MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 AXIUM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number UNK-NV-AXIUM

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

Patient Problems Aspiration/Inhalation (1725); Hemorrhage/Bleeding (1888); Pneumonia (2011)

Event Date 08/18/2022

Event Type  Death  

Manufacturer Narrative

B3.The date of online publication is used for reported event date.G3.As the model and lot number of the axium coil(s) were not provided, the pma/501k reference number cannot be known.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.

Event Description

Leedman, s., thompson, a., phillips, t., sader, c.(2023).Major haemorrhage after non-surgical management of oropharyngeal squamous cell carcinoma.The journal of laryngology and otology, 137(6), 667¿672.Https://doi.Org/10.1017/s0022215122001918.Medtronic review of the literature article found a retrospective case series of patients with oropharyngeal squamous cell carcinomas who suffered major hemorrhage requiring embolization during or after chemoradiotherapy or radiation alone between 13-september-2013 and 08-january-2021.The total cohort included 14 patients, 7 of whom were in the control group and did not experience hemorrhage.Thus, 7 patients were included in the hemorrhage treatment group.Embolic materials used for hemorrhage treatment included axium platinum coils as well as 2 different non-medtronic devices.It was not specified which treatment was utilized in each case.There were no reported device malfunctions or deficiencies.It was additionally noted that the 2 patients who were included in the hemorrhage group that were treated with radiation alone were treated with non-curative intent.Of the patients 7 that underwent hemorrhage embolization procedures, it was noted that 3 patients died.2 of these patients died due to large recurrent oropharyngeal bleeds and the other died from aspiration pneumonia.It should be noted that both patients who were treated with non-curative intent were among the patients who had an outcome of mortality.

• Brand Name: AXIUM
• Type of Device: DEVICE, NEUROVASCULAR EMBOLIZATION
• 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: 18123489
• MDR Text Key: 327989892
• Report Number: 2029214-2023-02203
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNK-NV-AXIUM
• Device Catalogue Number: UNK-NV-AXIUM
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/03/2023
• 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
• Patient Age: 65 YR
• Patient Sex: Male