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| Model Number 1DLMC03 |
| Device Problems
Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190); Loosening of Implant Not Related to Bone-Ingrowth (4002)
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| Patient Problems
Pain (1994); Hernia (2240); No Information (3190)
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Event Type
Injury
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Manufacturer Narrative
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The initial reporter's complete address is (b)(6).It should be noted that the gore dualmesh® 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 a patient asserts a complaint arising from the implantation of a gore dualmesh® biomaterial device based on an unspecified alleged injury and/or alleged product deficiency.As no specific information was provided as to the patient¿s complaint about the gore dualmesh® biomaterial device, this event is being documented based on a general allegation of an unknown product deficiency and/or alleged injury.
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Manufacturer Narrative
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B5: added additional information b7: added medical history h6: corrected patient code.Conclusion code remains unchanged h10/11: added medical record summary additional details regarding the patient's clinical course were ascertained from a review of medical records and are as follows: surgical records prior to(b)(6) 2010, including prior hernia repair leading to ¿recurrent ventral hernia¿, as well as ¿hysterectomy and tubal ligation¿, ¿prior cholecystectomy¿, and ¿gastric bypass¿ all noted in records dated (b)(6) 2010, were not provided.Records dated (b)(6) 2010 state the patient presented with abdominal pain.Ct results of the pelvis states: ¿there are clips in the gallbladder fossa consistent with prior cholecystectomy.The liver, pancreas, adrenal glands, and kidneys are unremarkable.There is surgical material involving the stomach consistent with prior surgery.There is splenomegaly with the spleen measuring 14.4 cm.There is a small ventral hernia containing nondilated loops of small bowel.Otherwise the large and small bowel is unremarkable.The appendix is unremarkable.¿ it is unclear what ¿surgical material involving the stomach consistent with prior surgery¿ is referring to.Operative records dated (b)(6) 2010 state the patient underwent repair of an incarcerated recurrent ventral hernia.¿the patient is a 29-year-old woman who has had abdominal pain for the past five days.She came to the emergency room and a ct scan demonstrated loops of small bowel trapped in a recurrent ventral hernia.The patient had had several surgical procedures including hysterectomy and tubal ligation.Gastric bypass had been done by me about 3 years ago through an upper abdominal incision which was sound.¿ the (b)(6) 2010 records state: ¿skin and subcutaneous incision was made just above the umbilicus to about 6 cm below the umbilicus superior.The incision was carried down with multiple hernia defects seen and old suture was encountered with likely tevdek material but there was no mesh.The peritoneal cavity was entered.The small bowel was collapsed and fell into the abdominal cavity without any evidence of ischemia or perforation.The peritoneal cavity was clean.The fascial edges were cleaned from the hernia sac which had coursed towards the patient's right lower abdomen.Then a gore-tex dual mesh measuring 10 x 15 cm was oriented with the long axis horizontal and secured with multiple sutures deep to the peritoneum through the fascia.When these were all tied individually, the mesh with the smooth side was facing the bowel and there was overlying fascia above it.The fascia was then closed directly over the mesh with running double-stranded 0-nylon suture.The mesh had been soaked in ancef solution and additional ancef irrigation was used to irrigate the wound.Scarpa's layer was closed with 0-vicryl and the skin with running 4-0 monocryl.¿ the records confirm a gore dualmesh® biomaterial (1dlmc03/6964412) was implanted during the procedure.Records dated (b)(6) 2011 state: ¿this is a 30-year-old female who originally had the roux-en-y gastric bypass procedure in 2007 and has lost approximately 120 pounds but has gained approximately 70 pounds back.She began experiencing severe abdominal pain primarily to the left of her incision line for the last week.It initially was more pronounced when she was in the lying position but as the days progressed, no matter whether she was lying, sitting or standing, the pain was constant and it was sharp in nature.There were no alleviating factors that were effective in controlling the pain.Over the last couple of days, she has also been having waves of nausea.She went to the physician's office yesterday with the complaints and a ct scan of the abdomen and pelvis were performed, which showed that she had a small midline abdominal ventral hernia containing some mesenteric fat as well as a low midline pelvic ventral hernia containing mesenteric fat and a loop of small bowel.There was no obstructive bowel pattern, however, that was identified.She was transferred as a direct admission to the hospital and is scheduled for surgery this afternoon.¿ operative records dated (b)(6) 2011 state the patient underwent laparoscopic recurrent ventral incisional hernia repair with mesh.Indications state the patient ¿is a 30-year-old female who had weight loss surgery with open roux en y gastric bypass in 2007.Since then, she had lost 150 lbs.In (b)(6) 2010, the patient had ventral incisional hernia in the lower abdomen which has required an open ventral hernia repair with mesh.Several days ago, the patient presented with an acute pain in the lower abdomen from the area where she had the previous mesh repair just below the umbilicus, more so on the left side and was seen in the emergency room where ct scan confirmed incarcerated incisional hernia and the patient was then seen in the office at which point she was put on urgently for surgery with the diagnosis of incarcerated recurrent ventral incisional hernia.Patient is now presenting with a tender bulge at the level of her previous surgical incision in the midline.Patient denies any symptoms of intermittent bowel obstruction associated with the bulging.Clinical examination confirmed the presence of an incisional hernia with clinical evidence of incarceration or strangulation.¿ findings from the (b)(6) 2011 procedure state: ¿the liver was normal.The gallbladder was not visualized.There were extensive adhesions found to the previous midline mass.There were no internal hernias identified.The hernia was on the lower part of the previous mesh which has shrunk and is now shivered up in the upper part and leaving a large defect which measures 6 cm x 7 cm.There was incarceration of the omentum and bowel but these were viable with no evidence of strangulation.It was repaired with a piece of rectangular covidien parietex composite(r) size 10 cm by 15 cm allowing at least 5 cm overlap on each side of the hernia.¿ the (b)(6) 2011 operative report states: ¿the adhesions were taken down using harmonic scalpel or bluntly as indicated.This tedious portion of the operation was done with care to avoid any injury to the bowels.The hernia contents were dissected free from the sac itself and reduced back into the peritoneal cavity.We decided to leave the mesh in place because taking it out would entail much more dissection and bleeding.The fact that the small piece just simply lay cephalad to the previous hernia and would be incorporated into the new mesh which was going to be placed in.The pneumoperitoneum pressure was reduced to 10 mm hg and the edges of the hernia defect were measured using transcutaneous and transfascial markings with a spinal needle to determine the craniocaudal and the lateral extent.We take into consideration all the smaller swiss cheese defects to form an aggregate.¿ the (b)(6) 2011 operative report continues: ¿the appropriate mesh material and mesh size was selected to allow an overlap of at least 5 cm on each side after the defect was partially reapproximated with #2 pds sutures.The mesh was marked with the corrugated side facing upward against the abdominal wall.Six cardinal sutures of o ethibond were placed to allow transfascial securing of the mesh against the abdominal wall.The mesh was soaked in antibiotic solution then introduced into the abdominal cavity using the 12 mm port.It was then deployed intracorporally with the smooth nonadherent side facing downward to serve as a barrier against intestinal adhesions to the mesh itself.The previously placed sutures were then grasped with a suture passer transfascially and brought up against the abdominal wall using a reverse parachute technique.This allows the mesh to lay snugly against the abdominal wall without any excess folds.We then use an absorbable tacker every 1 cm apart to secure the mesh circumferentially around the hernia defect and to the abdominal wall.¿ the records confirm a non-gore device was used during the procedure.There was no mention of infection and no mention of gore device removal.Operative records dated (b)(6) 2011 state the patient underwent laparoscopic ventral incisional hernia repair with mesh.¿the patient is a 30-year-old female who had weight loss surgery with open roux en y gastric bypass in 2007.Since then she has lost 100 lbs.Patient is now presenting with a tender bulge at the level of her previous surgical incision in the midline.Patient denies any symptoms of intermittent bowel obstruction associated with the bulging.She has had a recurrent umbilical hernia repaired with mesh in 2010.Clinical examination confirmed the presence of an incarcerated incisional hernia in the upper midline with no clinical evidence of strangulation.We recommend laparoscopic incisional hernia repair with mesh to prevent the risk of intestinal obstruction and strangulation.¿ operative findings from the (b)(6) 2011 procedure state: ¿the liver was normal.The gallbladder was not visualized.There were extensive adhesions found at the level of the previous incisional hernia repair in the umbilical area.There were no internal hernias identified.The ventral incisional hernia measures 5 cm by 5 cm, taking into consideration all the aggregates of small swiss-cheese hernias.There was incarceration of omentum and bowels but these were viable with no evidence of strangulation.It was repaired with a piece of rectangular covidien parietex composite(r) size 10 cm by 15 cm allowing at least s cm overlap on each side of the hernia.¿ the (b)(6) 2011 operative report states: ¿the adhesions were taken down using harmonic scalpel or bluntly as indicated.This tedious portion of the operation was done with care to avoid any injury to the bowels.¿ ¿the hernia contents were dissected free from the sac itself and reduced back into the peritoneal cavity.The pneumoperitoneum pressure was reduced to 10 mm hg and the edges of the hernia defect were measured using transcutaneous and transfascial markings with a spinal needle to determine the craniocaudal and the lateral extent.We take into consideration all the smaller swiss cheese defects to form an aggregate.The appropriate mesh material and mesh size was selected to allow an overlap of at least 5 cm on each side after the defect was partially reapproximated with #2 pds sutures.The mesh was marked with the corrugated side facing upward against the abdominal wall.Six cardinal sutures of o ethibond were placed to allow transfascial securing of the mesh against the abdominal wall.The mesh was soaked in antibiotic solution then introduced into the abdominal cavity using the 12 mm port.It was then deployed intracorporeally with the smooth nonadherent side facing downward to serve as a barrier against intestinal adhesions to the mesh itself.¿ the (b)(6) 2011 operative report continues: ¿the previously placed sutures were then grasped with a suture passer transfascially and brought up against the abdominal wall using a reverse parachute technique.This allows the mesh to lay snugly against the abdominal wall without any excess folds.We then use an absorbable tacker every 1 cm apart to secure the mesh circumferentially around the hernia defect and to the abdominal wall.We then irrigated the abdomen with copious amounts of normal saline.We ensured that the mesh was appropriately positioned.We then placed two on-q pain buster catheters pre-peritoneally, one on each side for post operative pain control.The pneumoperitoneum was allowed to escape.The ports were removed under direct visualization.We approximated the skin using absorbable suture.The skin edges were approximated well.¿ the records confirm a non-gore device was used during the procedure.There was no mention of infection and no mention of gore device removal.Records between 2011 and 2013 were not provided.Records dated (b)(6) 2013 state the patient presented with abdominal pain.Abdominal exam notes state: ¿inspection: huge, bowel sounds: normal, palpation: mild abdominal tenderness, in the right lower quadrant and left lower quadrant.¿ cts taken during the visit state: ¿evidence for gastric bypass procedure.No focal bowel dilation.Dehiscence rectus muscles.Sequela from prior hernia repair midline with apparent mesh protruding between rectus muscles.Interval resolution fluid collection caudal to mesh.Appendix normal caliber.Diverticula colon with no ct evidence for diverticulitis.Incomplete distention sigmoid colon.¿ ¿impression: 1.No evidence for acute process.2.Cholecystectomy, gastric bypass procedure, prior ventral hernia repair.3.Dehiscence rectus muscles, diverticulosis and spondylosis.¿ ct imaging results dated (b)(6) 2014 taken for an indication of ¿left-sided abdominal pain after falling off a bike¿ states: ¿bowel and mesentery: no free air or free fluid.Bowel is normal in caliber.No mesenteric adenopathy.The appendix is unremarkable in appearance.Patient is status post gastric bypass with no dilation of both the native stomach and gastric pouch.Small of fluid in the gastric pouch is noted.Patient also status post ventral mesh placement.No herniation of bowel loops is noted.I stasis of midline lower bowel wall is noted.¿ ¿no pelvic free air or free fluid.No pelvic or inguinal adenopathy.There is a moderate degree of constipation.¿ ¿impression: cystic structure suggestive of right ovarian cyst.Moderate 2 large degree of constipation.¿ records dated (b)(6) 2015 state the patient was seen for follow up status post ¿gastric bypass in 2007.States that for the past couple months she has been having abdominal pain that feels like "her insides are being twisted".Reports the pain radiates to her back and also has waken her up at night at times.Also reports she has 'been having bad diarrhea for past 3 weeks.She was seen in the ed at mercy on 7/18/15 for the abdominal pain and had a ct done.States that she had some nausea and vomiting a few days ago, but has been eating her normal diet for the most part.Patient reports nausea, abdominal pain and vomiting, but denies chest pain, chills, diabetes, fever, gero, hyperlipidemia, hypertension, sob or sleep apnea, bloody stools.¿ operative records dated (b)(6) 2015 state the patient underwent laparoscopic lysis of adhesions at the jejunojejunostomy.¿the patient is a 34-year-old woman who underwent gastric bypass surgery a number of years ago.She has had symptoms of abdominal discomfort and bloating for about 2 months and went to south buffalo mercy last week.A ct scan showed contrast backing up into the bypass stomach suggesting an obstruction or internal hernia at the jejunojejunostomy.Plan was for urgent diagnostic laparoscopy.¿ the (b)(6) 2015 records state: ¿the cecum was identified.There were patchy areas of the small bowel and cecum, which appeared to have limbs on them.Bowel was viable.The terminal ileum was seen where it joined the cecum and it was traced back to the jejunojejunostomy.Initially, the roux limb and the common channel were seen, but the biliopancreatic limb appeared to be retracted and very shortened.However, with mobilization of the anastomosis and possibly lysing some adhesions were in the area, the biliopancreatic limb was now free and quite mobile.The anastomosis was seemed very patulous with some folding and some thickening.All limbs were traced back satisfactorily with no evidence of petersen for a mesenteric hernia.The impression was that there were adhesions at this anastomosis, which were causing partial obstruction or even intussusception.There was no evidence of significant bleeding.There were no abnormalities seen in the upper abdomen as well.It was quite possible that the patient will need a revision of anastomoses sometime in the future.We will follow her symptoms.¿ there was no mention of infection and no mention of device removal.Records dated (b)(6) 2015 state the patient was seen status post lysis of adhesions at anastomosis.¿states she is doing a little better but still having some lower belly tenderness.Reports it no longer feels like ¿her insides are being twisted¿ but feeling very bloated.Reports she wanted to talk with dr.(b)(6) about having her [jejunojejunostomy] revised in the future.Also states that she has been having issues with constipation and took some miralax otc.Last bm was yesterday.¿ records dated (b)(6) 2015 state the patient was seen status post diagnostic laparoscopy with lysis of adhesions.¿she feels the pain ls somewhat better.She has had chronic constipation which has now returned.She is taking fiber and drinking water.She has bloating and gas and wilt speak today with our dietitian.¿ records dated (b)(6) 2015 state the patient was seen status post diagnostic laparoscopy with lysis of adhesions.¿she still has intermittent mid abdominal pain and occasionally feels nauseated.No vomiting.Bm's are loose.¿ records dated (b)(6) 2015 state: ¿patient returns for 6 week postop visit following surgery for lysis of adhesions.Although she initially felt well, she has return of persistent pain.My thoughts at the time of her laparoscopy were that she might need revision.¿ operative records dated (b)(6) 2015 state the patient underwent laparoscopic revision of a jejunojejunostomy.¿the patient is a 34-year-old woman, who has had episodes of abdominal discomfort for the past several months.She underwent a diagnostic laparoscopy about 2 months ago and was found to have adhesions at the jejunojejunostomy.These were taken down, although because of the kinking of the anastomosis the possibility revision was presented to the patient to be done possibly at a later date.She was well initially for several weeks, but then developed a similar discomfort with no other obvious pathology and she was offered revision of the jejunojejunostomy.¿ the (b)(6) 2015 records state: ¿using a 30 degree angled scope, the roux limb was identified forcing down to a twisted jejunojejunostomy.It appeared that most of the twist was at the connection of the roux limb through the anastomosis.The biliopancreatic limb appeared generally healthy with only minor adhesion.It was not dilated.Furthermore, the common channel also appeared to be totally benign and unobstructed.Decision was then made therefore to remove the roux limb of the jejunojejunostomy as close to the anastomosis as possible and to move it.This was accomplished by freeing up a few adhesions in the area and then placing a brown load 60 mm long tri-stapler across the anastomosis and firing it.A short bit of mesentery was taken with a 2.5 mm vascular load stapler.Approximately 10 cm distal and through a very healthy-appearing common channel, a new enteroenterostomy was made with the tan load 60 mm long tri-stapler.Suture was used to align the small bowel to itself to close the jejunojejunostomy and to close the mesenteric defect.At the completion of the procedure all limbs of the bowel appeared to lying in good position without any kinking or twisting and no residual mesenteric defect.¿ there was no mention of infection and no mention of device removal.Records dated (b)(6) 2015 state: ¿patient presents today for first postop visit following laparoscopic revision of [jejunojejunostomy].She is doing well with eating and drinking, but complains of constipation.She is quite worried about this.She denies any recurrence of her abdominal symptoms.She is only recently off narcotics for post op pain.¿ records dated (b)(6) 2015 state: ¿34-year-old female with a past medical history of gastric bypass status post revision in september of this year by dr.(b)(6).Presenting with worsening left-sided abdominal pain for the past week.Patient states that the pain feels 10 out of 10 and sharp and it never goes away.She denies any urinary frequency or burning denies any nausea denies any diarrhea.No episodes of retching.She states that the pain has been there since she was last discharged however for the past 2 days has been much worse.¿ ¿on exam patient is afebrile she has normal vital signs physical exam patient is significant tenderness to palpation on the left upper and left lower quadrant.We'll obtain basic labs as well as an x-ray to rule out any free air plan to contact her surgeon for further races.¿ the records indicate the patient was diagnosed with constipation and discharged.Ct imaging results dated (b)(6) 2015 state: ¿postsurgical findings status post cholecystectomy and gastric bypass.No evidence of bowel obstruction.Some hyperdense material, likely surgical mesh other surgical material seen along the ventral abdominal wall.Recommend correlation with patient history.There is no evidence of extravasation of oral contrast.A moderate amount of stool ls seen with the colon consistent with constipation.There are prominent left periaortic lymph nodes which are likely reactive.Otherwise no acute noncontrast ct findings are seen within the abdomen and pelvis.¿ abdominal x-rays taken (b)(6) 2015 state: ¿the patient is status post cholecystectomy.There is suggestion of linear chain suture material in the left mid abdomen.Overall, the bowel gas pattern is nonobstructive.There is no evidence of pneumoperitoneum.A moderate amount of stool is noted within the colon.Visualized lung bases are clear.A screw is noted within the left proximal femur.Osseous and soft tissue structures are otherwise unremarkable.¿ records dated (b)(6) 2016 state: ¿patient returns for follow up visit about 4 months after revision of [jejunojejunostomy] for pain at anastomosis.Patient denies any postop symptoms.¿ records dated (b)(6) 2016 state: ¿patient is a 35-year-old caucasian female with a past medical history depression, neck pain, chronic constipation, obesity, migraines, obesity, sleep apnea.Patient presented to erie county medical center for severe abdominal pain.Patient previously went to mercy and kub show retained stool in the colon.Patient was discharged with some type pf suppository.She only took about 2 doses with resulting 1 bowel movement.She decided come in because she did not continue having stool.Of note, patient recently was hospitalized for a right total hip with replacement on (b)(6) 2016for a slipped capital femoral epiphysis with degenerative joint disease with ortho buffalo gen.Patient was discharge on a lot of opiates for pain control.She was only discharged on senna 50 twice a day and docusate daily.Patient take milk of magnesia on a daily basis for her chronic constipation.Patient reported having decreased bowel movements since her surgery.She had 1 small bowel movement on tuesday and a number bowel movement 2 nights ago.Patient continued to take all her pain medications.¿ ¿medical decision making: domino pain secondary to constipation.¿ records dated (b)(6) 2016 stated the patient was seen for evaluation of left hip and low back pain.¿patient says that she feels like she strained her back and left hip.Patient complains of pain in her left back and left hip.Since that time patient rates pain as moderate in intensity.Patient does not have any weakness in her lower extremities but does have worsening pain with range of motion.Patient is on multiple pain medications including oxycodone 15 mg.¿ records dated (b)(6) 2017 state: ¿patient returns for follow up visit about 18 months after revision of the jejunojejunostomy for pain.The common channel was not shortened.Patient has residual hip pain following replacement done last september.The patient ls tolerating solids and liquids, but reports constipation that is difficult to manage.¿ records dated (b)(6) 2017 state: ¿36-year-old female with past surgical history significant for gastric bypass in 2008 with subsequent jejunostomy revision in 2015, presents to the er complaining of abdominal pain.She states that she has had gradually worsening epigastric/mid abdominal pain with nausea over the past week or so.She did presents dr.(b)(6) office today to have this evaluated, per the patient he suspects she may have a new hernia, and was advised to have it evaluated by dr.(b)(6) in the surgery clinic as an outpatient, but to come to the er if pain became severe.After eating dinner this evening, she felt that the pain was more severe, and unrelieved with tramadol at home, so she did present to the er.She is complaining of some nausea, but has not vomited.She has noticed some increase in urinary frequency.She had a bowel movement about 2 days ago, which is normal for her.¿ additional (b)(6) 2017 records state: ¿she has been doing some heavy lifting at home and recovering from hip replacement in physical therapy.¿ social history indicates marijuana use.The (b)(6) 2017 records state: ¿imaging results: ct abdomen/pelvis with iv and oral contrast-moderate to large amount of stool in the colon, possible constipation.No residual or incisional ventral hernia is noted at this time.No small bowel obstruction.¿ ¿medical decision making: i did discuss this case with dr.(b)(6) as he just saw the patient today.He was quite surprised that she presented to the er, but is amenable to a ct in the light of worsening abdominal pain.Ct was, however, negative for any acute abnormality, including new acute hernia.Constipation was noted, she is already on a large dose of stool softeners, but will be discharged home with an enema.She will continue to follow up with surgery as an outpatient, as well as her primary doctor and dr.(b)(6) as needed.¿ ct images dated (b)(6) 2017 state: ¿patient status post roux-en-y gastric bypass.Contrast passes normally into the small bowel.No abnormally dilated loops of bowel.No abnormal bowel wall thickening.There is a large volume of stool in the colon.No free fluid.No pneumoperitoneum.There are postsurgical changes in the anterior abdominal wall with hernia mesh placement.There is no recurrent hernia.¿ records dated (b)(6) 2017 state the ¿patient returns for follow up visit after er visit for abdominal pain.Ct scan shows a small amount of air in bypassed stomach but not obstruction and no recurrence of her ventral hernia.Patient has periumbilical discomfort.She vomited once or twice.¿ physician notes state: ¿because she had prior laparoscopic lysis of adhesions and revision of jejunojejunostomy, i am reluctant to reoperate unless there is a clear indication.She agreed to undergo an ugi to assess the roux limb outlet.¿ 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® 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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Event Description
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It was reported the patient alleges the following injuries: severe abdominal pain, mesh revision, additional surgeries.
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Manufacturer Narrative
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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: on (b)(6) 2010: (b)(6), pa.Emergency room visit.Cc: abdominal pain, right lower quadrant.Pain does not radiate.Described as crampy, sharp.Began 2 days ago, alleviated by nothing, aggravated by nothing.Associated signs and symptoms: diarrhea, nausea.Severity of pain: moderate.Not experienced similar episodes in past.States she has a lump in abd, sent by pmd [private medical doctor] for eval of hernia.Psh: hernia repair, c-section, tubal ligation, hysterectomy, abortion, d&c, gastric bypass.Exam: abdomen; negative for distension, guarding, masses, rebound tenderness.Bowel sounds active, soft, mild tenderness right of umbilicus.Hernia: located right of umbilicus, reducible.Wt 242 lbs.Differential dx: non-specific abd pain, bowel obstruction, hernia, incarcerated.On (b)(6) 2010: (b)(6), md.Discharge summary.Discharge dx: incarcerated recurrent ventral hernia.Hospital course: repair with mesh implant.D/c instructions: follow up in 1 week.Diet and activity as tolerated.On (b)(6) 2011: (b)(6), md, facs.Discharge summary.Final dx: incarcerated, recurrent ventral incisional hernia, s/p bariatric surgery.Hospital course: identified recurrent hernia in lower aspect of precious repair.Incarcerated with omentum.Denies signs of bowel obstruction.Acute pain when admitted, rehydrated and pain controlled.Brought to surgery, laparoscopic incisional hernia repair with mesh, extensive lysis of adhesions.Postoperatively develop nausea, pain, diarrhea.She improved.Discharge home, follow up outpatient.Discharge condition: pain controlled, pump catheter.Incisions clean and dry.Followup: office couple weeks.Instructions remove catheter on her own.Activities as tolerated.On (b)(6) 2011: [missing records: records for the ct scan showing the ¿fluid collection in rectus¿ were not provided.] on (b)(6) 2011: (b)(6), mbbs.History & physical.Hpi: no fever.Ct showed fluid collection in rectus.Gi: abd pain, diarrhea alternates with constipation, no n/v.Exam: abdomen soft, tender midline, bs+.Wt.253.6 lb.Impression: scheduled for laparoscopic surgery under general anesthesia.Cleared for procedure.On (b)(6) 2011: (b)(6), md, f.A.C.S.Discharge summary.Discharge dx: incisional hernia.Hospital course: physician¿s office with complaints of upper abdominal pain, workup revealed incisional hernia.Postop no wound infection or complications.Abdominal incision sites with steri-strips dry, intact.Abdominal binder for up moving, seemed to contain some pain.Discharge instructions: may shower.Activity as tolerated, may climb stairs in moderation.Followup dr.(b)(6) 7-10 days.Instructed steri-strips will fall off, not to manually remove them.