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 07/17/2023

Event Type  Death  

Manufacturer Narrative

Continuation of d10: product id unk-nv-solitaire (unknown); product type: ; implant date n/a; explant date n/a g2: citation: authors: choi, s., lee, e., lee, s.B., won, y., lee, s.B., kim, y.W., kim, c.-i., sheen, j.J.Usefulness of additional diffusion mri acquisition prior to mechanical thrombectomy for acute large vessel occlusion in the early time period at a ct-based stroke center.Clinical neurology and neurosurgery 233 2023.Doi:10.1016/j.Clineuro.2023.107901 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.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

Choi s, lee e, lee sb, et al.Usefulness of additional diffusion mri acquisition prior to mechanical thrombectomy for acute large vessel occlusion in the early time period at a ct-based stroke center.Clinical neurology and neurosurgery.2023;233.Doi:10.1016/j.Clineuro.2023.107901 medtronic literature review found a report of patient complications in association with a solitaire stent retriever.The purpose of this article was to investigate whether evaluating the infarction core using additionally acquired diffusion magnetic resonance imaging (mri) could help improve the assessment of prognosis including complication rates and modify the strategy for mechanical thrombectomy in endovascular procedures.There were 123 total patients included in the study, 82 in the small infarction core group (less than 60 cc) and 41 in the large infarction core group (more than 60 cc).Of the 123 total patients, 69 were male and the mean age was 72.04 years.It is unclear how many patients underwent mechanical thrombectomy using a solitaire stent retriever.The article does not state any technical issues during use of the solitaire.The following intra- or post-procedural outcomes were noted:  mortality occurred in 2 patients in the small infarction group and 6 patients in the large infarction group.Any intracranial hemorrhage within 48 hours occurred in 56 patients in the small infarction group and 35 patients in the large infarction group. symptomatic intracranial hemorrhage within 48 hours occurred in 6 patients in the small infarction group and 15 patients in the large infarction group. - decompressive craniectomy within 7 days occurred 2 patients in the small infarction group and 5 patients in the large infarction group. re-occlusion occurred in 11 patients in the small infarction group and 1 patient in the large infarction group.

• 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: 18450470
• MDR Text Key: 332172616
• Report Number: 2029214-2024-00033
• Device Sequence Number: 1
• Product Code: NRY
• Combination Product (y/n): N
• Reporter Country Code: KS
• 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: 01/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2024
• 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: 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): Death
• Patient Age: 72 YR
• Patient Sex: Male