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W. L. GORE & ASSOCIATES, INC. GORE® DUALMESH® PLUS BIOMATERIAL; MESH, SURGICAL, POLYMERIC
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| Device Problem
Insufficient Information (3190)
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| Patient Problems
Abscess (1690); Unspecified Infection (1930)
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| Event Date 03/19/2015 |
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Event Type
Injury
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Event Description
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It was reported to gore that the patient underwent laparoscopic ventral hernia repair on (b)(6) 2015, whereby a gore® dualmesh® plus biomaterial was implanted.The complaint alleges that on (b)(6) 2015, an additional procedure occurred whereby the gore device was explanted.It was reported the patient alleges the following injuries: abdominal pain, hernia recurrence, mesh infection, and the need for additional surgical intervention.Additional event specific information was not provided.
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Manufacturer Narrative
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Product identification records for the alleged gore device were not provided.Therefore, a review of the manufacturing records could not be performed.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 gore® dualmesh® plus biomaterial instructions for use addresses the following adverse reactions among others: ¿possible adverse reactions with the use of any tissue deficiency prosthesis may include, but are not limited to, contamination, infection, inflammation, adhesion, fistula formation, seroma formation, hematoma, and recurrence." the gore® dualmesh® plus biomaterial instructions for use also states: ¿strict aseptic techniques should be followed.If an infection develops, it should be treated aggressively.An unresolved infection may require removal of the material.".
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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: implant preoperative complaints: (b)(6) 2015: (b)(6) md.Preoperative diagnosis: ventral hernia.Implant procedure: laparoscopic ventral hernia repair with mesh.[implant: gore® dualmesh® plus biomaterial, 1dlmcp04/ni, 15cm x 19cm x 1mm thick, oval.] implant date: (b)(6) 2015 [outpatient procedure] (b)(6) 2015: (b)(6) md.Operative report.Preoperative diagnosis: ventral hernia.Postoperative diagnosis: ventral hernia.Wound classification: ¿1 ¿ procedure: ¿after informed consent was obtained, the patient was placed supine on the operating room table.Anesthesia was administered.A foley was placed.The abdomen was prepped and draped in sterile fashion.A hassan port was placed under direct vision in the left upper quadrant.A 5 port was placed in the right lower quadrant and one in the left upper quadrant and one in the left lower quadrant.We then used a harmonic scalpel to take down the omental adhesions that were stuck in the ventral hernia.The hernia defect was measured.It was approximately 5 x 5 cm.At this point, we used a piece of 15 x 19 gore dualmesh.However, this was trimmed on the long side.We used 0 ethibonds on four points of the mesh.We then rolled the mesh up and placed it into the abdomen.It was then unrolled and anchored transfascially covering the defect on all four corners.Once this was done, laparoscopic tacker was used to double row tack all around the entire mesh.The ports were then withdrawn.The hassan fascial port site was closed with 0 vicryls.4-0 monocryl was used to close the skin incisions.¿ (b)(6) 2015: implant record.¿gore mesh¿.Ref #: 1dlmcp04.Size: ¿15 x 19 x 1.¿ explant preoperative complaints: (b)(6) 2015: (b)(6) md.Radiology report.Procedure: ct abd [abdomen] and pelvis w/wo [with/without] contrast.Indication: abdominal pain.Findings: ¿imaging to the lung bases is unremarkable.No urinary tract calculi or hydronephrosis is seen.The liver, spleen, pancreas, and both adrenals are unremarkable.This exam lack of the for gallbladder pathology.There is symmetric excretion of contrast from bilateral kidneys.There is a 1 cm right renal cyst noted.The abdominal aorta is normal in caliber.Small and large bowel loops maintain a nonobstructing pattern.Appendix is normal in appearance.Urinary bladder is unremarkable.The right ovary and uterus appears surgically absent.The left ovary is grossly unremarkable with limited evaluation on this examination.In the midline of the abdomen due to the umbilicus connecting to the umbilicus there is a fluid collection measuring approximately 10 x 11 x 9 cm in size.There is a meshlike material seen within the anterior aspect of the fluid collection.There is some minimal wall enhancement is seen anteriorly.No free air or adenopathy is seen.On bone windows, no degenerative changes are noted.¿ impression: ¿10 x 11 cm fluid collection in the anterior periumbilical mid abdomen with some questionable enhancement anteriorly worrisome for an abscess.There is some mesh like material seen within this fluid collection.Clinical correlation is recommended.¿ (b)(6) 2015: (b)(6) md.Indication.¿the patient is a 43-year-old female who is status post laparoscopic ventral hernia repair with mesh.She was seen in the emergency room, complaining of nausea, vomiting, night sweats and dizziness, as well as mid abdominal pain.She had a cat scan that showed an 11 cm fluid collection above and below the mesh.Decision was made to proceed with exploratory laparotomy.