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Model Number 1DLMCP04 |
Device Problems
No Apparent Adverse Event (3189); Insufficient Information (3190)
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Patient Problems
Adhesion(s) (1695); Pain (1994); Not Applicable (3189)
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Event Date 08/18/2012 |
Event Type
Injury
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Manufacturer Narrative
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(b)(6).It should be noted that the gore dualmesh® plus biomaterial instructions for use includes 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.¿.
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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) 2009 whereby a gore dualmesh® plus biomaterial was implanted.The complaint alleges that on (b)(6) 2012, an additional procedure was performed whereby explant of the gore device was performed.It was reported the patient alleges the following injuries: adhesions, abdominal pain, removal of mesh.Additional event specific information was not provided.
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Manufacturer Narrative
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Conclusion code remains unchanged.Additional details regarding the patient's clinical course were ascertained from a review of medical records and are as follows: records prior to (b)(6) 2009, including details regarding the ct scan and origin of the ¿prior abdominal incisions¿ mentioned in the (b)(6) 2009 records, were not provided.Operative records dated (b)(6) 2009 indicate the patient underwent laparoscopic roux-en-y divided gastric bypass and laparoscopic ventral hernia repair with mesh.Postoperative diagnoses state: ¿1.Refractory morbid obesity with body mass index 60 6 [sic].2.Hypertension.3.Osteoarthritis.4.Degenerative joint disease.5.Multiple incarcerated incisional ventral hernias.¿ the records state the patient ¿¿is a 37-year-old patient¿seen in the office for consideration for bariatric surgery.The patient underwent complete preoperative evaluation and was felt to be a candidate for bariatric intervention given her history of refractory morbid obesity with bmi 60 6 [sic], multiple comorbid conditions, including hypertension, obstructive sleep apnea and degenerative joint disease.The patient had also had a ct scan, which revealed evidence of multiple ventral incisional hernias with incarcerated fat through prior abdominal incisions.¿ the (b)(6) 2009 operative report states: ¿a laparoscope was placed into the abdominal cavity, where extensive adhesions were noted from the patient¿s prior abdominal surgeries.Adhesiolysis within the abdominal cavity was required for placement of additional trocars.¿ ¿upon mobilization of the omentum the multiple ventral hernias were identified.These were consistent with the findings on the preoperative ct scan.The contents of the hernias were reduced in an effort to completely mobilize the omentum.¿ the operative report indicates a roux-en-y gastric bypass procedure was performed.The (b)(6) 2009 operative report states: ¿the patient was placed supine.The upper abdomen was flooded with saline and the gastrojejunostomy was immersed.Oxygen was flooded through the orogastric tube at one liter per minute with the roux limb occluded and was noted to pass readily through the anastomosis, with no evidence of a leak at the gastrojejunostomy.The upper abdomen was irrigated and suctioned clear.All operative sites were examined and hemostasis was deemed adequate in all areas.A penrose drain was placed around the gastrojejunal anastomosis, brought out through the left lateral abdominal wall incision, sutured in placed with a silk suture, and placed into a collection bag.¿ the (b)(6) 2009 operative report continues: ¿attention was then turned to the ventral hernias.Multiple defects were noted along the midline in the area of the patient's prior abdominal surgeries.On this basis it was elected to proceed with ventral hernia repair.The appropriate measurements were taken.A piece of gore-tex dualmesh was brought onto the field.The mesh was trimmed to the appropriate size and placed into the abdominal cavity, after four stay sutures of #0 vicryl were placed.In four quadrants of the mesh.The mesh was then pulled to the abdominal wall but securing the stay sutures through four small stab incisions made in the anterior abdominal cavity.The sutures were retrieved using the superior fascial closure device.These sutures were then tied snugly in order to position the mesh against the abdominal wall.A protacking device was then used circumferentially around the mesh to secure the mesh into position between the stay sutures.At the completion the mesh was noted to cover all defects appropriately and the tacks were noted to be spaced approximately 1 cm apart.The mesh appeared in good position.The operative sites were again examined.The entire abdomen was irrigated and suctioned clear.All operative sites were deemed hemostatic.The incisions were closed with running 4-0 monocryl sutures and dressed with dermabond.¿ the records confirm a gore dualmesh® plus biomaterial (1dlmcp04/06455039) was used for the ventral hernia repair.Operative records dated (b)(6) 2010 indicate the patient underwent supracervical abdominal hysterectomy, bilateral salpingo-oophorectomy, and adhesiolysis.Postoperative diagnoses state: ¿pelvic mass, consistent with fibroids, resulting in abnormal uterine bleeding, anemia, with large uterus approximately 700 g with normal appearing ovaries bilaterally.Adhesions were noted.¿ findings from the procedure state: ¿other pertinent was mesh in the upper abdomen near the site of a previous incision.This was not cut or entered in any fashion.¿ there was no mention of infection and no mention of the gore device in the records.Records between 2010 and 2012 were not provided.Operative records dated (b)(6) 2012 indicate the patient underwent ¿1.Diagnostic laparoscopy converted to open.2.Exploratory laparotomy.3.Small bowel resection.4.Removal of abdominal wall mesh.5.Remnants of g-tube gastrostomy placement.6.Central line placement.¿ postoperative diagnoses state: ¿1.Small bowel obstruction from adhesive band.2.Necrotic small bowel.¿ findings from the procedure state: ¿tight adhesive band that created a twist in the common channel just distal to the jejunojejunostomy.This created a segment of 45 cm of necrotic small bowel.¿ indications for the procedure state the patient ¿¿presented to the emergency room earlier this morning with abdominal pain.Ct scan demonstrated a small bowel obstruction.She was taken emergently to the operating room for exploratory laparotomy.¿ records regarding the aforementioned emergency room visit and ct scan taken were not provided.The (b)(6) 2012 operative report states: ¿the patient's abdomen was prepped and draped in the sterile fashion.We began with a right upper quadrant 5 mm incision.Scope was inserted under direct visualization.Carbon dioxide was insufflated and a 30-degree scope was reinserted.Examination revealed a markedly dilated necrotic black appearing loop of small bowel in the patient's left abdomen.At this point, the decision was made to convert to open.We did note the patient had small bowel adherence to the anterior abdominal wall at this site of a previous dual mesh placement.Upper midline laparotomy incision was made with the scalpel and carried down through the skin to the fascia.The fascia was divided with bovie electrocautery.The peritoneum was bluntly entered and then the incision carried through the fascia into the peritoneal cavity.We then carefully extended the incision inferiorly using metzenbaum scissors to take the adhesions of the small bowel down off of the dual mesh.There were no enterotomies made.¿ the (b)(6) 2012 records continue: ¿once all the small bowel was done, we extended the incision inferiorly to allow good exposure.A bookwalter was placed.We then began running the terminal ileum from the cecum all the way back posteriorly.We, doing this, arrived to a large dilated necrotic loop of bowel.There did not appear to be an internal hernia.Instead, there was a tight adhesive band and a loop of the common channel that herniated through this adhesive band and twisted on its own mesentery.This adhesive band was taken down.There were a couple of other adhesive bands divided as well.Once this bowel was reduced, there were no other areas of necrosis.Examination revealed that the necrotic segment was the common channel just distal to the jejunojejunostomy.The biliopancreatic limb and the roux limb all were viable.They were dilated from the bowel obstruction, but no other injuries or adhesions noted.We did examine the retro-roux space and this was closed and there was no jejunojejunostomy defect.¿ the (b)(6) 2012 operative report states: ¿at this point, we proceeded to resect the necrotic small bowel segment with blue load gia staplers x2 just distal to the jejunojejunostomy on the common channel side and then about 4 cm distal to the area that was obstructed.The mesentery was taken down using a ligasure device.Next, we brought the distal common channel up alongside the more proximal roux limb and the antimesenteric sides were sutured together with a 3-0 silk suture.Enterotomies were made with bovie electrocautery in both the roux limb and the ¿dictation cut off¿ [sic]¿.The (b)(6) 2012 operative report continues: ¿the inside of the new anastomosis was examined and there was good hemostasis.The open enterotomies were then elevated with allis clamps and a ta stapler was placed beneath these and fired, allowing closure of the anastomosis with good healthy tissue and there were open channels both proximally and distally to the anastomosis.The ta stapler fire was oversewn with 3-0 vicryl lembert sutures and the mesenteric defect that was created from the small bowel resection was closed with multiple figure of eight 3-0 silk sutures.The (b)(6) 2012 operative report states: ¿during entry into the abdomen, we did divide the dual mesh that was present.The dual mesh was excised in its entirety using bovie electrocautery as well as the protacs that were present around the edges of the mesh.Finally, we placed a gastrostomy tube in the remnant stomach on the patient's left side.A counter incision was made through her abdomen.A 20 french foley was brought through that abdominal incision and a gastrotomy made in the remnant stomach.There was some bile expressed during resection of that incision.A 2-0 pursestring suture was placed around that and the tip of the foley was placed within the remnant stomach and the pursestring suture cinched down.We then inflated the balloon with 10 ml of saline.At this point, we closed the fascia with a running o pds times two and the skin was irrigated and closed with skin staples and a sterile dressing.At the end of the case, the patient was unstable and she had pulmonary edema and had difficulty oxygenating and ventilating.She was taken in critical condition to the intensive care unit.¿ there was no mention of infection of the gore device.A potential relationship, if any, between the alleged injuries or complications and the gore device is unclear from the provided information at this time.The gore dualmesh® plus biomaterial instructions for use states regarding suturing: ¿use only nonabsorbable sutures, such as gore tex® suture, with a noncutting needle (such as taper or piercing point) of appropriate size to anchor the device.The use of absorbable sutures may lead to inadequate anchoring of gore® dualmesh® plus biomaterial to the host tissue and necessitate reoperation.For best results, use monofilament sutures.Suture size should be determined by surgeon preference and the nature of the reconstruction.¿ it should be noted that the gore dualmesh® plus biomaterial instructions for use includes 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.¿ 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 result code.Conclusion code remains unchanged.
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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: (b)(6) 2012: (b)(6) department of health certificate of death.Death at age 50 years.Place of death: (b)(6) hospital.Immediate cause: cardiopulmonary arrest, underlying cause[s]: respiratory failure, pulmonary edema secondary to aspiration, ischemic bowel, small bowel obstruction, internal hernia.Manner of death: natural.Autopsy: no.Did tobacco use contribute to death: unknown.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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Previous patient codes (1695, 1994) were reported based on the original complaint and are no longer applicable per gore¿s investigation.The investigation has been completed.Based upon gore¿s investigation 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.This event will be closed as no problem detected.The following information was determined from the medical records.Medical records: the known medical records span december 22, 2009 through august 18, 2012 and not all records received in this time span are relevant to the gore® dualmesh® plus biomaterial.Records from june 19, 2010 through august 17, 2012 were not provided.Patient information: medical history: obesity (b)(6) 2009: bmi 60.6, hypertension, obstructive sleep apnea, multiple incarcerated incisional ventral hernias.Prior surgical procedures: [none provided].Implant preoperative complaints: (b)(6) 2009: [the patient was] ¿seen in the office for consideration for bariatric surgery.The patient underwent complete preoperative evaluation and was felt to be a candidate for bariatric intervention given her history of refractory morbid obesity with bmi 60 6 [sic], multiple comorbid conditions, including hypertension, obstructive sleep apnea and degenerative joint disease.The patient had also had a ct scan, which revealed evidence of multiple ventral incisional hernias with incarcerated fat through prior abdominal incisions.¿ implant procedure: laparoscopic roux-en-y divided gastric bypass and laparoscopic ventral hernia repair with mesh.Implant: gore® dualmesh® plus biomaterial (06455039/1dlmcp04) 15 cm x 19 cm, oval.Implant date: (b)(6) 2009 [hospitalization dates unknown].Description of hernia being treated: ¿a laparoscope was placed into the abdominal cavity, where extensive adhesions were noted from the patient¿s prior abdominal surgeries.The left upper quadrant however was void of adhesions and an incision was made in this area in the midclavicular line and a 12-mm trocar was placed in this location.The camera was then switched to this area where adhesiolysis was undertaken using sharp dissection, the harmonic scalpel and blunt dissection.Adhesiolysis within the abdominal cavity was required for placement of additional trocars.Once adhesiolysis was completed, 12-mm trocars were placed in the right upper quadrant midclavicular line, midline, and left lateral abdominal wall.The omentum was elevated and split along its length to expose the transverse colon.Upon mobilization of the omentum the multiple ventral hernias were identified.These were consistent with the findings on the preoperative ct scan.The contents of the hernias were reduced in an effort to completely mobilize the omentum.¿ [the operative report indicates a roux-en-y gastric bypass procedure was performed.] ¿attention was then turned to the ventral hernias.Multiple defects were noted along the midline in the area of the patient's prior abdominal surgeries.On this basis it was elected to proceed with ventral hernia repair.The appropriate measurements were taken.A piece of gore-tex dualmesh was brought onto the field.¿ implant size and fixation: ¿the mesh was trimmed to the appropriate size and placed into the abdominal cavity, after four stay sutures of #0 vicryl were placed.In four quadrants of the mesh.The mesh was then pulled to the abdominal wall but securing the stay sutures through four small stab incisions made in the anterior abdominal cavity.The sutures were retrieved using the superior fascial closure device.These sutures were then tied snugly in order to position the mesh against the abdominal wall.A protacking device was then used circumferentially around the mesh to secure the mesh into position between the stay sutures.At the completion the mesh was noted to cover all defects appropriately and the tacks were noted to be spaced approximately 1 cm apart.The mesh appeared in good position.The operative sites were again examined.The entire abdomen was irrigated and suctioned clear.All operative sites were deemed hemostatic.The incisions were closed with running 4-0 monocryl sutures and dressed with dermabond.¿ no post-operative records were provided.Relevant medical information: (b)(6) 2010: supracervical abdominal hysterectomy, bilateral salpingo-oophorectomy and adhesiolysis. ¿a vertical skin incision was made, carried down sharply to the fascia.This was deviated slightly to the left to avoid entry into the mesh near the umbilicus.¿ ¿other pertinent was mesh in the upper abdomen near the site of a previous incision.This was not cut or entered in any fashion.¿ explant preoperative complaints: (b)(6) 2012: [the patient] ¿presented to the emergency room earlier this morning with abdominal pain.Ct scan demonstrated a small bowel obstruction.She was taken emergently to the operating room for exploratory laparotomy.¿ explant procedure: diagnostic laparoscopy converted to open.Exploratory laparotomy.Small bowel resection.Removal of abdominal wall mesh.Remnants of g-tube gastrostomy placement.Central line placement.Explant date: (b)(6) 2012 [hospitalization dates unknown].¿examination revealed a markedly dilated necrotic black appearing loop of small bowel in the patient's left abdomen.At this point, the decision was made to convert to open.We did note the patient had small bowel adherence to the anterior abdominal wall at this site of a previous dual mesh placement.Upper midline laparotomy incision was made with the scalpel and carried down through the skin to the fascia.The fascia was divided with bovie electrocautery.The peritoneum was bluntly entered and then the incision carried through the fascia into the peritoneal cavity.We then carefully extended the incision inferiorly using metzenbaum scissors to take the adhesions of the small bowel down off of the dual mesh.There were no enterotomies made.Once all the small bowel was done, we extended the incision inferiorly to allow good exposure.A bookwalter was placed.We then began running the terminal ileum from the cecum all the way back posteriorly.We, doing this, arrived to a large dilated necrotic loop of bowel.There did not appear to be an internal hernia.Instead, there was a tight adhesive band and a loop of the common channel that herniated through this adhesive band and twisted on its own mesentery.This adhesive band was taken down.There were a couple of other adhesive bands divided as well.Once this bowel was reduced, there were no other areas of necrosis.Examination revealed that the necrotic segment was the common channel just distal to the jejunojejunostomy.The biliopancreatic limb and the roux limb all were viable.They were dilated from the bowel obstruction, but no other injuries or adhesions noted.We did examine the retro-roux space and this was closed and there was no jejunojejunostomy defect.At this point, we proceeded to resect the necrotic small bowel segment with blue load gia staplers x2 just distal to the jejunojejunostomy on the common channel side and then about 4 cm distal to the area that was obstructed.The mesentery was taken down using a ligasure device.Next, we brought the distal common channel up alongside the more proximal roux limb and the antimesenteric sides were sutured together with a 3-0 silk suture.Enterotomies were made with bovie electrocautery in both the roux limb and the ¿dictation cut off¿ [sic].The inside of the new anastomosis was examined and there was good hemostasis.The open enterotomies were then elevated with allis clamps and a ta stapler was placed beneath these and fired, allowing closure of the anastomosis with good healthy tissue and there were open channels both proximally and distally to the anastomosis.The ta stapler fire was oversewn with 3-0 vicryl lembert sutures and the mesenteric defect that was created from the small bowel resection was closed with multiple figure of eight 3-0 silk sutures.During entry into the abdomen, we did divide the dual mesh that was present.The dual mesh was excised in its entirety using bovie electrocautery as well as the protacks that were present around the edges of the mesh.Finally, we placed a gastrostomy tube in the remnant stomach on the patient's left side.A counter incision was made through her abdomen.A 20 french foley was brought through that abdominal incision and a gastrotomy made in the remnant stomach.There was some bile expressed during resection of that incision.A 2-0 pursestring suture was placed around that and the tip of the foley was placed within the remnant stomach and the pursestring suture cinched down.We then inflated the balloon with 10 ml of saline.At this point, we closed the fascia with a running o pds times two and the skin was irrigated and closed with skin staples and a sterile dressing.At the end of the case, the patient was unstable and she had pulmonary edema and had difficulty oxygenating and ventilating.She was taken in critical condition to the intensive care unit.¿ conclusion: it should be noted that the gore® dualmesh® plus biomaterial instructions for use includes 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.¿ 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, dysphagia, erosion or extrusion and related harms, exposure or protrusion and related harms, fever, fistula, gerd recurrence, recurrence, ileus, increased procedure time and related harms, irritation or inflammation, infection, pain, paresthesia, perforation, revision / re-intervention, seroma or hematoma and related harms, wound complications and wound dehiscence.Many of the potential complications are associated with the patient¿s underlying disease progression, co-morbidities, additional medical history and/or other surgical procedures.The above inherent risks are typically detailed in standard informed consent documents.The device was not able to be returned to gore for evaluation; therefore, a direct product analysis could not be conducted.Review of the manufacturing records verified that the lot met all pre-release specifications.The investigation concluded that there is no relationship between the device history record findings and the event.All available information has been placed on file for use in product surveillance tracking, trending and follow-up.Section c1: name: plus antimicrobial product coating.Manufacturer/compounder: w.L.Gore & associates, inc.Lot number: 06455039.Additional manufacturer narrative: 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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