MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 REBAR; CATHETER, CONTINUOUS FLUSH

Model Number UNK-NV-REBAR

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

Patient Problems Fever (1858); Inflammation (1932); Liver Damage/Dysfunction (1954); Nausea (1970); Pain (1994)

Event Date 08/03/2021

Event Type  Injury  

Event Description

Ozgur o, sindel ht.Giant hepatic hemangioma treatment with transcatheter arterial embolisation and transcatheter arterial chemoembo lisation; comparative results.Turkish journal of medical sciences.2021;51(6):2943-2950.Summary: treatment of hepatic hemangiomas is a controversial topic, and traditional treatment is surgical excision.Transcatheter arterial embolisation (tae) and transcatheter arterial chemoembolisation (tace) have been reported as minimally invasive treatment methods.To the best of our knowledge, there are no studies comparing use of tace and tae for hepatic hemangioma treatment.The aim of the study is to compare symptom resolution, size reducing effects, and complications of tace and tae for the treatment of giant hepatic hemangiomas.Identified events: 1.22 tae patients what post embolization syndrome consisting of abdominal pain, nausea, loss of appetite, and a low-grade fever.The most common symptom was pain.According to mccaffery pain scale, the average score was 7.0 ± 0.8 (95% ci 6.7¿7.2, minimum 4, maximum 9, median 7).The patients were managed with mild analgesics.Their hospitalization was extended to 48 hours.Following the 48 hours, they were discharged upon resolution of the pain.2.3 tae patients had temporary leukocytosis in the first week.3.36 tae patients had elevated liver function tests, which returned to less than twice the normal values or to normal limits.4.12 tae patients who had elevated liver function tests and remained elevated were followed up for another 24 hours and their lfts were within normal limits at the end of the 48 hours.5.15 tace patients had their post procedural hospitalization extended to 48 hours because of their pain.

Manufacturer Narrative

Ozgur o, sindel ht.Giant hepatic hemangioma treatment with transcatheter arterial embolisation and transcatheter arterial chemoembo lisation; comparative results.Turkish journal of medical sciences.2021;51(6):2943-2950.This value is the average age of the patients reported in the article as specific patients could not be identified.This value reflects the gender of the majority of the patients reported in the article as specific patients could not be identified.Please note that this date is based off of the date that the article was accepted for publication as the event dates were not provided in the published literature.It was not possible to ascertain specific device information from the article or to match the events reported with previously reported events.Correspondence has been sent to the author of the article inquiring about individual patient information and additional information regarding the reported events.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: REBAR
• Type of Device: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• Manufacturer (Section G): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• Manufacturer Contact: glen belmer ; 9775 toledo way; irvine, CA 92618 ; 6122713209
• MDR Report Key: 15000377
• MDR Text Key: 295783782
• Report Number: 2029214-2022-01158
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• Reporter Country Code: TU
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNK-NV-REBAR
• Device Catalogue Number: UNK-NV-REBAR
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/13/2022
• 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): Required Intervention; Hospitalization
• Patient Age: 49 YR
• Patient Sex: Male