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| Model Number 1405010010 |
| Device Problem
Insufficient Information (3190)
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| Patient Problems
Hernia (2240); No Clinical Signs, Symptoms or Conditions (4582)
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| Event Date 05/16/2014 |
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Event Type
Injury
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Manufacturer Narrative
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It should be noted that the gore-tex® soft tissue patch instructions for use addresses the following adverse reactions among others: ¿possible adverse reactions with the use of any tissue deficiency prosthesis may include, but are not limited to, contamination, infection, inflammation, adhesion, fistula formation, seroma formation, hematoma, and recurrence." the gore-tex® soft tissue patch instructions for use also states: ¿strict aseptic techniques should be followed.If an infection develops, it should be treated aggressively.An unresolved infection may require removal of the material.".
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Event Description
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It was reported to gore that the patient underwent congenital diaphragmatic hernia repair on (b)(6) 2014 whereby a gore-tex® soft tissue patch was implanted.It was reported the patient alleges the following injuries: pneumoperitoneum, free air, concern for a perforated viscus, loop of small intestine ischemic and perforated, serosal tear, resect 30cm segment of small bowel, ischemic small bowel, ostomy mucous fistula formation, adhesions, medial recurrence, spleen adherent to patch, stomach, colon, and pancreas were within the chest, colon herniated into the chest.Additional event specific information was not provided.
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Manufacturer Narrative
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B7: added medical history.H6: conclusion code remains unchanged.H10/11: added medical record information.Additional details regarding the patient's clinical course were ascertained from a review of medical records and are as follows: relevant medical information: (b)(6) 2014: (b)(6).Nurse notes- intraoperative record.Weight 3.6 kg [7.9 pounds].Procedure: diaphragmatic hernia repair.Dressings: 4 x 4, mastisol, prox-strips secured with tegaderm to abdomen.Implant procedure: left congenital diaphragmatic hernia repair with gore-tex patch (8 cm x 6 cm).Implant: gore-tex® soft-tissue patch [1405010010/(b)(6), 5 cm x 10 cm x 1mm; diaphragm].Implant date: (b)(6) 2014 (hospitalization- admitted (b)(6) 2014 discharge date no indicated).(b)(6) 2014: (b)(6).(b)(6) md.Operative report.Preoperative diagnosis: left congenital diaphragmatic hernia.Weight 3.6 kg.Postoperative diagnosis: left congenital diaphragmatic hernia.Weight 3.6 kg.Name of procedure: left congenital diaphragmatic hernia repair with gore-tex patch (8 cm x 6 cm).Assistant: (b)(6), md.Anesthesia: general endotracheal.Estimated blood loss: 10 ml.Specimens: none.Patient condition: critical.Indication for procedure: this is a 2-week-old african american female who presented to (b)(6) with respiratory distress and a left congenital diaphragmatic hernia.She was undergone initial stabilization with fluid resuscitation and ventilator support.She now presents at an appropriate window for repair of her diaphragmatic hernia.The risks and benefits of the procedure were discussed in detail with the family and they wished to proceed with the procedure.Operative consent was obtained.Description of procedure: ¿this procedure was performed in the neonatal intensive care unit.The child was positioned appropriately on the neonatal bed and all pressure points were padded.The abdomen was then prepped and draped in the standard surgical fashion.A left subcostal incision was made with the cutting current of the bovie cautery.Dissection was carried down through the subcutaneous tissue and abdominal wall musculature with bovie cautery.We then entered the abdomen sharply and opened it the entire length of our incision.On visualization of the abdomen we were able to mobilize the left lobe of the liver by taking down the triangular ligament.This was mobilized medially.We then were able to reduce the contents from the diaphragmatic hernia.There was no sac.Within the left chest there as colon, small bowel and spleen.The spleen was reduced last and all of these contents were packed into the abdomen.On reducing the small bowel, a small serosal tear was created and this was repaired with interrupted silk suture.Once the contents were packed into the abdomen we were able to