| Device Problems
No Apparent Adverse Event (3189); Insufficient Information (3190)
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| Patient Problems
Adhesion(s) (1695); No Code Available (3191); No Clinical Signs, Symptoms or Conditions (4582)
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| Event Date 08/09/2010 |
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Event Type
Injury
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Manufacturer Narrative
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(b)(6).(b)(4).It should be noted that although the brand name and lot# of a gore device has not been provided, the instructions for use for the vast majority of gore¿s eptfe patch products that are indicated for the reconstruction of soft tissue deficiencies include the following warnings among others: ¿possible reactions with the use of any tissue deficiency prosthesis may include, but are not limited to, contamination, infection, inflammation, adhesion, fistula formation, seroma formation, hematoma, and recurrence.¿.
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Event Description
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It was reported to gore that the patient underwent laparoscopic ventral hernia repair on (b)(6) 2004, whereby an alleged gore device was implanted.The complaint alleges that on (b)(6) 2010, an additional procedure occurred whereby the gore device was explanted.It was reported the patient alleges the following injuries: extensive lysis of adhesions, separation of the mesh, additional surgeries.Additional event specific information and medical records have been requested.
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Manufacturer Narrative
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The plaintiff voluntarily withdrew the lawsuit on march 29, 2019, therefore, this event will be captured as a false claim.Code 4316: appropriate term/code not available is being used for "false claim.".
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Manufacturer Narrative
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Other relevant history: added medical history.Code 4118/3221 - product identification records for the alleged gore device was not provided.Therefore, a review of the manufacturing records could not be performed.Conclusion code remains unchanged.Additional details regarding the patient's clinical course were ascertained from a review of medical records and are as follows: medical records dated (b)(6) 2003 state: ¿chief complaint: morbid obesity.¿ the records state: ¿the patient is a 35-year-old, white male who is 5' 11¿ tall, weighs 401.1 pounds with a calculated body mass index of 57.This patient is 230 pounds above his ideal body weight.[the patient] suffers from exertional dyspnea, pedal edema, heartburn, multiple joint pain and arthritis as a result of his morbid obesity.He has been obese most of his adult life and has tried multiple methods of weight loss in the past including using the help of his personal physicians, weight watcher's, weight loss programs, low calorie, low fat diets as well as meridia.He has lost a maximum of [illegible] pounds and has regained all this weight back and is here today for evaluation [illegible] roux-en-y-gastric exclusion surgery as treatment of his morbid obesity.¿.Operative records dated (b)(6) 2003 indicate the patient underwent roux-en ¿y gastric bypass.Preoperative and postoperative diagnosis ¿morbid obesity, gerd, borderline htn [hypertension], dyspnea on exertion, fluid retention, djd [degenerative joint disease].¿ operative findings state ¿a retro-colic, ante-gastric roux-en-y jejunal bypass was performed to an approximate 15-20 cc isolated gastric pouch based on the lesser curve.The anastomosis was done in a hand-sewn two-layer technique.¿.Operative records dated (b)(6) 2003 state: ¿an upper midline incision was made to the umbilicus.The subcutaneous tissue was divided with electrocautery and bluntly by pulling on both sides of the abdominal wall.The midline fascia was identified and opened the full length of the incision.The peritoneum was penetrated bluntly over the liver and opened the full length of the incision.The falciform ligament was excised with electrocautery and 0-chromic ties.Initial abdominal findings were notable for a normal liver, gallbladder and no suspicious masses.The upepr [sic] g-e junction was noted to be deep.A balfour retractor was placed over lap pads.· attention was turned to the infra-colic abdomen.The ligament of treitz was identified and the small bowel was run distally until an adequate mesenteric length was seen and the vascular arcades were confirmed to be symmetric.¿.Operative records dated (b)(6) 2003 continue: ¿the small bowel was divided at this point with an ethicon linear 55mm stapler with a blue load.An additional fire of the stapler was made down through the first vascular arcade.Hemostasis was obtained with electrocautery.The small bowel was now run distally and the roux limb was fashioned.A stay suture of 3-0 silk was placed at the base of the roux limb and the distal aspect of the biliopancreatic limb.The remainder of the small bowel was carefully measured and found to be 560 cm to the cecum.This was the common channel length.