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| Catalog Number 1DLMC07 |
| Device Problem
Insufficient Information (3190)
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| Patient Problem
Unspecified Infection (1930)
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| Event Date 12/04/2020 |
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Event Type
Injury
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Manufacturer Narrative
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(b)(4).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.".
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Event Description
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It was reported to gore that the patient underwent open incisional hernia repair on (b)(6) 2020 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: additional surgery, pain, removal, infection.Additional event specific information was not provided.
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Manufacturer Narrative
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B7: added medical history.H6: conclusion code remains unchanged.H10/11: added medical record information.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.12/04/20 ¿ 12/07/20: (b)(6) hospital.Microbiology.Abdominal wound culture and gram stain.Gram stain wounds: no wbc(s).No organisms seen.Surgical culture aerobic/ anaerobic.Organism 1: staphylococcus aureus mrsa.Rare.Mrsa detected using pbp2 assay.Organism 2: pseudomonas aeruginosa.Rare.Organism 3: mixed gram pos/neg flora.Few.Multiple morphotypes: further workup in not warranted.Organism 4: prevotella species.Moderate.Id= prevotella denticola.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.
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Manufacturer Narrative
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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) 2019: (b)(6) hospital.(b)(6) md.History and physical.History of present illness: ¿the patient i s a 53-year -old female, who presented with abdominal pain, nausea, and vomiting, gradually worsening in severity for the past 2 days and also pain in lower abdomen.Denies any fever or chills.She reports no nausea or vomiting.¿ physical examination: ¿abdomen: soft and nontender.Bowel sounds present.Diffuse tenderness.No rebound.No guarding.Postop tenderness.No organomegaly.¿ impression: ¿abdominal pain, acute appendicitis, history of stage 4 breast cancer with metastasis to liver, and hyponatremia.¿ plan: ¿admit, monitor, surgical evaluation.¿ (b)(6) 2019: (b)(6) hospital.(b)(6) md.Operative note.Assistant: (b)(6) postoperative diagnosis: perforated appendix.Procedure: not provided.Specimen: appendix, pus sent for culture and sensitivity. indication: ¿acute appendicitis.¿ procedure: ¿after informed consent and preop antibiotic, the patient was taken to the operating room.After induction of anesthesia, abdomen was cleaned with antiseptic solution and draped with a sterile towel.An oblique incision was made at mcburney point.Skin, subcutaneous tissue, and scarpa fascia were cut.Muscles were separated.Peritoneum opened.Upon opening the peritoneum, there was approximately 15 to 20 ml of foul-smelling pus, which was drained, sent for culture and sensitivity.Area was packed.Then, a pre-ileal severely inflamed appendix ruptured at the tip was identified.Mesoappendix was tied with silk.Base of the appendix crushed and tied with silk, and the appendix was removed.After that, the peritoneal cavity was irrigated with 200 ml of warm saline.All fluid was aspirated.Sponge and instrument counts were correct.Wound closed in layer.Muscles were approximated with #1 vicryl.External oblique aponeurosis sutured with #1 vicryl.The skin closed with staples, and half-inch iodoform pack was placed into subcutaneous space.A sterile dressing applied.The patient was extubated and transferred to recovery room in a stable condition.¿ implant preoperative complaints: (b)(6) 2020: (b)(6) hospital.(b)(6) md.History and physical.¿patient is a very pleasant 54-year-old woman initially seen in the office on (b)(6) 2020.She describes a long history of abnormality in her abdomen.She had undergone ct scan on (b)(6) 2020 as part of her routine followup.This demonstrated a wide-mouth hernia containing large loops of bowel without obstruction.She is status post an appendectomy, open, in the last year.She is also status post diagnosis of inflammatory ductal carcinoma of the lb [left breast], t4n2m1 with metastasis to the liver, (b)(6) 2014, treated with bilateral simple mastectomy, right sentinel lymph node biopsy and axillary dissection, l ad [left axillary dissection] with subsequent tchp [chemotherapy regiment], continual hp [chemotherapy] since the reconstruction.She has had multiple procedures for reconstruction.She did undergo her last procedure performed (b)(6) 2019 at which time she had transverse rectus abdominal myocutaneous flap with donor muscle from the right rectus abdominal muscle to the left breast and revision of right breast reconstruction with a ryan flap and reinforcement of the lateral capsule by dr.Redmon with acellular dermis placement.Subsequent to that, she noted development of a bulge in her abdomen which has increasingly become larger to the point where she is unable to have normal activities.She is admitted at this time for repair of a large abdominal wall hernia, probably postsurgical.¿ physical examination: ¿abdomen: large defect in the abdominal wall which is reducible.It is unclear if there is residual muscle present in the abdominal wall.¿ impression: ¿abdominal wall hernia post surgical intervention.¿ plan: ¿repair postsurgical hernia with mesh reinforcement.¿ (b)(6) 2020: (b)(6) hospital.(b)(6) md.History of present illness: ¿the patient is a 54-year-old female, status post a large incisional hernia post tram [transverse rectus abdominis] flap and ryan flap reconstruction post mastectomy for carcinoma of the left breast.She was maintained on herceptin and perjeta and has had problems with healing in the past; therefore, the perjeta was held for surgery.¿ implant procedure: reduction and repair of large incisional hernia with reconstruction of abdominal wall using gore dualmesh.[implant: gore® dualmesh® biomaterial, 1dlmc07/18597953249, 20cm x 30cm x 1mm thick].Implant date: (b)(6) 2020 [hospitalization dates (b)(6) 2020].(b)(6) 2020: (b)(6) hospital.(b)(6) md.Operative report.Pre and postoperative diagnosis: large incisional hernia.Anesthesia: general.Blood loss: minimal.Complications: none.Wound classification: ¿clean.¿ findings: ¿the patient was noted to have a large defect present with a hernia that was at least 12 x 12 cm.The defect was totally isolated and the hernia sac was separated from the fatty tissue and skin and appeared to extend below the umbilicus.There was a second hernia in the umbilical area as well as 1 lateral on the right.These were all separated and isolated.Following complete separation from the surrounding tissue, an area of previous surgical scar was cleared from the tram flap and ryan flap reconstruction.Due to the tram flap and ryan flap reconstruction, the abdominal musculature had been used and could not be incorporated into the repair.The superior and inferior aspects of the defects were closed with 0 silk suture; however, the central portion was reconstructed using gore dualmesh.Drains were placed and closure was performed to the skin that was somewhat tight from previous surgery.¿ procedure: ¿the patient was taken to the operating room at which time general endotracheal anesthesia was obtained.The abdomen was prepped and draped in normal sterile manner using betadine.Using a #15 blade, an incision was made through skin and subcutaneous tissue laterally from the area of the large defect in the central abdominal wall.Using slow dissection, the skin and fatty tissue were separated from the hernia sac to isolate the hernia completely.It was isolated down to the fascia and posterior fascia on the left.Scar tissue was present which was slowly separated from the hernia sac.This was from the previous tram flap.Total mobilization of the hernia sac was performed to allow reduction.There was a second hernia present laterally on the right which was totally isolated and reduced and closed with 0 silk suture.There was also a hernia at the area of the umbilicus which was closed with 0 silk suture.Using 0 silk interrupted suture, the superior and inferior aspects of the defect were closed as far as possible as there was no further muscles.The central portion could not be closed without extreme tension; therefore, using gore dualmesh, the abdominal fascia was reconstructed.Following this, the repair was felt to be adequate.The mesh was sutured in place, both at the edge as well as laterally to allow extra strengthening.Following this, drains were placed and brought out through 2 separate stab wounds, using 19-blake drains.Repair was felt to be adequate and sustainable.Subcutaneous tissues were closed with 3-0 vicryl.Marcaine block was given to the skin.Skin was closed with 4-0 vicryl.Extra suture with 3-0 nylon was placed for reinforcement due to the tightness of the skin from previous tram flap.Dressing was then applied.The patient tolerated the procedure well, was taken to the recovery room post extubation in stable condition with pressure dressing and binder in place.¿ (b)(6) 2020: (b)(6) hospital.Implant record: description: ¿mesh dual 1x20x30cm.Serial number: (b)(6).Catalog number: 1dlmc07.Expiration date: 8/31/23.Body site: abdomen.Quantity: 1.Manufacturer: wl gore associates inc.¿ (b)(6) 2020: (b)(6) hospital.(b)(6) md.Discharge summary.¿d/c [discharge] with op [outpatient] f/u [follow up] for drain removal.¿ explant preoperative complaints: (b)(6) 2020: (b)(6) hospital.(b)(6) md.Preoperative diagnosis: ¿infected abdominal wall mesh.¿ (b)(6) 2020: (b)(6) hospital.Provider name illegible.History and physical: chief complaint: ¿exposed mesh.¿ details of present illness: ¿(b)(6) 2020 gortex [sic] mesh placed.¿ impression: ¿infected abd [abdominal] wall mesh.¿ plan: ¿remove mesh is or [operating room ].¿ explant procedure: excision of abdominal wall mesh.Explant date: (b)(6) 2020 [hospitalization dates unknown].(b)(6) 2020: (b)(6) hospital.(b)(6) md.Operative note.Assistant: (b)(6) postoperative diagnosis: infected abdominal wall mesh.Anesthesia: general.Estimated blood loss: 10 ml.Specimens: infected abdominal wall mesh and wound cultures.Complications: none.Wound classification: findings: ¿infected gore-tex mesh that measured 9 x 6.5 and extended an additional 3cm inferior.¿ procedure: ¿after informed consent was obtained the patient was brought back to the operating room and underwent general endotracheal anesthesia.Given her open abdominal wound and exposed gortex [sic] mesh was sewn in circumferentially with what appeared to be interrupted silk sutures.The mesh was freed up and the sutures cut circumferentially and the mesh was excised.There appeared to be a separate piece of mesh that extended inferiorly that was also excised.The superior piece of mesh measured 9 x 6.5 cm and the inferior portion extended 3 cm.The mesh was sent for gross pathology and wound cultures anaerobic and anaerobic [sic] were obtained of purulence seen in the wound.At the base of the wound was healthy appearing granulation tissue with no signs of exposed bowel.A valsalva maneuver was done to ensure that there were no obvious hernia defects.Care was taken to remove all permanent sutures that were seen.The wound was copiously irrigated and then cleaned with a chlorhexidine scrub brush.Hemostasis was achieved and the wound was packed with a wet-to-dry kerlix an [sic] abdominal binder was placed.The patient tolerated the procedure well.¿ 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.
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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.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 adhesions and related harms, bowel obstruction, contamination, defect recurrence and related harms, dysphagia, erosion or extrusion and related harms, exposure or protrusion and related harms, fever, fistula, gerd recurrence, infection, irritation or inflammation, mesh migration, mesh contraction, pain, paresthesia, seroma or hematoma and related harms, tissue ischemia, wound dehiscence, and additional intervention including surgery.¿ the instructions for use further warn: ¿strict aseptic techniques should be followed.Failure to do so may result in infection and related serious potential patient harms.An unresolved infection may require device removal.¿ the instructions for use further warn: ¿if device exposure occurs, treat to avoid contamination or device removal may be necessary.Exposure or protrusion of the device could result in infection, pain, and additional intervention including surgery.¿ 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 exposure may reflect abdominal wall wound dehiscence as a function of a patient¿s poor tissue quality or loss of anchorage of fixation or may be related to individual patient comorbidities, and technical and/or procedural aspects of the repair.These factors include, but are not limited to, fixation type, suture technique, type of and tension on the incision, and wound classification at time of procedure.Post-operative factors such as the development of a post-operative infection, an incision and drainage procedure, or wound packing could result in mesh exposure.Additionally, patient comorbidities that could influence wound dehiscence leading to mesh exposure include, but are not limited to, smoking and obesity.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, dysphagia, erosion or extrusion and related harms, exposure or protrusion and related harms, fever, fistula, gerd recurrence, hernia or soft tissue deficiency recurrence, ileus, increased procedure time and related harms, irritation or inflammation, infection, pain, paresthesia, perforation, revision/re-intervention, seroma or hematoma and related harms, wound complications and wound dehiscence.Additional complications associated with procedures to address urogynecologic soft tissue deficiencies may include, but are not limited to, defecatory problems, dyspareunia, organ injury, pelvic pain, urinary problems, vaginal bleeding or discharge, and vaginal dysfunction.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.After multiple requests, specific lot number information was not provided for this device, but product type has been confirmed.Review of the manufacturing and sterilization records could not be performed as a valid lot number was not provided.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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