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W. L. GORE & ASSOCIATES, INC. GORE® BIO-A® TISSUE REINFORCEMENT; MESH, SURGICAL, POLYMERIC
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Back to Search Results |
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| Model Number FS2030 |
| Device Problems
Off-Label Use (1494); Improper or Incorrect Procedure or Method (2017); Microbial Contamination of Device (2303)
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| Patient Problems
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)
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| Event Date 01/22/2021 |
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Event Type
Injury
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Manufacturer Narrative
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(b)(4).Additional details regarding the patient's clinical course were ascertained from a review of medical records and are as follows: relevant medical information: on (b)(6) 2020: at (b)(6).Do (b)(6).History and physical.Chief complaint: concern for fascial dehiscence, infected mesh.A (b)(6) year old male with history of (b)(6) skin infection requiring drain placement and diverticulitis status post sigmoidectomy (2017), status post retro-rectus ventral hernia repair on (b)(6) presented to (b)(6) emergency department earlier today after he experiences a popping sensation emanating from this surgical incision immediately followed by a gush of brown, foul smelling discharge from his incision shortly after coughing spell earlier today.He has been having intermittent nausea since discharge but denies any other symptoms.He experienced a similar sensation in 2017, when he suffered a fascial dehiscence a couple days post-operative from his sigmoid colectomy.He is not currently taking any blood thinners.Denies fevers, chest pain, shortness of breath, abdominal pain, vomiting, diarrhea, and urinary symptoms.No other associated symptoms or modifying factors at this time.Never smoker.Exam: abdomen soft, non-distended.No rebound or guarding.No masses or organomegaly.Midline incision closed with staples.Moderate surrounding erythema.Significant tender to palpate.Staples removed mid incision.Brownish discharge emanating from opening.Incision was probed and mesh was able to be palpated but no obvious bowel was appreciated.Weight (b)(6) pounds, bmi 28.05.Glucose 114-120 h, white blood cell 10.07-10.8.Impression/plan: ctap significant for 13 x 11 x 5.6 cm complex fluid and air collection deep to the umbilicus, the site or prior herniorrhaphy.Appearance is consistent with phlegom or developing postsurgical abscess.Concern for infected mesh with possible fascial dehiscence.Plan to go to or for exploratory laparotomy with surgical washout and possible closure of abdominal wall.Implant procedure/explant procedure #1: exploratory laparotomy with explantation of mesh, wound debridement, reimplantation of bridging bio-a mesh, placement of jp drain and provena [sic] wound vac.Implant: gore® bio-a® tissue reinforcement [fs2030/(b)(4), 30x20cm].Implant/explant date: on (b)(6) 2020 (hospitalization (b)(6) 2020).On (b)(6) 2020: at (b)(6) medical center.Dr.(b)(6).Operative report.Incision/procedure start time: 8:00 pm.Incision close/procedure end time: 9:26 pm.Surgeon(s)/proceduralist(s) and assistants: (b)(6).Surgical indication: a (b)(6) year-old male who is status post a retrorectus ventral hernia repair for an incarcerated ventral hernia.Patient has a history of sigmoidectomy in 2017 with subsequent fascial dehiscence.He presented to (b)(6) after hearing a pop and noticed a large amount of brown/bloody fluid coming from his midline laparotomy.Patient had intermittent nausea since his procedure on (b)(6), but denies any other symptoms.He noticed the sensation was similar to his fascial dehiscence in 2017.H e takes no medications at home and denies any other bowel or bladder complaints.His ct scan of his abdomen pelvis was concerning for a subcutaneous abscess with subsequent violation of the fascial layers of the abdomen resulting in dehiscence and bowel evisceration.The wound was opened by the emergency room physician and was subsequently cultured by the surgical team and probed.It was deemed that the mesh had migrated and was no longer in place and there was concern for palpation of bowel.At this point in time it was decided that the patient would benefit from urgent intervention.The patient was taken urgently to the operating room.Patient had received scheduled zoysn [sic] and vancomycin just prior to arrival to ccag.Surgery/procedure(s): exploratory laparotomy with explantation of mesh, wound debridement, reimplantation of bridging bio a mesh, placement of jp drain and provena wound vac.Anesthesia: general.Surgery/procedure details: ¿the patient was brought to the operating room, placed on the operating table in supine position, and general anesthesia was induced.A timeout was completed verifying the correct patient, procedure, site, positioning and implants or special equipment that would be needed prior to beginning the procedure.Antibiotics had been administered by the outside facility within acceptable timing limits.The anterior abdominal wall was prepped and draped in standard sterile fashion using betadine.The previous midline wound was opened by removing staples.At this point in time the wound opened up to the level of the mesh and fascia of the previous procedure with purulent and sanguinous drainage.The prior mesh was noted to be nonadherent and not fixed within the subcutaneous space and was pulled out with a pair debakeys without any strain or effort.It was then sent for culture.It was noted that there was a large abscess cavity within the subcutaneous tissue as well as an 11 x 8 cm fascial dehiscence.His posterior fascia and anterior fascia were fused from his prior laparotomies and sigmoid resections.The small bowel was protruding through this fascial defect.At this point in time the wound was copiously irrigated.Approximately 400 ml of normal saline were used to irrigate the wound.The visible previous fascial sutures were removed.The small bowel that was protruding through the fascial dehiscence was taken down from its adhesions to the peritoneum surrounding the defect.Multiple layers of adhesions were taken down to free up the small bowel.It was then eviscerated from the body and ran within reason to evaluate for any signs of perforation or fistulous connection to the patient's abscess cavity.It was noted that there were inflammatory rind on portions of the small bowel however there was no perforation or serosal injury.The small bowel was then put back in place in its anatomical position.After running the small bowel, attention was turned to repair of the dehiscence.Due to the patient's large abscess cavity and mesh infection, the fused posterior and anterior fascial planes were of poor quality and it was determined that a bridging mesh would best be suited for this patient knowing that his recurrence rate of a ventral hernia would be high.A 30 x 20 bioa mesh was trimmed down to a size 13 cm x 13 cm to be used as a bridging mesh with overlap onto the fascia.Approximately 10 2-0 pdo quill sutures were used in a circumferential pattern around the fascial edges as u stitches to tack this bio a mesh to his fascia.The mesh was secured down in a flat position with no noted bowel escaping from the edges of the mesh.At this point in time the wound was meticulously evaluated for hemostasis and observed to be adequate.Due to the nature of the patient's recent infection and large abscess cavity, a 19 french round jp drain was placed in subcutaneous tissue on top of the mesh.To prevent a complete evisceration in the event that this repair failed we elected to close his skin, which was approximated with staples loosely.A praveena [sic] wound vac was placed over his midline incision.The patient tolerated the procedure well and was brought to the postanesthesia care unit in stable condition.He will be watched postoperatively with serial abdominal exams, be placed in abdominal binder and continue with postoperative antibiotics.¿ preoperative diagnosis: fascial dehiscence of a midline laparotomy from an incarcerated ventral hernia.Postoperative diagnosis: same as preop.Estimated blood loss: 100 mls.Specimens: mesh.Implantable devices: mesh bio-a 30 x 20 cm surgical bioabsorbable reinforcement scaffold tissue ¿ log4470438.Type: graft.Serial no: (b)(4).Manufacturer wl gore & assoc.Lrb: n/a.No used: 1.Action: implanted.Drains: 19-french round jp drain, praveena wound vac.Complications: none.Participation in surgery/procedure: i performed the surgery under the direct supervision of dr.(b)(6) who was present for all critical steps and decisions for the entirety of the procedure.I was present for the critical and key portions of the surgery and i was immediately available to provide assistance.Unknown: [facility ni].Implant record.Implant: mesh bio-a 30x20cm surgical bioabsorbable reinforcement scaffold tissue.Serial number: (b)(4).Model/cat no: fs2030.Log4470438.Area: abdomen.W.L.Gore & associates.The records confirm a gore® bio-a® tissue reinforcement (fs2030/(b)(4)) was implanted during the procedure.Relevant medical information: on (b)(6) 2020: at (b)(6).Lab.White blood count 10.07 h, glucose 114 h.On (b)(6) 2020: at (b)(6).Do (b)(6).Procedure report.Procedure: incision/drainage.Type: abscess.Size: 15cm.Location: trunk.Trunk location: abdomen.Pre-procedure details: skin preparation- chloraprep.Procedure type: simple.Procedure details: incision depth- fascia, wound management- probed and delocuated, drainage- purulent, drainage amount- copious.Wound treatment: wound left open, no packing materials.Post-procedure details: patient tolerated procedure well, no immediate complications.On (b)(6) 2020: at (b)(6).Dr.(b)(6).Radiology- x-ray abdomen.Indication: post-operative/ post-procedure assessment, symptomatic.Impression: post surgical change.No acute process identified involving the abdomen.On (b)(6) 2020: at (b)(6).Lab.Glucose 132 h, white blood count 10.34 h.On (b)(6) 2020: at (b)(6).Dr.(b)(6).Consultation- infectious disease.We were asked to evaluate for (b)(6) and antibiotic recommendation.Exam: abdomen soft, non-tender, positive bowel sounds, wound vac and jackson-pratt.Impression: (b)(6) surgical site infection.Plan: continue zosyn and vancomycin for now.Plan for upon discharge augmentin and bactrim ds twice a day.On (b)(6) 2020: at (b)(6).Dr.(b)(6).Discharge summary.Admitted: (b)(6) 2020.Reason in hospital: fascial dehiscence of a midline laparotomy from incarcerated ventral hernia.Summary of what happen while in hospital: a (b)(6) year-old status post retrorectus ventral hernia repair for incarcerated ventral hernia (b)(6) 2020.History sigmoidectomy 2017, with subsequent fascial dehiscence.Presented to (b)(6) after hearing pop and noticed large amount brown/bloody fluid come from midline laparotomy.Sensation similar to fascial dehiscence in 2017.Ct scan abdomen pelvis concerned for subcutaneous abscess with subsequent violation of fascial layers of abdomen resulting in dehiscence and bowel evisceration.Wound opened by emergency room physician, cultured by surgical team and probed.Deemed the mesh had migrated and was no longer in place and there was concern for palpation of bowel.Decided would benefit from urgent intervention.Post op recovery complicated with acute kidney injury, improving with fluids.Cultures positive for (b)(6), infectious disease consulted to direct antibiotic therapy.This afternoon, stable for discharge home.Jackson-pratt drain removed prior to discharge.Prevena vac intact to midline incision.Will need labs in 1 week, follow up dr.(b)(6) in 1 week, follow up dr.(b)(6) in 2 weeks.Resolved problems: wound dehiscence.Operations: on (b)(6) 2020, exploratory laparotomy with explantation of mesh, wound debridement, reimplantation of bridging bio a mesh, placement of jackson pratt drain and prevena wound vac.Lifting restricted to: 15 pounds for 4 weeks.On (b)(6) 2021: at (b)(6).(b)(6), aprn, cnp.History and physical.Presents in presurgical testing.Developed hernia one month after surgery.Told could not connect all muscles and would most likely develop a hernia.Cat scan a few months ago and dr.(b)(6) confirmed it was a hernia.Surgery recommended, agreed to proceed as planned.Scheduled for open ventral hernia repair with mesh on (b)(6) 2021 with dr.(b)(6).History of diverticulitis, status post partial colectomy in (b)(6) 2020, tumor removal.Never smoker.Positive diverticulitis, hernia, and abdominal pain.Weight (b)(6) pounds, bmi 27.84.Impression/plan: ventral hernia without obstruction or gangrene.Open ventral hernia repair with mesh.Explant procedure #2: exploratory laparotomy.Lysis of adhesions in excess of 1 hour.Excision of previous mesh.Small bowel resection with stapled side-to-side anastomosis.Myofascial cutaneous release/posterior component separation with transversus abdominis release on the left side.Myofascial cutaneous release/posterior component separation with transversus abdominis release on the right side.Incisional hernia repair with mesh.Explant date: (b)(6) 2021 (hospitalization unknown).On (b)(6) 2021: at (b)(6) medical center.Dr.(b)(6).Operative report.Incision/procedure start time: 1:46 pm.Incision close/procedure end time: 4:51 pm.Preoperative diagnosis: recurrent incisional hernia.History of (b)(6) infection.Mesh infection.Abdominal pain.Status post partial colectomy.Postoperative diagnosis: recurrent incisional hernia.History of (b)(6) infection.Mesh infection.Abdominal pain.Status post partial colectomy.Assistant: (b)(6) md, resident physician.Surgical procedure: exploratory laparotomy.Lysis of adhesions in excess of 1 hour.Excision of previous mesh.Small bowel resection with stapled side-to-side anastomosis.Myofascial cutaneous release/posterior component separation with transversus abdominis release on the left side.Myofascial cutaneous release/posterior component separation with transversus abdominis release on the right side.Incisional hernia repair with mesh.Findings: 15 x 7.5 cm incisional hernia with overlying previous mesh.Dense small bowel adhesions to the previous mesh and abdominal wall.Estimated blood loss: 100 ml.Intravenous fluids: 3300 ml.Urine output: 150 ml.Specimens: previous mesh.Small-bowel resection.Complications: none.Implants: parietex macroporous mesh, measuring 15 x 26 cm.Indications for procedure: this is a (b)(6) year-old male, who was referred to us for evaluation of a recurrent incisional hernia.He has a history of a prior ventral hernia repair in (b)(6) 2020, from which he suffered postoperative dehiscence and infection.Because of this postoperative dehiscence and infection, he underwent an exploratory laparotomy, removal of previous mesh, and incisional hernia repair with a bridging biologic mesh.Since that operation, he has recovered well; however, continues to have an incisional hernia.He also complains of pain mostly in the left lower quadrant.He did not have any signs of obstructive symptoms.Given all these findings, i offered him an incisional hernia repair with mesh.Risks, benefits, and alternatives were explained to the patient and consent was obtained.Description of procedure: ¿the patient was brought to the operating room on the patient cart and safely transferred to the operating room table without any issues.He was kept in supine position with both arms out.General anesthesia was induced via endotracheal tube.All joints and pressure points were padded in neutral position.A foley catheter was inserted in sterile fashion.The abdomen was prepped and draped in sterile fashion.A time-out was performed.The procedure began with a generous midline laparotomy, encompassing the previous scar.I tried to enter the abdomen at a cephalad position away from the previous dissection.However, this proved to be exceedingly challenging because of the density of adhesions.Once within the peritoneal cavity, i noted that there were dense small bowel adhesions to the previous mesh and the abdominal wall.These were taken down by a combination of blunt dissection, electrocautery, and sharp dissection.This lysis of adhesions took in excess of 1 hour to complete.During this lysis of adhesions, i ended up with a segment of approximately 20 cm of small bowel which had 1 enterotomy in it and one 4 cm serosal injury.This enterotomy and serosal injury were in line with the difficulty of the disease.In order to address this, i performed a small bowel resection of this 20 cm segment of small bowel.This was performed by transecting the proximal distal ends using a 60 mm purple load stapler.The mesentery was taken using a ligasure bipolar device.The ends of the small bowel then re-anastomosed using a side-to-side stapled anastomosis technique.This was performed using a 60 mm purple load stapler.The common enterotomy was closed using a 3-0 pds suture.This was then over sewed by 3-0 silk sutures.Following this, the mesenteric window was closed using 3-0 silk sutures.The abdomen was now irrigated copiously and i turned my attention to fixing the hernia.I began the hernia repair by excising the previous mesh.This mesh was sent for pathologic evaluation.Following this, i identified the edges of healthy fascia and opened the posterior rectus sheath on both sides.This posterior rectus sheath dissection was taken to the linea semilunaris on both sides.Following this, upon trying to bring the edges of the fascia together, i found them to be under significant tension and i elected to perform a bilateral transversus abdominis release.The transversalis fascia and the transversus muscle were released on the right side and then on the left side.This bilateral transversus abdominis release was performed to encompass this hernia, which measured approximately 15 x 7.5 cm.Following this transabdominal release, i was able to bring together the fascial edges with ease.Two full-thickness defects in this posterior layer were fixed using 3-0 vicryl sutures.The 2 edges of the posterior rectus sheath were sewed together using running 3-0 pds sutures.At this point, i measured my entire dissection flap to be approximately 15 x 26 cm.A polypropylene, lightweight, macroporous mesh was selected and cut to this size and placed within this cavity.Tisseel was sprayed on top of the mesh to help fixated.Linea alba was then recreated by bringing together the anterior rectus sheath using figure-of-eight 0 pds sutures.The umbilicus was now reconstructed using 4-0 monocryl sutures.The skin was then closed using skin staples.A prevena vac was then placed on top of it.All sponges, sharps, and instruments were counted correct.I was present for the entire procedure.Patient was then extubated and transferred to the postanesthesia care unit in stable condition.¿ on (b)(6) 2021: at (b)(6) medical center.Implant record.Implant: mesh parietex macroporus 45 x 30cm surgical.Area: abdomen.Relevant medical information: on (b)(6) 2021: at (b)(6) medical center.Dr.(b)(6).Pathology.Specimen: mesh, old mesh; small intestine resection.Final diagnosis: fibro adipose tissue containing numerous foreign body granulomas (mesh); resection of small bowel- serosal adhesions with foreign body granulomas containing material consistent with surgical mesh.Gross description: mesh: received in formalin labeled ¿mesh¿ are multiple irregular membranous tan-gray fragments surrounded by adipose tissue aggregating to 11 x 5 x 2 cm.Upon sectioning no nodularity or induration is identified; small intestine resection: received in formalin labeled ¿small intestine resection¿ is an unoriented segment of small intestine measuring 19 cm in length and 2 cm in diameter.The serosal surface is brown-tan and ragged.Both mucosal ends are arbitrarily inked blue and orange.Upon opening, the mucosal surface demonstrates usual tan prominent intestinal folding with no polyps or lesions identified.The average wall thickness is 0.2 cm.No possible lymph nodes are identified upon sectioning the attached adipose tissue.On (b)(6) 2021: at (b)(6) medical center.Do (b)(6).Discharge summary.Admit date: (b)(6) 2021.Reason in hospital: ventral hernia.Summary of what happened while in hospital: admitted to floor after surgery.Procedure went well.Wound vac and abdominal binder in place.Diet advanced as tolerated.Ambulated without assistance.Pain controlled with oral pain meds.Passing gas, no bowel movement.Vitals and patient well enough for discharge home on (b)(6) 2021.Resolved problems: ventral hernia.Operations: ventral hernia repair with component separation.Disposition: home with self-care.Activity when leave: resume normal activities after 24 hours.Lifting restricted to 15-20 pounds at least until seen as outpatient.May shower and bathe.Follow up in 2 weeks (b)(6).Start taking oxycodone ir (roxicodone) every 6 hours as needed for pain.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® bio-a® tissue reinforcement 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® bio-a® tissue reinforcement 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 incarcerated ventral hernia repair on (b)(6) 2020, whereby a gore® bio-a® tissue reinforcement was implanted.The complaint alleges that on (b)(6) 2021, an additional procedure occurred whereby the gore device was explanted.It was reported the patient alleges the following injuries: adhesions, surgery to remove mesh, bowel resection, wound vac, severe and chronic pain/discomfort.Additional event specific information was not provided.
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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® bio-a® tissue reinforcement 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® bio-a® tissue reinforcement 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® bio-a® tissue reinforcement instructions for use include warnings and addresses the following potential clinical and device adverse events: possible adverse events with the use of any tissue deficiency prosthesis or soft tissue reinforcement surgical procedures may include, but are not limited to, additional intervention including surgery, adhesions and related harms, bowel obstruction, defect recurrence and related harms, dyspareunia, dysphagia, erosion or extrusion and related harms, exposure or protrusion and related harms, fever, fistula, gerd recurrence, infection, irritation or inflammation, pain, paresthesia, seroma or hematoma and related harms, tissue ischemia, urinary problems, vaginal bleeding or discharge, vaginal dysfunction, and wound dehiscence.The instructions for use further warn: ¿the safety and effectiveness of this device has not been established for use in patients who have a surgical site infection that cannot be treated successfully prior to device placement (e.G., use of surgical mesh in an infected surgical site).Use of any surgical mesh in the presence of infection could result in potentially serious patient harms and additional intervention, including surgery.¿ the instructions for use further warn: ¿as with any mesh, use of gore® bio-a® tissue reinforcement in the presence of contamination may result in dyspareunia, fever, infection, irritation or inflammation, pain, and wound dehiscence, and may require removal of the mesh if infection occurs.¿ 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 warn: ¿it is recommended that the device be placed next to well-vascularized tissue.Gore® bio-a® tissue reinforcement is not recommend for permanent bridging of fascial defects.The gore® bio-a® tissue reinforcement may be suture-tacked to host tissue for stabilization.¿ all fixation devices should be used in accordance with the manufacturer¿s instructions for use.The physician should reference the manufacturer¿s instructions for use and any supporting clinical literature regarding any potential adverse reactions related to fixation devices.Individual medical decisions, if inconsistent and/or non-conforming to the device manufacturer¿s recommendations, ifu, or recognized best practices, may result in or contribute to an adverse event.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 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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