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 06/24/2020

Event Type  Death  

Manufacturer Narrative

Fernández menéndez s, murias quintana e, vega valdés p, et al.Efficacy and safety of endovascular treatment in acute tandem carotid occlusions: analysis of a single-center cohort.Cerebrovasc dis extra.2020;10(2):50¿8.Doi.Org/10.1159/000507919.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

Fernández menéndez s, murias quintana e, vega valdés p, et al.Efficacy and safety of endovascular treatment in acute tandem carotid occlusions: analysis of a single-center cohort.Cerebrovasc dis extra.2020;10(2):50¿8.Doi.Org/10.1159/000507919 medtronic literature review found reported of patient complications in association with solitaire thrombectomy.The purpose of this article was to assess the efficacy and safety of acute endovascular treatment in stroke due to tandem occlusions in our center and compare the results with previous reports.The authors reviewed 99 cases of patients treated for stroke due to tandem occlusions using with emergent carotid stenting and intracranial mechanical thrombectomy.Of the 99 patients, the average age was 67.5 years, 22 were female and 77 were male.Successful recanalization was defined as a tici score of 2b-3 and a good functional outcome was defined as a modified rankin scale score =2 at 90 days.Symptomatic intracranial hemorrhage (sich) was considered when associated with worsening on the national institutes of health stroke scale (=4 points).Intracranial hemorrhagic bleeds were classified as hemorrhagic infarction (hi1 and hi2) or parenchymal hematoma according to the definition of the ecass ii study, considering as sich those that led to clinical deterioration, as defined by an increase =4 points on the nihss.Endovascular treatment was performed using an antegrade approach, direct aspiration of the carotid obstruction, and simple angioplasty (ultrasoft 5 × 20 mm) to facilitate access to the intracranial occlusion.Subsequently, the guide catheter with a balloon was advanced through the carotid stenosis (concentric 8 fr), followed by extraction of the intracranial thrombus using a stent retriever (solitaire fr covidien-ev3) accompanied by aspiration from the guide catheter.Last of all, a stent was implanted across the cervical carotid lesion (wallstent; stryker-boston scientific).The article does not state any technical issues during use of the solitaire device.The following intra- or post-procedural outcomes were noted: at 3 months, 20 patients had died.Univariate analysis showed that older age, a history of coronary heart disease, a higher nihss score, lower values on the aspects, no recanalization, and a longer time until recanalization were associated with a higher mortality rate.

Manufacturer Narrative

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

Additional information received reported the published article was regarding a series of patients with tandem occlusion.There have been no complications associated with medtronic products.The rate of bleeding complications is the same as in published clinical trials, there were no technical complications associated with the procedures or device malfunction.Solitaire fr devices were used 4x20, 4x40 or 6x40, though it could not be specified which devices were used in which cases.All devices were discarded after use.

• Brand Name: UNKNOWN SOLITAIRE
• Type of Device: CATHETER, THROMBUS RETRIEVER
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• MDR Report Key: 11395284
• MDR Text Key: 234467679
• Report Number: 2029214-2021-00218
• Device Sequence Number: 1
• Product Code: NRY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Type of Report: Initial,Followup
• Report Date: 03/19/2021

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-SOLITAIRE
• Device Catalogue Number: UNK-NV-SOLITAIRE
• Device Lot Number: NOT-REP
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/06/2021
• Initial Date FDA Received: 03/01/2021
• Supplement Dates Manufacturer Received: 03/03/2021
• Supplement Dates FDA Received: 03/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Required Intervention
• Patient Age: 67 YR