MAUDE Adverse Event Report: BIOCOMPATIBLES U.K. LIMITED DC BEAD; EMBOLIC AGENT

Model Number 100-300 UM

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

Patient Problems Embolism (1829); Fever (1858); Nausea (1970); Pain (1994); Malaise (2359); Ascites (2596); No Code Available (3191)

Event Date 11/27/2014

Event Type  Injury  

Event Description

This initial report concerns an (b)(6) male pt and was received from the user facility via the distributor on (b)(6) 2015.The pt's concomitant diseases hepatic cirrhosis (type b) and diabetes mellitus.The pt underwent a tace procedure during which he received one vial of drug eluting dc bead (100-300 micrometers) loaded with 48.75 mg epirubicin (epirubicin hydrochloride) on (b)(6) 2014.At an unreported time post tace the pt developed nausea (non-serious).Treatment medications included intravenous primperan (metoclopramide) for nausea and cocarl (paracetamol) was prescribed for pain.On (b)(6) 2014 approx one day post tace, the pt developed pyrexia (non-serious) and hyper-transaminasaemia (non-serious).Cocarl (paracetamol) was prescribed for pyrexia.On (b)(6) 2014, the pt recovered from nausea.On (b)(6) 2014 approx four days post tace, a contrast-enhanced ct was performed because of the pt's pyrexia and malaise.Hepatic infarction in the left lobe (lateral segment) and a moderate amount of ascites were observed, leading to hospitalization.Furosemide and spironolactone were prescribed as treatment medications.On (b)(6) 2014, the pt's abdominal bloating was strong, and a diuretic agent was started.The pyrexia and pain recovered.On (b)(6) 2014, a further ct exam was performed.The hepatic infarction focus showed almost no change, but the ascites has decreased.Subsequently, the abdominal bloating and malaise improved and the hyper-transaminasaemia recovered.On (b)(6) 2014 the pt's malaise had recovered and on (b)(6) 2014 the ascites were resolving and the pt was discharged from the hosp.On (b)(6) 2015 the hepatic infarction has not recovered but its volume has shrunk.At the time of reporting it was reported that the pt had recovered from nausea, malaise, pyrexia, pain and hyper-transaminasaemia, the ascites were resolving but had not recovered from the hepatic infarction.In the opinion of the reporter, the hepatic infarction was considered to have been caused due to embolic effect of dc bead.The reporter stated that the presence of venous tumor embolism may have induced the hepatic infarction.The hyper-transaminasaemia was considered to be post - tace syndrome.The underlying disease was considered to be the other contributing factor of ascites.The reporting physician concluded that the pt's nausea, malaise, hepatic infarction, pyrexia, pain, ascites, and hyper-transaminasaemia were probably related to dc bead.

Manufacturer Narrative

Dc bead with epirubicin was reported to have been used in the treatment of this pt.Dc bead is not registered to be used in combination with epirubicin.The equivalent product lc bead is available in the usa and is indicated for the treatment of hypervascular tumors and avms.The device has not been sent to the mfr for eval.No batch review was possible for this case as the lot number could not be ascertained.No product malfunction/deficiency has been identified.Co med assessment: the pt received deb-tace therapy and then subsequently developed fever, nausea and hepatic infarction (identified by ct scan).This required hospitalization.Pt also had ascites.Events were improving.Also observed shrinking hepatic infarction by two months after the procedure.This event is medically reportable.This event is currently under investigation by the mfr and the conclusions of this investigation/any new info received will be communicated as a follow up report.

Manufacturer Narrative

(b)(4).Medical assessment: the patient received deb-tace therapy and then subsequently developed fever, nausea and hepatic infarction (identified by ct scan), this required hospitalization.The patient also had ascites, events were improving some resolved and shrinking of hepatic infarction two months after the procedure.Follow up information indicates that infarction focus persists but symptoms have resolved.This is a medically reportable event.Five days after deb tace, the patient's abdominal bloating was strong, and a diuretic agent was started the patient recovered from pyrexia and pain.A further ct examination was performed and the hepatic infarction focus showed almost no change, but the ascites has decreased.Subsequently, the abdominal bloating improved and the patient recovered from nausea, malaise, pyrexia, pain and hypertransaminasemia.The patient was recovering from ascites and the patient was discharged from hospital.At the time of hospital discharge the patient's hepatic infarction did not recover but its volume has shrunk.As of (b)(6) 2015, the patient did not recover from infarction focus, but the accompanying symptoms resolved.In the opinion of the reporter, the hepatic infarction was considered to due to dc bead and that the underlying disease was the other contributing factor.The reporter stated that the presence of venous tumor embolism may have induced the hepatic infarction.The hyper-transaminasemia was considered to be post-tace syndrome.The underlying disease was considered to be the other contributing factor of ascites.The reporting physician concluded that the patient's nausea, malaise, hepatic infarction, pyrexia, pain, ascites, and hyper-transaminasemia were probably related to dc bead.Additional information was received from the treating physician via the company distributor on april 24, 2015.It was reported that the treating physician was experienced with the tace procedure.It was reported that the patient did not have an underlying condition of portal vein thrombosis, hepatic vein thrombosis or portal hypertension.The manufacturer's investigation into this complaint was concluded.The potential contributory factors were investigated and assessed as part of this complaint.It was concluded that non-target embolization (procedural complication) along with the patient's underlying disease condition at the time of deb-tace could have contributed to the event.No capas have been identified as a result of this investigation.No device failure, trend in a type of incident or unexpected risk to patient or users health, has been identified given the root cause analysis.Embolic ifus states "potential complications" as a consequence of the deb-tace procedure.

