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W. L. GORE & ASSOCIATES, INC. GORE® DUALMESH® PLUS BIOMATERIAL; MESH, SURGICAL, POLYMERIC
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| Model Number 1DLMCP03 |
| Device Problem
Insufficient Information (3190)
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| Patient Problems
Unspecified Infection (1930); No Clinical Signs, Symptoms or Conditions (4582)
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| Event Date 11/07/2018 |
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Event Type
Injury
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Manufacturer Narrative
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It should be noted that the gore® dualmesh® 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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Event Description
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It was reported to gore that the patient underwent open incisional hernia repair on (b)(6), 2018 whereby a gore® dualmesh® plus biomaterial was implanted.The complaint alleges that on (b)(6), 2018, an additional procedure occurred whereby the gore device was explanted.It was reported the patient alleges the following injuries: severe and chronic pain/discomfort, infection, wound drainage.Additional event specific information was not provided.
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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: relevant medical information: on (b)(6) 2017: (b)(6) hospital.(b)(6) , md, phd.History and physical.I have been asked to see this patient for surgical evaluation as a potential live liver donor.Is an otherwise healthy 41 year-old woman who is interested in being a live liver donor for her mother (b)(6).Only significant medical history is congenital dysplasia of her hip, and had some surgery on her hip.Has also undergone a laparoscopic cholecystectomy.Has been on a weight loss program for quite some time now, and has lost about 13 pounds.Rarely drinks, but is a former cigarette smoker who quit about six weeks ago.Past medical history: hip dysplasia, congenital.Past surgical history: cholecystectomy, laparoscopic, 2005.Femur osteotomy as a child for hip dysplasia; later required bone spur removal, bilateral.Inguinal hernia repair, right, 1980.Tonsillectomy at age 24.Current medications: hydrocodone-acetaminophen, ibuprofen for congenital hip dysplasia.Social history: former smoker who smoked for about 10-year period of time, smoking about a half pack of cigarettes a day; quit about 6 weeks ago.Has never had a blood transfusion and never used intravenous illicit drugs.Does have several tattoos; they were professionally done.Weight 186 lb, bmi 30.25.Exam: gastrointestinal soft, mildly obese, nontender, normal bowel sounds, no hernias; no surgical scars.Impression/plan: 41 year-old who is interested in being a live liver donor for her mother.We began the evaluation process.I have no contraindication to her moving ahead with the live-donor evaluation.She has normal liver function tests, but body mass index is 30.25, therefore does met criteria for a selective pre-donation liver biopsy.On (b)(6) 2017: (b)(6) hospital.(b)(6) , md phd.Anesthesia record.Asa 2.On (b)(6) 2017: (b)(6) hospital.(b)(6) , md.Operative report.Preoperative diagnosis: healthy live liver donor.Postoperative diagnosis: healthy live liver donor.Name of procedure: laparoscopically assisted living donor right hepatectomy.Liver biopsy.Incision and exploration of intrahepatic ducts.Intraoperative ultrasound x2.Indications for procedure: (b)(6) is an otherwise healthy 41 year-old woman who has completed full evaluation to be considered as a live liver donor for her mother.(b)(6) is blood group o and the recipient is blood group o.The recipient suffers from autoimmune hepatitis and cirrhosis.Her current meld score is 25.The donor has undergone a complete medical and psychosocial evaluation, including 3 dimensional radiologic imaging, that has deemed her suitable to be live liver donor for her mother.(b)(6) is taken to the operating room now for a laparoscopically assisted living donor right hepatectomy and cholecystectomy.On (b)(6) 2017: department of pathology(b)(6).(b)(6), md.Pathology.Accession#: (b)(4).Final diagnosis: liver, biopsy: near-normal liver with mild ductal reaction.On (b)(6) 2017: (b)(6) hospital.(b)(6) , md.Radiology-us abdomen complete/doppler.Indication: status post right hepatectomy/liver donor postop day 1, evaluate for fluid collection.Impression: status post right hepatectomy with patent vasculature in the left hepatic lobe demonstrating appropriate velocities, direction of flow and waveforms.No perihepatic fluid collection.On (b)(6) 2017: (b)(6) hospital.