MAUDE Adverse Event Report: SEPRAFILM; MCN

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Fever (1858); Inflammation (1932); Pain (1994); Swelling (2091); Cancer (3262)

Event Date 07/06/2018

Event Type  Injury  

Event Description

Rectal cancer recurrent [rectal cancer recurrent].Pyrexia [pyrexia].Case narrative: initial information received on (b)(6) 2018 regarding a solicited valid serious case received from a physician, in the scope of unsponsored study "unspon_o_seprafilm".Center id: unk; patient id: (b)(6); country: (b)(6).Study title: unsponsored study involving seprafilm.This case involves a (b)(6) years old male patient (b)(6) who experienced rectal cancer recurrent and pyrexia, while he was treated with the use of medical device carboxymethylcellulose, sodium hyaluronate [seprafilm].The patient's past medical history included colon cancer on (b)(6) 2018, blood culture on (b)(6) 2018, blood culture on (b)(6) 2018 and aspiration bone marrow on (b)(6) 2018.The patient's past medical treatment(s), vaccination(s) and family history were not provided.On (b)(6) 2018, consent to participate in the (b)(6) study was obtained.On (b)(6) 2018, low anterior resection of rectum, removal of mucosa of the anal canal, subtotal colectomy, and coloanal anastomosis were performed.The patient started using seprafilm for drug use for unknown indication.On (b)(6) 2018, the patient was discharged from the hospital with a favorable postoperative course.On (b)(6) 2018, the patient started receiving chemotherapy (xelox therapy) for large intestine carcinoma.On (b)(6) 2018, ct showed inflammation of the ascending colon.On (b)(6) 2018, endoscopy showed recurrent colitis ulcerative.Around (b)(6) 2018, the patient began to have pyrexia of 38.5 degrees celsius.On (b)(6) 2018, pyrexia in the 37 degrees celsius range persisted.The patient was treated with drip infusion of veen-d.On (b)(6) 2018, the patient had pyrexia in the 38 degrees celsius range that had developed on the day before.Appetite impaired developed.The patient was admitted to the hospital for further examination.Blood culture was performed.Chest x-ray revealed no infiltrative shadow.Abdominal x-ray showed no evident abnormalities.On the same day, rectal cancer recurrent developed (corrective treatment: mfolfox6+ avastin therapy), on (b)(6) 2018, the patient had the right buttock and leg pain.On (b)(6) 2018, the patient had pyrexia to 40 degrees c.Ct examination revealed swollen lymph nodes in the pelvis and no tumor.On (b)(6) 2018, echocardiogram performed, and endocarditis infective was denied.On (b)(6) 2018, endoscopy revealed abatement of colitis ulcerative.On (b)(6) 2018, it was highly unlikely that pyrexia occurred due to infection.As a result, there was a high possibility of recurrence of lymph nodes due to rectal cancer.On (b)(6) 2018, chemotherapy for large intestine carcinoma (mfolfox6 therapy) was started.On (b)(6) 2018, blood culture was performed.On (b)(6) 2018, mri examination and bone marrow aspiration were performed.On (b)(6) 2018, genetic test was performed.On (b)(6) 2018, chemotherapy for large intestine carcinoma (mfolfox6 + avastin therapy) was started.On (b)(6) 2018, pyrexia declined.The event "pyrexia" resolved as of (b)(6) 2018, the patient had not recovered from the event "rectal cancer recurrent".The patient developed an event of a serious rectal cancer recurrent.This event was assessed as medically significant.The patient was hospitalized on the same day this event occurred.The patient developed an event of a serious pyrexia.The patient was hospitalized on the same day this event occurred.Relevant laboratory test results included: abdominal x-ray - on (b)(6) 2018: [no evident abnormality].Chest x-ray - on (b)(6) 2018: [no infiltrative shadow].Computerised tomogram -on (b)(6) 2018: [showed inflammation of the ascending colon]; on (b)(6) 2018: [revealed swollen lymph nodes in the pelvis with no abscess].Echocardiogram - on (b)(6) 2018: [endocarditis infective was denied].Endoscopy - on (b)(6) 2018: [recurrence of colitis ulcerative was observed.]; on (b)(6) 2018: [colitis ulcerative abated].Final diagnosis was pyrexia and rectal cancer recurrent.The patient was treated with oxaliplatin (oxaliplatin), fluorouracil (fluorouracil), calcium folinate (leucovorin ca) and atorvastatin calcium (avastin [atorvastatin calcium]).The patient outcome is reported as recovered / resolved on (b)(6) 2018 for pyrexia and as not recovered / not resolved on an unknown date for rectal cancer recurrent.Rectal cancer recurrent is considered to be not related to carboxymethylcellulose and sodium hyaluronate by the reporter and not reportable by the company based on company causality assessment.Pyrexia is considered to be unassessable to carboxymethylcellulose and sodium hyaluronate by the reporter and reportable by the company based on company causality assessment.Reporter comment: the causal relationship could not be assessed because of pyrexia of unknown cause.Additional reporter comment (on 13-aug-2018): the causality with the use of medical device of seprafilm could be denied, because there was a high possibility of recurrent rectal cancer as the result of examination.Additional information was received on 13-aug-2018 by the physician: added concurrent conditions, laboratory data, an event "rectal cancer recurrent", and reporter comment.Updated outcome of the event "pyrexia" and the clinical course.Investigation summary was received on 24-aug-2018: investigation summary # (b)(4).

Event Description

Rectal cancer recurrent [rectal cancer recurrent].Pyrexia [pyrexia].Case narrative: initial information received on (b)(6) 2018 regarding a solicited valid serious case received from a physician, in the scope of unsponsored study "unspon_o_seprafilm".Center id: unk; patient id: (b)(6); country: japan.Study title: unsponsored study involving seprafilm.This case involves a 50 years old male patient (175 cm and 66 kg) who experienced rectal cancer recurrent and pyrexia, while he was treated with the use of medical device carboxymethylcellulose, sodium hyaluronate [seprafilm].The patient's past medical history included colon cancer on (b)(6) 2018, blood culture on (b)(6) 2018, blood culture on (b)(6) 2018 and aspiration bone marrow on (b)(6) 2018.The patient's past medical treatment(s), vaccination(s) and family history were not provided.On (b)(6) 2018, consent to participate in the (b)(4) study was obtained.On (b)(6) 2018, low anterior resection of rectum, removal of mucosa of the anal canal, subtotal colectomy, and coloanal anastomosis were performed.The patient started using seprafilm for drug use for unknown indication.On (b)(6) 2018, the patient was discharged from the hospital with a favorable postoperative course.On (b)(6) 2018, the patient started receiving chemotherapy (xelox therapy) for large intestine carcinoma.On (b)(6) 2018, ct showed inflammation of the ascending colon.On (b)(6) 2018, endoscopy showed recurrent colitis ulcerative.Around (b)(6) 2018, the patient began to have pyrexia of 38.5 degrees celsius.On (b)(6) 2018, pyrexia in the 37 degrees celsius range persisted.The patient was treated with drip infusion of veen-d.On (b)(6) 2018, the patient had pyrexia in the 38 degrees celsius range that had developed on the day before.Appetite impaired developed.The patient was admitted to the hospital for further examination.Blood culture was performed.Chest x-ray revealed no infiltrative shadow.Abdominal x-ray showed no evident abnormalities.On the same day, rectal cancer recurrent developed (corrective treatment: mfolfox6+ avastin therapy), on (b)(6) 2018, the patient had the right buttock and leg pain.On (b)(6) 2018, the patient had pyrexia to 40 degrees c.Ct examination revealed swollen lymph nodes in the pelvis and no tumor.On (b)(6) 2018, echocardiogram performed, and endocarditis infective was denied.On (b)(6) 2018, endoscopy revealed abatement of colitis ulcerative.On (b)(6) 2018, it was highly unlikely that pyrexia occurred due to infection.As a result, there was a high possibility of recurrence of lymph nodes due to rectal cancer.On (b)(6) 2018, chemotherapy for large intestine carcinoma (mfolfox6 therapy) was started.On (b)(6) 2018, blood culture was performed.On (b)(6) 2018, mri examination and bone marrow aspiration were performed.On (b)(6) 2018, genetic test was performed.On (b)(6) 2018, chemotherapy for large intestine carcinoma (mfolfox6 + avastin therapy) was started.On (b)(6) 2018, pyrexia declined.The event "pyrexia" resolved as of on (b)(6) 2018, the patient had not recovered from the event "rectal cancer recurrent".The patient developed an event of a serious rectal cancer recurrent.This event was assessed as medically significant and was leading to intervention.The patient was hospitalized on the same day this event occurred.The patient developed an event of a serious pyrexia.This event was leading to intervention.The patient was hospitalized on the same day this event occurred.Relevant laboratory test results included: abdominal x-ray: on (b)(6) 2018: [no evident abnormality].Chest x-ray: on (b)(6) 2018: [no infiltrative shadow].Computerised tomogram: on (b)(6) 2018: [showed inflammation of the ascending colon]; on (b)(6) 2018: [revealed swollen lymph nodes in the pelvis with no abscess].Echocardiogram: on (b)(6) 2018: [endocarditis infective was denied].Endoscopy: on (b)(6) 2018: [recurrence of colitis ulcerative was observed.]; on (b)(6) 2018: [colitis ulcerative abated].Final diagnosis was pyrexia and rectal cancer recurrent.The patient was treated with oxaliplatin (oxaliplatin), fluorouracil (fluorouracil), calcium folinate (leucovorin ca), atorvastatin calcium (avastin [atorvastatin calcium]) and calcium chloride dihydrate, glucose, potassium chloride, sodium acetate, sodium chloride (veen d).The patient outcome is reported as recovered / resolved on (b)(6) 2018 for pyrexia and as not recovered / not resolved on an unknown date for rectal cancer recurrent.Rectal cancer recurrent is considered to be not related to carboxymethylcellulose and sodium hyaluronate by the reporter and not reportable by the company based on company causality assessment.Pyrexia is considered to be unassessable to carboxymethylcellulose and sodium hyaluronate by the reporter and reportable by the company based on company causality assessment.Reporter comment: the causal relationship could not be assessed because of pyrexia of unknown cause.Additional reporter comment (on 13-aug-2018): the causality with the use of medical device of seprafilm could be denied, because there was a high possibility of recurrent rectal cancer as the result of examination.Additional information was received on 13-aug-2018 by the physician: added concurrent conditions, laboratory data, an event "rectal cancer recurrent", and reporter comment.Updated outcome of the event "pyrexia" and the clinical course.Investigation summary was received on 24-aug-2018: investigation summary#: (b)(4).Investigation summary#: (b)(4).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.Amendment on 09-jan-2019: product "malfunction" field was amended ("yes" was deleted), and seriousness criterion "intervention required" was additionally chosen.

• Brand Name: SEPRAFILM
• Type of Device: MCN
• MDR Report Key: 8197471
• MDR Text Key: 133092754
• Report Number: 1220423-2018-00012
• 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,s
• Type of Report: Initial,Followup
• Report Date: 01/11/2019

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: 12/26/2018
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/07/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Weight: 66