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W. L. GORE & ASSOCIATES, INC. GORE® DUALMESH® PLUS BIOMATERIAL; MESH, SURGICAL, POLYMERIC
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| Model Number 1DLMCP04 |
| Device Problem
Insufficient Information (3190)
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| Patient Problems
Unspecified Infection (1930); No Clinical Signs, Symptoms or Conditions (4582)
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| Event Date 08/10/2016 |
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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.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 a legal admission by anyone that the product described in this report has any defects or has malfunctioned, as defined from a legal standpoint.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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Event Description
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It was reported to gore that the patient underwent laparoscopic ventral hernia repair on (b)(6) 2002 whereby a gore® dualmesh® plus biomaterial was implanted.The complaint alleges that on (b)(6) 2016, an additional procedure occurred whereby the gore device was explanted.It was reported the patient alleges the following injuries: additional surgery, recurrence, diarrhea, infection, leukocytosis, nausea, pain & suffering.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: laparoscopic ventral hernia repair.Implant: gore® dualmesh® plus biomaterial w/ corduroy surface ref: 1dlmcp04 ; lot: 01269508 implant date: (b)(6), 2002 [hospitalization (b)(6), 2002] ¿ (b)(6) 2002: (b)(6) hospital (b)(6) (b)(6), va).(b)(6), m.D.Operative report.Pre- and postoperative diagnosis: ventral hernia.Anesthesia: general.Estimated blood loss: minimal.Specimens: n/a.¿ indications: ¿this patient is a 27-year-old female who is status post procedure with an incision hernia at the periumbilical position.She was brought to the operating room for laparoscopic ventral hernia repair.¿ ¿ procedure: "after obtaining an informed consent, the patient was brought to the operating room and placed supine on the operating room table.After induction of general endotracheal anesthesia, the patient was prepped and draped in the usual sterile fashion.Access was gained to the peritoneal cavity through a right upper quadrant incision using the hasson technique.Once the hasson cannula was secured in place, the abdomen was insufflated with 15 mmhg.A 360 degree look around revealed there to be adhesions in the superior portion of the incision.We took these adhesions gently.Only a couple of adhesions needed to be lysed in order to have circumferential access around the hernia.There were no incarcerated hernia contents.There were two hernias side by side, and the defects collectively measured a 10 cm circle.A 14 cm piece of dual mesh was placed after #0 gore suture was secured in four locations evenly spaced around the circumference of the mesh.The mesh was secured using the suture passer device, circumferentially and with transfascial sutures.Between the sutures, the endotacking device was used to secure the mesh edges along the anterior abdominal wall.The mesh easily fit around the perimeter of the hernia defect.The hernia defect was completely covered.At the end of the procedure a 360 degree look around revealed there to be no abnormalities and good hemostasis.Each of the trocars was removed under direct vision.The right upper quadrant hasson cannula was closed with 1-0 vicryl figure-of-eight suture.The wound was irrigated copiously with antibiotic solution.The skin was closed with 4-0 vicryl suture.Each of the four suture sites was closed and approximated with steri-strips and benzoin.A sterile dressing was placed on each of the incisions.A total of three trocars were used; a 10 mm and two 5 mm trocars on the right side of the abdomen.The patient tolerated the procedure well and was transferred to the recovery room with stable vital signs." ¿ (b)(6) 2002: (b)(6) hospital (b)(6) ((b)(6), va).Implant information: gore® dualmesh corduroy antimicrobial.Item: 1dlmcp04; lot: 01269508, size: 15 cm x 19 cm, expiration date: n/a, quantity: (b)(4).¿ the records confirm gore® dualmesh® plus biomaterial w/ corduroy surface (ref: 1dlmcp04; lot: 01269508) was implanted during the procedure.Relevant medical information: no interim medical records.Revision procedure: repair of lower two ventral hernias with 6.4 cm ventral patch.Repair of the upper ventral hernia with 4.3 cm ventral patch.Revision date: (b)(6), 2016 [hospitalization: (b)(6), 2016] ¿ (b)(6) 2016: (b)(6) hospital (b)(6) ((b)(6), va).(b)(6), m.D.Operative report.Preoperative diagnosis: epigastric ventral hernias x 3.Postoperative diagnosis: epigastric ventral hernias x 3 with incarcerated fat.Anesthesia: general.Estimated blood loss: 10 ml.Specimens: n/a.Drains: none.¿ indications: "¿ 41-year-old female with a pmh [past medical history] of chronic pancreatitis s/p distal pancreatectomy and splenectomy 17 years ago.She has chronic abdominal pain and diarrhea which were worsening for the past month.She had a ct scan a week ago and it demonstrated 3 epigastric ventral hernias.I counseled her at length that her worsening abdominal pain and diarrhea might not be secondary to her hernias.She understood but would like to have them repaired.I recommended open repair due to her multiple abdominal surgery.I would combined the inferior 2 hernias into one and repair it with mesh.The superior one will be repaired with mesh.Benefit and risks were discussed with her, consent was obtained." ¿ findings: ¿three epigastric ventral hernias with likely incarcerated preperitoneal fat.The location and size of the defect listed as below.The lowest hernia: 1 cm x 2 cm (transverse) fascial defect.14 cm superior to the umbilicus and 4 cm superior to the upper edge of the old mesh.The middle hernia: 2 cm x 3.5 cm (transverse) fascial defect with a 1.5 cm width fascial bridge from the middle hernia, 15 cm superior to the umbilicus.The highest hernia: 2 cm x 3 cm (transverse) fascial defect with a 4 cm fascial bridge from the middle one, 20 cm superior to the umbilicus.¿ ¿ procedure: "¿a vertical midline incision was made along the scar over the middle ventral hernia using scalpel.The incision was brought down to the fascia using bovie.Of note, her abdominal wall fat was 6 cm deep.The middle ventral hernia was exposed and found contained fat.After the fascial edge was cleared, the preperitoneal fat was completely reduced.The hernia defect was 2.0 x 3.5 cm.The undersurface of the fascia around the fascial edge was dissected with blunt dissection and electrocautery between the parietal peritoneum and the fascia to a depth of 2 cm in order to make a landing zone for the mesh.The lowest hernia defect was then palpated through the middle fascial defect.The lowest hernia contained fat as well and was similarly isolated and reduced.The undersurface of the fascial edge was created to a depth of 2-3 cm.Then the incision was extended cephalad, the upper hernia was found, isolated and reduced.Similarly a 3-cm depth undersurface along the fascial edge was created with blunt and bovie dissection.At this point, a 6.4 cm ventral patch was brought the field.Cardial sutures with #0 ethibond were placed through the fascia and mesh bilaterally and superior to the middle fascia edge and inferior to the lowest fascia edge.The mesh was then inserted through the middle fascial defect and placed against undersurface of the fascia.The sutures were then tied down over the fascia.The mesh was brought up to the fascial edge by pulling the tabs and it was found to lay flat.The lowest fascial defect was closed transversely over and through the mesh using two #0 ethibond sutures in figure of eight.The middle fascial defect was similarly closed transversely over and through the mesh tabs using two #0 ethibond sutures in figure of eight.At this point, a 4.3 cm ventral patch was brought to the field.Cardial sutures with #0 ethibond were placed through the fascia and mesh bilaterally, superior and inferior around the upper hernia fascia edge.The mesh was then inserted through the upper hernia fascial defect and placed against undersurface of the fascia.The sutures were then tied down over the fascia.The mesh was brought up to the fascial edge by pulling the tabs and it was found to lay flat.The upper mesh was overlapped with lower mesh by 1 cm.Then, the upper hernia fascial defect was closed transversely over and through the mesh tabs using two #0 ethibond sutures in figure of eight.The wound was irrigated.Hemostasis was achieved using bovie.The deep subcutaneous layer was closed using interrupted 3-0 vicryl.A #4-0 vicryl was then used in a running subcuticular fashion to close the skin.The skin was dressed with dermabond, and the patient was awoken without complication." ¿ (b)(6) 2016: (b)(6) hospital (b)(6) ((b)(6), va).Implant information.Ventral patch 6.4 cm.Ventral patch 4.3 cm.Quantity: (b)(4).¿ (b)(6) 2016: (b)(6) hospital (b)(6) ((b)(6), va).Pathology report.Report not provided.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: 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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