MAUDE Adverse Event Report: BIOCOMPATIBLES UK LTD DC BEAD; HCG/KRD

Model Number 100-300 OR 300-500UM

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Occlusion (1984); Stenosis (2263)

Event Type  No Answer Provided  

Event Description

Hepatic arterial damage grade iii (occlusion) [hepatic artery occlusion]; hepatic arterial damage grade ii (overt stenosis) [hepatic artery stenosis]; hepatic arterial damage grade i (no or slight wall irregularity)/overflow damage [arterial injury]; loaded with non-ionic contrast medium [off label use of device].Case description: initial information received on (b)(6) 2016: this spontaneous medical device report was received from a literature article entitled "hepatic arterial damage after transarterial chemoembolization for the treatment of hepatocellular carcinoma: comparison of drug-eluting bead and conventional chemoembolization in a retrospective controlled study" published in acta radiologica regarding 54 patients, 44 male, and 10 female, with age range of 34-88.The patients' medical history included hepatocellular carcinoma, child-pugh class a/b/c was 51/3/0 respectively; (b)(6), non-c status was 37/6/11 respectively; maximal tumor size 3.34 +/- 2.17 cm; union for international cancer control (uicc) staging i/ii/iii/iv was "22/19/13"; angiography of the superior mesenteric artery was performed to check for portal vein patency and hepatopetal flow and angiography of the celiac artery and common hepatic artery were then performed to map the arterial anatomy and identify arterial feeders of the hcc.The patients' concomitant medications were unknown.The patients received a single session of deb-tace with dc bead (lot number and expiration date not provided) typically 2 or 4 ml of deb with a diameter of 100-300 or 300-500 microm was loaded with doxorubicin (35mg/ml of deb), dose per patient was 65 mg +/- 38, and visipaque non-ionic contrast medium on unknown dates for hepatocellular carcinoma as an initial treatment.31 patients had 1 targeted segment, 15 patients had 2 targeted segments, 7 patients had 3-4 targeted segments and 1 patient had 5-7 targeted segments.The level of embolization was 33 patients with subsegmental, and 21 patients with segmental.If the hcc was larger than 5 cm with rich vascularity, deb with a diameter of 300-500 microm was used.The injection rate was very slow to avoid reflux of deb to adjacent arteries.The end point of embolization was near stasis of blood flow during at least 10 seconds and clearing of residual tumor staining.On unspecified dates, after deb-tace, 13 patients (24.1%) developed hepatic arterial damage grade i/overflow damage was observed in 21 patients (38.9%), 10 patients (18.5%) developed hepatic arterial damage grade ii, and 31 patients (57.4%) developed hepatic arterial damage grade iii.Hepatic arterial damage (had) grades were in accordance with the criteria proposed by maeda et al.As follows: grade i, no or slight wall irregularity; grade ii, overt stenosis; and grade iii, occlusion.Grades ii and iii were regarded as significant had.In addition, "overflow damage", was defined as had proximal to a selected branch for chemoembolization.One of the 54 patients with grade ii a8 had at follow-up after 6 weeks, was a (b)(6) woman.Another of the 54 patients, treated for multiple hccs and developed grade iii a8 had, was a (b)(6) man.Another of the 54 patients who developed had overflow damage of the entire a2 artery at follow-up at 20 weeks was a (b)(6) woman.The treatment for and outcomes of the events was unknown.The authors did not assess the severity of the overflow damage and assessed the hepatic arterial damage grade i as no or slight wall irregularity, the hepatic arterial damage grades ii and iii as significant hepatic arterial damage.The authors referenced published literature to note that "had is related to toxic arteritis induced by chemotherapeutics".The authors further noted "we cannot conclude that the use of deb itself induces had as the mean dose of doxorubicin was significantly greater for deb-tace" (with dc bead) as compared with the control group (conv-tace) in each grade.The authors reiterated in their conclusion that the possible risk factors for had are doxorubicin dose in deb-tace.The company considers the events of had grade i, grade ii and grade iii as serious (medically significant) and the event "loaded with non-ionic contrast medium" as not assessable.Follow-up information will be requested.Case comment: the reported events of hepatic artery occlusion, hepatic artery stenosis, arterial injury and off-label use of device are considered to be unlisted.In agreement with the authors, the company considers the events of hepatic artery occlusion, hepatic artery stenosis, arterial injury as related to treatment with doxorubicin eluting beads with dc bead.Off label use of device is not assessable.This single 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.

Event Description

Hepatic arterial damage grade iii (occlusion) [hepatic artery occlusion]; hepatic arterial damage grade ii (overt stenosis) [hepatic artery stenosis]; hepatic arterial damage grade i (no or slight wall irregularity)/overflow damage [arterial injury]; loaded with non-ionic contrast medium [off label use of device].Case description: initial information received on (b)(6) -2016: this spontaneous medical device report was received from a literature article entitled "hepatic arterial damage after transarterial chemoembolization for the treatment of hepatocellular carcinoma: comparison of drug-eluting bead and conventional chemoembolization in a retrospective controlled study" published in acta radiologica regarding 54 patients, 44 male, and 10 female, with age range of 34-88.The patients' medical history included hepatocellular carcinoma, child-pugh class a/b/c was 51/3/0 respectively; (b)(6) status was 37/6/11 respectively; maximal tumor size 3.34 +/- 2.17 cm; union for international cancer control (uicc) staging i/ii/iii/iv was "22/19/13"; angiography of the superior mesenteric artery was performed to check for portal vein patency and hepatopetal flow and angiography of the celiac artery and common hepatic artery were then performed to map the arterial anatomy and identify arterial feeders of the hcc.The patients' concomitant medications were unknown.The patients received a single session of deb-tace with dc bead (lot number and expiration date not provided) typically 2 or 4 ml of deb with a diameter of 100-300 or 300-500 microm was loaded with doxorubicin (35mg/ml of deb), dose per patient was 65 mg +/- 38, and visipaque non-ionic contrast medium on unknown dates for hepatocellular carcinoma as an initial treatment.31 patients had 1 targeted segment, 15 patients had 2 targeted segments, 7 patients had 3-4 targeted segments and 1 patient had 5-7 targeted segments.The level of embolization was 33 patients with subsegmental, and 21 patients with segmental.If the hcc was larger than 5 cm with rich vascularity, deb with a diameter of 300-500 microm was used.The injection rate was very slow to avoid reflux of deb to adjacent arteries.The end point of embolization was near stasis of blood flow during at least 10 seconds and clearing of residual tumor staining.On unspecified dates, after deb-tace, 13 patients (24.1%) developed hepatic arterial damage grade i/overflow damage was observed in 21 patients (38.9%), 10 patients (18.5%) developed hepatic arterial damage grade ii, and 31 patients (57.4%) developed hepatic arterial damage grade iii.Hepatic arterial damage (had) grades were in accordance with the criteria proposed by (b)(4) as follows: grade i, no or slight wall irregularity; grade ii, overt stenosis; and grade iii, occlusion.Grades ii and iii were regarded as significant had.In addition, "overflow damage", was defined as had proximal to a selected branch for chemoembolization.One of the 54 patients with grade ii a8 had at follow-up after 6 weeks, was a (b)(6) woman.Another of the 54 patients, treated for multiple hccs and developed grade iii a8 had, was a (b)(6) man.Another of the 54 patients who developed had overflow damage of the entire a2 artery at follow-up at 20 weeks was a (b)(6) woman.The treatment for and outcomes of the events was unknown.The authors did not assess the severity of the overflow damage and assessed the hepatic arterial damage grade i as no or slight wall irregularity, the hepatic arterial damage grades ii and iii as significant hepatic arterial damage.The authors referenced published literature to note that "had is related to toxic arteritis induced by chemotherapeutics".The authors further noted "we cannot conclude that the use of deb itself induces had as the mean dose of doxorubicin was significantly greater for deb-tace" (with dc bead) as compared with the control group (conv-tace) in each grade.The authors reiterated in their conclusion that the possible risk factors for had are doxorubicin dose in deb-tace.The company considers the events of had grade i, grade ii and grade iii as serious (medically significant) and the event "loaded with non-ionic contrast medium" as not assessable.Follow-up information will be requested.Follow-up information was received on 30-jun-2016: follow-up information has been sought.As of 30-jun-2016, no additional information has been received.Follow-up information is expected.Case comment: the reported events of hepatic artery occlusion, hepatic artery stenosis, arterial injury and off-label use of device are considered to be unlisted.In agreement with the authors, the company considers the events of hepatic artery occlusion, hepatic artery stenosis, arterial injury as related to treatment with doxorubicin eluting beads with dc bead.Off label use of device is not assessable.This single 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.

• Brand Name: DC BEAD
• Type of Device: HCG/KRD
• Manufacturer (Section D): BIOCOMPATIBLES UK LTD; farnham, surrey ; UK
• 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: 5716847
• MDR Text Key: 47229576
• Report Number: 3002124545-2016-00045
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): N
• Reporter Country Code: KS
• 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: 06/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 100-300 OR 300-500UM
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/30/2016
• 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