|
|
| Model Number 1DLMC03 |
| Device Problem
Insufficient Information (3190)
|
| Patient Problems
Abscess (1690); Fistula (1862); Unspecified Infection (1930); No Clinical Signs, Symptoms or Conditions (4582)
|
| Event Date 01/17/2020 |
|
Event Type
Injury
|
|
Manufacturer Narrative
|
|
It should be noted that the gore® dualmesh® biomaterial instructions for use addresses the following adverse reactions among others: ¿possible adverse reactions with the use of any tissue deficiency prosthesis may include, but are not limited to, contamination, infection, inflammation, adhesion, fistula formation, seroma formation, hematoma, and recurrence.The gore® dualmesh® biomaterial instructions for use also states: ¿strict aseptic techniques should be followed.If an infection develops, it should be treated aggressively.An unresolved infection may require removal of the material.
|
| |
|
Event Description
|
|
It was reported to gore that the patient underwent open incarcerated incisional hernia repair on (b)(6) 2018, whereby a gore® dualmesh® biomaterial was implanted.The complaint alleges that on (b)(6) 2020, an additional procedure occurred whereby the gore device was explanted.It was reported the patient alleges the following injuries: abscess, debridement, fistula, incision and drainage, infection, mesh removal, pain.Additional event specific information was not provided.
|
| |
|
Manufacturer Narrative
|
|
B7: added medical history.H6: conclusion code remains unchanged.H10/11: added medical record information.Additional details regarding the patient's clinical course were ascertained from a review of medical records and are as follows: relevant medical information: (b)(6) 2018: (b)(6) medical center.(b)(6) md.History and physical.Symptomatic ventral hernia and spindle cell lesion of the right frontal hairline region.Patient has previously undergone bilateral brachioplasty, bilateral thoracoplasty, bilateral augmentation mastopexy and panniculectomy in march of this year.Cosmetic surgery done in mexico.We never had her surgical reports.Patient describes hernia being found at time of panniculectomy and believes the hernia was not fixed at that time.Full anatomy of patient¿s panniculectomy is not known.Patient had an abnormal ct, which does delineate her hernia defect.(b)(6) 2018: (b)(6) medical center.(b)(6) md.History and physical.58-year-old female who has undergone a few abdominal surgeries.This includes placement of lap-band; in 2003.Band was removed in 2013 after motor vehicle accident.2015, had gastric sleeve bariatric surgery in mexico, and reports that same year had hernia repaired in esophagus.Back surgery in 2017.In march of this year, underwent panniculectomy and an incisional hernia was discovered around the umbilicus.This was not repaired.In addition, she has had other surgery including mastopexies and placement of implants.Also had bilateral brachioplasties and torsoplasty by having excess soft tissue removed from later chest.The incisional hernia has been increasing in size and becoming more uncomfortable.Did have evaluation by cat scan (b)(6) 2018 of abdomen and pelvis.Incisional hernia at the periumbilical region contained fatty tissue.In addition, diastasis recti was identified with the medial margins of the rectus muscles being up to 10 cm apart from each other.Plan is repair of incisional hernia with mesh and advancement of bilateral rectus abdominal muscles for reinforcement of hernia repair.Social history: lifelong non-smoker.Drinks alcohol socially.Does not use illicit drugs.Exam: afebrile.Weight 183 pounds at 5 feet 1 inch.Exam: abdomen soft.Evidence of healing panniculectomy incision.At and below the umbilicus is a hernia that reduces most of the way when lying down.Diastasis recti is about 10 cm wide and rectus muscles separated by 10 cm.Impression/plan: incisional hernia which mostly reduces.Diastasis recti.Plan is repair of ventral hernia with mesh and reinforcement and strengthening of closure with advancement of bilateral rectus abdominal muscles.Patient has skin cancer of right forehead with positive margin or near-positive margin.Plan by dr.(b)(6) will be re-excision of that skin cancer.Both procedures scheduled for (b)(6) 2018.Implant procedure: re-excision of right forehead spindle cell tumor.Incarcerated incisional hernia repair with mesh.Bilateral rectus abdominis muscle advancement with lateral release.Implant: gore® dualmesh® biomaterial [1dlmc03/(b)(6) , 15cm x 10 cm x 1 mm].Implant date: (b)(6) 2018 ((b)(6) -[not indicated], 2018).