(b)(6) , md; elizabeth pomfret, md.Discharge summary.Admit date: (b)(6) 2017.Discharge date: (b)(6) 2017.Hospital course: admitted (b)(6) 2017.Taken to operating room where laparoscopic assisted live donor right hepatectomy, incision and exploration of intrahepatic ducts, liver biopsy, intraoperative ultrasound x2 was performed without complication.Course initially complicated by high drain output which resolved quickly.On day of discharge, pain well controlled with oral pain medications.Discharged with prescription for analgesics and instructed to return to clinic for follow up.Exam: abdominal drain serosanguinous, midline incision with steristrips in place.Post-op activities: no lifting more than 10 pounds, no driving for 6 weeks, no straining of belly muscles for 6 weeks; shower daily, keep incision clean and dry.On (b)(6) 2018: (b)(6) hospital.(b)(6) , do.Radiology-ct abdomen/pelvis with iv contrast.Indication: status post liver donation, gated with persistent small perihepatic fluid collection.Prominent new rectus muscle diastases with protrusion of large bowel and mesentery.Otherwise, no abdominal wall hernia.Ventral abdominal scarring present.Impression: interval resolution of perihepatic fluid collections with cystic changes within the caudate lobe favored to be the sequelae of prior hepatectomy.New rectus muscle diastases with protrusion of large bowel and mesentery as detailed above.On (b)(6) 2018: (b)(6) hospital.(b)(6) , md.(b)(6) , md phd.History and physical.History update and physical from dr.(b)(6) note (b)(6) 2018.I have reviewed the information, history and indications.There are no changes to medical history or examination since (b)(6) 2018.She has signed consent for open incisional ventral hernia repair with mesh.All questions and concerns have been addressed.On (b)(6) 2018: (b)(6) hospital.(b)(6) , md.Procedure report.Procedure: epidural catheter nerve block.Indication: performed at surgeon¿s request.Pain diagnosis abdomen.Implant procedure: incisional hernia repair.Implantation of mesh.Implant: gore® dualmesh® plus biomaterial [1dlmcp03/17410286, 10cm x 15cm x 1mm].Implant date: (b)(6) 2018 (hospitalization (b)(6) 2018).On (b)(6) 2018: (b)(6) hospital.(b)(6) , md phd.Pre-op diagnosis: incisional hernia s/p liver donation.Post-op diagnosis: same.Anesthesia: general.Surgeon(s): (b)(6) md phd.Staff: circulator: (b)(6)., rn.Circulator relief: (b)(6) , rn.Scrub: (b)(6).Scrub secondary: (b)(6) , rn.Estimated blood loss: 200 ml.Drains: none.Total iv fluids: 1400 ml.Specimens: id: 1) hernia sack.Type: tissue in formalin.Tests: permanent pathology request.Collected by: (b)(6).Md phd.Time: (b)(6) 2018 0935.Destination: pathology.Implants: implant name: mesh dual 10cmx15cmx1mm ¿ (b)(6).Type: implant.Inv.Item: mesh dual 10cmx15cmx1mm.Serial no.: (b)(6).W l gore & assoc inc wlgr.Lot no.[not indicated].Lrb: n/a.No.Used: 1.Complications: none.Findings: large incisional hernia.Disposition: awakened from anesthesia, extubated and taken to the recovery room in a stable condition, having suffered no apparent untoward event.Condition: doing well without problems.Technique: ¿the patient is a 41-year-old female who underwent liver resection as a living donor for her mother a little over 3 months ago.She reports that she had a coughing spell and developed a large incisional hernia.She presents now for elective repair.The patient was brought to the operating room placed in supine position.After adequate general endotracheal anesthesia her abdomen was prepped and draped widely in usual sterile fashion.She was given 2 g of ancef for antibiotic prophylaxis.Preoperatively an epidural catheter was placed for postoperative pain management.A formal timeout was undertaken to verify patient identification, antibiotics have been given and dvt prophylaxis with venodyne boots was in place.The lower portion of the midline incision was opened with electrocautery.There was a large hernia sac and this was completely resected down to the anterior fascia.The hernia sac was sent to pathology for histologic examination.Circumferential skin flaps were raised to expose a rim of normal fascia.Once this was completed the repair was performed using an underlay mesh that was anchored circumferentially with 0 prolene horizontal mattress sutures.Once the mesh was in place the fascia was closed over the mesh using a running 0 pds suture.Redundant skin was resected.The skin was closed using 2-0 vicryl deep dermal sutures followed by 4-0 monocryl subcuticular suture.The wound was dressed with a dry sterile dressing and an abdominal binder.The patient tolerated the procedure well and was transferred to the recovery room extubated in stable condition.Sponge and instrument count were correct x2.