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

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

Patient Problem Insufficient Information (4580)

Event Date 01/01/2019

Event Type  Death  

Manufacturer Narrative

This value is the average age of the patients reported in the article as specific patients could not be identified.This value reflects the gender of the majority of the patients reported in the article as specific patients could not be identified.Please note that this date is based off of the date of publication of the article [or the date that the article was accepted for publication] as the event dates were not provided in the published literature.If information is provided in the future, a supplemental report will be issued.

Event Description

Deng y, jia b, huo x, peng y, cao y, chen s, et al.Association of cardioembolism and intracranial arterial stenosis with outcomes of mechanical thrombectomy in acute ischemic stroke. world neurosurg. (2019) 121:e154¿e8.Doi: 10.1016/j.Wneu.2018.09.058 medtronic literature review found reported of patient complications in association with solitaire thrombectomy.The purpose of this article was to review different outcomes in patients with acute ischemic stroke (ais) who receive thrombolytic treatment based on the various etiologic subtypes.The aim of this study was to estimate the association of different stroke etiologies, particularly cardioembolism (ce) and intracranial arterial stenosis (icas), with mt outcomes in patients with ais.A diagnosis of ce was made based on evidence of atrial fibrillation, cardiac conditions that predispose to emboli formation (e.G., postinfarction akinetic left cardiac ventricular wall), and dilated cardiomyopathy.Icas was defined as a fixed focal stenosis at the occlusion site after retrieval.The authors reviewed 140 cases of patients treated for acute ischemic stroke (ais) using a solitaire mechanical thrombectomy.Of the 140 patients, the average age was 63 years, 54 were female and 86 were male.The primary outcome measure was a favorable outcome, which was defined as a 90-day modified rankin scale score between 0 and 2.Secondary outcomes included successful reperfusion (modified thrombolysis in cerebral infarction grades of 2b-3), symptomatic intracerebral hemorrhage (sich), and 90-day mortality.The article does not state any technical issues during use of the solitaire.The following intra- or post-procedural outcomes were noted: 1.Death occurred in 18 patients within the 90 day clinical outcome assessment.

• 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: david gustafson ; 9775 toledo way; irvine, CA 92618 ; 7635149628
• MDR Report Key: 11393026
• MDR Text Key: 234039990
• Report Number: 2029214-2021-00215
• 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,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/03/2021
• 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