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
Adhesion(s) (1695); Obstruction/Occlusion (2422)
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Event Date 11/08/2019 |
Event Type
Injury
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Event Description
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It was reported to gore that the patient underwent laparoscopic incisional hernia repair on (b)(6) 2015 whereby a gore® dualmesh® plus biomaterial was implanted.The complaint alleges that on (b)(6) 2019 and (b)(6) 2020, additional procedures occurred whereby the gore device was explanted.It was reported the patient alleges the following injuries: none reported.Additional event specific information was not provided.
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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)].Additional details regarding the patient's clinical course were ascertained from a review of medical records and are as follows: relevant medical information: none provided.Implant preoperative complaints: (b)(6) 2015: (b)(6) medical center.(b)(6) indication: ¿the patient is a (b)(6) male who had a previous appendectomy with incision at his umbilicus.He developed a hernia and this had been enlarging and is symptomatic.He therefore required hernia repair.¿ implant procedure: laparoscopic incisional herniorrhaphy with mesh prosthesis.[implant: gore® dualmesh® plus biomaterial, 1dlmcp03/13790870, 10cm x 15cm x 1mm thick, oval] implant date: (b)(6) 2015 [hospitalization dates unknown].(b)(6) 2015: (b)(6) medical center.(b)(6) assistant: (b)(6) anesthesia: general.Estimated blood loss: minimal.Complications: none.Specimens: none.Preoperative and postoperative diagnosis: incisional hernia.Classification surgical wound: clean.Description of hernia being treated: ¿after informed consent was obtained, the patient was taken to the operating room, laid in supine position, placed under general endotracheal anesthesia.Abdomen was prepped and draped in the usual sterile fashion.Skin was infiltrated with 0.5% marcaine.A 5 mm optical trocar was inserted in the left upper quadrant.After, insertion, the abdomen was insufflated with carbon dioxide to 15 mmhg.A second port was then placed in the left lower quadrant.This was a 5 mm port.The hernia defect was identified _____ [sic] at the umbilicus.¿ implant size and fixation: ¿a 10 x 15 piece of gore dualmesh was obtained.Fascial sutures were placed equal distance apart around the periphery of the mesh.It was then rolled and placed into the abdomen.The transfacial sutures were then brought out through the abdominal wall through individual stab incisions using gore suture passer.It was appropriately positioned over the hernia defect with at least 4 cm of overlap on all sides.The transfacial sutures were then tied.The mesh was then secured around its periphery using absorbable laparoscopic tacks.These were placed approximately 1 cm apart around the entire periphery of the mesh.The operative field was then reevaluated and noted to be hemostatic.The carbon dioxide was evacuated from the abdomen.The ports were removed.Dermabond was then applied.The incision was closed using 4-0 vicryl in subcuticular fashion.Dermabond was applied.The patient tolerated the procedure well.He was then awakened and taken to the recovery room in stable condition.All sponge and instrument counts were correct at the end of the procedure.¿ implant record: ¿mesh dual plus 10 x 15.Type: implant.Qty: 1.Model #: 1dlmcp03.Lot #: 13790870.Site: abdomen.Mfg: gore.Expiration date: 2/2018.¿ relevant medical information: (b)(6) 2019: (b)(6) medical center.(b)(6).Anesthesia: general.Estimated blood loss: less than 50 ml.Complications: none.Drains: none.Preoperative and postoperative diagnosis: incisional hernia.Procedure: exploratory laparotomy and lysis of adhesions.Indications: ¿small bowel obstruction with worsening bandemia.¿ classified surgical wound: clean-contaminated.Procedure: ¿the patient was taken to the operating room and placed supine upon the operating room table, at which time general anesthesia was induced.Foley catheter was placed.The patient's abdomen was prepped and draped in the usual sterile fashion.Abdomen was entered through a lower midline incision and it was extended up the side and beyond the umbilicus.Care was taken while opening the mesh.Upon entering the abdomen, i found an adhesive band to the lower left corner of the mesh, that had the bowel wrapped around it.I divided this band and continued opening up.He had a large amount of adhesions to the right side of the mesh, that i felt we had to mobilize to make sure that all was clear.I opened up across his previously placed floor mesh and was able to free the abdominal wall completely.The bowel was viable throughout its course.I then ran the bowel proximal to distal and back distal to proximal, then proximal to distal one last time.All adhesions were freed.The bowel had no enterotomies and was completely viable throughout its course.There was already matriculation of enteral contents distally through the bowel.The patient's abdomen was copiously irrigated with warm normal saline.Hemostasis was checked for and found to be excellent.The patient's abdomen was then closed using interrupted smead-jones closure of 0 prolene suture, to make sure that the mesh was reapproximated well, subcutaneous tissue was copiously irrigated with warm normal saline.Skin was closed with clips.Sterile dressing was applied.Tap block was instilled per anesthesia, and the patient was awakened from anesthesia and taken to the recovery room in stable condition.