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W. L. GORE & ASSOCIATES, INC. GORE® DUALMESH® PLUS BIOMATERIAL; MESH, SURGICAL, POLYMERIC
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| Model Number 1DLMCP08 |
| Device Problem
Insufficient Information (3190)
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| Patient Problems
Hernia (2240); No Code Available (3191)
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| Event Date 03/03/2009 |
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Event Type
Injury
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Manufacturer Narrative
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(b)(4).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.".
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Event Description
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It was reported to gore that the patient underwent laparoscopic ventral incisional hernia repair on (b)(6) 2008 and (b)(6) 2009 whereby a gore® dualmesh® plus biomaterial was implanted.The complaint alleges that on (b)(6) 2009, an additional procedure occurred whereby the gore device was explanted.It was reported the patient alleges the following injuries: lysis of adhesions, removal of mesh due to pain.Mesh had rolled up inferiorly.Approximately 5cm of inferior ptfe mesh was cleared off for mesh placement.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: (b)(6) medical center, (b)(6) md, indications: ¿this is a 43-year-old lady who previously had a laparoscopic sigmoidectomy with laparoscopic cholecystectomy.She has a ventral incisional hernia repair at her umbilical incision, as well as a port site incisional hernia in her superior port site.She has pain and wishes to have these repaired.¿ implant procedure: extensive lysis of adhesions, laparoscopic ventral hernia repair with dualmesh.Implant: gore® dualmesh® plus biomaterial ((b)(6)/1dlmcp08) 26 x 34 cm.Implant date: (b)(6) 2008 [hospitalization dates unknown].(b)(6) medical center, (b)(6) md, anesthesia: general, preop diagnosis: ventral incisional hernia, postop diagnosis: ventral incisional hernia procedure: ¿a 5 mm incision was made in the right upper quadrant and a 5 mm visiport was used to methodically go through her abdominal wall until we got into her abdominal cavity with the visiport.The gas insufflation was started and her abdomen distended nicely.We then inserted the port the remainder of the way through her abdominal wall into the abdominal cavity after we were free from any hollow or solid organs.We then placed a 5 mm port under direct guidance in her right lower quadrant.The 5 mm 30 degree scope was used for visualization.She had several omental adhesions within what appeared to be [sic] very large incisional herniae [sic].The omentum was taken down with a combination of sharp dissection and bovie cautery.We did not discover any bowel within her hernia.Careful attention was made to hemostasis.After approximately 20 to 30 minutes of lysis of adhesions, we felt comfortable that her hernia was not reduced.She had several defects.She had a defect near her umbilicus which extended superiorly with a small bridge of good fascia.She then had, as well, an inferior hernia which was smaller.She had a port site hernia at the superior port site from her previous surgery.This was very small and appeared to be incarcerated only with a small piece of preperitoneal fat.We measured her hernia defect and discovered it was going to require a piece of mesh approximately 25 cm x 22 cm.A piece of gore dualmesh was brought onto the field and cut to fit.The four corners of the mesh were sutured with ethibond suture.The mesh was then rolled up and inserted into the abdomen after the right upper quadrant port site was removed and the port site was made larger.This was done under direct visualization.Once the mesh was in the abdomen, the right upper quadrant port, which was now a 10 mm port, was replaced.The mesh was unfolded and using a gore suture passer the four corners of the mesh which had suture were then brought up through the abdominal wall and sutured through small incisions on the abdominal wall.This made the mesh quiet [sic] taut and at this point we turned our attention to tacking in the mesh.The abdominal pressure was reduced to approximately 8 operation 10 [sic].The surgical tacker was brought onto the field and the mesh was tacked along the periphery of the entire mesh.Several other tacks were used for tacking up the mesh to the abdominal wall for assurance of nonmigration.The left upper quadrant port site, which had been placed previously as a 5 mm port site, was then removed and the mesh ws placed over the port site and tacked down.At this point, we had an excellent repair with nicely tight mesh without undue tension.We desufflated the abdomen.The fascia in the right upper quadrant incision was closed with a single vicryl suture.All incisions had marcaine injected for local pain control.All incisions were closed with 4-0 monocryl interrupted subcuticular sutures.Dermabond and episeal were used for dressing.¿ relevant medical information: none provided.Partial explant #1/implant #2 preoperative complaints: (b)(6) 2009: (b)(6) medical center, (b)(6) md, indications: [the patient] ¿is a 44-year-old white female who is a patient of dr.(b)(6).The patient has previously undergone colon surgery, as well as a ventral hernia repair with ptfe mesh.The patient was seen in surgical follow-up and noted to have lower abdominal pain.Ct scan of the abdomen and pelvis was obtained showing a recurrent hernia inferior to a previously-placed mesh.¿ partial explant #1/implant #2 procedure: laparoscopic ventral hernia repair with mesh.Laparoscopic lysis adhesions.Implant: gore® dualmesh® plus biomaterial ((b)(6)/1dlmcp04) 15 x 19 cm.Partial explant #1/implant #2 date: (b)(6) 2009 [hospitalization dates unknown] (b)(6) 2009: (b)(6) medical center, (b)(6) md, assistant: (b)(6) anesthesia: general, preop diagnosis: recurrent ventral hernia, postop diagnosis: recurrent ventral hernia findings: ¿1.An approximately 3 x 4 cm defect inferior to the previously-placed ptfe mesh, moderately dense omental and small bowel adhesions to the previously-placed mesh. 2.Lysis of adhesions of approximately 45 minutes. 3.A 15 x 19 cm ptfe mesh used for repair with eight transfascial sutures. 4.Protrack/permasorb absorbable tacks used for tacking the periphery.¿ description of procedure: ¿an ioban dressing was placed.A left upper quadrant, small incision was made just subcostally.An [sic] nasogastric tube was placed prior to surgery as well.A veress needle was advanced percutaneously into the peritoneum.The abdomen was insufflated.Using optiview technique, a 5-mm port was placed in the left mid quadrant laterally.Once the port was advanced into the abdominal cavity, there was noted to be moderate dense adhesions in the midline and left upper quadrant.We were unable to see a veress needle at this time.Secondary to this, we were able to find a window to the right upper quadrant and a 5-mm trocar was placed under direct visualization in the right upper quadrant.At this time, the veress needle was identified and seen to have caused no injury and to be within the peritoneal cavity.At this time, the veress needle was removed.Two other 5-mm trocars were placed in the right lateral abdomen under direct visualization and adhesiolysis was begun with sharp dissection.There was noted to be moderately to dense omental and small bowel adhesions.A small, 3 x 4 cm defect was seen inferior to the mesh as some the mesh had rolled up inferiorly.Approximately 5 cm of inferior ptfe mesh was cleared off for mesh placement.We performed sharp adhesiolysis for approximately 45 minutes to one hour.Following adhesiolysis, the bowel was examined and there was no evidence of any bowel injury.The omentum was examined and there was no evidence of any acute bleeding.Careful inspection of the bow was performed.At this time, the hernia defect was measured.It was noted to be approximately 3 x 4 cm, and was measured using spinal needle under direct visualization.At this time, the area of the uppermost portion of the cleared off adhesions of the mesh was documented with the spinal needle.A 15 x 19 cm ptfe mesh was chosen for repair to obtain at least 4-cm overlap of the entire hernia defect.At this time, cv-0 gore-tex sutures replaced in the cardinal areas of the mesh, in the upper, lower, right and left midline of the mesh.At this time, the mesh was rolled as a scroll.The left lateral 5-mm portside was upsized to a 12 mm.A grasper was placed through the 12-mm port and the mesh graft brought to the abdominal wall into the abdominal cavity.The mesh was then unrolled.The cardinal sutures were then brought up.Initially, the superior one was brought up with the suture passer under direct visualization.The left lateral was then brought up.The mesh was then pulled taut inadequate area of inferior abdomen was found for the lower cardinal suture which was brought up using direct vision with the suture passer.Again, the sutures were brought up taught and the right lateral cardinal suture was brought up the abdominal wall.Once these sutures were pulled up the abdominal wall, the mesh was noted to be in good position with the wide overlap of the hernia defect.These sutures were tied.The lower portion of the mesh that was covering the abdominal wall was tacked on to the periphery using the permasorb absorbable tack.This was done on the inferior portion of the mesh.Where there was mesh-mesh overlap on the superior portion of the mesh, a protacker was used for tagging of the periphery.Following this, the upper cv-0 gore-tex and the lateral one broke during tying, so a #1 prolene was placed where the cv gore-tex sutures had been placed.Four more transfascial sutures were placed in between the previously placed cardinal sutures using a spinal needle and suture passer, again a #1 prolene suture was used.This was done under direct visualization.The mesh was then noted to be in good position with adequate transfascial suture fixation period to assist with mesh tacking, another 5-mm trocar was placed in the left lower quadrant under direct visualization.The upsized 12-mm trocar in the left lateral abdomen was closing suture passer with a 0 vicryl figure-of-eight suture.This was done under direct visualization.The bowel and omentum were again inspected.There was no evidence of any intraabdominal bowel injury, and no evidence of any active bleeding from the omentum.The mesh was noted to be in good position with good overlap of the hernia defect, as well as some overlap of the previously placed ptfe mesh.All 5-mm ports were removed under direct visualization without evidence of any bleeding.The abdomen was desufflated.The skin incisions were closed with 4- monocryl subcuticular stitches.Dermabond was applied to these, as well as the transfascial suture sites.¿ relevant medical information: none 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 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.H6: updated results code.Conclusion code remains unchanged.It should be noted that the gore® bio-a® tissue reinforcement 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® bio-a® tissue reinforcement 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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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.In the absence of additional information or medical records from the complainant, this event file will be closed with the information provided.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.Based upon the information received, the device remains in the patient and was not available for evaluation.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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