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Adhesive intestinal obstruction (entire small intestine) [small intestinal obstruction].([abdominal pain]).Allergic reaction suspected [application site allergy].Case narrative: initial information received on 17-dec-2018 regarding an unsolicited valid serious case received from (lp) japan-(b)(6) lsa-pcp under reference: (b)(4) on (b)(6) 2019 and transmitted to (b)(6).This case involves a 42 years old male patient (165 cm and 53.8 kg) who experienced adhesive intestinal obstruction (entire small intestine) and allergic reaction suspected, while he was treated with with the use of medical device carboxymethylcellulose, sodium hyaluronate [seprafilm].The patient's past medical history included congenital small intestinal atresia from on (b)(6) 1976, small intestine operation on (b)(6) 1976, dizziness, iron deficiency anaemia and transfusion.The patient's past medical treatment(s), vaccination(s) and family history were not provided.At the time of the event, the patient had ongoing food allergy and tobacco user.Note: inpatient.Concomitant medications included cefmetazole sodium (cefmetazole sodium) for prophylaxis.On an unknown date, when the patient was 33 years old or around, he came to suffer abdominal pain frequently.The symptom usually abated spontaneously after 4- or 5-hour fasting.On (b)(6) 2018, at around 16:00, abdominal pain started.The patient made an outpatient visit to an emergency center, and was then sent to the emergency outpatient department of the reporting hospital.A diagnosis of adhesive intestinal obstruction was made, and the patient was admitted to the gastroenterology department of the reporting hospital.An ileus tube was inserted.On (b)(6) 2018, the patient presented to the reporting department.A surgery was scheduled.On (b)(6) 2018, the patient transferred from the gastroenterology department to the reporting department.On(b)(6) 2018, method: the patient underwent laparoscopic synechiotomy and partial resection of small intestine, during which one sheet of seprafilm was placed under the wound in a periumbilical region.A drainage tube was inserted.Intraoperative findings: remnant of past repair of the congenital small intestinal obstruction was observed.Small 2-centimeter incision was made in the lower umbilical region, where no adhesion was observed.A 12-mm port was inserted to create the pneumoperitoneum, and intra-abdominal observation was made.The wound in the upper median region was noted to have extensively adhered to small intestines.Adhesions were also observed in the ileocecal region, involving abdominal wall and small intestines.Firstly, a 5-mm port and a 12-mm port were inserted into the suprapubic region and the left lower abdominal region, respectively.The adhesion in the right lower abdominal part was removed.Then, another 5-mm port was inserted from the right abdomen.One more 5-mm port was inserted into the left.A total of 5 ports were used.Crowded adhesions were seen here and there in the small intestine, in which complex adhesions were observed between small intestines, and in greater omentum, sigmoid mesocolon, and parietal peritoneum.A lateral approach was taken in the right lower abdominal part, so as to ensure mobilization outside the body cavity, and the ileocecal region was mobilized.As preoperative ct showed the appendix in the retroperitoneal region, prophylactic appendectomy was performed, and mesoappendix was disposed.After this, a medial approach was taken, to remove the adhesion between mesentery and retroperitoneum.The adhesion to sigmoid mesocolon was also removed.Then, the adhesions between the wound and the small intestines were removed, and the adhesions between the greater omentum and small intestines were extensively removed.The pneumoperitoneum procedure was ended, and a small incision was made in the umbilical region.At first, alexis s was inserted, but it failed to take out the intestinal tract.The incision was widened to 6 centimeters to allow the insertion of alexis m.Multiple crowed adhesions in the ileum were detected, and were carefully removed.Serous membrane damage was reinforced with 4-0 pds as appropriate.The dilatation of anal portions of ileum, which was previously observed on ct scan, was confirmed, but it had a trifurcated shape, and was unable to be analyzed anatomically.The terminal of the cecum was identified, and the appendix was resected, and its root was buried.After this, the regions from the terminal ileum to rostral portions were seen.The trifurcated intestinal tract was identified.Other tract than rostral portions was being closed, and was identified as an anastomotic site created at the time of past small intestinal obstruction repair.This site was approximately 25 centimeters in length, and it appeared that a stenosis occurred in an anal portion of the anastomotic site and caused dilatation.Also, cystic dilation was found in an anal portion about 10 centimeters away from the end.In rostral portions up to treitz, multiple crowded adhesions were seen and were removed.Treitz was confirmed.At this time, small blood vessels of mesentery were torn and were ligated.The trifurcated tract was treated in a way that resections were made in an oral portion 25 centimeters away from the non-dilated anastomotic site (with signia purple 60mm) as well as in an anal portion 20 centimeters away from the anastomotic site (with signia camel 60mm).The terminal was buried.The ramified site was reinforces with 3 stitches, and the mesentery was closed.For irrigation, saline solution 2000 ml was used.Pneumoperitoneum was created again, and the absence of any bleeding was confirmed.Uk 15fr was inserted from the left and was kept in the pelvic cavity.The ports were removed.Seprafilm was kept in place.The peritoneal continuous suturing was done with 2-0 polysorb and 0-pds needle with looped thread.Wound lavage was done.The surgery was ended with subcutaneous buried suture.On (b)(6) 2018, the patient resumed oral fluid intake.On (b)(6) 2018, the ileus tube was removed.On (b)(6) 2018, the drainage tube was removed.On (b)(6) 2018, seven days after the surgery, abdominal pain developed after meal.This pain was considered to be of postoperative enterocolitis, and was treated with fasting and fluid replacement.On (b)(6) 2018, upper abdominal pain occurred after lunch.X-ray showed niveau, indicating a state of subileus.On (b)(6) 2018, ct showed dilatation of small bowel wall in wide areas.No apparent stenosis was observed, and conservative treatment was chosen.Cv catheter was inserted, and total parenteral nutrition (tpn) was started, in combination with enteral feeding.On (b)(6) 2018, the abdominal pain became worse.On (b)(6) 2018, ct was performed for reassessment, because of the abdominal pain which started in the night of the previous day.It was determined that re-surgery would be necessary.Ct showed small bowel wall thickening, which was indicative of adhesion.Residues were also seen.The patient underwent the second laparotomy, in which synechiotomy and partial enterectomy were performed.There was one section that was affected by stenosis.Glass-like hard adhesion was detected in the entire area.Thus, the events "adhesive intestinal obstruction (entire small intestine)" and "allergic reaction suspected" occurred, and these events were apparently consistent with the seprafilm application site.Intraoperative findings: upper abdominal midline incision was made from the xiphisternum to the point incised in the prior surgery.Extensive adhesions were observed in diverse areas including the wound.Firstly, the adhesion to the abdominal wall was removed.Intestinal tract-to-tract adhesions were also removed.The site where seprafilm was applied in the prior surgery was also found to have solidly adhered to diverse regions including the prior anastomotic site, staple line, serous membrane reinforcement site, greater omentum, and transverse mesocolon.In small intestines, crowed adhesions were detected in two regions; one was the jejunum in the left upper abdominal part in particular where the patient had symptoms, and the other was the ileum in the right lower abdominal part including the prior anastomotic site.These adhesions were solid and thick, and the greater omentum was also noted to have solidly adhered to intestinal tract.A steatitis-like state was observed.An allergic reaction was suspected.Adhesions in the left upper abdominal part were removed, but partial stenosis was found.A rostral portion of this part was resected with endo gia purple 60mm, and an anal portion was resected with endo gia black 60mm at the area where adhesions started in the right lower abdominal part.A total of about 50 cm of the tract was resected.Mesentery was ligated and separated, to resect the tract.Then, side-to-side anastomosis was performed (with purple 60mm).The entry hole was closed with a single knot in all layers with 4-0 pds.The ramified part was reinforced with two stitches.The serous membrane damage was reinforced before and after the anastomosis.For irrigation, 4000 ml saline solution was used.Uk 15 fr drain was inserted from the left lower abdominal part and it came to the anastomosis site via a space between transverse mesocolon and jejunal mesocolon.For the peritoneum, continuous suturing with 1-0 polysorb was made in the caudal and anterior parts of the prior surgical wound.In the prior surgery, the peritoneum was extensively lost at the time of removing intestinal tract adhesions.Fascia was sutured with a single knot with 0-pds+.After subcutaneous irrigation, the derm was buried with 3-0 pds.The surgery was completed.Seprafilm was kept in place as usual (according to the reporter, seprafilm was usually kept in place except for contamination cases).On (b)(6) 2018, the drainage tube was removed, and a gastric catheter was inserted.On (b)(6) 2018, the gastric catheter was removed.On (b)(6) 2018, enteral feeding was resumed.Pyrexia and abdominal pain developed, for which antibiotic therapy was started.On (b)(6) 2018, the cv catheter was removed.On (b)(6) 2018, meals were resumed.On (b)(6) 2018, the patient was discharged with a favorable postoperative course.The nest visit and x-ray were scheduled for on (b)(6) 2018.On an unknown date, the abdominal pain resolved.On (b)(6) 2019, the adhesive intestinal obstruction (entire small intestine) resolved.The outcome of "allergic reaction suspected" was unknown.The patient developed an event of a serious adhesive intestinal obstruction (entire small intestine) (small intestinal obstruction) 15 days after starting use of carboxymethylcellulose and sodium hyaluronate.This event was assessed as medically significant and was leading to intervention.Due to this event patient's hospitalization was prolonged.The patient was discharged on (b)(6) 2018 (hospitalization during 48 days).The patient developed an event of a non-serious allergic reaction suspected (application site hypersensitivity) 15 days after starting use of carboxymethylcellulose and sodium hyaluronate.The patient developed an event of a serious abdominal pain 8 days after starting use of carboxymethylcellulose and sodium hyaluronate.This event was assessed as medically significant and was leading to intervention.Due to this event patient's hospitalization was prolonged.The patient was discharged on (b)(6) 2018 (hospitalization during 48 days).Relevant laboratory test results included: computerised tomogram: on (b)(6) 2018: [dilatation of small bowel wall is widely seen.No apparent stenosis is observed.]; on (b)(6) 2018: [small bowel wall thickening, indicative of adhesion, was observed.Residues are detected.] x-ray: on (b)(6) 2018: [niveau is observed, showing a state of subileus.] final diagnosis was allergic reaction suspected and severe adhesive intestinal obstruction (entire small intestine).An unknown corrective treatment was received.The patient outcome is reported as recovered / resolved on (b)(6) 2019 for adhesive intestinal obstruction (entire small intestine), as unknown for allergic reaction suspected and as recovered / resolved on an unknown date for abdominal pain.Reporter comment: the event "adhesive intestinal obstruction (entire small intestine)" was probably related to seprafilm.It is unknown whether there was any other causative factor.During the re-surgery, inflammatory thickening and glass-like hard adhesions were observed in wide areas including intestinal tract and greater omentum.These findings are unusual.The seprafilm application site was found to be solidly adhered to the peritoneum and intestinal tract.This was suggestive of an allergic reaction.After the re-surgery, paralytic ileus persisted.Two weeks after the re-surgery, intestinal motility improved, and oral intake of food was started.On the basis of the intraoperative findings, the responsibility of seprafilm was presumed.Additional information was received on 23-jan-2019: investigation summary was received (investigation summary#: (b)(4).No product lot number was provided by the reporter; therefore sanofi biosurgery quality assurance is unable to perform a specific lot history review/investigation in response to this event.Seprafilm adhesion barrier serves as a temporary bioresorbable barrier separating apposing tissue surfaces.The physical presence of the membrane separates adhesiogenic tissue while the normal tissue repair process takes place.When applied as directed, seprafilm adhesion barrier can be expected to reduce adhesions within the abdominopelvic cavity.Approximately 24 to 48 hours after placement, the membrane becomes a hydrated gel that is slowly resorbed within one week.Components are excreted in less than 28 days.All seprafilm lots manufactured by sanofi are released for shipment by quality assurance only after successful completion of quality control certificate of analysis testing and review of all device history records and associated manufacturing process documentation.This lot release procedure provides assurance that all product lots are manufactured under specified process parameters and pass final product and sterility specifications.Product safety metrics are compiled by sanofi global pharmacovigilance and epidemiology and presented to senior management.Any trending signal is discussed during these trending meetings and escalated to the safety governance for adjudication.As a lot history review/investigation was unable to be completed and no trending signal has been identified at this time, no capa is considered necessary however; sanofi will continue to monitor and trend these types of events and implement appropriate corrective actions where applicable.If a lot number for this event is reported at a later date, this product event will be reopened and a lot investigation will be performed by sanofi biosurgery quality assurance at that time.Additional information was received on 25-jan-2019 from the physician: updated patient information (inpatient status, date of birth, height, weight, medical history), added lab data, updated concomitant drug information, added events "abdominal pain" and "allergic reaction suspected," added reporter comment, changed outcome date of "adhesive intestinal obstruction (entire small intestine)," updated clinical course, and updated company comment.
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