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Model Number 1DLMCP04 |
Device Problems
No Apparent Adverse Event (3189); Insufficient Information (3190)
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Patient Problems
Obstruction/Occlusion (2422); Not Applicable (3189)
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Event Date 02/22/2017 |
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 incisional hernia repair on (b)(6) 2014 whereby a gore® dualmesh® plus biomaterial was implanted.The complaint alleges that on (b)(6) 2017, an additional procedure occurred whereby the gore device was explanted.It was reported the patient alleges the following injuries: small bowel obstruction, removal of mesh, revision surgery.Additional event specific information was not provided.
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Manufacturer Narrative
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Updated results code for manufacturing evaluation.Conclusion code remains unchanged.
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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: records prior to (b)(6) 2014, including records for previous abdominal procedures, including cholecystectomy, cesarean sections, and ventral hernia repair, were not provided.History and physical note dated (b)(6) 2014, states: ¿had prior lap cholecystectomy and developed trocar site hernia.In 2005 dr.(b)(6) performed open incisional hernia repair with onlay mesh.She noted a bulge develop over the last year and some increasing discomfort or foreign sensation when she bends over.¿ operative records dated (b)(6) 2014, indicate the patient underwent laparoscopic repair of recurrent incisional hernia with mesh.Patient ¿with a prior history of open onlay repair of an incisional hernia at her upper midline.The patient developed a recurrence and desired repair.¿ operative findings dated (b)(6) 2014,states: ¿a 5 x 8 cm incisional hernia defect area.Primarily suture reapproximated and repaired with a 15 x 19 cm piece of dual mesh plus biomaterial with double crown protack fixation.¿ the operative records dated (b)(6) 2014, continue: ¿the abdomen was inspected completely.There was noted to be some herniated omentum and colon through the defect in the upper abdomen.With manual compression externally and internal traction, this was reduced with no injury to the bowel.The hernia defect area was circular.As well, during the dissection of the falciform ligament, there was noted to be a more superiorly-located epigastric hernia.¿ the records dated (b)(6) 2014,state: ¿after the falciform ligament was completely divided, spinal needles were placed at the extreme edges of the hernia defect inferiorly, superiorly and laterally.The x and y coordinates were drawn in the anterior abdominal wall to orient the hernia defect area anteriorly, measuring intracorporeally with a metric ruler.The defect was 5 cm wide and 8 cm in vertical dimension.I elected to first primarily suture reapproximate the defect closed, which was done so with 3 figure-of-eight #1 novafil sutures through separate small stab incisions.¿ the operative records dated (b)(6) 2014,continue: ¿once the abdomen was desufflated, the fascial defect came together very well as all sutures were tied down.The abdomen was then reinsufflated and inspected.I changed to a new set of sterile gloves, opened a 15 x 19 cm piece of dual mesh plus biomaterial, trimmed it and rolled it tightly and brought it in through the peritoneal cavity directly through the 12 mm trocar with no contact with the skin.¿ records dated (b)(6) 2014, state: ¿the mesh was unfurled and then the superior aspect of the mesh was tacked to the anterior abdominal wall.Utilizing a 5 mm overlap superiorly along the y axis, which was measured intracorporeally, a 7.5 cm was measured laterally and along the x axis the left lateral aspect of the mesh was tacked to the abdominal wall.The inferior aspect of the mesh was stretched into the lower abdomen along the y axis.The inferior aspect of the mesh was tacked.¿ operative records dated (b)(6) 2014, continue: ¿coming from the other side, the right lateral aspect of the mesh was stretched laterally towards the right and along the x axis the right lateral aspect of the mesh was tacked to the abdominal wall.At this juncture, with 4-point fixation the mesh.The mesh was tacked circumferentially further around the entire perimeter of the mesh utilizing the [sic] pro tack device.The mesh lay in taut position against the anterior abdominal wall.¿ the operative records dated (b)(6) 2014, state: ¿i then placed an additional layer of pro tack fixation points more centrally along the mesh for a double crown technique.The mesh lay in good position with more than adequate coverage of the entire closed hernia defect area of the abdominal wall.The operative site was inspected.There was good hemostasis from the omentum, which had been reduced from the hernia.As well, the colon was intact with no injury.¿ ¿skin was then closed with 4-0 monocryl and skin glue.¿ the records confirm a gore dualmesh®plus biomaterial (1dlmcp04/11928274) was used during the procedure.Discharge summary for hospital admission (b)(6) 2014, to(b)(6) 2014, indicates secondary diagnosis of morbid obesity, chronic anemia, atrial fibrillation, postoperative seroma.Records dated between (b)(6) 2014, and (b)(6) 2017 were not provided.Operative records dated (b)(6) 2017 indicate postoperative diagnosis of small bowel obstruction from recurrent incisional hernia.The patient underwent exploratory laparotomy, extensive lysis of adhesions, removal of hernia mesh, and repair of recurrent incisional hernia.Operative findings dated (b)(6) 2017 states: ¿large incisional hernia recurrence containing incarcerated transverse colon, omentum and small bowel, complete disruption of the right side of the hernia mesh fixation with mesh being pulled over to the patient's left side and bowel contents bulging around this into the subcutaneous space.There was a single loop of small intestines that was twisted against a adhesive band on the right lateral aspect of the hernia.This was clearly the site of transition identified on preoperative ct scans.Resulting hernia defect after extirpation of the mesh measured 15 x 10 cm.Hernia sac was used as a fascial bridge during hernia repair.¿ operative records dated (b)(6) 2017 continue: ¿the patient presented approximately 3 years status post incisional hernia repair in 2014 which was performed in (b)(6) she initially underwent an open primary repair followed by a laparoscopic hernia repair with a piece of dualmesh with metal tack fixation.She has developed a partial small bowel obstruction with evidence of disruption of the right side of the hernia mesh and large incarcerated hernia.She was managed nonoperatively for several days without improvement and is being taken to the operating room for relief of her bowel obstruction.¿ records dated (b)(6) 2017 state: ¿midline incision was made from just below the xiphoid around the umbilicus inferiorly through the skin and subcutaneous tissue with a knife.Dissection down to the anterior fascia was performed at the most cephalad portion of the incision corresponding to intact fascia on the ct scan.Continued dissection inferiorly was then carefully performed with combination of cautery and metzenbaum scissors until identifying the large hernia sac.¿ operative records dated (b)(6) 2017 continue: ¿this was isolated and mobilized circumferentially.The sac was quite large and extending subcutaneously on either side of the midline.This was completely dissected around to the level of the anterior sheath bilaterally to a point adjacent to the umbilicus inferiorly.There was a lot of thickened scar tissue present here in a bunching of the old hernia mesh.The hernia sac was entered with cautery along the midline with care taken to salvage as much of the sac as possible for potential closure.