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| Model Number 1DLMC08 |
| Device Problem
Insufficient Information (3190)
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| Patient Problems
Abscess (1690); Unspecified Infection (1930); No Clinical Signs, Symptoms or Conditions (4582)
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| Event Date 01/22/2006 |
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Event Type
Injury
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Manufacturer Narrative
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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 ventral incisional hernia repair on (b)(6) 2002 whereby a gore® dualmesh® biomaterial was implanted.The complaint alleges that on (b)(6) 2006, an additional procedure occurred whereby the gore device was explanted.It was reported the patient alleges the following injuries: abscess, infected mesh, removal of mesh, pain and 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 incisional hernia, ventral region.Implant: gore® dualmesh® plus biomaterial [1dlmc08/01180892].Implant date: (b)(6) 2002 (hospitalization unknown).On (b)(6) 2002: (b)(6), md.Operative report.Preoperative diagnosis: incisional hernia, ventral.Postoperative diagnosis: same.Anesthesia: general endotracheal anesthesia.Ebl: less than 100 cc.Indication: this is a 34-year-old male with morbid obesity.He apparently lost approximately 160 pounds to reduce his weight from 600 pounds to 420-440 pounds.In the process, the patient also underwent failed gastric reduction procedure with subsequent incisional hernia in the ventral region.The patient presents at this time for symptomatic ventral hernia with no obstructive symptoms, however, the patient is quite uncomfortable.The patient was identified preoperatively.He was given two grams of ancef iv.He also had sequential compression devices in place.He had signed a consent form for repair of ventral hernia.Technique: ¿he is brought to the operating room and placed in supine on the operating room table.After induction of general endotracheal anesthesia, in a satisfactory manner, the patient¿s abdomen was prepped and draped in the standard sterile fashion.A midline incision was made with a #10 blade, followed by electrocautery through the underlying subcutaneous tissue to expose a very large omental and preperitoneal incisional hernia through multiple fascial defects along the entire midline incision.This was taken down with a combination of blunt and electrocautery dissection to the fascial edge.It was cleared.The fascia itself was opened to connect the fascial defects.The preperitoneal and omental hernia was taken down, circumferentially.A portion of omentum was resected with tying off the small bleeding vessels with 3-0 vicryl.The specimen was passed off the table for evaluation of lipoma.The overlying and underlying fascia circumferentially was cleared from the adventitia.The largest piece of dual cortex mesh we had was placed in the abdominal wound, covered proximally, 1 x 1.5 feet area.This was tacked in place with #1 pds, approximately 2-4 cm off the edge of the fascia circumferentially in a tensionless manner, following which the fascial edges were sutured to the mesh in a circumferential manner with four separate stitches.Two jackson-pratt drains were placed bilaterally and allowed to overlie this region.The wound itself was thoroughly irrigated with warm saline and suctioned free several times, after which the deep drains were approximated with simple running stitches of 3-0 vicryl, followed by closure of the skin with staples.The jackson-pratt drains were set to bulb suction.The patient was allowed to awaken per anesthesia and was extubated prior to removal from the room.Foley was attempted to be placed, secondary to patient¿s history of urinary tract infections and low ability to be mobilized during the night, secondary to size.A #14 french foley was unable to be passed, secondary to stricture near the prostate.A coude foley was attempted and failed as well.Dr.(b)(6) from urology was consulted to perform a cystoscopy and placement of foley.Please see his notes for details.The patient was taken back to the post anesthesia care unit in stable condition, having tolerated the procedure well without difficulty.¿ needles, sponge and instrument counts were correct at the end of the case.On (b)(6) 2002: (b)(6).Implant sticker.Implant: gore-tex dualmesh biomaterial.Item#: 1dlmc08, lot#: 01180892.The records confirm a gore® dualmesh® biomaterial (1dlmc08/01180892) was implanted during the procedure.Explant procedure: excision infected ventral abdominal wall mesh primary closure of fascia and placement of retention sutures with packing of the subcutaneous tissue explant date: (b)(6), 2006 (hospitalization (b)(6), 2006).On (b)(6) 2006: (b)(6), md.Operative report.Preoperative diagnosis: infected abdominal wall mesh.Postoperative diagnosis: infected abdominal wall mesh.Anesthetic: general endotracheal anesthesia.Estimated blood loss: approximately 100 ml.Fluids: 2300 ml crystalloids.Urine: 700 ml.Condition: stable.Indication: (b)(6) is a 38-year-old male with type 2 diabetes mellitus.The patient had a ventral hernia repair in 2002.Subsequently, he had an incarcerated incisional hernia, which was repaired in (b)(6) of 2005 by (b)(6) at that time, the bowel was reduced.There was no ischemia noted, and a kugel patch composite mesh was placed.This was performed on (b)(6) 2005.An abscess developed for which an incision and drainage was performed on (b)(6) 2005.The patient has been doing twice daily dressing changes since then.On (b)(6) 2005 [possibly meant to (b)(6) 2006; going of chronology of events], the patient noticed increasing pain, erythema, and signs of infection, which provoked his presentation to (b)(6).Plan today is for definitive treatment of this problem.Technique: ¿after receiving informed consent, the patient was brought to the operating room where general anesthesia was induced.A 16-gauge foley was attempted to be placed.It was, however, unable to be placed.Next, a 14-gauge coude catheter was successfully placed within the bladder with free flow of urine.The patient was prepped and draped in the standard surgical fashion.The patient had an approximately 8 cm lateral open wound in the right upper quadrant/periumbilical area.This incision was continued until an abscess sac anterior to the mesh was reached.The incision was then brought to midline and was continued in approximately 30 cm ventral incision.Dissection proceeded to the level of the mesh, which was elevated up from the subcutaneous tissue by and abscess cavity.The abscess contents were sent for culture and sensitivity, aerobic and anaerobic, including fungal.The gore-tex mesh was identified and sutured in place using prolene sutures.These were cut free and the mesh was removed.The mesh, having been made of gore-tex-like material had virtually zero tissue ingrowth and was easily removed.Next, the fascia was closed using interrupted sutures of #1 pds sutures in figure-of-eight interrupted fashion.These were interspaced with nylon retention sutures.After the pds sutures had completely closed the fascia, the retention sutures were tied using red rubber foley catheter tubing for the exposed nylon in order to prevent skin breakdown.Following this, this stryker pulse irrigator was used in the subcutaneous tissues and on the fascia.Three liters were pulse irrigated to clean the wound.Next, kerlix dressing moistened with normal saline was placed within the wound.The wound was then covered by sterile dressing.The patient was extubated and taken to the recovery room in stable condition.¿ 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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Manufacturer Narrative
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H6: updated results code.Conclusion code remains unchanged 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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Additional details regarding the patient's clinical course were ascertained from a review of medical records and are as follows: implant procedure: repair of incisional hernia, ventral region.Implant: gore® dualmesh® plus biomaterial [1dlmc08/(b)(6)] implant date: (b)(6) 2002 (hospitalization unknown) (b)(6) 2002: (b)(6) medical center.(b)(6) md.Operative report.Preoperative diagnosis: incisional hernia, ventral.Postoperative diagnosis: same.Anesthesia: general endotracheal anesthesia.Ebl: less than 100 cc.Indication: this is a 34-year-old male with morbid obesity.He apparently lost approximately 160 pounds to reduce his weight from 600 pounds to 420-440 pounds.In the process, the patient also underwent failed gastric reduction procedure with subsequent incisional hernia in the ventral region.The patient presents at this time for symptomatic ventral hernia with no obstructive symptoms, however, the patient is quite uncomfortable.The patient was identified preoperatively.He was given two grams of ancef iv.He also had sequential compression devices in place.He had signed a consent form for repair of ventral hernia.Technique: ¿he is brought to the operating room and placed in supine on the operating room table.After induction of general endotracheal anesthesia, in a satisfactory manner, the patient¿s abdomen was prepped and draped in the standard sterile fashion.A midline incision was made with a #10 blade , followed by electrocautery through the underlying subcutaneous tissue to expose a very large omental and preperitoneal incisional hernia through multiple fascial defects along the entire midline incision.This was taken down with a combination of blunt and electrocautery dissection to the fascial edge.It was cleared.The fascia itself was opened to connect the fascial defects.The preperitoneal and omental hernia was taken down, circumferentially.A portion of omentum was resected with tying off the small bleeding vessels with 3-0 vicryl.The specimen was passed off the table for evaluation of lipoma.The overlying and underlying fascia circumferentially was cleared from the adventitia.The largest piece of dual cortex mesh we had was placed in the abdominal wound, covered proximally, 1 x 1.5 feet area.This was tacked in place with #1 pds, approximately 2-4 cm off the edge of the fascia circumferentially in a tensionless manner, following which the fascial edges were sutured to the mesh in a circumferential manner with four separate stitches.Two jackson-pratt drains were placed bilaterally and allowed to overlie this region.The wound itself was thoroughly irrigated with warm saline and suctioned free several times, after which the deep drains were approximated with simple running stitches of 3-0 vicryl, followed by closure of the skin with staples.The jackson-pratt drains were set to bulb suction.The patient was allowed to awaken per anesthesia and was extubated prior to removal from the room.Foley was attempted to be placed, secondary to patient¿s history of urinary tract infections and low ability to be mobilized during the night, secondary to size.A #14 french foley was unable to be passed, secondary to stricture near the prostate.A coude foley was attempted and failed as well.Dr.(b)(6) from urology was consulted to perform a cystoscopy and placement of foley.Please see his notes for details.The patient was taken back to the post anesthesia care unit in stable condition, having tolerated the procedure well without difficulty.¿ needles, sponge and instrument counts were correct at the end of the case.(b)(6) 2002: (b)(6) medical center.Implant sticker.Implant: gore-tex dualmesh biomaterial.Item#: 1dlmc08.Lot#: 01180892.The records confirm a gore® dualmesh® biomaterial (1dlmc08/(b)(6)) was implanted during the procedure.Relevant medical information: no interim medical records.Additional procedure: hernia reduction along with repair of the fascial defect with dualmesh procedure date: (b)(6) 20015 [hospitalization (b)(6) 2005] (b)(6) 2005.(b)(6) m.D.Operative report.Pre- and postoperative diagnosis: incarcerated incisional hernia.Anesthesia: general.Indications: ¿the patient is a 38-year-old, obese gentleman who presented with partial small bowel obstruction secondary to incarcerated incisional hernia.The patient previously has had a hernia surgery in the same area and the ct scan revealed loop of bowel which was found to be incarcerated just into the previously placed mesh on the right side of the midline above and to the right of the umbilicus.¿ findings: ¿two fascial defects to the right side of the midline above the umbilicus which when combined had a total fascial defect area of about 6 x 6 cm.Loop of bowel incarcerated in the hernial sac.After opening the sac the bowel loop appeared viable and of normal color.A 14 x 11 cm kugel' s composite mesh used for hernia repair.¿ procedure: ¿¿following this, skin incision was made in the skin and subcutaneous tissue along the previous midline scar mark in the form of a supraumbilical incision.This was deepened using diathermy, and then dissection was carried out to the right side of the midline, raising the skin flap, taking care not to enter the hernial sac.There was a lot of scar tissue in the area and after meticulous dissection the hernial sac was identified the fascial defect was as noted above, and the hernial sac was found to be containing loops of bowel which were found to be incarcerated.The loops were already reduced after removing the adhesions, taking care not to damage the bowels.This was done using dissecting scissors.The fat tissue was removed around the margins of the fascial defect.At the same time another small fascial defect was found just adjacent to the initial fascial defect and these were joined together.The total defect was then found to be 6 x 6 cm.An adequate free of margin was cleared all around the fascial defect to facilitate the placement of preperitoneal dualmesh.At this stage a lateral extension was made off the previously placed midline incision to form a t-shaped incision.This facilitated adequate exposure of the operative area.Hemostasis was insured.Then 14 x 11 cm mesh was taken and placed in a preperitoneal manner, and using prolene 0 suture the mesh was anchored in all the four quadrants with interrupted sutures.Care was taken not to go through and through the mesh, and only the external layer of the mesh was incorporated in the suture.Following this, care was taken that no loops of bowel would be caught between the mesh and the anterior abdominal wall.Following this, using a prolene 0 running suture, the margin of the mesh was anchored with the anterior abdominal fascia the anterior abdominal fascia appeared to be strong.On the inferomedial portion of the fascial defect, the mesh placed from previous surgery was found to be forming the medial border.The distal mesh was anchored in placed.Following this, the wound was thoroughly washed with bacitracin solution, and then closure was done in layers.The subcutaneous tissue along with the deep dermal tissue was approximated with a running vicryl 3-0 suture, and then skin was closed with skin staples.Aseptic dressing was done.No drain was put in.Operative blood loss was less than 50 ml.There were no complications to the surgery.Count of swabs, instruments, and needles at the end of surgery was all correct.No tissue was sent for histopathology.¿ (b)(6) 2005: (b)(6) saint mary¿s.Implant information.Kugel¿s composite mesh.Size: 14 x 11 cm.Expiration date: n/a.Quantity: (b)(4).Additional procedure: i & d of wound.Date of procedure: (b)(4) 2005 [hospitalization (b)(4) 2005] (b)(6) 2005: (b)(6) m.D.Operative report.Pre- and postoperative diagnosis: infected wound.Indication: the patient with wound infection and sepsis.Procedure: ¿¿staples were removed laterally.The incision was opened.This was opened even more laterally over the lateral part where the hernia incision was made.The fascia appeared to be intact over the mesh.The wound was irrigated with six liters of pulse irrigation fluid.The patient tolerated the procedure well and was transferred to the recovery room.¿ explant procedure: excision infected ventral abdominal wall mesh primary closure of fascia and placement of retention sutures with packing of the subcutaneous tissue explant date: (b)(6) 2006 (hospitalization b)(6) 2006) b)(6) 2006: (b)(4) md.Operative report.Preoperative diagnosis: infected abdominal wall mesh.Postoperative diagnosis: infected abdominal wall mesh.Anesthetic: general endotracheal anesthesia.Estimated blood loss: approximately 100 ml.Fluids: 2300 ml crystalloids.Urine: 700 ml.Condition: stable.Indication: mr.B)(6) is a 38-year-old male with type 2 diabetes mellitus.The patient had a ventral hernia repair in 2002.Subsequently, he had an incarcerated incisional hernia, which was repaired in b)(6)2005 by dr.(b)(6).At that time, the bowel was reduced.There was no ischemia noted, and a kugel patch composite mesh was placed.This was performed on b)(6) 2005.An abscess developed for which an incision and drainage was performed on b)(6) 2005.The patient has been doing twice daily dressing changes since then.On b)(6) 2005 [possibly meant to b)(6) 2006; going of chronology of events], the patient noticed increasing pain, erythema, and signs of infection, which provoked his presentation to saint mary¿s heath care.Plan today is for definitive treatment of this problem.Technique: ¿after receiving informed consent, the patient was brought to the operating room where general anesthesia was induced.A 16-gauge foley was attempted to be placed.It was, however, unable to be placed.Next, a 14-gauge coude catheter was successfully placed within the bladder with free flow of urine.The patient was prepped and draped in the standard surgical fashion.The patient had an approximately 8 cm lateral open wound in the right upper quadrant/periumbilical area.This incision was continued until an abscess sac anterior to the mesh was reached.The incision was then brought to midline and was continued in approximately 30 cm ventral incision.Dissection proceeded to the level of the mesh, which was elevated up from the subcutaneous tissue by and abscess cavity.The abscess contents were sent for culture and sensitivity, aerobic and anaerobic, including fungal.The gore-tex mesh was identified and sutured in place using prolene sutures.These were cut free and the mesh was removed.The mesh, having been made of gore-tex-like material had virtually zero tissue ingrowth and was easily removed.Next, the fascia was closed using interrupted sutures of #1 pds sutures in figure-of-eight interrupted fashion.These were interspaced with nylon retention sutures.After the pds sutures had completely closed the fascia, the retention sutures were tied using red rubber foley catheter tubing for the exposed nylon in order to prevent skin breakdown.Following this, this stryker pulse irrigator was used in the subcutaneous tissues and on the fascia.Three liters were pulse irrigated to clean the wound.Next, kerlix dressing moistened with normal saline was placed within the wound.The wound was then covered by sterile dressing.The patient was extubated and taken to the recovery room in stable condition.¿ 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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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.Through gore's investigation and based on the available information 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.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: ¿as with any implantable surgical device, strict aseptic techniques should be followed.If an infection develops, it should be treated aggressively.An unresolved infection may require removal of the device.¿ 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.Review of the manufacturing and sterilization 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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