(b)(6) 2018: (b)(6) medical center.(b)(6) md.Operative report.Surgeon: dr.(b)(6) preoperative diagnoses: spindle cell tumor of the right forehead.Incarcerated incisional abdominal wall hernia.Postoperative diagnoses: spindle cell tumor of the right forehead.Incarcerated incisional abdominal wall hernia.Procedure performed: by dr.(b)(6): re-excision of right forehead spindle cell tumor.Please see her dictation for that.Performed by me with dr.(b)(6) assisting: incarcerated incisional hernia repair with mesh.Bilateral rectus abdominis muscle advancement with lateral release.Estimated blood loss: 150 ml.Findings: incarcerated incisional hernia around the umbilicus with complicated hernia sac.Description of procedure: ¿the patient was brought to the operating room and was in the supine position on the operating room table with the arms outstretched.Dr.(b)(6) approached the right forehead 1st after adequate endotracheal anesthesia was obtained.Please see her dictation.The abdomen was then prepped and draped sterilely after placement of a foley catheter.2% xylocaine with epinephrine was used for local anesthesia.Her several month old panniculectomy incision was approached, and the scar from the lateral anterior thigh on the left to the anterior lateral thigh on the right of the panniculectomy was then excised.Dissection was carried down through the skin and subcutaneous tissue to the fascia.The skin and subcutaneous tissue were elevated working through a lot of previous scar tissue, and the elevation was carried superiorly from panniculectomy scar.The dissection was carried along the anterior fascia saving some of the perforators.The dissection was carried around the hernia and umbilicus to near the xiphoid but not quite to the xiphoid.The hernia was approached then and some the hernia sac was dissected away from the subcutaneous tissue and off the fascia.This was freed up from the left of the midline and also a bit from right of the midline leaving the hernia sac with large umbilicus and very floppy redundant subcutaneous fat and skin.A decision was made to sacrifice the umbilicus.A v-shaped incision was made from above the umbilicus down to the edge of the panniculectomy incision.This was an inverted v.Dissection was carried down through the skin and subcutaneous tissue down to the fascia.The hernia sac was left mostly intact as the umbilicus and subcutaneous fat and skin was excised and handed off the field.This allowed much better exposure of the hernia sac.The hernia sac had been entered medially and several loops of bowel were noted within the hernia.These were reduced, and several adhesions to the hernia sac were divided to allow better reduction of the bowel.The hernia sac was excised circumferentially and handed off the field.The undersurface of the anterior abdominal was cleared of some adhesions to the omentum and some strands and some adhesions to the small bowel.The abdominal wall was reinspected, and it was noted that the fascial defect was about 15 cm vertical by 10 cm horizontal.There was also noted that there was a wide diastasis with the medial edge of the rectus muscle being about 15 cm apart.So a lateral release along the lateral edge of the rectus muscle was performed, (b)(6) on the left side which allowed mobilization of the rectus muscle and advancement of the rectus muscle medially.This was repeated on the right side and the lateral release with a vertical incision of the anterior fascia along the lateral edge of the rectus muscle.This lateral release was about 7 to 8 cm long.The medial edge of the rectus muscle was marked with india ink on the anterior fascia.Then, the rectus muscles were advanced medially bilaterally with interrupted 0 ethibond mattress sutures.The attenuated fascia between the rectus muscle was dunked below the suture line.The advancement of the rectus muscle bilaterally allowed good fascial tissue to sew the dual mesh too.Dual mesh was cut to size 10 cm x 10 cm and placed into the abdomen.The mesh was secured circumferentially with 0 ethibond suture placed in a running fashion circumferentially.Then, the reapproximation of the rectus muscles and advancement of the rectus muscle continued over the mesh, and the closure continued with interrupted 0 ethibond suture placed in a mattress fashion.There was minimal tension at the midline after this closure.Some of the scar tissue at the panniculectomy closure was released along the fascia to decrease tension of the closure.There had been a small opening in the fascia at the panniculectomy mid line site.This was closed with 0 ethibond suture.The on-q catheters were then placed through the skin and subcutaneous tissue at the superior aspect of the incision.They were secured through a tissue tunneled to same place superiorly.On the right lateral aspect at the panniculectomy incision, a 10-french jp drain was brought into the incision right across the inferior aspect to our dissection.The catheters were secured with nylon sutures.Then, the full panniculectomy incision was reclosed as well as midline incision was closed with interrupted 0 ethibond in the deep subcutaneous tissue and some in the more superficial subcutaneous tissue.A 3-0 monocryl was also used in the deep dermis and then in the subcuticular layer in a running fashion.The incisions were washed and dried.Then on-q pump was attached to the catheters.The jp was attached to a suction jp bulb.Mepilex dressings were placed, an abdominal binder was placed, and the patient was awakened, extubated, and taken to the recovery room in stable condition.She tolerated the procedure well without complication.¿ (b)(6) 2018: mat-su regional medical center.Intraoperative record.Procedure implants: description: mesh hernia dual 15cmx10cmx1mm.Total qty: 1.Serial #: (b)(6).Catalog nbr: 1dlmc03.Manufacturer wl gore.The records confirm a gore® dualmesh® biomaterial (1dlmc03/(b)(6)) was implanted during the procedure.Relevant medical information: (b)(6) 2018: mat-su regional medical center.[provider not indicated].Intraoperative record.Height 5¿ 1¿, weight 180 pound, bmi 34.Asa classification: mild to moderate systemic disturbance.Procedure: open ventral hernia repair with mesh, advancement of bilateral rectus abdominis muscle.Wound class: class 1 clean.(b)(6) 2018: [facility not indicated].(b)(6) md, facs.Office notes.On (b)(6) 2018 patient underwent incarcerated incisional hernia repair with mesh, bilateral rectus abdominis muscle advancement with lateral release.Patient reports eating/drinking normally, having normal bowel movements, no having fever, no experiencing nausea/vomiting, minimal taking pain medication.Exam: incision(s) clean, dry, intact.Erythema/infection; drainage: no.Return to work (b)(6) 2018.Restrictions: 10 pound lifting limit.Return to office next week.(b)(6) 2018: [facility not indicated].(b)(6) md, facs.Office notes.Patient reports abdomen is very swollen.Exam: incision(s) clean, dry, intact.Erythema/infection: no.Drainage: small amount.Large fluctuant seroma across lower abdomen extending to above umbilicus.Multiple aspiration attempts not successful.Restrictions: 10 pound lifting limit until end of (b)(6).Return to office (b)(6) 2018.Referred to ultrasound for aspiration.(b)(6) 2018: (b)(6) medical center.(b)(6) md.History and physical.Underwent open ventral hernia repair with mesh and advancement of bilateral rectus abdominis muscles (b)(6) 2018.Drains that were placed at that time, were pulled or fell out.Has had intermittent drainage from incision, which was at the panniculectomy area.Sometimes the drainages are a little purulent and other times it is serosanguineous.Has had a couple of ultrasounds which continued to show a fluid collection in this area.Recently, we asked the radiologist to do an ultrasound guided aspiration.Staphylococcus aureus was cultured on (b)(6).This was sensitive to most antibiotics except ampicillin and penicillin.Had an aspiration with removal of fluid on (b)(6), and an ultrasound on (b)(6), showed re-accumulation of the fluid.The fluid is at the junction of the subcutaneous fat and abdominal wall musculature.This is at the inferior deep aspect of the surgical incision.Abscess persists and had not resolved with oral antibiotics.Plan is incision and drainage with possible closure again on (b)(6) 2018.Exam: afebrile.Weight 183 pounds.Abdomen has healed panniculectomy incision.No drainage noted.Midline is not particularly tender.No erythema.Scar on each side of midline at panniculectomy incision site where drainage had been noted to be coming from, but none on exam.Impression: abdominal wall abscess, status post repair of abdominal wall hernia with mesh.Plan: incision and drainage of abdominal wall abscess.(b)(6) 2018: (b)(6) medical center.(b)(6) md.Operative report.Surgeon: (b)(6) md.Preoperative diagnosis: abdominal wall abscess status post ventral hernia repair with mesh.Postoperative diagnosis: abdominal wall abscess status post ventral hernia repair with mesh.Procedure: incision and drainage of abdominal wall abscess.Anesthesia: general endotracheal with (b)(6), crna.Local was administered by the surgeon.Estimated blood loss: 20 ml.Findings: the pigtail catheter placed by dr.