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

Model Number UNK-NV-MARKSMAN

Device Problems Break (1069); Unintended Movement (3026)

Patient Problem Foreign Body In Patient (2687)

Event Date 04/16/2023

Event Type  Injury  

Manufacturer Narrative

G2: citation: authors: ali, a., shapiro, m., nossek, e., esparza, r., narayan, v., sharashidze, v., & raz, e.Bailout endovascular techniques applied in a complicated basilar thrombectomy case.Journal of neurointerventional surgery 2023.Doi:10.1136/jnis-2022-019687.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.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

Ali a, shapiro m, nossek e, et al.Bailout endovascular techniques applied in a complicated basilar thrombectomy case. journal of ne urointerventional surgery.May 2023.Doi:10.1136/jnis-2022-019687.  medtronic literature review found a report of marksman catheter fragmentation and migration in association with marksman catheter thrombectomy.The purpose of this article was to describe a method and technique used to retract a fragmented piece of the marksman catheter that was used in a basilar artery thrombectomy that had migrated into the left posterior cerebral artery.The authors reviewed 1 case of a patient treated for basilar artery occlusion using marksman catheter in the thrombectomy.The patient was 60 years old with a history of a prior left cerebellar stroke, hypertension, atrial fibrillation and was on eliquis.The patient's presenting symptoms were forced gaze, right lower facial droop, no leg effort against gravity bilaterally, mild to moderate sensory loss bilaterally, and severe dysarthria (nihss score 14).  the patient's vessel was tortuous at the origin of the left vertebral artery.The accessed vessel was the left radial artery with a 6f sheath.The post operative angiography showed complete revascularization of the right anterior communicating pica that was previously occluded and also a marksman catheter fragment.The markman catheter tip was successfully removed with a zoom aspiration catheter.The article states the marksman catheter encountered fragmentation and then distal migration of a marksman microcatheter tip into the left posterior cerebral artery.The following intra- or post-procedural outcomes were noted: marksman catheter fragment broke and migrated into the left posterior cerebral artery successful retrieval and revascularization was completed.

Manufacturer Narrative

Review of the complaint files found this event was a duplicate of information reported in mdr 2029214-2022-00967.All future reporting for this event will be submitted in mdr 2029214-2022-00967.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

Review of the complaint files found this event was a duplicate of information reported in mdr 2029214-2022-00967.All future reporting for this event will be submitted in mdr 2029214-2022-00967.

• 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: 18350636
• MDR Text Key: 330811771
• Report Number: 2029214-2023-02399
• Device Sequence Number: 1
• Product Code: KRA
• 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,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• 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
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 60 YR