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

Model Number NV UNK SOLITAIRE

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

Patient Problem Insufficient Information (4580)

Event Date 02/03/2022

Event Type  Death  

Event Description

Liu, h., zhang, y., fan, h., wen, c., (2022) risk factors and functional outcomes with early neurological deterioration after mechanical thrombectomy for acute large vessel occlusion stroke, journal of neurological surgery, 84, doi https://doi.Org/ 10.1055/a-1762-0167.Medtronic literature review found report of patient complications in association with solitaire stent.The study analyzed data from 79 patients with large vessel occlusion who received mechanical thrombectomy (mt).Authors aimed to investigate the incidence, risk factors, and functional outcomes with early neurological deterioration (end) after mt, and therefore aim to provide evidence for more precise clinical practice.Of the 79 patients, the median age was 63 years, 52 were males and 27 were females.Patients with occluded arteries were: 40 at middle cerebral artery (mca) (50.6%), 20 at internal carotid artery (ica) (25.3%), and 19 at vertebral basilar artery (ba) (24.1%).The article does not state any technical issues during use of the solitaire.14 patients died after mt.There were 19 patients with functional outcome after 90 days mrs >2 (75.9%).Of the patients with poor functional outcome, 32 experienced end with two or more national institutes of health stroke scale (nihss) increase.The incidence of end after mt was 32/79 (40.5%), of which 12 had ischemic stroke progression, 11 had encephaledema, and nine had symptomatic cerebral hemorrhage.Among the 32 end cases, three deteriorated within 24 hours, four within 24 to 48 hours, and 25 within 48 to 72 hours.There were 19 patients with functional outcome after 90 days mrs >2 (75.9%).  12 patients experienced unsuccessful reperfusion (mtici 2b).

Manufacturer Narrative

G2: citation: authors: liu, h., zhang, y., fan, h., wen, c.,.Risk factors and functional outcomes with early neurological deterioration after mechanical thrombectomy for acute large vessel occlusion stroke.Journal of neurological surgery 84 2022.Doi: 10.1055/a-1762-0167 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 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.

• Brand Name: 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: 18486266
• MDR Text Key: 332601255
• Report Number: 2029214-2024-00083
• Device Sequence Number: 1
• Product Code: NRY
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 01/10/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: NV UNK SOLITAIRE
• Device Catalogue Number: NV UNK SOLITAIRE
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/13/2023
• 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: 63 YR
• Patient Sex: Male