(b)(6)in radiology went down to a fluid pocket, which appeared to be between the fascia and the previously placed mesh, which had been placed posterior to the fascia.The pocket did seem to be the space that had previously been drained by subcutaneous drain, so the pocket may be anterior to the fascia, it was unclear today.Description of procedure: ¿the patient was brought to the operating room.She was in the supine position on the operating room table.After adequate general endotracheal anesthesia was obtained, she was prepped and draped in the sterile fashion.The local used was 1% xylocaine with epinephrine mixed with 0.2% ropivacaine.The patient had come from radiology where dr.(b)(6) had placed a pigtail catheter into the abscess cavity.This abscess cavity was not palpated clinically, and there was no erythema, so the guide drain was not necessary to find the pocket of abscess/fluid.The catheter was followed deeply through the skin, subcutaneous tissue, deep subcutaneous tissue to a layer with some substance, which may have been fascia, but it seemed to go into the pocket of fluid which had previously been drained intraoperatively, which had actually been anterior to the fascia.The drain was removed.The pocket was drained of clear fluid.The pocket was debrided sharply with a surgical curette.Some biopsies were taken of the posterior wall of the pocket.Then, a flat 7-french jp drain was brought in through a separate stab wound on the right and placed into the pocket area.Then, the wound was closed with 0 pds in the deepest layer that i had opened.Then 3-0 vicryl was used in the subcutaneous layer and then skin slips were placed.The abdomen was washed and dried.Betadine ointment was applied to the incision to the jp exit site and then dressings were applied.The patient was then awakened, extubated, and taken to the recovery room in stable condition.She tolerated the procedure well without complications.¿ plan: i renewed her doxycycline 100 mg p.O.Twice a day.She says she has enough pain pills at home.After 48 or 72 hours, she can remove the dressings and shower and then put new betadine ointment on the incision and jp exit site and then fresh dressings.I plan to see her in the office next week.(b)(6) 2018: (b)(6) medical center.(b)(6) rn.Intraoperative record.Weight 180 pound, bmi 34.Asa classification: mild to moderate systemic disturbance.Wound class: 4 dirty.Specimen: posterior layer of abdominal wound.(b)(6) 2019: (b)(6) medical center.(b)(6) md.Operative report.Preoperative diagnosis: postoperative seroma after right anterior total hip arthroplasty.Postoperative diagnosis: postoperative seroma after right anterior total hip arthroplasty.Procedure: irrigation, debridement, and washout of postoperative seroma.Indications: the patient is a 58-year-old female, who about a month ago underwent a right anterior hip total arthroplasty.She has been doing well, but developed seroma postoperatively.The seroma started to a leak a couple days ago.She denies any systemic symptoms, and we discussed irrigation, debridement, and closure of seroma.(b)(6) 2019: (b)(6) medical center.(b)(6) md.History and physical.Underwent right total hip replacement on (b)(6).Developed postoperative seroma, which expelled itself.Taken for irrigation and debridement (b)(6).Grew out staphylococcus and methicillin resistant staphylococcus aureus, and was placed on 6 weeks of intravenous antibiotics.Developed discharge from most recent surgery and was admitted.White blood cell count 7.6 and c-reactive protein of 6.8.Improved over next course of 24 to 48 hours with an incisional wound vacuum assisted closure and discharged 1/12/19.Past medical history: obesity; depression.Medications: gabapentin, vicodin, vancomycin.Impression: postoperative drainage after serum irrigation and debridement.Plan: admission for observation; monitor labs, clinical status and apply incisional wound vacuum assisted closure.(b)(6) 2019: (b)(6) medical center.(b)(6) md.Operative report.Preoperative diagnosis: right hip infection after total hip arthroplasty.Postoperative diagnosis: right hip infection after total hip arthroplasty.Procedure: right hip head and liner exchange and irrigation and debridement.Indications: the patient is a 58-year-old female, who just about 6 weeks ago underwent a total hip arthroplasty.She was doing well until about january 4 where i took her for irrigation and debridement of seroma, at that time was thought to be superficial and she did well for about a week later and then had increasing pain and increasing white blood cell count.The discussion was had as she has been on iv antibiotics to take her to the operating room for head and liner exchange, irrigation and debridement.