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| Model Number 1DLMC07 |
| Device Problems
Improper or Incorrect Procedure or Method (2017); Insufficient Information (3190)
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| Patient Problems
Unspecified Infection (1930); Pain (1994); Seroma (2069); No Code Available (3191)
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| Event Date 05/30/2007 |
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Event Type
Injury
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Manufacturer Narrative
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(b)(4).(b)(6).It should be noted that the gore dualmesh® biomaterial instructions for use includes warnings and addresses the following adverse reactions among others: ¿strict aseptic techniques should be followed.If an infection develops, it should be treated aggressively.An unresolved infection may require removal of the material.¿ ¿possible adverse reactions with the use of any tissue deficiency prosthesis may include, but are not limited to, contamination, infection, inflammation, adhesion, fistula formation, seroma formation, hematoma, and recurrence.¿.
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Event Description
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It was reported to gore that the patient underwent laparoscopic abdominal wall reconstruction on (b)(6) 2006, whereby a whereby a gore dualmesh® biomaterial was implanted.The complaint alleges that on (b)(6) 2007, an additional procedure was performed whereby explant of the gore device was performed.It was reported the patient alleges the following injuries: chronic abdominal pain, open draining wound, mesh infection, mesh removal.Additional event specific information was not provided.
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Manufacturer Narrative
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Updated manufacturing and sterilization evaluation results code.Conclusion code remains unchanged.
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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: operative records dated (b)(6) 2006 indicate the patient underwent the following procedures: ¿1.Exploratory laparotomy with total abdominal hysterectomy and right salpingo-oophorectomy.2.Excision of fascial mass.3.Dual mesh closure of fascial defect.4.Jackson-pratt drain placement.¿ the following diagnoses are noted: pelvic pain; uterine fibroids; intrafascial mass, possible desmoid; dysmenorrhea; menorrhagia; urinary stress continence.Findings from the (b)(6) 2006 procedure state: ¿the uterus was about 8-10 weeks size with irregularities and intramural fibroids.Right ovary appeared normal but a little bit scarred down to the right sidewall.Ureters tracked normally through the pelvis.The left ovary was healthy and unremarkable.There is a 3 x 5 cm intrafascial subfascial mass, solid in nature, at the symphysis in close approximation to rectus abdominus insertion on the symphysis and to the pyramidalis muscles.¿ the (b)(6) 2006 operative notes regarding the fascial defect repair state: ¿the retractor was then removed and muscles allowed to fall to the midline.The mass and defect in the fascia was then palpated.Kochers were placed on the fascial edge and the subcutaneous tissue gradually dissected down to the mass.The mass was surrounded and eventually excised at the symphysis and extending from the right edge of the pfannenstiel to just across the midline.This left a fascial defect of about 5 cm x 3 cm at the symphysis.¿ the (b)(6) 2006 operative notes continue: ¿a dual mesh graft was then introduced, 10 x 20 cm size.It was trimmed down, tacked laterally underneath the fascia, over the rectus abdominus muscles, using 0 prolene interrupted about every 2 cm.Gradually, the mesh was laid flat and brought around to the other wide, trimmed flat, and undermined the fascia but over the rectus abdominus muscles.The fascia was tacked down to the residual fascia at the symphysis and underneath the fascia near the umbilicus along the edge.The pfannenstiel was then closed with an 0 pds.The fascial defect was then tacked down to the underlying mesh with interrupted 0 pds at about 1 cm intervals.¿ ¿the tension-free tape suburethral sling was not performed due to concerns about infection in the graft from vaginal exposure.This will be performed at a later date if necessary.¿ the records confirm a gore dualmesh® biomaterial (1dlmc07/04393533) was used during the procedure.A discharge summary dated (b)(6) 2006 states: ¿the patient is a 42 year-old woman with a long history of pelvic pain, which began after her cesarean section about 9 or 10 years ago.She had documented hemorrhoids, uterus with fibroids, menorrhagia, dyspareunia, and dysmenorrhea.In addition, she had a mass in the fascia at the right edge of the mons pubis, which was originally thought to be a keloid.