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 Problem Insufficient Information (4580)

Event Date 01/01/2018

Event Type  Death  

Event Description

Jin woo kim, byung hoon lee, <(>&<)> yoon joon hwang.(2018).Comparison of solitaire-fr and trevo-provue thrombectomy in patients with anterior circulation large artery occlusion.Iranian journal of radiology, 15(1), 1¿6.Https://doi.Org/10.5812/iranjradiol.14404 medtronic review of the literature article found a retrospective comparison of patients treated for ischemic stroke with a solitaire 4x20 stent retriever or non-medtronic (trevo) 4x20 stent retriever.21 patients were treated with a solitaire.17 of the 21 patients underwent iv rtpa before stent retriever thrombectomy.Successful recanalization was achieved in 19 patients treated with solitaire thrombectomy and 10 patients were noted to have good clinical outcome (defined as mrs 0-2) at 3 months.No device malfunctions were reported in the article.Post-operative complications noted in the article included: - 3 patient mortalities were reported.In the article, mortality was defined as death within 90 days of treatment administration.- 2 patients experienced symptomatic intracranial hemorrhage.In the article, symptomatic intracranial hemorrhage (sich) was defined as the presence of a large parenchymal hematoma and an increase of 4 points or more in the nihss score compared to the score on admission.

Manufacturer Narrative

A separate report will be submitted regarding the serious injuries/adverse events reported in the article.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.

• 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: 15276036
• MDR Text Key: 298402191
• Report Number: 2029214-2022-01428
• Device Sequence Number: 1
• Product Code: NRY
• Combination Product (y/n): N
• Reporter Country Code: KS
• 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: 08/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2022
• 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
• Date Manufacturer Received: 08/08/2022
• 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): Death
• Patient Age: 67 YR
• Patient Sex: Male
• Patient Race: Asian