|
W. L. GORE & ASSOCIATES, INC. GORE® DUALMESH® PLUS BIOMATERIAL; MESH, SURGICAL, POLYMERIC
|
Back to Search Results |
|
| Model Number 1DLMCP08 |
| Device Problem
Insufficient Information (3190)
|
| Patient Problems
Abscess (1690); Unspecified Infection (1930); Inflammation (1932)
|
| Event Date 12/28/2018 |
|
Event Type
Injury
|
|
Manufacturer Narrative
|
|
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)].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.".
|
| |
|
Event Description
|
|
It was reported to gore that the patient underwent laparoscopic ventral hernia repair on (b)(6) 2018 whereby a gore® dualmesh® plus biomaterial was implanted.The complaint alleges that on (b)(6) 2018, an additional procedure occurred whereby the gore device was explanted.It was reported the patient alleges the following injuries: abscess, inflammation, infection, surgery to remove mesh, abdominal wall reconstruction.Additional event specific information was not provided.
|
| |
|
Manufacturer Narrative
|
|
Additional details regarding the patient's clinical course were ascertained from a review of medical records and are as follows: relevant medical information: (b)(6) 2018: (b)(6) hospital.(b)(6) md.Radiology - ct abdomen/ pelvis with contrast.History: ventral hernia without obstruction or gangrene.Left inguinal hernia.Findings: there is irregularly shaped soft tissue density deep to the right rectus abdominis muscle, new compared to the prior exam, measuring 1.5 cm in diameter.This is favored to represent postsurgical change related to interval cholecystectomy, possibly an evolving area or fat necrosis.Abdominal wall: new compared to the prior examination, there is a moderate-sized fat-containing periumbilical hernia located superior and to the right of the umbilicus, with the neck of the hernia measuring approximately 2 cm at maximum.This hernia contains only fat.There is also a small to moderate-sized fat-containing left inguinal hernia, as seen on the prior examination.Osseous structures: unremarkable.Impression: 1) interval cholecystectomy.2) irregularly shaped 1.5 cm focus of soft tissue density deep to the right rectus abdominis.This is most likely postoperative in nature, possibly representing fat necrosis.3) new fat-containing periumbilical hernia, emanating just superior and to the right of the umbilicus.4) unchanged fat-containing left inguinal hernia.(b)(6) 2018: (b)(6) crna.Anesthesia record.Past medical history: +psychiatric history, pituitary tumor, hypertension, current smoker, diabetes mellitus type 2 (blood sugar 173), basal cell carcinoma face, peripheral vascular disease, psychosis, ventral hernia without obstruction, non-recurrent unilateral inguinal hernia without obstruction, parastomal hernia without obstruction.Asa 3.(b)(6) 2018: (b)(6) md.History and physical.Hpi: enlarging tender bulge above umbilicus.Past surgical history: appendectomy 1960, cholecystectomy (b)(6) 2017, double hernia repair at age of 5.Past medical history: intracranial tumor 2004, type 2 diabetes mellitus.Social history: marital status: divorced.Smoking status: heavy tobacco smoker, 0.5 packs/ day, cigarettes.Alcohol use: occasionally whiskey.Drug use: no.Physical exam: abdominal: soft.Exhibits no mass.No tenderness.Hernia is present.Hernia confirmed positive in the ventral area.Assessment and plan: 1) ventral hernia without obstruction or gangrene.Laparoscopic mesh repair of the hernia was recommended.Procedure explained in detail.Possible complications of bleeding, infection, injury to bowel and conversion to open procedure explained.Postoperative pain, disability and scar formation were discussed.All patient questions were answered to full satisfaction and the wish to proceed with surgery was expressed.2) non-recurrent unilateral inguinal hernia without obstruction or gangrene.Asymptomatic hernia.Observe for now.Implant procedure: laparoscopic mesh repair ventral hernia, adhesiolysis.Implant: ¿gore-tex mesh¿ [id/ size not indicated].Implant date: (b)(6) 2018 (hospitalization (b)(6) 2018).(b)(6) 2018: (b)(6) hospital.(b)(6) md.Operative report.Attending surgeon: (b)(6) md.Anesthesia: general.Primary care provider: (b)(6).Preoperative diagnosis: ventral hernia.Postoperative diagnosis: ventral hernia.Operative findings: the patient and the surgical site were identified and informed consent was obtained.Patient was brought to operating room and placed on the operating table in supine position.Time-out was performed and all members of surgical team confirmed the patient¿s identity and the surgical site.Intravenous antibiotic was given preoperatively.General endotracheal anesthesia was induced.Entire abdomen was prepped and draped in a sterile fashion.0.5% naropin was injected at the incision sites.5 mm trocar was inserted through a left upper quadrant incision under camera guidance.Pneumoperitoneum was induced with carbon dioxide pressure was maintained and tolerated well at 15 mm of mercury.Three trocars were inserted in the left flank area under direct vision.Approach was switched to this site.There is well-defined the hernia defect above and dried edema umbilicus.Omental adhesions around the perimeter of the hernia defect were lysed using scissors and cautery for hemostasis.The falciform ligament was divided in its lower portion exposing more of the anterior abdominal wall to provide adequate room for overlap with the repair was marked on the anterior abdominal wall using transabdominally