¿ explant preoperative complaints: (b)(6) 2019: (b)(6) medical center.(b)(6).Indication: infected abdominal wall mesh with ventral hernia.Explant procedure: removal of infected abdominal wall mesh.Primary repair of incisional hernia.Explant date: (b)(6) 2019 (hospitalization dates unknown).(b)(6) 2019: (b)(6) medical center.(b)(6).Anesthesia: general.Estimated blood loss: less than 100 ml.Complications: none.Drains: none.Preoperative and postoperative diagnosis: infected abdominal wall mesh with ventral hernia.Classified surgical wound: dirty and/or infected.Procedure: ¿the patient was taken to the operating room and placed supine upon the operating room table, at which time general anesthesia was induced.The patient's abdomen was prepped and draped in the usual sterile fashion.Abdomen was entered through his previous midline incision under toupe magnification.The abdominal wall was slowly and carefully entered and dissected free.I found obvious purulence surrounding the gore-tex mesh in the midline.This was slowly and carefully dissected free, taking care not to injure the abdominal wall viscera.I mobilized the inflammatory plate deep to the mesh and resected most of this.There was a portion of it that was too adherent to the small bowel to resect, and so i left it adherent and just trimmed it off.The bowel was completely viable throughout the abdomen and was run proximally and distally with no evidence of obstruction or problems or enterotomy being seen.I resected the umbilicus where the majority of his herniation and the infection was.I then closed the abdominal wall using interrupted figure-of-eight sutures of heavy weight prolene.This gave a good abdominal wall closure.The subcutaneous tissue was copiously irrigated with warm normal saline.The skin was loosely approximated, leaving gaps for drainage.Wound vac sponge was placed through this and wound vac was placed on the abdominal wall.This was connected to suction.Anesthesia then placed a tap block.The patient was extubated and taken to the recovery room in stable condition.¿ pathology report: none provided.Relevant medical information: (b)(6) 2020: (b)(6).Assistants: (b)(6).Preoperative and postoperative diagnoses: small bowel obstruction.Procedure: exploratory laparotomy and lysis of adhesions.Anesthesia: general.Estimated blood loss: none.Specimens: none.Complications: none.Indications: ¿this is a (b)(6) m [male] with history of prior abdominal surgeries including umbilical hernia repair with mesh, subsequent sbo [small bowel obstruction] and exploratory laparotomy.Presented to ed with 1 day of pain.Ct scan concerning for closed loop.Focal tenderness over area of concern on imaging.Plan to proceed to or for ex lap given concern for bowel ischemia.¿ findings: ¿viable small bowel.Few scattered adhesions, primarily in the left lower quadrant and under umbilical mesh.Point of constriction from adhesive band.¿ procedure: ¿the patient was brought to the operating room and general anesthesia was induced.The patient was placed in supine position.The abdomen was prepped and draped in a sterile fashion.A timeout was performed and antibiotics were confirmed.A midline periumbilical laparotomy was made, and the abdomen was entered above the prior laparotomy scar.There are adhesions between a loop of decompressed small bowel and the umbilical mesh - this was taken down without injury to the bowel.There were a few scattered adhesions throughout the abdomen that were easily disrupted as i mobilized the bowel out of the abdomen.The small bowel was run from lot [ligament of treitz] to terminal ileum, and all was viable.There was transition point in the mid/distal jejunum and evidence of prior focal external compression of the bowel, likely from an adhesive band.No definitive second proximal transition point was identified.The bowel was reduced into the abdomen.The omentum was freed from the right side wall to allow coverage of the bowel beneath our incision.The abdominal wall fascia was closed with #1 pds suture in running fashion.The skin was closed with staples.Counts: correct.I was present for the entire operation as dictated.Post-op condition: stable.Post-op disposition: pacu [post anesthesia care unit ].¿ 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.