¿ (b)(6) 2015: (b)(6) md.Microbiology report.Aerobic bacterial culture source: ¿abdominal abscess.¿ result: ¿no growth.¿ (b)(6) 2015: (b)(6) md.Microbiology report.Anaerobic culture source: ¿abdominal abscess.¿ result: ¿no growth in 72 hours.¿ explant procedure: exploratory laparotomy, removal of infected mesh, ventral hernia repair primarily.Explant date: (b)(6) 2015 [hospitalization dates (b)(6) 2015] (b)(6) 2015: (b)(6) md.Operative report.First assist: (b)(6) rnfa, fnp.Preoperative diagnosis: infected mesh.Postoperative diagnosis: infected mesh.Wound classification: not provided.Procedure: ¿after informed consent was obtained, the patient was placed supine on the operating room table.Anesthesia was administered.A foley was placed.The abdomen was prepped and draped in sterile fashion.An incision was made above and below the umbilicus.Bovie electrocautery was used to dissect down to the hernia defect that was covered with mesh.We entered the hernia sac.We encountered some fluid here that was sent for culture.We went ahead and opened the mesh.We encountered a large amount of what appeared to be straw-colored fluid here.Cultures were obtained of this as well.The mesh was removed along with all the tack [sic] and sent for pathology.The abdomen was then irrigated out and the fascia was closed using interrupted 0 vicryls.The wound was then irrigated out and the drain was placed here due to the suspected mesh infection to evacuate the fluid.A 4-0 monocryl was used to close the skin.The patient tolerated the procedure well.¿ (b)(6) 2015: (b)(6) md.Pathology report.Diagnosis: ¿infected mesh: synthetic mesh material and inflamed soft tissue consistent with infected mesh.No atypia is seen.¿ specimen and source: ¿infected mesh.¿ clinical information: ¿abdominal abscess s/d vhr [ventral hernia repair] with mesh.¿ gross examination: ¿the specimen is received in a container of formalin accompanied by a requisition form both labeled ¿(b)(6) , infected mesh.¿ the specimen consists of two pieces of tan mesh material with adherent soft tissue measuring 11.7 x 7.9 x 0.2 cm and 12.6 x 4.4 x 0.2 cm.Also received in the container are multiple blue metallic screws each measuring 0.7 cm in length and 0.3 cm in diameter.Represented sections of the mesh are submitted in a single cassette and a gross photograph is obtained.¿ microscopic description: ¿unless gross only is specified, the final diagnosis for each specimen is based on a microscopic examination of representative sections of tissue.¿ (b)(6) 2015: (b)(6) md.Discharge summary.Admission diagnosis: infected gore mesh.Discharge diagnosis: infected gore mesh.Procedure: exploratory laparotomy with mesh removal.Hospital course: ¿the patient is a 43-year-old female with a history of a lap ventral hernia repair with mesh.She was complaining of abdominal pain, fever and nausea.She had a cat scan that showed a 10 cm fluid collection, worrisome for abscess.She was taken to the operating room.An exploratory laparotomy was performed.The mesh was removed.We did encounter a large amount of fluid that was possibly straw-colored.The mesh was not incorporated into anything.The hernia defect was then closed primary [sic].She was admitted to the floor.She did have an ng [nasogastric] tube.She was on clindamycin and levaquin.On postop day one, her foley was removed.On day two, the patient did experience a cutaneous rash.We were unsure of what caused this.Her morphine was stopped and she was changed to demerol.She was also given benadryl.The next day, the rash was more closely related to the clinda [clindamycin] after administration.Therefore, clindamycin was stopped and vancomycin was started.She was started on clears on postop day three.Her rash subsequently cleared.On day four, her diet was advanced to regular diet.She was continued on vancomycin and levaquin.She was later discharged home.She is to follow-up in surgery clinic on monday.She does have a jp [jackson pratt] drain that she will record daily.She will be sent home on bactrim and cipro [ciprofloxacin ].¿ relevant medical information: (b)(6) 2015: (b)(6) md.Discharge instructions.¿follow up 2-3 weeks with (b)(6).Within [sic] call for appointment.¿ discharge to: ¿home.¿ activity: ¿ambulate as tolerated.¿ diet: ¿regular.¿ ¿call physician if temp 101 or higher, call physician for any pain not relieved with medication, call physician with any questions or concerns, call physician if increased breathing problems, call physician if increased vomiting, diarrhea or loss of appetite, call physician if incision becomes red, swollen, tender or any drainage, call physician for excessive bleeding.¿ discharge patient condition: ¿stable.¿ 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 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® plus biomaterial instructions for use include warnings and addresses the following adverse reactions among others: ¿possible adverse reactions with the use of any tissue deficiency prosthesis may include, but are not limited to, contamination, infection, inflammation, adhesion, fistula formation, seroma formation, hematoma, and recurrence.¿ the instructions for use further warn: ¿as with any implantable surgical device, strict aseptic techniques should be followed.If an infection develops, it should be treated aggressively.An unresolved infection may require removal of the device.¿ the instructions for use further state: ¿for best results, use monofilament sutures.¿ 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.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.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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