen was irrigated with 2.5 liters of warm saline.The rest of the large bowel was inspected and no perforations were identified.The duodenum was inspected and no perforations were identified.At this point the fascia was grasped and the subcutaneous fat was dissected away using cautery.The fascia was closed with two #1 vicryls on a ctx needle.The subcutaneous tissue was irrigated and the skin was closed with staples.The entire abdomen was cleaned and dried and a dry dressing was applied.Addendum: once the ulcer was removed with the stapler a nasogastric tube was palpated and placed in the proximal antrum and secured.Once the patient was cleaned and the dry dressing was applied to the incision the patient was woken up, extubated and taken back to the recovery room in stable condition.¿ ¿ on (b)(6) 2009: (b)(6) medical center.(b)(6), md.Pathology.Specimen received: ¿stomach, greater curvature.¿ final diagnosis: ¿stomach, wedge resection of greater curvature.Chronic penetrating ulcer with perforation and peritonitis.Special stain for helicobacter pylori negative.¿ gross description: ¿received in a container of formalin labeled ¿(b)(6)' and ¿greater curvature stomach¿ is a wedge-shaped portion of tissue with a staple line along one edge.It measures 6.2 x 2.4 x 1.7 cm.The outer surface is tan-pink and focally hyperemic.An irregular, rubbery, possible defect with surrounding yellow purulent exudate measures 1 x 1 cm.This area is inked blue.The staple line is removed and the stapled margin is inked orange.Upon sectioning, the mucosa is tan-pink and glistening and the previously described irregular area displays a possible perforation.No mass lesions are identified.Sections are submitted as labeled: a through c ¿ entire area containing blue-inked possible perforation; d ¿ representative remaining stomach.¿ microscopic description: ¿sections taken from around the grossly identified area of mural disruption show a prominent peritoneal and serosal inflammatory reaction.This is associated with what appears to be mural necrosis.There is hemorrhage and mural inflammatory reaction.Some areas show what appears to be chronic ulcer base.Adjoining gastric mucosa shows increased chronic inflammation.Routine stain does not show structures suggestive of helicobacter.There does not appear to be gastric atrophy.None of the sections show intestinal metaplasia.There is no dysplasia or malignancy.Special stain for helicobacter pylori is negative.¿ ¿ on (b)(6) 2009: (b)(6) hospital.(b)(6), md.Discharge instructions: ¿asked to abstain completely from alcohol as well as nonsteroidal anti-inflammatory drugs.[nsaids].I asked the patient to come see me in 10 days for removal of her staples.¿ implant #2 preoperative complaints: ¿ on (b)(6) 2009: (b)(6) hospital.(b)(6), md.Indications: ¿ms.(b)(6) is a 62-year-old female very well known to me.Approximately 1-1/2 years ago she underwent an exploratory laparotomy and repair of a perforated gastric ulcer.She then underwent laparoscopic repair of an incisional hernia but unfortunately she developed another gastric ulcer perforation and had to be taken back for another exploratory laparotomy.I then saw the patient in consultation for the possibility of repairing her incisional hernia at the time of a total abdominal hysterectomy for uterine prolapse.The risks, benefits and complications of an open incisional hernia repair were discussed with her.We also discussed revision of her scar as she had ulcerations.Risks include but are not limited to bleeding, infection, injury to the bowel, recurrence of the hernia, small -bowel obstruction, adverse reaction to the medications.(b)(6) understood, her questions were answered to her satisfaction and she wished to proceed.No guarantees were given or implied.¿ ¿ on (b)(6) 2009: (b)(6) hospital.(b)(6), md.Indications: ¿patient is a 62-year-old multiparous patient with symptomatic pelvic relaxation and a recurrent hernia presenting for definitive treatment.Informed consent was obtained for total abdominal hysterectomy, anterior and posterior repair, incisional hernia repair with revision and scar, extensive lysis of adhesions and other indicated procedures.¿ implant#2 procedure: laparotomy with revision of scar, extensive lysis of adhesions, total abdominal hysterectomy with bilateral salpingo-oophorectomy.Resection of small bowel nodule with intraoperative consultation, mesenteric nodule biopsy.Appendectomy.Placement of mesh.Anterior and posterior repair.[implant: gore® dualmesh® biomaterial, 1dlmc07/ 06190641, 20cm x 30cm x 1mm thick] implant #2 date: (b)(6) 2009 [hospitalization dates (b)(6) 2009].¿ on (b)(6) 2009: (b)(6) hospital.(b)(6), md.Operative report.Cosurgeon: (b)(6), md.Preoperative diagnosis: ventral hernia.Pelvic relaxation with uterine prolapse.Postoperative diagnosis: incisional hernia.Small bowel carcinoid with metastases to mesentery.Uterine prolapse.Anesthesia: general.Estimated blood loss: 200 ml.Complications: none. wound classification: findings: ¿large incisional hernia with weakness along the entire length of the old incision site.Also noted was erosion of her old scar.Incidentally found were 2 lesions, one of the small terminal ileum and one of the mesentery of the terminal ileum, both of which were removed.Frozen section was done on the nodule from the small bowel, which showed carcinoid.¿ procedure: ¿the total abdominal hysterectomy and bilateral salpingo-oophorectomy as well as the anterior-posterior repair will be dictated by dr.(b)(6).The patient was taken to the operating room and placed in the supine position after placement of a spinal anesthetic.She was then placed under general anesthesia and intubated.The foley was placed as were sequential compressive devices.The patient was given one dose of antibiotics prior to incision.The abdomen was then prepped and draped from nipples to upper thighs including perineum.The patient's legs were in stirrups positioned by dr.(b)(6).The patient was then draped and an incision was then made around the old scar excising it completely.The fascia was then carefully entered.The incision was elongated all the way down to the pubis.The abdomen was entered around the bellybutton, adhesions were encountered which were slowly and meticulously dissected.Once all of the adhesions were lysed and the small bowel was removed away from the peritoneum, the small bowel and large bowel were both packed away giving us a better view of the uterus.The omni retractor was used for retraction of bowel and of abdominal wall.At this point i assisted dr.(b)(6) in doing a total abdominal hysterectomy and bilateral salpingo-oophorectomy.Once the total abdominal hysterectomy and bilateral salpingo-oophorectomy procedure was complete the small bowel was released and it was inspected from the ligament of treitz all the way down to the cecum.Approximately 3 inches from the ileocecal valve a nodule was palpated in the small bowel.This was resected, enucleated and sent for frozen section.The enterotomy was closed in 2 layers and tested for leaking.When the frozen section came back as carcinoid the small bowel was inspected once more as was the mesentery.A small nodule within the mesentery between vessels was also noted and enucleated and sent for permanent pathology.At this point the appendix was identified, the mesoappendix was clamped and dissected.The neck of the appendix was clamped times 2 and was dissected.The specimen was removed.The appendiceal stump was suture ligated and the mesoappendix stump was suture ligated as well.No bleeding was identified from either the appendiceal stump or the mesoappendix stump.The appendix was removed due to the possibility of its containing a carcinoid and this being the primary source.The large bowel was then inspected and no other nodules were identified.The peritoneum and retroperitoneum were inspected.No nodules were identified.The liver was palpated and again no masses were identified.The spleen was palpated.It was enlarged but again no nodules were palpated.At this point the fascia was reapproximated with #1 vicryl suture times 2.A skin flap was then made to accommodate a large mesh.A 20 x 30-mm [sic] mesh was then placed and tacked to healthy fascia laterally on the left and the right superior just below the xiphoid process, inferiorly just above the pubis symphysis.The skin was then closed using staples as well as some #1 prolene sutures, which would be removed in 5 days.At this point dr.(b)(6) started her anterior -posterior repair.I cleaned the patient's abdomen and placed a large abd [abdominal] dressing on it and covered the area with a sterile green towel.¿ ¿ on (b)(6) 2009: (b)(6) hospital.Implant sticker: ¿ref #: 1dlmc07.Lot #: 06190641.Size: 20.0 cm x 30.0 cm x 1.0mm ¿.¿ on (b)(6) 2009: (b)(6) hospital.(b)(6), md.Operative report.Assistant: (b)(6), md.Preoperative diagnosis: incisional hernia, recurrent, with skin breakdown.Pelvic relaxation including uterine prolapse with erosion of cervix.Rectocele.Cystocele.Postoperative diagnosis: hernia.Pelvic organ prolapse.Carcinoid tumor of small bowel.Anesthesia: general, spinal.Estimated blood loss: 200 ml.Specimens: frozen section, carcinoid tumor of the small bowel; appendix, uterus, cervix, bilateral tubes and ovaries, mesenteric nodule.Complications: none. findings: ¿extensive hernia superior to the umbilicus, small bowel carcinoid, pelvic relation, smooth liver, grossly normal-appearing appendix.¿. procedure: ¿the patient was taken to the operating room with an intravenous line running.She received preoperative antibiotics.Sequential compressive devices were cycling, and she was given a spinal anesthetic without any difficulty.She was subsequently given a general anesthetic.The patient was placed in the supine position with her legs in the bumblebee stirrups.Attention was directed to the abdomen after she was prepped and draped and a time-out procedure was performed to confirm the patient and the scheduled procedure.The skin was marked, the skin breakdown was excised and the incision extended from the symphysis pubis to the xiphoid process.This incision was carried down through the skin to the underlying fascia.The fascia was in very poor condition.There was noted to be [sic] hernia present superior to the umbilical remnant with extensive lysis of adhesions.The peritoneal cavity was subsequently entered and extensive lysis of adhesions was continued.The pelvis was essentially free of adhesions and attention was directed to packing the bowels out of the operative area and the abdominal hysterectomy was completed.The round ligaments were identified after the uterus was elevated with kocher clamps; the round ligaments were transected and held.The infundibulopelvic ligaments were identified, the ureteric pathways were out of the operative area.The infundibulopelvic ligaments were doubly clamped, transected, transfixed and suture ligated.Serial pedicles were taken of the uterus and cervix, which was subsequently amputated.There was a small remnant of the cervix at the cuff, and this was removed.The cuff was closed using interrupted sutures of 0 vicryl.The patient did not appear to have a deep pelvis and occult culdoplasty was not performed.Irrigation was completed and hemostasis was noted.The remainder of the abdominal procedure will be dictated by dr.(b)(6).After closure of the abdominal incision dr.(b)(6) left the operating room and the anterior and posterior repair were completed.The patient had previously been placed in a lithotomy position in the bumblebee stirrups and appropriate placement was made.A posterior retractor was placed inside the vault to examine the extent of the defect.The attention was directed initially to the posterior repair.A dilute pitressin solution was used to distend the tissues and an incision was made posteriorly in a triangular shape.The mucosal surface was elevated and incised using metzenbaum scissors.The underlying endopelvic fascia was dissected off the mucosal surface as the tissues were held on traction with allis clamps.The defect-directed repair was completed with interrupted sutures of 2-0 vicryl.Excess tissue was trimmed and the mucosal edges were reapproximated with 3-0 vicryl.Attention was directed to the anterior repair in which a similar fashion the tissue was elevated with allis clamps and the skin of the mucosal surface was incised.A dissection was completed to identify the ilioinguinal fascia and a defect-directed repair was completed.This tissue was re-approximated using 3-0 vicryl.Careful inspection demonstrated that there was the appearance of some denuded tissue at the cuff, which was repaired with an interrupted suture of 0 vicryl.The apex of the posterior repair continued to have some bleeding and figure-of-8 sutures were placed with 3-0 vicryl.Once hemostasis was noted vaginal packing was placed, sponge, lap and needle counts were correct times 2 prior to complete closure of the abdomen and also prior to complete closure of the vaginal defect.Counts were correct at the end of the case.The patient was taken to the recovery room in stable condition.