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

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problems Abdominal Pain (1685); Adhesion(s) (1695); Purulent Discharge (1812); Erythema (1840); Fistula (1862); Hemorrhage/Bleeding (1888); Inflammation (1932); Foreign Body In Patient (2687); Patient Problem/Medical Problem (2688); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

Enterocutaneous fistula [enterocutaneous fistula] ([intestinal obstruction], [abdominal pain], [bowel peristalsis increased], [intestinal adhesions], [subcutaneous emphysema], [postoperative discharge], [localised erythema], [skin hypertrophy]).Case narrative: initial information received on 24-apr-2019 regarding an unsolicited valid serious case issued from a literature article: authors: nagata y, kadono j, motoi s, tasaki t, imoto y.Title: a case of an enterocutaneous fistula caused by sodium hyaluronate carboxymethylcellulose bioresorbable membrane-induced intestinal adhesions journal: journal of abdominal emergency medicine.2019;39(3):519-523.This case involves a (b)(6) years old male patient ((b)(6)) who experienced enterocutaneous fistula, while he using with the use of medical device carboxymethylcellulose, sodium hyaluronate [seprafilm].The patient's past medical history included small intestinal perforation (at the age of (b)(6) years), abdominal operation, laparotomy, abdominal adhesions, intestinal adhesion lysis and haemostasis.The patient's past medical treatment(s), vaccination(s) and family history were not provided.The patient's family history was nothing special.At the time of the event, the patient had ongoing aortic aneurysm.On an unknown date, the patient having an abdominal aortic aneurysm underwent a surgery to replace the aorta with vascular prosthesis through a midline incision in the upper and lower abdominal region.The patient had a past history of laparotomy for traumatic small intestinal perforation, and had intraabdominal adhesions between the small intestine and abdominal wall as well as between small intestines mainly in the upper abdominal region.Adhesiolysis was performed for these adhesions.During the adhesiolysis, several sites in small intestinal serous membrane were damaged, and were sutured with absorbable threads.There was no intraabdominal contamination.Shortly after this surgery, a laparotomic hemostasis was performed, in which two sheets of seprafilm of 12.7 cm by 14.7 cm were placed for reducing a risk of postoperative adhesion in the area between the incision wound and the intestinal tract.Absorbable threads were used to close the abdomen.On an unknown date (12 days after the surgery), adhesive intestinal obstruction occurred, and conservative treatment alleviated the obstruction.Abdominal pain persisted even after the patient changed his hospital.On an unknown date (42 days after the surgery), a discharge of intestinal juice from the surgical wound was noted.A diagnosis of enterocutaneous fistula was made, and the patient was re-admitted to the reporting hospital.At the admission, body height was 147 cm, body weight was 36.1 kg, and body temperature was 36.1 degrees c.Redness in the abdominal midline incision wound and a discharge of intestinal juice from the wound were noted.No peritoneal irritation sign was observed.Intestinal peristaltic sound was increasing.Blood chemistry test results included wbc 6610/ul and increased crp of 8.36 mg/dl.Abdominal ct findings included adhesion between the small intestine and abdominal wall and subcutaneous emphysema in the wound.These findings led to a diagnosis of enterocutaneous fistula, and the patient underwent a surgery urgently.In the surgery, an incision was made along the previous incision wound.Purulent discharge was noted in the area surrounding the fistula, and inflammation and high-level thickening were observed in the surrounding abdominal wall.The adhesion between the small intestine and peritoneum was seen only in the area where seprafilm had been applied.The adhesion between small intestines was dense, and was further combined with the thickened peritoneum noted in the seprafilm application site.As it was difficult to remove the adhesions only, a partial resection of the small intestine was made at 50 cm from treitz ligament and at 60 cm from the ileocecum.The thickened peritoneum combined with the small intestine was collectively excised, and side-to-side anastomosis was performed.The operative time was 6 hours and 13 minutes, and the volume of haemorrhage was 2200 ml.Histopathology test results were as follows: a wide-range fibrosis in the small intestinal subserous layer as well as a large number of giant phagocyte cells containing a clear fibrotic foreign body were seen.The foreign body showed double refraction on polarization microscope, while seprafilm did not show double refraction.No foreign body reaction was seen in the area surrounding the absorbable threads used during the previous surgery for suturing the small intestinal serous membrane and for closing the abdomen.On an unknown date (26 days after the repeat laparotomy), the patient was discharged with a favorable postoperative course.The patient developed an event of a serious enterocutaneous fistula.This event was assessed as medically significant.The patient was hospitalized for this event.The patient developed an event of a serious adhesive intestinal obstruction (intestinal obstruction).This event was assessed as medically significant.The patient was hospitalized for this event.The patient developed an event of a serious abdominal pain.This event was assessed as medically significant.The patient was hospitalized for this event.The patient developed an event of a serious peristaltic sound of the bowel increased (gastrointestinal hypermotility).This event was assessed as medically significant.The patient was hospitalized for this event.The patient developed an event of a serious adhesion of small intestine-to-abdominal wall (abdominal adhesions).This event was assessed as medically significant.The patient was hospitalized for this event.The patient developed an event of a serious subcutaneous emphysema of wound (subcutaneous emphysema).This event was assessed as medically significant.The patient was hospitalized for this event.The patient developed an event of a serious excretion of intestinal fluid from the surgical wound (post procedural discharge).This event was assessed as medically significant.The patient was hospitalized for this event.The patient developed an event of a serious redness of the wound of middle abdomen (erythema).This event was assessed as medically significant.The patient was hospitalized for this event.The patient developed an event of a serious abdominal wall surrounding fistula highly thickened due to inflammation (skin hypertrophy).This event was assessed as medically significant.The patient was hospitalized for this event.Relevant laboratory test results included: body temperature - on an unknown date: 36.1 cel [upon admission] c-reactive protein - on an unknown date: 8.36 mg/dl [crp at 8.36 mg/dl and increase in crp was observed.] computerised tomogram abdomen - on an unknown date: [adhesion of small intestine-to-abdominal wall was noted and subcutaneous emphysema was noted in wounded area.] laboratory test - on an unknown date: [upon admission: redness of the wound of middle abdomen and excretion of intestinal fluid from the wound were observed.Peritoneal irritation was not noted.Peristaltic sound of the bowel increased.]; on an unknown date: [relaparotomy was performed along with the previous surgical wound.Purulent drainage was noted from the area around fistula, and the surrounding abdominal wall highly thickened due to inflammation.Adhesion of small intestine and peritoneum was observed only in the area where seprafilm was attached.Intense adhesion of small intestine-to-small intestine and thickened peritoneum where seprafilm was attached became a bundle.] pathology test - on an unknown date: [extensive fibrosis of subserosal layer of small intestine and many multinucleated giant cells which phagocytized clear fibrous foreign body were observed.During the previous surgery, there was no foreign-body reaction around the absorbable surgical suture used for repair of subserosal layer of small intestine and laparotomy.] white blood cell count - on an unknown date: 6610 /ul.Final diagnosis was enterocutaneous fistula.An unknown corrective treatment was received.The patient outcome is reported as recovering / resolving for enterocutaneous fistula, as recovering / resolving for adhesive intestinal obstruction, as recovering / resolving for abdominal pain, as recovering / resolving for peristaltic sound of the bowel increased, as recovering / resolving for adhesion of small intestine-to-abdominal wall, as recovering / resolving for subcutaneous emphysema of wound, as recovering / resolving for excretion of intestinal fluid from the surgical wound, as recovering / resolving for redness of the wound of middle abdomen and as recovering / resolving for abdominal wall surrounding fistula highly thickened due to inflammation.Reporter comment: [adhesion of small intestine-to-abdominal wall].Adhesion was noted in the area where seprafilm was attached, there was no pathological foreign body response in the area around the absorbable surgical suture, and the foreign body had similar fibrous structure to seprafilm.For the reasons mentioned above, seprafilm was considered as the cause of the adhesion.

Event Description

Enterocutaneous fistula [enterocutaneous fistula] ([intestinal obstruction], [abdominal pain], [bowel peristalsis increased], [intestinal adhesions], [subcutaneous emphysema], [postoperative discharge], [localised erythema], [skin hypertrophy]) case narrative: initial information received on 24-apr-2019 regarding an unsolicited valid serious case issued from a literature article nagata y, kadono j, motoi s, tasaki t, imoto y a case of an enterocutaneous fistula caused by sodium hyaluronate carboxymethylcellulose bioresorbable membrane-induced intestinal adhesions journal of abdominal emergency medicine.2019;39(3):519-523.This case involves a 79 years old male patient (147 cm and 36.1 kg) who experienced enterocutaneous fistula, while he using with the use of medical device carboxymethylcellulose, sodium hyaluronate [seprafilm].The patient's past medical history included small intestinal perforation (at the age of 62 years), abdominal operation, laparotomy, abdominal adhesions, intestinal adhesion lysis and haemostasis.The patient's past medical treatment(s), vaccination(s) and family history were not provided.The patient's family history was nothing special.At the time of the event, the patient had ongoing aortic aneurysm.On an unknown date, the patient having an abdominal aortic aneurysm underwent a surgery to replace the aorta with vascular prosthesis through a midline incision in the upper and lower abdominal region.The patient had a past history of laparotomy for traumatic small intestinal perforation, and had intraabdominal adhesions between the small intestine and abdominal wall as well as between small intestines mainly in the upper abdominal region.Adhesiolysis was performed for these adhesions.During the adhesiolysis, several sites in small intestinal serous membrane were damaged, and were sutured with absorbable threads.There was no intraabdominal contamination.Shortly after this surgery, a laparotomic hemostasis was performed, in which two sheets of seprafilm of 12.7 cm by 14.7 cm were placed for reducing a risk of postoperative adhesion in the area between the incision wound and the intestinal tract.Absorbable threads were used to close the abdomen.On an unknown date (12 days after the surgery), adhesive intestinal obstruction occurred, and conservative treatment alleviated the obstruction.Abdominal pain persisted even after the patient changed his hospital.On an unknown date (42 days after the surgery), a discharge of intestinal juice from the surgical wound was noted.A diagnosis of enterocutaneous fistula was made, and the patient was re-admitted to the reporting hospital.At the admission, body height was 147 cm, body weight was 36.1 kg, and body temperature was 36.1 degrees c.Redness in the abdominal midline incision wound and a discharge of intestinal juice from the wound were noted.No peritoneal irritation sign was observed.Intestinal peristaltic sound was increasing.Blood chemistry test results included wbc 6610/ul and increased crp of 8.36 mg/dl.Abdominal ct findings included adhesion between the small intestine and abdominal wall and subcutaneous emphysema in the wound.These findings led to a diagnosis of enterocutaneous fistula, and the patient underwent a surgery urgently.In the surgery, an incision was made along the previous incision wound.Purulent discharge was noted in the area surrounding the fistula, and inflammation and high-level thickening were observed in the surrounding abdominal wall.The adhesion between the small intestine and peritoneum was seen only in the area where seprafilm had been applied.The adhesion between small intestines was dense, and was further combined with the thickened peritoneum noted in the seprafilm application site.As it was difficult to remove the adhesions only, a partial resection of the small intestine was made at 50 cm from treitz ligament and at 60 cm from the ileocecum.The thickened peritoneum combined with the small intestine was collectively excised, and side-to-side anastomosis was performed.The operative time was 6 hours and 13 minutes, and the volume of haemorrhage was 2200 ml.Histopathology test results were as follows: a wide-range fibrosis in the small intestinal subserous layer as well as a large number of giant phagocyte cells containing a clear fibrotic foreign body were seen.The foreign body showed double refraction on polarization microscope, while seprafilm did not show double refraction.No foreign body reaction was seen in the area surrounding the absorbable threads used during the previous surgery for suturing the small intestinal serous membrane and for closing the abdomen.On an unknown date (26 days after the repeat laparotomy), the patient was discharged with a favorable postoperative course.The patient developed an event of a serious enterocutaneous fistula.This event was assessed as medically significant and was leading to intervention.The patient was hospitalized for this event.The patient developed an event of a serious adhesive intestinal obstruction (intestinal obstruction).This event was assessed as medically significant and was leading to intervention.The patient was hospitalized for this event.The patient developed an event of a serious abdominal pain.This event was assessed as medically significant and was leading to intervention.The patient was hospitalized for this event.The patient developed an event of a serious peristaltic sound of the bowel increased (gastrointestinal hypermotility).This event was assessed as medically significant and was leading to intervention.The patient was hospitalized for this event.The patient developed an event of a serious adhesion of small intestine-to-abdominal wall (abdominal adhesions).This event was assessed as medically significant and was leading to intervention.The patient was hospitalized for this event.The patient developed an event of a serious subcutaneous emphysema of wound (subcutaneous emphysema).This event was assessed as medically significant and was leading to intervention.The patient was hospitalized for this event.The patient developed an event of a serious excretion of intestinal fluid from the surgical wound (post procedural discharge).This event was assessed as medically significant and was leading to intervention.The patient was hospitalized for this event.The patient developed an event of a serious redness of the wound of middle abdomen (erythema).This event was assessed as medically significant and was leading to intervention.The patient was hospitalized for this event.The patient developed an event of a serious abdominal wall surrounding fistula highly thickened due to inflammation (skin hypertrophy).This event was assessed as medically significant and was leading to intervention.The patient was hospitalized for this event.Relevant laboratory test results included: body temperature - on an unknown date: 36.1 cel [upon admission] c-reactive protein - on an unknown date: 8.36 mg/dl [crp at 8.36 mg/dl and increase in crp was observed.] computerised tomogram abdomen - on an unknown date: [adhesion of small intestine-to-abdominal wall was noted and subcutaneous emphysema was noted in wounded area.] laboratory test - on an unknown date: [upon admission: redness of the wound of middle abdomen and excretion of intestinal fluid from the wound were observed.Peritoneal irritation was not noted.Peristaltic sound of the bowel increased.]; on an unknown date: [relaparotomy was performed along with the previous surgical wound.Purulent drainage was noted from the area around fistula, and the surrounding abdominal wall highly thickened due to inflammation.Adhesion of small intestine and peritoneum was observed only in the area where seprafilm was attached.Intense adhesion of small intestine-to-small intestine and thickened peritoneum where seprafilm was attached became a bundle.] pathology test - on an unknown date: [extensive fibrosis of subserosal layer of small intestine and many multinucleated giant cells which phagocytized clear fibrous foreign body were observed.During the previous surgery, there was no foreign-body reaction around the absorbable surgical suture used for repair of subserosal layer of small intestine and laparotomy.] white blood cell count - on an unknown date: 6610 /ul final diagnosis was enterocutaneous fistula.An unknown corrective treatment was received.The patient outcome is reported as recovering / resolving for enterocutaneous fistula, as recovering / resolving for adhesive intestinal obstruction, as recovering / resolving for abdominal pain, as recovering / resolving for peristaltic sound of the bowel increased, as recovering / resolving for adhesion of small intestine-to-abdominal wall, as recovering / resolving for subcutaneous emphysema of wound, as recovering / resolving for excretion of intestinal fluid from the surgical wound, as recovering / resolving for redness of the wound of middle abdomen and as recovering / resolving for abdominal wall surrounding fistula highly thickened due to inflammation.Reporter comment: [adhesion of small intestine-to-abdominal wall] adhesion was noted in the area where seprafilm was attached, there was no pathological foreign body response in the area around the absorbable surgical suture, and the foreign body had similar fibrous structure to seprafilm.For the reasons mentioned above, seprafilm was considered as the cause of the adhesion.Additional information was received on 23-may-2019: added investigation summary (investigation summary# 215216, event id: 58490).Additional information was received on 27-may-2019: this information identified that this case is a duplicate of case 2015sa168488.This case (b)(4) will be deleted from the sanofi database and nullified.All the information of this case has been merged into the case(b)(4).

• Brand Name: SEPRAFILM
• Type of Device: MCN
• Manufacturer (Section D): GENZYME CORPORATION(FRAMINGHAM); 76 new york avenue; framingham 01701
• MDR Report Key: 8595058
• MDR Text Key: 144672403
• Report Number: 1220423-2019-00012
• 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
• Report Date: 05/31/2019

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: No Information
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/09/2019
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/07/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 79 YR
• Patient Weight: 36