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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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B7: added medical history.H6: updated results code.Conclusion code remains unchanged.H10/11: added medical record information.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)].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) 2015: (b)(6) medical center, (b)(6) md indication: ¿the patient is a 38-year-old male who had a previous appendectomy with incision at his umbilicus.He developed a hernia and this had been enlarging and is symptomatic.He therefore required hernia repair.¿ implant procedure: laparoscopic incisional herniorrhaphy with mesh prosthesis.[implant: gore® dualmesh® plus biomaterial, 1dlmcp03/(b)(6), 10cm x 15cm x 1mm thick, oval] implant date: (b)(6) 2015 [hospitalization dates unknown] ¿ (b)(6) 2015: (b)(6) medical center.Dr.Anesthesia: general.Estimated blood loss: minimal.Complications: none.Specimens: none.Preoperative and postoperative diagnosis: incisional hernia.¿ classification surgical wound: clean.¿ description of hernia being treated: ¿after informed consent was obtained, the patient was taken to the operating room, laid in supine position, placed under general endotracheal anesthesia.Abdomen was prepped and draped in the usual sterile fashion.Skin was infiltrated with 0.5% marcaine.A 5 mm optical trocar was inserted in the left upper quadrant.After, insertion, the abdomen was insufflated with carbon dioxide to 15 mmhg.A second port was then placed in the left lower quadrant.This was a 5 mm port.The hernia defect was identified _____ [sic] at the umbilicus.¿ ¿ implant size and fixation: ¿a 10 x 15 piece of gore dualmesh was obtained.Fascial sutures were placed equal distance apart around the periphery of the mesh.It was then rolled and placed into the abdomen.The transfascial sutures were then brought out through the abdominal wall through individual stab incisions using gore suture passer.It was appropriately positioned over the hernia defect with at least 4 cm of overlap on all sides.The transfascial sutures were then tied.The mesh was then secured around its periphery using absorbable laparoscopic tacks.These were placed approximately 1 cm apart around the entire periphery of the mesh.The operative field was then reevaluated and noted to be hemostatic.The carbon dioxide was evacuated from the abdomen.The ports were removed.Dermabond was then applied.The incision was closed using 4-0 vicryl in subcuticular fashion.Dermabond was applied.The patient tolerated the procedure well.He was then awakened and taken to the recovery room in stable condition.All sponge and instrument counts were correct at the end of the procedure.¿ ¿ implant record: ¿mesh dual plus 10 x 15.Type: implant.Qty: (b)(4).Model #: 1dlmcp03.Lot #: (b)(6).Site: abdomen.Mfg: gore.Expiration date: (b)(6) 2018.¿ revision procedure: exploratory laparotomy and lysis of adhesions.Revision date: (b)(6) 2019.¿ (b)(6) 2019: (b)(6) medical center.(b)(6) md anesthesia: general.Estimated blood loss: less than 50 ml.Complications: none.Drains: none.Preoperative and postoperative diagnosis: incisional hernia.Indications: ¿small bowel obstruction with worsening bandemia.¿ ¿ classified surgical wound: clean-contaminated.¿ procedure: ¿the patient was taken to the operating room and placed supine upon the operating room table, at which time general anesthesia was induced.Foley catheter was placed.The patient's abdomen was prepped and draped in the usual sterile fashion.Abdomen was entered through a lower midline incision and it was extended up the side and beyond the umbilicus.Care was taken while opening the mesh.Upon entering the abdomen, i found an adhesive band to the lower left corner of the mesh, that had the bowel wrapped around it.I divided this band and continued opening up.He had a large amount of adhesions to the right side of the mesh, that i felt we had to mobilize to make sure that all was clear.I opened up across his previously placed floor mesh and was able to free the abdominal wall completely.The bowel was viable throughout its course.I then ran the bowel proximal to distal and back distal to proximal, then proximal to distal one last time.All adhesions were freed.The bowel had no enterotomies and was completely viable throughout its course.There was already matriculation of enteral contents distally through the bowel.The patient's abdomen was copiously irrigated with warm normal saline.Hemostasis was checked for and found to be excellent.The patient's abdomen was then closed using interrupted smead-jones closure of 0 prolene suture, to make sure that the mesh was reapproximated well, subcutaneous tissue was copiously irrigated with warm normal saline.Skin was closed with clips.Sterile dressing was applied.Tap block was instilled per anesthesia, and the patient was awakened from anesthesia and taken to the recovery room in stable condition.¿ explant preoperative complaints: ¿ (b)(6) 2019: (b)(6) medical center.(b)(6) md.Indication: infected abdominal wall mesh with ventral hernia.Explant procedure: removal of infected abdominal wall mesh.Primary repair of incisional hernia.Explant date: (b)(6) 2019 (hospitalization dates unknown).¿ (b)(6) 2019: (b)(6) medical center.(b)(6) md.Anesthesia: general.Estimated blood loss: less than 100 ml.Complications: none.Drains: none.Preoperative and postoperative diagnosis: infected abdominal wall mesh with ventral hernia.¿ classified surgical wound: dirty and/or infected.¿ procedure: ¿the patient was taken to the operating room and placed supine upon the operating room table, at which time general anesthesia was induced.The patient's abdomen was prepped and draped in the usual sterile fashion.Abdomen was entered through his previous midline incision under toupe magnification.The abdominal wall was slowly and carefully entered and dissected free.I found obvious purulence surrounding the gore-tex mesh in the midline.This was slowly and carefully dissected free, taking care not to injure the abdominal wall viscera.I mobilized the inflammatory plate deep to the mesh and resected most of this.There was a portion of it that was too adherent to the small bowel to resect, and so i left it adherent and just trimmed it off.The bowel was completely viable throughout the abdomen and was run proximally and distally with no evidence of obstruction or problems or enterotomy being seen.I resected the umbilicus where the majority of his herniation and the infection was.I then closed the abdominal wall using interrupted figure-of-eight sutures of heavy weight prolene.This gave a good abdominal wall closure.The subcutaneous tissue was copiously irrigated with warm normal saline.The skin was loosely approximated, leaving gaps for drainage.Wound vac sponge was placed through this and wound vac was placed on the abdominal wall.This was connected to suction.Anesthesia then placed a tap block.The patient was extubated and taken to the recovery room in stable condition.¿ ¿ pathology report: none provided.Relevant medical information: ¿ (b)(6) 2020: (b)(6) hospital.(b)(6) md.Preoperative and postoperative diagnoses: small bowel obstruction.Procedure: exploratory laparotomy and lysis of adhesions.Anesthesia: general.Estimated blood loss: none.Specimens: none.Complications: none.- indications: ¿this is a 43 yo.M [male] with history of prior abdominal surgeries including umbilical hernia repair with mesh, subsequent sbo [small bowel obstruction] and exploratory laparotomy.Presented to ed with 1 day of pain.Ct scan concerning for closed loop.Focal tenderness over area of concern on imaging.Plan to proceed to or for ex lap given concern for bowel ischemia.¿ - findings: ¿viable small bowel.Few scattered adhesions, primarily in the left lower quadrant and under umbilical mesh.Point of constriction from adhesive band.¿ - procedure: ¿the patient was brought to the operating room and general anesthesia was induced.The patient was placed in supine position.The abdomen was prepped and draped in a sterile fashion.A timeout was performed and antibiotics were confirmed.A midline periumbilical laparotomy was made, and the abdomen was entered above the prior laparotomy scar.There are adhesions between a loop of decompressed small bowel and the umbilical mesh - this was taken down without injury to the bowel.There were a few scattered adhesions throughout the abdomen that were easily disrupted as i mobilized the bowel out of the abdomen.The small bowel was run from lot [ligament of treitz] to terminal ileum, and all was viable.There was transition point in the mid/distal jejunum and evidence of prior focal external compression of the bowel, likely from an adhesive band.No definitive second proximal transition point was identified.The bowel was reduced into the abdomen.The omentum was freed from the right side wall to allow coverage of the bowel beneath our incision.The abdominal wall fascia was closed with #1 pds suture in running fashion.The skin was closed with staples.Counts: correct.I was present for the entire operation as dictated.Post-op condition: stable.Post-op disposition: pacu [post anesthesia care unit ].¿ 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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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® 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.¿ the investigation has been completed.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.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.The instructions for use further warn: ¿when using this device as a permanent implant and exposure occurs, treat to avoid contamination, or device removal may be necessary.¿ individual medical decisions and/or actions of healthcare professional or device user, if inconsistent and/or non-conforming to the device manufacturer¿s recommendations, ifu, or recognized best practices, may result in or contribute to an adverse event.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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