¿.Operative records dated (b)(6) 2003 state: ¿at the previously placed stay suture two enterotomies were made and a side-to-side jejunojejunostomy was fashioned with the ethicon linear 55mm stapler utilizing a blue load.The common enterostomy was inspected for bleeding and closed with an ethicon ta-60 stapler.Two 3-0 silk sutures were placed at the vertex of the anastomosis to relieve tension.The mesenteric defect was closed with a running 3-0 maxon and all staple lines were over-sewn.The efferent limb was tacked to the distal aspect of the jejunojejunostomy to avoid kinking.Hemostasis and a patent efferent limb and anastomosis were confirmed.Attention was now turned to the upper abdomen.¿.Operative records dated (b)(6) 2003 state: ¿the falciform ligament was taken down with electrocautery over the dome of the liver to the diaphragm.An upper hand retractor blade was placed over lap pads and directed and fixed toward the left shoulder.The patient was now placed in steep reverse trendelenburg positioning.The left lobe of the liver was mobilized by dividing the ligamentous attachments with cautery and then the liver was reflected and fixed toward the right shoulder with an additional padded attachment of the upper hand retractor.Excellent visualization of the ge junction was confirmed.The soft tissue just lateral to the angle of his was divided with sharp dissection and a window was made into the retro-gastric space.Care was taken to avoid the spleen and short gastric vessels, which were preserved.Operative records (b)(6) 2003 states: ¿finger dissection was then used to create a retro-gastric tunnel, which was brought out to a point on the lesser curvature 7 cm distal to the ge junction.Care was taken to sweep and preserve the vagal branches medially.A penrose drain was placed and used for retraction.A rolled moist lap was placed to protect the spleen.An ethicon linear 100mm stapler with a blue load w8s now placed through the retro-gastric tunnel and the ng tube was removed.A pouch of approximately 15-20 cc was fashioned and the stapler was fired.Full division was obtained and both staple lines were oversewn with 3-0 maxon sutures.¿.Operative records dated (b)(6) 2003 continue: ¿attention was now turned to the dependent aspect of the greater curvature and an opening was made in the gastro-colic omentum.Finger dissection was used to create a retro-colic window through the transverse colon mesentery in an avascular space.The roux limb was inspected and confirmed to be viable and untwisted.The limb was now brought up through the retro-colic tunnel and was found to easily reach the gastric pouch without tension.A two-layer hand-sewn gastrojejunal anastomosis was now performed.The first layer consisted of a running 3-0 prolene suture which incorporated the staple line of the gastric pouch.¿.Operative records dated (b)(6) 2003 state: ¿two enterotomies of 14 mm were made on the gastric pouch and the jejunum.The inner layer was fashioned with a running 3-0 maxon double armed suture completed over a 34 french bougie.The final outer layer was made with a running 3-0 prolene suture placed in a horizontal mattress fashion.The bougie was removed and an ng tube guided down through the anastomosis.Three successive forceful insufflations of 60 cc's of air were done with the anastomosis under sterile water.No air bubbles were noted.The ng tube was removed and the irrigant fluid was suctioned and hemostasis confirmed.The roux limb was tacked to the bypassed stomach with two interrupted sutures of2-0 chromic.¿.Operative records dated (b)(6) 2003 state: ¿the infra-colic roux limb was straightened and confirmed untwisted and then also sutured to the colonic mesentery with multiple 3-0 silk sutures.Additionally, all potential small bowel mesenteric defects were closed with multiple sutures of2-0 silk and these maneuvers closed the peterson defect as well.The jejunojejunostomy was inspected and found to be patent and hemostatic.All retractors were removed and hemostasis confirmed throughout the abdomen.The omentum was replaced and the midline fascia was closed with a running looped and multiple interuupted [sic] figure of eight# 1 pds sutures.The subcutaneous tissues were thoroughly irrigated and a subcutaneous jp drain was placed.The skin was closed with a running, subcuticular, 3-0 monocryl suture.Steri strips and sterile dressings were applied.¿.Discharge summary dated (b)(6) 2003 for hospital admission (b)(6) 2003 states: ¿the patient was admitted to the hospital after outpatient evaluation of co-morbidities, for elective gastric exclusion to treat her medically intractable severe obesity.Gastric exclusion was performed uneventfully on (b)(6) 2003.The patient had an uneventful postoperative course.Gastrograffin swallow was performed on the second postoperative day and demonstrated that the anastomosis was patent and there was no leakage.Subsequent to the negative gastrograffin swallow, the patient was begun on water and subsequently advanced to clear liquids, which were tolerated without significant difficulty.The patient was discharged the 3rd postoperative day to home.¿.Medical records dated (b)(6) 2004 state: ¿chief complaint: medical clearance for hernia repair.¿ the records state: ¿the patient is a 37 year old white male who is 5' 11" tall and weighs 257.6 lbs.He has a calculated bmi of 36.[the patient] underwent gastric bypass surgery on (b)(6) 2003 for treatment of morbid obesity.Since that time he has lost 146 lbs.And has done well.He began to notice a hernia sometime in june.He states that the hernia became very painful and progressed to enlarge in size over the ensuing months.He reports severe pain with any excertion [sic] requiring opiod analgesic[sic] treatment.He is scheduled to undergo repair of this hernia and is here for medical clearance prior to the procedure.¿.Operative records dated (b)(6) 2004 indicate the patient underwent laparoscopic incisional ventral hernia repair with mesh, lysis of adhesions for postoperative diagnosis ¿symptomatic incisional hernia, past history of morbid obesity, s/p gastric bypass surgery¿¿ and ¿adhesions.¿ operative findings state: ¿dense intra-abdominal adhesions were found throughout the abdomen.A large segment ofomentum was ·incarcerated into separate hernia defects in the midline.Extensive laparoscopic lysis of adhesions was done.A gortex mesh repair was done laparoscopically.¿.Operative records dated (b)(6) 2004 state: ¿the hernia defect was palpable in the periumbilical mid-abdomen and appeared to be septated throughout the upper aspect of the long upper mid line incision.A veress needle was placed in the right subcostal margin and insuffiation with co2 was begun.After insuffiation an optiview port 10 mm was placed in the right lateral abdomen.Two additional ports, 5 and 10 mm, were placed on the right sided abdomen and additional 5 mm on the left lateral abdomen.Insuffiation was done with co2 to 15 mm hg.A 45 degree laparoscope was inserted and laparoscopy revealed a nonnal gallbladder, liver and dense adhesions of omentum throughout the upper and lower abdomen predominantly in the midline.¿.Operative records dated (b)(6) 2004 state: ¿the harmonic scalpel was used to perform extensive lysis of adhesions due to clear incarcerated omentum form the hernia defects.This was done for a lengthy period of time.The hernia defects were multiple [sic] along the midline with the predominant defect in the periumbilical area, approximately 6-8 cm.A 20 x 30 cm piece of gortex mesh with long marking sutures of 2-0 ethibond at all comers and the two sides was placed into the abdomen.The gortex was unfurled and aligned to fully overlap all fascial defects.¿.Operative records dated (b)(6) 2004 continue: ¿stab incisions of 34 mm were made and a suture passer device was used to pull and secure the mesh up to the abdominal wall.An ethicon hernia anchor device was used to attach the mesh to the abdominal wall fasica [sic] circumferentially every 2 cm.Bleeding was noted at the left lower abdominal wall after placement of an anchor clip and this was controlled with pressure and externally placed #1 pds sutures deep into the soft tissue above and below the area.Hemostasis was obtained and confirmed.The mesh was confirmed to cover all defects with a large overlap.Thorough irrigation was done and hemostasis confirmed.The bladeless trocas were removed and hemostasis confirmed.The skin and all trocar sites were closed with 3-0 monocryl suture in a subcuticular fashion or steri-strips.Sterile dressing were applied.¿ product identification records were not provided.Records between 4/19/2004 and 12/2/2009 were not provided.Medical records dated (b)(6) 2009 state: ¿chief complaint: medical clearance for gastric banding over previous bypass.¿ the records state: ¿the patient is a 42-year-old male who is 71 inches tall and weighs 335 pounds.The patient has a calculated bmi of 46.7 and is 175 pounds above his ideal body weight.The patient suffers from exertional dyspnea, water retention of the lower extremities and multiple joint pain as a result of his morbid obesity.The patient has been obese most of his adult life and has tried multiple methods of weight loss in the past including using the help of his personal physician, weight watchers, weight loss programs, low-cal low-fat diets, fasting.The patient has lost a maximum of 180 pounds after undergoing roux-en-y gastric bypass in 2002.However, the patient has regained all this weight back and is here at the request of his surgeon dr.Schram for medical evaluation and clearance prior to undergoing gastric banding over previous bypass as definitive treatment of morbid obesity.¿.Operative report dated (b)(6) 2009 indicates the patient underwent laparoscopy, lysis of adhesions.Preoperative diagnosis ¿morbid obesity, history of gastric bypass.¿.Postoperative diagnosis ¿morbid obesity, extensive intra-abdominal adhesions.