MAUDE Adverse Event Report: GENZYME CORPORATION(FRAMINGHAM) SEPRAFILM; MCN

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

Patient Problem Obstruction/Occlusion (2422)

Event Type  Injury  

Event Description

Intestinal obstruction (postoperative complication) [intestinal obstruction].Case narrative: initial information received on 27-nov-2019 regarding an unsolicited valid serious case issued from a literature article.Title: o-11-4 efforts and consideration of seprafilm insertion after laparoscopic total cystectomy.Author: sano t, yanagisawa t, enei y, sakanaka k, takahashi k, atsuta m, et al.Journal: the 33rd congress of japanese society of endourology (21,22,23-nov-2019), unk;unk:unk.This case was issued in publication in which another related case was reported: (b)(4) (cluster).This case involves adult patient who experienced intestinal obstruction (postoperative complication), while he/she using with the use of medical device carboxymethylcellulose, sodium hyaluronate [seprafilm].The patient's past medical history included urinary cystectomy.The patient's past medical treatment(s), vaccination(s) and family history were not provided.On an unknown date, seprafilm was attached to the pelvic floor for prevention of adhesions after laparoscopic total cystectomy.On an unknown date, intestinal obstruction (postoperative complication) developed.On an unknown date, the outcome of intestinal obstruction (postoperative complication) was unknown.The patient developed an event of a serious intestinal obstruction (postoperative complication).This event was assessed as medically significant and was leading to intervention.Final diagnosis was intestinal obstruction (postoperative complication).It was not reported if the patient received a corrective treatment.The patient outcome is reported as unknown for intestinal obstruction (postoperative complication).Reporter comment: not reported.

Event Description

Intestinal obstruction (postoperative complication).Case narrative: initial information received on 27-nov-2019 regarding an unsolicited valid serious case issued from a literature article.Title: o-11-4 efforts and consideration of seprafilm insertion after laparoscopic total cystectomy author: sano t, yanagisawa t, enei y, sakanaka k, takahashi k, atsuta m, et al.Journal: the 33rd congress of japanese society of endourology (21,22,23-nov-2019), unk;unk:unk.This case was issued in publication in which another related case was reported: 2019sa331689 (cluster).This case involves adult patient who experienced intestinal obstruction (postoperative complication), while he/she using with the use of medical device carboxymethylcellulose, sodium hyaluronate [seprafilm].The patient's past medical history included urinary cystectomy.The patient's past medical treatment(s), vaccination(s) and family history were not provided.On an unknown date, seprafilm was attached to the pelvic floor for prevention of adhesions after laparoscopic total cystectomy.On an unknown date, intestinal obstruction (postoperative complication) developed.On an unknown date, the outcome of intestinal obstruction (postoperative complication) was unknown.The patient developed an event of a serious intestinal obstruction (postoperative complication) (intestinal obstruction).This event was assessed as medically significant and was leading to intervention.Final diagnosis was intestinal obstruction (postoperative complication).It was not reported if the patient received a corrective treatment.The patient outcome is reported as unknown for intestinal obstruction (postoperative complication).Reporter comment: the physician denied the causal relationship between seprafilm and intestinal obstruction (postoperative complication).As the 5 cases were all paralytic cases, there was no relationship with functional service provider (fsp).Additional information was received on 12-dec-2019 from the physician: changed causality as reported for the event; and added reporter comment.

Event Description

Intestinal obstruction (postoperative complication) [intestinal obstruction] case narrative: initial information received on 27-nov-2019 regarding an unsolicited valid serious case issued from a literature article.Title: o-11-4 efforts and consideration of seprafilm insertion after laparoscopic total cystectomy author: sano t, yanagisawa t, enei y, sakanaka k, takahashi k, atsuta m, et al.Journal: the 33rd congress of japanese society of endourology (21,22,23-nov-2019), unk;unk:unk.This case was issued in publication in which another related case was reported: 2019sa331689 (cluster).This case involves adult patient who experienced intestinal obstruction (postoperative complication), while he/she using with the use of medical device carboxymethylcellulose, sodium hyaluronate [seprafilm].The patient's past medical history included urinary cystectomy.The patient's past medical treatment(s), vaccination(s) and family history were not provided.On an unknown date, seprafilm (lot #, unknown) was attached to the pelvic floor for prevention of adhesions after laparoscopic total cystectomy.On an unknown date, intestinal obstruction (postoperative complication) developed.On an unknown date, the outcome of intestinal obstruction (postoperative complication) was unknown.The patient developed an event of a serious intestinal obstruction (postoperative complication) (intestinal obstruction).This event was assessed as medically significant and was leading to intervention.Final diagnosis was intestinal obstruction (postoperative complication).It was not reported if the patient received a corrective treatment.The patient outcome is reported as unknown for intestinal obstruction (postoperative complication).Reporter comment: the physician denied the causal relationship between seprafilm and intestinal obstruction (postoperative complication).As the 5 cases were all paralytic cases, there was no relationship with functional service provider (fsp).Additional information was received on 12-dec-2019 from the physician: changed causality as reported for the event; and added reporter comment.Additional information was received on 18-dec-2019: no new information was received.Additional information was received on 24-jan-2020: received comet complaint case summary (comet complaint id: 100011285).Correction to the previous report: updated clinical course.

Event Description

Intestinal obstruction (postoperative complication) [intestinal obstruction].Case narrative: initial information received on 27-nov-2019 regarding an unsolicited valid serious case issued from a literature article.Title: o-11-4 efforts and consideration of seprafilm insertion after laparoscopic total cystectomy.Author: sano t, yanagisawa t, enei y, sakanaka k, takahashi k, atsuta m, et al.Journal: the 33rd congress of japanese society of endourology (21,22,23-nov-2019), unk;unk:unk.This case was issued in publication in which another related case was reported: (b)(4) (cluster).This case involves adult patient who experienced intestinal obstruction (postoperative complication), while he/she using with the use of medical device carboxymethylcellulose, sodium hyaluronate [seprafilm].The patient's past medical history included urinary cystectomy.The patient's past medical treatment(s), vaccination(s) and family history were not provided.On an unknown date, seprafilm (lot #, unknown) was attached to the pelvic floor for prevention of adhesions after laparoscopic total cystectomy.On an unknown date, intestinal obstruction (postoperative complication) developed.On an unknown date, the outcome of intestinal obstruction (postoperative complication) was unknown.The patient developed an event of a serious intestinal obstruction (postoperative complication) (intestinal obstruction).This event was assessed as medically significant and was leading to intervention.Final diagnosis was intestinal obstruction (postoperative complication).It was not reported if the patient received a corrective treatment.The patient outcome is reported as unknown for intestinal obstruction (postoperative complication).Reporter comment: the physician denied the causal relationship between seprafilm and intestinal obstruction (postoperative complication).As the 5 cases were all paralytic cases, there was no relationship with functional service provider (fsp).Additional information was received on 12-dec-2019 from the physician: changed causality as reported for the event; and added reporter comment.Additional information was received on 18-dec-2019: no new information was received.Additional information was received on 24-jan-2020: received comet complaint case summary (comet complaint id: (b)(4)).Correction to the previous report: updated clinical course.Additional information was received on 12-feb-2020: investigation summary (investigation summary (b)(4), event id: (b)(6)) was obtained.Added reporter information.Correction to the previous report: corrected company comment (in the japanese field only).

Event Description

Intestinal obstruction (postoperative complication) [intestinal obstruction].Case narrative: initial information received on 27-nov-2019 regarding an unsolicited valid serious case issued from a literature article.Title: o-11-4 efforts and consideration of seprafilm insertion after laparoscopic total cystectomy.Author: sano t, yanagisawa t, enei y, sakanaka k, takahashi k, atsuta m, et al.Journal: the 33rd congress of japanese society of endourology (21,22,23-nov-2019), unk;unk:unk.This case was issued in publication in which another related case was reported: (b)(4)(cluster).This case involves adult patient who experienced intestinal obstruction (postoperative complication), while he/she using with the use of medical device carboxymethylcellulose, sodium hyaluronate [seprafilm].The patient's past medical history included urinary cystectomy.The patient's past medical treatment(s), vaccination(s) and family history were not provided.On an unknown date, seprafilm (lot #, unknown) was attached to the pelvic floor for prevention of adhesions after laparoscopic total cystectomy.On an unknown date, intestinal obstruction (postoperative complication) developed.On an unknown date, the outcome of intestinal obstruction (postoperative complication) was unknown.The patient developed an event of a serious intestinal obstruction (postoperative complication) (intestinal obstruction).This event was assessed as medically significant and was leading to intervention.Final diagnosis was intestinal obstruction (postoperative complication).It was not reported if the patient received a corrective treatment.The patient outcome is reported as unknown for intestinal obstruction (postoperative complication).Reporter comment: the physician denied the causal relationship between seprafilm and intestinal obstruction (postoperative complication).As the 5 cases were all paralytic cases, there was no relationship with functional service provider (fsp).Additional information was received on 12-dec-2019 from the physician: changed causality as reported for the event; and added reporter comment.Additional information was received on 18-dec-2019: no new information was received.Additional information was received on 24-jan-2020: received comet complaint case summary (comet complaint id: (b)(4)).Correction to the previous report: updated clinical course.Additional information was received on 12-feb-2020: investigation summary (investigation summary #225006, event id: (b)(4)) was obtained.Added reporter information.Correction to the previous report: corrected company comment (in the japanese field only).

Manufacturer Narrative

Attachment: [2019sa331771-english translation.Pdf].

• Brand Name: SEPRAFILM
• Type of Device: MCN
• Manufacturer (Section D): GENZYME CORPORATION(FRAMINGHAM); 76 new york avenue; framingham 01701
• MDR Report Key: 9465265
• MDR Text Key: 188588046
• Report Number: 1220423-2019-00027
• 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,Followup,Followup
• Report Date: 08/17/2020

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: No Information
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/13/2019
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 12/27/2019; 02/06/2020; 02/26/2020; 08/17/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention