|
|
| Model Number 1DLMC04 |
| Device Problem
Insufficient Information (3190)
|
| Patient Problems
Fistula (1862); Unspecified Infection (1930); No Clinical Signs, Symptoms or Conditions (4582)
|
| Event Date 12/18/2019 |
|
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 umbilical hernia repair on (b)(6) 2019 whereby a gore® dualmesh® biomaterial was implanted.The complaint alleges that on (b)(6) 2019 and (b)(6) 2020, additional procedures occurred whereby the gore device was explanted.It was reported the patient alleges the following injuries: infection, fistula, drainage, surgery to remove mesh, severe and chronic pain/discomfort.Additional event specific information was not provided.
|
| |
|
Manufacturer Narrative
|
|
Additional details regarding the patient's clinical course were ascertained from a review of medical records and are as follows: implant procedure: open umbilical hernia repair with mesh.Implant: gore® dualmesh® biomaterial [1dlmc04/20274731, 15cm x 19cm x 1mm thickness; abdomen] implant date: (b)(6) 2019 (same day surgery) on (b)(6) 2019: (b)(6).(b)(6) , md.Operative report.Preoperative diagnosis: symptomatic umbilical hernia.Postoperative diagnosis: same.Assistants: (b)(6) , md.(b)(6) , md.Anesthesia: (b)(6).Fluid replacement: see anesthesia records.Estimated blood loss: 10 cc.Findings: umbilical hernia containing small amount of infarcted omental fat.Specimens: none.Drains: none.Disposition: to pacu then home.Indication for the procedure: ¿ms.(b)(6) is a young woman who has presented to the (b)(6) emergency department and acs surgery clinics for evaluation of a symptomatic umbilical hernia.She has undergone ct demonstrating a small fat-containing umbilical hernia.Given her symptoms, she desired hernia repair.The indications, risks, benefits, and alternatives were discussed in detail with the patient and written informed consent was provided.Description of procedure: ¿the patient was brought to the operating room and placed supine on the or table.All pressure points were appropriately padded.The patient was then intubated without difficult and general endotracheal anesthesia was induced to good effect.Intravenous antibiotics were administered.The skin of the abdomen was then prepped with chloraprep and draped in the standard sterile fashion.After a final pause, a #15 blade scalpel was used to make a curvilinear skin incision at the umbilicus.Dissection was carried down through the subcutaneous tissues using cautery.Dissection was carried circumferentially around the umbilical stalk.In dissecting the stalk, the hernia sac was entered, revealing a 2x5cm area of infarcted omental fat.A kelly clamp was applied across the fat, which was excised with cautery and the clamped tissue was tied off with 3-0 vicryl.Midline fascia was identified inferiorly and a kocher clamp was applied.Fascia was cleared circumferentially using a combination of blunt and sharp dissection.Once the fascia had been cleared, the defect was measured (3 x 2.5 cm).A piece of dualmesh was cut to a circle of 7 cm diameter.This was affixed to the fascia at four points using 2-0 prolene suture, ensuring that the mesh laid flat with the smooth side of the mesh in the peritoneal cavity prior to tying down the sutures.Interrupted 2-0 prolene sutures were then placed between the fixation points.The umbilicus was recreated by tacking the skin down using 2-0 vicryl and the deep dermal tissue were closed with interrupted vicryl sutures.Skin was closed with running 4-0 monocryl.Skin glue was applied.The patient was awakened, extubated, and transported to the post-anesthesia care unit in stable condition.At the conclusion of the case, all sponge, needle, and instrument counts were correct.I was present and scrubbed for the procedure.¿ on (b)(6) 2019: (b)(6).Implant record.Implant: mesh dual 15 cm x 19 cm x 1 mm.Serial number: (b)(6).Lot number: (01) 00733132600977.Manufacture: w l gore & assoc inc.Catalog number: 1dlmc04.Size: 15.0 cm x 19.0 cm x 1.0 mm.Expiration date: 01/31/24.Implant site: abdomen.Quantity: 1.The records confirm a gore® dualmesh® biomaterial (1dlmc04/20274731) was implanted during the procedure.Relevant medical information: on (b)(6) 2019: (b)(6).(b)(6) , md; (b)(6) , do.Consultation.Presents to the emergency department for drainage from umbilicus following a recent umbilical hernia repair on (b)(6) 2019.Per the patient, had been recovering well at home and was recently seen in clinic with no complications, but awoke this morning with a large amount of clear drainage on shirt.Called in to the clinic and was told come into the emergency department for evaluation.On arrival here to the emergency department, was noted to have clear serous draining without purulence or surrounding skin erythema or induration.Denies fever, chills, nausea, vomiting, chest pain, or shortness of breath.Had been having normal bowel movements and a good appetite since the surgery.Pain is well controlled.Medications includes omeprazole and zantac.Surgical history of caesarean section, esophageal dilation.Denies tobacco.Weight 95 kg, bmi 32.9.Exam: abdomen soft, non-tender, serous drainage from umbilical wound.No surrounding inflammation.No pain.Impression/plan: likely spontaneously draining seroma following an umbilical hernia repair with mesh.No systemic signs of infection at this time.New dressing applied, instructed patient to continue dressing changes as needed at home.Patient to return to acs clinic within 1 week to ensure improvement and no development of infection.Precautions given to patient regarding signs of infection.On (b)(6) 2019: (b)(6) clinic.(b)(6) , jms.Office notes.Last seen in clinic on (b)(6) and seemed to be resolving.Presents today with concerns of a ¿raised red area¿ at umbilicus; area is tender to touch.Denies fever, chills, nausea, vomiting, diarrhea.Is back to work.Denies tobacco use.Exam: abdomen soft, non-distended.Umbilical incision with one centimeter erythema, area of fluctuance consistent with stitch abscess, draining small amount seropurulent fluid.Impression/plan: will give course of bactrim and have follow up on monday; explained to patient in detail that is opens over weekend, must come to emergency room for eval (patient with mesh).On (b)(6) 2019: (b)(6) clinic.(b)(6) , np.Office notes.Presents with concerns of continued drainage.Exam: abdomen soft, non-distended.Umbilical incision no erythema, no cellulites; no fluctuance; much improved from last visit.Impression/plan: suture granuloma.Will apply silver nitrate to aid in healing; if does not resolve, will get ultrasound to eval for possible abscess; discussed case in detail with dr.(b)(6).On (b)(6) 2019: (b)(6) clinic.(b)(6) , np.Office notes.Presents with concerns of continued drainage for umbilical incision.Had a likely seroma that was spontaneously draining which prompted her to emergency room.Had been seen several times for this and has had two rounds of ten day course bactrim.Denies fever, nausea, vomiting, diarrhea or significant pain.Frustrated with nonhealing wound.Weight 99.54 kg.Exam: abdomen soft, non-distended.Umbilical incision no erythema, no cellulitis, no fluctuance; much improved from last visit, slight yellowish drainage.Impression/plan: draining cutaneous sinus tract.With continued drainage, concern of mesh infection; will get ct scan, place on longer course keflex; follow up after ct scan.On (b)(6) 2019: [facility not indicated].(b)(6) , mbbs.Radiology- ct abdomen pelvis.Clinical statement: 33 year old female employee here, chronic draining umbilical wound, status post umbilical hernia repair (b)(6) 2019.Impression: interval changes of recent umbilical hernia repair.Mesh is rippled in appearance and the lateral margins are displaced medially.Anterior to the umbilical mesh, there is a 3.6 x 0.7 cm fluid collection visualized adjacent to the skin surface.This may represent a seroma, but abscess/infection is not excluded.Stable polycystic kidneys.No bowel obstruction or inflammation.On (b)(6) 2019: (b)(6).(b)(6) , md.Operative report.Pre operative diagnosis(es): abscess after procedure.Post operative diagnosis(es): same as pre operative diagnosis (es).Indication for procedure: 33 yo f s/p umbilical hernia repair w mesh 7-16-19 with concerns of continued drainage from umbilical incision.Procedure performed: incision and drainage of umbilical abscess.Description of procedure: ¿consent obtained.Patient taken to the operating suite and placed supine on the table.General anesthesia via et tube.Abdomen prepped and draped.Timeout performed.Antibiotics per protocol.Abdominal sinus probed.Cautery used to remove sinus tract to old subcutaneous suture.Wound irrigated with saline solution.Wound measured 2cm x 1cm x 1cm deep.No fascia excised, all skin and subcutaneous fat.Wound packed.Patient reversed from anesthesia and brought to the recovery suite.