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 Problem Insufficient Information (4580)

Event Date 01/01/2020

Event Type  Death  

Event Description

Literature was reviewed regarding a novel technique of stent placement via gateway balloon in intracranial atherosclerosis-associated large vessel occlusion.Preliminary experience suggests possible safety and feasibility of deploying neuroform atlas stent through a compatible gateway balloon microcatheter without the need for ich-associated microcatheter exchange, using marksman, react, and solitaire.Further studies with long-term clinical and angiographic follow-up are warranted to corroborate the initial findings.Adverse events included patients with vessel dissection, groin hematoma, intracranial cerebral hemorrhage, and death.One patient required balloon angioplasty for the solitaire stent.  1.Two patients were found to have vessel dissection in the stented segment classified as biffl grade 2.2.Three patients had developed groin hematoma that resolved with conservative management.3.One patient had ich post-op that was asymptomatic.This was deemed a hemorrhagic infarction (hi) 2 as per ecass 3 ich classification.4.4 patients (18%) died within 90 days.

Manufacturer Narrative

B3: date is approximate.Month and year are confirmed valid.G2: citation: authors: memon m, ezzeldin m, biswas a, ahmad r, nisar t, singla a, muhammad n, shaltoni h, kan p, zaidat o, khandelwal p.Novel technique of stent placement via gateway balloon in intracranial atherosclerosis-associated large vessel occlusion.Journal of neuroimaging 33:773¿780 2023.10.1111/jon.13139 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 submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• 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: 19214171
• MDR Text Key: 341402825
• Report Number: 2029214-2024-00800
• 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: Foreign,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/30/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 04/02/2024
• Initial Date FDA Received: 04/30/2024
• 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 H11...
• Patient Outcome(s): Death
• Patient Age: 66 YR
• Patient Sex: Male