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W. L. GORE & ASSOCIATES, INC. GORE® SYNECOR® INTRAPERITONEAL BIOMATERIAL; MESH, SURGICAL, POLYMERIC
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| Model Number GKFR2025 |
| Device Problem
Insufficient Information (3190)
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| Patient Problems
Hernia (2240); No Code Available (3191)
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| Event Date 05/31/2019 |
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Event Type
Injury
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Manufacturer Narrative
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(b)(4).It should be noted that the gore® synecor intraperitoneal 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 laparoscopic ventral hernia repair on (b)(6) 2018 whereby a gore® synecor® intraperitoneal biomaterial was implanted.The complaint alleges that on (b)(6) 2019, an additional procedure occurred.It was reported the patient alleges the following injuries: hernia recurrence; chronic pain; mesh migration.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 preoperative complaints: (b)(6) 2018: (b)(6) , indications for procedure: ¿this is a 52-year-old female who presented to the office with complaints of an incisional hernia.It was decided that she would undergo a laparoscopic ventral hernia repair.¿ implant procedure: laparoscopic ventral hernia repair.Implant: gore® synecor intraperitoneal biomaterial (b)(6) /gkfr2025) 20 x 25 cm rectangle.Implant date: (b)(6) 2018 [hospitalization dates unknown].(b)(6) , preop diagnosis: ventral hernia, postop diagnosis: ventral hernia, anesthesia: general operative report: ¿preoperative antibiotics were given prior to incision.Anesthesia was initiated and the patient was then intubated.The patient was then prepped and draped in a normal sterile fashion.A time out procedure was performed to verify the correct patient, site and procedure.Local anesthesia was infiltrated in the left upper quadrant and the 5 millimeter incision was carried out at that time.Then under optiview, a 5 millimeter port was placed using a 5 millimeter laparoscope into the abdominal cavity and insufflation was initiated.Then under direct visualization, two further 5 millimeter ports were placed, one in the left lower quadrant and one in the mid abdomen.Upon inspection of the hernia, the patient was noted to actually have two hernias, one in the epigastric region and one inferior to the umbilicus.The hernias had some incarcerated omentum which was taken down bluntly and then once the area in question was measured out, it was decided that a 25 x 15 size mesh would be fashioned and used for placement.Once the mash was fashioned it was secured at the north, west, east and south points with 0 prolene to be brought transfacisally.The mesh was brought through one of the port sites and the sutures were then brought transfascially in the same points, then the mesh was secured in place using a secure strap tacker.Insufflation was then seized and ports were removed.The incisions were closed using interrupted 4-0 moncryl addressed with dermabond.At the end of the procedure, all lap, sponge, needle and instrument counts were found to be correct.¿ relevant medical information: (b)(6) 2019: (b)(6) , ct abdomen/pelvis w/ contrast for history of hypertension, history of ventral hernia: [results and impression not provided] (b)(6) 2019: (b)(6).Laparoscopic incarcerated ventral hernia repair preop diagnosis: recurrent incarcerated ventral hernia repair, postop diagnosis: recurrent incarcerated ventral hernia repair, anesthesia: general operative report: ¿on the left side of the patient's abdomen i did an open insertion of the hasson trocar.Pneumoperitoneum was created up to 50 [sic] mmhg.Two other trocars were placed on the left side of the patient¿s abdomen.The patient had omentum and transverse colon herniated in the hernia defect in the epigastric region.We can visualize the previous mesh that was placed.It appeared to slide off the previous hernia defect.The defect was approximately 8 x 10 centimeters in size with the abdomen deflated.Omentum and transverse colon were taken down away from the hernia sac using the harmonic scalpel.The falciform ligament was also taken down using the harmonic scalpel.This allowed us to see the entire defect.We inspected the transverse colon.There was no evidence of abnormalities.Using a 20 x 25 syencor mesh the mesh was marked at the 12, 3, 6, and 9 o¿clock position using a gore suture.The mesh was also placed over the abdominal defected and marked on the abdominal wall.Small incisions were made after inserting the mesh into the patient¿s abdominal cavity and using the suture passer.The mesh was brought up to the abdominal wall and secured at the 12, 3, 6, and 9 o¿clock positions.The mesh was then secured using the absorbable securestrap staples in a circumferential manner.The abdomen was inspected again.The small bowel and transverse colon appeared to be normal without any abnormalities.There was no evidence of any visible bleeding.The defect with the 12 millimeter trocar was closed using a suture passer device.All skin incisions were injected with 0.25% marcaine and diluted with exparel local anesthetic.All incisions were closed using the stapler.¿ 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® synecor intraperitoneal 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 results code.Conclusion code remains unchanged.It should be noted that the gore® synecor intraperitoneal 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® synecor intraperitoneal 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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Manufacturer Narrative
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H6: updated health effect.H6: updated investigation finding.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.It should be noted that the gore® synecor intraperitoneal 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.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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Manufacturer Narrative
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H6: updated health effect.H6: updated investigation finding.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.It should be noted that the gore® synecor intraperitoneal 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.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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