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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
Abscess (1690); Unspecified Infection (1930); Hernia (2240); Obstruction/Occlusion (2422)
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| Event Date 01/11/2020 |
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Event Type
Injury
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Manufacturer Narrative
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The plus antimicrobial product coating contains silver carbonate [approximately 800 micrograms per cubic centimeter of product (g/cm3)], and chlorhexidine diacetate [approximately 1600 micrograms per cubic centimeter of product (g/cm3)].It should be noted that the [mesh device brand] 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 [mesh device brand] 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 ventral hernia repair on (b)(6) 2016 whereby a gore® dualmesh® plus biomaterial was implanted.The complaint alleges that on (b)(6) 2020 and (b)(6) 2020, additional procedures occurred whereby the gore device was explanted.It was reported the patient alleges the following injuries: seroma, infected mesh, abscess, small bowel obstruction, dense adhesions, recurrence, removal of crumpled mesh, and pain and suffering.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: (b)(6) 2009: (b)(6) medical center.[signature illegible].Pre-anesthetic consultation.No smoking, occasional back pain, (b)(6) 2009 laparoscopic cholecystectomy; tubal, c-section x2.Height 5¿6¿, weight 230.Asa ii.(b)(6) 2009: (b)(6) medical center.(b)(6) md.Operative report.Preoperative diagnosis: ventral (incisional) hernia).Postoperative diagnosis: ventral (incisional) hernia.Procedure performed: repair of ventral hernia with dermamatrix graft (12-cm x 6-cm graft).Assistant: (b)(6) cfa.Anesthesia: general endotracheal anesthesia.Background: ¿this patient is a 36-year-old female who had observed a swelling at the area of mid abdomen, extending around both supra and infraumbilical areas and had become progressively worse with symptoms at this time especially upon exertion and her nature of her work caused exertional lifting, and so she was having problem in her job at this time, and she had previous procedures done like tubal ligation she had cesarean section done and she had a laparoscopic cholecystectomy done, and the most prominent portion of this hernia was around the area of the umbilicus through the old incisional scar in that area.The patient had a ct scan done and it was consistent with a ventral hernia containing some abdominal contents, but reducible.So, the patient was told about the risks and benefits of the procedure especially some bleeding, infection, possible injury to intraabdominal organs during dissection, and possible adverse effect from the anesthetics during this procedure, and even death.The patient fully understood the risks, benefits, and options of procedure as explained to her, and she fully consented to have the procedure done.¿ description of procedure: ¿she was taken to the operating room and under general endotracheal anesthesia, the abdomen was prepped and draped.An incision was then made extending from above the umbilicus to the right of the umbilicus and to just below the umbilical area using a #10 surgical blade, and the incision was taken down to subcutaneous tissue to expose the underlying hernia sac at the mid portion of the abdomen.The hernia sac was a large fibrotic hernia sac containing no intraabdominal contents at the time it was opened as all the contents had been reduced after the patient under anesthesia.So, we dissected around the hernia sac and dissected the hernia sac free using an electrocautery and after the hernia sac was fully dissected out, it was removed and sent for histopathology.Intraabdominal contents, there was one area of loop of small bowel that was adherent to the area near the opening in the anterior abdominal wall area and the adhesions were then taken down.Lysis of adhesions was done of the loop of bowel and then we proceeded to cauterize the edge of the hernia defect, the fascial edge, with the electrocautery, and then the wound was irrigated with gu irrigant and the defect itself was about 12 x 6 cm.We did use a dermamatrix graft, 12 cm x 6 cm in size, to repair the defect and after mobilizing the flap circumferentially, the dermamatrix was tacked in position using #1 prolene suture in a running fashion circumferentially, and then after the graft was in place, the wound again was irrigated with some gu irrigant and the subcutaneous tissue was irrigated and hemostasis was maintained using electrocautery.A #19 round blake drain was then placed in the subcutaneous tissue and brought to the outside the skin through an extra incision from the abdominal wound and then affixed to the skin using 3-0 nylon suture and then we proceeded to further close the abdominal wound using 3-0 interrupted vicryl suture and then a 4-0 monocryl subcuticular suture for approximation of the skin edges, and then with steri-strips gauze.A total of 30 ml of 0.25% marcaine with epinephrine was injected in and around the surgical area before closure of the wound.As stated, there was one drain inserted, a blake drain, and the specimen sent was the redundant hernia sac, the ventral hernia.There were no intraoperative complications during this procedure.Estimated blood loss was approximately 10 ml.Intravenous fluid used was 1300 ml of crystalloid solution and at the end neosporin ointment and steri-strips were applied to the wound edges and gauze dressing, and an abdominal binder was then applied also, and the patient was removed from the operating room table and was transported in a stretcher.The patient tolerated the procedure well and was taken from the operating room to the postanesthetic care unit in a stable condition.¿ (b)(6) 2009: (b)(6) medical center [assigned].Implant record.M.Bontiss dermamatrix.(b)(6) 2009: (b)(6) medical center.(b)(6) md.Pathology report.Accession #: (b)(6).Physicians: (b)(6) md.Diagnosis: ventral hernia sac: hernia sac with fibrosis, slight chronic inflammation, and reactive changes.Gross description: received in formalin labeled ¿ (b)(6), ventral hernia sac¿ is an 8.0 x 7.5 x 3.0 cm saccular tissue.One surface has fat and is red-pink and saggy.The inner surface is tan-pink, congested, and wrinkled.Representative sections are submitted.2/1.Microscopic description: microscopic examination is performed.Clinical history: ventral hernia.Specimen list: ventral hernia sac.(b)(6) 2014: [facility ni].Perioperative record.Wound class: 1 ¿ clean.Height 5¿6¿, weight 235 lbs, bmi 37.9.Implant record.Prolene soft mesh.Specimen: hernia sac.Mesh.(b)(6) 2014: (b)(6) hospital.(b)(6) md.Operative report.Preoperative diagnosis: recurrent ventral hernia.Postoperative diagnosis: recurrent ventral hernia.Procedures performed: open repair retrorectus mesh placement with rectus muscle advancement.Debridement of old mesh.Anesthesia: general.Estimated blood loss: about 100 ml.Condition: sable throughout the procedure.Complications: none.Indications: ¿ms.(b)(6) was referred to the surgical clinic.She has undergone 2 previous abdominal wall hernia repairs using mesh at an outside institution.She had experienced recurrence of the hernia after each repair.She also had a severe postoperative wound infection, which required drainage of the abdominal incision following the last repair of the hernia.She has since gained a lot of weight.On ct scan, she showed a large amount of small intestines and omentum in the hernia sac.She complains of some pain and some nausea consistent with intermittent bowel obstruction.She requests repair.She is brought in today.We discussed previously and repeated the discussion today regarding the management of abdominal wall hernia.This included but not limited to observation, abdominal binders, and surgical exploration.She requested exploration because of the massive nature of hernia and the fact that 2 previous repairs had failed and that rectus muscles were separated, we opted for an open repair with retromuscular placement of mesh and advancement of the rectus muscle towards the midline.She agrees with this.She understands the potential for infection in the wound especially in view of her morbid obesity and the extensive nature of the hernia.She is in agreement to proceed.She has received dvt prophylaxis with heparin 5000 units.She also has infectious prophylaxis with a gram of vancomycin.She has sc devices to the lower extremities.She has been n.P.O.Overnight.¿ description of procedure: ¿following the clearance by anesthesia, she was taken into the operating room.She was placed under general anesthesia.She was __ [sic].A foley catheter has been placed.The abdomen was prepped and draped sterilely.We started with a midline incision starting from the mid epigastric region to just below the umbilicus, curving around the umbilicus.We carried this through the subcutaneous tissues.Upon entering the subcutaneous tissues external to the anterior abdominal fascia.We opened this mesh.___ [sic] by the large hernia, which had pushed this into the subcutaneous tissue.There was another piece of mesh that was on top of the rectus muscle and was adherent to the rectus muscle.The hernia itself was lodged between the 2 sets of mesh, the one superficial to rectus muscle and the other in the subcutaneous tissues.We reduced the hernia.Then, we developed a flap consisting of the peritoneum and posterior rectus sheath on both sides.This allowed us to close the peritoneal cavity with the posterior rectus sheath and peritoneum.We then placed a 12 x 12 mesh between the posterior rectus sheath and the rectus muscle.This secured to the rectus muscle with a normal 0 gore-tex sutures.We then mobilized the rectus muscle by releasing it from its junction to the external oblique muscle.This allowed the rectus muscle bilaterally to be mobilized into the center of the incision.We were then able to close the rectus muscle over the mesh using interrupted sutures __ [sic] #1 prolene.Following this __ [sic] defect over the rectus and the subcutaneous pocket where the herniation had been.We debrided the mesh external to the rectus and the superficial to the skin.We debrided most of the peritoneal covering and then closed the subcutaneous tissues with interrupted sutures of 2-0 vicryl.We placed a jp drain on both sides of the midline.The skin was approximated with staples, and abdominal binder was applied.General anesthesia was reversed.The patient tolerated the procedure well and was returned to the recovery room in good condition.¿ (b)(6) 2014: (b)(6) hospital.(b)(6) md, pathologist.Pathology report.Accession #: (b)(6).Case number: (b)(4).Ordering physician: (b)(6).Final diagnosis: a) hernia sac: hernia sac.B) mesh (gross only).Clinical history: pre-op diagnosis: incisional hernia.Gross description: a) hernia sac.Received in formalin are multiple fragments of pink-tan fibromembranous soft tissue that are 8.0 x 4.5 x 0.5 cm in aggregate.Representative sections are submitted.B) mesh.Received in formalin is an 8.0 x 4.0 x 0.5 cm tan-white fragment of mesh.The specimen is submitted for gross description only.Specimen: a) hernia sac.B) mesh.Implant procedure: open repair of recurrent ventral hernia with intraperitoneal placement of mesh.Evacuation of intra-abdominal hematoma.Panniculectomy, removal of excess skin and fatty tissue of abdominal wall.Implant: gore® dualmesh® plus biomaterial (1dlmcp03/(b)(6)), 10 x 15 cm.Implant date: (b)(6) 2016 (hospitalization ni): (b)(6) 2016: (b)(6) hospital.(b)(6) md.Operative report.Preoperative diagnoses: recurrent abdominal incisional ventral hernia.Large postoperative abdominal seroma.Morbid obesity.Postoperative diagnoses: postoperative hematoma.Recurrent abdominal ventral hernia.Morbid obesity.Procedure performed: open repair of recurrent ventral hernia with intraperitoneal placement of mesh.Evacuation of intra-abdominal hematoma.Panniculectomy, removal of excess skin and fatty tissue of abdominal wall.Anesthesia: general endotracheal tube anesthesia.Estimated blood loss: 350 ml.Drains: none.Complications: none.Specimens: 1) hematoma capsule and hematoma contents to pathology for permanent section and identification.2) excess skin, fatty tissue and hernia sac to pathology for permanent section and identification.Disposition: to recovery area in stable condition.Indication for procedure: ¿the patient is a 43-year-old female with a significant history of incisional abdominal hernia, status post attempted repair x3.On the last repair, patient had a displacement mesh and ___ [sic] postoperatively, large midline hematoma.The patient then noticed significant increasing right lower quadrant abdominal pain, consistent with recurrent hernia.This was also demonstrated by computed tomography.The patient also suffers from significant morbid obesity.Based on the size of the hematoma and failure to evacuate with percutaneous treatment, it was thought patient should proceed to the operating room.Prior to procedure, diagnosis, prognosis, proposed surgical and nonsurgical alternatives with risks and benefits were discussed with the patient in detail, along with diagnosis and treatment.Based on pt¿s body habitus and the very large size of the hematoma, it was felt that resection of redundant skin would be necessary in order to prevent necrosis or reaccumulation of the hematoma.