(b)(6) 2019: (b)(6) medical center.(b)(6) md.Operative report.Surgeon: (b)(6) md.Preoperative diagnosis: perforated diverticulitis.Indication: treat perforation.Operative diagnosis: perforated diverticulitis.Operative procedure: sigmoid resection with end colostomy and hartmann¿s pouch.Assistant: (b)(6) rnfa, anp.Anesthesia: general endotracheal anesthesia.Operative note: ¿ms.(b)(6) is a 58-year-old female, who is currently hospitalized after having a washout of her right hip with vac placement.She has had severe abdominal pain today.Ct scan demonstrated free air and fluid consistent with perforated diverticulitis and she was taken emergently to the operating room.The patient was brought to the operating room and after induction of general endotracheal anesthesia, abdomen was prepped and draped in the usual sterile fashion.We utilized her prior incision and extended it superiorly.Subcutaneous tissues was divided with electrocautery.She had extremely dense thick tissue through her fascia down to what appeared to be gore-tex mesh that we had to go through.Her abdominal wall was not very compliant at all and it was very this and firm.I did have to extend her incision more superiorly to allow us to have adequate visualization.We did encounter murky fluid as we went into the abdominal cavity, we irrigated this out copiously.At this point, we identified the sigmoid colon, she had a large amount of stool within the colon and we identified the point of perforation.There was no distinct abscess at this point, i think we had disrupted with abscesses forming, but a lot of thickened rind on the bowel.The area of diverticular disease was fairly compact and therefore we divided proximal and distal to this and then divided the mesentery through clamps and suture ligation with 2-0 silk suture.The specimen was sent to pathology for permanent section.The abdomen was again irrigated copiously.Hemostasis was ensured.We marked a spot in her abdominal wall where the colon was brought out very easily without tension, a circular incision was made here and the subcutaneous tissue was excised.The fascia was incised in a cruciate incision and through the muscle, the posterior rectus was incised.The proximal end of the colon was then brought up through this without difficulty.I again irrigated the abdomen as much as possible, ensured no further contamination.The fascia was then closed with double-stranded 0 pds suture.We closed partially and then laid some seprafilm underneath the abdominal wall to hopefully help with future surgical exploration.The subcutaneous tissue was irrigated copiously as well and then skin closed with staples.We then matured the colostomy with interrupted 3-0 vicryl suture, it gave an excellent pink colostomy with no evidence of any tension.Colostomy bag and sterile dressings were placed.The patient was then awakened, extubated, brought to recovery room in good condition.¿ counts: correct.Complications: none.Blood loss: minimal.(b)(6) 2019: (b)(6) medical center.(b)(6) rn.Intraoperative record.Asa classification: sever systemic disturbance emergency.Wound class: class 3 contaminated.(b)(6) 2019: (b)(6) medical center.(b)(6) md.Discharge summary.Discharge diagnoses: status post right hip irrigation and debridement, head and liner exchange, as well as status post hemicolectomy with ostomy placement.Hospital course: admitted postoperatively after right hip irrigation and debridement, head and liner exchange on (b)(6) 2019.Did develop abdominal pain and distention.Ct abdomen demonstrated ruptured diverticulitis and she underwent hemicolectomy with ostomy placement on (b)(6) 2019 by dr.(b)(6).Postoperatively, required nasogastric tube secondary to ileus and has improved thereafter with white count down to 7.She is ambulatory; ostomy is leaking output and is feeling well to go.(b)(6) 2019: (b)(6) medical center.