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Ileus [ileus] ([application site pain], [eosinophil count increased], [c-reactive protein increased], [pyrexia], [vomiting]).Case narrative: initial information received on (b)(6) 2018 regarding an unsolicited valid serious case received from (b)(6) group employee under reference (b)(4) on and transmitted to sanofi.This case involves a (b)(6) female patient (159 cm (b)(6)) who experienced ileus, while she was treated with the use of medical device carboxymethylcellulose, sodium hyaluronate [seprafilm].The patient's past medical history included gastrointestinal injury in (b)(6) 1955 and surgery in (b)(6) 1955.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 hydrosalpinx, food allergy, dermatitis atopic and non-tobacco user.Concomitant medications included cefazolin (cefazolin) for infection prophylaxis; paracetamol (paracetamol) for product used for unknown indication; and omeprazole (omeprazole) for product used for unknown indication.Preoperative condition: good health, well-nourished.Anaemia: no.Radiotherapy: no.On (b)(6) 2018, the patient was admitted.On (b)(6) 2018, a laparotomy for left salpingectomy was performed (intraoperative heat therapy: none), in which two sheets of seprafilm (carboxymethylcellulose, sodium hyaluronate) was used.Both sheets were placed directly under the abdominal wall, and the condition of placement was favorable.Pressure pain and ileus symptom(s) were seen in the application site.Pre-existing adhesion was observed around a uterine tube, and detachment was made.Sutured layers consisted of two layers; fascia and dermis, where interrupting manual suturing was performed with absorbable mono thread.There was no combined use of other medical device.On (b)(6) 2018, the patient was re-admitted with pyrexia, abdominal pain and vomiting.Ct showed film-shaped opacities in the seprafilm application site.A diagnosis of ileus was made, for which antibiotic therapy was started.Later, the pyrexia was alleviated but ileus symptom persisted.There was pain in the site where seprafilm was placed (directly under the abdominal wall).Pooling was observed in the surrounding area, and therefore, drainage was performed.Ascites was aspirated for culture test, and drain fluid gave negative result.The bacterial culture test on specimen from the seprafilm application site, which was performed to detect any aerobic and anaerobic bacteria, gave no findings.Eosinophils increased to 14.4, and crp increased to 10.32.Cefmetazole was administered at a daily dose of 2 g for infection control.On (b)(6) 2018, an improving trend in ileus was seen, but pyrexia relapse, for which antibiotic (firstcin) was resumed.On (b)(6) 2018, pyrexia was absent, and the oral antibiotic was replaced by an oral antiallergic drug.The patient was discharged.The ileus and pyrexia resolved on this day.The patient developed an event of a serious ileus.This event was assessed as medically significant.The patient was hospitalized on the same day this event occurred.The patient was discharged on (b)(6) 2018 (hospitalization during 13 days).The patient developed an event of a serious seprafilm application site pain after surgery (application site pain).This event was assessed as medically significant.The patient was hospitalized for this event during 13 days.The patient was discharged on (b)(6) 2018 (hospitalization during 13 days).The patient developed an event of a serious eosinophils increased (eosinophil count increased).This event was assessed as medically significant.The patient was hospitalized for this event during 13 days.The patient was discharged on (b)(6) 2018 (hospitalization during 13 days).The patient developed an event of a serious crp increased (c-reactive protein increased).This event was assessed as medically significant.The patient was hospitalized for this event during 13 days.The patient was discharged on (b)(6) 2018 (hospitalization during 13 days).The patient developed an event of a serious pyrexia.This event was assessed as medically significant.The patient was hospitalized on the same day this event occurred.The patient was discharged on (b)(6) 2018 (hospitalization during 13 days).The patient developed an event of a serious vomiting.This event was assessed as medically significant.The patient was hospitalized on the same day this event occurred.The patient was discharged on (b)(6) 2018 (hospitalization during 13 days).Relevant laboratory test results included: c-reactive protein - on (b)(6) 2018: 8.60 unk; on (b)(6) 2018: 10.3 unk; on an unknown date: 10.32 unk.Culture negative - on an unknown date: negative.Eosinophil count - on an unknown date: 14.4 unk.Eosinophil percentage - on (b)(6) 2018: 9.2 %.White blood cell count - on (b)(6) 2018: 12700 unk; on (b)(6) 2018: 7600 unk.Final diagnosis was ileus.The patient was treated with cefmetazole sodium (cefmetazole na) and cefozopran hydrochloride (firstcin).The patient outcome is reported as recovered / resolved on (b)(6) 2018 for ileus, as recovered / resolved on an unknown date for seprafilm application site pain after surgery, as recovered / resolved on an unknown date for eosinophils increased, as recovered / resolved on an unknown date for crp increased, as recovered / resolved on (b)(6) 2018 for pyrexia and as recovered / resolved on an unknown date for vomiting.Reporter comment: the causality with seprafilm: probably related.Reporter comment (added on (b)(6) 2018): the causal relationship between seprafilm and the event ileus was unknown.The patient had a risk factor (historical condition) which was a possible causative factor for this event.The ileus symptom(s), attributable to inflammation, was observed, but its direct relation to seprafilm was uncertain.No product lot number was provided by the reporter; therefore sanofi-genzyme 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 genzyme 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-genzyme 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-genzyme biosurgery quality assurance at that time.Additional information was received on (b)(6) 2018 from the physician: updated patient information, added historical/concurrent conditions, changed indication of seprafilm and concomitant drug, changed cefmetazole na from concomitant drug to corrective treatment, added corrective treatment firstcin, added surgery details to narrative, added lab data, added hospitalization details, added reporter comment, added "pyrexia" and "vomiting" as associated symptoms of ileus, and updated narrative.Additional information was received on (b)(6) 2018: investigation summary was received (investigation summary #(b)(4), event id (b)(4)).Company comment was updated, and investigation results were added to the seprafilm field.
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