¿ operative findings states: ¿the patient was found to have extensive adhesions of the omentum and bowel to the entire anterior abdominal wall which prevented us from proceeding with a laparoscopic band over bypass placement.¿.Operative records dated (b)(6) 2009 state: ¿we were able to take down some of the adhesions bluntly and sharply but the patient had such extensive adhesions that we were not able to even place other trocars safely.I then had a discussion with his wife to see if the patient would want to proceed with an open band placement or hold off and wait on other options and she thought that the patient would want is to wait so the case was stopped at that time.The abdomen was desufflated.Trocars were removed.Skin incisions were closed with 3-0 monocryl in subcuticular stitch.Steri-strips and sterile dressings were applied.¿.Medical records dated (b)(6) 2010 states: ¿chief complaint: medical clearance for laparotomy with placement of gastric band over previous gastric bypass.¿ the records state ¿the patient is a pleasant 43-year-old male who is 71 inches tall and weighs 350.7 pounds.The patient has a calculated bmi of 48.9 and is 190 pounds above his ideal body weight.The patient suffers 'from exertional dyspnea, hypertension, water retention of the lower extremities and multiple joint pain as a result of his morbid obesity.The patient has been obese most of his adult life and has tried multiple methods of weight loss in the past including using the help of his personal physician, weight watchers, weight loss programs, low-cal low-fat diets, fasting.The patient has lost a maximum of 40 pounds using weight watchers.However, the patient has regained all this weight back and is here at the request of his surgeon dr.Schram for medical evaluation and clearance prior to undergoing placement of gastric band over previous gastric bypass as definitive treatment of morbid obesity.¿.Operative records dated (b)(6) 2010 indicate the patient underwent placement of a band over bypass and extensive lysis of.Preoperative and postoperative diagnosis ¿morbid obesity, status post gastric bypass, extensive adhesions, previous repair of ventral hernia.¿ operative findings state: ¿the patient has a lot of extensive adhesions from his previous surgery and ventral hernia repair.¿.Operative records dated (b)(6) 2010 state: ¿a 6-inch incision was made in the upper midline from the xiphoid down towards the umbilicus, and carried down through the subcutaneous tissue down to the fascia.The fascia was opened superiorly just below the xiphoid process and the peritoneum was entered.We carefully were able to divide the previous gerotex [sic] mesh.¿approximately 40 minutes were spent trying to carefully remove all the adhesions to the anterior abdominal wall.¿ the small bowel and colon were plastered to the mesh and to the anterior abdominal wall and to the liver edge.¿.Operative records dated (b)(6) 2010 continue: ¿these adhesions were carefully taken down with metzenbaum scissors and cautery.Then we were able to elevate the left lobe of the liver and carefully take down all the adhesions of the small bowel to the lower edge and the undersurface of the left lobe of the liver.The liver was then retracted cranially.The patient was put into a reverse trendelenburg position.The angle of his was identified and was dissected free with the metzenbaum scissors and the right crus was identified.A goldfinger was then placed in front of the right crus in a retrogastric tunnel to the angle of his.This was utilized to guide a realize band around the stomach and through the retrogastric tunnel.¿.Operative records dated (b)(6) 2010 state: ¿the band was then fastened anteriorly and the tab was removed.The tubing was then brought up through a small incision in the fascia in the right upper quadrant and was attached to a port which was then affixed.To the fascia with a velocity port applier.The abdomen was then generously irrigated with normal saline.The fascia was closed with running looped 0 nylon.The port was aspirated with a syringe and the wound was bathed in betadine and then irrigated with water.The skin was closed with running 3-0 monocryl subcuticular stitch.Steri-strips and sterile dressings were then applied.¿.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 although the brand name and lot# of a gore device has not been provided, the instructions for use for the vast majority of gore¿s eptfe patch products that are indicated for the reconstruction of soft tissue deficiencies include the following warnings among others: ¿possible 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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All previous patient codes (1695, and 3191 other code for "separation of the mesh") were reported based on the original complaint and are no longer applicable per gore¿s investigation.H10/11: updated final codes.Conclusion code 4316: appropriate term/code not available used for "withdrawn complaint".This claim was withdrawn, and the alleged product complaint is no longer being pursued at this time.No further investigation is required at this time.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.
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Manufacturer Narrative
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H6: health effect impact code: f26: no health consequences or impact.H6: additional investigation conclusion code: d17: appropriate term/code not available for "withdrawn complaint.¿ previous patient code (1695) was reported based on the original complaint and are no longer applicable per gore¿s investigation.This claim was withdrawn, and the alleged product complaint is no longer being pursued at this time.No further investigation is required at this time.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.Medical records: the known medical records span (b)(6) 2003 through (b)(6) 2010 and not all records received in this time span are relevant to the alleged ¿gore-tex mesh.¿ records between (b)(6) 2004 and (b)(6) 2009 were not provided.No product identification records were provided.Patient information: medical history: history of tobacco use.Obesity.? on (b)(6) 2003: 71 inches, 401.1 lbs., bmi 57.¿morbid obesity¿ ¿this patient is 230 pounds above his ideal body weight¿ ¿¿ suffers from exertional dyspnea, pedal edema, heartburn, multiple joint pain and arthritis as a result of his morbid obesity.He has been obese most of his adult life and has tried multiple methods of weight loss in the past including using the help of his personal physicians, weight watcher's, weight loss programs, low calorie, low fat diets as well as meridia.He has lost a maximum of [illegible] pounds and has regained all this weight back and is here today for evaluation [illegible] roux-en-y-gastric exclusion surgery as treatment of his morbid obesity.¿ ? on (b)(6) 2003: morbid obesity ? on (b)(6) 2004: 71 inches, 257.6 lbs., bmi 36.¿¿underwent gastric bypass surgery on (b)(6) 2003 for treatment of morbid obesity.Since that time, he has lost 146 lbs.And has done well.¿ ? on (b)(6) 2009: 71 inches, 335 lbs., bmi 46.7: ¿¿ is 175 pounds above his ideal body weight.¿ ¿the patient has lost a maximum of 180 pounds after undergoing roux-en-y gastric bypass in 2002.However, the patient has regained all this weight back and is here at the request of his surgeon dr.(b)(6) for medical evaluation and clearance prior to undergoing gastric banding over previous bypass as definitive treatment of morbid obesity.¿ hyperlipidemia.Hypertension.Gastroesophageal reflux disease [gerd].Degenerative joint disease [djd].Prior surgical procedures: jaw surgery (1989).(b)(6) 2003: open roux-en-y.(b)(6) 2010: placement of a band over bypass and extensive lysis.Rotator cuff repair [unknown date].Left knee arthroscopy [unknown date].Relevant medical information: on (b)(6) 2003: ¿the patient is a 35-year-old, white male who is 5' 11¿ tall, weighs 401.1 pounds with a calculated body mass index of 57.This patient is 230 pounds above his ideal body weight.[the patient] suffers from exertional dyspnea, pedal edema, heartburn, multiple joint pain and arthritis as a result of his morbid obesity.He has been obese most of his adult life and has tried multiple methods of weight loss in the past including using the help of his personal physicians, weight watcher's, weight loss programs, low calorie, low fat diets as well as meridia.He has lost a maximum of [illegible] pounds and has regained all this weight back and is here today for evaluation [illegible] roux-en-y-gastric exclusion surgery as treatment of his morbid obesity.¿ on (b)(6) 2003: roux-en ¿y gastric bypass.¿a retro-colic, ante-gastric roux-en-y jejunal bypass was performed to an approximate 15-20 cc isolated gastric pouch based on the lesser curve.The anastomosis was done in a hand-sewn two-layer technique.¿ ¿an upper midline incision was made to the umbilicus.The subcutaneous tissue was divided with electrocautery and bluntly by pulling on both sides of the abdominal wall.The midline fascia was identified and opened the full length of the incision.The peritoneum was penetrated bluntly over the liver and opened the full length of the incision.The falciform ligament was excised with electrocautery and 0-chromic ties.Initial abdominal findings were notable for a normal liver, gallbladder and no suspicious masses.The upepr [sic] g-e junction was noted to be deep.A balfour retractor was placed over lap pads.Attention was turned to the infra-colic abdomen.The ligament of treitz was identified and the small bowel was run distally until an adequate mesenteric length was seen and the vascular arcades were confirmed to be symmetric.¿ ¿the small bowel was divided at this point with an ethicon linear 55mm stapler with a blue load.An additional fire of the stapler was made down through the first vascular arcade.Hemostasis was obtained with electrocautery.The small bowel was now run distally and the roux limb was fashioned.A stay suture of 3-0 silk was placed at the base of the roux limb and the distal aspect of the biliopancreatic limb.The remainder of the small bowel was carefully measured and found to be 560 cm to the cecum.This was the common channel length.