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H6: codes 4118/3221 - product identification records for the alleged gore device was not provided.Therefore, a review of the manufacturing records could not be performed.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: records prior to (b)(6)2002, including records for previous hernia repairs, were not provided.Operative records dated (b)(6)2002 indicate ¿the patient underwent ventral incisional hernia repairs x2, subfascial mesh (ptfe dual mesh), layered wound closure (11cm).¿ the patient ¿is a 45-year-old male who developed a painful bulging in the lower part of the upper midline incision when he was lifting a heavy door frame at work.Operation is indicated for symptom relief of a painful supraumbilical bulge and to avoid the complications of strangulation of the incompletely reducible ventral incisional hernia.¿ operative findings dated (b)(6)2002 state: ¿incarcerated preperitoneal fat protruding through two hernia defects.The upper defect was a wide defect which measured approximately 6 cm and there was smaller satellite defect which measured approximately 3 cm located approximately 2 cm below the first one.Both had incarcerated preperitoneal fat protruding through the fascial edges were contracted and retracted and scarred.The quality of the fascial tissue in that area was not very good and therefore mesh reinforcement was required to provide adequate strength to the repair and also bridge the gap between the contracted scarred down fascial defect.¿ the records dated (b)(6)2002 continue: ¿an incision was made over the palpable defect and the scar was excised in this area.Incision was then carried down through the subcutaneous tissues to the protruding tissue in the subcutaneous space.This protruding fatty tissue was dissected away from surrounding subcutaneous adipose tissue down to the level of the fascia.The fascial adhesions were lysed using electrocautery at the site of the larger hernia as well as the smaller hernia.¿ operative records dated (b)(6)2002 state: ¿an attempt was made to reduce the incarcerated tissue through the subfascial position but the tissue would not reduce easily since it had been outside of its normal domain for some time.The suprafascial preperitoneal adipose tissue was then amputated above kelly clamps and the stumps were suture ligated with 3-0 vicryl suture.This allowed the tissue to then retract to a subfascial location.¿ records dated (b)(6)2002 state: ¿an attempt was made to create a subfascial pocket which to insert mesh but this could not be completely done because there was no adequate hernia sac which would provide a barrier between the intra-abdominal contents and the mesh.The fascia bridge between the two hernias was then divided to create one large defect.An appropriate piece of ptse [sic] dual mesh was cut and tailored to suit to fit below the fascia extending well beyond the margins of the fascial defect.¿ operative records dated (b)(6)2002 continue: ¿where possible pre-peritoneal adipose tissue with underlying peritoneum was then mobilized and then sewn to the peritoneum around the periphery of the fascia defect but away from the edges in order to create a new preperitoneal pocket into which the mesh would be positioned.Once this had been accomplished, a nice barrier of tissue was then separating the intra-abdominal contents from the area of the mesh placement.¿ the records dated (b)(6)2002 continue: ¿the mesh was placed down into the subfascial position above the sutured preperitoneal barrier and was sewn around the periphery of the fascial defect with u-stitches of 0-pds suture.This provided complete coverage of the fascial defect with the edges extending well under the edges of the contracted fascial tissue.The fascial bridge which had been previously divided as then sewn over the mesh repair for additional reinforcement using a figure-of-eight suture of 0-pds.¿ operative records dated (b)(6)2002 state: ¿around the periphery of the larger fascial defect, two additional sutures were placed reapproximating the scarred fascial edge to the underlying visible mesh.These were also of 0-vicryl.All of the sutures were absorbable and would not cause any persistent postoperative pinching for the patient.A 10-french blake drain was then placed above the fascia and brought out through a lower stab wound.The drain was secured on to the skin using 3-0 nylon suture.The wound was then closed in layers with interrupted 3-0 vicryl for the subcutaneous layers.The skin was closed with automatic skin stapler and one-quarter-inch steri-strips were placed between the skin staples to allow for earlier staple removal.An occlusive sterile dressing was applied to complete the operation.¿ records dated (b)(6)2002 do not provide product identification records for a gore device.Records between (b)(6)2002 and (b)(6)2004 were not provided.Operative records dated (b)(6)2004 indicate the patient underwent repair of recurrent ventral hernia.The records state: ¿his previous midline incision was opened.Dissection was carried down through the skin and subcutaneous tissue and then the hernia sac was identified.This was a very large sac and was separated from the surrounding subcutaneous tissue and overlying skin, dissecting this down to the fascial edges.¿ the operative records dated (b)(6)2004 state: ¿the sac was opened and contained colon and omentum, and this was adherent in a portion of the sac, and we actually ended up needing to do an omentectomy and completely resected the sac all the way around the fascial edges.This resulted in the fascial edges being completely free and we undermined the subcutaneous tissue on the anterior aspect of the fascia, such that we had a good 2 cm exposed area of the fascial.¿ records dated (b)(6)2004 continue: ¿we then sutured in a gore-tex dual mesh with the smooth side against the visceral peritoneum and the rough side to the outside.These sutures were placed interrupted in a circumferential fashion using u-sutures, such that there was a 1.5 to 2 cm overlap of fascia with this mesh circumferentially.We placed all of the sutures and then removed our packs, and we then completed tying all of these sutures.The repair appeared very sound.Hemostasis was secure.Abdominal wound was irrigated with saline, as well as betadine and then was closed in two layers with polysorb sutures, and the skin was closed using the skin stapler.¿ the records confirm a gore® dualmesh® biomaterial (1dlmc03/02804601) was used during the procedure.There was no mention of the alleged gore device implanted in 2002 and no mention of device removal in the records.Operative records dated (b)(6)2004 indicate the patient underwent laparoscopic repair of recurrent ventral hernia.The records state: ¿a camera was inserted, pneumoperitoneum was created, and this revealed that the patient had multiple adhesions with multiple small bowel loops up to the patch that had been previously placed.¿ the operative records dated (b)(6)2004 state: ¿we placed two other 5 mm trocars in the lower abdomen on the left side and we were able to take down these adhesions without difficulty.All of the adhesions of the bowel to the patch were taken down with cotton tip dissectors and no sharp dissection was performed until the bowel was well removed from the patch.There was no suggestion of any visceral injury.¿ records dated (b)(6)2004 continue: ¿once all the adhesions were taken down it was obvious this patient had a herniation on the right side of the patch where it had pulled away from the fascia.We marked this area on the skin and used an appropriate sized gore-tex dualmesh patch, 10 x 15 in size, and we placed the appropriate retaining sutures that were 6 in total and suspended the patch over this defect without difficulty or complication.¿ operative records dated (b)(6)2004 state: ¿all of the sutures were placed and the patch was then pulled up.They were tightened and then we used the tacker to circumferentially tack the mesh.The repair appeared very sound.We saw no evidence of any other defects and there was no bleeding incurred and - we did -not - -perform any irrigat.Fon.The wounds were closed with 2-0 and 4-0 polysorb sutures and skin glue was used for the skin.¿ the records confirm a gore® dualmesh® biomaterial (1dlmc03/02821759) was used during the procedure.There was no mention of device removal in the records.Records dated after (b)(6)2004 were not provided.A potential relationship, if any, between the alleged injuries or complications and the gore device is unclear from the provided information at this time.It should be noted that the gore® dualmesh® biomaterial instructions for use includes 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.¿ 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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Updated patient codes.Previous patient code (2240) was reported, based on the original complaint.And are no longer applicable per gore¿s investigation.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.This event will be closed as no problem detected.Medical records: the known medical records span april 18, 2002 to september 1, 2004.And not all records received in this time span are relevant to gore® dualmesh® biomaterial devices (3).The product identification information for the gore device implanted on (b)(6) 2002 were not provided.Patient information: medical history: (b)(6) 2002, ventral incisional hernia, incompletely reducible; (b)(6) 2004, recurrent ventral hernia; (b)(6) 2004, recurrent ventral hernia.Prior surgical procedures: unknown dates, ventral incisional hernia repair x2.Implant #1 preoperative complaints: (b)(6) 2002, ¿the patient is a 45-year-old male, who developed a painful bulging in the lower part of the upper midline incision when he was lifting a heavy door frame at work.Operation is indicated, for symptom relief of a painful supraumbilical bulge.And to avoid the complications of strangulation of the incompletely reducible ventral incisional hernia¿.Implant #1 procedure: ventral incisional hernia repair with subfascial mesh (ptfe dual mesh).Implant: no product identification provided.Implant #1 date: (b)(6) 2002.Description of hernia being treated: ¿incarcerated preperitoneal fat protruding through two hernia defects.The upper defect was a wide defect, which measured approximately 6 cm.And there was smaller satellite defect, which measured approximately 3 cm located approximately 2 cm below the first one.Both had incarcerated preperitoneal fat protruding through the fascial edges were contracted and retracted and scarred.The quality of the fascial tissue in that area was not very good.And therefore, mesh reinforcement was required to provide adequate strength to the repair.And also bridge the gap between the contracted scarred down fascial defect.An incision was made over the palpable defect.And the scar was excised in this area.Incision was then carried down through the subcutaneous tissues to the protruding tissue in the subcutaneous space.This protruding fatty tissue was dissected away from surrounding subcutaneous adipose tissue down to the level of the fascia.The fascial adhesions were lysed using electrocautery at the site of the larger hernia as well as the smaller hernia.An attempt was made to reduce the incarcerated tissue through the subfascial position, but the tissue would not reduce easily, since it had been outside of its normal domain for some time.The suprafascial preperitoneal adipose tissue was then amputated above kelly clamps.And the stumps were suture ligated with 3-0 vicryl suture.This allowed the tissue to then retract to a subfascial location¿.Implant size and fixation: ¿an attempt was made to create a subfascial pocket, which to insert mesh, but this could not be completely done, because there was no adequate hernia sac.Which would provide a barrier between the intra-abdominal contents and the mesh.The fascia bridge between the two hernias was then divided to create one large defect.An appropriate piece of ptfe dual mesh was cut and tailored to suit to fit below the fascia extending well beyond the margins of the fascial defect.Where possible pre-peritoneal adipose tissue with underlying peritoneum was then mobilized.And then sewn to the peritoneum around the periphery of the fascia defect, but away from the edges in order to create a new preperitoneal pocket into, which the mesh would be positioned.Once this had been accomplished, a nice barrier of tissue was then separating the intra-abdominal contents from the area of the mesh placement.The mesh was placed down into the subfascial position above the sutured preperitoneal barrier and was sewn around the periphery of the fascial defect with u-stitches of 0-pds suture.This provided complete coverage of the fascial defect with the edges extending well under the edges of the contracted fascial tissue.The fascial bridge, which had been previously divided as then sewn over the mesh repair for additional reinforcement using a figure-of-eight suture of 0-pds.Around the periphery of the larger fascial defect, two additional sutures were placed reapproximating the scarred fascial edge to the underlying visible mesh.These were also of 0-vicryl.All of the sutures were absorbable and would not cause any persistent postoperative pinching for the patient.A 10-french blake drain was then placed above the fascia and brought out through a lower stab wound.The drain was secured on to the skin using 3-0 nylon suture.The wound was then closed in layers with interrupted 3-0 vicryl for the subcutaneous layers.The skin was closed with automatic skin stapler and one-quarter-inch steri-strips were placed between the skin staples to allow for earlier staple removal.An occlusive sterile dressing was applied to complete the operation¿.Implant #2 preoperative complaints: no information.Implant #2 procedure: repair of recurrent ventral hernia.Implant: gore® dualmesh® biomaterial ( (b)(4), 10cm x 15 cm, oval).Implant #2 date: (b)(6), 2004 description of hernia being treated: ¿his previous midline incision was opened.Dissection was carried down through the skin and subcutaneous tissue.And then the hernia sac was identified.This was a very large sac and was separated from the surrounding subcutaneous tissue and overlying skin, dissecting this down to the fascial edges.The sac was opened and contained colon and omentum.And this was adherent in a portion of the sac, and we actually ended up needing to do an omentectomy.And completely resected the sac all the way around the fascial edges.This resulted in the fascial edges being completely free.And we undermined the subcutaneous tissue on the anterior aspect of the