¿ findings: abscess of umbilicus, phlegmon, possible sinus tract on deep wall abscess cavity.Meds/ prep/ pos/ monitoring/ dressing: pre-operative antibiotics/ medications: cefoxitin: 2,000 mg.Anesthetic utilized: general endotracheal.Estimated blood loss: 5 ml.Intravenous fluid: crystalloid: 1,000 ml.Specimen: umbilical abscess: sent to microbiology.Implants and stents: none.Complications: none.Drains: none.Sponge, needle, instrument, and implant count: correct.Wound classification: iv.Plant to return to or/procedure area within 30 days? yes.Resident: paquin md, rebecca.Attending: (b)(6).On (b)(6) 2020: (b)(6) clinic.(b)(6) , np; (b)(6) , md.Office notes.Wound drainage.Had borderline indication for mesh implantation at umbilical hernia secondary to a defect greater than two centimeters.We elected due to bmi and other health considerations to place the mesh.After placement of mesh had a nonhealing wound of the umbilicus.Continued to drain fluid from the umbilicus.After nonoperative treatment we have elected to take her to the or.Once there we removed a sinus tract which appeared to be related to her suture.There was questionable involvement of mesh.We elected not to remove the mesh at that tim [sic] (1) she was last seen in clinic on january 23 and had minimal drainage.Presents today in further check to discuss plan of care.Wound had closed but still has slight drainage at times.Denies other issues denies fever, nausea, vomiting, diarrhea.Weight 106.360 kg, bmi 36.8.Exam: abdomen soft, non-distended.Wound closed, no drainage noted on exam however small amount of bandage.Impression/plan: incision and drainage of umbilical abscess/excision of sinus tract on december 18 presents in wound check.Patient¿s wound has closed but still reports slight drainage that she has to keep covered.No fever or drainage noted on exam however when packing bandage removed fibrinous drainage noted on packing.Discussed at length with patient that she still may need to have mesh removed if this continues, discussed that she could continue to monitor drainage.Recommend returning to clinic in two months if still having issues would then plan to explant mesh.Seen with dr.(b)(6).Explant procedure: explant infected mesh.Primary umbilical hernia repair.Explant date: (b)(6) 2020 (hospitalization unknown).On (b)(6) 2020: (b)(6).(b)(6) , md.Operative report.Pre operative diagnosis(es): history of umbilical hernia repair.Infected hernioplasty mesh.Post operative diagnosis(es): same as pre operative diagnosis (es).Indication for procedure: 34f with history of umbilical hernia repair with mesh complicated by persistent drainage from fistula tract taken to or for mesh explanation and primary hernia repair.Description of procedure(s): ¿patient was consented prior to transportation to the operating suite.Patient placed supine on the operative table.General anesthesia was administered via endotracheal tube.Antibiotics were administered via protocol.Abdomen was prepped and draped.Small midline incision approximately 3 cm was made at the midline through the umbilicus.We excluded the infected sinus tract.Incision was carried down to the fascia which was opened sharply with a knife.Some purulent was encountered and this was cultured.A pocked above the intra-abdominal mesh easily explored using blunt dissection and sharp dissection with knife.Mesh was removed after grasping with forceps and cutting sutures.Mesh was delivered from the field for permanent pathology.Copious bacitracin antibiotics irrigation was used to cleanse the wound.Intra-abdominal contents were examined and there were no injuries to bowel.Given the state of contamination we like to perform a primary repair.The size of the remaining defect was 2-1/2 cm.We closed the fascia with interrupted figure-of-eight 0 prolene sutures.Subcutaneous tissue was closed using 3-0 vicryl suture.Deep dermal suture was applied in interrupted fashion.The skin was left open.Wound was dressed with sterile dressing.Patient was received general anesthesia extubated and brought to recovery suite.¿ findings: infected mesh with associated abscess and fistula tract- explanted and excised.Primary fascial closure of 2 cm defect and skin loosely stapled to allow continued drainage.Meds/ prep/ pos/ monitoring/ dressing: pre-operative antibiotics/ medications: cefazolin: 2,000 mg.Sterile preparation: in usual fashion, with chloraprep, with full drapes, gown, gloves and mask.Position: supine.Monitoring during procedure: blood pressure monitoring, cardiac monitor, pulse ox.Dressing applied: adhesive bandage.Anesthetic utilized: general endotracheal.Estimated blood loss: 10 ml.Intravenous fluid: crystalloid: 650 ml.Specimen: none.Prosthesis, implants, drains, and stents: none.Complications: none.Sponge, needle, instruments, and implant count: correct.Wound classification: iv.Plan to return to or/procedure area within 30 days? no.Resident: (b)(6) , md, mitra.Attending: (b)(6).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® 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
|
|
H10/11: corrected explant date.On (b)(6) 2020: explant infected mesh.
|
| |
|
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 mesh may include, but are not limited to, contamination, infection, inflammation, adhesion, fistula formation, seroma formation, hematoma, pain, exposure (extrusion), mesh contraction, bowel obstruction and recurrence.Additional adverse reactions associated with use of urogynecology applications may include dyspareunia, vaginal bleeding or discharge, vaginal dysfunction, and urinary problems.¿ 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.¿ the instructions for use further states: ¿if gore® dualmesh® biomaterial is cut too small, excessive tension may be placed on the suture line, which may result in recurrence of the original, or development of an adjacent tissue defect.¿ 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.Individual medical decisions, if inconsistent and/or non-conforming to the device manufacturer¿s recommendations, ifu, or recognized best practices, may result in or contribute to an adverse event.As with any surgical procedure, there are always risks of complications for surgical repair of hernias and soft tissue deficiencies, with or without mesh.These may include but are not limited to, adhesions and related harms, bleeding, bowel obstruction, compromised device biocompatibility, contamination which may lead to patient harms, device damage, dysphagia, erosion or extrusion and related harms, exposure or protrusion and related harms, fever, fistula, gerd recurrence, defect recurrence and related harms, ileus, increased procedure time and related harms, irritation or inflammation, infection, mesh migration, mesh contraction, pain, paresthesia, perforation, revision/re-intervention, seroma or hematoma and related harms, tissue ischemia, wound complications and wound dehiscence and additional intervention including surgery.Many of the potential complications are associated with the patient¿s underlying disease progression, co-morbidities, additional medical history and/or other surgical procedures.The above inherent risks are typically detailed in standard informed consent documents.The device was not able to be returned to gore for evaluation; therefore, a direct product analysis could not be conducted.Review of the manufacturing and sterilization records verified that the lot met all pre-release specifications.W.L.Gore & associates, inc.(gore) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by gore, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Blank fields present on this report include required fields and fields determined to be not applicable.Blank required fields indicate that the information was not provided, was deemed unavailable or was not applicable.This report does not constitute an admission or a conclusion by fda, gore, or its associates that the device, gore or its associates caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects" or has "malfunctioned".These words are included in the report and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.
|
| |
|
Search Alerts/Recalls
|
|
|
