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| Catalog Number 1DLMC07 |
| Device Problem
Insufficient Information (3190)
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| Patient Problems
Foreign Body Reaction (1868); Hematoma (1884); Unspecified Infection (1930); Seroma (2069); Obstruction/Occlusion (2422)
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| Event Date 03/03/2009 |
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Event Type
Injury
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Manufacturer Narrative
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(b)(4) - product identification records for the alleged gore device were not provided.Therefore, a review of the manufacturing records could not be performed.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.".
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Event Description
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It was reported to gore that the patient underwent open incisional hernia repair on (b)(6) 2009 whereby a gore® dualmesh® biomaterial was implanted.The complaint alleges that on (b)(6) 2009, an additional procedure occurred whereby the gore device was explanted.It was reported the patient alleges the following injuries: dense adhesions, recurrence, mesh infection, mesh removal, hematoma, bowel obstruction, and pain and suffering.Additional event specific information was not provided.
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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 procedure: incisional hernia repair with mesh.Lysis of multiple adhesions.Removal of previously placed collagen mesh.Implant: gore® dualmesh® biomaterial [1dlmc08/illegible].Implant date: (b)(6) 2009 (hospitalization (b)(6) 2009) on (b)(6) 2009: (b)(6) medical center.(b)(6) md.Operative report.Preoperative diagnosis: incisional hernia.Postoperative diagnosis: incisional hernia.Operative procedure: incisional hernia repair with mesh.Lysis of multiple adhesions.Removal of previously placed collagen mesh.Assistant: (b)(6).Procedure note: ¿the patient was brought to the operating room, prepped and draped in normal sterile manner after being placed under general anesthesia and intubated.An incision approximately 15 cm in length was made in the midline at previous surgical site with blunt dissection and electrocautery down to the level of the incisional hernia.The patient's hernia was approximately 8 x 8 cm in.Size.The hernia sac was reduced back into the abdomen.The fascia was grasped using kochers and multiple adhesions were taken (learn using sharp dissection, taking care not to damage any.Small bowel.There was good resection of the adhesions, good take down the adhesions using sharp dissection, clearing a margin approximately 6 to 8 cm on all sides for mesh placement.The patient at the superior aspect of the hernia had some collagen mesh that was balled up in a specimen that was approximately 6 x 4 x 2 cm in size.This was resected using sharp dissection and electrocautery and sent for pathology and culture.It looked to be the old collagen mesh which either had balled up or had come unfastened.After all the margins were cleared, the dual mesh gore-tex mesh was placed in the abdomen and sutured in place using 2-0 prolene suture.This was tacked in place in approximately 3 cm increments to the fascia so that no bowel could become herniated in the new mesh.The fascia was then closed using a marring 0 looped maxon suture.The area had been irrigated well with copious amounts of normal saline and suctioned dry prior to the mesh placement and again after the fascia was closed.It was again irrigated well with normal saline and suctioned dry.The skin was closed using staples.The patient tolerated the procedure well.Estiamted blood loss during the case was 50ml.The patient, depending on his pain level and comfort of going home, will either be admitted to the hospital for pain management or be discharged home with pain medications and close follow-up.¿ on (b)(6) 2009: (b)(6) medical center.Implant sticker.Gore dualmesh® biomaterial.Catalogue number: 1dlmc08.Lot/batch code: [illegible].The records confirm a gore® dualmesh® biomaterial (1dlmc08/[illegible]) was implanted during the procedure.Relevant medical information on (b)(6) 2009: (b)(6) medical center.(b)(6) md.Progress notes.Post-op.Afebrile/ vital signs stable.Wound clean dry intact.Vicodin for pain.Follow up 7-10 days.On (b)(6) 2009.(b)(6) medical center.(b)(6) physician orders.Admit to recovery room.Discharge if pain controlled.[illegible].Able to ambulate and urinate.Explant procedure: lysis of multiple adhesions.Repair of 2 upper abdominal hernias with primary closure using ethibond.Surgisis mesh placement with closure of the wound.Explant date: (b)(6) 2009 (hospitalization ni) on (b)(6) 2009: (b)(6) medical center.(b)(6) md.Operative report.Preoperative diagnosis: incisional hernia.Postoperative diagnosis: multiple incisional hernias.Procedure: lysis of multiple adhesions.Repair of 2 upper abdominal hernias with primary closure using ethibond.Surgisis mesh placement with closure of the wound.Assistant: (b)(6) md.Procedure note: ¿the patient was brought to the operating room, prepped and draped in normal sterile manner after being placed under general anesthesia and intubated.Incision was made from approximately 4 cm below the xiphoid process to the umbilicus.Upon dissection, a midline hernia was encountered.This was reduced into the abdomen and the abdomen was, centered.The fascia was cleared from underneath the fascia using blunt dissection and the abdomen was opened.Previously placed gore-tex dual mesh was removed due to significant inflammatory response to the mesh and fluid accumulation.Gram stain sent in the operating room was negative for any organisms.The patient also had to the right of the umbilicus, a resolving hematoma which had encapsulated.This was sent for pathology to confirm that was a hematoma.Upon exploration of the abdomen, multiple adhesions were taken down using blunt dissection and electrocautery.There were 2 interloop hernias which were taken down using sharp dissection and the inflammatory reaction was causing the adhesion of the bowels, was taken down using sharp dissection.The bowel was healthy and no serosal tears were encountered.On examination of the fascia to the right of the midline, upper abdominal hernia which was closed using interrupted #0 ethibond suture and to the left of the.Midline, there was another hernia closed using ethibond suture.No other hernias were encountered.Surgisis mesh was then placed in the abdomen after soaking for 15 minutes in normal saline.This was tacked in place using #3-0 vicryl suture.Alter the abdomen was irrigated with copious amounts of normal saline and suctioned dry, there was good hemostasis throughout the case.Estimated blood loss was less than 200 ml.Two 15-french round blake drains were then placed, one from the right upper quadrant and one from the left upper quadrant.These were placed in the paracolic gutters towards the.Pelvis.The midline incision was then closed using a running #0 maxon loop suture.Skin was closed using staples.The patient tolerated the procedure well.¿ 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.In the absence of additional information or medical records from the complainant, this event file will be closed with the information provided.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.¿ the instructions for use further warn: ¿strict aseptic techniques should be followed.If an infection develops, it should be treated aggressively.An unresolved infection may require removal of the material.¿ 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.After multiple requests, specific lot number information was not provided for this device, but product type has been confirmed.Review of the manufacturing and sterilization records could not be performed as a valid lot number was not provided 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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