fascia, such that we had a good 2 cm exposed area of the fascial¿.Implant size and fixation: ¿we then sutured in a gore-tex dual mesh with the smooth side against the visceral peritoneum and the rough side to the outside.These sutures were placed interrupted in a circumferential fashion using u-sutures, such that there was a 1.5 to 2 cm overlap of fascia with this mesh circumferentially.We placed all of the sutures and then removed our packs.And we then completed tying all of these sutures.The repair appeared very sound.Hemostasis was secure.Abdominal wound was irrigated with saline, as well as betadine and then was closed in two layers with polysorb sutures.And the skin was closed using the skin stapler¿.Implant #3 preoperative complaints: no information.Implant #3 procedure: laparoscopic repair of recurrent ventral hernia.Implant: gore® dualmesh® biomaterial (1dlmc03/02804601), 10cm x 15cm, oval) implant #3 date: (b)(6) 2004.Description of hernia being treated: ¿a camera was inserted.Pneumoperitoneum was created, and this revealed, that the patient had multiple adhesions with multiple small bowel loops up to the patch that had been previously placed.¿we placed two other 5 mm trocars in the lower abdomen on the left side.And we were able to take down these adhesions without difficulty.All of the adhesions of the bowel to the patch were taken down with cotton tip dissectors.And no sharp dissection was performed, until the bowel was well removed from the patch.There was no suggestion of any visceral injury¿.Implant size and fixation: ¿once all the adhesions were taken down, it was obvious this patient had a herniation on the right side of the patch, where it had pulled away from the fascia.We marked this area on the skin and used an appropriate sized gore-tex dualmesh patch, 10 x 15 in size.And we placed the appropriate retaining sutures that were 6 in total.And suspended the patch over this defect without difficulty or complication.All of the sutures were placed and the patch was then pulled up.They were tightened.And then we used the tacker to circumferentially tack the mesh.The repair appeared very sound.We saw no evidence of any other defects.And there was no bleeding incurred.And we did not perform any irrigation.The wounds were closed with 2-0 and 4-0 polysorb sutures and skin glue was used for the skin¿.Conclusion: device #1 ¿ptfe dual mesh¿ it should be noted, that the instructions for gore® dualmesh® biomaterial includes 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 gore® dualmesh® biomaterial ifu also states, ¿use only nonabsorbable sutures, such as gore-tex® suture, with a noncutting needle (such as taper or piercing point) of appropriate size to anchor the device.The use of absorbable sutures may lead to inadequate anchoring of gore® dualmesh® biomaterial to the host tissue and necessitate reoperation.For best results, use monofilament sutures.Suture size should be determined by surgeon preference and the nature of the reconstruction¿.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, dysphagia, erosion or extrusion and related harms, exposure or protrusion and related harms, fever, fistula, gerd recurrence, recurrence, ileus, increased procedure time and related harms, irritation or inflammation, infection, pain, paresthesia, perforation, revision/re-intervention, seroma or hematoma and related harms, wound complications and wound dehiscence.Many of the potential complications are associated with the patient¿s underlying disease progression, co-morbidities, additional medical history and/or other surgical procedures.Individual medical decisions, 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.After multiple requests, product identification information was not provided for device #1, documented as ¿ptfe dual mesh¿.And thus it could not be confirmed, to be a gore hernia device.Review of the manufacturing and sterilization records could not be performed, as a valid lot number was not provided.In an abundance of caution for product surveillance tracking and trending purposes only.This event has been analyzed, coded and reported as necessary, assuming it is a gore hernia device.All available information has been placed on file for use in product surveillance tracking, trending and follow-up.Based upon the information received, the device remains in the patient.And was not available for evaluation.Review of the manufacturing and sterilization records could not be performed, as a valid lot number was not provided.In an abundance of caution for product surveillance tracking and trending purposes only.This event has been analyzed, coded and reported as necessary assuming, it is a gore hernia device.All available information has been placed on file for use in product surveillance tracking, trending and follow-up.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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