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

Model Number 100-300 MICROM

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Death (1802); Liver Damage/Dysfunction (1954); Perforation (2001); Rupture (2208); Foreign Body In Patient (2687)

Event Date 03/18/2016

Event Type  Injury  

Manufacturer Narrative

Dc bead 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

Hepatic failure [hepatic failure], hcc invaded in the bile duct was thought to be perforated and ruptured [perforation bile duct], hemobilia [haemobilia].Case description: initial information received on 07-jul-2017: this serious literature medical device report was presented on the (b)(6) group of japan by maiko n.Et al., entitled "hemobilia after transcatheter arterial chemoembolization using a drug-eluting bead for hepatocellular carcinoma with intrahepatic bile duct invasion", concerning a (b)(6) female patient.The patient's medical history included type c hepatic cirrhosis and hepatocellular carcinoma (hcc) which was treated repeatedly since (b)(6) 2010 with transcatheter arterial chemoembolization (tace), sorafenib, and others.The patient's concomitant medication were not provided.In (b)(6) 2014, hcc with peripheral intrahepatic biliary dilation was noted in the dorsolateral segment of the left hepatic lobe (s2).Tace using drug-eluting beads (deb-tace) was performed, with favourable therapeutic effects.In (b)(6) 2016, multiple hccs were noted, with the major lesion as a hcc of 74 mm in size with indistinct margin in the left lobe of the liver.Similar peripheral biliary dilatation was present, suggestive of bile duct invasion.On an unspecified date in (b)(6) 2016, for the lesion, deb-tace with dc bead (lot number and expiration date not reported) was performed through the left hepatic artery for hepatocellular carcinoma.After embolization, an angiogram was obtained with a catheter via the left hepatic artery.Tumor stain of hcc in the left lobe disappeared.However, an image was obtained from the left hepatic duct to the common bile duct.On an unspecified date in (b)(6) 2016, plain ct showed retention of contrast material in the gallbladder.Hcc invaded in the bile duct was thought to be perforated and ruptured by deb-tace [perforation bile duct] [haemobilia].Coil embolization was performed for the feeding vessel to the ruptured site.After it was confirmed that an angiogram no longer showed visualization of the left hepatic duct and the common bile duct, the procedure was completed.After the procedure, black stools were noted once.Other than that, the subsequent course was uneventful, without progression of anaemia or complications such as cholangitis.On hospital day 15, the patient was discharged.After discharge, no recurrence of hemobilia was noted.On an unspecified date in 2016, three months after transcatheter arterial embolization (tace), the patient died of hepatic failure by hepatic cancer [hepatic failure].Black stools and anaemia were consequences of the event haemobilia and as such subsumed under the latter.The reporter did not assess the seriousness of the events bile duct was thought to be perforated and ruptured and hemobilia and assessed both events possibly related to the administration of dc bead.The reporter assessed the event hepatic failure as serious (fatal) and not related to the administration of dc bead.The reporter concluded that to date, several cases with tumour rupture after deb-tace for hcc had been reported: "we hereby report our experience on a rare case of hemobilia after deb-tace for hcc with intrahepatic bile duct invasion, with a literal view.Tace is an effective therapy for non-resectable hcc.However, in the presence of tumour localization and others, a risk of tumour rapture has to be taken into consideration in therapeutic selection." the company assessed all the events as serious hepatic failure (death, medically significant), perforation bile duct (hospitalization, medically significant), haemobilia (hospitalization, medically significant).Follow-up information will be requested.Case comment: hepatic failure was considered unanticipated according to dc bead current reference safety information, whereas perforation bile duct and haemobilia was anticipated.In agreement with the assessment made by the reporter, the company considered that perforation bile duct and haemobilia were related to the administration of dc bead and hepatic failure was not related to the administration of dc bead.There was no report of device failure or malfunction.

Manufacturer Narrative

Dc bead with epirubicin 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.Dc bead with epirubicin is considered off-label use.

Event Description

Hepatic failure [hepatic failure].Hcc invaded in the bile duct was thought to be perforated and ruptured [perforation bile duct], hemobilia [haemobilia], dc bead loaded with 50 mg of epirubicin [off label use of device].Case description: initial information received on 07-jul-2017: this serious literature medical device report was presented on the 53rd annual meeting of liver cancer study group of japan by maiko n.Et al., entitled "hemobilia after transcatheter arterial chemoembolization using a drug-eluting bead for hepatocellular carcinoma with intrahepatic bile duct invasion", concerning a (b)(6) female patient.The patient's medical history included type c hepatic cirrhosis and hepatocellular carcinoma (hcc) which was treated repeatedly since (b)(6) 2010 with transcatheter arterial chemoembolization (tace), sorafenib, and others.The patient's concomitant medication were not provided.In (b)(6) 2014, hcc with peripheral intrahepatic biliary dilation was noted in the dorsolateral segment of the left hepatic lobe (s2).Tace using drug-eluting beads (deb-tace) was performed, with favourable therapeutic effects.In (b)(6) 2016, multiple hccs were noted, with the major lesion as a hcc of 74 mm in size with indistinct margin in the left lobe of the liver.Similar peripheral biliary dilatation was present, suggestive of bile duct invasion.On an unspecified date in (b)(6) 2016, for the lesion, deb-tace with dc bead (lot number and expiration date not reported) was performed through the left hepatic artery for hepatocellular carcinoma.After embolization, an angiogram was obtained with a catheter via the left hepatic artery.Tumour stain of hcc in the left lobe disappeared.However, an image was obtained from the left hepatic duct to the common bile duct.On an unspecified date in (b)(6) 2016, plain ct showed retention of contrast material in the gallbladder.Hcc invaded in the bile duct was thought to be perforated and ruptured by deb-tace [perforation bile duct] [haemobilia].Coil embolization was performed for the feeding vessel to the ruptured site.After it was confirmed that an angiogram no longer showed visualization of the left hepatic duct and the common bile duct, the procedure was completed.After the procedure, black stools were noted once.Other than that, the subsequent course was uneventful, without progression of anaemia or complications such as cholangitis.On hospital day 15, the patient was discharged.After discharge, no recurrence of hemobilia was noted.On an unspecified date in 2016, three months after transcatheter arterial embolization (tace), the patient died of hepatic failure by hepatic cancer [hepatic failure].Black stools and anaemia were consequences of the event haemobilia and as such subsumed under the latter.The reporter did not assess the seriousness of the events bile duct was thought to be perforated and ruptured and hemobilia and assessed both events possibly related to the administration of dc bead.The reporter assessed the event hepatic failure as serious (fatal) and not related to the administration of dc bead.The reporter concluded that to date, several cases with tumour rupture after deb-tace for hcc had been reported: "we hereby report our experience on a rare case of hemobilia after deb-tace for hcc with intrahepatic bile duct invasion, with a literal view.Tace is an effective therapy for non-resectable hcc.However, in the presence of tumour localization and others, a risk of tumour rapture has to be taken into consideration in therapeutic selection." the company assessed all the events as serious hepatic failure (death, medically significant), perforation bile duct (hospitalization, medically significant), haemobilia (hospitalization, medically significant).Follow-up information will be requested.Follow-up information received on 28-jul-2017: pre-tace condition of hcc: number of tumours: 1; tumour size (maximum diameter): 74 mm.Presence of hepatic cirrhosis (type c): complication, underlying hepatic function: score 9, thrombosis: none.On (b)(6) 2016, tace was performed using one vial dc bead (100-300 microm) loaded with 50 mg of epirubicin (epirubicin hydrochloride) [off label use of device].The degree of embolization (rate of disappearance of the contrast medium, 5 heartbeats as a reference) was fast (weak embolization); the embolization site was s2 (segment).On (b)(6) 2016, during tace, the patient experienced hemobilia.Initial symptoms developed after completion of tace at 12:50.Coil embolization was performed for hepatic rupture.No extrahepatic infiltration observed.The patient recovered from the hemobilia on an unknown date.No vascular lake observed before or during tace.On an unspecified date in (b)(6) 2016 the patient died of hepatic cancer.The reporter did not assess the seriousness of the event dc bead loaded with 50 mg of epirubicin (off label use of device).The company assessed the event off label use of device as non-serious.At the time of this final report, no further information was outstanding or expected.Case comment: hepatic failure and off label use of device were considered unanticipated according to dc bead current reference safety information, whereas perforation bile duct and haemobilia were anticipated.In agreement with the assessment made by the reporter, the company considered that perforation bile duct and haemobilia were related to the administration of dc bead and hepatic failure was not related to the administration of dc bead.Off label use of device is not an adverse event per se but a special scenario and therefore not assessable.There was no report of device failure or malfunction.

• Brand Name: DC BEAD
• Type of Device: HCG/KRD SINGLE USE IMPLANTABLE MEDICAL DEVICE
• Manufacturer (Section D): BIOCOMPATIBLES UK LTD; farnham, surrey united kingdom; farnham, surrey ; UK
• Manufacturer (Section G): BIOCOMPATIBLES UK LTD; farnham business park; weydon lane; farnham, GU9 8 QL; UK GU9 8QL
• Manufacturer Contact: sandra bausback ; lakeview, riverside way; watchmoor park; camberley, surrey GU15 -3YL ; UK GU15 3YL
• MDR Report Key: 6735219
• MDR Text Key: 80758298
• Report Number: 3002124543-2017-00037
• 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,l
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 100-300 MICROM
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/28/2017
• 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): Death; Hospitalization; Other
• Patient Age: 71 YR