visualize a nice anterior rim of diaphragm; however, this discontinued laterally and there was no posterior rim.We then were able to visualize a small left lung in the upper chest.We then fashioned a patch for a patch repair of this since there was no posterior rim and this would not be able to be fixed primarily.We then fashioned a gore-tex patch that was 8 cm x 6 cm.We then used 2-0 nurolon sutures to sew in the posterior portion of the patch and these sutures were sewn around the posterior ribs.Medially we took small bites of the muscle and adventitia around the aorta and then utilized the medial portion of the diaphragm at the hiatus.All of these sutures were ties down carefully.Surgicel was placed on the suture line.We then began the anterior closure of the diaphragmatic defect, sewing the patch to the anterior rim of the diaphragm with 2-0 nurolon suture.Once this was completely sewn in the child then began to have some hypercarbia and there was concern for kinking or mucous plugging in the tube.The packs were pulled out of the abdomen and allowed appropriate ventilation.We then evaluated the bowel.The child was malrotated; however, there were no ladd bands to be noted.The bowel was placed back into the abdomen.The spleen was placed in the left upper quadrant.The suture line at the diaphragmatic hernia repair was inspected and it was hemostatic.We then began closure of the fascia with running vicryl suture.The child continued to be hypercarbic.This the existing endotracheal tube was removed and the child was reintubated in the nicu.Immediately there became increased chest wiggle and the gases improved.The fascial closure was then finished and the subcutaneous tissue was reapproximated with 4-0 vicryl suture and the skin was reapproximated with 5-0 monocryl subcuticular sutures.Mastisol and steri-strips were applied and sterile dressings.The postoperative gas showed an improving respiratory acidosis.The postoperative chest x-ray showed the endotracheal tube in good position, full aeration of the right lung and a left-sided pneumothorax from left congenital diaphragmatic hernia repair.This concluded our procedure.All sponge and needle counts were reported as correct at the end of the case.I was present and participated in the entire procedure.The patient was left in the neonatal intensive care unit in critical condition.¿ (b)(6) 2014: (b)(6).Implant record.Implant: goretex soft tissue patch 5 cm x 10 cm x 1 mm.Manufacturer: w l gore general surgery and vasc.Model #: 1405010010.Serial #: (b)(6).Lot #: 6953420.Quantity: 1.Implant size: goretex soft tissue patch 5 cm x 10 cm x 1 mm.Expiration date: 08/03/2014.Body site implanted: diaphragm.¿ the records confirm a gore-tex® soft-tissue patch (1405010010/(b)(6)) was implanted during the procedure.Relevant medical information: (b)(6) 2014: (b)(6) (b)(6) md.Operative report.Preoperative diagnosis: status post left congenital diaphragmatic hernia repair.Pneumoperitoneum.Postoperative diagnosis: status post left congenital diaphragmatic hernia repair.Ischemic small bowel.Names of procedures: 1.Reopening of recent laparotomy.2.Small-bowel resection.3.Enteroenterostomy.4.Creation of jejunostomy.5.Creation of mucous fistula.Co-surgeon: (b)(6) md.Anesthesia: general endotracheal anesthesia.Estimated blood loss: 10 ml.Specimens: small bowel to surgical pathology.Patient condition: critical.Indications for procedure: this is a less than 2-week-old female who recently underwent left congenital diaphragmatic hernia repair.She had done well postoperatively and the ventilator has been weaned.On this morning¿s x-ray, it showed pneumoperitoneum.There was a significant amount of free air and we recommended exploration for concern for a perforated viscus.The risks and benefits of the procedure were discussed in detail with the mother and she signed operative consent.Description of procedure: ¿this procedure was performed in the neonatal intensive care unit.General endotracheal anesthesia was performed and perioperative antibiotics were administered.A time-out was performed with the entire operative team.The patient¿s abdomen was then prepped and draped in the standard surgical fashion.A 15-blade scalpel was used to reopen the prior left subcostal incision.Dissection was carried down through the subcutaneous tissue with bovie cautery.The prior place sutures were removed and the abdomen was opened.Initially, upon entry into the abdomen there was no contamination noticed.We did note her previous serosal tears in the small bowel; the one that was unrepaired and the one that was repaired.After eviscerating the small bowel down in the right lower quadrant, there was a loop of small intestine that appear that this was a closed-looped obstruction or secondary to