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 Problem Arrhythmia (1721)

Event Date 06/21/2021

Event Type  Death  

Event Description

Qi y, sun y, wang y, et al.The application of ¿stilted building¿ technique in the embolization of aneurysms with secondary branches.Biomed research international.2021;2021:9976541.Doi:10.1155/2021/9976541.Medtronic literature review found a report of patient complications in potentially association an echelon microcatheter, rebar catheter, and hyperglide balloon catheter.The purpose of this article was to evaluate the curative effect and safety of the ¿stilted building¿ technique, in which a larger diameter coil that is slightly larger than the diameter of the aneurysm was chosen to form a stable internal frame to support the sidewall of the aneurysm and the wall of the branch artery, resembling the pillars of the ¿stilted building¿ and providing a strong support point for the aneurysm to later be filled with coils.Twenty-five patients (18 female, mean age (b)(6) years) were included in the retrospective study.All 25 patients successfully underwent aneurysm embolization.No aneurysms recurred among the patients who completed the follow-up.A patient with a right posterior communicating aneurysm died of postoperative ventricular fibrillation.

Manufacturer Narrative

Qi y, sun y, wang y, et al.The application of ¿stilted building¿ technique in the embolization of aneurysms with secondary branches.Biomed research international.2021;2021:9976541.Doi:10.1155/2021/9976541.See manufacturer report # 2029214-2021-01566 and 2029214-2021-01567 for other events mentioned in the article.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

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.

Event Description

Additional information received reported this literature had been communicated with the surgeon in (b)(6) hospital, and the adverse events mentioned in the article were not directly related to medtronic equipment/products.

• 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: 12943036
• MDR Text Key: 281825879
• Report Number: 2029214-2021-01568
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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,Followup
• Report Date: 01/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2021
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/23/2021
• 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: 63 YR
• Patient Sex: Female