MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 UNKNOWN SOLITAIRE; CATHETER, THROMBUS RETRIEVER

Model Number UNK-NV-SOLITAIRE

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

Patient Problems Stroke/CVA (1770); Vasoconstriction (2126); Vascular Dissection (3160); Unspecified Nervous System Problem (4426)

Event Date 05/31/2022

Event Type  Injury  

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.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that a patient treated with a solitaire 6x40mm had complications.On (b)(6) 2022, the patient experienced a stroke.The initial nihss score was 25.The patient was transferred to another hospital.The thrombectomy was done and it required two attempts to partial recanalisation.During intervention it was observed vasospasm cerebral in the left middle cerebral artery following passage of the stent and considering the intracranial artery dissection, there was a high risk of hemorrhage with anticoagulation.The vasospasm required 1mg of nimodipine.The patient then started neurological status deterioration (vigilance disorders)required a decompressive craniectomy.The second scan showed a m1 thrombus (6mm), and an occlusive dissection of the post-bulbar segment of the left internal carotid artery.Those lead to a stroke in the left intern carotid artery.Event assessed as possibly related to the study procedure.The patient recovered from the cerebral vasospasm on (b)(6) 2022.

• Brand Name: UNKNOWN SOLITAIRE
• Type of Device: CATHETER, THROMBUS RETRIEVER
• 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: 16817493
• MDR Text Key: 314035085
• Report Number: 2029214-2023-00702
• Device Sequence Number: 1
• Product Code: NRY
• 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,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/26/2023

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-SOLITAIRE
• Device Catalogue Number: UNK-NV-SOLITAIRE
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/20/2023
• Initial Date FDA Received: 04/26/2023
• Date Device Manufactured: 09/08/2022
• 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
• Patient Age: 46 YR
• Patient Sex: Male