Event Description

This follow up report summarises the findings from the manufacturers investigation report and reports additional information received on april 24, 2015.Previously reported information concerns a (b)(6) male patient.The patient's concomitant diseases included hepatic cirrhosis (type b) and diabetes mellitus.The patient underwent a deb-tace procedure with one vial of dc bead (100-300pm) loaded with 48.75 mg epirubicinv.) the patient developed nausea, malaise and pain and received intravenous primperan for nausea and cocarl for pain.One day post tace the patient developed pyrexia and hyper-transaminasemia and received cocarl (paracetamol) for pyrexia.Two days following the procedure, the patient recovered from nausea.Four days post tace, a ct scan revealed hepatic infarction in the left lobe (lateral segment) and a moderate amount of ascites leading to hospitalization and the patient received furosemide and spironolactone.

Manufacturer Narrative

Company medical assessment: follow up information indicates that infarction focus persists but symptoms have resolved and that this remains a medically reportable event.Subsequently, the abdominal bloating improved pain and the patient recovered from nausea, malaise, pyrexia, and hyper-transaminasemia the patient was recovering from ascites and the patient was discharged from hospital.At the time of hospital discharge the patient's hepatic infarction did not recover but its volume has shrunk.In the opinion of the reporter, the hepatic infarction was considered to have been caused due to embolic effect of dc bead.The reporter stated that the presence of venous tumor embolism may have induced the hepatic infarction.The hyper-transaminasemia was considered to be post-tack syndrome.The underlying disease was considered to be the other contributing factor of ascites.The reporting physician concluded that the patient's nausea, malaise, hepatic infarction, pyrexia, pain, ascites, and hyper-transaminasemia were probably related to dc bead.Additional information was received from the user facility via the company business partner on february 19, 2015.On november 27, 2014, the patient developed pain and the following day received cocarl (paracetamol).As of january 16, 2015, the pt did not recover from infarction focus, but the accompanying symptoms resolved.The reporting physician stated that the underlying disease was considered to be the other contributing factor of hepatic infarction and reported off-label use of hepatic embolization (due to the use of epirubicin).

Event Description

The initial information provided concerns a (b)(6) male patient.The patient's concomitant diseases included hepatic cirrhosis (type b) and diabetes mellitus.The pt underwent a deb-tace procedure with one vial of dc bead (100-300pm) loaded with 48.75 mg epirubicin (epirubicin hydrochloride).The patient developed nausea, malaise and pain and received intravenous primperan for nausea and cocarl for pain.One day post tace the patient developed pyrexia and hyper-transaminasaemia and received cocarl (paracetamol) for pyrexia.Two days following the procedure, the patient recovered from nausea.Four days post tace, a ct scan revealed hepatic infarction in the left lobe (lateral segment) and a moderate amount of ascites leading to hospitalization and the patient received.Furosemide and spironolactone.Five days after deb tace, the patient's abdominal bloating was strong, and a diuretic agent was started.The patient recovered from pyrexia and pain.A further ct examination was performed and the hepatic infarction focus showed almost no change, but the ascites has decreased.

• Brand Name: DC BEAD
• Type of Device: EMBOLIC AGENT
• Manufacturer (Section D): BIOCOMPATIBLES U.K. LIMITED; farnham bus.; park, weydon ln; farnham, surrey england GU9 8 QL; UK GU9 8QL
• Manufacturer Contact: 252732732
• MDR Report Key: 4637919
• MDR Text Key: 5614350
• Report Number: 3002124545-2015-00005
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K094018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Distributor,distributor,forei
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 02/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 100-300 UM
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/23/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: GRANISETRON HYDROCHLORIDE; ATRAPINE SULFATE HYDRATE; CEFMETAZOLE NA; MORPHINE HYDROCHLORIDE HYDRATE
• Patient Outcome(s): Hospitalization
• Patient Age: 84 YR
• Patient Weight: 59