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

Model Number UNK-NV-MARKSMAN

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

Patient Problems Failure of Implant (1924); Skin Discoloration (2074); Visual Disturbances (2140); Impaired Healing (2378); Respiratory Insufficiency (4462)

Event Date 04/28/2023

Event Type  Injury  

Event Description

Gennaro p, cioni s, bracco s, et al.A single-center retrospective analysis of 14 head and neck avms cases treated with a single-day combined endovascular and surgical approach.Journal of personalized medicine.2023;13(5).Doi:10.3390/jpm13050757 medtronic literature review found a report of patient complications in association with onyx liquid embolic and a marksman microcatheter.The purpose of this article was to present a retrospective single-center study of 14 patients with arteriovenous malformations (avms) of the head and neck region undergoing combined endovascular and surgical treatment in a single day.Eight patients were male and six were females, aged between 9 and 63 years, with a mean age of 34.5 years.Embolization was performed using different liquid or mechanical embolic materials.The mechanical embolic materials include particles, coils, and plugs, while the liquid embolic materials include adhesive (nbca, n-butyl cyanoacrylate) and non-adhesive materials (evoh, ethylene-vinyl alcohol).Among the latter are available different commercial preparations, such as squid, phil, and onyx.Liquid non-adhesive embolizing materials was used in six patients.Particles alone were used in only two patients, liquid adhesive materials alone were used in one patient, and liquid adhesive materials supplemented with particles were used in three patients.Microcatheters used in procedures included magic 1.2f, headway27, headway21, headwayduo 156, marksman or rapidtransit microcatheters.It is unclear what if any events involved onyx or a marksman microcatheter.The article does not state any technical issues during use of the onyx or marksman.The following intra- or post-procedural outcomes were noted:  - post-surgical complications occurred in four patients: two patients had wound dehiscence resolved with surgical plasty, one patient had an asymmetry of the lips treated with lipofilling, and one patient complained of a cheek skin discoloration due to the ectasic vessel around the avm treated with chemical peels or microdermabrasion. - two of the 14 patients required further radicalization surgery to remove residual embolized lesions. - one patient reported worsened symptoms of various grades of functional impairment due to avms, such as visual disturbances, breat hing restriction, and chewing difficulties.

Manufacturer Narrative

Continuation of d10: product id unk-nv-onyx (unknown); product type: ; implant date n/a; explant date n/a g2: citation: authors: gennaro, p., cioni, s., bracco, s., cascino, f., latini, l., abbagnato, m., massarelli, o., <(>&<)> gabriele, g.A single-center retrospective analysis of 14 head and neck avms cases treated with a single-day combined endovascular and surgical approach.Journal of personalized medicine 13(5) 2023.Doi:10.3390/jpm13050757 earliest date of publication used for date of event no unique device identifier (serial/lot) numbers were provided; without this information it could not be determined whether these observations have been previously reported.Without return of the product no definitive conclusion can be made regarding the clinical observations.See manufacturer report # 2029214-2023-02418 for another report from this article.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: MARKSMAN
• 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: 18361495
• MDR Text Key: 330934723
• Report Number: 2029214-2023-02419
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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: 12/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNK-NV-MARKSMAN
• Device Catalogue Number: UNK-NV-MARKSMAN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/05/2023
• 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
• Treatment: SEE H10...
• Patient Outcome(s): Required Intervention
• Patient Age: 34 YR
• Patient Sex: Male