(b)(6) md.History and physical.Has had some new drainage from the panniculectomy incision on the left.This has been treated with antibiotics, and persistently has drained.On (b)(6) a limited ultrasound of the midline lower abdominal wall at the site of the draining wound showed a complex fluid collection deep to the subcutaneous soft tissues measuring approximately 5.3 x 1.1 cm.This appeared to communicate with the deeper complex collection containing echo dense material and measuring 4.4 x 1.6 cm.Patient comes now for surgical debridement and drainage of the multiloculated complex fluid collection in left lateral abdominal wall.Exam: afebrile.Weight 238 pounds; bmi 45.Abdomen obese.Well-healed incision in the midline in the right panniculectomy.Left panniculectomy shows open wound close to midline with yellowish fluid draining.No erythema noted.Impression/plan: persistent draining wound in the left panniculectomy and hernia repair site.Multiloculated complex fluid collection has been found deep to the subcutaneous tissues.Plan is incision and drainage of fluid collection and debridement on (b)(6) 2019.(b)(6) 2019: (b)(6) medical center.(b)(6) md.Operative report.Surgeon: (b)(6) md.Preoperative diagnosis: abdominal wall abscess.Postoperative diagnosis: abdominal wall abscess.Procedures: incision and drainage of abdominal wall abscess.Debridement of abdominal wound to and into the fascia.Anesthesia: general endotracheal by dr.(b)(6).Bilateral tap blocks by dr.(b)(6).Estimated blood loss: 50 ml.Findings: the small opening in the left panniculectomy incision retracted to the midline.There was also a tract deep to the fascia overlying the mons pubis.Description of the procedure: ¿the patient was brought to the operating room.After adequate endotracheal anesthesia was obtained, the bilateral tap blocks were placed.She was then prepped and draped in the usual sterile fashion.A curette was used to probe the open wound and then to follow the open wound superiorly and medially into the midline.Therefore, a midline incision was made through her previous midline incision and dissection carried down through the skin and subcutaneous tissue into the cavity in the very deep subcutaneous tissue.This was opened to the curette.A further area of probing was noted deep to the wound where other purulent material was found.This area was opened and was opened to the fascia.Hemostasis was obtained with cautery.Then, a sharp surgical curette was used to debride the abscess cavity, especially inferiorly and also along the entire tract that had been opened up.Hemostasis was obtained with cautery.Then, the wound was packed with betadine, moistened 4x4s, and an abd.The patient was then awakened, extubated, and taken to the recovery room in stable condition.She tolerated the procedure well without complications.¿ plan: she will be placed in observation bed for iv antibiotics.Ask physical therapy to evaluate for possible wound vac care.(b)(6) 2019: (b)(6) medical center.(b)(6) rn.Intraoperative record.Asa classification: mild to moderate systemic disturbance.Wound class: 2 clean contaminated.Case specimens: abdominal wound culture.(b)(6) 2019: (b)(6) medical center [assigned].(b)(6) pt.Therapy notes-physical therapy.Surgeon requested notification with dressing change to observe wound bed.Patient agreed to dressing change and expressed concern over returning to home situation.Removed vacuum assisted closure dressing due to alarming for low-pressure.Wound #1: location: distal abdominal midline.Exudate: minimal amount of serosanguineous drainage.Wound bed: fully granular, bright beefy red.Shape: irregular.Peri-wound: intact, dry, warm.Odor: none.Wound cleansed with normal saline and light brushing with no necrotic tissue removed.Black foam applied to wound bed and secured to wound vacuum assisted closure with full suction achieved at 125 mm mercury negative pressure continuous setting.Discharge recommendations: outpatient wound care.Impression: wound bed is fully granular and does have a shallow cavity at the distal portion that will benefit from continued application of wound vacuum assisted dressings to reduce wound depth and increased granulation tissue.¿ (b)(6) 2019: (b)(6) medical center.(b)(6) md.Discharge summary.Principal diagnosis: abdominal wall abscess.Summary of stay: presented with abdominal wall abscess after having gastric sleeve bariatric surgery, panniculectomy, incisional hernia repair with bilateral rectus abdominis muscle advancement.Had a longstanding seroma, which was treated many times after her incisional hernia.Discovered new drainage from panniculectomy incision.Antibiotics were not successful in resolving the issue.Taken to operating room for incision and drainage and debridement.Wound left open and wound care started later that day with wound vacuum assisted closure.Cultures showed no anaerobic growth after 5 days and the culture showed no growth 3 days after the procedure.When home wound vacuum assisted closure was arranged and home care was arranged she was ready for discharge.Discharged (b)(6) 2019 to home.Home health care arrangement was to come in 3 times a week to change the wound vacuum assisted closure.Prescription for ofloxacin every day for 2 weeks was written.She did not really have much restriction in her activity.To follow up with me (b)(6) 2019.