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 Problems Intracranial Hemorrhage (1891); Perforation (2001); Bronchopneumonia (2437); Respiratory Failure (2484); Vascular Dissection (3160); Cerebral Edema (4403); Ischemia Stroke (4418); Embolism/Embolus (4438); Gastrointestinal Hemorrhage (4476); Renal Impairment (4499)

Event Date 10/13/2022

Event Type  Injury  

Manufacturer Narrative

Associated with mdr #: 2029214-2024-00095 g3.As the device generation/model/lot information was not provided in the article, pma/501k number is unknown.A2.Reported patient age (65 years) is the median age for all patients included in the the article study group.A3.Reported patient sex (male) is representative of the majority of patient in the article study group.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

Jovin, t.G., li, c., wu, l., wu, c., chen, j., jiang, c., shi, z., gao, z., song, c., chen, w., peng, y., yao, c., wei, m., li, t., wei, l., xiao, g., yang, h., ren, m., duan, j., ¿ ji, x.(2022).Trial of thrombectomy 6 to 24 hours after stroke due to basilar-artery occlusion.The new england journal of medicine, 387(15), 1373¿1384.Https://doi.Org/10.1056/nejmoa2207576 medtronic review of the literature article found a randomized trial conducted over 5 years comparing outcomes and risks of thrombectomy and medical therapy for the treatment of basilar-artery stroke, a type of stroke associated frequently with poor prognosis.Thrombectomies were performed with solitaire stent retrievers.106 patients underwent mechanical thrombectomy with solitaire.There were no device malfunctions reported in the literature article and reperfusion was successful in 88% of patients.Good functional outcome was reported in 46% of patient in the thrombectomy group compared to 24% in the control/medical treatment group.The following patient adverse events for patients in the thrombectomy group were noted: serious adverse events without noted mortality included, intracranial angioplasty or stent was performed in 60 patients after reperfusion failure.Symptomatic intracranial hemorrhage was reported in 9 patients and the authors concluded this was most likely due to reperfusion.Intra-operative complications occurred in 9 cases including 4 cases of vessel dissection, 3 cases of vessel perforation, and distal embolization in 5 cases.Other adverse events that were considered secondary outcomes included: 51 patients were noted to experience pneumonia.14 patients experienced malignant brain edema.15 patients were noted to have gastrointestinal hemorrhage.3 patients had renal insufficiency.21 patients experienced respiratory failure.

• 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: 18498870
• MDR Text Key: 332724600
• Report Number: 2029214-2024-00096
• 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: 01/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2024
• 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): Disability; Required Intervention; Life Threatening
• Patient Age: 65 YR
• Patient Sex: Male