¿ procedure in detail: ¿the patient was brought to the operating room on (b)(6) 2016, at which time she was intubated per anesthesia without difficulty.A foley catheter was also placed under sterile conditions.She was prepped and draped in the usual sterile fashion and a timeout was called, identifying the patient, the proposed procedure, the operative site, the allergies, comorbidities, and position.All in the operating theater were in agreement of these parameters and at this point the procedure commenced.A midline incision was then recreated and hemostasis was achieved with electrocautery.Dissection was carried down to a large encapsulated structure.This was measured at 27 x 23 cm.This was incised and contents were consistent with resolving hematoma.Cultures were captured and sent to microbiology for aerobic and anaerobic culture and sensitivity.At this point, the entire capsule was excised.This was complicated by the fact that the capsule was adherent to the anterior abdominal wall and care was taken not to compromise the integrity of the otherwise intact midline hernia repair.Once this was accomplished, the dissection was carried to the hernia located on the patient¿s right flank.This involved mobilization of skin and fatty cutaneous flaps.This was accomplished, and exposed a 3 x 3 cm hernia defect on the right side.This was incised, the hernia sac was sent as part of the specimen and hernia was then repaired using a 10 x 16 gore dualmesh plus mesh cut to a 10 x 10 cm mesh.This was secured circumferentially using gore 0 vicryl sutures placed every centimeter on the external circumference of the mesh in an intraperitoneal fashion, under direct visualization.To this end, the defect was completely closed.At this point, the overlying muscle tissue was then reapproximated using running #1 looped pds suture.The advancement flap, consisting of skin and subcutaneous fatty tissue, were then advanced bilaterally and an upside down t-shaped incision was then created removing excess skin and fatty tissue.This was done to prevent significant pocket, dead space, and recurrent hematoma.At this point, the abdominal wall was then closed using multiple interrupted 0, 2-0, and 3-0 vicryl sutures.Two 24-french channel drains were placed prior to complete closure and tisseel and floseal were placed in the open free surface areas.Hemostasis was also achieved with meticulous use of electrocautery prior to full closure.Once the abdominal wall was completely closed, the upside down t incision was then dressed with a customizable prevena-type wound vac.The patient was ten extubated per anesthesia without difficulty and taken to the recovery area in stable condition.The patient tolerated this procedure well.¿ (b)(6) 2016: (b)(6) hospital.Implant record.Type: implant.Size: 10 cm x 15 cm.Qty: 1.Serial #: (b)(6).Expiration: 09/2018.Model #: 1dlmcp03.Site: abdomen.Mfg: w l gore and associates.The records confirm a gore® dualmesh® plus biomaterial (1dlmcp03/(b)(6)) was implanted during the procedure.Relevant medical information: (b)(6) 2016: (b)(6) hospital.(b)(6) md.Pathology report.Accession #: (b)(6).Referring physician: (b)(6).Specimen: a) abdominal wall hematoma & capsule.B) ventral hernia sac.C) abdominal fat & skin.Pre-op diagnosis: abdominal wall seroma / ventral hernia.Final diagnosis: a) abdominal wall hematoma and capsule: fibromembranous capsule and hematoma.B) ventral hernia sac: fibromembranous hernia sac.C) abdominal fat and skin: skin and subcutaneous fat.Gross description: a) ¿abdominal wall hematoma and capsule.¿ received without preservative are two sac-like pieces of pinkish gray fibromembranous tissue that together measure approximately 20 x 13 x 0.5 cm.The surfaces are smooth on one side and the other side is somewhat shaggy with attached fibrin adhesion and fat.Also present in the container are multiple pieces of soft brownish tan blood clots that together measure 12 x 10 x 5.8 cm.Several fragments of blue suture material are also present.Sections of the fibrous capsule are submitted in cassettes a1 and a2.B) ¿ventral hernia sac.¿ received in formalin is a sheet of gray-tan fibromembranous tissue measuring 7 x 5 x 0.4 cm.One surface is smooth and shiny and the other shows fibrous adhesions and fat attached.A section is submitted in cassette b.C) ¿abdominal fat and skin.¿ received in a biohazard bag without preservative are multiple pieces of tan skin and subcutaneous fat that together weigh 2830 grams and measure 30 x 30 x 5.0 cm.The skin surfaces are smooth and tan with no identifiable gross lesions.The umbilicus is noted in one of the pieces of skin.The margins are lined by blue ink.Section of the deep fascia margin is submitted in cassette a1, a section of the skin is submitted in cassette a2, and a section from the umbilicus area is submitted in cassette a3.(b)(6) 2020: (b)(6) md.Radiology-ct abdomen/pelvis with contrast.Indication: nausea/vomiting.Incompletely visualized large right lower quadrant broad necked spigelian hernia.Calcification noted along inferior aspect of the hernia within the abdominal musculature.Medially there is a 1.4 x 7.7 cm fluid collection between muscular layers of the abdominal wall.Subcutaneous fat stranding present within the anterior abdominal wall fat.(b)(6) 2020: (b)(6) md.Consultation.States on her way home from work she started to feel nauseated, had cold sweats, began vomiting.Last bowel movement was earlier that day, has been passing gas even after emesis.Nausea since resolved.Epigastric pain.States has had hernia for years with multiple repairs and revision surgeries.In 2009 she had 2 repairs of that hernia as well as a lap ccy that year.In 2010 she had an emergency surgery for what was described as infected mesh.In 2014 she had another hernia repair.In 2016 another hernia repair and tummy tuck.Patient states hernia returned a few months after surgery.It is never reduced.It occasionally causes her discomfort.She works in a laundry room so her job requires a lot of pushing.Had one sbo (b)(6) 2019, resolved nonoperatively.Has small area of drainage at her umbilicus that has been present for 6-7 months.Patient places a washcloth to collect the drainage but it does not bother her.History of dvt 2010, abdominal wall mesh removal 2010, cesarean section x2, right spigelian hernia repairs 2009 x2, 2014, 2016, laparoscopic cholecystectomy 2009, tubal ligation.Never smoker, alcohol 2x per year, drugs never.Exam: abdomen; soft, obese, large irreducible right sided hernia, nontender, no guarding or rebound, well healed laparotomy scar, pen tip sized spot at umbilicus with what appears to be an area of granulation tissue with no expressible fluid, no palpable underlying fluid collection, serous drainage on the washcloth overlying the area.Plan: admit, consider small bowel follow through in morning.(b)(6) 2020: (b)(6) md/(b)(6) do.Progress notes.History of chronic right spigelian hernia with several failed repairs, presenting with partial small bowel obstruction with passage of flatus.Ng decompression.Or today.(b)(6) 2020: (b)(6) md.Progress notes.This bowel obstruction is a new problem to me, she will require further workup in the form of emergency abdominal surgery with significant risk factors.This is acute illness with potential risks and bodily function.We¿re doing that today.Data reviewed include ct, large spigelian hernia with 20% domain loss.Wbc 13.3.(b)(6) 2020: (b)(6) hospital.(b)(6) md; (b)(6) md, surgical resident.Operative report.Preoperative diagnoses: small bowel obstruction.Incarcerated recurrent ventral hernia.Postoperative diagnosis: small bowel obstruction.Infected abdominal mesh, small bowel obstruction, abdominal wall abscess, recurrent incisional hernia incarcerated.Procedure performed: lysis adhesions abdominal cavity: pr freeing bowel adhesion, enterolysis.Removal therapeutic implant abdominal cavity: pr remove mesh from abd wall for infection.Repair hernia ventral: pr repair recur incis hernia, strang.Application vacuum-assisted drainage device torso: pr negative pressure wound therapy dme >50 sq cm.Anesthesia: general endotracheal anesthesia.Case type: urgent/emergent.Estimated blood loss: 100 ml.Specimen(s): mesh, hernia sac.Complications: none.Postop condition: stable.Postop disposition: pacu.Indications: ¿this is a 47-year-old with the following condition: incarcerated incisional hernia recurrent with bowel obstruction.