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| Device Problem
Insufficient Information (3190)
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| Patient Problems
Unspecified Infection (1930); Obstruction/Occlusion (2422); No Clinical Signs, Symptoms or Conditions (4582)
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| Event Date 07/15/2005 |
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Event Type
Injury
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Manufacturer Narrative
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(b)(4)- product identification records for the alleged gore device were not provided.Therefore, a review of the manufacturing records could not be performed.It should be noted that the gore® dualmesh® 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® 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 ventral hernia repair on (b)(6) 2003 whereby a gore® dualmesh® biomaterial was implanted.The complaint alleges that on (b)(6) 2005, (b)(6) 2007 and (b)(6) 2009, additional procedures occurred whereby the gore device was explanted.It was reported the patient alleges the following injuries: bowel obstructions, bowel perforation, infection, recurrences, dense adhesions, removal of mesh, and 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 procedure: diagnostic laparoscopy, lysis of adhesions, repair of incarcerated ventral hernia.Implant: [ni] [ni, 15 x 19 cm].Implant date: (b)(6) 2003 (hospitalization ni).On (b)(6) 2003: (b)(6) center.(b)(6), md.Operative report.Assistant: (b)(6), md.Preoperative diagnosis: small bowel obstruction secondary to incarcerated ventral hernia.Postoperative diagnosis: small bowel obstruction secondary to incarcerated ventral hernia.Anesthesia: general with endotracheal tube.Indications: the patient is a fifty-five-year-old woman who presented with a couple of days of nausea and vomiting.She developed abdominal pain earlier in the day and presented to the emergency department.She is morbidly obese.Because of the difficulty with physical examination, the patient underwent a ct scan of the abdomen.Ct scan demonstrated multiple loops of bowel extending into an abdominal defect.Proximal to this the small bowel was significantly dilated with what appeared to be fecalization.Because of her medical problems and the concern that should this persist that she may develop ischemia of the small bowel, she was taken promptly to the operating room.Description of procedure: ¿after informed consent was obtained, the patient was brought to the operating room.She was placed on the table in supine position.After appropriate monitors were placed, general anesthesia was induced.She had been given antibiotics preoperatively and sequential compression devices were placed on the legs.The abdomen was then prepped and draped in the usual sterile fashion.A small incision was made in the left upper quadrant.Blunt dissection was used to expose the anterior rectus fascia.A 5 mm optiview trocar was then inserted into the abdomen and pneumoperitoneum was established to 15 mmhg.The laparoscope was then inserted which showed a number of omental adhesions to the anterior abdominal wall.Two additional trocars were placed; both of these were 5 mm.One was in the sub-xiphoid position and one was in the right upper quadrant just inferior to the patient¿s previous open cholecystectomy incision.The adhesions were taken down using sharp dissection with a small amount of electrocautery.Care was taken to avoid electrical injury to any adjacent structures.Once this was done, there was a large amount of small bowel extending up into a very tight ventral abdominal wall hernia.There was a dense, thickened, inflamed sac containing this.Dissection around this was extremely tedious, while ultimately all of the small bowel was able to be reduced into the abdomen.This portion of the operation took almost three hours.Having accomplished this, the bowel was inspected.There was one small tear in what was felt to be a peritoneal peel on top of the bowel, but since the serosal injury could not be ruled out this was closed in a lembert fashion with #3-0 silk in an intracorporeal fashion.The remainder of the small bowel was viable and without injury.Repair of the hernia was undertaken using a 15 x 19 cm piece of gore-tex dual mesh.Six sutures of cv-0 gore-tex material were pre-placed circumferentially around the mesh.The mesh was then rolled up and inserted into the abdomen.Once inside, it was unfurled and an endo-close device used to bring the sutures through the anterior abdominal wall.Once all of these had been brought through, each of the sutures was tied down, anchoring the mesh in place.The overlap averaged probably 5 cm around the defect.In between the anchoring sutures and to smooth out the application of the mesh, a protac device was used to put spiral tacks.Once this had been performed, there was a smooth application of the mesh to the anterior abdominal wall.Each of the trocars was then removed and the abdomen allowed to desufflate.The left upper quadrant trocar had been replaced to 12 mm to allow the introduction of the mesh and the fascia in this site was closed using #0 vicryl suture in a figure-of-eight fashion.0.5% marcaine was then infiltrated into the skin and subcutaneous tissues at each of the incisions, which were then closed with #4-0 vicryl in a running fashion.A sterile dressing of mastisol and steri-strips was placed over each of the incisions as well as the six stab sites for the anchoring sutures.The patient tolerated the procedure without difficulty.She was extubated in the operating room and brought to recovery in stable condition.¿ product identification records for the alleged ¿gore-tex dual mesh¿ were not provided.Relevant medical information: on (b)(6) 2005: (b)(6) medical center.(b)(6), md.Operative report.Assistant: (b)(6).Preoperative diagnosis: incarcerated incisional hernia and umbilical hernia.Postoperative diagnosis: strangulated incisional hernia with a few-centimeter segment of gangrenous small bowel and umbilical hernia.Operation: laparoscopic repair of strangulated incisional hernia with laparoscopically assisted small bowel resection and umbilical hernia repair.Anesthesia: general by (b)(6), md.Indications: ms.(b)(6) is a 57-year-old morbidly obese female who underwent incarcerated hernia repair about 2 years ago.A few months ago she noticed a small protuberance in her lower abdomen and pannus.The night prior to surgery, she presented to the emergency department with nausea and vomiting.Physical exam was limited due to her morbid obesity.She had a normal white blood cell count and normal electrolytes.A computed tomography scan was performed that showed loops of small bowel going up into a hernia and that she was obstructed proximal to this.A gastrostomy tube was placed and she had marked improvement in her symptoms.She was aggressively hydrated overnight and brought to the operating room urgently for repair.Procedure: ¿after informed consent was obtained, the patient was taken to the operating room and was placed on the table in a supine position.After placement of appropriate monitors, general anesthesia was induced.Under sterile conditions a foley catheter was placed.The abdomen was then prepped and draped sterilely.Marcaine 0.5% was infiltrated into the skin, subcutaneous tissue and preperitoneal space prior to each of the incisions.A 5-millimeter optiview trocar was inserted under the left costal margin after a small incision had been made.Pneumoperitoneum was then established to 15 millimeters of mercury.A laparoscope was inserted confirming no visceral injury.There were a few adhesions between the omentum and the anterior abdominal wall.Immediate seen was a loop of small bowel going into a hernia just inferior to her previous repair.This likely was from tearing of the muscle from one of the anchoring sutures.Two additional trocars were then placed.Each of these was 5-millimeter.One was in the left mid abdomen and the other was in the epigastric region.Though tedious, with slow gentle traction ultimately the incarcerated loop was able to be reduced.One portion of this was black.It was watched for a reasonable amount of time.Some of the bowel that was in the hernia pinked up though there continued to be a region appearing gangrenous.For that reason, a limited laparotomy was made at the umbilicus.Additionally, there was an umbilical hernia there.The fascia was opened approximately 5 centimeters.A protractor was used for retraction as well as a wound protector.The small bowel was eviscerated and the gangrenous segment was resected.Then 3-0 vicryl stay sutures were placed between the proximal and distal segments.Enterotomies were created on either side and a 55-millimeter linear stapler was fired to create an anastomosis.A ta60 stapler was then used to close the enterotomy and staple off the resection.The mesentery for this loop of small bowel was taken between kelly clamps and ligated with 2-0 vicryl ties completing the resection.Then 3-0 silk sutures were used to lembert the anastomosis and the anastomosis was dropped back into the abdomen.The wound was irrigated and the fascia reapproximated with a #1 pds in a running fashion.A piece of alloderm 6 x 12 centimeters was used to repair the defect and 6 pds sutures were preplaced and the mesh put into the abdomen prior to fascial closure.Pneumoperitoneum was then re-established.Each of the anchoring sutures were brought through the full thickness of the abdominal wall with a very smooth application of the mesh to the anterior abdominal wall.Spiral tacks were then placed circumferentially to smooth the mesh to the fascia.With a good application of the mesh, the abdomen was allowed to deflate.Each of the trocars was removed.The skin incisions were all closed with a 4-0 monocryl in a subcuticular fashion.A sterile dressing of mastisol and steri-strips was then applied.The patient tolerated the procedure without difficulty, was extubated in the operating room and brought to recovery in stable condition.