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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
Obstruction/Occlusion (2422); No Clinical Signs, Symptoms or Conditions (4582)
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| Event Date 11/02/2012 |
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Event Type
Injury
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Manufacturer Narrative
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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.".
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Event Description
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It was reported to gore that the patient underwent open ventral hernia repair on (b)(6) 2000 whereby a gore® dualmesh® plus biomaterial was implanted.The complaint alleges that on (b)(6) 2012, an additional procedure occurred whereby the gore device was explanted.It was reported the patient alleges the following injuries: ventral hernia repair, small bowel obstruction due to mesh, pieces of the gore tex mesh were removed due to adhesions that involved the small bowel, causing the obstruction, adhesiolysis was performed.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: implant procedure: vih repair, rivas ¿ stoppa repair with mesh, lysis of adhesions, abdominoplasty.Implant: gore® dualmesh® plus biomaterial [1dlmp201/ (b)(6)] implant date: (b)(6) 2000 (hospitalization [ni]); ¿ (b)(6) 2000: (b)(6).(b)(6) , md.Operative report.Preoperative diagnosis: recurrent ventral incisional hernia (reducible), partial sob.Postoperative diagnosis: recurrent vid (incarcerated), adhesive disease.Indication: 38 y/o hf with recurrent, symptomatic vih since 1994.Hernia was increasing in size and became symptomatic.Attending surgeon: (b)(6) md.Primary surgeon: (b)(6) md.Anesthesia: get.Ebl: 100.Complications: none.Antibiotics: ancef.Blood transfused: 0.Narrative: ¿the risks, benefits, complications, expected outcomes, and alternative therapies were discussed with the patient.The risk of wound infection, hematoma formation, injury to an intra-abdominal organ, and recurrent hernia were explained to the patient who freely signed the operative permit.With the patient in the supine position and after the induction of adequate anesthesia, the abdomen was prepped and draped in the usual sterile fashion.A lower midline incision was made through the previous scar and carried down to the hernia sac.The hernia sac was dissected free of the surrounding tissues and isolated.The omentum and small bowel which were adherent to the sac were carefully dissected free without injury to underlying structures.The sac contents were then reduced through the fascial defect and the hernia sac was excised.The remainder of the fascia was palpated, noting multiple other fascial defects more cephalad.The incision was then extended superiorly and the additional hernia sacs were dissected free.Omentum was noted to be incarcerated within these hernias.General abdominal exploration revealed adhesions and ovarian simple cysts (clear).The small bowel was run from ligament of treitz to cecum and adhesions were lysed.The fascia was then separated from the subcutaneous tissues laterally to the abdominal sidewall, to free the fascia.A rives-stoppa repair was fashioned with goretex mesh and the overlying fascial defect was closed with interrupted braided permanent suture.The wound was thoroughly irrigated, and excellent hemostasis achieved.Three jp drains were placed within the subcutaneous space and exited through separate stab incisions inferiorly.The subcutaneous tissue was coated using interrupted absorbable stich and skin edges were approximated with staples and a sterile dressing applied.Blood loss was 100cc.The patient tolerated the procedure well and was taken to pacu in satisfactory condition.All counts were reported as correct.¿ faculty attestation statement: i was present and scrubbed for the entire procedure.¿ (b)(6) 2000: (b)(6) [assigned].Implant record.Implant: gortex dualmesh antimicrobial.Item #: 1dlmp201.Lot #: (b)(6).¿ the records confirm a gore® dualmesh® plus biomaterial (1dlmp201/ (b)(6)) was implanted during the procedure.Relevant medical information: ¿ (b)(6) 2008: (b)(6).Preoperative record.Past medical history: obesity.Surgical history: c section x 4, bilateral tubal ligation, cholecystectomy, hysterectomy.¿ (b)(6) 2008: (b)(6).(b)(6) md.Operative report.Preoperative diagnosis: ventral incisional hernia, b ovarian cyst.Postoperative diagnosis: same.Rives-stoppa repair of ventral incisional hernia with mesh.Primary surgeon: (b)(6) md.Attending surgeon: (b)(6) md.Assistant: (b)(6) do.Anesthesia: get.Asa class 3.Anesthesia faculty: (b)(6) md.Antibiotics: cipro, vanc.Estimated blood loss: 150.Transfusions: 0.Complications: none.Specimens: none.Indication: 47 yo female with symptomatic incarcerated low vih and b ovarian cysts after hysterectomy, requesting vihr and b oophorectomy.Time out: immediately prior to procedure, time out was performed to include correct patient, agreement on procedure to be performed, correct side, site, position, and availability of any special implants that might be required.Risks and benefits of the procedure were discussed with the patient preoperatively who understands and agrees.Informed consent on chart.Procedure: ¿after adequate geta was obtained, the abdomen was prepped and draped in the normal sterile fashion.An incision was made in the anterior abdominal wall through the previous scar.The subcutaneous tissue was carefully dissected and the hernia sac identified.The hernia sac was excised in its entirety.The fascial edges were cleared of all excess tissue.The fascia was carefully palpated and no other defects were noted.A sheet of gore-tex mesh was noted to be sutured to the fascia superior to our incision and was noted on ct obtain pre-operatively and was confirmed to be intact.After extensive lysis of adhesions, taking care to not created any injuries, the ovaries were noted at which point the gyn physician, dr.Funk, was called to the room.The ovaries were removed and an intra-op urology consult was made to confirm that the left and right ureters were intact and uninvolved with the large ovarian cysts.No ureteral injury was noted.We irrigated the abdomen copiously and ensured hemostasis.Some fibrin sealant was placed in the left retroperitoneal space.We performed a rives-stoppa type repair with an underlay bard composix kugel, 19.6 cm x 24.6 cm, mesh which was taken into place with transcutaneous carter thompson needle placed interrupted sutures.The repair was noted to be tension free.The wound was again irrigated with nss and hemostasis was obtained with electrocautery.The fascia was closed over the prior goretex and newly placed kugel mesh with 2 double stranded loop pds.The subcutaneous tissue was reapproximated using interrupted vicryl sutures.The skin closed with staples.The carter-thompson sites were reapproximated with dermabond.All counts were correct.The patient tolerated the procedure well and was transferred to rr in stable condition.¿ attending surgeon attestation: i was present for the key portions of the procedure (abdominal entry, lysis of adhesions, placement of mesh) and immediately available for the remainder.¿ (b)(6) 2008: (b)(6).Implant record.Bard composix kugel hernia patch/19.6 cm x 24.6 cm/lot hurg0873/ exp 08-2012.¿ (b)(6) 2008: (b)(6).(b)(6) md.Operative report.Preoperative diagnosis: ovarian cyst.Postoperative diagnosis: bilateral simple ovarian cyst.Bilateral oophorectomy.Anesthesia: get.Asa class: 2.Anesthesia faculty: (b)(6) , md.Anesthesia house staff: (b)(6) do.Antibiotics: vancomycin 1 gram/ciprofloxacin 400 mg.Estimated blood loss: 50.Transfusions: 0.Complications: none.Specimens: right/left ovaries.Indication: pelvic pain and bilateral ovarian cysts.Narrative: ¿after informed consent obtained, pt taken to or 10 and time out verified.General surgery performed exploratory laparotomy and lysis of extensive adhesions and entered abdominal cavity without complications.General surgery present to perform ventral hernia repair.I scrubbed in and with general surgery assistance freed bilateral simple appearing ovarian cysts from pelvic adhesions.The left infundibulopelvic ligament was excised and the ovary/cyst removed and sent to pathology.Attention was then turned to the right ovary.The ovary/cyst was freed of adhesions, ip ligated clear from ureter and the specimen sent to pathology.There was concern for ureteral injury and small 1 x 2 cm hematoma noted at pedical.Dr.(b)(6) scrubbed and examined pt and felt ureter to be clear of incision.Urology consult obtained and they agreed ureter to be medial to the ip ligament.Ip ligament religated and hematoma felt to be stable.Pt hemastatic upon completion.Attention was then returned to the general surgery team to complete the procedure/incision closure and hernia repair.¿ attending surgeon attestation: i performed the entire case.Explant procedure: excision of mesh x2, lysis of adhesions.[partial explant] explant date: (b)(6) 2012 (hospitalization [ni]).¿ (b)(6) 2012: (b)(6).(b)(6) md.Operative report.Preoperative diagnosis: small bowel obstruction.Postoperative diagnosis: small bowel obstruction due to adhesed bowel to mesh.Primary surgeon: (b)(6) md.Attending surgeon: (b)(6) md.First assistant: (b)(6) md.Anesthesia: get.Asa class: 3.Anesthesia faculty: (b)(6) md.Antibiotics: cipro/flagyl.Estimated blood loss: 50.Transfusions: 0.Complications: none.Specimens: mesh x2.Indication: ms.(b)(6) is a 51-year-old female who presented with abdominal pain, nausea/vomiting, and closed loop obstruction on ct scan with obstruction at previously placed mesh.Time out: immediately prior to procedure, time out was performed to include correct patient, agreement on procedure to be performed, correct side, site, position, accurate procedure consent, relevant images, antibiotics, fluids, safety precautions, and availability of any special implants that might be required.Procedure: ¿the patient was preoperatively counseled on the risk of bowel resection, fistula, injury to surrounding structures, recurrent hernia, evisceration, heart attack, stroke, and death.The patient was a jehovah's witness, who declined blood products and any foreign biologic material.The patient was brought to the or.She was placed in a supine position.Geta was administered.The patient was prepped and draped in the usual sterile fashion.The midline incision was made superior to the previous incisions.The peritoneum was entered.The mesh was identified on the inferior border of this incision.With caution, the mesh (likely the goretex mesh) was removed from the ventral abdominal wall.The incision was extended inferiorly to nearly the level of the pubis.There was decent incorporation of the mesh to the ventral abdominal wall.Following this, we noticed that there was another hard area plastered too the bowel that represented another piece of mesh that was adhesed to the bowel (likely the previously placed kugel mesh).We were able remove the mesh from the bowel as there was a capsule around the mesh that we kept on the bowel.This mesh extended down to the level of the pubis.After this mesh was removed.We carefully began adhesiolysis.There were several areas of kinking of the bowel, but the bowel appeared viable.We ran the bowel from, the ligament of trietz to the cecum and released the significant adhesions.Following this, we repaired some areas of deserosalization [sic] on the small bowel that was adhesed to the mesh with interrupted 3-0 silk sutures.The bowel was- examined again and appeared healthy and intact.The abdomen was irrigated thoroughly.As the patient was a jehovah¿s witness, we were not able to place biologic mesh to repair her ventral hernia.Therefore, we raised flaps and found that the midline abdominal wall would close without tension.We did not perform a myofascial release as we were going to preserve this in case she had a recurrence.We closed the abdominal wall using double stranded pds and interrupted 1 vicryl suture.Two blake drains were placed in the subcutaneous space.The skin was closed using staples.The patient was extubated and taken to the pacu in stable condition.¿ attending surgeon attestation: i was present and scrubbed for the entire procedure.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 results code.Conclusion code remains unchanged.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.This claim was withdrawn, and the alleged product complaint is no longer being pursued at this time.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.No further investigation is required at this time.Based upon gore¿s investigation 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, and ¿withdrawn.¿ 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® 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.¿ 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.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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