¿ ¿at the previously placed stay suture two enterotomies were made and a side-to-side jejunojejunostomy was fashioned with the ethicon linear 55mm stapler utilizing a blue load.The common enterostomy was inspected for bleeding and closed with an ethicon ta-60 stapler.Two 3-0 silk sutures were placed at the vertex of the anastomosis to relieve tension.The mesenteric defect was closed with a running 3-0 maxon and all staple lines were over-sewn.The efferent limb was tacked to the distal aspect of the jejunojejunostomy to avoid kinking.Hemostasis and a patent efferent limb and anastomosis were confirmed.Attention was now turned to the upper abdomen.¿ ¿the falciform ligament was taken down with electrocautery over the dome of the liver to the diaphragm.An upper hand retractor blade was placed over lap pads and directed and fixed toward the left shoulder.The patient was now placed in steep reverse trendelenburg positioning.The left lobe of the liver was mobilized by dividing the ligamentous attachments with cautery and then the liver was reflected and fixed toward the right shoulder with an additional padded attachment of the upper hand retractor.Excellent visualization of the ge junction was confirmed.The soft tissue just lateral to the angle of his was divided with sharp dissection and a window was made into the retro-gastric space.Care was taken to avoid the spleen and short gastric vessels, which were preserved.¿finger dissection was then used to create a retro-gastric tunnel, which was brought out to a point on the lesser curvature 7 cm distal to the ge junction.Care was taken to sweep and preserve the vagal branches medially.A penrose drain was placed and used for retraction.A rolled moist lap was placed to protect the spleen.An ethicon linear 100mm stapler with a blue load w8s now placed through the retro-gastric tunnel and the ng tube was removed.A pouch of approximately 15-20 cc was fashioned and the stapler was fired.Full division was obtained and both staple lines were oversewn with 3-0 maxon sutures.¿ ¿attention was now turned to the dependent aspect of the greater curvature and an opening was made in the gastro-colic omentum.Finger dissection was used to create a retro-colic window through the transverse colon mesentery in an avascular space.The roux limb was inspected and confirmed to be viable and untwisted.The limb was now brought up through the retro-colic tunnel and was found to easily reach the gastric pouch without tension.A two-layer hand-sewn gastrojejunal anastomosis was now performed.The first layer consisted of a running 3-0 prolene suture which incorporated the staple line of the gastric pouch.¿ ¿two enterotomies of 14 mm were made on the gastric pouch and the jejunum.The inner layer was fashioned with a running 3-0 maxon double armed suture completed over a 34 french bougie.The final outer layer was made with a running 3-0 prolene suture placed in a horizontal mattress fashion.The bougie was removed and an ng tube guided down through the anastomosis.Three successive forceful insufflations of 60 cc's of air were done with the anastomosis under sterile water.No air bubbles were noted.The ng tube was removed and the irrigant fluid was suctioned and hemostasis confirmed.The roux limb was tacked to the bypassed stomach with two interrupted sutures of 2-0 chromic.¿ ¿the infra-colic roux limb was straightened and confirmed untwisted and then also sutured to the colonic mesentery with multiple 3-0 silk sutures.Additionally, all potential small bowel mesenteric defects were closed with multiple sutures of 2-0 silk and these maneuvers closed the peterson defect as well.The jejunojejunostomy was inspected and found to be patent and hemostatic.All retractors were removed and hemostasis confirmed throughout the abdomen.The omentum was replaced and the midline fascia was closed with a running looped and multiple interuupted [sic] figure of eight# 1 pds sutures.The subcutaneous tissues were thoroughly irrigated and a subcutaneous jp drain was placed.The skin was closed with a running, subcuticular, 3-0 monocryl suture.Steri strips and sterile dressings were applied.¿ implant preoperative complaints: on (b)(6) 2004: ¿chief complaint: medical clearance for hernia repair.¿ ¿the patient is a 37-year-old white male who is 5' 11" tall and weighs 257.6 lbs.He has a calculated bmi of 36.[the patient] underwent gastric bypass surgery on (b)(6) 2003 for treatment of morbid obesity.Since that time he has lost 146 lbs.And has done well.He began to notice a hernia sometime in june.He states that the hernia became very painful and progressed to enlarge in size over the ensuing months.He reports severe pain with any excertion [sic] requiring opiod analgesic [sic] treatment.He is scheduled to undergo repair of this hernia and is here for medical clearance prior to the procedure.