¿ ¿ on (b)(6) 2009: (b)(6) medical center.(b)(6), md.Pathology report.Specimens received: ¿1.Terminal ileum lesion.2.Uterus, fallopian tubes and ovaries, bilateral.3.Appendix.4.Mesenteric mass, distal.¿ final diagnosis: ¿part 1 ¿ ileum, small resection: intestinal neuroendocrine tumor/carcinoid tumor.Part 2 ¿ uterus, fallopian tubes and ovaries, hysterectomy with bilateral salpingo-oophorectomy.A.Acute cervicitis.B.Inactive pattern endometrium.C.Submucosal, intramural and subserosal leiomyomas.D.Adenomyosis.E.Serosal endometriosis.F.Benign paratubal cysts.G.Ovaries without significant pathologic alteration.Part 3 ¿ appendix, appendectomy: fibrous obliteration of the appendiceal lumen.Part 4 ¿ mesenteric nodule, biopsy: metastatic neuroendocrine tumor.¿ gross description: ¿part i - received fresh for frozen section consultation in a container labeled ¿(b)(6)' and '#1 terminal ileum lesion¿ is a non-oriented 1.7 x 1.5 x 1.3 cm portion of mucosa and submucosa.A cross-section is submitted for frozen sectioning.The remaining tissue is entirely submitted in cassettes a and b.Part 2 - received in a container of formalin labeled ¿(b)(6)' and ¿cervix, uterus, bso [bilateral salpingo-oophores]' is a hysterectomy specimen with bilateral attached adnexa.The uterus weighs 102 grams and measures 11 cm superior to inferior, 5.2 cm comu to comu, and 3.3 cm anterior to posterior.The serosa is tan-pink with multiple adhesions on the anterior surface.A rubbery firm subserosal nodule on the anterior fundus measures 0.4 cm in greatest dimension.The endocervix is tan and glistening and the slit-like os [sic] measures 1 cm in diameter.The endocervical canal is unremarkable and the transformation zone is focally hyperemic.The endometrial canal measures 4.2 cm in length and 3 cm comu to comu.The endometrium is glistening and tan, measuring up to 0.1 cm in thickness.Multiple white whorled submucosal and intramural nodules measure up to 3.4 cm in greatest dimension.No areas of hemorrhage or necrosis within any of the nodules are identified.No other mass lesions are identified.Also within the container is a rubbery tan-pink tissue measuring 2.4 x 1.4 x 0.9 cm.The tissue contains a long blue suture.Upon sectioning, the tissue has smooth tan-white cut surfaces and is consistent with cervix or vaginal tissue.The right fimbriated fallopian tube measures 4.2 cm in length and 0.5 cm in diameter.Multiple thin-walled paratubal cysts containing thin serous fluid measure up to 0.8 cm in greatest dimension.No mass lesions are identified.The right ovary measures 2.3 x 1.3 x 1.1 cm.Upon sectioning, one cyst with a smooth lining measures 0.4 cm in greatest dimension.No mass lesions are identified.The left fimbriated fallopian tube measures 3.3 cm in length and 0.5 cm in diameter.No cysts or mass lesions are identified.The left ovary measures 2.7 x 1.6 x 1.1 cm.The cut surfaces are unremarkable with a single smooth-lined cyst measuring 0-2 cm in greatest dimension.No mass lesions are identified.Sections are submitted as labeled: 2a - serosa including subserosal nodule; 2b -cervix; 2c - anterior endomyometrium with submucosal nodule; 2d - posterior endomyometrium; 2e - representative submucosal and intramural nodules; 2f - separate rubbery tissue containing suture; 2g - right fallopian tube with paratubal cysts and right ovary with cyst 2h - left fallopian tube and left ovary with cyst.Part 3- received in a container of formalin labeled ¿(b)(6)' and ¿appendix' is a 7.3 cm in length appendix with an average diameter of 0.7 cm.The serosa is tan-pink and smooth with no purulent exudate identified.The surgical margin is inked blue.The mucosa is yellow-tan and glistening and the wall thickness measures 0.1 cm.No fecaliths, perforations or mass lesions are identified.Representative sections, including the surgical margin, distal tip and cross-section, are submitted in cassette 3a.Part 4- received in a container of formalin labeled ¿hart kathryn¿ and ¿distal mesenteric mass¿ is a tan rubbery tissue measuring 1.6 x 1.3 x 0.7 cm.Upon sectioning, the cut surfaces are solid, smooth and tan-gray.The specimen is entirely submitted in cassettes 4a and 4b.