¿ explant procedure: diagnostic laparoscopy, adhesiolysis, removal of old dualmesh, repair of multiple incisional hernias with 7 x 9 inch composix ex mesh.Explant date: (b)(6) 2007 (hospitalization ni).On (b)(6) 2007: (b)(6) medical center.(b)(6), md.Operative report.Preoperative diagnosis: incarcerated incisional hernia.Postoperative diagnosis: three incisional hernias, recurrent.Anesthesia: general.Indications: ms.(b)(6) is a 58-year-old morbidly obese woman who has undergone multiple previous surgeries.Her most recent was a strangulated hernia repair related to a recurrence of an incisional hernia.After the small bowel was resected, her fascia was closed primarily and reinforced using alloderm.She presents to the hospital with signs and symptoms of bowel obstruction.On imaging studies, a ct shows recurrence both above and below her previous dualmesh repair, as well as a small incisional hernia at the level of her subcostal incision from cholecystectomy.She, therefore, is brought to the operating room for adhesiolysis and repair.Description of procedure: ¿after informed consent was obtained, the patient was brought to the operating room.She was placed on the table in the supine position.After appropriate monitors were placed, general anesthesia was induced.She already had a foley catheter and nasogastric tube and these were left in place.She received 2 gm of ancef intravenously for prophylaxis.The abdomen was then prepped and draped sterilely.A small incision was made under the left costal margin and a 5 mm optiview trocar and laparoscope were inserted into the abdomen under direct vision.Pneumoperitoneum was then established to 15 mmhg.A laparoscope was inserted, confirming the no visceral injury had occurred.Immediately seen was then old lower midline dualmesh, both inferior and superior to that were hernia defects.There were a couple loops of small bowel adherent to adhesive bands that appeared to have twisted around that.Once the bands were lysed, all the small bowel was able to be pulled out of the hernias which no longer appeared obstructing.There was some incarcerated omentum in the cholecystectomy incision and this was able to be reduced without difficulty as well.A total of three trocars were used, a 5 mm left midabdomen, a 5 mm left lower quadrant and the first trocar was exchanged for a 12 mm trocar.After all the adhesions had been lysed, the majority of the previous dualmesh was ripped off the abdominal wall using blunt dissection and an electrocautery and was sent off to pathology.In order to provide sufficient overlap for each of the hernias, a 7 x 9 inch composix ex mesh was chosen for the repair.Six anchoring sutures of cv0 were preplaced.The mesh was then rolled up and inserted into the abdomen.Each of the anchoring sutures was pulled through the full thickness of the abdominal wall.The size of the mesh allowed for a 3 cm overlap at the level of the pubic bone and approximately 6 cm overlap for each of the other hernias.Once each of the anchoring sutures was pulled down there was an excellent application of the mesh.Spiral tacks were then placed at 1 cm intervals circumferentially around the mesh and at about 3-4 cm intervals in an inner layer.There was no evidence of any bleeding.The 12 mm trocar was then removed.The fascia was reapproximated with a 0-0 vicryl suture placed using the endo-close device, which was airtight.The abdomen was then allowed to deflate and all the trocars removed.Each of the skin incisions was closed with a 4-0 monocryl in a subcuticular fashion.A sterile dressing of mastisol and steri-strips was then applied.The patient tolerated the procedure without difficulty.All counts were correct at the end of the case.As the operative surgeon i was present for the entire procedure.¿ relevant medical information: on (b)(6) 2009: (b)(6) medical center.(b)(6), md.Operative report.Assistant: (b)(6).Preoperative diagnosis: recurrent incisional hernia.Postoperative diagnosis: recurrent incisional hernia.Procedures performed: diagnostic laparoscopy.Extensive adhesiolysis.Recurrent incision hernia repair with 12 cm pco parietex mesh.Placement of on-q pump.Anesthesia: general by (b)(6), crna.Indications: the patient is a 60-year-old woman who has presented multiple times with incisional hernias over the years.Some of these have been frankly strangulated and were initially repaired with alloderm in a bridging fashion.This obviously recurred, and she was then repaired with a synthetic mesh.Most recently, it had failed in the left lower quadrant where it seemed one of the anchoring sutures had pulled away.She is morbidly obese and