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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SEPRAFILM; MCN
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SEPRAFILM; MCN Back to Search Results
Device Problem Unexpected Therapeutic Results (1631)
Patient Problems Adhesion(s) (1695); Obstruction/Occlusion (2422); No Code Available (3191)
Event Type  Injury  
Event Description
Strangulation ileus.Impaction of small intestine in left thoracic cavity [impaction of intestine].Case narrative: upon internal review on 28-jun-2019, this case previously considered as non-valid became valid.Initial information received on 12-jun-2019 regarding a solicited valid serious case received from (b)(6) under reference on 28-jun-2019 and transmitted to sanofi, in the scope of post-marketing sponsored study.Center id: unk; patient id: unk; country: (b)(6), study title: (b)(6).[literature information]: title: (b)(6) study on merits and demerits of product for adhesion prevention seprafilm for subtotal excision of esophagus with laparotomy approach.Authors: miyachi m, saito t, watanabe y, asai y, kawai r, kawai t, et al.Journal: the 73rd annual meeting of the japan esophageal society.2019; unk: 135.This case was issued in publication in which 5 other related cases were reported: (b)(4) (cluster).This case involves adult patient who experienced strangulation ileus and impaction of small intestine in left thoracic cavity, while he/she using with the use of medical device carboxymethylcellulose, sodium hyaluronate [seprafilm].The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.On an unknown date, seprafilm was used for laparotomy.On an unknown date, impaction of small intestine in left thoracic cavity and strangulation ileus developed.Outcome of impacted impaction of small intestine in left thoracic cavity and strangulation ileus was unknown.The patient developed an event of a serious strangulation ileus (mechanical ileus).This event was assessed as medically significant.The patient developed an event of a serious impaction of small intestine in left thoracic cavity (intestinal obstruction).This event was assessed as medically significant.Final diagnosis was impaction of small intestine in left thoracic cavity and strangulation ileus.An unknown corrective treatment was received.The patient outcome is reported as unknown for strangulation ileus and as unknown for impaction of small intestine in left thoracic cavity.Mechanical ileus is considered to be related to carboxymethylcellulose and sodium hyaluronate by the reporter and reportable by the company based on company causality assessment.Intestinal obstruction is considered to be related to carboxymethylcellulose and sodium hyaluronate by the reporter and reportable by the company based on company causality assessment.Reporter comment: not reported.Additional information based on internal review on 28-jun-2019: this case previously considered as non-valid became valid (correction to the previous report: "non valid case" was deleted from classification; and initial justification was deleted).No new information was received from the reporter.
 
Event Description
Strangulation ileus.Impaction of small intestine in left thoracic cavity.Case narrative: upon internal review on 28-jun-2019, this case previously considered as non-valid became valid.Initial information received on 12-jun-2019 regarding a solicited valid serious case received from (lp) japan-kaken lsa-pcp under reference (b)(4) on 25-jul-2019 and transmitted to sanofi, in the scope of post-marketing sponsored study.Center id: unk; patient id: unk; country: japan.Study title: unsponsored study involving seprafilm.[literature information]: title: p118-6 study on merits and demerits of product for adhesion prevention seprafilm for subtotal excision of esophagus with laparotomy approach authors: miyachi m, saito t, watanabe y, asai y, kawai r, kawai t, et al.Journal: the 73rd annual meeting of the japan esophageal society.2019; unk: 135.This case was issued in publication in which 5 other related cases were reported: (b)(4) (cluster).This case involves adult patient who experienced strangulation ileus and impaction of small intestine in left thoracic cavity, while he/she using with the use of medical device carboxymethylcellulose, sodium hyaluronate [seprafilm].The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.On an unknown date, seprafilm was used for laparotomy.On an unknown date, impaction of small intestine in left thoracic cavity and strangulation ileus developed.Outcome of impacted impaction of small intestine in left thoracic cavity and strangulation ileus was unknown.The patient developed an event of a serious strangulation ileus (mechanical ileus).This event was assessed as medically significant.The patient developed an event of a serious impaction of small intestine in left thoracic cavity (intestinal obstruction).This event was assessed as medically significant.Final diagnosis was impaction of small intestine in left thoracic cavity and strangulation ileus.An unknown corrective treatment was received.The patient outcome is reported as unknown for strangulation ileus and as unknown for impaction of small intestine in left thoracic cavity.Causality for mechanical ileus with carboxymethylcellulose and sodium hyaluronate: not reported by the reporter and reportable by the company based on company causality assessment.Causality for intestinal obstruction with carboxymethylcellulose and sodium hyaluronate: not reported by the reporter and reportable by the company based on company causality assessment.Reporter comment: the use of seprafilm reduces postoperative adhesive ileus; however, without aura, incidence of strangulation ileus due to abnormal hiatus that occurred during the surgery becomes high.Esophageal hiatus at the time of resection of the esophagus under laparotomy and impacted intestinal tract in hiatus area around diaphragm were the cause of strangulation ileus.The factor was that the attachment of seprafilm to area neighbor to the above lesion disturbed adhesion.Additional information based on internal review on 28-jun-2019: this case previously considered as non-valid became valid (correction to the previous report: "non valid case" was deleted from classification; and initial justification was deleted).No new information was received from the reporter.Additional information was received on 25-jul-2019 by the physician: added reporter information.Additional information was received on 24-jul-2019: received investigation summary (investigation summary # (b)(4), event id: (b)(4)), and added reporter information and company comment.Correction to the previous report: corrected reporter causality, and added reporter comment.
 
Event Description
Strangulation ileus [strangulation ileus] impaction of small intestine in left thoracic cavity [impaction of intestine].Case narrative: upon internal review on 28-jun-2019, this case previously considered as non-valid became valid.Initial information received on 12-jun-2019 regarding a solicited valid serious case received from (lp) japan-kaken lsa-pcp under reference (b)(4) on (b)(6) 2019 and transmitted to sanofi, in the scope of post-marketing sponsored study.Center id: unk; patient id: unk; country: japan study title: unsponsored study involving seprafilm.[literature information] title: p118-6 study on merits and demerits of product for adhesion prevention seprafilm for subtotal excision of esophagus with laparotomy approach authors: miyachi m, saito t, watanabe y, asai y, kawai r, kawai t, et al.Journal: the 73rd annual meeting of the japan esophageal society.2019; unk: 135.This case was issued in publication in which 5 other related cases were reported: (b)(4)(cluster).This case involves adult patient who experienced strangulation ileus and impaction of small intestine in left thoracic cavity, while he/she using with the use of medical device carboxymethylcellulose, sodium hyaluronate [seprafilm].The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.On an unknown date, seprafilm was used for laparotomy.On an unknown date, impaction of small intestine in left thoracic cavity and strangulation ileus developed.Outcome of impacted impaction of small intestine in left thoracic cavity and strangulation ileus was unknown.The patient developed an event of a serious strangulation ileus (mechanical ileus).This event was assessed as medically significant.The patient developed an event of a serious impaction of small intestine in left thoracic cavity (intestinal obstruction).This event was assessed as medically significant.Final diagnosis was impaction of small intestine in left thoracic cavity and strangulation ileus.An unknown corrective treatment was received.The patient outcome is reported as unknown for strangulation ileus and as unknown for impaction of small intestine in left thoracic cavity.Causality for mechanical ileus with carboxymethylcellulose and sodium hyaluronate: not reported by the reporter and reportable by the company based on company causality assessment.Causality for intestinal obstruction with carboxymethylcellulose and sodium hyaluronate: not reported by the reporter and reportable by the company based on company causality assessment.Reporter comment: the use of seprafilm reduces postoperative adhesive ileus; however, without aura, incidence of strangulation ileus due to abnormal hiatus that occurred during the surgery becomes high.Esophageal hiatus at the time of resection of the esophagus under laparotomy and impacted intestinal tract in hiatus area around diaphragm were the cause of strangulation ileus.The factor was that the attachment of seprafilm to area neighbor to the above lesion disturbed adhesion.Additional information based on internal review on 28-jun-2019: this case previously considered as non-valid became valid (correction to the previous report: "non valid case" was deleted from classification; and initial justification was deleted).No new information was received from the reporter.Additional information was received on 25-jul-2019 by the physician: added reporter information.Additional information was received on 24-jul-2019: received investigation summary (investigation summary #217161, event id: 59062), and added reporter information and company comment.Correction to the previous report: corrected reporter causality, and added reporter comment.
 
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Brand Name
SEPRAFILM
Type of Device
MCN
MDR Report Key8802439
MDR Text Key151441268
Report Number1220423-2019-00019
Device Sequence Number1
Product Code MCN
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,l
Type of Report Initial,Followup,Followup
Report Date 08/19/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/18/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Patient Sequence Number1
Patient Outcome(s) Other; Required Intervention;
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