¿ implant procedure: laparoscopic incisional ventral hernia repair with mesh, lysis of adhesions.Implant date: (b)(6) 2004.Description of hernia being treated: ¿dense intra-abdominal adhesions were found throughout the abdomen.A large segment of omentum was incarcerated into separate hernia defects in the midline.Extensive laparoscopic lysis of adhesions was done.A gortex mesh repair was done laparoscopically.¿ ¿the hernia defect was palpable in the periumbilical mid-abdomen and appeared to be septated [sic] throughout the upper aspect of the long upper mid line incision.A veress needle was placed in the right subcostal margin and insufflation with co2 was begun.After insufflation an optiview port 10 mm was placed in the right lateral abdomen.Two additional ports, 5 and 10 mm, were placed on the right sided abdomen and additional 5 mm on the left lateral abdomen.Insufflation was done with co2 to 15 mm hg.A 45 degree laparoscope was inserted and laparoscopy revealed a normal gallbladder, liver and dense adhesions of omentum throughout the upper and lower abdomen predominantly in the midline.¿ ¿the harmonic scalpel was used to perform extensive lysis of adhesions due to clear incarcerated omentum form [sic] the hernia defects.This was done for a lengthy period of time.The hernia defects were multiple [sic] along the midline with the predominant defect in the periumbilical area, approximately 6-8 cm.¿ implant size and fixation: ¿a 20 x 30 cm piece of gortex mesh with long marking sutures of 2-0 ethibond at all comers [sic] and the two sides was [sic] placed into the abdomen.The gortex was unfurled and aligned to fully overlap all fascial defects.¿ ¿stab incisions of 34 mm were made and a suture passer device was used to pull and secure the mesh up to the abdominal wall.An ethicon hernia anchor device was used to attach the mesh to the abdominal wall fasica [sic] circumferentially every 2 cm.Bleeding was noted at the left lower abdominal wall after placement of an anchor clip and this was controlled with pressure and externally placed #1 pds sutures deep into the soft tissue above and below the area.Hemostasis was obtained and confirmed.The mesh was confirmed to cover all defects with a large overlap.Thorough irrigation was done and hemostasis confirmed.The bladeless trocas [sic] were removed and hemostasis confirmed.The skin and all trocar sites were closed with 3-0 monocryl suture in a subcuticular fashion or steri-strips.Sterile dressing were applied.¿ product identification records were not provided.No post-operative records were provided.Relevant medical information: on (b)(6) 2009: ¿chief complaint: medical clearance for gastric banding over previous bypass.¿ the records state: ¿the patient is a 42-year-old male who is 71 inches tall and weighs 335 pounds.The patient has a calculated bmi of 46.7 and is 175 pounds above his ideal body weight.The patient suffers from exertional dyspnea, water retention of the lower extremities and multiple joint pain as a result of his morbid obesity.The patient has been obese most of his adult life and has tried multiple methods of weight loss in the past including using the help of his personal physician, weight watchers, weight loss programs, low-cal low-fat diets, fasting.The patient has lost a maximum of 180 pounds after undergoing roux-en-y gastric bypass in 2002 [sic].However, the patient has regained all this weight back and is here at the request of his surgeon dr.Schram for medical evaluation and clearance prior to undergoing gastric banding over previous bypass as definitive treatment of morbid obesity.¿ on (b)(6) 2009: laparoscopy, lysis of adhesions.Preoperative diagnosis ¿morbid obesity, history of gastric bypass.¿ postoperative diagnosis ¿morbid obesity, extensive intra-abdominal adhesions.¿ ¿the patient was found to have extensive adhesions of the omentum and bowel to the entire anterior abdominal wall which prevented us from proceeding with a laparoscopic band over bypass placement.¿ ¿we were able to take down some of the adhesions bluntly and sharply but the patient had such extensive adhesions that we were not able to even place other trocars safely.I then had a discussion with his wife to see if the patient would want to proceed with an open band placement or hold off and wait on other options and she thought that the patient would want is to wait so the case was stopped at that time.The abdomen was desufflated.Trocars were removed.Skin incisions were closed with 3-0 monocryl in subcuticular stitch.Steri-strips and sterile dressings were applied.¿ on (b)(6) 2010: ¿chief complaint: medical clearance for laparotomy with placement of gastric band over previous gastric bypass.