MAUDE Adverse Event Report: GENZYME BIOSURGERY (SEPRAFILM/PACK) SEPRAFILM; MCN

Lot Number ASKU

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

Patient Problems Fever (1858); Inflammation (1932); Ascites (2596)

Event Date 05/03/2018

Event Type  Injury  

Event Description

Peritoneal fluid retention [ascites] ([pyrexia], [inflammation]).Case narrative: initial information received on 16-may-2018 regarding an unsolicited valid serious case received from a physician.This case is linked to case (b)(4).This case involves a (b)(6) male patient (165.5 cm and (b)(6)) who experienced peritoneal fluid retention, "while he using with" the use of medical device carboxymethylcellulose, sodium hyaluronate [seprafilm].The patient's past medical history included small intestine operation on (b)(6) 2018, colon cancer in (b)(6) 2013, colectomy in (b)(6) 2013 and colectomy in (b)(6) 2016.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 colon cancer recurrent in (b)(6) 2017 and non-tobacco user.In (b)(6) 2013, left hemicolectomy was performed for cancer of descending colon.In (b)(6) 2016, partial resection of the area including the anastomotic site was performed for local recurrence in the left upper abdomen.During the perioperative period, the patient had adhesive intestinal obstruction; however, when re-laparotomy was performed, the adhesion was very strong and adhesiolysis was difficult.Fortunately, the condition improved conservatively.On (b)(6) 2018, a surgery was performed for intestinal obstruction caused by adhesion of small intestine to the recurrent nodes in the left abdominal retroperitoneum.Relatively strong adhesion was observed in a wide area, centering on the previous midline incisional wound, and adhesiolysis of the whole area was managed to be performed.A small intestine to small intestine bypass surgery (the oral side and anal side of the small intestinal tumour-adhesion site) was performed.When the surgery was completed, 1 sheet of seprafilm was applied to the area including the umbilicus, rather caudally.The anastomotic site was attached to the margin of the application site or was located rather left side of application site.A closed drain was placed, dropped down from the area near the anastomotic site to the direction of intrapelvic region, and the surgery was completed.On (b)(6) 2018, the patient had pyrexia of around 39°c (39°c or above and below 40°c), high inflammation finding level, and ct showed fluid retention directly below the abdominal wall of the abdominal midline.Drainage was performed through a small incision in the midline wound.The drainage showed properties close to ascites, and was not purulent.No bacteria were detected on a culture of the same fluid.On (b)(6) 2018, peritoneal fluid retention resolved.On an unknown date, the drainage was favorable, and subsequently the pyrexia resolved rapidly and the inflammation finding was resolving.The patient developed an event of a serious peritoneal fluid retention (ascites) 7 days after starting use of carboxymethylcellulose and sodium hyaluronate.This event was assessed as medically significant.The patient developed an event of a serious pyrexia of 39-40 degrees c (pyrexia) 7 days after starting use of carboxymethylcellulose and sodium hyaluronate.This event was assessed as medically significant.The patient developed an event of a serious high inflammation finding level (inflammation) 7 days after starting use of carboxymethylcellulose and sodium hyaluronate.This event was assessed as medically significant.Relevant laboratory test results included: culture - on (b)(6) 2018: [no bacteria detected in fluid].Final diagnosis was peritoneal fluid retention.An unknown corrective treatment was received.The patient outcome is reported as recovered / resolved on (b)(6) 2018 for peritoneal fluid retention, as recovered / resolved on an unknown date for pyrexia of 39-40 degrees c and as recovered / resolved on an unknown date for high inflammation finding level.Reporter comment: other possible causative factors for the adverse events: ascites: void in intraperitoneal organs, predisposition to adhesion, mass of abdominal organs (large).The fluid was not macroscopically purulent, and no bacteria were detected on a culture, either.However, detailed relationship to bacteria was unknown.Pyrexia: the possibility that the fluid trapped by seprafilm during the period immediately after surgery when the volume of ascites was large causing the conditions including pyrexia could not be ruled out.Additional information was received on (b)(6) 2018 by the same reporter: updated patient information, medical history, indication for the use of seprafilm, event verbatim, symptoms, reporter's casuality assessment, reporter comment, and clinical course.Additional information was received on 03-aug-2018: added investigation summary.Case comments: 2018/08/03: 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.

• Brand Name: SEPRAFILM
• Type of Device: MCN
• Manufacturer (Section D): GENZYME BIOSURGERY (SEPRAFILM/PACK); 76 new york avenue; framingham MA 01701
• Manufacturer (Section G): GENZYME BIOSURGERY (SEPRAFILM/PACK); 76 new york avenue; framingham MA 01701
• Manufacturer Contact: darlene kadel ; 55 corporate drive, ms 55b-220; a; bridgewater, NJ 08807
• MDR Report Key: 8162918
• MDR Text Key: 130328196
• Report Number: 2246315-2018-00731
• 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
• Remedial Action: Notification
• Type of Report: Initial
• Report Date: 12/14/2018

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
• Device Lot Number: ASKU
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/13/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Weight: 70