¿ on (b)(6) 2018: (b)(6) hospital.(b)(6) , md; (b)(6).Brief post-op note.Pre-op diagnosis: incisional hernia s/p liver donation.Post op diagnosis: same.Procedure(s): incisional hernia repair with mesh s/p liver donation.Description: large ventral incisional hernia repair with underlay mesh.Surgeon(s): (b)(6).Md phd.Assistant: (b)(6).Anesthesia: general.Estimated blood loss: 0-50 ml.Was hemorrhage/hematoma a procedural complication? no.Complications: none.Specimens: id: 1) hernia sack.Type: tissue in formalin.Tests: permanent pathology request.Collected by: (b)(6).Md phd.Time: (b)(6) 2018 0935.Destination: pathology.Findings: large fascial defect.Hernia sack excised and sent for pathology.Bowel viable and non-incarcerated.On (b)(6) 2018: (b)(6) hospital.Implant record.Implants: mesh dual 10cmx15cmx1mm ¿ (b)(6).Inventory item: mesh dual 10cmx15cmx1mm.Implant name: mesh dual 10cmx15cmx1mm ¿ (b)(6).Manufacturer: w l gore & assoc inc wlgr.Action: implanted.Serial no: (b)(6).Laterality: n/a.Number used: 1.Model/cat no: 1dlmcp03.Area: abdomen.The records confirm a gore® dualmesh® plus biomaterial (1dlmcp03/17410286) was implanted during the procedure.Relevant medical information: on (b)(6) 2018.Department of pathology, (b)(6).(b)(6) , md phd.Pathology report.Accession #: (b)(4).Final diagnosis: hernia sac, repair: mesothelial lined fibrovascular and adipose tissue with focal giant cell reaction, consistent with a hernia sac.Clinical history: status post laparoscopically assisted living donor right hepatectomy (b)(6) 2017, now with a large incisional hernia.Gross description: received in formalin labeled ¿(b)(6) kowal/ hernia sack¿ is a 30 x 8 x 1.5 cm soft tissue fragment composed of pink, glistening membranous tissue and adherent yellow, lobulated adipose tissue.Sectioning reveals glistening off-white cut surfaces with no grossly discernible nerves or large vessels.Representative sections are submitted as (a1).On (b)(6) 2018: (b)(6) hospital.Lab.White blood cell count 11.8 h (4.0-11.1).On (b)(6) 2018: (b)(6) hospital.(b)(6) , md; (b)(6) , md phd.Discharge summary.Admit date: (b)(6) 2018.Discharge date: (b)(6) 2018.Final diagnoses: incisional hernia.Status post donor right hepatectomy.Key point for follow up: postop op follow up appointment.Lifting restrictions.Pathology: final diagnosis: hernia sac, repair: mesothelial lined fibrovascular and adipose tissue with focal giant cell reaction, consistent with a hernia sac.Condition at discharge: stable.Reason for hospitalization: status post laparoscopically-assisted living donor right hepatectomy on (b)(6) 2017 complicated by incisional hernia presents for elective repair of incisional hernia.Hospital course: presented (b)(6) 2018 for elective incisional hernia repair with mesh by dr.(b)(6).Had epidural for pain control.On postoperative day 1 advanced to clear liquid diet which she tolerated.Ambulating with pain well controlled.Postoperative day 2 advanced to regular diet; having bowel function.In the evening epidural was removed.Postoperative day 3, day of discharge doing well clinically.Pain controlled on oral medication.Vital signs stable, afebrile, and saturating well on room air.Tolerating regular diet with normal bowel function.Was voiding spontaneously.Ambulating unassisted.Wound care instructions and teaching provided including lifting/activity restrictions and abdominal binder.Return precautions discussed with patient, including fevers, persistent nausea/vomiting/diarrhea, worsening pain not controlled with oral medications, shortness of breath, chest pain, pus or expanding redness at wounds, inability to void.Instructed to follow up with primary care provider and as scheduled for postoperative visit.Weight 189 lb 14.4 oz, bmi 31.60.Exam: abdominal appropriate postop mild tenderness to palpation.Incision is clean/dry/intact without drainage or surrounding erythema.Abdominal binder in place.Instructions provided at discharge: follow-up: (b)(6) , md phd.Follow up with liver transplant clinic in two weeks.On (b)(6) 2018: (b)(6).Lab.Anaerobic culture: source: wound deep.Value: few anaerobic gram positive cocci; two colony types.Aerobic culture: source: wound, deep.Value: few streptococcus dysgalactiae; few multiple bacterial morphotypes.Direct gram stain: value: few gram positive cocci; few polymorphonuclear cells; heavy red blood cells.Blood culture: value: no growth.On (b)(6) 2018: (b)(6) hospital.(b)(6) , md; (b)(6) , md.History and physical.Presents with concern for a second wound infection.States wound had been healing well, after the wound vacuum assisted closure was placed at end of april.Had follow-up appointment a few days ago and it was decided to place a wound vacuum assisted closure over the superior incision.Since that time, has noticed some redness around upper part of wound.She feels a little off.Denies chills, but temperature has been running a little higher than normal.Denies nausea and vomiting.Current medications: acetaminophen, doxycycline, oxycodone.Review of systems: positive for fever, abdominal pain, skin rash and wound.Exam: is in respiratory distress.Abdominal soft, no distention.There is tenderness; there is rebound.No guarding.Midline incision with 2 cm superior opening and 3 cm inferior opening down to fascia, pink granulation tissues, no purulent drainage, no fluctuance, minimal peri-incisional erythema over the superior aspect of the incision.Impression/plan: history of ventral hernia repair from prior live liver donation, complicated by incisional wound infection, being treated, re-presenting with new peri-incisional erythema.Wound appears healthy without purulent discharge, non-toxic appearing.Minimal erythema around wound vacuum assisted closure tape surrounding the superior pole of the incision.Antibiotics, labs, wound cultures, wet to dry dressing, regular diet, tylenol.On (b)(6) 2018: (b)(6) hospital.(b)(6) , md; (b)(6) , md.Consultation.Seen for evaluation of potential wound infection.Underwent live liver donation (b)(6) 2017.Subsequently developed large ventral hernia requiring repair.The incision for that surgery dehisced and became infected.Initially treated with wound vacuum assisted closure over the inferior wound and a 14 day course of doxycycline.Upper wound treated with sterile packing.This recently closed and on monday (b)(6) , upper wound was re-opened, cleaned out and wound vacuum assisted closure placed.On wednesday, noted redness surrounding abdominal wounds.States no changes to wound vacuum assisted closure were made.Erythema did not spread past abdomen and no other skin changes.Did have some nausea and low grade fevers (99.5) with this.Today, erythema has completely resolved after receiving dose of ceftriaxone and vancomycin.Feels well without other symptoms.Exam: abdominal soft, bowel sounds normal, no distention, no tenderness.Central abdomen covered by wet to dry dressing.No surrounding erythema.Mild tender to palpation at right lower border of dressing.Impression/plan: presented with concern of second wound infection.10 day course doxycycline + augmentin to cover likely skin organisms.Follow up in surgery clinic for further wound management.C/f [unknown abbreviation] wound infection: previous wound infection after ventral hernia repair treated with doxycycline and wound vacuum assisted closure placed over inferior wound.Superior wound now with vacuum assisted closure after surgery visit (b)(6).Gram positive cocci in gram stain of inferior wound-unable to determine streptococcus versus staphylococcus at this time.Improved on antibiotics (vancomycin/ceftriaxone).Would not characterize as doxycycline failure, but perhaps not full coverage for skin/gastrointestinal organisms (doxycycline with poor streptococcus coverage, proximity to gastrointestinal source).On (b)(6) 2018: (b)(6) hospital.(b)(6) , md; (b)(6) , md.Discharge summary.Admit date: (b)(6) 2018.Discharge date: (b)(6) 2018.Principal problem: wound infection after surgery.Key points for follow up: wound care clinic.Hospital course: ventral hernia repair (b)(6) 2018 complicated by incisional wound infection in two locations requiring wound vacuum assisted closure placement.Readmitted for nausea and concern for wound infection.Wound cultures obtained and demonstrated streptococcus dysgalactiae.Infectious disease recommended a course of doxycycline and augmentin for 10 days.Hospitalization was uneventful had no recorded fevers.Hemodynamically stable.Discharged with wound care and teaching.She felt comfortable going home and follow-up appointment was scheduled.Follow-up: (b)(6) , md phd.On (b)(6) 2018: (b)(6) hospital.(b)(6) , md phd.History and physical.Presents with chronic infection midline wound.Presents now for wound debridement.Ros: significant for wound drainage and pain.Denies fever and chills.Exam: abdomen chronic draining sinus.Impression: wound infection, chronic.Plan: operating room drainage, antibiotics.On (b)(6) 2018: (b)(6) hospital.(b)(6) , crna.Anesthesia record.Asa 2.On (b)(6) 2018: (b)(6) hospital.(b)(6) , md phd.Operative report.Pre-op diagnosis: wound infection.Post-op diagnosis: same.Procedure(s): wound debridement.Anesthesia: general.Surgeon(s): (b)(6) , md phd; (b)(6) , md.Staff: circulator: (b)(6) , rn.Circulator relief: (b)(6) , rn.Scrub: (b)(6)., circulator secondary: (b)(6) , rn; (b)(6) , rn.Scrub secondary: (b)(6)., rn.Estimated blood loss: less than 50 ml.Drains: 1/4" penrose x2.Total iv fluids: 300 ml.Specimens: id 1: abdominal wound.Type: tissue in formalin.Test: permanent pathology request.Collected by: (b)(6)., md phd.Time (b)(6) 2018 1253.Destination: pathology.Complications: none.Findings: prolene sutures at bottom of wound causing reaction.Disposition: awakened from anesthesia, extubated and taken to the recovery room in a stable condition having suffered no apparent untoward event.Condition: doing well without problems.Technique: ¿the patient is a 42-year-old female with chronic wound infection status post living donation late last year.She has had several i&d¿s in the past.I am taking her to the operating room for definitive wound debridement.The patient was brought to the operating room placed in supine position.After adequate general endotracheal anesthesia her abdomen was prepped and draped widely in usual sterile fashion.She was given 2 g of ancef for antibiotic prophylaxis.A formal timeout was undertaken to verify patient identification, antibiotics have been given and dvt prophylaxis was in place.Previous incision was opened with electrocautery.2 draining sinuses were excised and a area of purulence was located just below the umbilicus.The umbilical stalk was transected to gain further entry into the wound.The wound was cleaned and cultured.Several prolene sutures were identified and these were removed sharply.Attention was turned to the superior sinus which was also excised widely.Both incisions were closed over 1/4 inch penrose drain using interrupted 3-0 vicryl sutures.Several small deep fascial defects were closed with interrupted 0 vicryl sutures.The wound was dressed with dry sterile dressing.Patient tolerated the procedure well and was discharged to the recovery room extubated in stable condition.Sponge and instrument count were correct x2.¿ on (b)(6) 2018: department of pathology, (b)(6).(b)(6) , md.Pathology report.Accession #: (b)(4).Final diagnosis: abdominal wound, debridement: skin and subcutaneous tissue with acute and chronic inflammation, areas of fibrosis and areas of erosion/ ulceration.Clinical history: chronic infection midline wound.Gross description: received is a formalin container labeled ¿(b)(6) / 3830402¿ designated ¿abdominal wound¿ containing two fibroadipose soft tissues, 3.4 x 2.7 x 1 cm and 4 x 2.5 x 1.3 cm, each surfaced with a wrinkled skin ellipse, 2.5 x 0.7 and 2.7 x 1.4 cm, respectively.Cut surfaces demonstrate fibrous tissue without discrete area of purulent material or abscess formation.Representative sections of each are submitted in (a1).On (b)(6) 2018: (b)(6) lab.Lab.Fungus culture: type: swab.Source: wound.Value: culture grew alternaria species.Aerobic culture, including gram stain: source: wound.Aerobic culture value: rare corynebacterium species.Direct gram stain value: no organisms seen; heavy red blood cells; moderate polymorphonuclear cells.Anaerobic culture: source: wound.Value: rare mixed anaerobic organisms; negative for bacteroides fragilis group and clostridium perfringens.On (b)(6) 2018: (b)(6) , md; (b)(6) , md phd.Discharge summary.Admit date: (b)(6) 2018.Discharge date: (b)(6) 2018.Final diagnoses: wound infection, status post laparoscopic exploration and wound debridement.Key points for follow up: continue home antibiotics.Follow up in clinic (b)(6) 2018 for dressing removal.Hospital course: laparoscopic exploration for wound debridement.Exam: abdomen dressing in place over wound.Weight 185 lb 14.4 oz.Bmi 30.94.On (b)(6) 2018: (b)(6) hospital.(b)(6) , md.(b)(6) , md.History and physical.Presents with concern for recurrent wound infection.States wound is draining purulent drainage from bottom of wound, and was sent for further evaluation and treatment of infection.Denies chills, but states temperature has been running a little higher than normal; denies nausea and vomiting.Current medications: amoxicillin-clavulanate, doxycycline, acetaminophen, oxycodone.Review of systems: positive for wound; mid abdominal wound with purulent drainage.Weight 190 lb 4.8 oz, bmi 31.67.Exam: abdominal soft, bowel sounds normal, no distention, midline wound with purulent drainage.Impression/plan: history of hernia repair from prior live liver donation, complicated by incisional wound infection with multiple interventions for recurrent infection, here for further wound debridement and treatment of persistent infection.Operating room today for debridement and wound vacuum assisted closure placement.On (b)(6) 2018: (b)(6) hospital.(b)(6) , md.Anesthesia record.Asa 2.On (b)(6) 2018: (b)(6) hospital.(b)(6) , md; (b)(6) , md.Operative report.[first page of report missing].Findings: chronic small fistula from umbilical skin to the wound, prolene suture at bottom of wound to the right of the midline causing [sic] reaction.Disposition: awakened from anesthesia, extubated and taken to the recovery room in a stable condition, having suffered no apparent untoward event.Condition: doing well without problems.Technique: ¿the patient is a 42-year-old female with chronic wound infection stats post living donation of liver late last year.She has had several i&d¿s in the past with chronic non healing wound and discharge.No systemic septic concerns.It was decided to explore the wound under general anaesthesia [sic] and preform [sic] debredement [sic].The patient was brought to the operating room placed in supine position.After adequate general endotracheal anesthesia her abdomen was prepped and draped widely in usual sterile fashion.A formal timeout was undertaken to verify patient identification, antibiotics have been given and dvt prophylaxis was in place.Previous incision was opened with electrocautery.Debridement was preformed [sic] of the wound wall bilaterally.A sinus tract was identified between the umbilical skin and the wound.It was decided to resect the umbilicus ¿ an option that was previously [sic] discussed with the pt.The umbilical stalk was transected to gain further entry into the wound.A prolene suture was identified 3cm to the right of the midline with chronic reaction around it.The suture was sharply removed and the site debrided and closed with interrupted 0 vicryl sutures.The wound was cleaned.Another site was located just caudal to the umbilicus that was again debrided and closed with vicryl sutures.Chronic granulation was debrided.The wound was irrigated and hemostasis was insured.A wound vac was left in place with a large deep black sponge.Patient tolerated the procedure well and was discharged to the recovery room extubated in stable condition.Sponge and instrument count were correct [sic] x2.¿ on (b)(6) 2018: (b)(6) hospital.(b)(6) , md.Progress notes.States abdomen feels tight, but denies pain, nausea or vomiting.Exam: wound vacuum assisted closure in place located in midline abdomen and draining slight serosanguinous fluid.There is some swelling to the right of the wound vacuum assisted closure that is firm and tender to palpation, but without erythema or calor.Patient states it had been there prior to surgery today.Impression/plan: continue close monitoring; regular diet; pain medications only if requested; no antibiotics.Pending clinical status, discharge tomorrow.On (b)(6) 2018: (b)(6) hospital.(b)(6) , md; (b)(6) , md.Discharge summary.Admit date: (b)(6) 2018.Discharge date: (b)(6) 2018.Principal problem: wound infection after surgery.Key points for discharge: wound vacuum assisted closure change in clinic on tuesday, confirm set up for home wound vacuum assisted closure changes.Hospital course: admitted for infected surgical site.Taken to operating room later that day where debridement was performed and wound vacuum assisted closure was placed.Progressed well post-operatively, and deemed well enough for discharge and discharged (b)(6) 2018.Follow-up: (b)(6) , md.Follow up with liver transplant clinic tomorrow.On (b)(6) 2018: (b)(6) hospital.(b)(6) , md.(b)(6) , md phd.History and physical.Has been suffering from surgical site infections status post multiple operations for wound exploration and debridement.Most recently on 8/25/18 underwent wound debridement and wound vacuum assisted closure.Current medications: cefazolin.Review of systems: positive for wound.Exam: abdominal soft, no distention, no tenderness.~3cm wound in center of abdomen with dressings on top.Impression/plan: discussed with patient the benefits, risks and alternatives to surgery.Patient agrees and would like to proceed.Operating room for abdominal wall exploration, debridement and removal of infected mesh.On (b)(6) 2018: (b)(6) hospital.(b)(6) , md.Anesthesia record.Asa 2.Weight 197 lb 9.6 oz.Bmi 32.88.See attachment for h10/11 continuation.
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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.¿ 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.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.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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