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W. L. GORE & ASSOCIATES, INC. GORE® DUALMESH® PLUS BIOMATERIAL; MESH, SURGICAL, POLYMERIC
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Back to Search Results |
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| Model Number 1DLMCP02 |
| Device Problem
Insufficient Information (3190)
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| Patient Problems
Obstruction/Occlusion (2422); No Clinical Signs, Symptoms or Conditions (4582)
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| Event Date 09/16/2020 |
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Event Type
Injury
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Manufacturer Narrative
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The plus antimicrobial product coating contains silver carbonate [approximately 800 micrograms per cubic centimeter of product (¿g/cm3)], and chlorhexidine diacetate [approximately 1600 micrograms per cubic centimeter of product (¿g/cm3)].It should be noted that the gore® dualmesh® plus biomaterial instructions for use addresses the following adverse reactions among others: ¿possible adverse reactions with the use of any tissue deficiency prosthesis may include, but are not limited to, contamination, infection, inflammation, adhesion, fistula formation, seroma formation, hematoma, and recurrence.".
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Event Description
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It was reported to gore that the patient underwent open ventral hernia repair on (b)(6) 2015 whereby a gore® dualmesh® plus biomaterial was implanted.The complaint alleges that on (b)(6) 2020, an additional procedure occurred whereby the gore device was explanted.It was reported the patient alleges the following injuries: removal of gore mesh, mesh was not incorporated into the fascia, mesh was entangled in very dense adhesions, stiff and unwieldy, small bowel resection, small bowel obstruction, incarcerated recurrent ventral hernia repaired with sutures.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) healthcare.(b)(6), do.Consultation.Hematochezia, rectal pain.Abdomen soft, obese.Plan: colonoscopy with higher risk of perforation due to radiation in pelvis.¿ (b)(6) 2008: (b)(6) healthcare.(b)(6), do.Procedure report.Preoperative diagnosis: hematochezia.Postoperative diagnosis: rectal and sigmoid colitis with grade 4 hemorrhoidal disease and colonic polyp at 45 cm.Operation performed: colonoscopy with multiple biopsies with cold biopsy polypectomy x1.¿ (b)(6) 2008: (b)(6) clinic.(b)(6), do.Office notes.Status post colonoscopy; no direct etiology of hematochezia found.Given trial of steroids; did not decrease rectal bleeding.Abdomen soft, nontender, no hernias.Impression: hematochezia, grade 4 hemorrhoidal disease.Plan: stapled hemorrhoidectomy.¿ (b)(6) 2008: (b)(6) healthcare.(b)(6), do.Operative report.Preoperative diagnosis: grade 4 hemorrhoidal disease.Postoperative diagnosis: grade 4 hemorrhoidal disease.Operation performed: procedure for prolapsed hemorrhoidal tissue.¿ (b)(6) 2008: (b)(6) clinic.(b)(6), do.Office notes.Medical history: adenocarcinoma of urethra, hemorrhoidal disease, hypothyroidism, methicillin-resistant staphylococcus aureus infection of ankle, methicillin-resistant staphylococcus aureus infection from peripherally inserted central catheter line.Surgical history: appendectomy, hysterectomy, urethral resection.Exam: obese.Abdomen soft, nontender, no hernias.Impression: hematochezia.¿ (b)(6) 2008: (b)(6) healthcare.(b)(6), do.Operative report.Preoperative diagnosis: hematochezia, rectal pain.Postoperative diagnosis: rectal polyp.Skin changes with stigmata from radiation treatment.Operations performed: transanal resection of rectal polyp.Rectal dilation.Rectal biopsy.¿ (b)(6) 2008: (b)(6) healthcare.(b)(6).Radiology ¿ ct abdomen/pelvis with contrast.Indication: left lower quadrant pain, urethral cancer.Findings: linear fluid collection along left pelvic sidewall, extending to the anterior left ventral abdominal wall.Shows apparent rim enhancement and some adjacent stranding.Could be postsurgical fluid collection.Metastatic disease and abscess considered, less likely.Mild diverticulosis.Impression: linear fluid collection with peripheral enhancement along left pelvic sidewall may be postsurgical.Radiation changes also considered.Abscess not excluded.Small nodule right lower lobe.¿ (b)(6) 2010: (b)(6) healthcare.(b)(6), md.History and physical.Social: doesn¿t smoke or drink.Weight: 227 lbs.Implant procedure: repair of hernia with gore dualmesh.Implant: gore® dualmesh® plus biomaterial (1dlmcp02/(b)(6)), 1mmx8x12cm] implant date: (b)(6) 2015 (hospitalization (b)(6) 2015) ¿ (b)(6) 2015: (b)(6) healthcare.(b)(6), md.Operative report.Preoperative diagnosis: ventral hernia.Postoperative diagnosis: 7 x 4 cm ventral hernia, left lower quadrant, possibly started as an incisional hernia.Indications: a 75-year-old woman with a symptomatic left lower abdominal hernia.Findings: a 7 x 4 cm hernia defect.We used an 8 x 12 dualmesh placed and secured with nonabsorbable sutures.From the ct scan, i thought she might have some radiation affect [sic] to the small intestine, but it did not appear to be affected.There was small bowel in the sac.Description: ¿the patient was brought to the operating room, general endotracheal anesthesia in the supine position.The patient¿s abdomen was prepped with chloraprep and draped.Skin was infiltrated with 0.25% marcaine with epinephrine.Incision was made transversely over the majority of the hernia which does seem to start near the midline.The hernia sac was dissected and removed.Small intestine placed back in the abdominal cavity.The edges of the internal and external oblique were freshened and freed from surrounding scar in hernia sac.This did not come together with just sutures and gore dualmesh was placed with the smooth side in the abdominal peritoneal cavity and secured with both interrupted and running sutures of 0 and #1 novafil.Hemostasis achieved.I was able to draw some of the hernia sac over the top of this to provide some coverage of the mesh.Subcutaneous tissue was closed with 3-0 vicryl.A 19 blake drain was placed and brought out through the inferior flap.Skin closed with a subcuticular 4-0 vicryl.She tolerated the procedure well and returned to the recovery room in stable condition.¿ ¿ (b)(6) 2015: (b)(6) healthcare.Implant record.Mesh dualmesh 1mmx8x12cm no-h ¿ log365449 - implanted.Inventory item: mesh dualmesh 1mmx8x12cm no-h.Serial number: (b)(6).Lot number: 12318406.Model/cat number: 1dlmcp02.Manufacturer: w.L.Gore and associates, inc.Status: implanted.¿ the records confirm a gore® dualmesh® plus biomaterial (1dlmcp02/(b)(6)) was implanted during the procedure.Relevant medical information: ¿ (b)(6) 2020: (b)(6).(b)(6), md.Radiology ¿ ct abdomen/pelvis with contrast.Indication: bowel obstruction high-grade suspected.Findings: left lower quadrant anterior abdominal wall hernia with mildly dilated loops of fluid-filled small bowel and fluid and inflammatory changes in the hernia sac concerning for strangulation.There is adjacent mesh consistent with prior hernia repair slightly more superior to current hernia.Impression: left lower quadrant anterior abdominal wall hernia containing mildly dilated loops of small bowel with fluid and inflammatory findings and mild dilation of the upstream small bowel concerning for strangulated hernia with bowel obstruction.Surgical consultation recommended.¿ (b)(6) 2020: (b)(6) healthcare.(b)(6), md.History and physical.Presents to emergency department with abdominal pain; pain on and off since wednesday; on further questioning, it has been present for a few months and she knows it to be a recurrent ventral hernia.Daughter notes area gets larger, mother pushes it in and goes down again.Some nausea, emesis of bilious fluid today.Last bowel movement today and was soft.Seen by dr.(b)(6) in billings regarding hernia repair last month and recommendation was made against having hernia repair as patient is high risk for complications with history of radiation for urethral cancer.Patient unsure when previous ventral hernia was repaired.Has not been avoiding heavy lifting or wearing a binder.Impression: i have reviewed vitals, labs and radiology.80 female with reducible recurrent incisional hernia previously repaired with mesh.With wide hernia neck, mildly dilated and easily reduced small bowel, strangulation is unlikely.Continues to have abdominal discomfort after pain medication however, so will admit for observation and pain control.Explained to patient and daughter present that hernia repair is risky given history of radiation and presence of previous mesh, however with repeated episodes of pain or with incarceration, one may then consider the benefit of surgery to outweigh the risks.Plan: admit, nothing by mouth for bowel rest, intravenous fluids, pain control, antiemetics, trend labs, abdominal binder, avoid heavy lifting, pushing, pulling, straining.**nurse noted bradycardia to 30s; will obtain ekg and consult hospitalist.Admit on telemetry.**daughter at bedside expressed concern with patient having surgical intervention here, relayed that dr.(b)(6) had advised against surgery but also did propose surgery if symptoms worsened.They inquire about transfer for management and for surgery.Noting that admission today is for observation, unclear if patient will need urgent or emergent intervention, thus may be unable to transfer at this point in care given no acute reason.Option of driving in personal vehicle to billings not advisable as observation is recommended to monitor for deterioration.After further discussion, they are in agreement for admission, observation, emergent surgical intervention here as needed, and will plan for follow up with dr.(b)(6) for planned surgical intervention upon discharge from hospital.Called billings clinic, left message for dr.(b)(6) who is covering for dr.(b)(6) to call back regarding patient case.