¿ ¿the patient is a pleasant 43-year-old male who is 71 inches tall and weighs 350.7 pounds.The patient has a calculated bmi of 48.9 and is 190 pounds above his ideal body weight.The patient suffers from exertional dyspnea, hypertension, water retention of the lower extremities and multiple joint pain as a result of his morbid obesity.The patient has been obese most of his adult life and has tried multiple methods of weight loss in the past including using the help of his personal physician, weight watchers, weight loss programs, low-cal low-fat diets, fasting.The patient has lost a maximum of 40 pounds using weight watchers.However, the patient has regained all this weight back and is here at the request of his surgeon dr.(b)(6) for medical evaluation and clearance prior to undergoing placement of gastric band over previous gastric bypass as definitive treatment of morbid obesity.¿ on (b)(6) 2010: placement of a band over bypass and extensive lysis.Preoperative and postoperative diagnosis ¿morbid obesity, status post gastric bypass, extensive adhesions, previous repair of ventral hernia.¿ ¿the patient has a lot of extensive adhesions from his previous surgery and ventral hernia repair.¿ ¿a 6-inch incision was made in the upper midline from the xiphoid down towards the umbilicus, and carried down through the subcutaneous tissue down to the fascia.The fascia was opened superiorly just below the xiphoid process and the peritoneum was entered.We carefully were able to divide the previous gerotex [sic] mesh.¿ ¿approximately 40 minutes were spent trying to carefully remove all the adhesions to the anterior abdominal wall.¿ ¿the small bowel and colon were plastered to the mesh and to the anterior abdominal wall and to the liver edge.¿ ¿these adhesions were carefully taken down with metzenbaum scissors and cautery.Then we were able to elevate the left lobe of the liver and carefully take down all the adhesions of the small bowel to the lower edge and the undersurface of the left lobe of the liver.The liver was then retracted cranially.The patient was put into a reverse trendelenburg position.The angle of his was identified and was dissected free with the metzenbaum scissors and the right crus was identified.A goldfinger was then placed in front of the right crus in a retrogastric tunnel to the angle of his.This was utilized to guide a realize band around the stomach and through the retrogastric tunnel.¿ ¿the band was then fastened anteriorly and the tab was removed.The tubing was then brought up through a small incision in the fascia in the right upper quadrant and was attached to a port which was then affixed.To the fascia with a velocity port applier.The abdomen was then generously irrigated with normal saline.The fascia was closed with running looped 0 nylon.The port was aspirated with a syringe and the wound was bathed in betadine and then irrigated with water.The skin was closed with running 3-0 monocryl subcuticular stitch.Steri-strips and sterile dressings were then applied.¿ conclusion: the alleged ¿gore-tex¿ mesh is being captured as gore-tex® soft tissue patch for product surveillance purposes only.It should be noted that the gore-tex® soft tissue patch adverse reactions among others: ¿possible adverse reactions with the use of any tissue deficiency prosthesis may include, but are not limited to, contamination, infection, inflammation, adhesion, fistula formation, seroma formation, hematoma, and recurrence.¿ as with any surgical procedure, there are always risks of complications for surgical repair of hernias and soft tissue deficiencies, with or without mesh.These may include but are not limited to, adhesions and related harms, bleeding, bowel obstruction, dysphagia, erosion or extrusion and related harms, exposure or protrusion and related harms, fever, fistula, gerd recurrence, recurrence, ileus, increased procedure time and related harms, irritation or inflammation, infection, pain, paresthesia, perforation, revision / re-intervention, seroma or hematoma and related harms, wound complications and wound dehiscence.Many of the potential complications are associated with the patient¿s underlying disease progression, co-morbidities, additional medical history and/or other surgical procedures.The above inherent risks are typically detailed in standard informed consent documents.Based upon the information received, the device remains in the patient and was not available for evaluation.After multiple requests, product identification information was not provided for this device and thus it could not be confirmed to be a gore hernia device.Review of the manufacturing and sterilization records could not be performed as a valid lot number was not provided.In an abundance of caution for product surveillance tracking and trending purposes only, this event has been analyzed, coded and reported as necessary assuming it is a gore hernia device.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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