MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 SOLITAIRE AB STENT; INTRACRANIAL NEUROVASCULAR STENT

Model Number UNK-NV-SAB

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

Patient Problems Hemorrhage/Bleeding (1888); Unspecified Nervous System Problem (4426); Swelling/ Edema (4577)

Event Date 10/26/2020

Event Type  Injury  

Manufacturer Narrative

Zang n, lin z, huang k, pan y, wu ya, wu yo, wang s, wang d, ji z, pan s.Biomarkers of unfavorable outcome in acute ischemic stroke patients with successful recanalization by endovascular thrombectomy.Cerebrovascular diseases.2020; 49:583¿592.Doi: 10.1159/000510804.Age or date of birth: 54 years is the average age of the patients who participated in the study.Patient sex: male is the majority of the participants.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

The purpose of this article was to identify plasma markers of unfavorable outcomes for patients with acute ischemic stroke (ais) after recanalization by endovascular thrombectomy (evt).  the authors reviewed 61 cases of patients treated for ais due to anterior large vessel occlusion who achieved recanalization by evt.Plasma samples were obtained between 18 and 24 h after recanalization.Unfavorable outcomes included futile recanalization at 90 days and overall early complications within 7 days after evt.Of the 61 patients, the average age was 53.9 years, 19 were female and 42 were male.  in total, 61 ais patients were selected with successful recanalization after evt using solitairetm ab stent retrievers, among whom 34 patients had futile recanalization, and 21 patients developed overall early complications, involving 20 patients with early neurological deterioration (end), 15 patients with malignant brain edema (mbe), 15 patients with brain herniation, and 9 patients with symptomatic hemorrhagic transformation (sht).Among the 21 patients who developed overall early complications, 2 patients developed brain herniation at the time which was close to sampling time; thus, they were excluded for analysis in overall early complications, while they were available for analysis in futile recanalization.It was found that the rates of end, mbe, brain herniation, or sht were significantly higher in patients with futile recanalization than those without.  the following intra- or post-procedural outcomes were noted: early neurological deterioration, malignant brain edema, brain herniation, and symptomatic hemorrhagic transformation.

• Brand Name: SOLITAIRE AB STENT
• Type of Device: INTRACRANIAL NEUROVASCULAR STENT
• 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: 16279106
• MDR Text Key: 308570495
• Report Number: 2029214-2023-00152
• Device Sequence Number: 1
• Product Code: NJE
• 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: 02/01/2023

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-SAB
• Device Catalogue Number: UNK-NV-SAB
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/12/2023
• Initial Date FDA Received: 02/01/2023
• 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): Required Intervention
• Patient Age: 54 YR