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® 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) 2015: (b)(6), pa; (b)(6).Office notes.Past couple of months abdominal pain, feels like ¿her insides are being twisted¿.Pain radiates to back, diarrhea past 3 weeks.Seen in emergency department 07/16/15 for abdominal pain, had ct done.Reports nausea, abdominal pain and vomiting.Weight 230 lb.5 oz, bmi 41.4.Impression/plan: obesity morbid, pain abdominal generalized, bariatric surgery status, diarrhea.Was seen by dr.(b)(6) as well today and ct reviewed.Discussed she should have diagnostic laparoscopy for possible internal hernia.[missing records: records for emergency department visit for abdominal pain and ct were not provided.] [missing records: records for the ct scan showing the ¿contrast backing up into the bypass stomach suggesting an obstruction or internal hernia at the jejunojejunostomy¿ were not provided.] (b)(6) 2015: (b)(6), md.Operative report.Preoperative diagnosis: internal hernia.Postoperative diagnoses: adhesion at the jejunojejunostomy.Operation performed: laparoscopic lysis of adhesions.Drains: no drains.Implants: (not dictated).Complications: no complications.Attending surgeon: (b)(6), md.Assistant surgeon: (b)(6), md.No qualified general surgery resident was available.Anesthesia: general anesthesia.Estimated blood loss: 2 ml of blood loss.Specimens: no specimens.Indications: the patient is a 34-year-old woman who underwent gastric bypass surgery a number of years ago.She has had symptoms of abdominal discomfort and bloating for about 2 months and went to south buffalo mercy last week.A ct scan showed contrast backing up into the bypass stomach suggesting an obstruction or internal hernia at the jejunojejunostomy.Plan was for urgent diagnostic laparoscopy.Procedure: ¿with the patient supine on the operating table, under adequate general anesthesia, the abdomen was prepped and draped in sterile fashion.She received deep venous thrombosis prophylaxis with heparin and antibiotic prophylaxis with ancef.A 0.25% marcaine was infiltrated in the skin and subcutaneous tissue and incision made in the right lower quadrant medial to the anterior/superior iliac spine for placement of a 10 mm 0-degree angled scope through a 12 mm trocar.Pneumoperitoneum was established.The scope was changed to a 30-degree angled scope and additional ports were inserted including another 12 mm trocar to the left of the midline at the same level and two 5 mm trocars more laterally in the right and left upper abdomen and slightly more cephalad.The cecum was identified.There were patchy areas of the small bowel and cecum, which appeared to have limbs on them.Bowel was viable.The terminal ileum was seen where it joined the cecum and it was traced back to the jejunojejunostomy.Initially, the roux limb and the common channel were seen, but the biliopancreatic limb appeared to be retracted and very shortened.However, with mobilization of the anastomosis and possibly lysing some adhesions were in the area, the biliopancreatic limb was now free and quite mobile.The anastomosis was seemed very patulous with some folding and some thickening.All limbs were traced back satisfactorily with no evidence of petersen for a mesenteric hernia.The impression was that there were adhesions at this anastomosis, which were causing partial obstruction or even intussusception.There was no evidence of significant bleeding.There were no abnormalities seen in the upper abdomen as well.It was quite possible that the patient will need revision of anastomoses sometime in the future, we will follow her symptoms.The pneumoperitoneum was evacuated and all instruments removed.The skin was closed with 4-0 vicryl with steri-strips and dry dressings applied and she was awakened, extubated and taken to recovery, having tolerated the procedure well.¿ (b)(6) 2015: (b)(6), md.Operative report.Preoperative diagnosis: chronic abdominal pain.Postoperative diagnosis: chronic abdominal pain.Operation: laparoscopic revision of jejunojejunostomy.Drains: no drains.Complications: no complications.Co-surgeon: (b)(6), md.Anesthesia: general.Estimated blood loss: 3 ml.Specimens: no specimens.Indications: the patient is a 34-year-old woman, who has had episodes of abdominal discomfort for the past several months.She underwent a diagnostic laparoscopy about 2 months ago and was found to have adhesions at the jejunojejunostomy.These were taken down, although because of the kinking of the anastomosis the possibility revision was presented to the patient to be done possibly at a later date.She was well initially for several weeks, but then developed a similar discomfort with no other obvious pathology and she was offered revision of the jejunojejunostomy.The patient's weight this morning was 220 pounds.She was given ancef and preoperative dose of heparin for deep venous thrombosis prophylaxis.¿with the patient supine on the operating table under adequate general anesthesia, the abdomen was prepped and draped in a sterile fashion.Marcaine 0.25% was infiltrated in the skin and subcutaneous tissue for use of an incision that had previously been made to the right lower quadrant.However, the 12 mm trocar could not be passed.A second incision was made in the left lower quadrant through which a 12 mm port was placed with a 10 mm 0 degrees angled scope.Pneumoperitoneum was established.The scope was changed to an angled port and inspection revealed that the first attempt had been blocked from entrance by the patient's abdominal wall mesh.Therefore, a second 12 mm trocar was placed in the right lower quadrant below the mesh and a 5 mm trocar more laterally.Finally, a 5 mm trocar was placed in the left mid lateral abdomen.Using a 30 degree angled scope, the roux limb was identified forcing down to a twisted jejunojejunostomy.It appeared that most of the twist was at the connection of the roux limb through the anastomosis.The biliopancreatic limb appeared generally healthy with only minor adhesion.It was not dilated.Furthermore, the common channel also appeared to be totally benign and unobstructed.Decision was then made therefore to remove the roux limb of the jejunojejunostomy as close to the anastomosis as possible and to move it.This was accomplished by freeing up a few adhesions in the area and then placing a brown load 60 mm long tri-stapler across the anastomosis and firing it.A short bit of mesentery was taken with a 2.5 mm vascular load stapler.Approximately 10 cm distal and through a very healthy-appearing common channel, a new enteroenterostomy was made with the tan load 60 mm long tri-stapler.Suture was used to align the small bowel to itself to close the jejunojejunostomy and to close the mesenteric defect.At the completion of the procedure all limbs of the bowel appeared to lying in good position without any kinking or twisting and no residual mesenteric defect.There was no active bleeding and all instruments were then removed with pneumoperitoneum deflated.Closure of the skin was done with 4-0 vicryl with steri-strips and dry dressings applied and the patient was awakened, extubated and taken to recovery room, having tolerated the procedure well.¿ (b)(6) 2015: (b)(6).Implant record.Covidien x ii [times 2].(b)(6) 2015: (b)(6), md.Discharge summary.Admitting diagnosis: abdominal pain.Discharge diagnosis: same due to kinking of jejunojejunostomy.Hospital course: patient admitted after revision of jejunojejunostomy and was passing flatus and tolerating liquids at time of discharge.Follow up sept 25 at office.Diet bariatric full liquids.Activity: resume as tolerated.Shower, resume as tolerated.Tub bath, resume as tolerated.Walking.