¿ the (b)(6) 2017operative records state: ¿there was a moderate amount of ascitic fluid that was evacuated.Contents appeared to be incarcerated omentum and transverse colon and small bowel.At the right lateral aspect of the hernia sac at the level of the anterior fascia was a loop of small bowel that was knuckled next to a adhesive band.This was carefully taken down and inspected.This showed a clear transition point from dilated to decompressed bowel.This was monitored for several minutes and developed peristalsis and good perfusion.¿ the (b)(6) 2017 records continue: ¿multiple adhesive bands from the hernia sac to the transverse colon and omentum were divided with cautery.Once the hernia sac was completely opened and exposed the anterior abdominal wall is inspected further.There were several metallic tacks present on the right upper portion of the posterior rectus sheath and peritoneum.These were divided and removed carefully with metzenbaum scissors.¿ operative records dated (b)(6) 2017 state: ¿a bunching of a large dualmesh was then seen pulled over across the midline to the left side of the abdomen densely adhered to the underlying peritoneum and posterior rectus sheath.Tedious and lengthy dissection was performed to remove the mesh and tacks with care taken to preserve as much of the posterior rectus sheath as possible for eventual abdominal wall reconstruction in the future.Ultimately the mesh was completely excised.¿ the (b)(6) 2017 records continue: ¿this and a portion of the hernia sac that was divided was submitted to pathology for review.Transverse colon was inspected and was without abnormality.Small bowel was then run in a hand over hand technique from the ligament of treitz to the terminal ileum.Again the transition point was identified and seemed to be well perfused and healthy.Resection was not performed.Contents were placed back into the abdomen.Made [sic] of a large uterine fibroid extending up the right para-midline.¿ the (b)(6) 2017 operative records state: ¿the remaining hernia defect was inspected and measured about 15 x 10 cm.The anterior fascia could not be completely reapproximated in a tension-free fashion.A portion of the inferior anterior sheath could be brought together and was done so using a running #1 single-stranded pds.The remainder of the incision was closed using the remaining hernia sac as a fascial bridge and securing this together with running #1 single-stranded pds suture.The large subcutaneous space that remained after reduction of the hernia contents was irrigated with sterile saline solution.Hemostasis was obtained with cautery.¿ records dated (b)(6) 2017 state: ¿two 19 french blake drains were inserted into the subcutaneous space in the right and left lower quadrants respectively and secured to the skin with a nylon stitch.These were placed to bulb suction.Deeper subcutaneous tissues tissues reapproximated with interrupted 2-0 vicryl sutures.The skin was closed with interrupted skin staples.Pressure dressing and an abdominal binder was applied.¿ the operative report dated (b)(6) 2017 states: ¿procedural difficulties: difficulties include.: increased time needed, easily justifying the use of modifier 22 (complex incisional hernia recurrence with bowel obstruction necessitating lengthy dissection to relieve obstruction and remove mesh.¿ pathology records for the (b)(6) 2017procedure were not provided.Discharge summary for hospital admission (b)(6) 2017 to (b)(6) 2017states: ¿patient was admitted with bowel obstructive changes secondary to a recurrent complex abdominal wall incisional hernia.She was managed nonoperatively for several days with ng tube decompression, intravenous fluid hydration but failed to make progress.She has continued high-output from the ng tube and was not having any bowel function.¿ the discharge summary for hospital admission (b)(6) 2017 to (b)(6) 2017continues ¿ct scan revealed complete disruption of the intraperitoneal mesh with significant loss of domain from herniating bowel loops.Given the complicating factor of bowel obstruction with the large amount of herniated bowel, he recommended proceeding with a temporizing repair strategy using the hernia sac instead of mesh to fix the hernia.She tolerated the procedure well and was transferred to the floor with multiple drains in place.She progressed slowly on the floor with gradual return of bowel function.¿ a potential relationship, if any, between the alleged injuries or complications and the gore device is unclear from the provided information at this time.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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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: (b)(6) 2014: (b)(6).Recurrent.Due to her obesity, she would be best served by having bariatric surgery first, followed by later panniculectomy and open incisional hernia repair with mesh.I have warned her to the higher risk of recurrence after laparoscopic incisional hernia repair with mesh in the obese population.The can still be an option if she decides against weight loss surgery.Revisit with her in 4 weeks after she has attended the bariatric session.Exam: abdomen, soft, nontender, nondistended, not completely reducible, minimally tender to deep palpation over hernia, skin intact.(b)(6) 2014: (b)(6).Office notes.Incisional hernia.Impression/plan: hernia, incisional recurrent.Had long discussion regarding the best treatment plan.Although i would prefer her to lose a significant amount of weight prior to any surgery, this is unlikely.She desires laparoscopic repair and we have discussed the risks and benefits of this and the likelihood of recurrent in morbid obesity.Will schedule her for surgery.Morbid obesity.Encouraged to visit weight loss seminar.History of present illness: sent by dr.Moses for recurrent incisional hernia.Had prior laparoscopic cholecystectomy and developed trocar site hernia.In 2005 had open incisional hernia repair with onlay mesh.She noticed a bulge develop over the last year and some increasing discomfort or foreign sensation when she beds over.Denies fever or chills, denies obstructive symptoms.Last time we met i encouraged her to seek information on bariatric surgery.Unfortunately her husband¿s state insurance plan will not cover bariatric surgery and she is unwilling to pay for this.She has also done some research and is tentative about even having bariatric surgery.Pain: left lower quadrant, intermittent, sharp, associated with meals at times.Weight 302 lbs, bmi 55.23.Exam: abdomen, soft, nontender, nondistended, hernia present, not completely reducible.Minimally tender to deep palpation over hernia.Skin intact.(b)(6) 2014: (b)(6).Post-op transfer note.Weight 140 kg.Previous surgeries: c-section x 2, laparoscopic cholecystectomy, hernia repair, bilateral tubal ligation 1999.History of hypertension, negative smoker.Asa 2.(b)(6) 2014: (b)(6).Immediate operative note/implant record.Implant sticker.Recurrent incisional hernia.Laparoscopic repair recurrent incisional hernia with mesh.15 x 19 dualmesh plus.Gore dualmesh® plus biomaterial.Ref catalogue number: 1dlmcp04.Lot batch code: 11928274.W.L.Gore & associates.Item #: a47132.Site: abdomen.Expiration date: 07/30/2016.Quantity: 1.Lot #: 11928274.Manufacturer: w.L.Gore & associates.Mfg catalog #: 1dlmcp04.Device type: implant.Mesh dual plus 15x19x1 a47132 1dlmcp04.(b)(6) 2014: (b)(6) hospital.Lab.Wbc 12.0 h (4.8-10.8).(b)(6) 2014: ((b)(6).Hernia follow up.Doing well at home with little pain.Has felt dizzy and short of breath when exerts herself.Exam: abdomen; soft, nontender, nondistended, no masses, seroma palpable, nontender, no hernia, incisions healing well.(b)(6) 2014: (b)(6).Office notes.Follow up hernia repair.Impression/plan: hernia, incisional recurrent.Return to work june 16, follow up 6 month mark from surgery.Morbid obesity.Encouraged to visit weight loss seminar.Continue iron daily.Pain: will get a quick sharp pain on occasion, depending on what she does, a little sore to touch.Exam: abdomen, soft, non-tender, non-distended, no masses.Seroma palpable, nontender.No hernia.Incisions healing well.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 instructions for gore® dualmesh® plus biomaterial 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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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: ??/??/03: [missing records: an operative report for hernia surgery.] ??/??/05: [missing records: an operative report for the hernia repair in 2005 by dr.Moses was not provided.] (b)(6) 2014: (b)(6).Office notes.Presents for recheck of hernia.Onset of hernia has been gradual and has been occurring [illegible] mild.Complains of hernia just left of umbilicus.States hernia has been onset for 10 years, but has been [illegible] of an abdominal bulge all the time.Had hernia repair in 2005 by (b)(6).Had attempted laparoscopic repair previously and [illegible].Transitioning care from russell brant.Painful bowel movements, stomach pain and constipation.Incision healing well.Hernias: incisional ¿ incarcerated.Patient with incisional hernia extending to left of midline just above umbilicus it is not reducible.Assessment and plan: patient education ¿ hernia surgery ¿ traditional repair discussed with patient and provided information.Abdomen ct scan.Follow-up after completion of diagnostic tests.(b)(6) 2014: (b)(6).Radiology-ct abdomen pelvis with contrast.Findings: contrast ct of abdomen and pelvis demonstrate lung bases to show no acute process.Imaging of abdomen demonstrates no solid organ masses, free fluid or fluid collections.Gallbladder is surgically absent.There is an anterior abdominal wall hernia with a large amount of bowel and fat within hernia sac.Wall defect measures up to 6 cm in size.I see no obvious obstructive changes or inflammatory changes.No bowel distention or obstruction is noted.Imaging of pelvis demonstrates soft tissue mass in right upper pelvis with a single calcification.Etiology is unclear but this is difficult to separate from the uterus and may be a large pedunculated fibroid.Other etiologies not excluded.No free fluid, fluid collections or focal inflammatory changes are seen in pelvis.Impression: large anterior wall hernia as discussed above.No obstructive change is seen.Partially calcified upper pelvic mass as discussed above likely pedunculated uterine fibroid but correlation and follow up pelvic ultrasound may be useful.02/??/17: [missing records: records for ct scan showing ¿recurrent hernia with some questionable dilated loops of small bowel suggesting possible bowel obstruction¿ were not provided.] (b)(6) 2017: (b)(6).History and physical.45-year-old morbidly obese female who underwent complex repair of abdominal wall hernia in 2014.Had repair done with mesh done laparoscopically.Doing well until monday prior to admission when she developed abdominal pain nausea and vomiting.States she was doing some lifting and straining.States she¿s not had a bowel movement since that time.Has intermittent nausea and vomiting.Experiences abdominal pain only when ambulating when lying still has no discomfort.Denies any fever of chills.No history of trauma.Gastrointestinal: nausea, vomiting, abdominal pain.Bowel sounds normal/active.Soft.Tenderness (mild tenderness over midline area in area of recurrent hernia).Hernia (midline hernia nonreducible mildly tender no overlying skin changes).White blood cell count 7000.Ct shows recurrent hernia with some questionable dilated loops of small bowel suggesting possible bowel obstruction and hernia no evidence of compromise bowel.Assessment/plan: patient with abdominal pain and incarcerated hernia.Has evidence of at least partial bowel obstruction.I see no evidence of compromised bowel and hernia sac.Going to discuss with associates to see if they feel like this can be repaired with component separation procedure at our institution.If not she may require transfer.In the meantime we will proceed with potassium replacement and medical evaluation to make sure she is an acceptable candidate for surgery.She will pose a significant risk due to comorbid problems including severe obesity hypertension and cardiac disease.(b)(6) 2017: (b)(6).Progress note.States abdomen is improved denies bowel movement or flatus.Nasogastric output copious.Abdomen minimal tenderness no guarding or rebound improved from yesterday¿s exam.Patient with incarcerated hernia and bowel obstruction some clinical improvement but is showing significant dehydration.Plan fluid bolus and repeat labs.(b)(6) 2017: (b)(6).Progress note.Nasogastric tube is in place.Had about 2.5 liters of gastric contents in canister over past 24 hours.Denies any bowel movements or flatus.Abdomen is minimally tender to palpation.Denies any nausea or vomiting.States she is very hungry.Afebrile overnight.Weight: 128 kg.Bmi: 51.6.Morbid obesity.Cardiovascular: tachycardia.Gastrointestinal: soft, tenderness (minimal), distended (mild).Negative to rebound, guarding.Assessment/plan: patient had slight improvement overnight.Nasogastric tube output still fairly high.Output is nonbilious however.Continue nasogastric decompression.Await return of bowel function.I had a discussion with patient¿s previous surgeon (dr.Carbonell) that performed her incisional hernia repair in 2014.She underwent an open primary repair of a 5 x 8 cm midline defect followed by laparoscopic intraperitoneal onlay mesh with 15 x 9 cm of dualmesh.Based on ct scan, patient has had complete disruption of the right and superior aspect of the intraabdominal peritoneal onlay mesh repair with incarceration of bowel within the hernia sac.Discussed findings with patient and possible treatment options, which include nonoperative management with nasogastric tube decompression, fluid hydration and observation for return of bowel function, with plans for eventual return to greenville for evaluation and treatment by dr.Carbonell.If patient does not improve clinically or radiologically, my plan would be for surgical exploration with lysis of adhesions for relief of bowel obstruction, mesh extirpation, and temporary abdominal wall reinforcement with plans for delayed definitive abdominal wall reconstruction several months down the road either here or in greenville.Lengthy discussion with patient and her husband was carried out and all questions answered.(b)(6) 2017: (b)(6).Progress note.Nasogastric tube in place.It put out over 3 liters of brownish foul-smelling material over the past 24 hours.Creatinine improved yesterday.Denies any bowel movements or flatus.Abdomen still mildly tender.Gastrointestinal: soft, tenderness (mild midline).Negative for rebound, guarding.(b)(6) 2017]: continue nasogastric decompression and fluid hydration.Despite patient¿s clinical improvement, i¿m still concerned about large volume of nasogastric output as well as the fact that she has not had any bowel movements or flatus.I¿m concerned the incarcerated small bowel and recurrent incisional hernia is not going to improve with nonoperative management given severity of recurrence.Plan to repeat ct scan tomorrow morning to see if any change in appearance of bowel involved in hernia.This will also serve as a guide for surgical planning as i believe that exploration with mesh extirpation and lysis of adhesions will be necessary.(b)(6) 2017: (b)(6).Progress note.Denies nausea or vomiting but states feels weak and hungry.Nasogastric tube in place.Output over past 24 hours has been about 3 liters.Described as almost feculent in nature by nursing.Still has not had any bowel movements or flatus yet.Abdomen is mildly distended and mildly tender to palpation.Still awaiting ct scan.Cardiovascular: tachycardia.Gastrointestinal: soft, tenderness (mild incisional).Negative for rebound, guarding.(b)(6) 2017]: continue nasogastric tube decompression.Patient has very scant bowel sounds and has not had return of bowel function despite several days of nonoperative measures.Follow-up ct of abdomen and pelvis.Plan exploration of abdomen tomorrow with lysis of adhesions to relieve obstruction and mesh extirpation.In all likelihood, patient will be left with hernia defect that¿ll be closed with hernia sac and skin with plans to repair at a later date on elective basis.Place peripherally inserted central catheter line.(b)(6) 2017: (b)(6).Radiology-ct abdomen pelvis with contrast.Ct of abdomen and pelvis with contrast demonstrates lung bases with atelectasis and small air bronchograms that appear more typical for atelectasis than pneumonic infiltration.A nasogastric tube is in place with small bowel abnormal distention and air-fluid levels.An anterior abdominal wall hernia contains segments of both small and large bowel with a transition zone involving a loop of small bowel with a transition from dilated to decompressed small bowel along inferior aspect of hernia consistent with expected site of obstruction.Foley catheter decompresses urinary bladder.Old anterior abdominal wall postsurgical changes appear disrupted in midline and right of midline where the width of large hernia sac containing small and large bowel measures up to 7.5 cm.Impression: bilateral basilar atelectasis.Small bowel obstruction at site of anterior abdominal wall hernia.(b)(6) 2017: (b)(6).Progress note.Patient had low grade fever overnight.Feeling okay this morning.Would like to eat something possible [sic].Nasogastric tube put out about 500 ml of gastric contents.Denies any nausea or vomiting but did have a little nausea last night.Very much would like to have nasogastric tube taken out even a [sic] she understands if she has nausea or vomiting, it will need to be replaced.Jackson-pratt drains put out about 15 serosanguineous fluid bilaterally.Abdominal binder and dressing in place.Plan: discontinue nasogastric tube and start clear fluids.Patient experiences any increased abdominal distention, nausea or vomiting, and nasogastric tube will need to be replaced to low intermittent wall suction.Discussed this with patient she prefers to do this rather than doing a clamping trial.Decreased maintenance fluids.Continue abdominal jackson-pratt drains.Strip and record output every shift.Continue abdominal binder.Patient needs to get out of bed and to chair.Ambulate with assistance with assistance if possible.Anticipate fever is related to atelectasis as patient has been laying in bed since surgery and not participating well with incentive spirometry.Encouraged aggressive pulmonary toilet.(b)(6) 2017: (b)(6).Consultation.Past medical history chronic atrial fibrillation, hypertension, ventral hernia, gastroesophageal reflux disease, and morbid obesity.Admitted (b)(6) 2017.(b)(6) 2017 underwent exploratory laparotomy.Since then noted to have tachycardia was a [sic] heart rates into 120¿s and today was noted to have heart rates in 140¿s with low blood pressure and fever.When i saw her she was complaining of dizziness and back pain.Denied headache, chest pain, shortness of breath, abdominal pain, chills, nausea, vomiting, diarrhea, melena or hematochezia.Cardiovascular: tachycardia.Gastrointestinal: bowel sounds normal, active, soft, 2 drains in place.Problem list/plan: sinus tachycardia: give digoxin 0.25 mg intravenous and if blood pressure improves consider beta blockers and/or calcium channel blockers.Rapid heart rate may be reflection of fever and low blood pressure as well.Postoperative fever: temperature = 101.4 f, given fever, drop in blood pressure and tachycardia sepsis needs to be considered and will do sepsis workup including lactic acid level.Leukocytosis: wbc 6,700 ? 20,700 postoperatively.Obtain chest x-ray, urine analysis with reflex cultures, blood cultures.Postoperative anemia due to acute blood loss: hemoglobin 11.6 ? 10.7 ? 8.7 postoperatively, has microcytosis and will do iron h and transfuse.Hypernatremia: sodium 139 ? 146 ? 155, increase free water and monitor.Metabolic acidosis: carbon dioxide 22 ? 17, may be due to sepsis, will give sodium bicarbonate and monitor.(b)(6) 2017: (b)(6).Progress note.Had bowel movement this morning and is passing flatus.Had about 400 ml total of nasogastric tube output over past 24 hours.Bilateral drains are still putting out bloody serous output.Not moving well except for a little bit around the room.Uncertain of participation and incentive spirometry.Chest x-ray showed concern for bibasilar consolidations.Has urinary tract infection.Abdominal dressing and binder in place.Plan: nasogastric tube clamping trial with sips of clear liquids.Placed back to low intermittent wall suction as needed for increasing nausea, vomiting.Plan to remove in morning if tolerates clears.Encouraged postop mobilization and ambulation around the halls.Needs to be out of bed to chair and participate in aggressive pulmonary toilet.Continue antibiotics.Continue to strip and record drain output daily.(b)(6) 2017: (b)(6).Progress note.Passing a lot of flatus.Nasogastric tube is out and tolerating clear liquids.Drains still putting out 20-25 serosanguineous fluid.Abdominal binder in place.Appropriate incisional tenderness.White blood cell count decreasing.Remains on antibiotics.Ambulated with physical therapy.Plan: advance diet as tolerated.Out of bed to chair daily.Continue physical therapy for postop mobilization.Continue antibiotics and monitor white blood cell count.(b)(6) 2017: (b)(6).Discharge summary.Admitted with bowel obstructive changes secondary to recurrent complex abdominal wall incisional hernia.Managed nonoperatively for several days with nasogastric tube decompression, intravenous fluid hydration but failed to make progress.Continued high-output from the nasogastric tube and was not having any bowel function.Given the complicating factor of bowel obstruction with large amount of herniated bowel, he recommended proceeding with a temporizing repair strategy using hernia sac instead of mesh to fix the hernia.Ultimately underwent surgery on (b)(6) 2017 where she had a laparotomy with mesh extirpation and hernia repair utilizing a significant portion of hernia sac to close the midline.Tolerated procedure well and was transferred to the floor with multiple drains in place.Progressed slowly on floor with gradual return of bowel function.Was tolerating a diet and having bowel function.Pain adequately controlled with oral pain medication.Drains remained in place given the high output of serosanguineous fluid.Medically stable for discharge.Activity: no heavy lifting greater than 10 pounds for 6 weeks.Other: strip and record drain output daily; wear abdominal binder as much as possible.Follow-up appointment: one week.Weight: 139.117 kg.Bmi: 56.03.Morbid obesity.Gastrointestinal: soft, tenderness (appropriate incisional), bilateral lower quadrant drains in place.(b)(6) 2017: (b)(6).Office notes.Status post exploratory laparotomy, extensive [illegible].Patient is 2 weeks postop procedure.No postoperative complications.Symptoms much improved compared to [illegible] instructions.Has shown improvement in activity level.Abdominal binder in place.Incision healing well.Bilateral lower quadrant drains in place with serosanguineous fluid.Appropriate incisional [illegible].Doing well after discharge from complicated recurrent incisional hernia procedure.Drains are still putting out [illegible] presently getting better.Recommend she continue to refrain from heavy lifting or excessive activity.Continue to use binder as needed.Follow up in 1 week.(b)(6) 2017: (b)(6).Office notes.Symptoms slightly improved compared to [illegible] instructions.Midline incision well-healed.Bilateral lower abdominal quadrant drains in place with serous output.Central depression at location of previous [illegible] abdomen.Patient doing well.Drains been in place entire postop period and are [illegible] abdomen.Drains be removed today and dry dressings placed.Refrain from heavy lifting for next 4-6 weeks.Follow up in 2 weeks.