serosal injury.This bowel was exteriorized and there was a frankly necrotic loop.However, on either side of this loop there were several questionable areas of ischemia.It was difficult to discern if it was a primary ischemic process or necrotizing enterocolitis.We then ran the bowel completely from the ligament of treitz all the way to the ileocecal valve and then back again to ensure that we did not miss any additional areas of perforation.One area of serosal tear was repaired with interrupted 4-0 vicryl suture.We then decided to resect an approximately 30-cm segment of small bowel including the areas of perforation.A hemostat clamp was used to make a window in the proximal and distal mesentery and silk ties were tied around the bowel.The bowel was divided and the mesentery was taken with bovie cautery.There was an additional segment distal in the proximal to mid ileum that also required resection.The bowel was tied with silk ties.The mesentery was taken with bovie cautery.We chose the site were we would bring out our proximal ostomy and mucous fistula.We then performed a primary anastomosis with 4-0 vicryl suture between the distal segments of small bowel and this area to be diverted with a mucous fistula.Once this anastomosis was achieved, we then turned our attention to creation of a site for the proximal ostomy and mucous fistula.The proximal ostomy was brought out below our left subcostal incision on the left side of the abdomen.A 15-blade scalpel was used to make an incision here and bovie cautery was carried down through the fascia.A hemostat clamp was used to widen the area and the proximal ostomy was pulled out of this stoma.We then elected to bring out the mucous fistula through a separate incision in the more medial aspect of the abdomen.Incision was made with a 15-blade scalpel and dissected was carried down through subcutaneous tissue with bovie cautery.A hemostat was used to bluntly dissect into the abdomen and enlarge this incision and fascial opening.The mucous fistula was grasped through the wound and pulled out of this existing stoma.A sufficient amount of length was pulled out for both the proximal and distal ostomy.We ensured that the mesenteries were not twisted.We then irrigated the abdomen copiously.A penrose drain was placed through a separate right lower quadrant incision to further drain the abdomen secondary to the small amount of contamination and the existing gore-tex patch in place.This was placed throughout the abdomen and up toward the left upper quadrant.The drain was sewn in with interrupted nylon suture.We then closed the fascia with running 2-0 vicryl suture.A vessel loop was placed on the subcutaneous tissue and the incision was reapproximated with interrupted monocryl suture.We then tacked the ostomy down to the skin with interrupted vicryl suture.Vaseline gauze was placed over the ostomies.This concluded our procedure.All sponge and needle counts were reported as correct at the end of the case.I was present and participated in the entire procedure.The patient was left in the neonatal intensive care unit in critical condition.¿.(b)(6) 2014: (b)(6).(b)(6) md.Surgical pathology.Final pathological diagnosis: intestine, small #1, segmental resection: extensive ischemic injury with edema, congestion, marked hemorrhage, and perforation with acute peritonitis (clinical: status post left congenital diaphragmatic hernia repair).Intensive, small #2, idem: edema, marked congestion, focal hemorrhage, and patchy ischemic injury with bowel wall thinning, and mild peritonitis (clinical: status post left congenital diaphragmatic hernia repair).Clinical history: two-week-old black female who is status post left congenital diaphragmatic hernia repair recently.She now has pneumoperitoneum with possible bowel injury/ perforation.Segmental small bowel resections were performed.(b)(6) 2014: (b)(6).(b)(6) rn.Nurse notes- intraoperative record.Weight 5.36 kg [11.7 pounds].Procedure: exploratory laparotomy, ostomy takedown, central line placement; colostomy closure; gastrostomy.Tubes and drains: ostomy with drainage bag noted.Dressings: bio-patch applied to left chest secured with tegaderm.2 x 2 gauze, mastisol, proxi-strip applied to abdomen.Specimen: mucous fistula and ostomy.(b)(6) 2014: (b)(6) hospital.(b)(6) md.Operative report.Preoperative diagnosis: status post left congenital diaphragmatic hernia repair.Status post jejunostomy and mucous fistula.Difficult intravenous access.Weight 12.2 kg [26.7 pounds].Postoperative diagnosis: status post left congenital diaphragmatic hernia repair.Status post jejunostomy and mucous fistula.Difficult intravenous access.Weight 12.2 kg.Names of procedures: 1.Placement of a tunneled 4.2 french, right internal jugular vein, broviac catheter.2.Use and surgeon interpretation of intraoperative fluoroscopy.3.Use and surgeon interpretation of intraoperative fluoroscopy.4.Use and surgeon interpretation of intraoperative ultrasound.5.Takedown of jejunostomy and mucous fistula with primary anastomosis.Assistants: (b)(6) md.Anesthesia: general endotracheal.Estimated blood loss: fifteen ml.Specimens: ostomy to surgical pathology.Mucous fistula to surgical pathology.Patient condition: stable.Indication for procedure: this is a 3-month-old infant who had a left congenital diaphragmatic hernia.She underwent patch repair.Postoperative she had a segment of ischemic small bowel and required re-exploration and ostomy mucous fistula formation.She also had difficult intravenous access.Plans for her today were to take her ostomy down and place a central venous line for intravenous access.The risks and benefits of the procedure were discussed in detail with the family and they wished to proceed with the procedure.Operative consent was obtained.Description of procedure: ¿the patient was taken to the operating room and general anesthesia was induced.A preoperative time-out was performed and then preoperative antibiotics were administered.Her upper neck and chest and abdomen were prepped and draped in the standard surgical fashion.The abdomen was draped out of the field during central venous line placement.The right internal jugular vein was identified with the ultrasound.A micropuncture needle was used to access the right internal jugular vein under direct intraoperative ultrasound.We visualized the needle puncturing the right internal jugular vein and venous aspirate was obtained.A wire was placed through the needle into the central venous system and confirmed to be there under intraoperative fluoroscopy.We then exchanged the wire for the central venous line.We then made an incision over the right anterior chest wall and tunneled the central venous line with the cuff buried in the subcutaneous tissue.We then carefully measured the central venous line for appropriate length.The dilator and sheath were placed over the wire into the central venous system under intraoperative fluoroscopy.The wire and dilator were removed and the catheter was placed through the peel-away sheath.The catheter flushed and drew without any difficulty and it was confirmed to be just above the cavoatrial junction on intraoperative fluoroscopy.The catheter was secured to the anterior chest wall with interrupted nylon suture.The right neck incision was closed with interrupted monocryl and dermabond.Biopatch and sterile dressings were applied.The central venous line was then draped out into the field and the abdomen was uncovered.We then placed multiple 5-0 silk sutures around both the ostomy and mucous fistula.We then reopened the left subcostal incision, carrying it through the fascia and into the peritoneum carefully.We then performed lysis of adhesions for approximately 1 hour.The ostomy and mucous fistula were carefully taken down with bovie cautery and freed away from the fascia.These were then taken down from the abdominal side and completely freed.Once we identified the proximal ostomy and the mucous fistula we carefully took down adhesions so that they were completely freed.We ensured that the mesenteries were not twisted.We then trimmed a portion of the ostomy and mucous fistula to freshen up the edges.We then closed the mesenteric trap with interrupted vicryl suture.After closing the mesenteric trap we then tested the anastomosis with a 25 gauge needle and saline.We then clamped off the distal portion of the intestine and saline went through the anastomosis and was milked back and forth with no evidence of leak.The bowel was then placed back into the abdomen.The abdomen was irrigated copiously.We then freed up the fascia at the ostomy site and closed the ostomy sites with interrupted 2-0 vicryl suture.We then created flaps at the left subcostal incision and freed up the fascia.This was then closed with 2-0 vicryl suture.The subcutaneous tissue was then reapproximated with interrupted 4-0 vicryl suture and the skin was closed with running 5-0 monocryl.At the ostomy sites a 4-0 monocryl purse-string suture was used to close these.Mastisol and steri-strips were applied and sterile dressings.This concluded our procedure.All sponge and needle counts were reported as correct at the end of the case.I was present and participated in the entire procedure.The patient was extubated and taken to the recovery room in stable condition.¿ (b)(6) 2014: (b)(6).(b)(6) md.Pathology.Final pathological diagnosis: intestine, small, mucous fistula, excision: consistent with mucous fistula.Eosinophilic infiltration.Intestine, small, jejunum, ostomy closure: ostomy site.Clinical history: eleven-week-old black female with a history of diaphragmatic hernia and ischemic bowel disease who is status post ostomy.Excision of mucous fistula and ostomy closure was performed.(b)(6) 2014: (b)(6) hospital.(b)(6) md.Letter to uab pediatric surgery, (b)(6) md.I had the pleasure of seeing baby girl (b)(6) in the pediatric surgery clinic today.She is a 4-month-old female who had a left congenital diaphragmatic hernia that underwent repair.Unfortunately postoperatively she had a bowel perforation and required exploration and creation of an ostomy and mucous fistula.This was subsequently taken down in late (b)(6) and she as discharged subsequently thereafter.Since her discharge to home, she has been doing very well.Feeding well, having 2-3 normal bowel movements per day.Mother comments she is not having any vomiting.Recently seen a cardiologist in mobile who was happy with her follow-up.They have taken her off medications and now off oxygen.Growth has been good since her discharge from hospital; current weight 7.39 kg [16.3 pounds].Exam: abdomen is soft, nondistended.Well healed left subcostal incision.Also has a well healed area where her ostomies were placed.I appreciate no evidence of inguinal hernias.Pa and lateral chest x-ray shows no evidence of any recurrence of her diaphragmatic hernia.She does have some small amount of density in her left lower lobe which may be related to atelectasis.Impression: status post left congenital diaphragmatic hernia repair, subsequent creation of an ostomy after bowel perforation and subsequent ostomy takedown.Plan: see her back in 2-3 months with repeat pa and lateral chest x-ray.(b)(6) 2015: (b)(6).(b)(6) md.Letter to uab pediatric surgery, (b)(6) md.Here for follow-up of her left-sided congenital diaphragmatic hernia.Last seen in clinic by my partner, dr.(b)(6), back in (b)(6).Since then, her mom states that overall she has been doing reasonably well.Feeding well and stooling regularly.Taking both formula and baby foods.Not having significant vomiting or reflux type symptoms.Had no significant abdominal distention.Denies respiratory difficulties.No recent fevers or illnesses.Exam: weight 9.9 kg [22 pounds].Abdomen is soft, nontender and nondistended.Her abdominal incision is well healed without any palpable fascial defects.Imaging: pa and lateral chest x-ray demonstrates clear lung fields for the most past, though there is some increased density in the region of the patch.I am suspicious that its appearance may suggest a recurrence of her diaphragmatic hernia.Impression/plan: recommend she undergo upper gastrointestinal study with small-bowel follow through.See her back in 6 months.(b)(6) 2015: (b)(6).(b)(6) md.Letter to (b)(6) pediatric surgery, (b)(6), md.She was followed up in our congenital diaphragmatic hernia clinic with dr.(b)(6) and there was some concern for possible recurrence of her diaphragmatic hernia.(b)(6) was been doing well.She is taking formula well and also taking baby food without any difficulty.No issues with vomiting or feeding intolerance and stooling on a regular basis.Occasionally she has cough but no fever and this cough is never productive.No symptoms of feeding intolerance or gastroesophageal reflux disease.She recently had an upper gastrointestinal done in mobile which suggests a recurrence of the left diaphragmatic hernia with what appears to be either a small bowel or colon within the left chest.Exam: weight 9.9 kg [22 pounds].Abdomen is soft and nondistended.Left upper quadrant subcostal incision from her diaphragm repair and 2 well-healed incisions form her ostomies.Imaging: i reviewed her upper gastrointestinal with small-bowel follow-through that was done in mobile which shows likely colon within the left hemithorax with slight dilation but there is no obstruction of this.I have also reviewed her prior echocardiogram which was done in april prior to her diaphragmatic repair.She had a mildly hyperplastic left pulmonary artery, some right ventricular hypertension, a left pda and mild mitral valve insufficiency.She had a repeat echocardiogram on (b)(6) 2014 which showed improvement in her right ventricular pa pressures and an otherwise normal echocardiogram.Impression: recurrence of left congenital diaphragmatic hernia.Plan: discussed in detail with the mother my recommendation for repair of this recurrent congenital "diaphragmatic" hernia.My concern would ne that this may lead to an obstructive process or if there is any torsion of the bowel while in the chest his would potentially lead to strangulation of the bowel.Currently she is asymptomatic and i have discussed the symptoms that would go along with potential obstruction and strangulation.I did discuss the need for repair.This will likely be through a laparotomy and possible use of thoracoscopy if needed.We will get this scheduled for a mutually convenient time.I explained the risks and benefits associated with the procedure including infection, bleeding, bowel injury, need for splenectomy, and possible recurrence.¿ (b)(6) 2015: (b)(6).(b)(6) md.(b)(6) (resident); (b)(6) (physician).History and physical.10 month old with history of previous left diaphragmatic hernia repair with gore-tex patch on (b)(6) 2014 presented with recurrent left diaphragmatic hernia.She had been followed in clinic and has been doing well.Eats normally and has normal bowel function.Upper gastrointestinal from osh revealed likely colon within left hemidiaphragmatic suggesting recurrence of diaphragmatic hernia.Parents deny any obstructive symptoms.Presents for placed repair of left diaphragmatic hernia.Exam: left upper quadrant surgical scar healed well.Ostomy site healed well.Impression/plan: recurrent hernia.Admit to dr.Russell pediatric surgery.Clear liquids today; nothing after midnight.Bowel prep today.(b)(6) 2015: (b)(6).(b)(6) (physician); (b)(6) (np).Discharge summary.Admit/discharge date: (b)(6) 2015.Hospital course and plan: admitted for an exploratory laparotomy repair of recurrent left diaphragmatic hernia, possible left "thoracoscopy" vs thoracotomy by dr.Russell on (b)(6) 2015.Surgery was canceled due to otitis media and fever.Discharged home to complete 7 more days of augmentin.¿ (b)(6) 2015: (b)(6).(b)(6) (resident); (b)(6) (physician).History and physical.11 month old with history significant for congenital diaphragmatic hernia status post repair who presents as a preoperative admission for or tomorrow for recurrent diaphragmatic hernia repair.Patient had a left sided congenital diaphragmatic hernia repair with a gore-tex patch on (b)(6) 2014, then had a small bowel repair with ostomy creation on (b)(6) 2014 then ostomy takedown on (b)(6) 2014.Has done well since that time.Tolerating feeds, having normal bowel movements and having no respiratory difficulties.Recent had an upper gastrointestinal at osh that was concerning for hernia recurrence.Given this imaging, she was booked for repair.Exam: abdomen soft, nondistended, nontender, well-healed scars and ostomy site.Impression/plan: recurrent diaphragmatic hernia.Admit to dr.Russell on pediatric surgery.Clear liquids today, nothing by mouth at midnight.Or tomorrow.Consent obtained from mother on chart.Bowel prep tonight.(b)(6) 2015: (b)(6).(b)(6) rn.Nurse notes- intraoperative record.Weight 10.67 kg [23.5 pounds].Procedure: exploratory laparotomy.Dressings: 2 x 2 and tegaderm, vaseline gauze applied to left chest.Mastisol, proxi-strips applied to abdomen.(b)(6) 2015: (b)(6).(b)(6) md.Operative report.Preoperative diagnosis: recurrent left congenital diaphragmatic hernia.Postoperative diagnosis: recurrent left congenital diaphragmatic hernia.Names of procedure: 1.Exploratory laparotomy.2.Repair of recurrent left congenital diaphragmatic hernia.Assistant: (b)(6) md.Anesthesia: general endotracheal anesthesia.Estimated blood loss: 15 ml.Specimens: none.Patient condition: stable.Indication for procedure: this is a 1-year-old female who had a congenital diaphragmatic hernia repaired with a gore-tex patch.On follow-up, there was concern that she had a recurrence of her hernia.An upper gi was performed and she had a medical recurrence.We recommended repair.This risks and benefits of the procedure were discussed in detail with the family and they wished to proceed with the procedure.Operative consent was obtained.Description of procedure: ¿the patient was taken to the operating room and general anesthesia was induced.A preoperative time-out was performed and perioperative antibiotics were administered.The chest and abdomen was prepped and draped in the standard surgical fashion.A 15-blade scalpel was used to make an incision over her prior left subcostal incision.This was opened with bovie cautery all the way down to the fascia.The peritoneum was entered sharply.We did take down the abdominal wall adhesions to the bowel carefully with sharp dissection.The spleen was densely adherent to the patch and this was carefully dissected free.We started from lateral and proceeded medial.The lateral portion of the patch was intact laterally and there was no evidence of ant recurrence in this area.We were able to define the posterior portion of the patch that was still in place.Her anterior diaphragm had stretched out and she had a good amount of anterior diaphragm present.In order to visualize, we decided to split the suture line between the native diaphragm and the patch so we could proceed medially in a safe fashion.We performed this.We opened the patch and it was apparent that the stomach, colon