(b)(6) 2015: (b)(6), md.Radiology-ct of abdomen/pelvis without intravenous contrast.Indication: status post gastric bypass revision in (b)(6) 2015 with left-sided flank pain for a couple of days.Impression: postsurgical finding status post cholecystectomy and gastric bypass.No evidence of bowel obstruction.Some hyperdense material, likely surgical mesh other surgical material seen along the ventral abdominal wall.Recommend correlation with patient history.No evidence of extravasation of oral contrast.A moderate amount of stool seen consistent with constipation.Prominent left periaortic lymph nodes which are likely reactive.Otherwise no acute noncontrast ct findings are seen within the abdomen and pelvis.(b)(6) 2015: (b)(6), md.Radiology-x-ray abdomen.Indication: left lower quadrant pain for one week, worse over last 2 days with difficulty defecating, nausea and vomiting 2 weeks ago.Impression: no evidence of bowel obstruction or pneumoperitoneum.Ordering provider: (b)(6), md.Records between (b)(6) 2015 and (b)(6) 2017 were not provided.(b)(6) 2017: (b)(6), md.Office notes.Follow up 18 months after revision of the jejunojejunostomy for pain.The common channel was not shortened.Patient has residual hip pain following replacement done last september.Reports constipation that is difficult to manage.Weight 204 lb.Bmi 36.7.Impression and plan: bariatric surgery status, constipation, iron deficiency anemia.Ferritin level is low but reluctant to take iron because of her constipation, will try.(b)(6) 2017: s (b)(6), md.Office notes.One week history of periumbilical pain, has been doing some heavy lifting at home and recovering from hip replacement in physical therapy, denies nausea or vomiting, persistent constipation.Weight 210 lbs, bmi 37.8.Abdomen; has palpable, tender, reducible incisional hernia at umbilicus.Impression/plan: bariatric surgery status, constipation, incisional hernia without obstruction or gangrene.I have asked her to see dr.(b)(6) or one of his general surgery colleagues.(b)(6) 2017: (b)(6), pa-c.Emergency department visit.Presents complaining of abdominal pain.States gradually worsening epigastric/mid abdominal pain with nausea over past week or so.Did presents dr.(b)(6) office today to have this evaluated, per the patient he [sic] suspects she may have a new hernia, was advised to have it evaluated by dr.(b)(6) in the surgery clinic as outpatient, but to come to the emergency room if pain became severe.After eating she felt pain was more severe, and unrelieved with tramadol at home.Complaining of some nausea, has not vomited.Non-smoker, reports marijuana.Exam: abdominal tenderness to palpation of the epigastrium, mildly tender questionably palpable hernia defect in the abdominal wall to the left of the umbilicus.Medical decision making: i did discuss this case with dr.(b)(6).He was quite surprised she presented to the er [emergency room] but is amenable to a ct in light of worsening abdominal pain.Ct was, however, negative for any acute abnormality, including new acute hernia.Constipation was noted, she is already on a large dose of stool softeners, but will be discharged home with an enema.She will follow up with surgery as an outpatient, as well her primary doctor and dr.(b)(6) as needed.(b)(6) 2017: (b)(6), md.Radiology-ct abdomen/pelvis with iv contrast.Indication: abdominal/flank pain.Impression: no bowel obstruction.Status post roux-en-y gastric bypass with patent anastomoses.Large volume of stool in the colon suggests constipation.Status post ventral hernia repair with mesh in place.No recurrent hernia.(b)(6) 2017: (b)(6), do; (b)(6), do.Emergency department visit.Presents with abdominal pain, nausea, vomiting.Pain began yesterday, over mid epigastric region, feels similar to previous hernia pain.Ct scan shows hernia without entrapment over the periumbilical region, patient reports pain only mildly improved.Addendum: abdominal cramping pain, she was concerned as she reports she had entrapment of a hernia in past as a complication of gastric bypass.Team spoken with bariatric surgeon who recommends that general surgery department evaluate patient.General surgery evaluated patient, she does have evidence of air in gastric remnant, concerned there may be a fistulization, general surgery recommends evaluation by bariatric surgeon.Called and spoke with dr.(b)(6) again, patient¿s presentation does not appear to be related to her hernia, bariatric surgeon states he has seen evidence of air in the remnant stomach in past and he will follow up with patient this week in office.Discharged; abdominal pain, constipation.(b)(6) 2017: (b)(6).Nurse notes.Abdominal pain that started approximately a month ago.Reports history of hernias, was supposed to follow up with surgery, but has not, positive nausea.(b)(6) 2017: (b)(6), md.Radiology-ct abdomen/pelvis.Indication: abdominal/flank pain worsening and now nausea.Impression: small amount of fluid and small air-fluid level present in the excluded part of the stomach.No free air or free fluid in abdomen or pelvis.Colonic constipation.Ventral midline lower abdominal and pelvic hernia repair with hernia material mesh in place unchanged from prior study.(b)(6) 2017: (b)(6), md.Consultation.Ongoing abdominal pain, past several months, exacerbation over past week and a half.Accompanied by nausea, some anorexia.History: ventral hernia repair (multiple, current mesh in place), hysterectomy (partial), gastric bypass with later vision secondary to internal hernia.Examination: abdomen tender to palpation (diffuse, mild).Impression/plan: acute abdominal pain, constipation.No acute indication for exploration seen on ct scan, there is an air fluid in the remnant stomach which is generally unusual after gastric bypass, could be indicative of a fistula, recommend patient be seen by bariatric surgeon and potentially undergoing egd, patient additionally has significant stool burden, recommend enema and bowel regimen to encourage more regular bowel movements.No evidence of recurrence of abdominal wall hernia.No evidence of obstruction.May have marginal ulcer and/or gastro-gastric fistula among other post-bypass sequelae.(b)(6) 2017: (b)(6), md.Office notes.Follow up visit after emergency room visit for abdominal pain.Ct showed small amount of air in bypassed stomach.No recurrence of ventral hernia.Patient has periumbilical discomfort.Vomited once or twice.Weight 208 lbs, bmi 37.4.Impression/plan: bariatric surgery status, constipation, generalized abdominal pain.Because she had prior laparoscopic lysis of adhesions and revision of jejunojejunostomy, i am reluctant to re-operate unless there is a clear indication.Upper gastrointestinal series to assess roux limb outlet.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® biomaterial instructions for use addresses the following adverse reactions among others: ¿possible adverse reactions with the use of any tissue deficiency prosthesis may include, but are not limited to, contamination, infection, inflammation, adhesion, fistula formation, seroma formation, hematoma, and recurrence.¿ w.L.Gore & associates, inc.(gore) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by gore, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Blank fields present on this report include required fields and fields determined to be not applicable.Blank required fields indicate that the information was not provided, was deemed unavailable or was not applicable.This report does not constitute an admission or a conclusion by fda, gore, or its associates that the device, gore or its associates caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects" or has "malfunctioned".These words are included in the report and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.
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Manufacturer Narrative
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Previous patient code (3190, 1994) was reported based on the original complaint and are no longer applicable per gore¿s investigation.The investigation has been completed.In the absence of additional information or medical records from the complainant, this event file will be closed with the information provided.The following information was determined from the medical records.Medical records: the known medical records span from july 29, 2010 through august 8, 2018, and not all records received in this time span are relevant to gore® dualmesh® biomaterial.Records from september 21, 2011 through july 20, 2015; from october 7, 2015 through february 6, 2017 were not provided.Patient information: medical history: obesity, (b)(6) 2010: 242 lbs; bmi 42.52, (b)(6) 2011: 253.6 lbs; bmi 44.9, (b)(6) 2015: 230 lbs; bmi 41.4, (b)(6) 2016: 221 lbs; bmi 39.8, (b)(6) 2017: 204 lbs; bmi 36.7, (b)(6) 2018: 211 lbs; bmi 38.6, incisional hernia, colon polyp, diverticulosis, iron deficiency anemia.Prior surgical procedures: 1999: hernia repair, (b)(6) 2007: gastric bypass, cholecystectomy, cesarean section, tubal ligation, hysterectomy, abortion, dilation and curettage.Implant preoperative complaints: (b)(6) 2010: ¿abdominal pain, right lower quadrant.Pain does not radiate.Described as crampy, sharp.Began 2 days ago, alleviated by nothing, aggravated by nothing.¿ ¿not experienced similar episodes in past.States she has a lump in abd [abdomen], sent by pmd [private medical doctor] for eval [evaluation] of hernia.¿ (b)(6) 2010: ct abdomen with contrast: ¿small ventral hernia containing nondilated loops of bowel.¿ implant procedure: repair of incarcerated recurrent ventral hernia.Implant: gore® dualmesh® biomaterial (6964412/1dlmc03) 10cm x 15cm, oval.Implant date: (b)(6) 2010 [hospitalized 7/29/10 ¿ 7/31/10] description of hernia being treated: ¿the incision was carried down with multiple hernia defects seen and old suture was encountered with likely tevdek material but there was no mesh.The peritoneal cavity was entered.The small bowel was collapsed and fell into the abdominal cavity without any evidence of ischemia or perforation.The peritoneal cavity was clean.The fascial edges were cleaned from the hernia sac which had coursed towards the patient¿s right lower abdomen.¿ implant size and fixation: ¿then a gore-tex dual mesh measuring 10 x 15 cm was oriented with the long axis horizontal and secured with multiple sutures deep to the peritoneum through the fascia.When these were all tied individually, the mesh with the smooth side was facing the bowel and there was overlying fascia above it.The fascia was then closed directly over the mesh with running double-stranded 0-nylon suture.The mesh had been soaked in ancef solution and additional ancef irrigation was used to irrigate the wound.¿ post-operative period: [two days] (b)(6) 2010: ¿follow up in 1 week.Diet and activity as tolerated.¿ relevant medical information: (b)(6) 2011: ¿severe abdominal pain, left of incision line for last week.More pronounced in lying position but progressed lying, sitting or standing, pain was constant, sharp.Waves of nausea.Physician¿s office yesterday with complaints and a ct of abdomen and pelvis performed, showed small midline abdominal ventral hernia containing mesenteric fat and low midline pelvic ventral hernia containing mesenteric fat and loop of small bowel.No obstructive bowel pattern identified.¿ (b)(6) 2011: laparoscopic recurrent ventral incisional hernia repair with mesh.¿there were extensive adhesions found to the previous midline mass.There were no internal hernias identified.The hernia was on the lower part of the previous mesh which has shrunk and is now shivered [sic] up in the upper part and leaving a large defect which measures 6 cm x 7 cm.There was incarceration of the omentum and bowel but these were viable with no evidence of strangulation.It was repaired with a piece of rectangular covidien parietex composite® size 10 cm by 15 cm allowing at least 5 cm overlap on each side of the hernia.¿ - ¿the hernia contents were dissected free from the sac itself and reduced back into the peritoneal cavity.We decided to leave the mesh in place because taking it out would entail much more dissection and bleeding.The fact that the small piece just simply lay cephalad to the previous hernia and would be incorporated into the new mesh which was going to be placed in.The pneumoperitoneum pressure was reduced to 10 mmhg and the edges of the hernia defect were measured using transcutaneous and transfascial markings with a spinal needle to determine the craniocaudaland [sic] the lateral extent.We take into consideration all the smaller swiss cheese defects to form an aggregate.The appropriate mesh material and mesh size was selected to allow an overlap of at least 5 cm on each side after the defect was partially reapproximated with #2 pds sutures.The mesh was marked with the corrugated side facing upward against the abdominal wall.Six cardinal sutures of 0 ethibond were placed to allow transfascial securing of the mesh against the abdominal wall.The mesh was soaked in antibiotic solution then introduced into the abdominal cavity using the 12 mm port.It was then deployed intracorporally with the smooth nonadherent side facing downward to serve as a barrier against intestinal adhesions to the mesh itself.The previously placed sutures were then grasped with a suture passer transfascially and brought up against the abdominal wall using a reverse parachute technique.This allows the mesh to lay snugly against the abdominal wall without any excess folds.We then use an absorbable tacker every 1 cm apart to secure the mesh circumferentially around the hernia defect and to the abdominal wall.¿ records indicate the gore device was not explanted and that an additional non-gore mesh device was implanted.(b)(6) 2011: ¿no fever.Ct showed fluid collection in rectus.¿ ¿scheduled for laparoscopic surgery under general anesthesia.Cleared for procedure.¿ (b)(6) 2011: laparoscopic incisional ventral hernia repair with mesh ¿there were extensive adhesions found at the level of the previous incisional hernia repair in the umbilical area.There were no internal hernias identified.The ventral incisional hernia measures 5 cm by 5 cm, taking into consideration all the aggregates of small swiss-cheese hernias.There was incarceration of omentum and bowels but these were viable with no evidence of strangulation.It was repaired with a piece of rectangular covidien parietex composite® size 10 cm by 15 cm allowing at least 5 cm overlap on each side of the hernia.¿ ¿the hernia contents were dissected free from the sac itself and reduced back into the peritoneal cavity.The pneumoperitoneum pressure was reduced to 10 mmhg and the edges of the hernia defect were measured using transcutaneous and transfascial markings with a spinal needle to determine the craniocaudal and the lateral extent.We take into consideration all the smaller swiss cheese defects to form an aggregate.The appropriate mesh material and mesh size was selected to allow an overlap of at least 5 cm on each side after the defect was partially reapproximated with #2 pds sutures.The mesh was marked with the corrugated side facing upward against the abdominal wall.Six cardinal sutures of 0 ethibond were placed to allow transfascial securing of the mesh against the abdominal wall.The mesh was soaked in antibiotic solution then introduced into the abdominal cavity using the 12 mm port.It was then deployed intracorporeally with the smooth nonadherent side facing downward to serve as a barrier against intestinal adhesions to the mesh itself.The previously placed sutures were then grasped with a suture passer transfascially and brought up against the abdominal wall using a reverse parachute technique.This allows the mesh to lay snugly against the abdominal wall without any excess folds.We then use an absorbable tacker every 1 cm apart to secure the mesh circumferentially around the hernia defect and to the abdominal wall.¿ records indicate that neither the gore device nor the previous implanted non-gore device were explanted.Records indicate an additional non-gore device was implanted on 9/19/11.(b)(6) 2015: ¿past couple of months abdominal pain, feels like ¿her insides are being twisted.¿ pain radiates to back, diarrhea last 3 weeks.Seen in emergency department 07/16/15 for abdominal pain, had ct done.Reports nausea, abdominal pain and vomiting.¿ ¿discussed she should have diagnostic laparoscopy for possible internal hernia.¿ (b)(6) 2015: laparoscopic lysis of adhesions.¿the cecum was identified.There were patchy areas of the small bowel and cecum, which appeared to have limbs on them.Bowel was viable.The terminal ileum was seen where it joined the cecum and it was traced back to the jejunojejunostomy.Initially, the roux limb and the common channel were seen, but the biliopancreatic limb appeared to be retracted and very shortened.However, with mobilization of the anastomosis and possibly lysing some adhesions were in the area, the biliopancreatic limb was now free and quite mobile.The anastomosis was seemed very patulous with some folding and some thickening.All limbs were traced back satisfactorily with no evidence of petersen for a mesenteric hernia.The impression was that there were adhesions at this anastomosis, which were causing partial obstruction or even intussusception.There was no evidence of significant bleeding.There were no abnormalities seen in the upper abdomen as well.It was quite possible that the patient will need revision of anastomoses sometime in the future, we will follow her symptoms.¿ (b)(6) 2015: laparoscopic revision of jejunojejunostomy ¿the scope was changed to an angled port and inspection revealed that the first attempt had been blocked from entrance by the patient's abdominal wall mesh.Therefore, a second 12 mm trocar was placed in the right lower quadrant below the mesh and a 5 mm trocar more laterally.Finally, a 5 mm trocar was placed in the left mid lateral abdomen.Using a 30 degree angled scope, the roux limb was identified forcing down to a twisted jejunojejunostomy.It appeared that most of the twist was at the connection of the roux limb through the anastomosis.The biliopancreatic limb appeared generally healthy with only minor adhesion.It was not dilated.Furthermore, the common channel also appeared to be totally benign and unobstructed.Decision was then made therefore to remove the roux limb of the jejunojejunostomy as close to the anastomosis as possible and to move it.This was accomplished by freeing up a few adhesions in the area and then placing a brown load 60 mm long tri-stapler across the anastomosis and firing it.A short bit of mesentery was taken with a 2.5 mm vascular load stapler.Approximately 10 cm distal and through a very healthy appearing common channel, a new enteroenterostomy was made with the tan load 60 mm long tri-stapler.Suture was used to align the small bowel to itself to close the jejunojejunostomy and to close the mesenteric defect.(b)(6) 2017: ¿one week history of periumbilical pain, has been doing some heavy lifting at home and recovering from hip replacement in physical therapy, denies nausea or vomiting, persistent constipation.¿ ¿abdomen; has palpable, tender, reducible incisional hernia at umbilicus.¿ (b)(6) 2017: emergency room: ¿states gradually worsening epigastric/mid abdominal pain with nausea over past week or so.Did presents dr.Caruana¿s office today to have this evaluated, per the patient he suspects she may have a new hernia, was advised to have it evaluated by dr.Flynn in the surgery clinic as outpatient, but to come to the emergency room if pain became severe.After eating she felt pain was more severe, and unrelieved with tramadol at home.Complaining of some nausea, has not vomited.Non-smoker, reports marijuana.Abdominal tenderness to palpation of the epigastrium, mildly tender questionably palpable hernia defect in the abdominal wall to the left of the umbilicus.I did discuss this case with dr.Caruana.He was quite surprised she presented to the er [emergency room] but is amenable to a ct in light of worsening abdominal pain.Ct was, however, negative for any acute abnormality, including new acute hernia.¿ (b)(6) 2017: ct abdomen with contrast: ¿no bowel obstruction.Status post roux-en-y gastric bypass with patent anastomoses.Large volume of stool in the colon suggests constipation.Status post ventral hernia repair with mesh in place.No recurrent hernia.¿ (b)(6) 2017: emergency room: ¿presents with abdominal pain, nausea, vomiting.Pain began yesterday, over mid epigastric region, feels similar to previous hernia pain.Ct scan shows hernia without entrapment over the periumbilical region, patient reports pain only mildly improved.Abdominal cramping pain, she was concerned as she reports she had entrapment of a hernia in past as a complication of gastric bypass.Team spoken with bariatric surgeon who recommends that general surgery department evaluate patient.General surgery evaluated patient, she does have evidence of air in gastric remnant, concerned there may be a fistulization, general surgery recommends evaluation by bariatric surgeon.Called and spoke with dr.Caruana again, patient¿s presentation does not appear to be related to her hernia, bariatric surgeon states he has seen evidence of air in the remnant stomach in past and he will follow up with patient this week in office.¿ (b)(6) 2017: ¿reports history of hernias, was supposed to follow up with surgery, but has not, positive nausea.¿ (b)(6) 2017: ct abdomen: ¿no free air or free fluid in abdomen or pelvis.Colonic constipation.Ventral midline lower abdominal and pelvic hernia repair with hernia material mesh in place unchanged from prior study.¿ (b)(6) 2017: ¿ct showed small amount of air in bypassed stomach.No recurrence of ventral hernia.¿ conclusion: it should be noted that the gore® dualmesh® 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.Based upon the information received, the device remains in the patient and was not available for evaluation.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.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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