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W. L. GORE & ASSOCIATES, INC. GORE® DUALMESH® PLUS BIOMATERIAL WITH HOLES; MESH, SURGICAL, POLYMERIC
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| Model Number 1DLMCPH03 |
| Device Problem
Insufficient Information (3190)
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| Patient Problems
Unspecified Infection (1930); No Clinical Signs, Symptoms or Conditions (4582)
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| Event Date 12/16/2003 |
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Event Type
Injury
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Event Description
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It was reported to gore that the patient underwent open incisional hernia repair on (b)(6) 2002 whereby a gore® dualmesh® plus biomaterial with holes was implanted.The complaint alleges that on (b)(6) 2003 and (b)(6) 2005, additional procedures occurred whereby the gore device was explanted.It was reported the patient alleges the following injuries: additional surgeries; adhesions; mesh removal; recurrence; bowel resection; infected mesh; seroma; abscess; wound vac; pain & suffering.Additional event specific information was not provided.
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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: exploratory laparotomy with extensive lysis of adhesions and mesh closure of the ventral hernia in the right lower quadrant.Implant: gore® dualmesh® plus biomaterial with holes ref: 1dlmcph03; lot: 01220786 implant date: (b)(6) 2002 [hospitalization (b)(6) 2002 ¿ discharge date unknown] (b)(6) 2002: duke university medical center (durham, nc).Thomas z.Hayward, m.D.Operative report.Preoperative diagnosis: small bowel obstruction.Postoperative diagnosis: small bowel obstruction with transition point at a ventral hernia from a previous appendectomy site.Anesthesia: general.Estimated blood loss: 75 cc.Indications: ¿patient is a 44-year-old african american female with diabetes and morbid obesity, four previous abdominal surgeries, who presents with an acute small bowel obstruction to an outside hospital.Ng tube decompression was tried for a period of four days, and she was transferred to our facility for definitive care.The risks, benefits, and alternatives to surgical therapy were discussed with the patient, and the patient agreed to undergo surgical therapy.¿ findings: ¿markedly dilated bowel with a clear transition point at the incarcerated ventral hernia.There was no perforation or evidence of bowel necrosis.¿ procedure: ¿the patient was taken to the operating room and was positioned, prepped, and draped in standard fashion.A midline incision was made.The dissection was carried down through the subcutaneous tissue.The abdomen was entered.Extensive lysis of adhesions requiring approximately 100-120 minutes was required in order to formally mobilize the bowel.The transition point was clearly visualized in the right lower quadrant at the previous appendectomy site.The hernia sac was removed and the bowel run from the ligament of treitz to the rectum without any other evidence of transition points.There were three serosal injuries that required oversewing with 3-0 vicryl with no bowel contamination.The hernia defect was oversewn with 0 prolenes and then, on top of this, a dual mesh, 10 x 6 cm mesh, was placed over the defect and sewn in in an intra-abdominal location.The bowel was returned to its normal anatomic position.Ng tube position was confirmed.The midline incision was then closed superiorly and inferiorly with #1 looped maxon.The patient tolerated the procedure without difficulty and was taken to the postop recovery unit in stable, satisfactory condition.I was personally present and scrubbed for the entire procedure.¿ (b)(6) 2002: duke university medical center.Implant information : gore® dualmesh® plus biomaterial with holes ref: 1dlmcph03; lot: 01220786.The records confirm gore® dualmesh® plus biomaterial with holes (ref: 1dlmcph03; lot: 01220786) was implanted during the procedure.Relevant medical information: additional surgery: ventral hernia repair with mesh and components separation.Additional surgery date: december 16, 2003 [hospitalization december 16, 2003 ¿ discharge date unknown] (b)(6) 2003: duke university medical center (durham, nc).Thomas z.Hayward, m.D.Operative report.Pre- and postoperative diagnosis: ventral hernia in morbidly obese female.Anesthesia: general.Estimated blood loss: minimal.Indications: ¿45 year old morbidly obese female s/p xlap for sbo secondary to right lower quadrant hernia from appendectomy site.The patient has now developed a midline hernia centered around the umbilicus and the patient now complains of increasing pain and occasional obstipation.A ct scan shows extensive small bowel and large bowel within the subcutaneous tissues without evidence of obstruction.The risks and benefits and alternatives to surgical therapy were discussed with the patient including a substantial risk of recurrence and increased risk of wound infection.¿ procedure: ¿the patient was brought the operating room and after initiation of anesthesia a foley and ngt were inserted and the patient was prepped and draped in standard fashion.An ioban drape was used to cover the skin in the surgical area.The previous incision in the midline centered at the umbilicus was made.The ventral hernias was identified.Extensive lysis of adhesions requiring 3 hours to complete was undertaken.At the conclusion of the lysis all contents had been reduced into the abdomen and both hernias reduced combined into one larger hernia.Additionally, the ct scan was concerning for a rlq hernia at the previous appendectomy site however the mesh was intact with about 1 cm of eventration but at least 3 cm of overlap on the interior of the abdominal wall defect.Elevation of the abdominal wall was performed with kocher clamps.A components separation technique was then performed bilaterally by incising the external oblique longitudinally and parallel to the lateral border of the rectus muscle.The external and internal oblique plains [sic] were opened.The superior portion extended up to the costal margin and the inferior portion stopped at the umbilicus.The posterior rectus sheath was also dissected off of the rectus muscles bilaterally.However, even with the component's separation technique the anterior abdominal wall couldn't be brought into opposition without extreme tension.A piece of vicryl mesh was sewn using o vicryl to the posterior abdominal wall fascia.A piece of polypropolene [sic] mesh was then sewn to the edges of both anterior abdominal fascia with overlap extending underneath the rectus muscles bilaterally at least 4 cm.Hemostasis was confirmed and the wound irrigated.Two additional 19 blake drains were placed through separate stab incisions into the subcutaneous tissues.All drains were secured with 2-0 nylons.Hemostasis was confirmed and the subcutaneous space irrigated.The subcutaneous tissue was closed in two layers with 2-0 vicryl.The skin closed with staples.Sterile dressings were applied and an abdominal binder placed.The patient was taken to the pacu in hemodynamically stable condition.I was personally present and scrubbed for the entire procedure.¿ (b)(6) 2003: duke university medical center.Implant information.Mesh, surgipro multifill ud 9 x 14 in.(b)(6) 2003: duke university medical center.Implant information.Mesh, vicryl knitted lf 12 x 12 in.(b)(6) 2003: duke university medical center.Pathology report.Diagnosis: a).¿hernia sac¿ (hernia repair): soft tissue consistent with hernia sac.B).¿belly button¿ (not specified): unremarkable skin and soft tissue.C).¿hernia cyst¿ (hernia repair): unremarkable soft tissue.Gross description: a).¿hernia sac¿ received fresh and placed in formalin.A 14 x 9 x 4.5 cm aggregate of two fragments of fibroadipose tissue is received.Each fragment exhibits a surface that is lined by a fibromembranous tissue is trabeculated and fibrotic.Sectioning exhibits fibrosis of the soft tissue with embedded suture material.Representative in a1.B).Belly button, received fresh and placed in formalin.A 4.5 x 2.5 cm roughly elliptical fragment of brown skin with a central 2 cm diameter consistent with umbilicus overlying up to 5.5 cm of subcutaneous tissue.Also in the container is a 1.5 x 0.8 x 0.4 cm fragment of brown skin.Sectioning exhibits fibrous scarring of the soft tissue with embedded suture material.Representative in b2.C)."hernia cyst, received fresh and placed in formalin.A 5.5 x 5.5 x 4 cm ovoid fragment of yellow fibroadipose tissue has a membranous surface that is trabeculated and thickened.Representative in c1.Explant procedure: excision of infected ventral hernia mesh.Excessive adhesiolysis (greater than 45 minutes).Small bowel resection.Small bowel enterotomy closure.Primary repair of ventral hernia.Explant date: (b)(6) 2005 [hospitalization: (b)(6) 2005 ¿ (b)(6) 2005] (b)(6) 2005: duke university medical center (durham, nc).Steven n.Vaslef, m.D.Operative report.Preoperative diagnosis: infected left hernia mesh.Postoperative diagnosis: infected left hernia mesh.Right lower quadrant hernia.Anesthesia: general.Estimated blood loss: 750 cc.Specimens: small bowel.Infected hernia mesh.Drains: two 19 blake drains in the inferior abdomen.Indications: ¿the patient is a 46-year-old female who is status post previous repair of ventral hernia with mesh in 2004.The patient had complaints of chronic nausea and vomiting, and was actually admitted to dr.Vaslef¿s service before surgery.The patient now presents for removal of infected mesh.The patient had a previous ct scan which demonstrated a large fluid collection in the superior abdomen overlying the mesh.This fluid collection in the superior abdomen overlying the mesh.This fluid collection was drained partially with a ct guided drain placement.The patient now presents for excision of the infected mesh.¿ procedure: ¿the patient was brought to the operating room and laid in supine position on the operating table.After induction of general anesthesia and administration of iv antibiotics, the patient's abdomen was prepped and draped in the standard surgical fashion.An elliptical incision was made over the previous vertical midline incision.The incision was made with a knife and electrocautery was used to remove the scar.Then, electrocautery was used to carry the incision down to the previous mesh.The mesh was readily identified and was incised all along its course throughout the incision.This mesh was the previous marlex mesh which had been well incorporated.Underlying this mesh, there was a piece of vicryl mesh that was not well-incorporated.The surrounding small bowel was adhered very tightly to this piece of mesh.Using careful dissection with the metzenbaum scissors, the small bowel was taken down from this piece of vicryl mesh and the incorporated marlex mesh.Great care was taken during this process to attempt to not create enterotomies.However, two enterotomies were created inadvertently in the right portion of the abdomen.Using careful dissection, the small bowel was divided freely from the overlying mesh.Then, using electrocautery the previous marlex and vicryl mesh was excised.This was done by starting first from the superior left side of the incision and moving in the clockwise direction carefully dividing the mesh from the abdominal wall.Then, the gore-tex mesh that the patient previously had in the right side of the abdomen was removed.This was done with electrocautery.Electrocautery was used to bovie around this portion of the mesh thereby removing not only the mesh, but all the associated scar tissue and leaving healthy abdominal muscle remaining.Then, attention was paid to the small bowel.The small bowel was run in its entirety from the ligament of treitz to the ileocecal valve.Adhesiolysis was also performed.This was done alternately with electrocautery and metzenbaum scissors with great care taken not to injure the small bowel.As stated before, two enterotomies were created earlier.The first enterotomy appeared to be in the jejunum.The second enterotomy appeared to be in the ileum.The second enterotomy made in the ileum was repaired in primary fashion using 3-0 silk interrupted sutures in longitudinal fashion.As we approached the second enterotomy, we noted that there was a portion of small bowel that was intimately incorporated with the mesh.In addition, the small bowel appeared thick and it did not appear obstructed.Hence, we decided that this may be directly the cause of the patient's symptoms.In addition, we decided that the risks of creating more enterotomies and injury to the small bowel in separating the mesh from the small bowel was too great.Hence, it was decided to resect this portion of small bowel and the associated jejunal enterotomy.Altogether, approximately 15 cm of small bowel was resected.The resection was done first using the blue load endo gia.After dividing the small bowel with the endo gia stapler, the associated mesentery was divided with alternate kelly clamps and 2-0 silk ties.Then, the endo gia stapler was used to create the new small bowel anastomosis.Two 2-0 silk sutures were used as anchoring stitches and after creating the new anastomosis with the endo gia stapler, the resultant bleeding was taken care of using electrocautery.We felt that our anastomosis was patent as we were able to pass the small bowel contents through the anastomosis in both directions.Our attention was then paid to closing the abdomen.First, it was noted that there was a small right lower quadrant abdominal wall defect.This defect was approximately 2 cm in diameter.This defect was closed in longitudinal direction with interrupted 1-0 prolene sutures.Next, attention was paid to closing the midline incision.First, skin flaps were raised in both directions using electrocautery.Skin flaps were raised until the abdominal incision was closed without tension.Then, the abdominal incision was closed using interrupted 1-0 prolene sutures in figure-of-eight fashion.Great care was taken during this process not to injure any of the underlying small bowel.While doing this closure, it was noted that at the inferior portion of the incision on the left side, there was a small arterial bleeding vessel.This was likely created by one of the fascial sutures.Hence, the fascia suture was removed and a figure-of-eight 2-0 prolene suture was used to close the bleeding site.Having achieved hemostasis in this fashion and having achieved hemostasis in general throughout the entire abdomen, the abdomen closure was continued using the 1-0 prolene sutures in interrupted figure-of-eight fashion.Next, hemostasis of the overlying subcutaneous tissue was achieved.Then, the subcutaneous tissue was closed using interrupted 2-0 prolene sutures.Then, the skin was closed with staples.Of note, after the abdominal fascia was closed, two 19-blake drains were created.These blake drains exited through the inferior abdomen.After the closure of the skin, a sterile dressing was applied over the skin.At the end of the case all counts were correct.¿ ¿(b)(6) 2005: duke university medical center.Rex c.Bentley, m.D.Pathology report.Diagnosis: a).¿mesh and hernia sac¿ (herniorrhaphy): surgical mesh and fibroadipose tissue with acute and chronic inflammation and foreign body reaction.B).¿small bowel¿ (resection): segment of small bowel with perforation and acute serositis.Gross examination: a."infected mesh and hernia sac" received fresh and placed in formalin is a 13.5 x 10.3 x 5.0 cm aggregate of tan-pink fibrous tissue and yellow adipose tissue which is embedded in a mesh material.Cut sections exhibits a tan-pink fibromembranous tissue.Representative sections are submitted in blocks a1-a2.B."resected small bowel", received fresh and placed in formalin is an unoriented segment of bowel (20.5 cm long x 4.3 cm in circumference) with attached mesentery at 3.4 cm.There is a full thickness defect of 3.5 x 1.5 cm.The mucosa around the defect is dusky.The full thickness defect is 7.0 cm from one margin and 8.5 cm from the other margin.There are also thick fibrous adhesions that attach one end of the bowel to the other.Block summary: b1- margin closest to the full thickness defect.B2- margin farthest from the full thickness defect.B3-b4- dusky mucosa.B5- uninvolved mucosa.Relevant medical information: (b)(6) 2005: duke university medical center.Steven n.Vaslef, m.D.Discharge summary.Hpi: the patient is a 46-year-old, african american female who presented to the emergency room on (b)(6) 2005 with abdominal pain, nausea and vomiting for approximately two days.She has a significant previous medical history for multiple small bowel obstructions following appendectomy.She has also had ventral hernia repairs in the past including 2003 when she had a ventral hernia repair with mesh placement and component separation.In 2002, she had an exploratory laparotomy for small bowel obstruction following a right lower quadrant ventral hernia repair at her old appendectomy site.In 2001, she had small -bowel obstruction secondary to incarcerated ventral hernia in the right lower quadrant.In 2001, she had a laparoscopic cholecystectomy and in 1995 she had a ruptured appendix that was removed.Pe: upon admission to the emergency room, she was alert and oriented x3.Her neurologic examination was intact with no focal deficits.Her lungs were clear to auscultation bilaterally.Her cardiovascular examination revealed regular rate and rhythm, normal s1s2.Her abdomen was distended with some tenderness on the right lower quadrant.She had no peritoneal signs.Her guaiac examination was negative.Musculoskeletal examination was normal and her pulses were palpable throughout all extremities.Hospital course: serum chemistries, coags, cbc, all of which were normal.Her gi panel was also normal.She had a kub taken in the emergency room which revealed multiple air fluid levels.She was admitted to the hospital for ct scan.She was also started on unasyn.While in-house, her ct of the abdomen revealed an anterior abdominal fluid collection adjacent to surgical mesh from her previous ventral hernia repair.This was drained percutaneously and cultures from this demonstrated streptococcal viridians as well as klebsiella pneumonia that was sensitive to unasyn.She was continued on unasyn.After the patient recovered from her percutaneous abscess drain and the acute inflammation subsided, she was taken to the or where the mesh from her previous ventral hernia was removed.Her ventral hernia was re-repaired.The patient tolerated the procedure well and postoperatively her course was not complicated.She was initially placed on bowel rest and once her bowels regained function her diet was slowly progressed.She tolerated food without incident.She continued on insulin while in-house.Her other medications included pepcid 20 mg iv q 12 h [hours], subcutaneous heparin dulcolax suppositories.Diflucan 150 mg p.O.X 1 for yeast infection.She was given oxycodone p.R.N.For pain control and this managed her pain very well.Her serum chemistries and cbc were also followed while in-house and her lab values remained very stable.Operative cultures were reportedly sent from the or; however, these cultures were never processed by the pathology lab.She was switched from iv unasyn to p.O.Augmentin for discharge purposes.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 with holes 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 with holes 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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H6: updated health effect.H6: updated investigation finding.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.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.It should be noted that the gore® dualmesh® plus biomaterial with holes 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 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 persistent/symptomatic seroma and wound management.Patient risk factors may include diabetes, smoking, age, malnutrition, immunosuppressive therapy, post-operative instruction noncompliance, and hygiene.The instructions for use further warn: ¿when using this device as a permanent implant and exposure occurs, treat to avoid contamination, or device removal may be necessary.¿ as with any surgical procedure, there are always risks of complications for surgical repair of hernias and soft tissue deficiencies, with or without mesh.These may include but are not limited to, adhesions and related harms, bleeding, bowel obstruction, compromised device biocompatibility, contamination which may lead to patient harms, device damage, dysphagia, erosion or extrusion and related harms, exposure or protrusion and related harms, fever, fistula, gerd recurrence, defect recurrence and related harms, ileus, increased procedure time and related harms, irritation or inflammation, infection, mesh migration, mesh contraction, pain, paresthesia, perforation, revision/re-intervention, seroma or hematoma and related harms, tissue ischemia, wound complications and wound dehiscence and additional intervention including surgery.Many of the potential complications are associated with the patient¿s underlying disease progression, co-morbidities, additional medical history and/or other surgical procedures.The above inherent risks are typically detailed in standard informed consent documents.The device was not able to be returned to gore for evaluation; therefore, a direct product analysis could not be conducted.Review of the manufacturing and sterilization records verified that the lot met all pre-release specifications.C1: the plus antimicrobial product coating contains silver carbonate [approximately 800 micrograms per cubic centimeter of product (g/cm3)], and chlorhexidine diacetate [approximately 1600 micrograms per cubic centimeter of product (g/cm3)].W.L.Gore & associates, inc.(gore) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by gore, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Blank fields present on this report include required fields and fields determined to be not applicable.Blank required fields indicate that the information was not provided, was deemed unavailable or was not applicable.This report does not constitute an admission or a conclusion by fda, gore, or its associates that the device, gore or its associates caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects" or has "malfunctioned".These words are included in the report and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.
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Manufacturer Narrative
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H6: conclusion code remains unchanged.It should be noted that the gore® dualmesh® plus biomaterial with holes 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 with holes 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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