¿ (b)(6) 2020: (b)(6).(b)(6), md.Radiology ¿ x-ray kub abdomen.Indication: partial small bowel obstruction.Findings: right hemidiaphragm is elevated.Colon mildly distended with stool and gas.Impression: air-filled loops of small and large bowel.No air-fluid levels seen or other radiographic evidence of obstruction.¿ (b)(6) 2020: (b)(6).(b)(6), md.Radiology ¿ x-ray abdomen 1 view.Indication: small bowel obstruction.Impression: increasing dilation of the small bowel suggesting worsening small bowel obstruction.¿ (b)(6) 2020: (b)(6).(b)(6), md.Radiology ¿ x-ray abdomen 1 view.Findings: stable dilation of small bowel suggesting obstruction.Impression: no short-term interval change.¿ (b)(6) 2020: (b)(6).(b)(6), md.Radiology ¿ ct abdomen/pelvis with contrast.Indication: abdominal pain, hernia suspected, hernia previously reduced left lower quadrant, now right lower quadrant pain.Findings: compressive atelectasis right lower lobe.Diffusely dilated small bowel loops, with evidence of herniated bowel and fat in the left lower quadrant, adjacent to the region of prior mesh repair.Associated edema and fluid in the herniated mesenteric fat, with high-grade small bowel obstruction.Small hiatal hernia.Ascites.Prior mesh repair left lower quadrant.Recurrent hernia at the margin of the mesh repair, associated with relatively high-grade small bowel obstruction.Impression: high-grade small bowel obstruction associated with recurrent herniation of small bowel mesentery in left lower quadrant, at margin of previous mesh repair.Findings similar to recent study; increased small bowel dilatation suggesting persistent and probably progressive obstruction.Bilateral pleural effusions.¿ (b)(6) 2020: (b)(6) healthcare.(b)(6), crna.Anesthesia record.Weight: 170 lbs., bmi 36.2 ((b)(6) 2020).Asa: 2.Explant procedure: exploratory laparotomy.Small bowel resection with primary anastomosis.Partial omentectomy.Abdominal washout and drain placement.Mesh extraction with ventral hernia repair.Explant date: (b)(6) 2020 (hospitalization (b)(6) 2020) ¿ (b)(6) 2020: (b)(6) healthcare.(b)(6), md.Operative report.Anesthetist: (b)(6), crna.Anesthesia: general.Preoperative diagnosis: small bowel obstruction due to recurrent, incarcerated ventral hernia.Postoperative: strangulated ventral hernia with infarcted small bowel.Indications: 80f presented with ventral hernia, reduced in ed and admitted for pain control.However hernia recurred and became incarcerated with concern for strangulation based on physical exam, labs and imaging.Recommendation was made for surgery.Informed consent was obtained from patient, case discussed in detail and at length with patient and family, including risk of complications related to h/o radiation, high risk of hernia recurrence.All questions were answered and the collaborative decision was made to proceed with surgery.Ct scan reviewed, no bladder involvement in hernia noted, small bowel within hernia, fluid noted in right paracolic gutter.Findings: ischemic portion of ileum.Small nodule on omentum.Displaced mesh.Dense scar tissue with thickened small bowel with radiation changes.Case description: ¿patient was brought into the or suite and placed on the table in the supine position.Scds were placed, antibiotics were still being infused from the floor.General anesthesia was induced, foley catheter was inserted which was difficult given radiation to urethra, however return of urine confirmed accurate placement.Abdomen was prepped and draped in usual sterile fashion, timeout was called the case was started.Using a 10 blade scalpel a midline infraumbilical incision was made going through patient¿s previous scar.Using blunt dissection the hernia sac was encountered to the left of midline, noted to contain black infarcted small bowel.Care was taken to minimize manipulation of the bowel to prevent perforation.The incision was extended cephalad to 2cm superior to the umbilicus, carried down to the level of the fascia using cautery.Fascia was divided with cautery, peritoneum bluntly penetrated with a finger, and while protecting intraabdominal organs the fascia was divided cephalad to the hernia.With careful exploration the hernia neck was identified and widened with cautery, however the bowel could not be pulled up.Concern was for possible frozen abdomen so decision was made to continue dissection until more of the underlying bowel could be visualized.The previous mesh was encountered which was partially covered in capsule but not incorporated into the fascia.It was entangled in very dense adhesions, made even more stiff and unwieldy by fibrosis related to radiation changes.Mesh was divided for better visualization.Ischemic omentum within the defect was transected with cautery to allow better visualization, passed off the field.A portion of this was sent as specimen because there was an attached subcentimeter white nodule of unclear significance.One dense adhesive band had formed a secondary hernia neck to the right of midline which contributed to the bowel and mesentery strangulation.The adhesion was taken down under direct visualization after which the compromised bowel was freed.The compromised bowel was noted to extend intraabdominally, resting within the right lower quadrant and pelvis.It was held in place by thin filmy adhesions easily broken by sweeping motions.The entire affected bowel was then gently pulled up into the field.There was serosanguinous fluid in the pelvis, no purulence or succus indicating perforation.On examination the bowel and associated mesentery were intact but deep red to black in color, mesentery was tapered to a point with sharp demarcation of viable and non-viable mesentery.55cm of small bowel was affected.The bowel was run proximally to the ligament of treitz and distally to the ileocecal valve, no other compromised bowel noted.The infarcted bowel was noted to be located in the distal ileum.It was resected using a gia stapler, mesentery take down with liagasure device with care to protect intraabdominal structures.Specimen passed off the field.Proximal bowel was healthy in appearance, distal small bowel was thickened, pale pink and smaller in caliber than proximal bowel indicating chronic radiation injury.Field was draped off and primary anastomosis created with a 70mm gia stapler with care to ensure proper alignment of bowel in side-to-side fashion.About 100ml of dark red fluid was suctioned from within the bowel, likely resulting from the now resected infarcted bowel.Resulting in enterotomy closed in two layers ¿ running 3-0 vicryl to bring mucosal edges together directly, followed by interrupted 3-0 silk in lembert fashion.Anastomosis palpated afterwards and noted to be intact, widely patent.Gloves and draping were then changed.Mesenteric defect closed with interrupted 3-0 vicryl.There was small bowel adherent to the mesh on the left side, these adhesions were taken down sharply with metzenbaum scissors revealing serosal tears in the small bowel wall.These were repaired with 3-0 vicryl.The mesh was then excised completely along with anchoring prolene sutures.The hernia sac was also excised with cautery and sent as specimen.Liver palpated and noted to be intact, stomach palpated with ng tube noted in good position.The entire abdomen was then copiously irrigated until clear using 2l warm ns followed by 1l warm antibiotic solution.Special attention paid to irrigating right abdomen and pelvis.Hemostasis achieved with cautery, fascial edges freshened excising scar tissue and residual sac fragments.Sac cavity in the left abdominal wall was closed with 2-0 vicryl.10mm flat drains were then placed ¿ one in the pelvis and the other in the right upper quadrant where fluid was noted on preop imaging.Fascia was then closed in running fashion with #1 double stranded pds.Left lower abdominal wall fascia was noted to be thin, however in the setting of ischemic infarcted bowel any permanent mesh placement has high likelihood infection so primary repair alone was carried out.Subcutaneous wound was irrigated with ns, previous abdominal scar excised with cautery.3-0 vicryl used to place deep dermal sutures and skin closed with staples.Drains sewn in place with 3-0 nylon, connected to bulb suction.Prevena wound vac applied to abdomen, drain dressings applied.Patient woken from anesthesia and transferred to pacu in stable condition.She tolerated the case well.¿ specimens: small bowel.Omentum with attached nodule.Hernia sac and mesh.Ebl: 200ml ¿ includes 100ml suctioned from within small bowel.Drains or implants: flat 10mm drains x 2.Complications: none.Condition: stable.Disposition: pacu.¿ (b)(6) 2020: (b)(6) healthcare.(b)(6), md.Operative note.Preoperative diagnosis: small bowel obstruction due to ventral hernia.Postoperative diagnosis: ventral hernia with ischemic strangulated ileum.Procedure: exploratory laparotomy, small bowel resection with primary closure, abdominal washout with drain placements.Findings: ischemic portion of ileum.Small nodule on omentum.Displaced mesh.Dense scar tissue with thickened small bowel consistent with radiation changes.Relevant medical information: ¿ (b)(6) 2020: (b)(6), inc.(b)(6), md.Pathology report.Id: (b)(6).S.Final diagnosis: specimen: 1.Small bowel resection.Diagnosis: a.Ischemic and hemorrhagic bowel infarction.B.Viable luminal margins.Specimen: 2.Omentum, biopsy.Diagnosis: nodular fat necrosis with dystrophic calcification.Specimen: 3.Hernia sac, excision.Diagnosis: mesh and fibroadipose tissue with fibrosis and chronic inflammation, consistent with hernia sac.Microscopic description: specimen 1 ¿ except for a minute focus of early ischemic enteritis, the stapled luminal margins are viable.Sections from the center of the bowel show diffuse transmural ischemic and hemorrhagic infarction.Specimen 2 ¿ microscopic examination reveals adipose tissue showing patchy mild chronic inflammation, focal fibrosis, and a nodular focus of fat necrosis with dystrophic calcification.Specimen 3 ¿ microscopic examination reveals mesh material and fibroadipose tissue with fibrosis and chronic inflammation.Clinical information: incisional hernia without obstruction or gangrene.Unspecified intestinal obstruction, unspecified as to partial versus complete obstruction.Gross description: specimen 1 is received in formalin in a container labeled ¿(b)(6) ¿ small bowel resection¿ and consists of a segment of small bowel with attached mesentery measuring 18 x 11 x 5 cm overall.The bowel is unoriented and is closed on both ends with surgical staples.Sections of the luminal margins are submitted in cassette ¿1a¿.The bowel shows diffuse purple-black serosal discoloration.The bowel is opened to reveal hemorrhagic fluid and diffuse mucosal hemorrhage.Representative sections of hemorrhagic bowel are submitted in cassettes ¿1b¿ ¿ ¿1c¿.Specimen 2 is received in formalin in a container labeled ¿(b)(6) ¿ omentum¿ and consists of one lobular tan-yellow piece of fibrofatty tissue with a tiny firm pink-white nodule.The specimen is submitted entirely in cassette ¿2a¿.Specimen 3 is received in formalin in a container labeled ¿(b)(6) ¿ hernia sac¿ and consists of multiple pieces of fibroadipose tissue with adherent mesh and attached sutures.Representative sections submitted in cassette ¿3a¿.Indications: abdominal discomfort.¿ (b)(6) 2020: (b)(6) healthcare.(b)(6), md.Discharge summary.Primary diagnosis: ventral hernia (resolved).Procedure: open ventral hernia repair with small bowel resection.Complications: none.Presented with abdominal pain.Workup revealed ventral hernia which was initially reduced with improvement in symptoms.Plan was for admission for pain control, outpatient repair given history of radiation and concern for complicated repair.During admission, hernia recurred, became strangulated, so underwent exploratory laparotomy with infarcted small bowel resection and hernia repair.Postoperatively, received intravenous antibiotics and pain control, diet slowly advanced after return of bowel function.Had upper abdominal discomfort related to stress gastritis which was treated with medications; also had sympathetic pleural effusion on right which improved.Preoperative leukocytosis resolved following surgery.Completed 7 days of intravenous antibiotics in total.Hypophosphatemia and hypomagnesemia were treated as well in the postoperative period.Now being discharged to swing bed for continued management of midline wound and jackson-pratt drains.Discharge to skilled nursing facility (swing bed).Facility orders: wound care: change midline abdominal wound dressing daily with gauze and tape.Monitor and record jackson-pratt drain output every shift.Mechanical soft diet for total of 2 weeks postoperatively.Ambulate 4 times a day, out of bed to chair at least twice daily.¿ (b)(6) 2020: (b)(6) healthcare.(b)(6), np.History and physical.80-year-old admitted with abdominal pain.Admitted (b)(6) 2020 with increasing abdominal pain for approximately 5 days and intermittent pain for a number of months, history of recurrent ventral hernia.Found to have incarcerated hernia and had a small bowel resection with primary anastomosis on (b)(6) 2020.Having formed stools, eating, continues to require dressing changes to operative site.Reports pain controlled.Continues with weakness.Admitted for physical debility, dressing changes.Positive malaise/fatigue, abdominal pain, myalgias, weakness.Medical history: anxiety, depression, fall, heartburn, history of deep vein thrombosis, history of methicillin-resistant staphylococcus aureus, hypertension, hypothyroid, diffuse large b cell lymphoma, neuropathy, transient ischemic attack, urethral cancer; had radiation and chemotherapy.Surgical history: abdominal surgery, appendectomy, colon resection 9/16/20, epidural steroid injection, ventral hernia repair with mesh, hysterectomy/oophorectomy, urethral resection/revision.Tobacco: never smoker.Impression: physical debility.History of hernia repair, lymphoma ¿ enrolled in clinical trial (b)(6).She underwent treatment with rituxan and chop.Original pet showed positive lymph node involvement in cervical region, supraclavicular region, superior mediastinum and spleen.Plan: debility-continue with physical therapy and occupational therapy.Incarcerated ventral hernia-repaired, continue with dressing change as recommended by surgeon.¿ (b)(6) 2020: (b)(6) healthcare.(b)(6), md.Discharge summary.Procedures: exploratory laparotomy with ventral hernia repair and resection of infarcted small bowel.Complications: none.Presented with abdominal pain and workup revealed ventral hernia.Hernia reduced in emergency department, recurred and became strangulated for which she underwent open ventral hernia repair with small bowel resection and re-anastomosis.Postoperatively, received intravenous antibiotics, tolerated soft diet, pain well controlled.Discharged after removal of drains and staples.Follow up 3-5 days.A potential relationship, if any, between the alleged injuries or complications and the gore device has not been established at this time based on available information.It should be noted that the gore® dualmesh® plus 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® plus 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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Manufacturer Narrative
