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 Headache (1880); Hemorrhage/Bleeding (1888); Visual Disturbances (2140)

Event Date 11/19/2020

Event Type  Injury  

Event Description

Medtronic received information that a patient who underwent a procedure with a solitaire platinum had binocular diplopia in far vision due to spontaneous subconjunctival bleeding in the left eye.The patient was treated for a aneurysm in the middle cerebral artery (mca), m1 in the left hemisphere.Pre-procedure mtici score was indeterminate. final post-procedure mtici score: 3. mrs score: 0.Nihss score: 13.Event occurred after procedure.Event possibly related to disease understudy.The event was possibly related to the procedure.No additional action taken.The event resolved (b)(6) 2020.

Manufacturer Narrative

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

Manufacturer Narrative

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

Event Description

Medtronic received information that a patient who underwent a procedure with a solitaire platinum had binocular diplopia in far vision due to spontaneous subconjunctival bleeding in the left eye.The patient was treated for a aneurysm in the middle cerebral artery (mca), m1 in the left hemisphere.Pre-procedure mtici score was indeterminate. final post-procedure mtici score: 3. mrs score: 0.Nihss score: 13.Event occurred after procedure.Event possibly related to disease understudy.The event was possibly related to the procedure.No additional action taken.The event resolved (b)(6) 2020.

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.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

Additional information was received indicating the patient's nihss score was 12, not 13, as initially reported.It was also reported the patient had a headache.The headache required concomitant treatment.The headache resolved on (b)(6) 2020.

• 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: 13056192
• MDR Text Key: 286154787
• Report Number: 2029214-2021-01644
• Device Sequence Number: 1
• Product Code: NRY
• Combination Product (y/n): N
• Reporter Country Code: SP
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2021
• 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?: No
• Date Manufacturer Received: 02/01/2022
• 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: 61 YR
• Patient Sex: Female
• Patient Weight: 89 KG