(b)(6) 2020: (b)(6) medical center.(b)(6) md.History and physical.Underwent incision and drainage and debridement of abdominal wound abscess (b)(6) 2019.Open wound has been treated with a wound vacuum assisted closure and this wound has been making great progress.However, last week, she began to have some drainage from the old panniculectomy scar on the right which was totally new.Panniculectomy scar is over a year old.Underwent a limited ultrasound (b)(6) 2020.There was an irregular area of low-attenuation.It was thought to be scarring or edema rather than an abscess.Area measured 2.6 x 0.9 cm.The deeper tissues were poorly seen with ultrasound and the radiologist recommended a cat scan that was performed also.There was scarring identified in the midline.There is mesh in the lower anterior abdomen and this is a substance that creates the posterior shadow in her ultrasound.There were no discrete fluid collections identified, which would be amenable to drainage.There were 2 new hernias, 1 is a ventral hernia centrally in the lower abdomen with contained loops of small bowel and the hernia aperture is 4.9 cm.There is no evidence for bowel obstruction.There was also a hernia in the patient¿s previous ostomy site in the left lower quadrant.This also contained loops of small bowel without obstruction.Review of systems: has had significant weight gain since original hernia repair in 2018, but her weight is dropping again down from 250.Current medications: senna supplement, levaquin.Exam: afebrile.Weight 228 pounds.Abdomen obese.Has well-healed vertical midline incision and mostly healed panniculectomy incision.At the intersection of the panniculectomy incision and the vertical midline incision, there is a small open wound with good granulation tissue.Several centimeters to the right is an open punctate wound, which is draining some serosanguineous and almost purulent material, very tender.Impression/plan: multiloculated abscess, fluid collection, drainage, previous hernia site repair and panniculectomy incision.Also has a new incisional hernia in the midline and new incisional hernia at the colostomy site in the left lower quadrant.On (b)(6) 2020 will do incision and drainage of abdominal wound abscess, restart intravenous antibiotics, and more aggressive wound care.See attachment for h10/11 continuation.
|
| |
|
Manufacturer Narrative
|
|
H6: updated results code.Conclusion code remains unchanged.It should be noted that the gore® dualmesh® biomaterial instructions for use addresses the following adverse reactions among others: ¿possible adverse reactions with the use of any tissue deficiency prosthesis may include, but are not limited to, contamination, infection, inflammation, adhesion, fistula formation, seroma formation, hematoma, and recurrence.The gore® dualmesh® biomaterial instructions for use also states: ¿strict aseptic techniques should be followed.If an infection develops, it should be treated aggressively.An unresolved infection may require removal of the material.W.L.Gore & associates, inc.(gore) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by gore, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Blank fields present on this report include required fields and fields determined to be not applicable.Blank required fields indicate that the information was not provided, was deemed unavailable or was not applicable.This report does not constitute an admission or a conclusion by fda, gore, or its associates that the device, gore or its associates caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects" or has "malfunctioned".These words are included in the report and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.
|
| |
|
Manufacturer Narrative
|
|
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® 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: ¿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.¿ individual medical decisions and/or actions of healthcare professional or device user, 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.
|
| |
|
Search Alerts/Recalls
|
|
|