¿ operative findings: incarcerated rlq hernia, bowel viable.Operative technique and details: ¿the patient was brought to the operating room and general anesthesia was induced.The patient was placed in supine position.The abdomen was prepped and draped in a sterile fashion.We made a midline incision and carried this down through the layers of the abdominal wall identifying the rectus sheath.We entered the peritoneal cavity and performed extensive adhesiolysis.We took down adhesions from the omentum to the abdominal wall as well as some adhesions between loops of small bowel.The bowel was dilated consistent with small bowel obstruction.We identified an incarcerated hernia in the right lower quadrant corresponding to previous incision.We were able to reduce this manually and took down some adhesions that it formed inside the hernia sac.The bowel was reduced back into the peritoneal cavity, we inspected the entirety of the small bowel from the ligament of treitz to the ileocecal valve.There was some serosal hemorrhages noted at the site of the obstruction, we were able to clearly identify the transition point consistent with the obstruction and everything distal appeared decompressed.The bowel all appeared viable we did not perform any bowel resection.We then identified that there was an abscess in the abdominal wall that was extending through muscle layers to the right lower quadrant where we identified a crumpled piece of ptfe mesh.We drained this abscess and explanted the ptfe, this was sent to pathology.Given the infected state of the abdominal wall, we are reluctant to put any heavy weight mesh.We initially attempted to open the retrorectus space but this was obliterated from previous surgery.At this point we elected to perform a large subcutaneous flap and this was taken down over the right lower quadrant exposing the hernia defect.We elected to perform a buttressed onlay repair of the hernia defect using #1 pds for closure and the onlay mesh was a light weight prolene soft.We took bites of the mesh with full-thickness bites of the closure of the abdominal wall.This left us with a very large subcutaneous defect.We did resect as much of the sac as possible and sent this to pathology.The peritoneal cavity was inspected and was hemostatic.We closed the midline laparotomy incision with #1 pds suture in a running fashion.The skin wound was dressed with a large greater than 100 cm2 wound vac dressing for the torso with the thought to close down the large cavity in the subcutaneous tissues from the previous hernia sac.¿ counts: correct.Presence statement: i was present for the entire operation as dictated.Overlap statement: there were no overlapping components to this operation.(b)(6) 2020: (b)(6) hospital.Implant record.Mesh/synthetic materials implant.Msh prolene soft polyprop.Manufacturer: ethicon, inc.(b)(6) 2020.(b)(6) medical center.(b)(6) md.Pathology report.Accession #: (b)(6).Submitting physician: (b)(6) md.Diagnosis: 1) hernia sac, excision: fibroadipose tissue with mild chronic inflammation.2) hernia, mesh removal: mesh and attached soft tissue (gross examination only).Clinical data: clinical history: unspecified.Procedure: unspecified.Specimen submitted: 1) hernia sac.2) mesh.Surgical pathology instructions: routine.Specimens received: 1) hernia sac.2) mesh.Gross description: 1) hernia sac: received fresh labeled with ¿(b)(6)¿ on the clinical and pathology labels, the mrn, and ¿hernia sac¿ is an 11.9 x 8.7 x 3.1 cm fragment of yellow lobular adipose tissue partially encased in a 0.2 cm thick pink and glistening membrane.Sectioning reveals homogenous tissue throughout.Representative sections are submitted in formalin as cassettes 1a-1b, 2/1 each.2) mesh: received fresh labeled with ¿(b)(6)¿ on the clinical and pathology labels, the mrn, and ¿mesh¿ is a 7.0 x 2.9 x 1.0 cm intact fragment of tan-brown plastic like material with numerous sutures, and a scant amount of adherent soft tissue.No tissue is submitted for microscopic examination.(b)(6) 2020: (b)(6) md/(b)(6) aprn.Discharge summary.Admit date: (b)(6) 2020.Course: sbo with passage of flatus.Small bowel follow through without passage of contrast to the colon and without return of bowel function.Or for exploratory lap, hernia repair with mesh, wound vac placed.Has done well postoperatively.Ready for discharge.