MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION CONTOUR; AGENTS, EMBOLIC, FOR TREATMENT OF UTERINE FIBROIDS

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

Patient Problems Pulmonary Embolism (1498); Dehydration (1807); Cardiac Enzyme Elevation (1838); Pulmonary Edema (2020); Renal Failure (2041); Electrolyte Imbalance (2196)

Event Date 03/18/2010

Event Type  Injury  

Manufacturer Narrative

Date of event estimated using the date the article was received for publication.Kiefer, matthew v et al.Chemoembolization of intrahepatic cholangiocarcinoma with cisplatinum, doxorubicin, mitomycin c, ethiodol, and polyvinyl alcohol: a 2-center study.Cancer vol.117,7 (2011): 1498-505.Doi:10.1002/cncr.25625.

Event Description

It was reported via literature article that patient complications occurred.This study describes a 2-center experience with hepatic artery chemoembolization for intrahepatic cholangiocarcinoma and adenocarcinoma of unknown primary.Specifically, morphological response rates, toxicity, and overall survival were assessed.Lobar or segmental chemoembolization with cisplatinum, doxorubicin, mitomycin-c, ethiodol, and contour polyvinyl alcohol particles was performed at monthly intervals for 1-4 sessions until the entire intrahepatic tumor burden was treated.Cross-sectional imaging and clinical and laboratory evaluation were performed before treatment, 1 month after treatment, and then every 3 months.A second cycle of treatment was performed for intrahepatic recurrence.Sixty-two patients were treated.Thirty-seven had pathologically proven cholangiocarcinoma, and 25 had poorly differentiated adenocarcinoma of unknown primary, likely cholangiocarcinoma.One hundred and twenty-two total procedures were performed during the initial cycle of treatment (mean, 2.0 per patient).Twenty patients received a second cycle, for a total of 165 procedures.There were 5 major complications.Postembolization syndrome (defined as ctcae toxicity grade 1 or higher post procedure pain, fever, nausea, or vomiting) was experienced after 65% of evaluable procedures; however, the syndrome was usually mild, with discharge on the day following procedure.Major complications occurred following 5 of the 165 procedures (3%).One patient developed pulmonary edema and elevated cardiac enzymes (grade 4) postprocedure.Another patient developed a pulmonary infarct 2 days postprocedure.One patient required readmission for severe postembolization syndrome.One patient was readmitted for hyperglycemia.One patient developed acute renal failure and dehydration postprocedure.All 5 patients with major complications recovered without significant consequences and were discharged.

• Brand Name: CONTOUR
• Type of Device: AGENTS, EMBOLIC, FOR TREATMENT OF UTERINE FIBROIDS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC LIMITED; model farm road; cork ; EI
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15085363
• MDR Text Key: 296399224
• Report Number: 2134265-2022-08056
• Device Sequence Number: 1
• Product Code: NAJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/29/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization