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W. L. GORE & ASSOCIATES, INC. GORE® DUALMESH® PLUS BIOMATERIAL; MESH, SURGICAL, POLYMERIC
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| Model Number 1DLMCP06 |
| 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 05/27/2010 |
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Event Type
Injury
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Manufacturer Narrative
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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)].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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Event Description
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It was reported to gore that the patient underwent open ventral hernia repair on (b)(6) 2008 whereby a gore® dualmesh® plus biomaterial was implanted.The complaint alleges that on (b)(6) 2010, an additional procedure occurred whereby the gore device was explanted.It was reported the patient alleges the following injuries: dense adhesions, infection, mesh removal, migration, abdominal pain, nausea, vomiting, bowel obstruction, pain and suffering.Additional event specific information was not provided.
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Manufacturer Narrative
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B7: added medical history.H6: conclusion code remains unchanged.H10/11: added medical record information.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: (b)(6) hospital.(b)(6), md.Preoperative diagnosis: abdominal pain, chronic cholecystitis with cholelithiasis.Implant procedure: diagnostic laparoscopy, lysis of adhesions, laparoscopic cholecystectomy and ventral hernia repair with mesh.[implant: gore® dualmesh® plus biomaterial, 1dlmcp06/05427096, 18cm x 24cm x 1mm thick.] implant date: (b)(6), 2008 [alleged implant date (b)(6), 2008.] [hospitalization dates (b)(6), 2008 ¿ discharge date was not provided.] ¿ (b)(6) 2008: (b)(6) hospital.(b)(6), md.Operative report.Assistant: ¿tech.¿ postoperative diagnosis: abdominal pain, chronic cholecystitis and cholelithiasis, with intraabdominal adhesions and incarcerated recurrent ventral incisional hernia.Anesthesia: general.Estimated blood loss: less than 200 ml.Specimen: gallbladder.Complications: none.¿ wound classification: not provided.¿ findings: ¿dense intraabdominal adhesions, thick-walled gallbladder, recurrent incarcerated ventral incisional hernia containing omentum.¿ ¿ procedure: ¿with the patient in the supine position and the abdomen widely prepped and draped in the usual aseptic fashion after adequate general anesthesia had been obtained the procedure was begun.A stab incision was created in the left upper quadrant.A veress needle was introduced into the abdomen atraumatically and insufflation achieved with carbon dioxide at 15 mmhg.A 5-mm trocar was advanced into the abdomen atraumatically and laparoscopic exploration carried out.Dense omental adhesions were noted to the midline abdominal incision and in the periumbilical region, as well as inferiorly.An 11-mm trocar was placed along the anterior axillary line in the left lower quadrant and a 5-mm trocar was placed caudad to this.This allowed gentle traction on the adhesions, which were then lysed with the endoshears and the harmonic scalpel where indicated.As all adhesions were taken down it was noted that some of the omentum was incarcerated within at least 3 ventral incisional hernia defects.These were recurrent hernias as the patient had a piece of mesh present on the abdominal wall already.Once all adhesions were taken down this allowed placement of an 11-mm trocar in the supraumbilical position, an 11-mm trocar in the epigastrium, and two 5-mm trocars in the right upper quadrant.Attention was directed to the gallbladder.The patient was placed in steep reverse trendelenburg and left lateral tilt position.Of note was a liver fracture just to the right of the falciform ligament of unclear etiology.This likely was a traction fracture after the fundus of the gallbladder had been grasped, but again this fracture was not witnessed.Either way, cautery was utilized in the fracture to effect hemostasis and a large piece of surgicel was placed within the fracture for additional hemostasis.The area was irrigated and all fluid aspirated free.Attention was then directed further to the gallbladder.The fundus was grasped and elevated over the liver edge.The hartmann's area was grasped and retracted inferolaterally.Dissection of the triangle exposed a very fatty triangle.The tissue was peeled away, exposing a cystic duct which was skeletonized, clipped, and divided.The artery was likewise clipped and divided.The gallbladder was then elevated out of the liver bed with a combination of blunt and sharp dissection.Electrocautery was used as indicated for hemostasis.The gallbladder was placed in a bag and brought out through the epigastric trocar site.The trocar was replaced.Copious irrigation was performed.There was no evidence for active bleeding, enteric contents, or bile leakage noted postprocedure.Omentum was then placed up into the hepatic bed for additional hemostasis and toward the fractured liver and again it appeared to effect adequate hemostasis.Again all fluid was aspirated free.There was no further active bleeding identified.Thus, attention was then directed to the abdominal wall and the hernia repair.The defect was marked circumferentially on the abdominal wall with a spinal needle and a marking pen.A 5-cm margin was then obtained around the hernia defect, resulting in approximately a 17 x 19 cm patch required for coverage of this defect.A 20 x 24 cm sheet of gore-tex dual mesh plus was obtained and cut to the appropriate size as determined on the abdominal wall and marked for orientation.4-0 gore-tex sutures were placed at appropriate intervals and then the mesh was rolled and introduced into the abdomen under direct vision.It was then unrolled and oriented as to the abdominal wall.Four stab incisions with the 11-blade followed by 8 passes of the suture passer allowed parachuting of the mesh to the anterior abdominal wall to effect excellent coverage of the defects.All 4 sutures were then tied and the knots tucked subcutaneously.The mesh was then affixed to the abdominal wall at 1-cm intervals with the protack stapling device.This was done without complete insufflation to allow adequate coverage of the defect.Full insufflation was then allowed and photographs were obtained of the mesh covering the abdominal wall in excellent fashion.The left lower quadrant 11-mm trocar site was closed with a 4.3-cm ventralex patch, which was introduced laparoscopically, pulled against the abdominal wall, and tacked with a protack stapling device.This effected excellent closure of this defect.Next, all trocars were removed under direct vision and the abdomen was desufflated.The fascia at the epigastrium was closed with an #0-vicryl suture and all skin edges approximated with skin staples.All sites were then injected with a total of 60 ml of 0.5 percent marcaine with epinephrine for postoperative analgesia.Dressings were applied.The patient was then awakened from anesthesia and taken to recovery in stable condition.She tolerated the procedure well.There were no complications.¿ ¿ [date not provided]: (b)(6) hospital.Implant sticker.¿gore dualmesh® plus biomaterial¿.Site: abdomen.Catalogue #: 1dlmcp06.Lot #: 05427096.Manufacturer: w.L.Gore & associates.¿ [date not provided]: (b)(6) hospital.Implant sticker.¿bard ventralex hernia patch ¿.Partial explant preoperative complaints: ¿ (b)(6) 2010: (b)(6) hospital.(b)(6), md.History & physical.Chief complaint: ¿abdominal pain, nausea, vomiting x4 hours.¿ history of present illness: ¿this is a 47-year-old obese female patient with past medical history significant for fibromyalgia and chronic pain syndrome, who presented with complaints of abdominal pain, nausea, and vomiting x4 hours prior to presentation.The patient also had intermittent chills, nausea and vomiting.In the emergency room, a ct of the abdomen without contrast was done, which showed what was concerning for partial small bowel obstruction at the terminal ileum.The patient is being admitted for further evaluation and management and possible surgery.¿ gi [gastrointestinal]: ¿positive abdominal pain, nausea and vomiting, but no diarrhea.The patient does complain of constipation and she has not had a bowel movement in several days.¿ abdomen: ¿there is tenderness to palpation diffusely.¿ assessment: ¿abdominal pain, nausea, and vomiting.Ct of the abdomen consistent with partial small bowel obstruction with possible stricture at the terminal ileum.Constipation.¿ partial explant procedure: exploratory laparotomy, extensive lysis of adhesions, adding 60 minutes to the procedure, partial omentectomy, partial removal of shifted mesh.Partial explant date: (b)(6), 2010 [hospitalization dates (b)(6), 2010 ¿ discharge date not provided.] ¿ (b)(6) 2010: (b)(6) hospital.(b)(6), md.Operative report.Assistant: (b)(6), physicians assistant [pa].Preoperative diagnosis: persistent partial small bowel obstruction with possible stricture.Postoperative diagnosis: extensive adhesions and possible previous mesh infection with shifting of the mesh.Anesthesia: general.Specimens: ¿portion of omentum and portion of mesh.Cultures of mesh taken as well.¿ ¿ wound classification: not provided.¿ procedure: ¿this 47-year-old patient has an extensive surgical history which includes ventral hernia repairs with mesh, total abdominal hysterectomy, colon resection for diverticular disease, as well as a cholecystectomy.She has been complaining of 2-3 weeks of central cramping abdominal pain that persists, especially after eating.She has a relative constipation.However, she is chronically constipated as per her history.She does have a history of chronic pain and fibromyalgia.She was evaluated with a cat scan and found to have what is believed to be a stricture near the anterior portion or the superior portion of the previously placed mashed [sic].She remained uncomfortable after a short course of observation.Additionally plain x-rays revealed some persistence of the dilatation of small bowel.The patient was advised of her options and she just chose to have surgical therapy.Preoperatively she was advised of the possibility of organ injury, bleeding, hernia, and possible incomplete resolution of all of her symptoms.The patient was then brought to operation.The patient was placed on the operating table in supine position.General anesthesia via endotracheal tube was administered without incident.Perioperative antibiotics were given.Scds [sequential compression devices] were in place.A foley catheter was placed and an ng [nasogastric] tube was placed.The patient's abdomen was prepped and draped in usual sterile manner with betadine gel.The patient had a midline incision, and the mesh by the imaging studies appeared to be from the level of the umbilicus going towards the pubis.There did not appear to be mesh or tack in the epigastric area.The upper portion of the midline incision was reopened carefully and subcutaneous tissues were sharply dissected to the anterior abdominal wall fascia, which was then tented up and incised.Some flimsy omental adhesions were near the epigastric area and this was freed gently and very carefully and slowly we coursed and caudad towards the umbilicus.Some small bowel adhesions were noted on the inner surface of the abdominal wall and they were able to be freed.Some particularly dense adhesions of the small bowel to the mesh tacks were noted and using careful sharp dissection the small bowel was able to be released from the area of the mesh where the tacks had been placed.These were permanent tacks.The mesh was then encountered and appeared that there was some separation of the mesh from the anterior abdominal wall.Some tacks appeared had been pulled away.These were freed and a small pocket was encountered that did not contain any purulent material or fluid but it gave evidence that possibly there may have been either shifting of the mesh or possible previous infection.The pocket was opened so that the mesh could be unfurled and the excess portion of mesh was then removed so that it would not curl back in.The central portion of the mesh was very adherent to the anterior abdominal wall and this had become well incorporated within the abdominal wall.A portion of the mesh was sent for culture, although clinically it did not look like there was active infection.Again, no pus was noted.Using a slow and careful dissection, the small bowel was able to be released from the rest of the mesh and some omentum was intimately adherent to the tacks on the lateral sides of the mesh and they were able to be freed.At this point, we are [sic] able to check ng placement in the stomach which was confirmed.Additionally, the small bowel was then examined.The ligament of treitz was identified and then the small bowel was then run towards the terminal ileum.Some particularly dense adhesions of some of the loops of jejunum were encountered and some bands were crossing the abdomen at this point, and they were able to be tied off with clamps and 3-0 and 0 vicryl ties.Some of the more flimsy adhesions were able to be freed sharply.This was done in a serial manner until another very dense adhesion of the ileum, which had been bound down into the pelvis was encountered and this was then followed into the pelvis.Fortunately the band was well-developed and was able to be ligated.Then we continued to follow the small bowel, and as we came towards the pelvis and the terminal ileum, several loops of bowel had become adhesed down into the pelvis, most likely secondary to the patient's hysterectomy.This was then carefully freed using sharp and slow dissection.Having the small bowel completely freed the appendix was examined and found to be within normal limits.It was atrophic and therefore was not removed.There was no evidence of an appendolith.The cecum was identified and palpated and found to be within normal limits.Additionally the colon was able to be palpated and found to be free of any particular strictures or abnormalities grossly.The small bowel was then run again from the terminal ileum back to ligament of treitz and 1 area of serosal erosion was noted and this was taken care of with a simple suture of 3-0 pds.At this point, a stricture in particular was not noted, what is most likely seen by the ct was the overlapping of the mesh adjacent to the small bowel, which may have actually been compressing the small bowel, and therefore true stricture was not noted and a small bowel resection was not required.The bowel was viable.Having completed the extensive lysis of adhesions, the omentum was then examined and it had become frayed, as it was adhered to the mesh and had multiple windows in it with potential of internal hernias.At this point, a distal partial omentectomy was carried out with clamps and 0 vicryl ties.The omentum was sent as specimen.The mesh was then examined again and to check to see if any other areas that had become loosened that could be removed.Fortunately, the rest of the mesh was intimately adherent to the anterior abdominal wall.The pelvis and the peritoneum was irrigated until the effluent was clear.A check for hemostasis revealed that hemostasis had been achieved.It should be noted this patient's platelet count is mildly depressed at 100 and, therefore, a careful check for hemostasis was made.At this point, the wound was able to be closed.The wound was closed with interrupted figure-of-eight sutures of #1 prolene.The subcutaneous tissues were irrigated thoroughly and the skin incision was closed loosely to allow for drainage in view of generous subcutaneous tissues with widely spaced staples.The wound was cleansed and dried and dressed with dry sterile gauze dressing.The patient tolerated the procedure well.All counts were correct.The patient's condition to recovery was good.¿ ¿ (b)(6) 2010: (b)(6) hospital.(b)(6), md.Pathology report.Specimen: ¿omental biopsy.¿ pathologic diagnosis: omentum: ¿1.Benign adipose tissue.2: no significant pathologic lesion.¿ clinical information: ¿persistent partial small bowel obstruction.Gross description: ¿the specimen is labeled omentum.Received fixed in formalin are two portions of lobulated omentum tan-yellow fat measuring 9.0 x 5.0 x 1.5cm and i3.0 x 9.O x i.5cm with aggregate weight of 80gms.External surface is tan-yellow and focally hemorrhagic and has lobulated appearance.Serial sections through both portions reveal tan-yellow fatty cut surface.Gross areas of tumors or any nodular masses are not seen.Representative sections are submitted in two cassettes ¿a1¿ and ¿a2¿.¿ microscopic description: ¿microscopic examination was performed.¿ a potential relationship, if any, between the alleged injuries or complications and the gore device has not been established at this time based on available information.It should be noted that the gore® dualmesh® plus biomaterial instructions for use addresses the following adverse reactions among others: ¿possible adverse reactions with the use of any tissue deficiency prosthesis may include, but are not limited to, contamination, infection, inflammation, adhesion, fistula formation, seroma formation, hematoma, and recurrence.The gore® dualmesh® plus biomaterial instructions for use also states: ¿strict aseptic techniques should be followed.If an infection develops, it should be treated aggressively.An unresolved infection may require removal of the material.W.L.Gore & associates, inc.(gore) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by gore, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Blank fields present on this report include required fields and fields determined to be not applicable.Blank required fields indicate that the information was not provided, was deemed unavailable or was not applicable.This report does not constitute an admission or a conclusion by fda, gore, or its associates that the device, gore or its associates caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects" or has "malfunctioned".These words are included in the report and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.
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Manufacturer Narrative
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H6: updated results code.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.The gore® dualmesh® plus biomaterial instructions for use also states: ¿strict aseptic techniques should be followed.If an infection develops, it should be treated aggressively.An unresolved infection may require removal of the material.W.L.Gore & associates, inc.(gore) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by gore, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Blank fields present on this report include required fields and fields determined to be not applicable.Blank required fields indicate that the information was not provided, was deemed unavailable or was not applicable.This report does not constitute an admission or a conclusion by fda, gore, or its associates that the device, gore or its associates caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects" or has "malfunctioned".These words are included in the report and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.
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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.¿ the ifu further warns, ¿as with any implantable surgical device, strict aseptic techniques should be followed.If an infection develops, it should be treated aggressively.An unresolved infection may require removal of the device.¿ procedure and specific patient factors may contribute to or cause infection, leading to contamination, exposure, lack of incorporation and/or seeding of device.Procedure related factors may include adherence to clinical guidelines on infection risk management, contamination of device prior to or during implant, and post-operative persistent/symptomatic seroma and wound management.Patient risk factors may include diabetes, smoking, age, malnutrition, immunosuppressive therapy, post-operative instruction noncompliance, and hygiene.As with any surgical procedure, there are always risks of complications for surgical repair of hernias and soft tissue deficiencies, with or without mesh.These may include but are not limited to, adhesions and related harms, bleeding, bowel obstruction, compromised device biocompatibility, contamination which may lead to patient harms, device damage, dysphagia, erosion or extrusion and related harms, exposure or protrusion and related harms, fever, fistula, gerd recurrence, defect recurrence and related harms, ileus, increased procedure time and related harms, irritation or inflammation, infection, mesh migration, mesh contraction, pain, paresthesia, perforation, revision/re-intervention, seroma or hematoma and related harms, tissue ischemia, wound complications and wound dehiscence and additional intervention including surgery.Many of the potential complications are associated with the patient¿s underlying disease progression, co-morbidities, additional medical history and/or other surgical procedures.The above inherent risks are typically detailed in standard informed consent documents.A portion of the device was not able to be returned to gore for evaluation; therefore, a direct product analysis could not be conducted.Based upon the information received, part of the device remains in the patient and was not available for evaluation.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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