(b)(6) 2017: (b)(6).Office notes.Patient¿s symptoms are worse compared to [illegible] instructions.Has decreased in activity level.Complains of moderate abdominal pain and swelling.[illegible] swallowing this week as well.Mild seroma present at central periumbilical region.Tenderness around previous drain site locations.No evidence of hernia recurrence at [illegible].Now 6 weeks status post open repair of recurrent incisional hernia with extirpation of mesh.Patient strains [sic] been removed [illegible] seroma present.Continue to avoid heavy lifting or physical activity for next several weeks.In review, patient¿s repair was done [illegible] hernia sac which was not the ideal fashion however was appropriate for her situation.Follow-up in 1 month at which point we [illegible] to greenville for consultation from dr.Carbonell.(b)(6) 2017: (b)(6).Office notes.Complains of an open wound.States area opened a few [illegible].2 draining sinuses along upper midline and just right of midline in the previous incisional site.Some purulent material draining [illegible] recurrent hernia given body habitus.Seen for increased drainage from incisional wound after complicated recurrent incisional hernia repair.This was a semi [illegible] abdominal wall reconstruction could be performed as a later date.This drainage is new to patient and could represent an infected seroma versus [illegible].[illegible] a ct scan of abdomen and pelvis to better evaluate abdominal anatomy and see if there is [sic] been recurrence of hernia versus [illegible].[illegible] return to greenville for definitive repair by dr.Carbonell.(b)(6) 2017: (b)(6).Radiology-ct abdomen pelvis with contrast.Imaging into abdomen demonstrates no solid organ masses, free fluid, fluid collections, or focal inflammatory changes.No bowel dilatation or obstructive changes are seen.Imaging into pelvis demonstrates a fluid collection in anterior pelvic wall most consistent with postoperative seroma.This measures 7.6 x 3.2 x 5.8 cm in transverse by ap by craniocaudal dimensions.No evidence of recurrent hernia is noted.Impression: subcutaneous anterior fluid collection in the postoperative seroma as noted above.Otherwise no acute process.Nonacute findings as discussed above.(b)(6) 2017: (b)(6).Office notes.Midline incision with small punctate opening at superior aspect with extension to subcutaneous fat no fascial violation.Just inferior [illegible] some serosanguineous looking fluid.No evidence of hernia recurrence.Follows up after ct scan of abdomen for draining wound at incision site.There appears to be a seroma present but [illegible].[illegible] daily dry dressing changes and follow-up in one week.(b)(6) 2017: (b)(6).Office notes.Midline abdominal incision healed.Draining sinus at the superior aspect the wound is closed down.There is a right lateral sinus [illegible] little better.Tender to palpation around the [sic].Follows up for wound check.Has a single draining sinus on right lateral aspect of wound.This correlates with [illegible] weeks despite local wound care.I recommended a ct-guided drain placement and continued monitoring in the office.I¿ll plan to pull this out over [illegible] needed for drainage.Follow-up one week after drain placement.(b)(6) 2017: (b)(6).Radiology-ct limit exam.Follow-up evaluation of abdominal wall seroma.When compared to (b)(6) 2017 a previously characterized anterior abdominal wall fluid collection most compatible with a seroma appears much smaller now measuring approximately 1.8 x 3.5 cm compared to 3.3 x 7.5 cm on prior exam.This appears much smaller.No definite mass or adenopathy.No gross bowel obstructive findings.Slight rectus muscular diastases again noted.Impression: limited examination prior to possible seroma aspiration shows much smaller fluid collection consistent with much smaller size of anterior abdominal wall seroma as discussed above.(b)(6) 2017: (b)(6).Office notes.Seroma improving.Small sinus tract very shallow now.Minimal tenderness.No signs of hernia recurrence at this time.Patient doing well.Did not need percutaneous drainage of seroma as this had significantly decreased on ct scan.Sinus [illegible].Follow up in 2-3 months.Follow up in 1 month or as needed.(b)(6) 2017: (b)(6).Office notes.Patient¿s symptoms are improved compared to preoperative [illegible] instructions.Has shown improvement in activity level and decreased in activity level.Patient would like [illegible].Abdominal incision is almost completely healed.There is a small little tract with about a half a centimeter off the right midline that is [illegible].Patient is now a little over 3 and half months after urgent repair of a strangulated recurrent incisional hernia.This was repaired [illegible] abdominal wall reconstruction was not performed as not to disrupt the potential myofascial planes for definitive reconstruction down the road.She [illegible] up now.Doing well.Feels better.Bowel function is returning to normal.Ready to go back and start working.Recommended [illegible] referral back to greenville to see dr.Carbonell who initially did her procedure.Understands and agrees with plan.(b)(6) 2017: [missing records: records for ct abdomen/pelvis showing ¿small palpable [illegible] nonincarcerated loop of colon¿ were not provided.] (b)(6) 2017: (b)(6).Office notes.Presents for follow up.Abdominal incisions well healed.No rebound or guarding.Mild bulge present in supraumbilical [illegible].About 10 months out from repair of recurrent abdominal incisional hernia with associated bowel [illegible] obstruction.Midline was reapproximated using the hernia sac as not to disrupt the planes of the myocutaneous space bilaterally.This was done [illegible] addressed at a later date as a higher level of care.Doing well.Back at work and having no limitations.Has a small palpable [illegible] nonincarcerated loop of colon.I explained this to patient that if she remains asymptomatic and is not functioning limited by this that we can [illegible] bothersome.Then we will need to likely refer her back to dr.Carbonell in greenville for definitive abdominal wall reconstruction.Follow up in 6 months or as needed.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 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 patient codes.H6: updated device code.H6: updated conclusion codes.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.Medical records: the known medical records span january 22, 2014 through november 30, 2017, and not all records received in this time span are relevant to gore® dualmesh® plus biomaterial.Records from june 5, 2014 through february 16, 2017 were not provided.Patient information: medical history: ventral hernia, hypertension, obesity, on (b)(6) 2014: 301lbs.; bmi 55, on (b)(6) 2014: 302lbs.; bmi 55.2, on (b)(6) 2015: bmi 55, on (b)(6) 2017: 282lbs.; bmi 51.6, on (b)(6) 2017: 287lbs.; bmi 52.4, on (b)(6) 2017: 307 lbs.; bmi 56.03, on (b)(6) 2017: 282lbs.; bmi 51.6, anemia, gastroesophageal reflux disease [gerd].Prior surgical procedures: 1997, 1999: cesarean section, 1999: bilateral tubal ligation, 2001: cholecystectomy, 2003: hernia surgery, 2005: open ventral hernia repair with onlay mesh.Implant preoperative complaints: on (b)(6) 2014: ¿hernia, incisional recurrent.Had long discussion regarding the best treatment plan.Although i would prefer her to lose a significant amount of weight prior to any surgery, this is unlikely.She desires laparoscopic repair and we have discussed the risks and benefits of this and the likelihood of recurrent in morbid obesity.Will schedule her for surgery.Morbid obesity.Encouraged to visit weight loss seminar.¿ ¿had prior laparoscopic cholecystectomy and developed trocar site hernia.In 2005 had open incisional hernia repair with onlay mesh.She noticed a bulge develop over the last year and some increasing discomfort or foreign sensation when she beds [bends] over.Denies fever or chills, denies obstructive symptoms.Last time we met i encouraged her to seek information on bariatric surgery.Unfortunately her husband¿s state insurance plan will not cover bariatric surgery and she is unwilling to pay for this.She has also done some research and is tentative about even having bariatric surgery.Pain: left lower quadrant, intermittent, sharp, associated with meals at times.