placed spinal needles.Minimum of 4 cm will be maintained be on the non hernia defect edges.Measurements were taken on deflated abdomen.Appropriate size dual mesh gore-tex patch was selected for the repair.Patch was trimmed for appropriate size and shape and marked.Four quadrant gore-tex sutures were placed around perimeter and then the patch was rolled and inserted into the abdominal cavity through the 12 mm trocar site.Patch was unrolled and positioned centrally underneath the hernia defect.The cardinal sutures were pulled through the abdominal wall using small stable incisions in suture passer.Care was taken to stretch the patch tightly against the undersurface of the anterior abdominal wall.Once this was assured the sutures were tied and knots were.Subcutaneously.Titanium tacks were then used to secure the edge of the patch to the peritoneum around perimeter at 1 cm intervals.Four additional transabdominal no sutures of gore-tex were placed under direct vision through small stab incisions in suture passer.Sutures were tied and not repaired subcutaneously.Abdomen was inspected.Good hemostasis was present.Number 0 vicryl was placed through the fascia at the 10 mm trocar site using endo closure instrument.All trocars removed under vision no bleeding was noted.Pneumoperitoneum was deflated and vicryl was tied obtaining secure fascial closure.Subcutaneous tissue was closed interrupted 3 vicryl skin was closed using staples.Sterile dressings and abdominal binder was secured.Patient was awakened and extubated in the operating room.He was taken to recovery room in satisfactory condition having tolerated procedure well.Estimated blood was negligible and there were no specimens.Estimated blood loss: no blood loss documented.Specimens: no specimen collected in procedure.Complications: none.Condition on discharge from operating room was stable.Product identification records for the alleged ¿gore-tex mesh¿ device were not provided.Relevant medical information: (b)(6) 2018.(b)(6) hospital.(b)(6) md.Radiology- ct abdomen and pelvis with contrast.History: mid abdominal pain for 2 weeks.History of cholecystectomy and hernia repair.Findings: status post ventral hernia repair, with a large 19 x 7 cm fluid collection associated with the hernia repair mesh.There is air within the superior portion of the collection.The collection is extraperitoneal.Impression: status post ventral hernia repair, with a large 19x7 cm extraperitoneal abdominal wall fluid collection associated with hernia repair mesh.Air also present within the collection raising concern for infection.(b)(6) 2018: (b)(6) hospital.(b)(6) md.History and physical.Doing well until month ago when developed periumbilical pain later associated with fever.Tylenol improved fever but pain was getting steadily worse and area hardened and developed ¿knots¿.Saw primary care physician and outpatient ct scan ordered but he never completed.Worsening of the symptoms brought him to emergency room today.Past surgical history: appendectomy 1960, cholecystectomy, double hernia repair at age 5, laparoscopic mesh repair of ventral hernia.History of anemia, hypertension, intracranial tumor, type 2 diabetes mellitus.Social history: smoking status: heavy tobacco smoker, 0.5 packs/ day, cigarettes, 15 cigarettes.Alcohol: occasionally, whiskey, states he has not had a drink in 3 months.Medications include: aspirin 325 mg, liraglutide (victoza 2-pack) 0.6 gm injection.Exam: abdominal: tenderness in epigastric area and periumbilical area.No rigidity and no guarding.Hernia present.Hernia confirmed positive in left inguinal area.Additional data: ct scan shows large fluid collections deep and superficial to goretex patch containing air/ gas, inflammatory reaction soft tissues around the patch, perhaps a hernia along the upper edge of the patch.Lab: wbc 10.5, glucose 168.Assessment and plan: infected prosthetic mesh of abdominal wall.The diagnosis is based on the symptoms of pain fever and ct scan findings of large fluid collections below and above the mesh containing gas.The transverse colon might be involved in this process at the upper colonic edge of the in gore-tex patch.Were this a recurrent hernia or primary colonic process is unknown.Infection could be also result of blood borne seeding from another source.Open laparotomy removal of the present gore-tex material and closure of the abdomen most likely utilizing a different material to reinforce the anterior abdominal wall was recommended.Procedure was explained in detail.Possibility of undiagnosed intra-abdominal processes and the need to deal with them intraoperatively was also discussed.Possible complications including bleeding infection non-healing were explained.Postoperative pain disability scar formation were discussed.All patient questions were answered to his full satisfaction and he wishes to proceed with surgery.Explant procedure: 1) excision of the infected gore-tex mesh.2) component separation with retrorectus mesh repair of the ventral hernia.3) central venous line placement explant date: (b)(6) 2018 (hospitalization (b)(6) 2018- (b)(6) 2019).(b)(6) 2018: (b)(6) md.Operative report.Primary care provider: (b)(6) md.Preoperative diagnosis: infected abdominal wall mesh.Postoperative diagnosis: infected abdominal wall mesh.Anesthesia: shephard.Procedure: the patient and surgical site were identified.An informed consent was obtained.Patient was brought to the operating room, placed on the operating table in supine position.Timeout was performed, and all members of surgical team confirmed patient¿s identity and surgical site.Intravenous antibiotic was given preoperatively.General endotracheal anesthesia was induced.The left paraclavicular area was prepped and draped in a sterile fashion using full sterile barrier seldinger technique, the left subclavian vein was cannulated with triple-lumen central venous line.All 3 lumens were aspirated with unobstructed venous blood flow and flushed with normal saline.The line was secured using silk sutures and covered with sterile dressing.The entire abdomen was then prepped and draped in a sterile fashion.Knife was used to make a midline vertical incision starting in the epigastrium and extending below the umbilicus bypassing it to the right.The subcutaneous tissue was dissected using cautery.There was inflammatory reaction in the subcutaneous tissue over the indurated mass in the periumbilical and supraumbilical area.Fascia was opened i this area and large cavity filled with a large amount of non-foul =smelling whitish pus was entered.A swab was taken for culture.This cavity filled with pus is superficial to the underlying gore-tex patch.The rest of the fascia was opened under direct vision using cautery.The gore-tex patch was then incised, and another abscess cavity which was deep to the patch was entered and evacuated using suction.The gore-tex material and all securing titanium tacks were then excised and removed in their entirety.The deep abscess base is inflamed omentum.It completely sealed this area from the peritoneal cavity.The omental attachments were dissected from the anterior abdominal wall using a combination of blunt and sharp dissection.This allowed entry into the abdomen.Inspection of all intraperitoneal structures which other than indurated omentum were normal.Specifically o intestinal pathology was encountered.The entire abdomen was irrigated with neosporin solution.All dissected areas were inspected, and good hemostasis is present.Next, the rectus abdominis muscle sheath was incised along the exposed edge on both sides of the incision and the anterior incision.This created a retrorectus space for placement of the mesh.Next, skin and subcutaneous tissue flaps were raised on both sides of the incision using cautery all the way to the external aponeurosis.This aponeurosis was then incised using cautery along the edge of the rectus abdominis muscle between the costal margin and the edge of the pelvic brim.This provided an additional few centimeters of give of the abdominal wall on both sides providing for relatively tension-free closure the abdomen was irrigated again with neosporin solution, and sponge and instrument count was conducted several times.It was correct.The posterior sheath of the recuts abdominis muscle was then closed using running #1 pds closing the abdominal cavity.Appropriate size phasix st mesh was then chosen for retrorectus placement.The mesh was trimmed to appropriate size and shape and placed on the posterior rectal sheath.Vicryl sutures around its perimeter.The anterior rectus sheath was then closed in a similar fashion using running #1 pds suture completely covering the mesh.Two 10 mm jackson-pratt drains were the inserted in each lower quadrant trough small stab incisions, and they were placed underneath the cutaneous flaps on each side.The drains were secured using nylon sutures.Sponge and instrument counts were conducted again and were correct.An the subcutaneous tissue was closed using interrupted 3-0 vicryl.Skin was closed using staples.Sterile dressing and abdominal binder were secured.Patient remained intubated throughout the surgery was transferred to the intensive care unit having tolerated the procedure well.Estimated blood loss: 100ml.Specimens: swab for culture.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.
|
| |
|
Manufacturer Narrative
|
|
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.
|
| |
|
Manufacturer Narrative
|
|
H6: updated health effect h6: updated investigation finding h6: updated type of investigation h6: updated investigation conclusions the investigation has been completed.¿based upon the totality of the information received over the course of the investigation and reported by gore in the previously submitted medical record narratives the following conclusions have been reached.As previously reported, all pertinent medical records requested may not have been received.In the absence of additional information or medical records from the complainant, this event file will be closed with the information provided.¿¿¿ ¿¿ previous patient codes were reported based on the original complaint and are no longer applicable and/or not reportable per gore¿s investigation.Following gore¿s investigation, the previously submitted annex f code has been updated to reflect gore¿s final conclusion.It should be noted that the gore® dualmesh® 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, pain, exposure (extrusion), mesh contraction, bowel obstruction 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.¿ 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.
|
| |
|
Manufacturer Narrative
|
|
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, pain, exposure (extrusion), mesh contraction, bowel obstruction 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.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.
|
| |
|
Search Alerts/Recalls
|
|
|
