MAUDE Adverse Event Report: BIOCOMPATIBLES U.K. LIMITED LC BEAD AND LC BEAD M1; EMBOLIC AGENT

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

Patient Problems Abdominal Pain (1685); Death (1802); Encephalopathy (1833); Fatigue (1849); Feeding Problem (1850); Fever (1858); Hemorrhage/Bleeding (1888); Inflammation (1932); Necrosis (1971); Pain (1994); Pneumonia (2011); Sepsis (2067); Swelling (2091); Thrombosis (2100); Weakness (2145); Ascites (2596)

Event Type  Death  

Event Description

This complaint was identified following a literature search conducted by the company on 02/19/2015.The article was published in the journal of vascular interventional radiology (jvir) 2015.Authors: amy r.Deipolyi, rhahmi oklu, shehab al-ansari, andrew x.Zhu, lipika hgoyal and suranu gangauli.Title: safety and efficacy of 70-150 um and 100-300 um drug-eluting bead tace for hcc.Patients with unresectable hcc underwent tace with one vial of 70-150 um (lc bead m1) loaded with 50 mg of doxorubicin followed by one vial of 100-300 um (lc bead) loaded with 50 mg of doxorubicin.This mixture was diluted with non-ionic contrast material and sterile water and slowly injected under fluoroscopic guidance into the targeted vessels until all debs were delivered or until near-stasis was achieved.All patients with unresectable hcc and liver lesions treated at least once with trans-arterial chemoembolization were included.Two patients underwent tace to selected segmental and sub-segmental branches.The celiac artery or superior mesenteric artery was catheterized with a5-fcatheter.A 2.8-fcoaxial microcatheter was used to select the right or left hepatic artery or a more selective arterial branch based on findings on cross-sectional imaging, angiography, and cone beam ct was performed during the procedure.Following the procedure, the patient's experienced severe post-embolization syndrome including fatigue, abdominal pain, decreased appetite and low-grade fevers.Patients ing roup had prolonged hospital stay.Seven patients had abdominal pain and ascites, three patients had gastrointestinal or tumoral bleeding, and one patient had encephalopathy.One patient with gastrointestinal bleeding was found to have new lobar portal vein thrombosis; another patient had esophageal variceal bleeding documented endoscopically the third patient had tumoral bleeding requiring embolization.One patient developed new biliary ductal dilatation and two patients developed cholecystitis.One patient was managed conservatively with resolution of cholecystitis whereas the other patient underwent cholecystectomy.Bilirubin levels after the procedure were higher.One patient died within 1 month from pneumonia and sepsis after a re-admission for severe ascites, mouth sores, decreased oral intake, right upper quadrant pain, and weakness.The author stated that two patients treated with the smaller debs developed cholecystitis compared with none of the patients who had received 100-300 um debs alone (group 1) and that lobar treatments of the right the hepatic artery maybe expected to increase the likelihood of non-target embolization to the cystic artery and cholecystitis.The author also stated that the only difference in treatment between groups 1 and 2 was the use of 70-150 um debs.The fact that no patients treated with 100-300 um debs alone developed cholecystitis may be due to the greater extent of coagulative necrosis induced by smaller debs.And the risk of hepatobiliary adverse events may be increased by the smaller size of debs alone and the fact that half of the procedures were performed in livers with five or more tumors, the results may not be generalized to selective embolizations.The author concluded that transarterial chemoembolization using 70-150 um debs followed by 100-300 um debs caused increased hepatobiliary adverse events compared with 100-300um debs alone but provided similar efficacy on one month follow-up imaging using mrecist.

Manufacturer Narrative

(b)(4).Lc bead with doxorubicin was reported to have been used in the treatment of this patient.Lc bead is indicated for the treatment of hypervascular tumors and avms.The use of lc bead with doxorubicin is considered off-label use.The literature article published adverse events in two groups of patients within the study.This medwatch relates to the second group (group 2) of patients.This medwatch report is linked to 3002124545-2015-00016 (group 1).The device has not been sent to the manufacturer for evaluation.No batch review was possible for this case as the lot number could not be ascertained.No product malfunction/deficiency has been identified.Medical assessment: published article outlined a number of "hepatobiliary events" having occured with deb-tace using m1 beads.Many were complications of cirrhosis and may not be related, but at least two were cholecystitis.Cholecystitis is a serious event that could be due to user error with regard to ectopic placement of beads.The paper's event is therefore medically reportable.

Manufacturer Narrative

The investigation into this complaint was complete.The potential contributory factors were investigated and assessed as part of this complaint.Cholecystitis could be due to user error with regard to ectopic placement of beads.The potential root cause was identified as a procedural complication.Embolic ifus were reviewed; the product ifus state "potential complications" related to procedure.

• Brand Name: LC BEAD AND LC BEAD M1
• Type of Device: EMBOLIC AGENT
• Manufacturer (Section D): BIOCOMPATIBLES U.K. LIMITED; 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 ; 252732732
• MDR Report Key: 4660121
• MDR Text Key: 16186738
• Report Number: 3002124545-2015-00017
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Literature,Health Professional,health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/19/2015
• 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
• Patient Outcome(s): Death; Hospitalization