¿ implant procedure: laparoscopic repair of recurrent incisional hernia with mesh.Implant: gore® dualmesh® plus biomaterial (11928274/1dlmcp04) 15cm x 19cm, oval.Implant date: on (b)(6) 2014 [hospitalized from on (b)(6) 2014].Description of hernia being treated: ¿there was noted to be some herniated omentum and colon through the defect in the upper abdomen.With manual compression externally and internal traction, this was reduced with no injury to the bowel.The hernia defect area was circular.As well, during the dissection of the falciform ligament, there was noted to be a more superiorly-located epigastric hernia.After the falciform ligament was completely divided, spinal needles were placed at the extreme edges of the hernia defect inferiorly, superiorly and laterally.The x and y coordinates were drawn in the anterior abdominal wall to orient the hernia defect area anteriorly, measuring intracorporeally with a metric ruler.The defect was 5 cm wide and 8 cm in vertical dimension.¿ implant size and fixation: ¿i elected to first primarily suture reapproximate the defect closed, which was done so with 3 figure-of-eight #1 novafil sutures through separate small stab incisions.Once the abdomen was desufflated, the fascial defect came together very well as all sutures were tied down.The abdomen was then reinsufflated and inspected.I changed to a new set of sterile gloves, opened a 15 x 19 cm piece of dual mesh plus biomaterial, trimmed it and rolled it tightly and brought it in through the peritoneal cavity directly through the 12 mm trocar with no contact with the skin.The mesh was unfurled and then the superior aspect of the mesh was tacked to the anterior abdominal wall.Utilizing a 5 mm [sic] overlap superiorly along the y axis, which was measured intracorporeally, a 7.5 cm was measured laterally and along the x axis the left lateral aspect of the mesh was tacked to the abdominal wall.The inferior aspect of the mesh was stretched into the lower abdomen along the y axis.The inferior aspect of the mesh was tacked.Coming from the other side, the right lateral aspect of the mesh was stretched laterally towards the right and along the x axis the right lateral aspect of the mesh was tacked to the abdominal wall.At this juncture, with 4-point fixation, the mesh was tacked circumferentially further around the entire perimeter of the mesh utilizing the protack device.The mesh lay in taut position against the anterior abdominal wall.I then placed an additional layer of protack fixation points more centrally along the mesh for a double crown technique.The mesh lay in good position with more than adequate coverage of the entire closed hernia defect area of the abdominal wall.¿ post-operative period: [one week] on (b)(6) 2014: discharge summary: ¿uneventful laparoscopic ventral hernia repair.Admitted.Foley removed, able to void, advance to liquid diet and then regular diet, tolerated well.Postoperative day 4, doing well, preparing for discharge, developed atrial fibrillation with rapid ventricular response.Transferred to icu, given lopressor, transitioned to oral metoprolol.Atrial fibrillation converted quickly, remained normal sinus rhythm.Postoperative day 5 noted to have hemoglobin 6.3, down from 7.3 on initial postop check, only marginally down from baseline 8 chronic anemia.Given 2 units of blood, tolerated well.Repeat hemoglobin 8.9.Pain well controlled, tolerating diet, having good bowel function, ambulating well.Discharged home postop day 6.¿ ¿morbid obesity with bmi of 55.Chronic anemia.Atrial fibrillation.Postoperative seroma.¿ relevant medical information: on (b)(6) 2014: ¿abdomen; soft, nontender, nondistended, no masses, seroma palpable, nontender, no hernia, incisions healing well.¿ on (b)(6) 2014: ¿morbid obesity.Encouraged to visit weight loss seminar.¿ ¿abdomen, soft, non-tender, non-distended, no masses.Seroma palpable, nontender.No hernia.Incisions healing well.¿ on (b)(6) 2017: ¿patient with abdominal pain and incarcerated hernia.Has evidence of at least partial bowel obstruction.I see no evidence of compromised bowel and hernia sac.Going to discuss with associates to see if they feel like this can be repaired with component separation procedure at our institution.¿ on (b)(6) 2017: ¿states abdomen is improved denies bowel movement or flatus.Nasogastric output copious.Abdomen minimal tenderness no guarding or rebound improved from yesterday¿s exam.Patient with incarcerated hernia and bowel obstruction some clinical improvement but is showing significant dehydration.¿ explant preoperative complaints: on (b)(6) 2017: ¿incisional hernia repair in 2014.She underwent an open primary repair of a 5 x 8 cm midline defect followed by laparoscopic intraperitoneal onlay mesh with 15 x 9 cm of dualmesh.Based on ct scan, patient has had complete disruption of the right and superior aspect of the intraabdominal peritoneal onlay mesh repair with incarceration of bowel within the hernia sac.¿ on (b)(6) 2017: ¿despite patient¿s clinical improvement, i¿m still concerned about large volume of nasogastric output as well as the fact that she has not had any bowel movements or flatus.I¿m concerned the incarcerated small bowel and recurrent incisional hernia is not going to improve with nonoperative management given severity of recurrence.¿ on (b)(6) 2017: ¿plan exploration of abdomen tomorrow with lysis of adhesions to relieve obstruction and mesh extirpation.In all likelihood, patient will be left with hernia defect that'll be closed with hernia sac and skin with plans to repair at a later date on elective basis.¿ on (b)(6) 2017: ct abdomen/pelvis: ¿an anterior abdominal wall hernia contains segments of both small and large bowel with a transition zone involving a loop of small bowel with a transition from dilated to decompressed small bowel along inferior aspect of hernia consistent with expected site of obstruction.¿ explant procedure: exploratory laparotomy.Extensive lysis of adhesions.Removal of hernia mesh.Repair of recurrent incisional hernia.Explant date: on (b)(6) 2017 [hospitalized on (b)(6) 2017].¿midline incision was made from just below the xiphoid around the umbilicus inferiorly through the skin and subcutaneous tissue with a knife.Dissection down to the anterior fascia was performed at the most cephalad portion of the incision corresponding to intact fascia on the ct scan.Continued dissection inferiorly was then carefully performed with combination of cautery and metzenbaum scissors until identifying the large hernia sac.This was isolated and mobilized circumferentially.The sac was quite large and extending subcutaneously on either side of the midline.This was completely dissected around to the level of the anterior sheath bilaterally to a point adjacent to the umbilicus inferiorly.There was a lot of thickened scar tissue present here in a bunching of the old hernia mesh.The hernia sac was entered with cautery along the midline with care taken to salvage as much of the sac as possible for potential closure.There was a moderate amount of ascitic fluid that was evacuated.Contents appeared to be incarcerated omentum and transverse colon and small bowel.At the right lateral aspect of the hernia sac at the level of the anterior fascia was a loop of small bowel that was knuckled next to an adhesive band.This was carefully taken down and inspected.This showed a clear transition point from dilated to decompressed bowel.This was monitored for several minutes and developed peristalsis and good perfusion.Multiple adhesive bands from the hernia sac to the transverse colon and omentum were divided with cautery.Once the hernia sac was completely opened and exposed the anterior abdominal wall is inspected further.There were several metallic tacks present on the right upper portion of the posterior rectus sheath and peritoneum.These were divided and removed carefully with metzenbaum scissors.A bunching of a large dualmesh was then seen pulled over across the midline to the left side of the abdomen densely adhered to the underlying peritoneum and posterior rectus sheath.Tedious and lengthy dissection was performed to remove the mesh and tacks with care taken to preserve as much of the posterior rectus sheath as possible for eventual abdominal wall reconstruction in the future.Ultimately the mesh was completely excised.¿ ¿the remaining hernia defect was inspected and measured about 15 x 10 cm.The anterior fascia could not be completely reapproximated in a tension-free fashion.A portion of the inferior anterior sheath could be brought together and was done so using a running #1 single-stranded pds.The remainder of the incision was closed using the remaining hernia sac as a fascial bridge and securing this together with running #1 single-stranded pds suture.The large subcutaneous space that remained after reduction of the hernia contents was irrigated with sterile saline solution.¿ relevant medical information: on (b)(6) 2017: ¿anticipate fever is related to atelectasis as patient has been laying in bed since surgery and not participating well with incentive spirometry.Encouraged aggressive pulmonary toilet.¿ on (b)(6) 2017: ¿noted to have tachycardia was a [sic] heart rates into 120¿s and today was noted to have heart rates in 140¿s with low blood pressure and fever.When i saw her she was complaining of dizziness and back pain.¿ ¿give digoxin 0.25 mg intravenous and if blood pressure improves consider beta blockers and/or calcium channel blockers.Rapid heart rate may be reflection of fever and low blood pressure as well.Postoperative fever: temperature = 101.4 f, given fever, drop in blood pressure and tachycardia sepsis needs to be considered and will do sepsis workup including lactic acid level.¿ on (b)(6) 2017: discharge summary: ¿underwent surgery on (b)(6) 2017 where she had a laparotomy with mesh extirpation and hernia repair utilizing a significant portion of hernia sac to close the midline.¿ 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.¿ 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, 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.There is insufficient information available for gore to reasonably draw conclusions related to aspects of the event, therefore conclusion code "4315 (-z): cause not established" is being used.Insufficient information may include limited or missing relevant medical records, involvement of multiple implanted devices (including non-gore devices) in the field of treatment, patient non-compliance, and/or a general lack of available detail or specificity related to an adverse event and/or device.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: 11928274.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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Manufacturer Narrative
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H6: updated patient codes.H6: updated device code.H6: updated conclusion codes.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.Medical records: the known medical records span january 22, 2014 through november 30, 2017, and not all records received in this time span are relevant to gore® dualmesh® plus biomaterial.Records from june 5, 2014 through february 16, 2017 were not provided.Patient information: medical history: ventral hernia, hypertension, obesity, on (b)(6) 2014: 301lbs.; bmi 55, on (b)(6) 2014: 302lbs.; bmi 55.2, on (b)(6) 2015: bmi 55, on (b)(6) 2017: 282lbs.; bmi 51.6, on (b)(6) 2017: 287lbs.; bmi 52.4, on (b)(6) 2017: 307 lbs.; bmi 56.03, on (b)(6) 2017: 282lbs.; bmi 51.6, anemia, gastroesophageal reflux disease [gerd].Prior surgical procedures: 1997, 1999: cesarean section, 1999: bilateral tubal ligation, 2001: cholecystectomy, 2003: hernia surgery, 2005: open ventral hernia repair with onlay mesh.Implant preoperative complaints: on (b)(6) 2014: ¿hernia, incisional recurrent.Had long discussion regarding the best treatment plan.Although i would prefer her to lose a significant amount of weight prior to any surgery, this is unlikely.She desires laparoscopic repair and we have discussed the risks and benefits of this and the likelihood of recurrent in morbid obesity.Will schedule her for surgery.Morbid obesity.Encouraged to visit weight loss seminar.¿ ¿had prior laparoscopic cholecystectomy and developed trocar site hernia.In 2005 had open incisional hernia repair with onlay mesh.She noticed a bulge develop over the last year and some increasing discomfort or foreign sensation when she beds [bends] over.Denies fever or chills, denies obstructive symptoms.Last time we met i encouraged her to seek information on bariatric surgery.Unfortunately her husband¿s state insurance plan will not cover bariatric surgery and she is unwilling to pay for this.She has also done some research and is tentative about even having bariatric surgery.Pain: left lower quadrant, intermittent, sharp, associated with meals at times.¿ implant procedure: laparoscopic repair of recurrent incisional hernia with mesh.Implant: gore® dualmesh® plus biomaterial (11928274/1dlmcp04) 15cm x 19cm, oval.Implant date: on (b)(6) 2014 [hospitalized from on (b)(6) 2014].Description of hernia being treated: ¿there was noted to be some herniated omentum and colon through the defect in the upper abdomen.With manual compression externally and internal traction, this was reduced with no injury to the bowel.The hernia defect area was circular.As well, during the dissection of the falciform ligament, there was noted to be a more superiorly-located epigastric hernia.After the falciform ligament was completely divided, spinal needles were placed at the extreme edges of the hernia defect inferiorly, superiorly and laterally.The x and y coordinates were drawn in the anterior abdominal wall to orient the hernia defect area anteriorly, measuring intracorporeally with a metric ruler.The defect was 5 cm wide and 8 cm in vertical dimension.¿ implant size and fixation: ¿i elected to first primarily suture reapproximate the defect closed, which was done so with 3 figure-of-eight #1 novafil sutures through separate small stab incisions.Once the abdomen was desufflated, the fascial defect came together very well as all sutures were tied down.The abdomen was then reinsufflated and inspected.I changed to a new set of sterile gloves, opened a 15 x 19 cm piece of dual mesh plus biomaterial, trimmed it and rolled it tightly and brought it in through the peritoneal cavity directly through the 12 mm trocar with no contact with the skin.The mesh was unfurled and then the superior aspect of the mesh was tacked to the anterior abdominal wall.Utilizing a 5 mm [sic] overlap superiorly along the y axis, which was measured intracorporeally, a 7.5 cm was measured laterally and along the x axis the left lateral aspect of the mesh was tacked to the abdominal wall.The inferior aspect of the mesh was stretched into the lower abdomen along the y axis.The inferior aspect of the mesh was tacked.Coming from the other side, the right lateral aspect of the mesh was stretched laterally towards the right and along the x axis the right lateral aspect of the mesh was tacked to the abdominal wall.At this juncture, with 4-point fixation, the mesh was tacked circumferentially further around the entire perimeter of the mesh utilizing the protack device.The mesh lay in taut position against the anterior abdominal wall.I then placed an additional layer of protack fixation points more centrally along the mesh for a double crown technique.The mesh lay in good position with more than adequate coverage of the entire closed hernia defect area of the abdominal wall.