MAUDE Adverse Event Report: SEPRAFILM; MCN

Device Problem Unexpected Therapeutic Results (1631)

Patient Problems Adhesion(s) (1695); No Code Available (3191)

Event Type  Injury  

Event Description

Strangulation ileus.Case narrative: 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, 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, strangulation ileus developed.Outcome of strangulation ileus was unknown.The patient developed an event of a serious strangulation ileus (mechanical ileus).This event was assessed as medically significant and was leading to intervention.Final diagnosis was strangulation ileus.It was not reported if the patient received a corrective treatment.The patient outcome is reported as unknown for strangulation ileus.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.Reporter comment: not reported.Additional information was received on 28-jun-2019: no new information was received.Amendment to the report dated 12-jun-2019: this case became "valid" (based on the information received on 12-jun-2019)." "non valid case" was deleted from the classification field, and "number of involved patients not reported/ patient not identifiable" was deleted from the initial justification field.

Event Description

Strangulation ileus.Case narrative: initial information received on 12-jun-2019 regarding a solicited valid serious case issued from a literature article: miyachi m, saito t, watanabe y, asai y, kawai r, kawai t, et al.P118-6 study on merits and demerits of product for adhesion prevention seprafilm for subtotal excision of esophagus with laparotomy approach.The 73rd annual meeting of the japan esophageal society.2019; unk: 135, in the scope of post-marketing sponsored study.Center id: unk; patient id: unk; country: japan study title: unsponsored study involving seprafilm.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, 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, strangulation ileus developed.Outcome of strangulation ileus was unknown.The patient developed an event of a serious strangulation ileus (mechanical ileus).This event was assessed as medically significant and was leading to intervention.Final diagnosis was strangulation ileus.It was not reported if the patient received a corrective treatment.The patient outcome is reported as unknown for strangulation ileus.Mechanical ileus is considered to be "causality not reported" to carboxymethylcellulose and sodium hyaluronate 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 was received on 28-jun-2019: no new information was received.Amendment to the report dated 12-jun-2019: this case became "valid" (based on the information received on 12-jun-2019)." "non valid case" was deleted from the classification field, and "number of involved patients not reported/ patient not identifiable" was deleted from the initial justification field.Additional information was received on 25-jul-2019: no new information was received.No follow-up is possible.Additional information was received on 24-jul-2019: investigation summary was received (investigation summary # (b)(4), event id: (b)(4)).Updated company comment and added reporter information.Correction to the previous report: corrected reporter causality assessment; and added reporter comment.

Event Description

Strangulation ileus [strangulation ileus].Case narrative: initial information received on 12-jun-2019 regarding a solicited valid serious case issued from a literature article: miyachi m, saito t, watanabe y, asai y, kawai r, kawai t, et al.P118-6 study on merits and demerits of product for adhesion prevention seprafilm for subtotal excision of esophagus with laparotomy approach.The 73rd annual meeting of the japan esophageal society.2019; unk: 135, in the scope of post-marketing sponsored study.Center id: unk; patient id: unk; country: japan study title: unsponsored study involving seprafilm.This case was issued in publication in which 5 other related cases were reported: (b)(4).This case involves adult patient who experienced strangulation 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, seprafilm was used for laparotomy.On an unknown date, strangulation ileus developed.Outcome of strangulation ileus was unknown.The patient developed an event of a serious strangulation ileus (mechanical ileus).This event was assessed as medically significant and was leading to intervention.Final diagnosis was strangulation ileus.It was not reported if the patient received a corrective treatment.The patient outcome is reported as unknown for strangulation ileus.Mechanical ileus is considered to be <> to carboxymethylcellulose and sodium hyaluronate 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 was received on 28-jun-2019: no new information was received.Amendment to the report dated (b)(6) 2019: this case became "valid" (based on the information received on 12-jun-2019)." "non valid case" was deleted from the classification field, and "number of involved patients not reported/ patient not identifiable" was deleted from the initial justification field.Additional information was received on 25-jul-2019: no new information was received.No follow-up is possible.Additional information was received on 24-jul-2019: investigation summary was received (investigation summary #217165, event id: 59063).Updated company comment and added reporter information.Correction to the previous report: corrected reporter causality assessment; and added reporter comment.

• Brand Name: SEPRAFILM
• Type of Device: MCN
• MDR Report Key: 8802208
• MDR Text Key: 151429722
• Report Number: 1220423-2019-00020
• 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

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/18/2019
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 08/01/2019; 08/19/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention