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| Model Number 1DLMC06 |
| Device Problem
Insufficient Information (3190)
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| Patient Problems
Hernia (2240); No Clinical Signs, Symptoms or Conditions (4582)
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| Event Date 11/26/2021 |
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Event Type
Injury
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Manufacturer Narrative
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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.
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Event Description
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It was reported to gore that the patient underwent open umbilical ventral hernia repair on (b)(6) 2013 whereby a gore® dualmesh® biomaterial was implanted.The complaint alleges that on (b)(6) 2021, an additional procedure occurred whereby the gore device was explanted.It was reported the patient alleges the following injuries: additional surgeries, pain, removal, adhesions, hernia recurrence, revision, bowel involvement.Additional event specific information was not provided.
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Manufacturer Narrative
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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.
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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) 2013: (b)(6) hospital.(b)(6).Preoperative diagnosis: ¿umbilical and ventral incisional hernia.¿ implant procedure: umbilical and ventral incisional hernia repair with reduction of incarcerated omentum.[implant: gore® dualmesh® biomaterial, 1dlmc06/10658108, 18cm x 21cm x 1mm thick].Implant date: (b)(6) 2013 [same day surgery].(b)(6) 2013: (b)(6) hospital.(b)(6).Assistants: biles, brubaker, and cook.Postoperative diagnosis: umbilical and ventral incisional hernia, with multiple hernia sacs and incarcerated omentum.Anesthesia: general.Estimated blood loss: 8-10 cc.Mesh: gore duomesh [sic].Complications: none.Wound classification: not provided.Procedure: ¿the patient was brought to the operating room at this time, an iv [intravenous therapy] in place, placed on the cardiac and blood pressure monitors, pulse oximeter, administered 2 liters nasal 02, given monitored and deep sedation by peter deforest, prepped and draped in the usual manner.The area of the umbilicus upwards was anesthetized with lidocaine with epinephrine, marcaine.Incision was made, readily encountered the hernia sac.This was from just below the umbilicus upwards approximately 4 inches.It did have multiple hernia sacs in addition to the larger one.Every time i thought i had defined everything, we would run into another hernia sac.He was an abdominal breather.We did have trouble just keeping the bowel in.The omentum had been incarcerated.We freed this in part and removed the excess hernia sac, again identifying all the hernias in this area.At one point in time as we were working, i actually had asked that he get deeper, and he was intubated so that we could work with better relaxation.One bleeder was suture ligated with 3-0 pds, others electrocoagulated.Once we defined the fascia circumferentially, i had elected to use a gore dualmesh and sutured this with a gore gore-tex cvo suture, cutting a piece of mesh and circumferentially sewing this with two continuously run sutures, one done on one side and the other on the other side.I had pushed the bowel and omentum in with a sponge stick and kept feeling to be sure that we did not have any bowel trapped in our suture line.Once this was done, i did trim the dualmesh in a couple of areas.Irrigation cleansed the wound.On-q was placed into the subcutaneous tissue, 3-0 pds closed the subcutaneous tissue, skin staples closed the skin.Dressing was applied.Binder was placed.He did well with the procedure.Estimated blood loss was 8 to 10 cc.There was no specimen for pathology.He returned to his room and home in good condition.He was given a prescription for lorcet 10/650, #20, refill one, for pain, to take one every six to eight hours as needed, to use advil or aleve in between.Diet and activity as tolerated, and resume any home medications.He was to see me in the office week after next.¿ (b)(6) 2013: (b)(6) clinic.Implant sticker: implant: ¿patch dualmesh goretex 18 x 24.Item#: 1dlmc06, lot #: 10658108.Serial number: (b)(6).Manufacturer: gore w.L.& associates.¿ explant preoperative complaints: (b)(6) 2021: (b)(6) hospital.(b)(6).History and physical.History of present illness; ¿(b)(6) weaver is a 56 y.O.[year old] male with recurrent incarcerated incisional hernia.Here for repair.¿ physical exam: ¿abdomen: soft, irreducible midline hernia.¿ assessment/plan: ¿56 y.O.Male with recurrent incarcerated incisional hernia.For lap [laparoscopic] likely open repair.Ventral hernia anatomy explained as well as goals of repair.Both open and laparoscopic approach explained.Complications include but are not limited to recurrence, infection of mesh, nerve injury w/ [with] chronic pain, vessel injury, or bowel or bladder injury with laparoscopic approach, and/or fistula/mesh erosion were all discussed.Questions addressed and patient wishes to proceed.¿ (b)(6) 2021: (b)(6) hospital.(b)(6).Indications: ¿bobby weaver is a 56 -year -old male seen in the office for periumbilical pain.He has a history of a prior open incisional hernia repair done with a gore dualmesh.This appears to have been done in an inlay fashion.A ct was done demonstrating a recurrent hernias.He is morbidly obese; however, there was a loop of bowel, which was causing a partial obstruction.Therefore, repair was proceeded without further wait.¿ explant procedure: laparoscopic incarcerated recurrent incisional hernia repair with mesh.Removal of deep implant (mesh).[implant: symbotex].Explant date: (b)(6) 2021 [same day surgery].(b)(6) 2021: (b)(6) hospital.(b)(6).Operative note.Assistant: (b)(6).Pre and post-operative diagnosis: incarcerated recurrent incisional hernia.Anesthesia: general.Estimated blood loss: 5 cc.Implants: 15 cm symbotex.Specimens: mesh.Complications: none.Wound classification: not provided.Findings: ¿a swiss cheese type hernia, predominantly above and within a prior inlay mesh repair.Herniated contents were reduced laparoscopically.An incision was made over the main defect and old mesh was removed.The defect was primarily closed and reinforced with a 15 cm symbotex mesh.¿ procedure: ¿after obtaining informed consent, the patient was brought to the operating room and placed supine on the operating table.General endotracheal anesthesia was induced.He was prepped and draped in the usual sterile fashion per protocol.Antibiotics were given.Timeout was done.Veress needle was inserted at palmer's point, abdomen was insufflated with carbon dioxide, partial pressure of 15 mmhg.A 5 mm trocar was placed in the left lateral abdomen using the optiview technique.Veress needle site was examined without underlying injury.It was removed and exchanged for an additional 5 mm trocar.One additional 5 mm trocar was placed in the left upper quadrant.The abdominal wall was examined.There was herniated small bowel and omentum through a periumbilical defect.The herniated contents were gradually reduced with blunt dissection, sharp dissection and then electrocautery.Bowel was safely reduced and the omentum was partially reduced.Some residual omentum was adherent to a prior mesh.Bowel was closely examined and was without injury.An incision was made over the hernia defect at the site of the prior inlay mesh.Dissection was carried down through skin and subcutaneous tissue and pseudocapsule was entered and prior gore mesh was encountered.This was completely excised both sharply and with electrocautery.Prior gore-tex sutures were cut and discarded.The mesh was handed off for pathological analysis.A well-lubricated 15 cm circle symbotex mesh was inserted through the defect and then it was closed with interrupted figure-of-eight #1 pds sutures.Pneumoperitoneum was reestablished.The mesh was unfolded and centered across the defect using a carter-thomason suture passer.I then tacked circumferentially in a double crown fashion using a secure strap.I did have to place 1 additional 5 mm trocar in the right lateral abdomen to facilitate tacking.Cardinal transfascial sutures were also done x4.At the conclusion, the mesh completely covered the defect and laid flat and the operative field was hemostatic.The abdomen was then desufflated.All 5 mm trocars were removed.All skin incisions were closed with 4-0 vicryl in an interrupted deep dermal fashion.Suture lines were reinforced with dermabond.At the end of the case, sponge, needle and instrument counts were correct x 2.The patient tolerated the procedure well without any apparent complication.At debrief was awakened and transferred to pacu in stable condition.¿ (b)(6) 2021: (b)(6) hospital.Implant record: ¿symbotex round 15cm.¿ (b)(6) 2021: (b)(6) hospital.Labin edi.Pathology: specimen #cs21-2001.Final diagnosis: ¿mesh, clinically recurrent incarcerated incisional hernia (gross examination).Source: ¿a.Mesh.¿ gross description: ¿the specimen is received in formalin, labeled mesh' consisting of an 8.0 x 7.8 x 0.1 cm white-tan square of mesh.No sections are submitted.The specimen is for gross diagnosis only.The gross specimen has been reviewed by dr.(b)(6).¿ (b)(6) 2021: (b)(6) clinic.(b)(6).Discharge summary: disposition: ¿home.Planned admission but discharged from pacu [post anesthesia care unit ].¿ 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.Through gore's investigation and based on the available information there is no available information that reasonably suggests that a gore device may have caused or contributed to death, serious injury or reportable malfunction, and is no longer considered reportable.Therefore, this event is being coded as no clinical signs, symptoms or conditions, no health consequences or impact and will be closed as no problem detected.Previous patient codes were reported based on the original complaint and are no longer applicable and/or not reportable per gore¿s investigation.Following gore¿s investigation, the previously submitted annex f code has been updated to reflect gore¿s final conclusion.It should be noted that the gore® dualmesh® biomaterial instructions for use include warnings and addresses the following adverse reactions among others: ¿possible adverse reactions with the use of any tissue deficiency prosthesis may include, but are not limited to, contamination, infection, inflammation, adhesion, fistula formation, seroma formation, hematoma, and recurrence.¿ medical records that indicate mesh ¿movement¿ or that the device led to a recurrence may reflect a recurrence as a function of a patient¿s poor tissue quality leading to fascial dehiscence or loss of anchorage of fixation, or may be related to the hernia type, individual patient comorbidities, and technical and procedural aspects of the repair.These factors include but are not limited to, fixation type, mesh shape/sizing used, and defect closure decisions.Additionally, a new, unrelated hernia can occur but may be referred to as a recurrent hernia.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 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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