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W. L. GORE & ASSOCIATES, INC. GORE® DUALMESH® PLUS BIOMATERIAL; MESH, SURGICAL, POLYMERIC
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| Model Number 1DLMCP04 |
| Device Problem
Insufficient Information (3190)
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| Patient Problems
Hernia (2240); No Clinical Signs, Symptoms or Conditions (4582)
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| Event Date 02/24/2010 |
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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 laparoscopic incisional hernia repair on (b)(6) 2004, (b)(6) 2007, and (b)(6) 2011 whereby gore® dualmesh® plus biomaterial devices were implanted.The complaint alleges that on (b)(6) 2010 and (b)(6) 2011, additional procedures occurred whereby the gore device was explanted.It was reported the patient alleges the following injuries: recurrence.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 #1 preoperative complaints: on (b)(6) 2004: (b)(6).Indication: ¿the patient is a 36-year-old gentleman who has undergone a previous repair of an umbilical hernia, which was done laparoscopically.He did well until several months ago when he noted some discomfort in the upper abdomen.Several weeks ago this became quite intense, doubling him over.He had been seen in the emergency room, and the cat scan demonstrated omentum to be contained in the hernia.¿ implant #1 procedure: laparoscopic repair of incarcerated incisional hernia.[implant: gore® dualmesh® plus biomaterial, 1dlmcp04/03050306, 15cm x 19cm x 1mm thick, oval] implant #1 date: (b)(6) 2004 [hospitalization dates (b)(6) 2004].On (b)(6) 2004: (b)(6).Operative report.Pre-and postoperative diagnoses: incisional hernia, incarcerated.Anesthesia: general.Wound classification: ¿i¿ [clean].Findings: ¿the patient had a defect measuring 7 x 8 cm at the upper aspect of his previous repair, which was button-holed and contained incarcerated omentum.¿ procedure: ¿the patient was placed in the supine position, and general endotracheal anesthesia was induced.Nasogastric tube and foley catheter were placed, and his abdomen was prepped and draped in the usual sterile fashion.Marcaine 0.25% with epinephrine was used to anesthetize each trocar site as they were created.A left upper quadrant incision was made, and subcutaneous tissue dissected to the muscle.The muscle was then opened using muscle-splitting technique.A blunt trocar was then placed into this wound, and carbon dioxide insufflation was achieved to a maximum of 15 mmhg pressure.Under laparoscopic control, another 10 mm trocar was placed in the left lower quadrant.The omentum was then gradually reduced using traction.Another 5 mm trocar site was placed in the left upper quadrant to ease this procedure.After reduction of all the omentum, the defect was visualized and measured.A piece of gore-tex dual mesh was then cut, measuring 15 x 19 cm, and was marked for orientation.Sutures of 2-0 vicryl were placed along each side.The mesh was then rolled.One of the 10 mm trocars was then removed, the mesh was inserted through this, and then the trocar was reinserted.The mesh was unrolled.Using a suture passer, the previously placed vicryl sutures were then brought out through the anterior abdominal wall.There was some redundancy in the mesh; therefore, the sutures were reintroduced a little bit further out in order to reduce some of the redundancy of the mesh.These sutures were tied.The mesh was then anchored to anterior abdominal wall using an origin tacker.Instruments and trocars were then removed under direct visualization.The original cut-down trocar site was closed with interrupted suture of 0 vicryl and skin was closed with staples.Betadine ointment was applied followed by dressings.He tolerated the procedure well and was taken to the recovery room awake, extubated, and in stable condition.¿ on (b)(6) 2004: (b)(6) medical center.Implant sticker: ¿dualmesh plus antimicrobial.Lot 03050306.Item: 1dlmcp04.¿ on (b)(6) 2004: (b)(6) medical center.(b)(6).Discharge summary.Final diagnoses: ¿1.Incarcerated incisional hernia.2.Postoperative ileus.3.Obesity.4.Proteinuria.¿ social history: ¿patient denies tobacco or alcohol use.¿ revision and implant #2 preoperative complaints: on (b)(6) 2007: (b)(6) medical center.(b)(6).Indications: ¿the patient is a 39-year-old male who has had a previous excision of a mass from his right posterior neck.He has had a slowly growing mass in the same location over several years which is now making it difficult for him to turn his head.The patient also has had a previous laparoscopic repair of an umbilical hernia.He has had recurrent pain in the area and cat scan confirms that he had a recurrent hernia at the level of the umbilicus.The hernia contain [sic] omentum by ct.¿ on (b)(6) 2007: (b)(6) medical center.No provider listed.History and physical.Chief complaint: ¿right neck lipoma; ventral hernia recurrence.Mr.(b)(6) is a 39-year-old gentleman who is here for followup of pain in the epigastric area.The patient states that he noticed symptoms suggestive of recurrence of hernia approximately 3 months ago.He states that this pain is a sense of fullness which progressively worsened since.He was recently seen in the emergency room on the 1st (b)(6), where he was given the diagnosis of recurrent ventral hernia.He currently denies fever or chills.Occasional nausea, no vomiting.Occasional constipation for which he is being treated with dulcolax p.O.[by mouth].He denies diarrhea.¿ review of systems: ¿this is significant for restricted rightward gaze of head secondary to a lipoma on the back of the right neck, as well as morbid obesity, hypertension, dyspnea on exertion secondary to obesity, abdominal pain, and constipation associated with ventral hernia recurrence.¿ [page 2 was not provided].Revision and implant #2: removal of right posterior neck mass, laparoscopic adhesiolysis with repair of incarcerated recurrent incisional hernia with dual mesh.[implant: gore® dualmesh® plus biomaterial, 1dlmcp04/04470347, 15cm x 19cm x 1mm thick, oval] revision and implant #2: (b)(6) 2007 [hospitalization dates unknown].On (b)(6) 2007: (b)(6) medical center.(b)(6).Operative report.Assistant: (b)(6) md.Preoperative diagnosis: ¿recurrent mass, right posterior neck; recurrent incarcerated incisional hernia.¿ anesthesia: general.Wound classification: ¿ii ¿ [clean-contaminated].Findings: ¿the patient has a well circumscribed fatty mass in the right posterior neck, which is approximately 6 to 7 cm.He also had a recurrent hernia which was just above the previous repair which contain [sic] incarcerated omentum.¿ procedure: ¿the patient was initially placed in the left lateral decubitus position.Intravenous sedation was given.His posterior neck was prepped and draped sterilely.A 0.5% marcaine with epinephrine was infiltrated along the proposed incision line which was through the old scar.A 6-cm skin incision was made and the subcutaneous tissues were dissected sharply.Using combined blunt dissection as well as sharp dissection, the lipoma was dissected free from the surrounding tissues.It was then excised and passed off the field.The wound was inspected for hemostasis which was achieved with cautery as needed.Additional anesthesia was infiltrated into the subcutaneous tissues.The wound was then closed with interrupted suture of 3-0 vicryl in the subcutaneous tissue followed by skin staples.A sterile dressing was applied.All draped were then taken down.The patient was repositioned in a supine position.General endotracheal anesthesia was then induced.A nasogastric tube and foley catheter were placed and his abdomen was prepped and draped in the sterile fashion.A 0.5% marcaine with epinephrine was used to infiltrate each incision as they were created.A previous left lateral upper abdominal incision was reopened and dissection proceeded through the subcutaneous tissue into the muscle layers.The muscle layers were spread using kelly clamps until the peritoneum was identified.The peritoneum was grasped between kelly clamps and incised with scissors.A blunt 10- to 12-mm trocar was then introduced.Carbon dioxide insufflation was achieved to a maximum of 15mmhg pressure.The laparoscope was introduced and the patient had omentum anteriorly located and attached to the anterior abdominal wall.Under direct visualization, a 5-mm trocar was placed in the left upper quadrant x2.Using combined traction with blunt dissection as well as some sharp dissection, the omentum was reduced.Hemostasis was achieved with cautery.The adhesions were very down [sic].Once the adhesions were completely taken down, i was able to visualize.The prior mesh was intact and in place except for a superior most margin.It is unclear whether this pulled loose, but this is where the patient had his hernia.The defect was marked and measured and was 7 x 10 cm.A 15 x 19 piece of dual mesh was then marked for orientation.The 0-vicryl sutures were placed on each border.The mesh was then rolled and passed through the larger trocar site after the trocar was removed.This was done with laparoscopic visualization.Once the mesh was placed into the abdomen, the trocar was repositioned.The mesh was then unrolled and oriented appropriately.Using a suture passer, the previously placed vicryls were grasped and delivered through the abdominal wall.There was some redundancy in the mesh; therefore, the sutures were repositioned until the mesh was held up against the anterior abdominal wall with any undue laxity.The sutures were then tied.Additional tacks were placed circumferentially to anchor the mesh to the anterior abdominal wall.At one point, the new mesh overlapped the old mesh.Irrigation was then performed.A 50 ml of 1% preservative-free lidocaine was placed into the peritoneal cavity as irrigation.All instruments and trocars were then removed under direct visualization.The 10- to 12-mm trocar site was closed with interrupted suture of 0 vicryl.Skin was closed with staples.Betadine ointment and sterile dressings were applied.He tolerated the procedure well and was awakened and extubated in the operating room and taken to the recovery room in stable condition.¿ on (b)(6) 2007: (b)(6) medical center.Implant sticker: ¿dualmesh plus biomaterial.Lot 04470347.Ref catalogue number: 1dlmcp04.W.L.Gore & associates.¿ partial explant preoperative complaints: on (b)(6) 2010: (b)(6) medical center.(b)(6).Indications: ¿this is a 42-year-old male who was scheduled to undergo a laparoscopic roux-en-y gastric bypass.He states he has had a previous umbilical hernia repair and he did very well on his preop diet.He was scheduled for laparoscopic bypass, possible open.¿ partial explant procedure: diagnostic laparoscopy with conversion to laparotomy, omentectomy, removal of mesh, ventral herniorrhaphy and open roux-en-y gastric bypass.Partial explant date: (b)(6) 2010 [hospitalization dates unknown].On (b)(6) 2010: (b)(6) medical center.(b)(6).Operative report.Assistant: (b)(6) pa.Preoperative diagnosis: morbid obesity and hypertension.Postoperative diagnosis: morbid obesity and hypertension with ventral hernia, severe intraabdominal adhesions.Anesthesia: general.Specimens: omentum and mesh.Wound classification: not provided procedure: ¿after all risks, complications and alternatives were explained to the patient and agreed upon, written informed consent was obtained per the patient.The patient was properly identified in the preoperative holding room.The patient was taken to the operating room and was placed in the supine position for induction of general endotracheal anesthesia.The patient was prepped and draped in a sterile fashion over the abdominal region.Then 0.5% marcaine with epinephrine was injected subcutaneously at all trocar sites.An 11 blade scalpel was used to make a right sided abdominal incision.Optiview trocar was used to gain direct access in the intraabdominal cavity.Co2 insufflation was initiated, creating a pneumoperitoneum.The laparoscope was placed in the abdomen and a few more trocars were placed on the right side after seeing that the patient had significant adhesions in his abdominal cavity.The omentum was tediously dissected down from the anterior abdominal wall.It was seen the patient had multiple gore-tex meshes overlapping each other near the other and it appeared on top of this it still had some recurrence along the periphery.Quite a bit of time was taken to dissect these adhesions down, however there were multiple loops of small bowel that was adhered to this mesh as well.After seeing this i felt like i could not adequately measure the roux limb and we would need to covert [sic] to an open procedure so at this point the trocars were removed.#10 blade was used to make a midline incision down through all layers.Electrocautery was used to dissect down to the intraabdominal cavity.The mesh was divided.The small bowel was tediously dissected down with metzenbaums from the mesh and laparotomy was completed.At this point there was significant amount of omentum that was caked onto the mesh and some of the mesh had to literally be excised from the abdominal wall.It was so tightly adherent and it was near an area of recurrence with some tacks that were partially exposed.Once i excised this mesh i then used the harmonic scalpel and removed the omentum off the transverse colon and passed this off as specimen.Next, i freed up all adhesions from the ligament of treitz to the terminal ileum with the metzenbaums and then we began the case.50 cm was measured from the ligament of treitz.The small bowel was divided at this point.Another 150 cm was measured to locate the area of the jejunal jejunostomy.At this point two enterotomies were created on both limbs.A side -to -side jejunal jejunostomy was performed with two fires.The remaining enterotomy was closed in transverse fashion with another gia-75.At this point the mesenteric defect at the jejunal jejunostomy was closed.Attention was taken to the upper abdomen.The bookwalter retractor had already been placed.The liver was retracted in a cephalad direction.The patient was placed in the standing position.The peritoneum was scored at the angle of his.Finger was used to bluntly dissect in the retrogastric fashion to the retrogastric space over to the lesser curvature of the stomach.The peritoneum and lesser curvature of the stomach was scored approximately 5 cm down from the gastroesophageal junction.A loose stapler was used to fire transversely, start the pouch and then fired up to the angle of his with further fires until the pouch was created.Staple lines were inspected and were intact.There was no persistent bleeding seen.At this point a small gastrotomy was right at the tip of the pouch and orville tube was passed per anesthesia through the mouth, pulled out and placed the anvil in place.The tube was removed.The roux limb was delivered up into the upper abdomen.An enterotomy was created in the distal end of the roux limb and a 25 mm eea was passed through the roux limb.The spikes were brought to the antimesenteric side, connected to the anvil and fired.The remaining diverticulum was removed utilizing the harmonic scalpel and the mesentery and a white stapler.At this point a bowel clamp was placed across the small bowel and placed in the upper abdomen.The endoscope was advanced transorally down the end of the pouch.There was no evidence of anastomotic leaks or bleeding.Adequate patency was seen.Next, two antitension sutures of 2-0 vicryl were used to tack the roux limb up to the gastric remnant on either side.20 ml of evicyl was placed around the anastomosis.15 french round blake drain was placed in the upper abdomen and brought out through a puncture site.At this point #1 prolene was used to close the fascia because there was some mesh still on either side of the opening.The defect ventral hernia was closed primarily with prolene suture without any significant tension.Subcutaneous tissues were copiously irrigated.The deep layers were closed with 2-0 vicryl.Skin staples were used to close the skin.All sponge and needle counts were correct.The patient was taken to the recovery room in stable condition per anesthesia.¿ on (b)(6) 2010: (b)(6) medical center.(b)(6) md.Pathology report.Tissue submitted: ¿omentum, with portion of mesh.¿ gross description: ¿received labeled ¿omentum with portion of mesh¿ is a multilobulated, yellowish-pink to yellowish-red fatty tissue consistent with an omentum.It measures 23 x 18 x 4 cm.The adipose tissue displays a 4 x 2 x 0.2 cm.Adhesed hemorrhagic mesh segment with multiple surgical sutures.The surrounding fatty tissue is somewhat hemorrhagic.There are additional areas of yellowish-tan fatty tissue with normal vascular arborization.The adipose tissue shows a single cyst 4 cm.From the mesh, measuring 1 cm.It is filled with straw-colored fluid.There are no suspicious lesions identified.Representative samples are submitted in two cassettes.¿ microscopic description: ¿the resected omental tissue shows fibrous and inflammatory changes with adhesions.I do not see acute inflammation or evidence of infection.The grossly noted cyst is an area of organized fat necrosis with cystic degeneration.A small area of calcification is present.¿ explant and implant #3 preoperative complaints: on (b)(6) 2011: (b)(6) medical center.(b)(6).Indications: ¿this 43 year old male is status post open roux en y gastric bypass.He has developed massive recurrent ventral hernia.He has had multiple ventral hernia repairs in the past with mesh placed.He was having problems with episodic incarcerations and scheduled for repair.¿ explant and implant #3 procedure: exploratory laparotomy, lysis of adhesions, repair of internal hernia, bilateral component separation with placement of biologic mesh and removal of old mesh.Panniculectomy and wound vac.[implant: alleged bio-a].Explant and implant #3 date: march 16, 2011 [hospitalization dates unknown].On (b)(6) 2011: (b)(6) medical center.(b)(6).Operative report.Assistant: (b)(6) pa.Preoperative diagnosis: recurrent ventral hernia.Postoperative diagnosis: recurrent ventral hernia, internal hernia, lipoma.Anesthesia: general.Specimens: hernia sac.Procedure: ¿after all risks, complications and alternatives were explained to the patient, agreed upon and written informed consent was obtained, the patient was properly identified in pre operative holding area.The patient was then taken to the operating room and placed in supine position.After induction of general anesthesia, the patient was prepped and draped in the usual sterile fashion in the abdominal region.The 10 blade scalpel was used to make midline incision down through his old incision and inferior to this, with cautery dissected down to subcutaneous tissues.Hernia sac was identified, opened and abdomen was entered.Laparotomy was completed in standard fashion, multiple loops of small bowel adherent up to the old laparoscopic mesh.These were tediously dissected down with sharp dissection.All the small bowel adhesions were freed.I ran the small bowel and checked for internal hernia, he did have an internal hernia at peterson space with no bowel in it.This was closed with 20 silk.There was no internal hernia defect at the jejunal jejunostomy.There was another smaller defect out laterally at an old trocar site that i would repair as well.At this point, the hernia sac was grasped with allis clamps and skin was grasped with allis clamp.Electrocautery was used to dissect the overlying subcutaneous fat off the hernia sac back to the fascial edge.The hernia sac was excised circumferentially.Large piece of old mesh that was balled up within the defect, this was excised as well.I then grasped the fascial edges, raised the subcutaneous fat off the fascia lateral to where the lateral border of the rectus muscle was.Punctured through the lateral border of the recuts muscle with hemostat to raise the external fascia mobilizing the muscles medially and raising the fascia laterally on both sides to relieve as much tension as possible.There was still a fair amount of tension bringing the fascial edges together.I had to release some of the pectoralis insertion superiorly and display some of the muscle fibers of the superior oblique muscles and added extra length.At this point, all bleeding was cauterized.One prolene was used in figure-of-eight fashion interrupted to close the midline fascia.I had to superiorly close the fascia beneath the tip of the xiphoid process where it would not close ' lout too much tension in order to close the defect appropriately.Once this was closed, two large pieces of bio a were obtained, utilizing 2-0 prolene to tack to the fascia overlying the primary repair.The wound was copiously irrigated with antibiotic irrigation with ancef.The patient was dosed with an extra dose of ancef during the surgery as well.At this point, he had significant lipoma of the abdominal wall and excessive skin as well.Utilizing marking pen, i demarcated circumferentially this area and excised probably a good 5 to 7 pounds of skin and subcutaneous fat to close down the dead space.At this point, two 19 french round blake drains were placed in subcutaneous spaces and left to rest inferiorly.Prior to closing the abdomen, i did identify the lateral defect at the old trocar site, closed with 2-0 prolene in a figure-of-eight fashion x4 both inferiorly on the peritoneal side and superiorly on the oblique side.The 2-0 vicryl was used to reapproximate the scarpa's fascia in the deep layers, leave the skin edges open.The wound was irrigated again, wound vac was placed in standard fashion with adequate suction, sealed the skin edges.All sponge and needle counts were correct.The patient was taken to the recovery room in stable condition per anesthesia.¿ implant record [was not provided].Pathology report [was not provided].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.
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Manufacturer Narrative
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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.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 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.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® 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, and recurrence.¿ medical records that indicate mesh ¿movement¿ or that the device led to a recurrence may reflect a recurrence as a function of a patient¿s poor tissue quality leading to fascial dehiscence or loss of anchorage of fixation, or may be related to the hernia type, individual patient comorbidities, and technical and procedural aspects of the repair.These factors include but are not limited to, fixation type, mesh shape/sizing used, and defect closure decisions.Additionally, a new, unrelated hernia can occur but may be referred to as a recurrent hernia.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 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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