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W. L. GORE & ASSOCIATES, INC. GORE® DUALMESH® PLUS BIOMATERIAL; MESH, SURGICAL, POLYMERIC
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| Model Number 1DLMCP03 |
| 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 12/05/2012 |
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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 laparatomy incision incisional hernia repair on (b)(6) 2008 whereby a gore® dualmesh® plus biomaterial was implanted.The complaint alleges that on (b)(6) 2012, an additional procedure occurred whereby the gore device was explanted.It was reported the patient alleges the following injuries: hernia recurrence, mesh migration, adhesions and severe pain.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 preoperative complaints: (b)(6) 2008: lea regional medical center.Algimantas jecius, md.Indications: ¿mrs.Rutledge is a 54-year-old female who was found to have a symptomatic incisional hernia.With this in mind it was felt repair was indicated.¿ implant procedure: incisional herniorrhaphy with mesh repair.[implant: gore® dualmesh® plus biomaterial, 1dlmcp03/05705594, 10cm x 15cm x 1mm thick, oval] implant date: (b)(6) 2008 [same day surgery] (b)(6) 2008: lea regional medical center.Algimantas jecius, md.Operative report.Pre/post diagnosis: incisional hernia.Anesthesia: general.Blood loss: minimal.Complications: none.Wound classification: not provided.Procedure: ¿the patient was brought to the operating room and placed in the supine position.General endotracheal anesthesia was then administered by shannon allen, c.R.N.A.After adequate level of anesthesia was obtained, a foley inserted, and the anterior abdominal wall was then prepped and draped in the usual sterile fashion.Preemptive anesthesia using 0.5% marcaine with epinephrine is locally infiltrated into the skin and subcutaneous tissue, which all skin incisions sites would be made.A vertical midline incision was then made above the hernial defect.Once the skin was incised, the subcutaneous tissues were dissected and there was noted to be two supraumbilical hernia defects.Once we identified the hernia sacs, dissected around this, and identified two 6-cm facial defects with a small bridge of fascia connected the two, went ahead and liberalized this.I felt inferiorly, did not feel any other weakness in that area, with the fascia clearly identified.A 10 x 15-cm gore-tex mesh was then brought into the field, taped and sized, secured into position with short runs of 0-prolene suture in a circumferential fashion to the good fascia.A direct fascial block was then performed with 0.5% marcaine with epinephrine.The subcutaneous tissues were irrigated.The skin was reapproximated with skin staples.A sterile dressing was placed over the wound.The patient was placed in an abdominal binder.Sponge, needle, and instruments were correct at the end of the procedure.The patient tolerated the procedure well.He [sic] was extubated in the main operating room and subsequently transported in the anesthesia recovery room in satisfactory condition.Once she recovers she will be discharged home.¿ (b)(6) 2008: lea regional medical center.Implant sticker: ¿gore® dualmesh® plus biomaterial.Ref number: 1dlmcp03, lot number: 05705594.Manufacturer: w.L.Gore & associates.¿ (b)(6) 2008: lea regional medical center.Algimantas jecius, md.Discharge instructions: ¿she is to call my office today to arrange for outpatient follow up in 7-10 days.Given a prescription for norco 5/325, 1-2 p.O.[by mouth] every 4 hours, total of 30, no refills and bactrim ds 1 p.O.B.I.D.[two times per day] for 7 days.No strenuous activities or lift anything greater than 15 pounds for 6 weeks.No driving until pain-free and off narcotics.Told to keep the area dry for 48 hours.Remove her bandage in 48 hours.Wear abdominal binder at all times.¿ explant preoperative complaints: (b)(6) 2012: skyridge medical center.Janet coombs, md.Indications: ¿the patient is a 58-year-old female who had some previous surgeries in new mexico, one for colon cancer and the other for ventral hernia.She said she had noticed for 4 or 6 months bulging of her abdomen.Then, in the last 4 or 5 days, she felt abdominal discomfort, increased distention and had diarrhea.She really did not complain of vomiting, but she is status post hiatal hernia repair.She came to emergency room because of her pain, and a ct scan shows there is bowel that appeared to be an incarcerated hernias at several points of the abdomen and thought it was suspicious for the loss of domain with mesh no longer adherent to her fascia.There was inflammation and fluid around some of the bowel loops indicating bowel compromise, so she is brought to the operating room for exploration.¿ explant procedure: exploratory laparotomy with removal of old mesh and repair of large ventral hernia with bilateral component separation technique.[implant: ultrapro} explant date: (b)(6) 2012 [hospitalization dates unknown].(b)(6) 2012: skyridge medical center.Janet coombs, md.Operative report.Preoperative diagnosis: incarcerated recurrent ventral incisional hernia.Postoperative diagnosis: incarcerated recurrent ventral incisional hernia, also with migration of previous mesh.Anesthesia: general.Wound classification: not provided.Findings: ¿she did have edema and in her subcutaneous issue around the hernia sac, and the hernia was incarcerated, and there were adhesions.Her mesh had actually migrated to where it was not adherent to mesh at all caudally.The fact that caudal portion had actually become adherent down in the abdomen stuck to some bowel loops.I did remove the old mesh.Then, her abdominal wall musculature was too far separated to close.She does have copd and is a smoker and i thought her recurrence risk was high, so i felt like the needed to have mesh repair.I used a 30 x 30 cm piece of ultrapro permanent mesh and placing it in a preperitoneal position after bilateral component separation by taking down the posterior rectus fascia and entering the preperitoneal space lateral on each side.¿ procedure: ¿the patient was brought to the operating room.After induction of general anesthesia, a foley catheter was placed.She was positioned with both arms out.The abdomen was prepped from above the xiphoid to the pubis with chloraprep and draped into a sterile field.A midline incision was made with a knife.I then used blunt and knife and some cautery dissection to dissect down through the subcutaneous fat.I did reach well-developed hernia sac, and there was actually some edema in the subcutaneous fat around the hernia sac.She actually had hernia defect both cephalad and caudal to a piece of mesh that was sort of still adherent in the middle portion of her abdominal defect.It appeared to be a piece of gore-tex mesh that was sutured with a permanent prolene suture.I did identify hernia and could dissect around it at a couple of spots cephalad and caudally, but it was very difficult [sic] identify what might be hernia sac versus adherent bowel.Once i did this fine, the fascial edge caudally [sic], i then carefully incised around that and dissected some of the hernia sac away from the fascia.Then, i lifted up the sac and held it with hemostats and opened the sac with scissors.At that point then, i could stick a finger and feel the areas where the bowel was free from the abdominal wall.I then could open the abdominal incision, and i did resect some of the hernia sac at this point.It appeared the rectus fascial edges were far apart from each other, especially caudally and in the middle of the wound.Then, as i began going cephalad, i ran into the gore-tex mesh.The mesh had bowel adherent to it in the middle, and i took the bowel and omentum down off the mesh carefully with sharp dissection.There was some inflammatory reaction at one point of the bowel, but i did not find any perforation.I have continued to tediously work the bowel off the mesh and work the mesh off the fascial edge which was a little bit difficult to identify.Eventually, i did get the piece of mesh removed and sent to pathology.Then, i decided to run the bowel to assess it, and i ran it from the ligament of treitz down.There were adhesions in several spots, and i took those off.A lot of adhesions were to the right lower quadrant where she had a colon resection.I ran the bowel until i reached anastomosis of an ileum to what appeared to be transverse colon.I did not see any bowel injury.I laid the bowel back into the abdomen with the omentum over it.Next, i began to examine how i could close her large hernia defect.Her rectus muscles were much too far apart to close them primarily.I decided to do a bilateral component separation.I identified the rectus muscle by palpation as there was still hernia sac in the midline.Once i could identify the edge of the rectus fascia, i opened it just lateral to the midline on the patient¿s left side and then, i could identify that i was in the correct plane posterior to the rectus muscle but anterior to the rectus fascia.I began cephalad and was able to create a posterior rectus sheath mobilization.When i got laterally, then entered the plane that was preperitoneal.This plane was entered and then, i could do mostly blunt dissection all the way to her iliac bone.I then went cephalad trying to stay in the same plane.It was a little difficult to identify as i went cephalad because some of her rectus muscle and fascia had been violated from a previous hernia repair and hernia opening.I took sometime to do the left component separation.I tried to separate it all the way posterior as far as i could reach.Then cephalad, i actually i [sic] dissected over the ribs during the component separation.In a similar manner, i did component separation on the right.There were some adhesions of omentum in the right abdomen especially, and i had to take those down.At this point then, i did have a posterior rectus fascia although some of it had torn.I checked one more time to be sure i had to open the preperitoneal space as far as i could laterally and going on the even posterior.I then reapproximated the posterior rectus fascia with some difficulty.I used interrupted 0 prolene.Some of the fascia was not a very good shape, but i was able to close most of it.Where some of the component separation had been done more lateral, there were a few holes, and i attempted to close those.I made sure that there was no bowel exposed in the small open areas of the posterior layer and then omentum covered any in those openings.This gave me a closure of a posterior layer in the midline.I then selected a 30 x 30 cm piece of ultrapro mesh to place in this preperitoneal space.I anchored the mesh through the skin and abdominal wall by taking the suture passer and used 0 prolene suture to go through the abdominal wall and through the mesh and pull it up taut on the right side.I used 3 sutures on that side.Then, i tried to pull the mesh for a fairly taut closure of the mesh and anchored the mesh through the abdominal wall using the closure kit suture passer on the left side.I had placed the piece of mesh in a diamond pattern.I then secured the mesh to a couple of places at the ribs and a couple of places caudally using 0 prolene stitch.Then, the anterior rectus fascia was closed over the mesh.I did take out some of the hernia sac anteriorly from the subcutaneous tissue to try to minimize the amount of fluid production in the wound.I was able to close the anterior rectus fascia after the component separation and placement of mesh which had been placed with tension.Once the anterior rectus fascial layer was closed, then the skin was closed with staples.Sterile gauze dressing was applied.Small points where i had passed the suture passer were closed with steri-strips.Gauze dressing was applied and then abdominal binder.This completed the procedure which the patient tolerated well.Because she has copd and is a chronic pain patient, i decided to leave her on the ventilator at least overnight.She was taken to the icu [intensive care unit] in satisfactory condition.Estimated blood loss of 400 cc.¿ pathology: 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.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 a legal admission by anyone that the product described in this report has any defects or has malfunctioned, as defined from a legal standpoint.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 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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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 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.The instructions for use further state: ¿cutting gore® dualmesh® plus biomaterial to the proper size is essential.Use sharp surgical instruments to trim the mesh.If gore® dualmesh® plus biomaterial is cut too small, excessive tension may be placed on the suture line, which may result in recurrence of the original, or development of an adjacent, tissue defect.¿ the instructions for use further includes a precaution which states, ¿ensure the size of the device is adequate for the intended repair.¿ 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, 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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