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W. L. GORE & ASSOCIATES, INC. GORE® DUALMESH® PLUS BIOMATERIAL; MESH, SURGICAL, POLYMERIC
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| Model Number 1DLMCP05 |
| Device Problem
Insufficient Information (3190)
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| Patient Problems
Abscess (1690); Unspecified Infection (1930); Obstruction/Occlusion (2422); No Clinical Signs, Symptoms or Conditions (4582)
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| Event Date 11/22/2006 |
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Event Type
Injury
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Manufacturer Narrative
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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 laparoscopic open ventral incisional hernia repair on (b)(6) 2005 and (b)(6) 2006 whereby gore® dualmesh® biomaterial and gore® dualmesh® plus biomaterial were implanted.The complaint alleges that on (b)(6) 2006, (b)(6) 2008, and (b)(6) 2008, additional procedures occurred whereby the gore device was explanted.It was reported the patient alleges the following injuries: dense adhesions, multiple bowel obstruction, recurrences, mesh infection, abscess, mesh removal, pain and suffering.Additional event specific information was not provided.
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Manufacturer Narrative
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Additional details regarding the patient's clinical course were ascertained from a review of medical records and are as follows: relevant medical information: on (b)(6) 2005: (b)(6), md; general surgeon.Office notes.Status post nissen fundoplication by dr.(b)(6) last year.Had history of barrett¿s esophagitis for which this surgery was performed.Comes to me complaining of epigastric pain.Has a ventral incisional hernia after his surgery.History of gastroesophageal reflux disease.Weight 205 pounds.Exam: abdomen soft, has a midline scar with some evidence of hypertrophy at the scar.In the epigastric region there is a palpable underlying hernia and defect for which hernias can be seen.Also has weakness in the lower portion of the incision with a possible diastasis.Impression/plan: ventral incisional hernia.On (b)(6) 2005: (b)(6), md; general surgeon.Office notes.Underwent a colonoscopy last week.Barium swallow was done that showed no hiatal hernia and no reflux.We are going to go ahead and do egd.After that, we will go ahead and repair his ventral incisional hernia.This hernia is still causing him discomfort and pain.On (b)(6) 2015: (b)(6), md; general surgeon.Office notes.Comes back after having egd and biopsy.Pathology results are negative for h-pylori, however on egd i was able to see two or three large ulcers in the stomach.Nissen seemed to be working fine and evidence of barrett¿s is not there anymore.At this time we are going to go ahead and schedule him to undergo his ventral incisional hernia repair.I have talked to him about all the risks and benefits of this surgery including insertion of mesh and complications with wound infections, recurrence of the hernia and he understands all the risks and benefits.Implant procedure #1: duo-patch mesh repair.Implant: gore® dualmesh® biomaterial [1dlmc04/02920924] implant date #1: (b)(6) 2005 (hospitalization (b)(6) 2005) (b)(6) 2005: (b)(6).(b)(6), md.Operative report.Preoperative diagnosis: large ventral hernia from previous nissen fundoplication.Postoperative diagnosis: same.Assistant: (b)(6), md.Preoperative diagnosis: this patient underwent nissen fundoplication by me several months ago.For reasons not quite clear, i don¿t know why the midline incision has totally broken down.He was worked by dr.(b)(6) and admitted to the hospital.I saw the patient this morning and he asked me if i would do the procedure and i said that is entirely possible.Details of procedure: ¿the patient was brought to the operating room and under general anesthesia, endotracheal tube in place, the abdomen was prepped and draped.The previous midline scar was excised and the abdomen was entered and i did not see any suture material anywhere.There was a complete breakdown of a previous midline incision.Omental adhesions were all taken down and lateral edges of the fascia was exposed so that i would be able to put my sutures and anchor it to the lateral fascia.I chose the largest duo-patch and using ethibond suture, and circumferentially i put the ethibond sutures in using a reverdin needle i did my usual apron technique where using a #11 blade a smaller incision was made circumferentially and the reverdin needle was passed from above into the peritoneal cavity, the suture was picked up and returned back.This was done in a circumferential manner, after which the omentum was placed under the patch.No bowel was allowed to get into contact with the patch and the sutures were tied down and any defect that was not completely closed was sutured closed with ethibond suture.Jackson ___ [sic] was inserted on top of the mesh which was brought up through a separate stab wound and the previous incision was closed using tedious suture and skin with ethicon staples.The was infiltrated with marcaine containing dexamethasone after which the patient was returned to the recovery room in satisfactory condition.Estimated blood loss about 50 cc.The patient did satisfactorily.(b)(6) 2005: (b)(6).Implant sticker.Dualmesh biomaterial.Lot: 02920924.Item: 1dlmc04.The records confirm a gore® dualmesh® biomaterial (1dlmc04/ 02920924) was implanted during the procedure.Relevant medical information: (b)(6) 2005: (b)(6).(b)(6), md.Discharge summary.Admitted: (b)(6) 2005.Brief history: a year ago, underwent open nissen fundoplication.After that developed a large incisional hernia.At this time was scheduled to undergo elective repair of this ventral incisional hernia.Hospital course: on (b)(6) 2005 underwent ventral incisional hernia repair with mesh.Postoperatively was transferred to the floor.On (b)(6) 2005, jackson-pratt drain was taken out, and his diet was then advanced.On (b)(6) 2005, was able to tolerate regular diet.Wound looked clean, dry, and intact, and he was discharged home.Was told to keep his abdominal binder on for at least six weeks and to avoid heavy lifting.(b)(6) 2006: (b)(6), md; general surgeon.Office notes.History of recurrent ventral incisional hernia.Last incisional hernia repair was done by dr.(b)(6) in 2005; had a nissen fundoplication prior to that.Comes back with an incarcerated ventral incisional hernia that is causing some symptoms and is bothering him and at this time he wants to have this repaired.I told him the best way to repair this recurrent ventral incisional hernia is with a laparoscopic mesh.Last repair was done open with a dual mesh.We will try to do it laparoscopically with a dual mesh and not try to go through that previous incision.I am concerned because he is a truck driver and still lifts heavy weights.He has promised me that he would try not to lift weights at this time and will try to be very careful.I have also gone into detail about the facts and have told him that because this is a redo ventral incisional hernia repair that the chance of recurrence is higher.Also he needs to be careful not to do heavy lifting because despite the best surgical repair, a hernia can happen again if the patient is not careful.At this time all of the perioperative complications including possibility of injury to the bowel, injury to any hollow or solid viscus, blood vessels, infection, mesh infection, and wound infection have been discussed in detail.Being scheduled for elective surgery.History of gastrointestinal bleeding, recurrent ventral incisional hernia which is symptomatic.Does not smoke.Exam: abdomen is soft, incision hernia present at previous incisional hernia scar; nontender, incarcerated, no signs of strangulation.Impression/plan: history of recurrent incisional hernia.Has been scheduled for elective repair and has gone through full counseling and informed consent process.(b)(6) 2006: (b)(6).[signature illegible].Pre-anesthesia questionnaire.Weight 220 lbs.Open nissen fundoplication 2 yrs ago.Implant procedure #2: laparoscopic incarcerated ventral incisional hernia repair.Extensive lysis of adhesions.Implantation of mesh.Implant: gore® dualmesh® plus biomaterial [1dlmcp05/04399617; 7 x 15 cm] implant date #2: (b)(6) 2006 (same day surgery).(b)(6) 2006: (b)(6).(b)(6), md.Operative report.Preoperative diagnosis: ventral incisional hernia, incarcerated.Postoperative diagnosis: incarcerated ventral incisional hernia.Extensive adhesions.Anesthesia: general.Estimated blood loss: minimal.Complications: none.Preoperative history: please see my detailed consult note.(b)(6) is a 60-year-old gentlemen who has an incarcerated ventral incisional hernia.At this time he has been scheduled for elective surgery.The patient had a previous hernia repair done by another surgeon that was done open.At this time the patient is being scheduled to undergo a laparoscopic repair.He has undergone a complete informed consent process and has given consent to this surgery.All of the risks and benefits of this operation have been exhaustively discussed with the patient.Operation: ¿the patient was brought to the operating room.At this time he was placed on the operating room table.He underwent scd placement.Endotracheal tube was placed.The patient underwent general anesthesia.After that his abdomen was prepped and draped in standard surgical fashion.A sterile dressing was placed on his abdomen.We infiltrated some local anesthetic into his right upper quadrant.Using a veress needle i was able to enter his peritoneal cavity.We then injected some saline, indicating that the saline easily passed through the veress needle.Co2 pneumoperitoneum was then established with low flow, the high flow; looking at the abdominal pressures we had no problems and pneumoperitoneum was established.At this time i then used a #10 scalpel and in the same area as the veress needle, after taking the needle out, we made a small 10 mm horizontal incision.I the used an optiview 10-11 mm laparoscopic videocamera inserted through the port.We were able to pass through the various layers of the abdominal wall under direct vision.We then entered into the peritoneal cavity itself with the 10-11 trocar.At this time the laparoscopic videocamera was inserted.At this time a brief examination showed us that there were extensive adhesions.The entire omentum was stuck to the abdominal wall around the area where the previous mesh had been present.At this time i placed another 10 mm port in the right lower quadrant under direct cameral view, we then started with out extensive lysis of adhesions.With the help of sharp metzenbaum scissors, millimeter by millimeter i was able to dissect the extensive adhesions that were present and separate the abdominal wall from the omentum.In order to move ahead i was able to pass a little bit around this curtain of omentum that was just a cup.I the placed a left lower quadrant 5 mm laparoscopic port and left upper quadrant 10 mm laparoscopic port.The camera was the switched to the left side and we started our laparoscopic adhesiolysis from the left side of the patient¿s abdomen.The transverse colon also seemed to be stuck to the abdominal wall as we visualized during our dissection.With the help of sharp metzenbaum scissors i then slowly separated the colon from the abdominal wall.With some difficulty we were able to pull down this colon without much problem.After we did this we next identified the incarcerated hernia with omentum stuck inside the hernia.The hernia was at the edge of the mesh superiorly in the epigastric region.We then pulled the omentum down from the hernia itself and separated the hernia sac.In doing so we also realized that part of the liver was also incorporated into the hernia which was also pulled down the liver.In doing so, there was a capsular tear on the liver, but there was no obvious bleeding.Next we isolated the hernia.We were still battling the extensive adhesions.It took me more that 2 hours to take down all the adhesions.This was very slow, long process.With electric bovie cautery and sharp metzenbaum scissors we were able to take down most of the adhesions.In doing so we were able to isolate and identify the mesh and also the hernia defect that was present on the superior aspect of the mesh in the epigastric area.The next part of the operation was implantation of the mesh.We used a dual mesh 7 x 15 cm.The hernia itself was isolated and drawn on the patient¿s abdominal wall with the help of a magic marker.Individual suture positions were identified.They were 2 cm apart from the defect.We then placed 4 quadrant sutures in the mesh itself.The mesh was then rolled and placed into the peritoneal cavity through one of the laparoscopic ports.The mesh and the sutures were then unruffled inside the peritoneal cavity with the help of laparoscopic instruments.We then used a laparoscopic grasping needle and grasped the 2 edges of individual sutures and tried to pull them out.Three of the four quadrant sutures were pulled out successfully in this manner.The fourth suture inadvertently got pulled out from the mesh itself, so we had to pull this suture from the peritoneal cavity.At this time we decided to use a intracorporeal suture.Ethibond suture was passed with a needle driver through the laparoscopic port and we then took a large bite of the mesh itself with the needle and pulled the suture out.The needle was then detached from the suture and extracted from the patient¿s body.After that we again used the grasper needle and we were able to successfully pull both ends of the sutures out.In this manner the mesh was tacked with the help of 4 quadrant sutures without problems.We then individually tied these sutures down, tacking the mesh all across the hernia defect.After that we used a laparoscopic tacking stapler and stapled the edges of the mesh with the help of our protac tacker.After making sure that all areas of the mesh were covered, i should also mention that the smooth side of the mesh was facing down towards the bowel and the rough surface was attached to the abdominal wall and the hernia sac itself.After that we made sure that we had no obvious injuries.I should also mention that when we entered we also checked for any obvious bleeding or injuries to the bowel or any other structures; none were found.At this time we slowly deflated the abdominal cavity, indicating that the mesh was placed and sutured without any tension.All of the laparoscopic instruments were then taken out.Since we did not use anything larger than 10 mm and we did not use any dissecting trocars, i did not need to close the fascia.After that we closed the skin incisions with the help of staples.This operation was completed.All of the needles, instruments, and swab counts were correct.The patient tolerated this operation well.He was then extubated.He also underwent a foley catheter because the operation was longer than expected.He was then taken back to the recovery room under the care of the anesthesiologist.¿ (b)(6) 2006: (b)(6).Implant sticker.Gore dualmesh® plus biomaterial.Ref catalogue number: 1dlmcp05.Lot batch code: 04399617.W.L gore & associates.The records confirm a gore® dualmesh® plus biomaterial (1dlmcp05/ 04399617) was implanted during the procedure.Relevant medical information: (b)(6) 2006: (b)(6).Discharge instructions.Activity restrictions: lifting 10 lbs x 6 wks.
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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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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 instructions for use further states: ¿to help maintain strict asepsis during surgery, special precautions and extremely careful preoperative site preparations are necessary.When operative infection is suspected, dissection of involved tissues should be considered.Any postoperative infection should be aggressively treated at the earliest possible time.An unresolved infection may require removal of the material.¿ procedure and specific patient factors may contribute to or cause infection, leading to contamination, exposure, lack of incorporation and/or seeding of device.Procedure related factors may include adherence to clinical guidelines on infection risk management, contamination of device prior to or during implant, and post-operative persistent/symptomatic seroma and wound management.Patient risk factors may include diabetes, smoking, age, malnutrition, immunosuppressive therapy, post-operative instruction noncompliance, and hygiene.The instructions for use further state: ¿for best results, use monofilament sutures.Suture size should be determined by surgeon preference and the nature of the reconstruction.¿ 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 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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