MAUDE Adverse Event Report: BIOCOMPATIBLES UK LTD DC BEAD; HCG/KRD SINGLE USE IMPLANTABLE MEDICAL DEVICE

Model Number 300-500 MICROM

Device Problem Insufficient Information (3190)

Patient Problems Embolism (1829); Inflammation (1932); Nausea (1970); Pain (1994); Vomiting (2144); Test Result (2695)

Event Type  No Answer Provided  

Manufacturer Narrative

Dc bead with doxorubicin hydrochloride was reported to have been used in the treatment of this patient.The equivalent product lc bead is available in the usa and is indicated for the treatment of hypervascular tumors and avms.

Event Description

Cholecystitis [cholecystitis] patient treated with dc-bead loaded with doxorubicin reported postembolization syndrome [post embolisation syndrome] increase in ast/alt and ggt [hepatic enzyme increased] elevated white blood cell count 3 to 4 days postprocedure [white blood cell count increased] inadvertent embolization of the cystic artery [procedural complication] case description: initial information received on 29-sep-2015: this literature medical device group case was published in 2008 from malagari in the journal cardiovascular interventional radiology with the title: transarterial chemoembolization of unresectable hepatocellular carcinoma with drug eluting beads: results of an open-label study of 62 patients.It reported an open-label, single center, single arm, study with 62 patients (48 male and 14 female, mean age 68 years old (46-81)) affected by unresectable hepatocellular carcinoma (hcc).The patient (unspecified age and gender) presented a medical history of cirrhosis due to controlled hepatitis infection.The patient presented a single lesion.The patient underwent repeated dc bead embolizations at 3-month intervals during the study period (3 sessions were scheduled for this study).The procedure was performed with local analgesia, antibiotic prophylaxis (cephalosporin and metronidazole) and antiemetic drugs.Prior to each embolization, the patient underwent angiography of the hepatic and mesenteric artery to demonstrate liver arterial anatomy and the feeding vessels of the tumor and to check for apparent venous shunt.On an unspecified date, the patient was treated with dc bead loaded with 150mg of doxorubicin (concentration of 37.5 mg/ml bead suspension: maximum dose 150mg).A loaded dc bead was mixed with an equal volume of nonionic contrast medium prior to delivery.Two different sizes of dc bead were used 100-300 microm and 300-500 microm in that order.The injection of loaded beads was performed into the feeding vessels using a 2.7-fr microcatheter.After dc bead-tace procedure (unspecified date and time), the patient experienced a cholecystitis, most likely due to inadvertent embolization of the cystic artery.The patient presented also post-embolization syndrome (including pain fever nausea and vomiting) and hepatic enzyme increased ( ast/alt and ggt increase after first embolization and then showed a continued decreasing trend after second and third embolization).The patient presented an elevated white blood cell count three to four days post-procedure.Post-embolization syndrome and hepatic enzymes increased resolved on an unspecified date.The outcome of the cholecystitis and elevated wbc was not reported.The authors considered the event cholecystitis as severe and clearly related to the procedure.Laboratory data were provided and were reported in the dedicated section.Case comment: cholecystitis, post-embolization syndrome, white blood cell count increased and hepatic enzymes increased are considered unlisted as per dc bead instructions for use.This case documented also a procedural complication (off-target embolization) and this is reported as potential complication in the current dc instruction for use.The authors assessed the events (cholecystitis, post-embolization syndrome, white blood cell count increased and hepatic enzymes increased ) as related to the treatment.The company considered also the events experienced by the patients as related to the product, as its role cannot be excluded.The authors did not report any seriousness criteria but upon review, the company assessed the event cholecystitis as serious (medically significant).This literature case report does not modify the risk benefit balance of dc bead.The company is continuously monitoring all respective reports received, and based on cumulative experience, will re-evaluate the available evidence on an ongoing basis.(b)(4).

Manufacturer Narrative

Dc bead with doxorubicin hydrochloride was reported to have been used in the treatment of this patient.The equivalent product lc bead is available in the usa and is indicated for the treatment of hypervascular tumors and avms.

Event Description

Cholecystitis [cholecystitis].Patient treated with dc-bead loaded with doxorubicin reported postembolization syndrome [post embolisation syndrome].Increase in ast/alt and ggt [hepatic enzyme increased].Elevated white blood cell count 3 to 4 days postprocedure [white blood cell count increased].Inadvertent embolization of the cystic artery [procedural complication].Case description: initial information received on (b)(6) 2015: this literature medical device group case was published in 2008 from malagari in the journal cardiovascular interventional radiology with the title: transarterial chemoembolization of unresectable hepatocellular carcinoma with drug eluting beads: results of an open-label study of 62 patients.It reported an open-label, single center, single arm, study with 62 patients (48 male and 14 female, mean age 68 yearsold (46-81)) affected by unresectable hepatocellular carcinoma (hcc).The patient (unspecified age and gender) presented a medical history of cirrhosis due to controlled hepatitis infection.The patient presented a single lesion.The patient underwent repeated dc bead embolizations at 3-month intervals during the study period (3 sessions were scheduled for this study).The procedure was performed with local analgesia, antibiotic prophylaxis (cephalosporin and metronidazole) and antiemetic drugs.Prior to each embolization, the patient underwent angiography of the hepatic and mesenteric artery to demonstrate liver arterial anatomy and the feeding vessels of the tumor and to check for apparent venous shunt.On an unspecified date, the patient was treated with dc bead loaded with 150mg of doxorubicin (concentration of 37.5 mg/ml bead suspension: maximum dose 150mg).A loaded dc bead was mixed with an equal volume of nonionic contrast medium prior to delivery.Two different sizes of dc bead were used 100-300 microm and 300-500 microm in that order.The injection of loaded beads was performed into the feeding vessels using a 2.7-fr microcatheter.After dc bead-tace procedure (unspecified date and time), the patient experienced a cholecystitis, most likely due to inadvertent embolization of the cystic artery.The patient presented also post-embolization syndrome (including pain fever nausea and vomiting) and hepatic enzyme increased ( ast/alt and ggt increase after first embolization and then showed a continued decreasing trend after second and third embolization).The patient presented an elevated white blood cell count three to four days post-procedure.Post-embolization syndrome and hepatic enzymes increased resolved on an unspecified date.The outcome of the cholecystitis and elevated wbc was not reported.The authors considered the event cholecystitis as severe and clearly related to the procedure.Laboratory data were provided and were reported in the dedicated section.Case comment: cholecystitis, post-embolization syndrome, white blood cell count increased and hepatic enzymes increased are considered unlisted as per dc bead instructions for use.This case documented also a procedural complication (off-target embolization) and this is reported as potential complication in the current dc instruction for use.The authors assessed the events (cholecystitis, post-embolization syndrome, white blood cell count increased and hepatic enzymes increased ) as related to the treatment.The company considered also the events experienced by the patients as related to the product, as its role cannot be excluded.The authors did not report any seriousness criteria but upon review, the company assessed the event cholecystitis as serious (medically significant).This literature case report does not modify the risk benefit balance of dc bead.The company is continuously monitoring all respective reports received, and based on cumulative experience, will re-evaluate the available evidence on an ongoing basis.(b)(4).Final assessment on 21-jan-2016: this case is a duplicate of case (b)(4), as consequence it will be nullified.

• Brand Name: DC BEAD
• Type of Device: HCG/KRD SINGLE USE IMPLANTABLE MEDICAL DEVICE
• Manufacturer (Section D): BIOCOMPATIBLES UK LTD; farnham business park; weydon lane; farnham, surrey GU9 8 QL; UK GU9 8QL
• Manufacturer (Section G): BIOCOMPATIBLES UK LTD; farnham business park; weydon lane; farnham, surrey GU9 8 QL; UK GU9 8QL
• Manufacturer Contact: farnham business park; weydon lane; farnham, surrey GU9 8-QL ; 4125273273
• MDR Report Key: 5184494
• MDR Text Key: 29831913
• Report Number: 3002124545-2015-00077
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): N
• Reporter Country Code: GR
• PMA/PMN Number: K094018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/29/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 300-500 MICROM
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/29/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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