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W. L. GORE & ASSOCIATES, INC. GORE® DUALMESH® PLUS BIOMATERIAL; MESH, SURGICAL, POLYMERIC
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| Model Number 1DLMCP03 |
| Device Problem
Insufficient Information (3190)
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| Patient Problems
Seroma (2069); No Clinical Signs, Symptoms or Conditions (4582)
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| Event Date 10/23/2007 |
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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 and umbilical hernia repair on (b)(6) 2007 whereby a gore® dualmesh® plus biomaterial was implanted.The complaint alleges that on (b)(6) 2007, an additional procedure occurred whereby the gore device was explanted.It was reported the patient alleges the following injuries: additional surgery, recurrence, wound vac (jp drains), seroma, 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: repair of both umbilical and ventral hernia using dualmesh.Implant: gore® dualmesh® plus biomaterial ref: 1dlmcp03; lot: 04556374 implant date: (b)(6), 2007 [hospitalization (b)(6), 2007 ¿ discharge date unknown] ¿ (b)(6) 2007: (b)(6) healthcare services (now known as (b)(6) hospital) ((b)(6), de).(b)(6), m.D.Operative report.Preoperative diagnosis: recurrent ventral hernia as well as umbilical hernia.Anesthesia: general.Estimated blood loss: n/a.Specimens: n/a.¿ wound classification: i.¿ indications: ¿a 32-year-old female who had a bulge in the periumbilical region, more of a ventral type, associated with increasing discomfort.The hernia defect measured about 12 cm in length by about 6 cm in breadth.The moment the patient laid down, the bulge would appear prominently.Also on physical examination, the finding was of an umbilical hernia, which was previously fixed with plug and patch method.¿ ¿ procedure: ¿¿an elliptical incision was made to encompass the old scar.The incision was carried down to subcutaneous tissue into the fascia.The hernia sac was mobilized underneath the fascia all around it using electrocautery.In the region of the umbilicus, there was a defect, which we could feel, but could not see and exploring this area, we inadvertently opened the peritoneum.The old mesh was excised.Attempt to close the peritoneum over this area was futile.So, we used dualmesh 10 cm x 15 cm in size and was anchored to the undersurface of the fascia with few interrupted sutures and then with an abdominal tacker, the mesh was held in position and the fascia was approximated.Skin and subcutaneous were irrigated and the incision was closed in layer.The skin was approximated using staples.¿ ¿ (b)(6) 2007: (b)(6) hospital ((b)(6), de).Implant sticker: gore® dualmesh® plus biomaterial ref: 1dlmcp03; lot: 04556374, size: n/a, expiration date: n/a, quantity: (b)(4).¿ other implant: autosuturetm ref: ptack30; lot: p6k780 ¿ the records confirm gore® dualmesh® plus biomaterial device (ref: 1dlmcp03; lot: 04556374) was implanted during the procedure.Relevant medical information: no interim medical records explant procedure: repair of right ventral hernia using a dual mesh.Explant date: (b)(6), 2007 [hospitalization: (b)(6), 2007¿ discharge date unknown] ¿ (b)(6) 2007: (b)(6) hospital (now known as (b)(6) hospital) ((b)(6), de).(b)(6), m.D.Operative report.Pre- and postoperative diagnosis: right recurrent ventral hernia.Anesthesia: general.Estimated blood loss: minimal.Specimens: n/a.Wound class: i ¿ drains: jackson-pratt drain.¿ indications: ¿the patient was admitted and had number of surgeries performed for the hernia repair.The last one was done on (b)(6), 2007, when the recurrent ventral hernia as well as umbilical hernia were addressed and were repaired with dual mesh.The patient continued to have some pain for the past couple of weeks and necessitated the visit to the emergency room and cat scan showed protrusion of the fat to the hernia sac on the ventral side.Because of the persistent symptoms and pain, she was taken for surgery.¿ ¿ procedure: ¿¿a transverse incision was made over the site of the previous surgery.The incision was carried down to subcutaneous tissue to expose anterior rectus sheath and this was opened and the staples of the previous surgery were seen.The whole of mesh was intact; however, on the lateral side, outside of this mesh, there was a defect, which allowed the fat to protrude through it.After incisions, the area was defined.The mesh was identified and was dissected free separated from the anterior rectus sheath and mesh was removed.The defect was then properly identified.A large dual mesh of kugel type was placed in position and was anchored using prolene sutures.Was also used to reach the gapping in certain locations.Having fixed this, the rectus sheath, which was spread, was approximated on top of the mesh and some skin and subcutaneous tissue was irrigated and jackson-pratt drain was left in position anterior to the anterior rectus sheath and then the incision was closed in layers.The subcutaneous tissue was approximated with 2-0 vicryl sutures.The size of the mesh this time was 19 x 15 cm.Jackson-pratt drain was left in subcutaneous tissue and brought out through a separate stab wound.The skin was approximated using staples.The patient tolerated the procedure well, was returned to the recovery room in satisfactory condition.Estimated blood loss was minimal.Hopefully, this will address her problem to everybody [sic] satisfaction.¿ ¿ (b)(6) 2007: (b)(6) hospital ((b)(6), de).Implant sticker: bard composix kugel hernia patch.Large oval.Ref: 0010202; lot: hurh0521, size: 13.6 cm x 17.8 cm / 5.4¿ x 7.0¿.Expiration date: n/a.Quantity: (b)(4).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.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 investigation findings 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.H6: corrected health effect - impact code.
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Manufacturer Narrative
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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 and sterilization 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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