MAUDE Adverse Event Report: SEPRAFILM; MCN

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Code Available (3191)

Event Type  Injury  

Event Description

Ileus [ileus].Case narrative: based on additional information received (or 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 [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.Center id: unk; patient id: unk; country: (b)(6).Study title: (b)(6).This case was issued in publication in which 5 other related cases were reported: (b)(4) (cluster).This case involves adult patient who experienced ileus, 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, product for adhesion prevention seprafilm (number of sheets unknown) was used during laparotomy.On an unknown date, ileus developed (under-the-wound group, 2 patients).Outcome of ileus was unknown.The patient developed an event of a serious ileus.This event was assessed as medically significant.Final diagnosis was ileus.It was not reported if the patient received a corrective treatment.The patient outcome is reported as unknown for ileus.Ileus 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 was received on 28-jun-2019: no new information was received in this report.Correction to the previous report: deleted "non valid" in classification and initial justification in general field.

Event Description

Ileus.Case narrative: based on additional information received (or 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 japan_other sanofi-japan group employee under reference (b)(4) 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 ileus, 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, product for adhesion prevention seprafilm (number of sheets unknown) was used during laparotomy.On an unknown date, ileus developed (under-the-wound group, 2 patients).Outcome of ileus was unknown.The patient developed an event of a serious ileus.This event was assessed as medically significant and was leading to intervention.Final diagnosis was ileus.It was not reported if the patient received a corrective treatment.The patient outcome is reported as unknown for ileus.Ileus to carboxymethylcellulose and sodium hyaluronate was not reported by the reporter and reportable by the company based on company causality assessment.Reporter comment: the use of seprafilm helps reduce postoperative adhesive ileus.However, we see increased occurrences of unexpected strangulation ileus as a complication of intraoperative abnormal hiatus.Strangulation ileus results from an impaction of intestinal tract in the peri-phrenic hiatus created during a laparotomic esophageal resection.The application of seprafilm to such susceptible region helped avoid adhesion, but this played a causal role in this case.Additional information was received on 28-jun-2019: no new information was received in this report.Correction to the previous report: deleted "non valid" in classification and initial justification in general field.Additional information was received on 25-jul-2019: no new information was received.Additional information was received on 24-jul-2019 (this information was registered on 25-jul-2019): investigation summary was received from gqp quality operations, industrial affairs, quality information management (investigation summary no.(b)(4), event id (b)(4)).Reporter information and company comment were added.Correction to the previous report: "causality as reported" was corrected and reporter comment was added.

Event Description

Ileus [ileus].Case narrative: based on additional information received (or 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 japan_other sanofi-japan group employee under reference (b)(4) 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 ileus, 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, product for adhesion prevention seprafilm (number of sheets unknown) was used during laparotomy.On an unknown date, ileus developed (under-the-wound group, 2 patients).Outcome of ileus was unknown.The patient developed an event of a serious ileus.This event was assessed as medically significant and was leading to intervention.Final diagnosis was ileus.It was not reported if the patient received a corrective treatment.The patient outcome is reported as unknown for ileus.Ileus to carboxymethylcellulose and sodium hyaluronate was not reported by the reporter and reportable by the company based on company causality assessment.Reporter comment: the use of seprafilm helps reduce postoperative adhesive ileus.However, we see increased occurrences of unexpected strangulation ileus as a complication of intraoperative abnormal hiatus.Strangulation ileus results from an impaction of intestinal tract in the peri-phrenic hiatus created during a laparotomic esophageal resection.The application of seprafilm to such susceptible region helped avoid adhesion, but this played a causal role in this case.Additional information was received on 28-jun-2019: no new information was received in this report.Correction to the previous report: deleted "non valid" in classification and initial justification in general field.Additional information was received on 25-jul-2019: no new information was received.Additional information was received on 24-jul-2019 (this information was registered on 25-jul-2019): investigation summary was received from gqp quality operations, industrial affairs, quality information management (investigation summary no.(b)(4), event id (b)(4)).Reporter information and company comment were added.Correction to the previous report: "causality as reported" was corrected and reporter comment was added.

• Brand Name: SEPRAFILM
• Type of Device: MCN
• MDR Report Key: 8764493
• MDR Text Key: 150160907
• Report Number: 1220423-2019-00018
• Device Sequence Number: 1
• Product Code: MCN
• Combination Product (y/n): N
• Number of Events Reported: 1
• 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 Received: 07/05/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention