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

Lot Number ASKU

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

Patient Problems Abdominal Pain (1685); Irritation (1941); Vomiting (2144); Stenosis (2263); Obstruction/Occlusion (2422); Abdominal Distention (2601)

Event Date 01/01/2019

Event Type  Injury  

Event Description

Recurrent intestinal obstruction [intestinal obstruction] ([vomiting]).Case narrative: initial information received on 08-jan-2020 regarding an unsolicited valid serious case issued from a literature article.Title: a successful case of systemic steroid administration for repeated intestinal obstruction.Author: tanimura s, yamauchi y, noda n, nakamura r, yamashita y.Journal: surgery, 2020, 82, 65-68.This case involves a (b)(6) years old female patient who experienced recurrent intestinal obstruction, while she was treated with the use of medical device carboxymethylcellulose, sodium hyaluronate [seprafilm].The patient's past medical history included laparotomy for sigmoid colon cancer (21 years earlier), hypertension, glaucoma, angina pectoris and intestinal obstruction (4 episodes).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 intestinal obstruction since (b)(6) 2019 and intestinal stent insertion.In the end of (b)(6) 2019, the patient visited the emergency outpatient department of authors' hospital for abdominal pain and vomiting, and received a diagnosis of intestinal obstruction, leading to hospitalization.Abdominal distension was present, while a peritoneal irritation sign was absent.On the same day, an ileus tube was inserted and the patient was hospitalized.At the time of hospitalization, she underwent ct.In the contrast image through an ileus tube, a responsible lesion was considered to be adhesion of surrounding areas of the upper small intestine near the treitz ligament and the bladder.Simple ct showed a lump of the small intestine in the upper abdomen, which was considered as a responsible lesion.After an ileus tube insertion, the volume of the discharge was gradually decreased and abdominal symptoms disappeared.The patient had requested to undergo surgery due to repeated intestinal obstruction since before and thus 4 days later, release of ileus was conducted under general anesthesia.Surgical findings: the abdominal incision was made in the median line.Adhesion was observed in the entire abdominal cavity.Remarkable adhesion to the upper small intestine was observed not only just below the surgical wound site in the abdominal wall but especially in the upper abdomen.Careful adhesiotomy revealed that the responsible site of intestinal obstruction was the small intestine located in the anus side about 20 cm from the treitz ligament and a fibrous band had firmly adhered to the transverse colon as well as the affected area of the small intestine.The obstruction was removed by adhesiotomy, and the ileus tube inserted before surgery was moved to the terminal ileum from the treitz ligament and inserted in the region.Surgery was completed after sufficient irrigation of the abdominal cavity and insertion/placement of an adhesion prevention absorbing barrier in sheet form (dosage used unknown).In 2019, on postoperative day 4, release of ileus was confirmed and the patient started eating meals.In 2019, on postoperative day 9, vomiting recurred and recurrent intestinal obstruction was diagnosed.After reinsertion of an ileus tube, conservative treatment was attempted, without improvement.Contrast image through an ileus tube showed delayed flow of contrast medium, restenosis in the responsible area of the upper small intestine and degenerative stenosis in its anus side.Ct findings showed a lump of the stenotic area which was the same as before the surgery.Decompression through an ileus tube was attempted for improvement for 8 days.However, no improvement was noted and repeated surgery was conducted.Findings of repeated surgery: the abdominal incision was made with the same procedure as the previous surgery.The lump of the small intestine became more severe compared with the previous findings and it was difficult to recognize the layers.A lump was observed in the oral area of the small intestine (about 20 cm from the treitz ligament) where adhesiotomy was performed in the previous surgery and this was a responsible lesion in the repeated surgery.The removal was performed by abrasion.As the contrast medium was confirmed to flow in the anus side of the small intestine, abrasion was not performed and the ileus tube insertion remained inserted.Seprafilm was placed in just below the abdominal wall and the repeated surgery was completed.Postoperative follow-up showed no improvement in the discharge volume of the ileus tube.Delayed flow of contrast medium and restenosis were observed in the upper small intestine where repeated surgical procedures were mainly performed, which were considered as prolonged inflammatory oedema attributable to surgical procedures.In the end of (b)(6) 2019, an informed consent was obtained following sufficient explanation and steroid pulse therapy was initiated on the 5th day of the repeated surgery.Methylprednisolone sodium succinate was intravenously administered at a dose of 750 mg from day 1 to 3 of the therapy and 375 mg from day 4 to 5, and betamethasone was orally started at a dose of 2 mg from day 6.On day 1 of the steroid pulse therapy, ileus promptly improved and on day 3, the ileus tube was removed.The contrast medium smoothly flowed and the restenosis of the upper small intestine which was observed after the repeated surgery showed a remarkable improvement although slight deformity remained.After the meal restart, recurrent symptoms were absent.The outcomes of recurrent vomiting and recurrent intestinal obstruction were resolving.In early (b)(6) 2019, the patient was discharged home.After that, betamethasone was continuously administered at a dose of 2 mg for 2 weeks followed by 1 mg for 2 weeks from the 3rd week and then the treatment was completed.As of the report in 2019, the patient no longer received oral treatment and had no recurrent abdominal symptoms for 6 months after hospital discharge.The patient developed an event of a serious recurrent intestinal obstruction.This event was assessed as medically significant and was leading to intervention.The patient developed an event of a serious recurrent vomiting.This event was assessed as medically significant and was leading to intervention.Relevant laboratory test results included: computerised tomogram - on an unknown date: [after the initial surgery: findings showed a lump of the stenotic area which was the same as before the surgery]; on an unknown date: [at the time of hospitalization: a lump of the small intestine in the upper abdomen which was considered as a responsible lesion.] scan with contrast - on an unknown date: [after the initial surgery: delayed flow of contrast medium, restenosis in the responsible area of the upper small intestine and degenerative stenosis in its anus side]; on an unknown date: [after repeated surgery: delayed flow of contrast medium and restenosis in the upper small intestine where repeated surgical procedures were mainly performed]; on an unknown date: [at the time of removal of ileus tube: the contrast medium smoothly flowed and the restenosis of the upper small intestine which was observed after the repeated surgery showed a remarkable improvement although slight deformity remained]; on an unknown date: [at the time of hospitalization: a responsible lesion was adhesion to surrounding areas of the upper small intestine near the treitz ligament and the bladder] final diagnosis was recurrent intestinal obstruction.The patient was treated with methylprednisolone sodium succinate for recurrent intestinal obstruction and betamethasone for recurrent intestinal obstruction.The patient outcome is reported as recovering / resolving for recurrent intestinal obstruction and as recovering / resolving for recurrent vomiting.Reporter comment: prolonged inflammatory oedema attributable to surgical procedures was considered.

Manufacturer Narrative

- attachment:.

Event Description

Recurrent intestinal obstruction [intestinal obstruction] ([vomiting]) case narrative: initial information received on 08-jan-2020 regarding an unsolicited valid serious case received from (lp) japan-kaken lsa-pcp under reference on 29-jan-2020 and transmitted to sanofi.[literature information] title: a successful case of systemic steroid administration for repeated intestinal obstruction author: tanimura s, yamauchi y, noda n, nakamura r, yamashita y.Journal: surgery, 2020, 82, 65-68 this case involves a 80 years old female patient who experienced recurrent intestinal obstruction, while she was treated with with the use of medical device carboxymethylcellulose, sodium hyaluronate [seprafilm].The patient's past medical history included cancer surgery, hypertension, glaucoma, angina pectoris and intestinal obstruction.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 intestinal obstruction since jan-2019 and intestinal stent insertion.In the end of jan-2019, the patient visited the emergency outpatient department of authors' hospital for abdominal pain and vomiting, and received a diagnosis of intestinal obstruction, leading to hospitalization.Abdominal distension was present, while a peritoneal irritation sign was absent.On the same day, an ileus tube was inserted and the patient was hospitalized.At the time of hospitalization, she underwent ct.In the contrast image through an ileus tube, a responsible lesion was considered to be adhesion of surrounding areas of the upper small intestine near the treitz ligament and the bladder.Simple ct showed a lump of the small intestine in the upper abdomen, which was considered as a responsible lesion.After an ileus tube insertion, the volume of the discharge was gradually decreased and abdominal symptoms disappeared.The patient had requested to undergo surgery due to repeated intestinal obstruction since before and thus 4 days later, release of ileus was conducted under general anesthesia.Surgical findings: the abdominal incision was made in the median line.Adhesion was observed in the entire abdominal cavity.Remarkable adhesion to the upper small intestine was observed not only just below the surgical wound site in the abdominal wall but especially in the upper abdomen.Careful adhesiotomy revealed that the responsible site of intestinal obstruction was the small intestine located in the anus side about 20 cm from the treitz ligament and a fibrous band had firmly adhered to the transverse colon as well as the affected area of the small intestine.The obstruction was removed by adhesiotomy, and the ileus tube inserted before surgery was moved to the terminal ileum from the treitz ligament and inserted in the region.Surgery was completed after sufficient irrigation of the abdominal cavity and insertion/placement of an adhesion prevention absorbing barrier in sheet form (dosage used unknown).In 2019, on postoperative day 4, release of ileus was confirmed and the patient started eating meals.In 2019, on postoperative day 9, vomiting recurred and recurrent intestinal obstruction was diagnosed.After reinsertion of an ileus tube, conservative treatment was attempted, without improvement.Contrast image through an ileus tube showed delayed flow of contrast medium, restenosis in the responsible area of the upper small intestine and degenerative stenosis in its anus side.Ct findings showed a lump of the stenotic area which was the same as before the surgery.Decompression through an ileus tube was attempted for improvement for 8 days.However, no improvement was noted and repeated surgery was conducted.Findings of repeated surgery: the abdominal incision was made with the same procedure as the previous surgery.The lump of the small intestine became more severe compared with the previous findings and it was difficult to recognize the layers.A lump was observed in the oral area of the small intestine (about 20 cm from the treitz ligament) where adhesiotomy was performed in the previous surgery and this was a responsible lesion in the repeated surgery.The removal was performed by abrasion.As the contrast medium was confirmed to flow in the anus side of the small intestine, abrasion was not performed and the ileus tube insertion remained inserted.Seprafilm was placed in just below the abdominal wall and the repeated surgery was completed.Postoperative follow-up showed no improvement in the discharge volume of the ileus tube.Delayed flow of contrast medium and restenosis were observed in the upper small intestine where repeated surgical procedures were mainly performed, which were considered as prolonged inflammatory oedema attributable to surgical procedures.In the end of feb-2019, an informed consent was obtained following sufficient explanation and steroid pulse therapy was initiated on the 5th day of the repeated surgery.Methylprednisolone sodium succinate was intravenously administered at a dose of 750 mg from day 1 to 3 of the therapy and 375 mg from day 4 to 5, and betamethasone was orally started at a dose of 2 mg from day 6.On day 1 of the steroid pulse therapy, ileus promptly improved and on day 3, the ileus tube was removed.The contrast medium smoothly flowed and the restenosis of the upper small intestine which was observed after the repeated surgery showed a remarkable improvement although slight deformity remained.After the meal restart, recurrent symptoms were absent.The outcomes of recurrent vomiting and recurrent intestinal obstruction were resolving.In early mar-2019, the patient was discharged home.After that, betamethasone was continuously administered at a dose of 2 mg for 2 weeks followed by 1 mg for 2 weeks from the 3rd week and then the treatment was completed.As of the report in 2019, the patient no longer received oral treatment and had no recurrent abdominal symptoms for 6 months after hospital discharge.The patient developed an event of a serious recurrent intestinal obstruction (intestinal obstruction).This event was assessed as medically significant and was leading to intervention.The patient developed an event of a serious recurrent vomiting (vomiting).This event was assessed as medically significant and was leading to intervention.Relevant laboratory test results included: computerised tomogram - on an unknown date: [after the initial surgery: findings showed a lump of the stenotic area which was the same as before the surgery]; on an unknown date: [at the time of hospitalization: a lump of the small intestine in the upper abdomen which was considered as a responsible lesion] scan with contrast - on an unknown date: [after the initial surgery: delayed flow of contrast medium, restenosis in the responsible area of the upper small intestine and degenerative stenosis in its anus side]; on an unknown date: [after repeated surgery: delayed flow of contrast medium and restenosis in the upper small intestine where repeated surgical procedures were mainly performed]; on an unknown date: [at the time of removal of ileus tube: contrast medium smoothly flowed and the restenosis of the upper small intestine which was observed after the repeated surgery showed a remarkable improvement although slight deformity remained]; on an unknown date: [at the time of hospitalization: a responsible lesion was adhesion to surrounding areas of the upper small intestine near the treitz ligament and the bladder] final diagnosis was recurrent intestinal obstruction.The patient was treated with methylprednisolone sodium succinate (methylprednisolone na succinate) for intestinal obstruction and betamethasone (betamethasone) for intestinal obstruction.The patient outcome is reported as recovering / resolving for recurrent intestinal obstruction and as recovering / resolving for recurrent vomiting.Reporter comment: prolonged inflammatory oedema attributable to surgical procedures was considered.Additional information was received on 29-jan-2020 from the physician: jp_local partner number was added.No other new information was received.Additional information was received on 28-feb-2020: no new information was received.

• Brand Name: SEPRAFILM
• Type of Device: MCN
• Manufacturer (Section D): GENZYME CORPORATION(FRAMINGHAM); 76 new york avenue; framingham 01701
• MDR Report Key: 9632908
• MDR Text Key: 190497962
• Report Number: 1220423-2020-00002
• 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: 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
• Device Lot Number: ASKU
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/27/2020
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/17/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 80 YR