¿ post-operative period: [one week].On (b)(6) 2014: discharge summary: ¿uneventful laparoscopic ventral hernia repair.Admitted.Foley removed, able to void, advance to liquid diet and then regular diet, tolerated well.Postoperative day 4, doing well, preparing for discharge, developed atrial fibrillation with rapid ventricular response.Transferred to icu, given lopressor, transitioned to oral metoprolol.Atrial fibrillation converted quickly, remained normal sinus rhythm.Postoperative day 5 noted to have hemoglobin 6.3, down from 7.3 on initial postop check, only marginally down from baseline 8 chronic anemia.Given 2 units of blood, tolerated well.Repeat hemoglobin 8.9.Pain well controlled, tolerating diet, having good bowel function, ambulating well.Discharged home postop day 6.¿ ¿morbid obesity with bmi of 55.Chronic anemia.Atrial fibrillation.Postoperative seroma.¿ relevant medical information: on (b)(6) 2014: ¿abdomen; soft, nontender, nondistended, no masses, seroma palpable, nontender, no hernia, incisions healing well.¿ on (b)(6) 2014: ¿morbid obesity.Encouraged to visit weight loss seminar.¿ ¿abdomen, soft, non-tender, non-distended, no masses.Seroma palpable, nontender.No hernia.Incisions healing well.¿ on (b)(6) 2017: ¿patient with abdominal pain and incarcerated hernia.Has evidence of at least partial bowel obstruction.I see no evidence of compromised bowel and hernia sac.Going to discuss with associates to see if they feel like this can be repaired with component separation procedure at our institution.¿ on (b)(6) 2017: ¿states abdomen is improved denies bowel movement or flatus.Nasogastric output copious.Abdomen minimal tenderness no guarding or rebound improved from yesterday¿s exam.Patient with incarcerated hernia and bowel obstruction some clinical improvement but is showing significant dehydration.¿ explant preoperative complaints: on (b)(6) 2017: ¿incisional hernia repair in 2014.She underwent an open primary repair of a 5 x 8 cm midline defect followed by laparoscopic intraperitoneal onlay mesh with 15 x 9 cm of dualmesh.Based on ct scan, patient has had complete disruption of the right and superior aspect of the intraabdominal peritoneal onlay mesh repair with incarceration of bowel within the hernia sac.¿ on (b)(6) 2017: ¿despite patient¿s clinical improvement, i'm still concerned about large volume of nasogastric output as well as the fact that she has not had any bowel movements or flatus.I'm concerned the incarcerated small bowel and recurrent incisional hernia is not going to improve with nonoperative management given severity of recurrence.¿ on (b)(6) 2017: ¿plan exploration of abdomen tomorrow with lysis of adhesions to relieve obstruction and mesh extirpation.In all likelihood, patient will be left with hernia defect that'll be closed with hernia sac and skin with plans to repair at a later date on elective basis.¿ on (b)(6) 2017: ct abdomen/pelvis: ¿an anterior abdominal wall hernia contains segments of both small and large bowel with a transition zone involving a loop of small bowel with a transition from dilated to decompressed small bowel along inferior aspect of hernia consistent with expected site of obstruction.¿ explant procedure: exploratory laparotomy.Extensive lysis of adhesions.Removal of hernia mesh.Repair of recurrent incisional hernia.Explant date: on (b)(6) 2017 [hospitalized on (b)(6) 2017].¿midline incision was made from just below the xiphoid around the umbilicus inferiorly through the skin and subcutaneous tissue with a knife.Dissection down to the anterior fascia was performed at the most cephalad portion of the incision corresponding to intact fascia on the ct scan.Continued dissection inferiorly was then carefully performed with combination of cautery and metzenbaum scissors until identifying the large hernia sac.This was isolated and mobilized circumferentially.The sac was quite large and extending subcutaneously on either side of the midline.This was completely dissected around to the level of the anterior sheath bilaterally to a point adjacent to the umbilicus inferiorly.There was a lot of thickened scar tissue present here in a bunching of the old hernia mesh.The hernia sac was entered with cautery along the midline with care taken to salvage as much of the sac as possible for potential closure.There was a moderate amount of ascitic fluid that was evacuated.Contents appeared to be incarcerated omentum and transverse colon and small bowel.At the right lateral aspect of the hernia sac at the level of the anterior fascia was a loop of small bowel that was knuckled next to an adhesive band.This was carefully taken down and inspected.This showed a clear transition point from dilated to decompressed bowel.This was monitored for several minutes and developed peristalsis and good perfusion.Multiple adhesive bands from the hernia sac to the transverse colon and omentum were divided with cautery.Once the hernia sac was completely opened and exposed the anterior abdominal wall is inspected further.There were several metallic tacks present on the right upper portion of the posterior rectus sheath and peritoneum.These were divided and removed carefully with metzenbaum scissors.A bunching of a large dualmesh was then seen pulled over across the midline to the left side of the abdomen densely adhered to the underlying peritoneum and posterior rectus sheath.Tedious and lengthy dissection was performed to remove the mesh and tacks with care taken to preserve as much of the posterior rectus sheath as possible for eventual abdominal wall reconstruction in the future.Ultimately the mesh was completely excised.¿ ¿the remaining hernia defect was inspected and measured about 15 x 10 cm.The anterior fascia could not be completely reapproximated in a tension-free fashion.A portion of the inferior anterior sheath could be brought together and was done so using a running #1 single-stranded pds.The remainder of the incision was closed using the remaining hernia sac as a fascial bridge and securing this together with running #1 single-stranded pds suture.The large subcutaneous space that remained after reduction of the hernia contents was irrigated with sterile saline solution.¿ relevant medical information: on (b)(6) 2017: ¿anticipate fever is related to atelectasis as patient has been laying in bed since surgery and not participating well with incentive spirometry.Encouraged aggressive pulmonary toilet.¿ on (b)(6) 2017: ¿noted to have tachycardia was a [sic] heart rates into 120¿s and today was noted to have heart rates in 140¿s with low blood pressure and fever.When i saw her she was complaining of dizziness and back pain.¿ ¿give digoxin 0.25 mg intravenous and if blood pressure improves consider beta blockers and/or calcium channel blockers.Rapid heart rate may be reflection of fever and low blood pressure as well.Postoperative fever: temperature = 101.4 f, given fever, drop in blood pressure and tachycardia sepsis needs to be considered and will do sepsis workup including lactic acid level.¿ on (b)(6) 2017: discharge summary: ¿underwent surgery on (b)(6) 2017 where she had a laparotomy with mesh extirpation and hernia repair utilizing a significant portion of hernia sac to close the midline.¿ 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.¿ 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, 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.There is insufficient information available for gore to reasonably draw conclusions related to aspects of the event, therefore conclusion code "4315: cause not established" is being used.Insufficient information may include limited or missing relevant medical records, involvement of multiple implanted devices (including non-gore devices) in the field of treatment, patient non-compliance, and/or a general lack of available detail or specificity related to an adverse event and/or device.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: 11928274.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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