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Manufacturer Narrative
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H6: updated results code.Conclusion code remains unchanged.It should be noted that the gore® dualmesh® biomaterial instructions for use addresses the following adverse reactions among others: ¿possible adverse reactions with the use of any tissue deficiency prosthesis may include, but are not limited to, contamination, infection, inflammation, adhesion, fistula formation, seroma formation, hematoma, and recurrence.The gore® dualmesh® biomaterial instructions for use also states: ¿strict aseptic techniques should be followed.If an infection develops, it should be treated aggressively.An unresolved infection may require removal of the material.W.L.Gore & associates, inc.(gore) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by gore, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Blank fields present on this report include required fields and fields determined to be not applicable.Blank required fields indicate that the information was not provided, was deemed unavailable or was not applicable.This report does not constitute an admission or a conclusion by fda, gore, or its associates that the device, gore or its associates caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects" or has "malfunctioned".These words are included in the report and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.
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Manufacturer Narrative
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H6: updated health effect.H6: updated investigation finding.H6: updated type of investigation.H6: updated investigation conclusions.The investigation has been completed.Based upon the totality of the information received over the course of the investigation and reported by gore in the previously submitted medical record narratives the following conclusions have been reached.As previously reported, all pertinent medical records requested may not have been received.Through gore's investigation and based on the available information there is no available information that reasonably suggests that a gore device may have caused or contributed to death, serious injury or reportable malfunction, and is no longer considered reportable.Therefore, this event is being coded as no clinical signs, symptoms or conditions, no health consequences or impact and will be closed as no problem detected.Previous patient codes were reported based on the original complaint and are no longer applicable and/or not reportable per gore¿s investigation.It should be noted that the gore® dualmesh® biomaterial instructions for use include warnings and addresses the following adverse reactions among others: ¿possible adverse reactions with the use of any tissue deficiency prosthesis may include, but are not limited to, contamination, infection, inflammation, adhesion, fistula formation, seroma formation, hematoma, and recurrence.¿ the instructions for use further warn: ¿as with any implantable surgical device, strict aseptic techniques should be followed.If an infection develops, it should be treated aggressively.An unresolved infection may require removal of the material.¿ procedure and specific patient factors may contribute to or cause infection, leading to contamination, exposure, lack of incorporation and/or seeding of device.Procedure related factors may include adherence to clinical guidelines on infection risk management, contamination of device prior to or during implant, and post-operative persistent/symptomatic seroma and wound management.Patient risk factors may include diabetes, smoking, age, malnutrition, immunosuppressive therapy, post-operative instruction noncompliance, and hygiene.As with any surgical procedure, there are always risks of complications for surgical repair of hernias and soft tissue deficiencies, with or without mesh.These may include but are not limited to, adhesions and related harms, bleeding, bowel obstruction, compromised device biocompatibility, contamination which may lead to patient harms, device damage, dysphagia, erosion or extrusion and related harms, exposure or protrusion and related harms, fever, fistula, gerd recurrence, defect recurrence and related harms, ileus, increased procedure time and related harms, irritation or inflammation, infection, mesh migration, mesh contraction, pain, paresthesia, perforation, revision/re-intervention, seroma or hematoma and related harms, tissue ischemia, wound complications and wound dehiscence and additional intervention including surgery.Many of the potential complications are associated with the patient¿s underlying disease progression, co-morbidities, additional medical history and/or other surgical procedures.The above inherent risks are typically detailed in standard informed consent documents.Based upon the information received, the device remains in the patient and was not available for evaluation.Review of the manufacturing and sterilization 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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