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H6: updated results code.Conclusion code remains unchanged.It should be noted that the gore® dualmesh® plus 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® plus biomaterial instructions for use also states: ¿strict aseptic techniques should be followed.If an infection develops, it should be treated aggressively.An unresolved infection may require removal of the material.W.L.Gore & associates, inc.(gore) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by gore, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Blank fields present on this report include required fields and fields determined to be not applicable.Blank required fields indicate that the information was not provided, was deemed unavailable or was not applicable.This report does not constitute an admission or a conclusion by fda, gore, or its associates that the device, gore or its associates caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects" or has "malfunctioned".These words are included in the report and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.
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Manufacturer Narrative
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H6: updated health effect.H6: updated investigation finding.H6: updated type of investigation.H6: updated investigation conclusions.The investigation has been completed.Based upon the totality of the information received over the course of the investigation and reported by gore in the previously submitted medical record narratives the following conclusions have been reached.As previously reported, all pertinent medical records requested may not have been received.Through gore's investigation and based on the available information there is no available information that reasonably suggests that a gore device may have caused or contributed to death, serious injury or reportable malfunction, and is no longer considered reportable.Therefore, this event is being coded as no clinical signs, symptoms or conditions, no health consequences or impact and will be closed as no problem detected.Previous patient codes were reported based on the original complaint and are no longer applicable and/or not reportable per gore¿s investigation.Following gore¿s investigation, the previously submitted annex f code has been updated to reflect gore¿s final conclusion.It should be noted that the gore® dualmesh® plus 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.¿ as with any surgical procedure, there are always risks of complications for surgical repair of hernias and soft tissue deficiencies, with or without mesh.These may include but are not limited to, adhesions and related harms, bleeding, bowel obstruction, compromised device biocompatibility, contamination which may lead to patient harms, device damage, dysphagia, erosion or extrusion and related harms, exposure or protrusion and related harms, fever, fistula, gerd recurrence, defect recurrence and related harms, ileus, increased procedure time and related harms, irritation or inflammation, infection, mesh migration, mesh contraction, pain, paresthesia, perforation, revision/re-intervention, seroma or hematoma and related harms, tissue ischemia, wound complications and wound dehiscence and additional intervention including surgery.Many of the potential complications are associated with the patient¿s underlying disease progression, co-morbidities, additional medical history and/or other surgical procedures.The above inherent risks are typically detailed in standard informed consent documents.The device was not able to be returned to gore for evaluation; therefore, a direct product analysis could not be conducted.Review of the manufacturing records verified that the lot met all pre-release specifications.C1: the plus antimicrobial product coating contains silver carbonate [approximately 800 micrograms per cubic centimeter of product (g/cm3)], and chlorhexidine diacetate [approximately 1600 micrograms per cubic centimeter of product (g/cm3)].W.L.Gore & associates, inc.(gore) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by gore, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Blank fields present on this report include required fields and fields determined to be not applicable.Blank required fields indicate that the information was not provided, was deemed unavailable or was not applicable.This report does not constitute an admission or a conclusion by fda, gore, or its associates that the device, gore or its associates caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects" or has "malfunctioned".These words are included in the report and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.
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