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

Model Number ISF-055-040

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

Patient Problems Paralysis (1997); Paresis (1998); Irritability (2421); Confusion/ Disorientation (2553); Ischemia Stroke (4418)

Event Date 03/26/2024

Event Type  Injury  

Manufacturer Narrative

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.

Event Description

Medtronic received a report that an artisse patient experienced left hemibody deficit.The patient was being treated for a right ica c6 aneurysm with a saccular morphology in the terminus vessel.Aneurysm dimensions: max diameter 3.6 mm and neck diameter 3.3 mm, dome height 6.1 mm and dome width 2.9 mm.Parent artery diameter distal to aneurysm: 2.4 mm.Parent artery diameter proximal to aneurysm: 5.9 mm.Ae result in the subject being hospitalized or a prolongation of an existing hospitalization.Mdt assessment: possibly related to index procedure, artisse device, not related to ancillary device or dapt.Post implant there was significant stasis.The patient recovered/resolved on (b)(6) 2024.

Event Description

Additional information was received that medtronic received a report that the patient experienced a right sylvian ischemic stroke with parieto-occipital hemorrhagic rearrangement post procedure.The event resulted in new or worsening of existing neurological deficits and symptoms last for more than 24 hours.They had confusion and left hemiparesis, logorrhea, agitation and facial paralysis.The event resulted in new hospitalization from (b)(6) 2024.Concomitant or additional treatment was given.The event recovered/resolved with sequalae on 2024-may-02.The event was noted as possibly related to the disease under study.The sponsor assessed the event as possibly related to the artisse device and not related to the index procedure, ancillary device, or dapt.The site assessed as possibly related to the device and ancillary device, causally related to the procedure, and not related to dapt.***us mdr decision corrected to not reportable as device is not marketed or similar device in us.No additional supplemental reports are required unless additional information received indicates reportable event.

Manufacturer Narrative

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: ARTISSE
• 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: 19172834
• MDR Text Key: 340924999
• Report Number: 2029214-2024-00733
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/10/2024

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: ISF-055-040
• Device Catalogue Number: ISF-055-040
• Device Lot Number: B563311
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/17/2024
• Initial Date FDA Received: 04/24/2024
• Supplement Dates Manufacturer Received: 05/08/2024
• Supplement Dates FDA Received: 05/10/2024
• Date Device Manufactured: 05/12/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 74 YR
• Patient Sex: Female
• Patient Weight: 54 KG