and pancreas were within the chest.Once we had completely dissected the patch free from the native diaphragm, we were able to reduce these structures with some lysis of adhesions as these structures were adherent to the lower lobe of the left lung.Once these were successfully reduced, we were able to define the medial anatomy with the aorta and the esophagus visualized.The orogastric tube could be palpated with ease.The left crus was defined medially.Once we defined these structures, we felt that we could close the native diaphragm and left crura to the patch without any placement of any additional patch.We used 2-0 nurolon sutures and started medially and tacked the patch to the left crura medially and then to the native diaphragm.We then proceeded along laterally, closing the patch back to the native diaphragm.Once we completed our repair, there was minimal tension between the patch and the diaphragm.It should be noted that prior to tying our sutures down we placed a left chest tube through an incision in approximately the 5th intercostal space.It was tunneled over the rib and we were able to visualize the chest tube in the chest prior to closure of the diaphragmatic defect.This was secured to the anterior chest wall with interrupted nylon suture.Once we had completed our closure of the diaphragm, we ensured that hemostasis was obtained.There were several areas of spleen that the capsule was disrupted and these were ensured to be hemostatic.Surgicel was placed on these areas along with bovie cautery.We then irrigated and ensued that hemostasis was obtained.The fascia was then closed with running 2-0 vicryl suture after creating some skin flaps to define healthy fascia.We then closed the subcutaneous tissue with interrupted vicryl suture and the skin was closed with 5-0 monocryl.Mastisol and steri-strips were applied and sterile dressings.The chest tube was hooked to a pleur-evac.This concluded our procedure.All sponge and needle counts were reported as correct at the end of the case.I was present and participated in the entire procedure.The patient¿s postoperative chest x-ray in the pacu was clear with no hemothorax or pneumothorax.¿.¿ (b)(6) 2015: (b)(6).(b)(6) (resident); (b)(6) (physician).Discharge summary.Admit date: (b)(6) 2015.Discharge date: (b)(6) 2015.Primary diagnosis: congenital diaphragmatic hernia.Hospital course and plan: admitted, taken to or, tolerated the procedure well.Some issues tolerating diet, otherwise benign post-operative course.Tolerating ape appropriate diet.Discharged in good condition.Weight 11.8 kg [26 pounds].Keep wound clean and dry.(b)(6) 2015: (b)(6).(b)(6) md.Letter to pediatric surgery, (b)(6) md.She underwent exploratory laparotomy with repair of her recurrent congenital diaphragmatic hernia on (b)(6) 2015.Since that time she had been doing very well.Eating and drinking without difficulty.Of note, recently she has developed a rash over her abdomen and her forehead and upper face and the mother has comments that they are being treated for eczema.No respiratory problems since operation.They come in today for routine postoperative follow-up.Exam: weight 10.9 kg [24 pounds].Abdominal incision is well healed.Assessment: status post repair of left congenital diaphragmatic hernia, recurrent.Plan: plan to see her back in 3 to 6 months with repeat pa and lateral chest x-ray.
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Manufacturer Narrative
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It should be noted that the gore-tex® soft tissue patch instructions for use addresses the following adverse reactions among others: ¿possible adverse reactions with the use of any tissue deficiency prosthesis may include, but are not limited to, contamination, infection, inflammation, adhesion, fistula formation, seroma formation, hematoma, and recurrence.The gore-tex® soft tissue patch instructions for use also states: ¿strict aseptic techniques should be followed.If an infection develops, it should be treated aggressively.An unresolved infection may require removal of the material.W.L.Gore & associates, inc.(gore) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by gore, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Blank fields present on this report include required fields and fields determined to be not applicable.Blank required fields indicate that the information was not provided, was deemed unavailable or was not applicable.This report does not constitute an admission or a conclusion by fda, gore, or its associates that the device, gore or its associates caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects" or has "malfunctioned".These words are included in the report and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.
