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W. L. GORE & ASSOCIATES, INC. GORE® SYNECOR® INTRAPERITONEAL BIOMATERIAL; MESH, SURGICAL, POLYMERIC
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| Model Number GKFC12 |
| Device Problem
Insufficient Information (3190)
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| Patient Problems
Abscess (1690); Unspecified Infection (1930)
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| Event Date 05/27/2020 |
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Event Type
Injury
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Manufacturer Narrative
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It should be noted that the gore® synecor® intraperitoneal 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® synecor® intraperitoneal 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 laparoscopic ventral hernia repair on (b)(6) 2020, whereby a gore® synecor® intraperitoneal 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: open draining wound, surgery to remove mesh, infection, abscess.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.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.Radiology ¿ ct abdomen/pelvis with contrast.Indication: (b)(6) medical center.(b)(6), md.Operative report.Pre-op diagnosis: acute cholecystitis.Post-op diagnosis: necrotic cholecystitis.Procedure: laparoscopic cholecystectomy.Findings: partially necrotic gallbladder.Significant inflammatory and postsurgical adhesions.Wound classification: contaminated.Complications: none.¿ (b)(6) 2018: (b)(6) medical center.(b)(6), md.Discharge summary.Discharge diagnosis: acute necrotizing cholecystitis.Underwent laparoscopic cholecystectomy; found significant inflammatory adhesions, partially necrotic gallbladder.Postoperatively, did well, continued on antibiotics, drain left in place due to inflammation.Leukocytosis improved; drain removed.Tolerating diet, ambulating.Follow up (b)(6) 2018.¿ (b)(6) 2020: (b)(6) medical center.(b)(6), md.Radiology ¿ ct abdomen/pelvis with contrast.History: umbilical hernia without obstruction or gangrene.Impression: ventral hernia with fat only present.Small hiatal hernia.¿ (b)(6) 2020: (b)(6).(b)(6), md.History and physical.Wt.305 lbs., bmi 57.6.Surgical history: hysterectomy (b)(6) 1998.Incisional ventral hernia at umbilicus after laparoscopic cholecystectomy.Initially scheduled for surgery in march; postponed due to covid-19 restrictions.Returns to discuss scheduling surgery; reports no major changes in interim.Hernia still present, causes intermittent pain.Seen by cardiologist; low risk.Abdomen soft, nondistended, tenderness to palpation at umbilicus.Easily reducible umbilical hernia palpable.Impression/plan: ventral incisional hernia.Previous ct demonstrated hernia approximately 2.8 x 2.5 cm.Plan laparoscopic repair.Schedule in 1-2 weeks.(b)(6) 2020: update: no changes.¿ (b)(6) 2020: (b)(6).Dr.(b)(6).Anesthesia record.Wt.132 kg, bmi 48.8.Asa class 3.Implant procedure: laparoscopic ventral hernia repair.Implant: gore® synecor® intraperitoneal biomaterial [(b)(6), 12 cm circular].Implant date: (b)(6), 2020 (hospitalization same day surgery).¿ (b)(6) 2020.(b)(6)medical center.(b)(6), md.Operative report.History: 64-year-old female with hernia at umbilical incision site from her previous laparoscopic cholecystectomy.Pre-op diagnosis: incisional ventral hernia.Post-op diagnosis: same.Description of procedure: ¿informed consent for the procedure was obtained from the patient after a thorough discussion and all questions were answered.The patient was taken to the or and laid supine on the or table.General anesthesia was initiated the patient was intubated.The patient¿s abdomen was then prepped and draped in usual sterile fashion.Preoperative timeout was performed which confirmed the correct patient and procedure.Veress needle was inserted in the left upper quadrant of the abdomen was insufflated.5 mm port was then placed using optiview entry.After placement of the 5 mm port were able to visualize dense adhesions of the omentum to the upper abdominal wall.A 12 mm port was then placed in a left lateral position.Using these ports were able to dissect bluntly to create space.A 5 mm port was placed in the left lower quadrant position.Using these ports were able to dissect bluntly to create space.A 5 mm port was placed in the left lower quadrant position.The remainder of these adhesions were taken down bluntly.Once this was completed we were able to visualize the hernia defect.It was a swiss cheese defect measuring a total of approximately 3 x3 cm.A 0 vicryl suture was used to partially close this fascial defect using a suture passer.A 9 cm round piece of intraperitoneal symbotex mesh was then chosen for the repair.A 3-0 prolene suture was tied in the center of the mesh.The mesh was then placed in the abdomen and the suture was grasped with a suture passer and pulled out through the same incision used to close the fascia.This was then tied, securing the mesh to the intra-abdominal wall.The mesh was then tacked circumferentially using absorbable tackers.In order to tack the left side appropriately a 5 mm port was placed on the right side.Once the mesh was secured the ports were removed under direct visualization.The initial port in the left upper quadrant was the last port removed after desufflating the abdomen.0.25% marcaine was injected at all the port sites for local anesthetic.The skin of all the incisions was closed with 4-0 monocryl subcuticular sutures and dermabond.The small puncture incision that was used for the suture passer was closed with dermabond.The patient was then awakened, extubated, and taken to the recovery area in good condition.¿ findings: patient with significant adhesions of omentum to the anterior abdominal wall.Patient with swiss cheese hernia defect measuring approximately 3 x 3 cm at her previous umbilical incision site.Anesthesia: geta.Anesthesiologist: adefeyisan.Estimated blood loss: 10 cc.Implants: symbotex intraperitoneal mesh placed.Iv fluids: crystalloid (see anesthesia record).Wound classification: clean.Complications: none.Disposition: dc home.¿ (b)(6) 2020: (b)(6).Implant sticker.Gore® synecor® intraperitoneal biomaterial.Ref: gkfc12.Sn: (b)(6).(b)(6) 2022.[handwritten: 12 cm circular.].¿ (b)(6) 2020: (b)(6).Implant record.Mesh synecor® circular 12cm goretex.Quantity: 1.Lot/serial #/din: (b)(6).Manuf dt/ exp dt/site: (b)(6) 2022 / operative site.Cat/batch #/size: gkfc12/12cm circular.¿ the records confirm a gore® synecor® intraperitoneal biomaterial ((b)(6)) was implanted during the procedure.Relevant medical information: ¿ (b)(6) 2020: (b)(6) medical center.(b)(6) do.Emergency department visit.Chief complaint: drainage from surgery site.Presents with abdominal wall pain.Underwent laparoscopic ventral hernia repair (b)(6).Last thursday, endorsing pain around surgical site; started on augmentin.Has been complaint with medication; however, this morning she awoke and noted her surgical site around umbilicus was draining.Denies fevers/constitutional symptoms.Medical history: morbidly obese.Never smoker.Abdomen soft, tender surrounding surgical site.No significant tenderness on deep palpation away from her surgical site infection.Obese, not necessarily distended.Erythema induration and exquisite pain on palpation of anterior abdominal wall adjacent to laparoscopic incision next to umbilicus.No obvious fluctuance.Yellowish-cloudy drainage able to be expressed from within navel area.Presentation concerning as has been on antibiotics since thursday and continues to demonstrate cellulitic changes with significant induration and active draining from 1 surgical site.Will obtain basic blood work, ct scan, blood cultures and initiate broad-spectrum antibiotics.White count 13.5 with left shift.Reviewed ct scan and shows significant inflammatory changes in anterior abdominal wall with some air-fluid levels.Also, area of fluid collection just deep to abdominal wall concerning for possible abscess.On-call surgeon requested nothing by mouth.Advise hospitalization for further treatment.Impression/plan: abscess abdominal wall.Admit.¿ (b)(6) 2020: (b)(6) medical center.(b)(6), md.Radiology ¿ ct abdomen/pelvis with intravenous contrast.Indication: abdominal wall abscess cellulitis.Findings: diffuse inflammatory change in anterior abdominal wall, probable abscess measuring 4.7 cm in diameter; could be a hernia with bowel present in a recurrent hernia with inflammatory changes surrounding hernia.Oral contrast recommended prior to intervention.Could be an intraperitoneal component larger in size measuring 7.6 x 9 cm.Impression: probable abscess in the subcutaneous tissues where previous hernia surgery performed with surrounding cellulitis and an intra-abdominal component larger in size; oral contrast recommended to assess the extent of abscess.¿ (b)(6) 2020: (b)(6) medical center.(b)(6), md.History and physical.Presented with pain and drainage from umbilicus.Underwent laparoscopic umbilical hernia repair on (b)(6) 2020.Seen in office last week; had erythema along abdominal wall that was marked and was placed on augmentin.Said erythema stayed about the same; this morning had drainage of purulent material from umbilicus and presented to emergency room.Official report of ct scan unavailable; by my report, there are obvious changes in subcutaneous tissue and what appears to be an abscess cavity right on umbilicus.Likely contiguous today that is draining pus through umbilicus at this time.Feeling better with wound drainage.Has had no fever, tolerating diet.Abdomen shows healed laparoscopic scars.Erythema that has been marked extending from umbilicus upward.Tender along the cellulitis, tenderness to deep palpation consistent with acute peritonitis.Gross purulent drainage from umbilicus.Discussed surgery today versus continued antibiotics.Currently on zosyn and vancomycin; will continue.Suspect this may help cellulitis and ultimately will need surgical drainage; on occasion, these have been able to be healed with antibiotics and wound vac.She would prefer to wait 24 hours, which i feel we can do.I have discussed with surgery; mesh will need to be removed; would likely be left with wound to heal by secondary intention and likely a recurrent hernia that may need to be dealt with in the future.¿ (b)(6) 2020: (b)(6).(b)(6).Anesthesia record.Wt.140 kg, bmi 51.4.Asa 2.Explant procedure: removal of infected mesh and drainage of intra-abdominal abscess.Explant date: (b)(6), 2020 (hospitalization (b)(6), 2020).¿ (b)(6) 2020: (b)(6) medical center.(b)(6), md.Operative report.Pre-op diagnosis: intra-abdominal abscess around ventral hernia mesh.Post-op diagnosis: same.Description of procedure: ¿informed consent for the procedure was obtained from the patient after a thorough discussion and all questions were answered.The patient was taken to the or and laid supine on the or table.General anesthesia was initiated and the patient was intubated.A foley catheter was placed.The patient's abdomen was then prepped and draped in usual sterile fashion.A midline laparotomy incision was made over the area of draining purulence.Subcutaneous tissues were entered and the abscess cavity was encountered.This was tracked through an opening in the fascia and into a subcutaneous pocket.The fascia was opened for approximately 1 to 2 cm was cranially and caudally to the abscess cavity.The mesh was then grasped and was able be freed up from the underlying fascia.It was removed in 1 piece.The abscess cavity was then irrigated.A 7 french flat drain was placed in the sub-fascial abscess cavity.Drain suture placed.The fascia was then closed with 0 vicryl interrupted sutures.The subcutaneous tissues were then packed with a wet-to-dry dressing.Sterile outer dressing was applied with a drain in the midline incision.The patient was then awakened, extubated, and taken to the recovery area in good condition.¿ findings: intra-abdominal abscess around the infected mesh.Mesh was removed in 1 piece.Abscess cavity irrigated and drain placed.Fascia closed and subcutaneous tissues packed with wet-to-dry dressing.Anesthesia: geta anesthesiologist: vullo.Estimated blood loss: 20 cc.Specimen(s): infected mesh sent for pathology.Iv fluids: crystalloid (see anesthesia record).Wound classification: dirty.Complications: none.Disposition: other (back to the floor).Note: ¿we will continue antibiotics.Continue to monitor wound and drain output.Awaiting culture sensitivities to de-escalate antibiotics.¿ relevant medical information: ¿ (b)(6) 2020: (b)(6) services, pc.(b)(6), md.Pathology report.Accession #: (b)(4).Clinical data: infected mesh from abdomen: intraabdominal infection.Diagnosis: surgical mesh, removal: consistent with surgical mesh, gross id.Soft tissue, surgical mesh site, resection: benign fibrous tissue with foreign body giant cell reaction and polarizable material present.Acute inflammation present.No atypia identified.Gross description: received in formalin labeled with the patient¿s name and number, and ¿infected mesh from abd¿ is an oval-shaped sheet of surgical mesh, which is grayish tan, with multiple small purple plastic ¿plug¿ like attachments distributed close to the periphery of the oval, each of which measures about 1 x 1 mm.Attached to the mesh are multiple small areas of soft tissue, ranging up to a 2.9 x 0.6 x 0.2 strip of fibrous soft tissue.Representative sections x2 of mesh with attached soft tissue submitted in cassette a1.Microscopic description: histologic sections demonstrates a benign fibrous tissue with foreign body giant cell reaction and polarizable material present.Acute inflammation is identified.No atypia identified.¿ (b)(6) 2020: (b)(6) medical center.(b)(6), md.Discharge summary.Postoperative laparoscopic ventral hernia repair.Admitted for abscess of abdominal wall associated with intra-abdominal mesh.Underwent drainage of abscess and removal of infected mesh.Postoperatively, did well initially; had a drain in subfascial space as well as wet-to-dry dressings.Then converted to a wound vac dressing and intra-abdominal drain removed.Did have acute kidney injury secondary to infection, intravenous contrast for ct and antibiotics.Nephrology started on lasix; stable.Currently off all antibiotics.Wound healing well with wound vac in place.Tolerating regular diet, ambulating without difficulty.Discussions with patient¿s children so she would not be home alone after discharge.Home health arranged for wound care.Follow-up with myself and nephrology.Maintain wound vac.¿ (b)(6) 2020: (b)(6) medical center.(b)(6), md.Radiology ¿ ct abdomen/pelvis without contrast.Indication: unspecified abdominal pain.Impression: previous cholecystectomy and hip surgery.Colonic diverticulosis without acute inflammatory process.Anterior abdominal wall hernia midline extending to the umbilicus containing small intestine.No associated bowel obstruction.¿ (b)(6) 2020: (b)(6).(b)(6), md.History and physical.Wt.294 lbs., bmi 48.9.Never smoker.Here for evaluation of ventral hernia.History of three hernia repairs at level of umbilicus with recurrence.Overweight.Last repair done without mesh.Does have pain at level of the mesh.No obstructive symptoms.Abdomen soft, nondistended with good bowel sounds.Does have a ventral incisional hernia at level of the umbilicus.Impression/plan: ventral hernia.Discussed laparoscopic ventral hernia repair.[updated (b)(6) 2020; no changes.].¿ (b)(6) 2020: (b)(6).(b)(6), md.Operative report.Pre-procedure diagnosis: current ventral hernia.Post-procedure diagnosis: same as pre-procedure dx.Procedure performed: attempted laparoscopic, turned to open ventral hernia repair.Assistant: hill.Anesthesia: general anesthesia.Technique/procedure: ¿after informed consent was taken, patient was taken to the operating room placed on supine position.General anesthesia and endotracheal intubation were performed without any complications.Skin of the abdomen was prepped and draped normal sterile fashion.Surgical time-out was obtain and everybody agreed.In left upper quadrant incision was made, and optiview visit trocar was used to access the abdominal cavity, pneumoperitoneum was created he [sic] immediately massive amount of adhesions were noted throughout the entire abdominal cavity.There was no space to attempt to place another trocar, this point i decided to convert the case to open.A midline incision of 10 cm was made was carried down to the subcutaneous tissue with a knife.Hernia sac was identified and (b)(6) was used to dissect the hernia sac away from the subcutaneous tissue.Hernia sac was then opened and resected.Fascial edges were identified and the subcutaneous tissue was cleared from the fascia approximately a 5 cm surrounding the hernia defect.Initial palpation of the abdominal cavity reveal large amount of adhesions, i was able to cleared adhesions most of them were small intestine densely adhered to anterior abdominal wall had to actually carved into the posterior layer of the fascia to separate the small intestine.Small serosal tear was noted, which was then reapproximated with a figure-of-eight 2-0 vicryl.A 6.4 cm round bard mesh was inserted, was fixated superior and inferior with an overlap of at least 3-5 cm on each side, then the mesh was fixated on the right lateral and left lateral aspects again making sure that the overlap was at least 3 cm.Four more sutures in between the previously placed sutures were done.For all the sutures were transfascial and a 0 ethibond was used.Hernia defect was then closed with 4 figure-of-eight prolene sutures.Thorough irrigation entire area was done.Subcutaneous tissue was approximated with 3-0 vicryl and the skin edges with staples.Sterile dressing was applied.Patient was awakened from anesthesia and then transported to the recovery room in good condition.¿ operative findings: massive amount of intra-abdominal adhesions to anterior abdominal wall composed of omentum as well as the small intestine.Ventral hernia defect of about 2 ½ cm to 3 cm in diameter.Complications: small serosal tear repaired with 2-0 vicryl.Estimated blood loss in ml¿s: minimal.Specimens removed/altered: none.Implants: 6.4 cm diameter mesh.¿ (b)(6) 2020: (b)(6).Implant sticker.Ventralex st hernia patch.Bard.¿ (b)(6) 2020: (b)(6).(b)(6), md.Discharge summary.Discharge medications: zofran for nausea, norco for pain.Discharge home/self-care, regular diet.Activity: light duty, no bending, no driving, no lifting greater than 10 lbs.Follow up in 2 weeks.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® synecor intraperitoneal 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® synecor intraperitoneal biomaterial instructions for use also states: ¿strict aseptic techniques should be followed.If an infection develops, it should be treated aggressively.An unresolved infection may require removal of the material.W.L.Gore & associates, inc.(gore) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by gore, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Blank fields present on this report include required fields and fields determined to be not applicable.Blank required fields indicate that the information was not provided, was deemed unavailable or was not applicable.This report does not constitute an admission or a conclusion by fda, gore, or its associates that the device, gore or its associates caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects" or has "malfunctioned".These words are included in the report and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.
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Manufacturer Narrative
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H6: updated results code.And component code.Conclusion code remains unchanged.It should be noted that the gore® synecor® intraperitoneal 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® synecor® intraperitoneal 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® synecor intraperitoneal 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 extrusions and related harms, exposure or protrusions and related harms, fever, fistula, gerd recurrence, infection, irritation or inflammation, mesh migration, mesh shrinkage, pain, parathesis, seroma or hematoma and related harms, tissue ischemia, wound dehiscence 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.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.
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