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Model Number 1DLMC07 |
Device Problem
Insufficient Information (3190)
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Patient Problems
Death (1802); Unspecified Infection (1930); Inflammation (1932); No Code Available (3191); No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
Injury
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Manufacturer Narrative
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(b)(4).The initial reporter's complete address is brenes (b)(6).It should be noted that the instructions for gore® dualmesh® biomaterial use includes warnings and addresses the following adverse reactions among others: ¿possible adverse reactions with the use of any tissue deficiency prosthesis may include, but are not limited to, contamination, infection, inflammation, adhesion, fistula formation, seroma formation, hematoma, and recurrence.¿.
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Event Description
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It was reported to gore that the patient underwent laparoscopic ventral hernia repair on (b)(6) 2006 whereby a gore® dualmesh® biomaterial was implanted.It was reported the patient alleges the following injuries: draining wounds with tube insertions; chronic infection & inflammation; sepsis; pain & suffering; death (b)(6) 2019.Additional event specific information was not provided.
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Manufacturer Narrative
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Code 3191 (no code available) is being used for "sepsis".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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Manufacturer Narrative
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Additional details regarding the patient's clinical course were ascertained from a review of medical records and are as follows: ??/??/??: [missing records: records for low anterior colon resection for a large villous adenoma of the rectum were not provided].??/??/??: [missing records: records for exploratory laparotomy, lysis of adhesions, small bowel resection times two and diverting sigmoid colostomy due to the complicated anastomotic problem were not provided].On (b)(6) 2006: [missing records: radiology records for ct scan of abdomen and pelvis to ensure did not have peristomal component were not provided].On (b)(6) 2006: (b)(6) hospital.(b)(6) , md.Operative report.First surgical assistant: (b)(6) , md.Anesthesia: general endotracheal anesthesia.Preoperative diagnosis (es): ventral incisional hernia.Postoperative diagnosis (es): ventral incisional hernia 19 cm x 10 cm.Name of operation: laparoscopic ventral hernia repair with polytetrafluoroethylene mesh, 30 cm x 20 cm.Estimated blood loss: 50 ml.Intraoperative fluids: 3400 ml of lactated ringer¿s.Preoperative medications: ancef 2 grams intravenous.Sponge, needle and instrument counts: counts correct.Complications: none.Drains: orogastric tube, foley catheter.Disposition: extubated to the recovery room in stable condition.Indications for procedure: the patient is a 66-year-old gentleman who has previously undergone multiple abdominal operations.He underwent a low anterior colon resection for a large villous adenoma of the rectum.He developed a postoperative leak with a chronic presacral abscess, eventually causing him a small bowel obstruction requiring exploratory laparotomy, lysis of adhesions, small bowel resection times two and diverting sigmoid colostomy due to the complicated anastomotic problem.In the postoperative period he developed pain and a bulge in his midline incision.The bulge increased in size over a short period of time.He was initially evaluated in the office and physical examination demonstrate a reducible midline ventral incisional hernia.The proximity to his colostomy was 4 to 5 cm.I obtained a ct scan of the abdomen and pelvis to ensure that he did not have a peristomal component.Ct scan did not demonstrate this.The risks, benefits and alternatives of treatment were reviewed with the patient and he elected to proceed with a laparoscopic ventral incisional hernia repair, possible open.The patient underwent mechanical and antibiotics bowel preparation preoperatively.Description of procedure: ¿the patient was brought to operating room and given general endotracheal anesthesia.He was placed supine and his arms were tucked at his sides and heavily padded.Sequential compression devices were placed in the lower extremities prior to induction of anesthesia.He was given ancef 2 grams intravenous, orogastric tube and foley catheter were placed.His colostomy was isolated by being packed with a 4 x 4 and covered with a tegaderm.His abdomen was then prepped and draped in a sterile fashion including ioban dressing.Initial trocar placement was in the right upper quadrant using the hasson technique.A balloon-tipped trocar was placed and the abdomen was insufflated with carbon dioxide to 15 mmhg.Under direct endoscopic vision, two 5-mm trocars were placed in the right lateral abdomen.The patient had extensive intra-abdominal adhesion mostly small bowel to the anterior abdominal wall and pelvis.These were taken down sharply.Cautery was not utilized during the dissection.Hemostasis was achieved with clips.The anterior abdominal wall, lateral sidewalls were completely cleared of small bowel adhesions.The colostomy was isolated in the left lateral abdomen.The stoma site was slightly dilated but no hernia was present.Falciform ligament was then taken down using cautery dissection.One area of serosal tear on the small bowel was oversewn with 0 ethibond suture.The entire small bowel and operative area was reinspected after the dissection and inspected serially during the dissection.There were no signs that the integrity of the bowel was of concern.At this point the defect was measured in the craniocaudal and transverse dimension.It measured 10 cm in the transverse dimension and 19 cm in craniocaudal dimension.The patient had a dominant hernia that measured only approximately 8 cm in the craniocaudal length but had an attenuated midline fascia, so therefore the entire incision was covered.Two 5-mm trocars were placed under direct vision in the right lateral abdomen.Cv-0 gore-tex sutures were placed midway along the longitudinal axis to each side of the mesh.The mesh was rolled like a scroll and introduced in the abdomen in retrograde fashion through the 10-mm port site, pulled in with a prestige grasper.The mesh was then unraveled and positioned appropriately.It should be noted that on the side of the colostomy, the distance between the upper defect and the colostomy was measured and two stay cv-0 gore-tex sutures were placed 10 cm apart on either side of where the mesh would wrap around the colostomy using a sugarbaker technique.The cranial fixation suture was placed first, then the two sutures around the colostomy site and then the suture in the lower part of the midline abdomen.The mesh sat nicely around the colostomy with appropriate amount of laxity but sill isolated the colostomy slightly lateral to its opening into the abdominal wall.The last fixation suture was then placed.The mesh was then tacked circumferentially except in the area of the colostomy with a spiral titanium tacker.The tacks were placed medially on the mesh on either side of the colostomy to close the inner aperture of the stoma site.#1 prolene sutures were then placed at 2-cm intervals circumferentially.Again, sutures were placed on either side of the tacks that were placed along the side of the colostomy.At the conclusion of the procedure, hemostasis was confirmed.The bowel was reinspected and again the integrity was not of concern.All trocars were removed and the abdomen was deflated after closing the initial hasson trocar site with interrupted 0 vicryl sutures using a suture passer.All trocar sites were closed with 4-0 monocryl subcuticular stitches.Dry sterile dressings consisting of benzoin and steri-strips were placed on all fixation suture sites and trocar sites.After this, the tegaderm and 4 x 4s were removed from the colostomy site and a stoma appliance was placed.The patient was awakened from general anesthesia and transferred to the recovery room in stable condition.The adhesiolysis took one hour and 28 minutes of operative time.I was present for the entire procedure including patient positioning and placement of the trocars, laparoscopic adhesiolysis, laparoscopic ventral hernia repair with mesh, and closure of all wounds.¿ on (b)(6) 2006: (b)(6) hospital.Implant record.Surgeon: (b)(6).Procedure: ventral hernia repair with mesh, laparoscopic.Location: abdomen.Implant sticker.Gore dualmesh® biomaterial.Ref catalogue number: 1dlmc07.Lot batch code: 04330212.W.L.Gore & associates.The records confirm a gore® dualmesh® biomaterial (1dlmc07/04330212) was implanted during the procedure.On (b)(6) 2018: [missing records: radiology records for ct scan showing ¿same but smaller collection¿ were not provided].On (b)(6) 2018: [missing records: radiology records for ct scan showing ¿mesh with associated extraluminal air and fluid¿ were not provided].On (b)(6) 2018: (b)(6).(b)(6) , md; (b)(6) , md.History and physical.79-year-old with significant co-morbidities who was restrained driver in a motor vehicle crash versus tree earlier today, unknown low speed, questionable loss of consciousness, confused and somewhat amnestic to event.Deconditioned with many co-morbidities including adrenal insufficiency on chronic steroids with history left hemicolectomy with end ileostomy and ventral hernia repair with mesh.Motor vehicle collision secondary to altered mental status from sepsis due to acute worsening of chronic right lower quadrant mesh infection.On ct, mesh with associated extraluminal air and fluid.Of note, same but smaller collection seen on prior imaging from (b)(6) 2018.Outside hospital pan-scan no other significant findings.Current outpatient prescriptions: aspirin (ecotrin), empagliflozin (jardiance).Impression/plan: following.On (b)(6) 2018: (b)(6) hospital.(b)(6) , md; (b)(6) , md.Procedure report.Procedure: image guided drainage peritoneal or retroperitoneal fluid collection.History/indication: 79-year-old man admitted with sepsis after motor vehicle collision.Prior ventral hernia repair with mesh and concern for hernia mesh infection.Interventional radiology consultation for fluid drainage in right lower quadrant.Attending presence: dr.Picus, attending radiologist, present from beginning to end of procedure.Sedation: moderate sedation administered under attending physician¿s direction and continuous monitoring by trained nurse specialist independent from those performing procedure.Total monitored sedation time 15 minutes.Technique: ¿risks, benefits and alternative were discussed and informed consent was obtained.Prior to beginning procedure, universal protocol was used to confirm the patient¿s identity and planned procedure.If fluoroscopy was used, the fluoroscopy time has been recorded in the electronic medical record.Maximum sterile barriers including cap, mask, hand hygiene, sterile gloves, sterile gown, large sterile drape and 2% chlorhexidine for cutaneous antisepsis were used.The skin overlying the fluid collection in the right lower quadrant was sterilely prepped, draped and infiltrates with 1% buffered lidocaine.The target collection was then assessed with a [sic] 18 gauge needle using imaging guidance which included ultrasound.Contrast was injected to confirm needle placement.A guidewire was advanced and coiled within the collection before dilating the tract to 12 french.A 12-french dawson-mueller was then advanced over the guidewire and secured in place with a stitch of 0-prolene.The catheter was connected to suction drainage.A sterile dressing was applied.A sample of the fluid was sent for culture.¿ estimated blood loss: minimal.Condition: stable.Discharged to: recovery and then to home.Findings: images from the procedure revealed a collection that was small and heterogeneously echogenic.The fluid appeared brown.An approximate volume of 6 cc was drained at the time of the procedure.Impression: successful image guided right lower quadrant fluid collection drainage.Plan: tube should be flushed with saline 5 ml normal saline twice a day.On (b)(6) 2018: (b)(6) hospital.Laboratory.Blood culture blood (final result).Direct specimen exam: stain: rare polymorphonuclear leukocytes seen.Abundant gram positive bacilli.Abundant gram negative bacilli.Preliminary report: abundant escherichia coli.Susceptibility testing results to follow.Abundant mixed aerobic and anaerobic microorganisms.Organism: escherichia coli.Organism: mixed aerobic and anaerobic microorganisms.On (b)(6) 2018: (b)(6) hospital.(b)(6) , md; (b)(6) , md.Consultation.Endocrinology.Reason for consult: low thyroid stimulating hormone.Chief complaint: confusion.History present illness: 79-year-old male with sick sinus syndrome status post pacemaker, paroxysmal atrial fibrillation status post maze, diabetes mellitus type two (on orals), htn, colon neoplasm status post colostomy, hypopituitarism secondary to toxic shock syndrome with central hypothyroidism and adrenal insufficiency, recent cholecystectomy, presented after motor vehicle collision and found to be in septic shock from infection involving prior hernia mesh.Recently admitted and status post cholecystectomy on (b)(6) 2018 for cholecystitis.Prior to admission, was driving, became confused and subsequently hit a tree.Outside hospital, abdominal imaging was concerning for free air/intraabdominal fluid, transferred to barnes.Findings thought to be from complex mesh infection (possible fistula or erosion).Now status post draining of fluid by interventional radiology on 11/09/[18].Upon admission, started on stress dose steroid due to adrenal insufficiency.On prednisone at home.Pituitary resection (b)(6) 2003 for non-secreting adenoma.On prednisone, levothyroxine, growth hormone and testosterone.For diabetes: on metformin and jardiance.Last a1c 6.6%.Reports 50-60 pounds weight loss over last 6-8 months.Poor appetite.Ongoing fever.Today still feeling unwell.Denies nausea/vomiting.Poor appetite.Past medical history: atrial fibrillation, gastroesophageal reflux disease, pacemaker 2010, pacemaker 2002, maze 1997, malignant melanoma 2000, type two diabetes mellitus.Past surgical history: colectomy.On (b)(6) 2018: [missing records: remainder of pages for (b)(6) 2018 endocrinology consultation were not provided].On (b)(6) 2018: (b)(6) hospital.(b)(6) , pa; (b)(6) , md.Progress note.Admitted (b)(6) 2018 with chief complain of motor vehicle collision likely secondary to altered mental status secondary to sepsis from intraabdominal infection now status post drain right lower quadrant, transferred to floor (b)(6) 2018, readmitted to surgical intensive care unit (b)(6) 2018 with atrial fibrillation with rapid ventricular response.Interval history: received lasix, pain well controlled.Denies dizziness/lightheadedness/palpitations.Exam: gastrointestinal: abdomen soft, mildly tender to palpation.Ostomy with soft stool.Jackson-pratt empty.Mild erythema surrounding jackson-pratt right flank, no clear demarcation.Laboratory: wbc 9.8 (3.8-9.9).Albumin 2.0 l (3.5-5.0).[impression/plan]: non-insulin dependent diabetes mellitus: hemoglobin a1c 6.6, sliding scale insulin available.Blood sugar 80-90, dextrose 5% lactated ringer¿s at 25, saline lock iv with good oral intake.Secondary adrenal insufficiency: continue prednisone 5 mg daily and 2.5 mg nightly.Deep vein thrombosis prophylaxis: sequential compression devices, lovenox daily.Infectious disease: sepsis secondary to intraabdominal abscess.Afebrile, normal white blood cell count but on chronic steroids.(b)(6) 2018 drain culture with escherichia coli and bacteroides fragilis.Inimitably on vancomycin/cefepime/flagyl/ mica, narrowed to ertapenem.Plan for 7-day course per surgery.(b)(6) 2018: blood culture: no growth to date.Daily oral prednisone 5 mg am, 2.5 mg pm.Started vitamin a.On (b)(6) 2018: (b)(6) hospital.(b)(6) , pa.Progress note.Radiology.History ventral hernia repair with mesh, status post laparoscopic cholecystectomy (b)(6) 2018 with intermittent fevers since then.Free air/fluid right anterior abdomen from ct (b)(6) 2018 with concern for mesh infection.Placed drain 11/09/18.Interval history: still in intensive care unit for atrial fibrillation with rapid ventricular response, no acute events.Exam: skin: dressing clean/dry/intact.Abdomen: soft, non-tender/non-distended.Assessment/plan: mesh infection status post drain placement.Monitor drain output, total parenteral nutrition versus oral challenge.Antibiotics ¿ ertapenem since (b)(6) 2018.Continue pain control.Monitor urine output, history benign prostatic hypertrophy.Home meds.On (b)(6) 2018: (b)(6) hospital.(b)(6) , md.Radiology-ct abdomen pelvis with contrast.History: 79-year-old presenting for follow-up of possible right lower abdominal wall fistula status post anterior percutaneous drainage catheter placement (b)(6) 2018.Comparison: ct chest, abdomen and pelvis (b)(6) 2018.Findings: visualized portions lung bases demonstrate atelectasis dependently with associated small bilateral pleural effusions.Within atelectatic lung, there is appearance of calcification, which was previously subtle on (b)(6) 2018.Of unknown etiology, may represent sequelae of sepsis/hypotensive state/acute renal insufficiency, amiodarone use or pulmonary alveolar microlithiasis.Partially visualized dual-chamber implanted cardioverter defibrillator.Calcified mitral valve.Heart size normal.No suspicious noncalcified pulmonary nodules within lung bases.Liver normal size and contour without intrahepatic biliary duct dilatation or focal suspicious hepatic lesions.Spleen and adrenal glands normal.Distal pancreatic atrophy and ductal dilatation with transition to normal caliber pancreatic duct in body of pancreas without underlying pancreatic body mass.Proximal body, head, and uncinate process of pancreas normal.Small bilateral renal cysts unchanged.No hydronephrosis.Nonobstructing 0.2 cm right superior pole renal calculus.Nonaneurysmal abdominal aorta with scattered aortoiliac calcification.Normal caliber inferior vena cava.No retroperitoneal, pelvic, inguinal or mesenteric adenopathy.Stomach and small bowel normal course and caliber.Postsurgical changes of rectal resection and left lower abdominal colostomy.Small fluid and gas containing collection within pre-sacral fat likely chronic post colonic resection.Colon nondilated.Stomach and small bowel normal course and caliber without evidence of obstruction.Multiple separate areas of anastomosis within distal small bowel unchanged.No evidence fistula, however lack of oral contrast which decreased sensitivity for fistula evaluation.Interval placement percutaneous right lower pelvic pigtail catheter with tip coiled in fluid and gas collection.Fluid and gas collection now measures approximately 18.6 x 4.2 cm and abuts and undermines ventral abdominal hernia mesh, best seen on slice location -530.5.Fluid now tracking within right paracolic reflection.Prostate nonenlarged.Foley catheter decompresses the bladder.Small fat-containing right inguinal hernia and fat-containing parastomal hernia within left anterior abdomen.Small amount subcutaneous air within right anterior abdominal wall likely secondary to percutaneous catheter placement.Progression of diffuse abdominal wall anasarca.Status post median sternotomy.Mild multilevel spondylosis.No destructive osseous lesions.Unchanged compression fracture thoracic 10 vertebral body.Unchanged right lumbar 2 pedicle enostosis.1) slight interval increased size of fluid and gas collection within right lower abdomen and anterior abdominal wall involving the ventral hernia mesh, despite percutaneous drainage catheter.2) suboptimal evaluation for enteric fistula secondary to lack or oral contrast.3) distal pancreatic atrophy and ductal dilatation without evidence of definite mass pancreatic body.Could be secondary to stricturing from remote chronic pancreatitis.4) hyperattenuation of atelectatic bilateral lower lungs, more than would be expected for atelectasis.Differential includes sequelae of sepsis/hypotensive state/acute renal insufficiency, amiodarone use or pulmonary alveolar microlithiasis.On (b)(6) 2018: (b)(6) hospital.(b)(6) , md; (b)(6) , md.Procedure report.Worsening collection with new fistula to bowel.Catheter was upsized to facilitate drainage and resolution.Plan: continue to monitor catheter output as well as clinical condition.Catheter should be flushed 5 ml normal saline 3 times daily.Follow-up two weeks, will need appointment if discharged prior to this time.Records span (b)(6) 2006 to (b)(6) 2018.A potential relationship, if any, between the alleged injuries or complications and the gore device is unclear from the provided information at this time.It should be noted that the gore® dualmesh® 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 results code.Conclusion code remains unchanged.
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Manufacturer Narrative
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Added medical history.Conclusion code remains unchanged.Added medical record information.Additional details regarding the patient's clinical course were ascertained from a review of medical records and are as follows: (b)(6) 2019: (b)(6) certification of death.Date of death: (b)(6) 2019.Age at death: 79 years.Manner of death: natural.Underlying cause: end stage sepsis ¿ 4 weeks.Hypertension ¿ years.Paroxysmal atrial fibrillation ¿ years.Type 2 diabetes mellitus ¿ years.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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Manufacturer Narrative
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H6: updated health effect.H6: updated investigation finding.H6: updated investigation conclusions.H6: health effect impact code: f26: no health consequences or impact.H6: medical device component: g04088: membrane.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.The instructions for use further warn: ¿when using this device as a permanent implant and exposure occurs, treat to avoid contamination, or device removal may be necessary.¿ 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.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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