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Manufacturer Narrative
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H6: updated health effect h6: updated investigation finding h6: updated type of investigation h6: updated investigation conclusions the investigation has been completed.Based upon the totality of the information received over the course of the investigation and reported by gore in the previously submitted medical record narratives the following conclusions have been reached.As previously reported, all pertinent medical records requested may not have been received.Through gore's investigation and based on the available information there is no available information that reasonably suggests that a gore device may have caused or contributed to death, serious injury or reportable malfunction, and is no longer considered reportable.Therefore, this event is being coded as no clinical signs, symptoms or conditions, no health consequences or impact and will be closed as¿no problem detected.Previous patient codes were reported based on the original complaint and are no longer applicable and/or not reportable per gore¿s investigation.Following gore¿s investigation, the previously submitted annex f code has been updated to reflect gore¿s final conclusion.It should be noted that the gore-tex® soft tissue patch instructions for use include warnings and addresses the following adverse reactions among others: ¿possible complications with the use of any tissue deficiency prosthesis may include, but are not limited to, infection, seroma formation, adhesions, hematomas, inflammation, fistula formation and recurrence.¿ it should be noted with use of the device in patients with the potential for growth, tissue expansion, or significant change in body habitus, the surgeon should be aware that the device will not stretch or change with the patient¿s body.Medical records that indicate mesh ¿movement¿ or that the device led to a recurrence may reflect a recurrence as a function of a patient¿s poor tissue quality leading to fascial dehiscence or loss of anchorage of fixation, or may be related to the hernia type, individual patient comorbidities, and technical and procedural aspects of the repair.These factors include but are not limited to, fixation type, mesh shape/sizing used, and defect closure decisions.Additionally, a new, unrelated hernia can occur but may be referred to as a recurrent hernia.As with any surgical procedure, there are always risks of complications for surgical repair of hernias and soft tissue deficiencies, with or without mesh.¿these may include but are not limited to, adhesions and related harms, bleeding, bowel obstruction, compromised device biocompatibility, contamination which may lead to patient harms, device damage, dysphagia, erosion or extrusion and related harms, exposure or protrusion and related harms, fever, fistula, gerd recurrence, defect recurrence and related harms, ileus, increased procedure time and related harms, irritation or inflammation, infection, mesh migration, mesh contraction, pain, paresthesia, perforation, revision/re-intervention, seroma or hematoma and related harms, tissue ischemia, wound complications and wound dehiscence and additional intervention including surgery.Many of the potential complications are associated with the patient¿s underlying disease progression, co-morbidities, additional medical history and/or other surgical procedures.¿the above inherent risks are typically detailed in standard informed consent documents.¿ 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.¿ 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 health effect.H6: updated investigation finding.H6: updated type of investigation.H6: updated investigation conclusions.The investigation has been completed.Based upon the totality of the information received over the course of the investigation and reported by gore in the previously submitted medical record narratives the following conclusions have been reached.As previously reported, all pertinent medical records requested may not have been received.Through gore's investigation and based on the available information there is no available information that reasonably suggests that a gore device may have caused or contributed to death, serious injury or reportable malfunction, and is no longer considered reportable.Therefore, this event is being coded as no clinical signs, symptoms or conditions, no health consequences or impact and will be closed as¿no problem detected.Previous patient codes were reported based on the original complaint and are no longer applicable and/or not reportable per gore¿s investigation.Following gore¿s investigation, the previously submitted annex f code has been updated to reflect gore¿s final conclusion.It should be noted that the gore-tex® soft tissue patch instructions for use include warnings and addresses the following adverse reactions among others: ¿possible complications with the use of any tissue deficiency prosthesis may include, but are not limited to, infection, seroma formation, adhesions, hematomas, inflammation, fistula formation and recurrence.¿ it should be noted with use of the device in patients with the potential for growth, tissue expansion, or significant change in body habitus, the surgeon should be aware that the device will not stretch or change with the patient¿s body.Medical records that indicate mesh ¿movement¿ or that the device led to a recurrence may reflect a recurrence as a function of a patient¿s poor tissue quality leading to fascial dehiscence or loss of anchorage of fixation, or may be related to the hernia type, individual patient comorbidities, and technical and procedural aspects of the repair.These factors include but are not limited to, fixation type, mesh shape/sizing used, and defect closure decisions.Additionally, a new, unrelated hernia can occur but may be referred to as a recurrent hernia.As with any surgical procedure, there are always risks of complications for surgical repair of hernias and soft tissue deficiencies, with or without mesh.These may include but are not limited to, adhesions and related harms, bleeding, bowel obstruction, compromised device biocompatibility, contamination which may lead to patient harms, device damage, dysphagia, erosion or extrusion and related harms, exposure or protrusion and related harms, fever, fistula, gerd recurrence, defect recurrence and related harms, ileus, increased procedure time and related harms, irritation or inflammation, infection, mesh migration, mesh contraction, pain, paresthesia, perforation, revision/re-intervention, seroma or hematoma and related harms, tissue ischemia, wound complications and wound dehiscence and additional intervention including surgery.Many of the potential complications are associated with the patient¿s underlying disease progression, co-morbidities, additional medical history and/or other surgical procedures.The above inherent risks are typically detailed in standard informed consent documents.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.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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Search Alerts/Recalls
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