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 Problems Hemorrhage/Bleeding (1888); Perforation of Vessels (2135); Vascular Dissection (3160); Unspecified Nervous System Problem (4426); Embolism/Embolus (4438); Thrombosis/Thrombus (4440); Insufficient Information (4580)

Event Date 12/16/2020

Event Type  Injury  

Event Description

Tomasello a, hernandez d, piñana c, et al.Mechanical thrombectomy with a novel device: initial clinical experience with the ana thrombectomy device.Journal of neuroradiology.2022;49(4):324-328.Doi:10.1016/j.Neurad.2020.11.003.Medtronic literature review found a report of patient complications in association with the solitaire stent and phenom catheter.The purpose of this article was to describe the safety and efficacy profile of the ana (anaconda biomed) catheter in a first-in-human study the first 35 consecutive patients in a single, large volume stroke center, intended to be treated with the ana catheter to perform the thrombectomy have been included in this study.The mean age of the patients in the study (n = 35) was 74.6 years (standard deviation (sd) 8.3), 54.3% (n = 19) of them were women.In all patients, once the guide catheter (6f neuronmax, penumbra) was placed at the level of the internal carotid artery, in a triaxial setting, a microcatheter (preferably phenom 21 (160 cm length), medtronic) was advanced over a micro guidewire to the clot.The ana catheter, in its retracted position, was then positioned as close as possible to the proximal aspect of the clot (terminal ica or mca), and the funnel was deployed to restrict flow locally.The microcatheter was then advanced through the occlusion site, and the sr (solitaire family, medtronic) deployed as in usual practice.At this point, the microcatheter was completely withdrawn to increase the aspiration lumen and manual aspiration (60cc vaclok® syringe) was applied through the ana funnel catheter.The sr was then, slowly pulled into the funnel while applying aspiration.When the distal ends of sr and ana funnel catheter are aligned, assuming that the clot was mobilized and copped into the funnel, both the ana+ the sr were simultaneously pulled out.The article does not state any technical issues during use of the solitaire or phenom.The following intra- or post-procedural outcomes were noted: -mrs 0-2 was achieved in 60.0% patients (n = 21) and mortality rate was 20% (n = 7).-1 intracranial vessel perforation -1 new territory embolization -2 extracranial ica dissection; one required stenting; first case was related with the 0.035 guidewire used to catheterize ica and observed before ana catheter was inserted.The second case was observed at the end of the procedure at the level of an ica curve -2 symptomatic hemorrhagic transformation -in 17.1% (n = 6) patients, rescue treatment was used -primary endpoint, defined as successful reperfusion (mtici 2b3) within 3 passes without rescue therapy, was achieved in 91.4% (n = 32) of patients with a rate of complete reperfusion (mtici 2c3) of 65.7%.

Manufacturer Narrative

G2: citation: authors: tomasello, a., hernandez, d., piñana, c., requena, m., liebeskind, d.S., nogueira, r.G., jovin, t., andersson, t., cognard, c., siddiqui, a., & ribo, m.Mechanical thrombectomy with a novel device: initial clinical experience with the ana thrombectomy device.Journal of neuroradiology 4 2022.Doi:10.1016/j.Neurad.2020.11.003 a.2.This value is the average age of the patients reported in the article as specific patients could not be identified.A.3.This value reflects the gender of the majority of the patients reported in the article as specific patients could not be identified.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.

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.

Event Description

Additional information received reported there was no medtronic product related to any adverse event.

• 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: glen belmer ; 9775 toledo way; irvine, CA 92618 ; 6122713209
• MDR Report Key: 17785398
• MDR Text Key: 323896477
• Report Number: 2029214-2023-01794
• Device Sequence Number: 1
• Product Code: NRY
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K203358
• 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,Followup
• Report Date: 10/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2023
• 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: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/11/2023
• 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: 75 YR
• Patient Sex: Female