(b)(6) 2020: (b)(6) md.Radiology-ct abdomen/pelvis with contrast.Indication: intra-abdominal and pelvic swelling, mass and lump, unspecified site.Drainage from incision site.Findings: colon and small bowel normal in appearance without focal inflammation or obstruction.Small bowel loops within the right lower quadrant immediately subjacent to right lower quadrant hernia mesh repair without evidence of inflammation or obstruction.No free air or free fluid within abdomen or pelvis.Mild stranding within anterior omentum subjacent to the hernia repair.Open midline laparotomy incision, multiple postoperative findings status post right lower quadrant spigelian hernia mesh repair.Along the right posterolateral margin of the surgical site there is a 3.1 x 8.0 x 6.7 cm fluid collection with mild surrounding stranding.More medially and along the abdominal wall musculature is a more tubular collection with similar imaging characteristics measuring 1.6 x 0.7 x 2.3 cm.More medial just to the right of midline is an additional thick-walled fluid collection measuring 3.9 x 1.5 x 4.6 cm.No evidence of air within these fluid collections.Moderate stranding and skin thickening surrounding the operative site and open midline laparotomy incision.(b)(6) 2020: (b)(6) trauma center.(b)(6) md.Office notes.Complex hernia repair, strangulated right lower quadrant spigelian hernia, repaired with large subcutaneous flap and onlay polypropylene mesh.She is recovering well.Developed a seroma secondary to premature sequestration of right lower quadrant cavity from remaining wound where she has wound vac therapy.Rest of wound healing well.Polypropylene mesh granulating nicely with no evidence of infection.I broke up some loculations right lower quadrant and evacuated some fluid.Will schedule for a potential percutaneous aspiration versus drainage of retained postoperative seroma.Continue wound vac therapy to the midline wound which is healing well.Explant procedure: not indicated.Explant date: not indicated.Relevant medical information: not indicated.A potential relationship, if any, between the alleged injuries or complications and the gore device has not been established at this time based on available information. it should be noted that the gore® dualmesh® plus biomaterial instructions for use addresses the following adverse reactions among others: ¿possible adverse reactions with the use of any tissue deficiency prosthesis may include, but are not limited to, contamination, infection, inflammation, adhesion, fistula formation, seroma formation, hematoma, and recurrence.The gore® dualmesh® plus biomaterial instructions for use also states: ¿strict aseptic techniques should be followed.If an infection develops, it should be treated aggressively.An unresolved infection may require removal of the material.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.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.In the absence of additional information or medical records from the complainant, this event file will be closed with the information provided.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: ¿as with any surgical procedure, there are always risks of complications in surgical repair of soft tissue deficiencies, with or without mesh.Complications may include but are not limited to, infection, inflammation, adhesion, fistula formation, seroma formation, perforation, wound dehiscence, wound complications, pain, bowel obstruction, ileus, revision/re-intervention, fever and recurrence.Additional complications associated with procedures to address urogynecologic soft tissue deficiencies may include, but are not limited to, dyspareunia, vaginal bleeding or discharge, vaginal dysfunction, and urinary problems.¿ 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 device.¿ 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.Medical records that indicate mesh ¿movement¿ or that the device led to a recurrence may reflect a recurrence as a function of a patient¿s poor tissue quality leading to fascial dehiscence or loss of anchorage of fixation, or may be related to the hernia type, individual patient comorbidities, and technical and procedural aspects of the repair.These factors include but are not limited to, fixation type, mesh shape/sizing used, and defect closure decisions.Additionally, a new, unrelated hernia can occur but may be referred to as a recurrent hernia.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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