¿ ¿on surgical, she was found to have an actual interfascial and subfascial mass involving both the rectus abdominus on the right slightly crossing the midline and the fascia itself.In addition to the hysterectomy, this required an excisional procedure.The resulting fascial defect was closed with a dual mesh gore-tex biomaterial laid under the fascia and the fascial defect stitched into the symphysis, laterally under the existing fascia, and just below the umbilicus.A jackson-pratt drain was placed in the subcutaneous tissue postoperatively.¿ records between (b)(6) 2006 and (b)(6) 2007 were not provided.A preoperative history and physical record dated around (b)(6) 2007 states: ¿the patient is a 42-year-old lady who had resection of a benign tumor from the abdominal wall about five months ago.The resection involved removal of the rectus sheath and this was reconstructed using dual mesh patch.Postoperatively the patient developed a seroma and subsequently this became infected.Recently a ct scan was performed demonstrating gas and fluid around the mesh.The mesh measures about 2 x 3 cm and is in the suprapubic region.The patient has no septic symptoms although she does have pain surrounding the drainage wound.¿ the h & p notes from around (b)(6) 2007 provide the following abdominal exam notes: ¿soft.There is infraumbilical tenderness and trace spotty inflammation.There is a draining sinus superior to the patient's pfannenstiel incision.A q-tip is easily admitted and seropurulent exudate is present.¿ the impression states: ¿i believe the patient has infected mesh, which will require removal.I have discussed this with her.It is anticipated that her sinus tract will be excised, the mesh will be removed, and the wound will be debrided and closed over suction drains.She understands that there is a risk of infection in her wound as well as a long-term risk of developing a hernia in the postoperative period.¿ operative records dated (b)(6) 2007 indicate the patient underwent ¿removal of infected mesh, curettage and irrigation of wound, and primary closure of abdominal wall.¿ the records state: ¿the patient had gynecologic surgery about 6 months ago resulting in an abdominal wall defect, which was treated with a dual-mesh prosthesis.Unfortunately, this has become chronically infected and she presents now for mesh removal.The patient has been nontoxic, but with seropurulent drainage from a sinus which developed over her incision.¿ the (b)(6) 2007 operative notes state: ¿after the induction of satisfactory general endotracheal anesthesia, the abdomen was prepped and draped in the usual sterile fashion.The skin surrounding the sinus tract was infiltrated with 0.25% marcaine with epinephrine.An elliptical incision was used, circumcising the sinus tract and deepened to the mesh.The mesh was noted to be surrounded by unhealthy-appearing granulation tissue.The mesh was removed, paying meticulous attention to removal of each of the circumferential prolene sutures.Following this, the posterior abdominal wall was noted to have a rather tough fibrous sheath covered by unhealthy-appearing granulation tissue.This was cleared by irrigation and curettage.The cavity remaining was drained with a 7-mm jackson-pratt drain brought out through a separate stab wound.The anterior fascia had a 4 x 4-cm defect, which was closed transversely without excessive tension using interrupted figure-of-eight sutures of 0-pds.The skin was closed with interrupted inverted intradermal sutures of 4-0 biosyn placed about 2 cm apart and steri-strips.¿ 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: ¿strict aseptic techniques should be followed.If an infection develops, it should be treated aggressively.An unresolved infection may require removal of the material.¿ ¿possible adverse reactions with the use of any tissue deficiency prosthesis may include, but are not limited to, contamination, infection, inflammation, adhesion, fistula formation, seroma formation, hematoma, and recurrence.¿ w.L.Gore & associates, inc.(gore) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by gore, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Blank fields present on this report include required fields and fields determined to be not applicable.Blank required fields indicate that the information was not provided, was deemed unavailable or was not applicable.This report does not constitute an admission or a conclusion by fda, gore, or its associates that the device, gore or its associates caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects" or has "malfunctioned".These words are included in the report and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.
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Manufacturer Narrative
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H6: updated patient codes.H6: updated device codes.H6: updated conclusion codes.H6: additional conclusion codes 4316: appropriate term/code not available used for ¿withdrawn complaint¿.This claim was withdrawn, and the alleged product complaint is no longer being pursued at this time.No further investigation is required at this time.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 (1994, 3191 used for ¿open draining wound¿) were reported based on the original complaint and are no longer applicable and/or not reportable per gore¿s investigation.The following information was determined from the medical records.Medical records: the known medical records span december 18, 2006 through may 30, 2007 and not all records received in this time span are relevant to the gore® dualmesh® biomaterial.Records from december 22, 2006 through april 24, 2007 were not provided.Patient information: medical history: gravida 5, para 3, abortus 2.Celiac disease.Prior surgical procedures: 1998: cesarean section.Implant preoperative complaints: [none provided].Implant procedure: exploratory laparotomy with total abdominal hysterectomy and right salpingo-oophorectomy.Excision of fascial mass.¿dual mesh¿ closure of fascial defect.Jackson-pratt drain placement.Implant: gore® dualmesh® biomaterial (04393533/1dlcm07) 20cm x 30cm.Implant date: (b)(6) 2006 [hospitalized december 18-22, 2006].Description of hernia being treated: ¿the retractor was then removed and muscles allowed to fall to the midline.The mass and defect in the fascia was then palpated.Kochers were placed on the fascial edge and the subcutaneous tissue gradually dissected down to the mass.The mass was surrounded and eventually excised at the symphysis and extending from the right edge of the pfannenstiel to just across the midline.This left a fascial defect of about 5 cm x 3 cm at the symphysis.¿ implant size and fixation: ¿a dual mesh graft was then introduced, 10 x 20 cm size.It was trimmed down, tacked laterally underneath the fascia, over the rectus abdominus muscles, using 0 prolene interrupted about every 2 cm.Gradually, the mesh was laid flat and brought around to the other wide [sic], trimmed flat, and undermined the fascia but over the rectus abdominus muscles.The fascia was tacked down to the residual fascia at the symphysis and underneath the fascia near the umbilicus along the edge.The pfannenstiel was then closed with a 0 pds.The fascial defect was then tacked down to the underlying mesh with interrupted 0 pds at about 1 cm intervals.¿.Post-operative period: [4 days]. 12/22/06: ¿the patient is a 42 year-old woman with a long history of pelvic pain, which began after her cesarean section about 9 or 10 years ago.She had documented hemorrhoids, uterus with fibroids, menorrhagia, dyspareunia, and dysmenorrhea.In addition, she had a mass in the fascia at the right edge of the mons pubis, which was originally thought to be a keloid.¿ ¿on surgical, she was found to have an actual interfascial and subfascial mass involving both the rectus abdominus on the right slightly crossing the midline and the fascia itself.In addition to the hysterectomy, this required an excisional procedure.The resulting fascial defect was closed with a dual mesh gore-tex biomaterial laid under the fascia and the fascial defect stitched into the symphysis, laterally under the existing fascia, and just below the umbilicus.¿.Explant preoperative complaints: (b)(6) 2007: ¿the patient is a 42-year-old lady who had resection of a benign tumor from the abdominal wall about five months ago.The resection involved removal of the rectus sheath and this was reconstructed using dual mesh patch.Postoperatively the patient developed a seroma and subsequently this became infected.Recently a ct scan was performed demonstrating gas and fluid around the mesh.The mesh measures about 2 x 3 cm and is in the suprapubic region.The patient has no septic symptoms although she does have pain surrounding the drainage wound.¿ ¿there is infraumbilical tenderness and trace spotty inflammation.There is a draining sinus superior to the patient's pfannenstiel incision.A q-tip is easily admitted and seropurulent exudate is present.¿ ¿i believe the patient has infected mesh, which will require removal.I have discussed this with her.It is anticipated that her sinus tract will be excised, the mesh will be removed, and the wound will be debrided and closed over suction drains.She understands that there is a risk of infection in her wound as well as a long-term risk of developing a hernia in the postoperative period.¿.Explant procedure: removal of infected mesh, curettage and irrigation of wound, and primary closure of abdominal wall.Explant date: (b)(6) 2007 [hospitalization dates unknown].¿an elliptical incision was used, circumcising the sinus tract and deepened to the mesh.The mesh was noted to be surrounded by unhealthy-appearing granulation tissue.The mesh was removed, paying meticulous attention to removal of each of the circumferential prolene sutures.Following this, the posterior abdominal wall was noted to have a rather tough fibrous sheath covered by unhealthy-appearing granulation tissue.This was cleared by irrigation and curettage.The cavity remaining was drained with a 7-mm jackson-pratt drain brought out through a separate stab wound.The anterior fascia had a 4 x 4-cm defect, which was closed transversely without excessive tension using interrupted figure-of-eight sutures of 0-pds.¿.Conclusion: 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.¿.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.¿.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 wound management.Patient risk factors may include diabetes, smoking, age, malnutrition, immunosuppressive therapy, post-operative instruction noncompliance, and hygiene.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.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.The above inherent risks are typically detailed in standard informed consent documents.The device was not able to be returned to gore for evaluation; therefore, a direct product analysis could not be conducted.Review of the manufacturing records verified that the lot met all pre-release specifications.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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