has had difficulty with healing in the past.Nonetheless, she had presented with brief incarceration and a small bowel obstruction related to this recurrence.Fortunately, she was able to be reduced and approve an elective outpatient procedure.She is here to have that done today.Description of procedure: ¿after informed consent was obtained, she was brought to the operating room.She was placed on the table in the supine position.After appropriate monitors were placed, general anesthesia was induced.She received 1 gram of ancef intravenously for prophylaxis, and sequential compression devices were placed on the legs.A foley catheter was then placed to decompress the bladder.The abdomen was then prepped and draped sterilely.Marcaine 0.5% was infiltrated into the skin and subcutaneous tissue prior to each of the incisions.A small incision was made under the left costal margin.A 5 mm optiview trocar and laparoscope were inserted into the abdomen under direct vision.Pneumoperitoneum was then established to 15 mmhg.A laparoscope was inserted confirming that no visceral injury had occurred, and a brief exploration was undertaken.She had a number of omental adhesions in the mid to upper abdomen.There were a few loops of small bowel that were adherent to the mesh in the lower abdomen, although these were fairly see through.In the left lower quadrant, there was an approximately 2 cm fascial defect in the region where 1 of the anchoring sutures had been placed which seemed like it had acutely torn and pulled through, leaving a fascial defect.Two 5 mm trocars were then placed along the left axillary line with 1 in the left lower quadrant and 1 in the left midabdomen.Using sharp scissor dissection, all of the loops of small bowel were able to easily be dissected off the anterior abdominal wall and the mesh.Most of the omentum extending into the epigastrium was able to be peeled off of the previous ptfe coating to clear the entire anterior abdominal wall without injury.This was somewhat tedious although was able to be performed without concern of injury.The decision was made to primarily repair the hernia given its small size and to reinforce this with an underlay coated mesh.A 12 mm trocar was placed along the right axillary line in the area of her previous right subcostal from an open cholecystectomy and a 5 mm in the left midabdomen.An endo-stitch was used to try and take bites of the fascia.The needle broke off within the tissues and was unable to be retrieved.Given that this was only 2-3 mm in size, rather than create a significant tissue entry by trying to retrieve it, this was left within the tissues.Using another endoclose and then a #1 pds using figure-of-8, the fascial defect was repaired primarily.The ptfe coating of the mesh in this area was stripped away, yielding the underlying polypropylene.To allow for an approximately 6 cm overlap in each direction, a 12 cm round pco-coated mesh was chosen for the repair.Four anchoring sutures of cv-0 suture were preplaced.The mesh was then rolled up and inserted into the abdomen.Each of the anchoring sutures was pulled through the full thickness of the abdominal wall and tied down giving a smooth application of the mesh.Absorbable tacks were then placed at approximately 1 cm intervals around the mesh to provide further fixation and prevent small bowel from being able to get trapped between the anchoring sutures.With a good mesh repair, 2 on-q pump catheters were placed in the preperitoneal position surrounding the mesh with good effect.A 12 mm trocar was then removed.The fascia was reapproximated with a 0-vicryl suture in a figure-of-8 using an endoclose device.Each of the trocars was then removed and the abdomen allowed to deflate.Each of the skin incisions was closed with 4-0 monocryl.She tolerated the procedure without difficulty and was brought to recovery in stable condition.With the exception of the 1 endo-stitch needle, the remainder of the counts were correct.She was extubated in the operating room and brought to recovery in stable condition.As the operative surgeon, i was present for the entire procedure.¿ 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® 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® 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® 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 warn: ¿strict aseptic techniques should be followed.If an infection develops, it should be treated aggressively.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.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.After multiple requests, specific lot number information was not provided for this device, but product type has been confirmed.Review of the manufacturing and sterilization records could not be performed as a valid lot number was not provided.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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