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 02/02/2019

Event Type  Injury  

Event Description

Kun zhang, zi-liang wang, bu-lang gao, jiang-yu xue, tian-xiao li, tong-yuan zhao, dong-yang cai, and ying-kun he; world neurosurgery; 2019; 127: e685-e691; use of a first large-sized coil versus conventional coils for embolization of cerebral aneurysms: effects on packing density, coil length, and durable occlusion; doi.Org/10.1016/j.Wneu.2019.03.242.Medtronic received information in a literature article that patients possibly treated with a solitaire stent had a decreased theraputic response.The objective of the article was to investigate effects of using a large-sized coil first on embolizing cerebral aneurysms compared with conventional coils.Forty-six patients with 51 saccular intracranial aneurysms who underwent embolization with a large-sized coil first were enrolled as the large-sized coil group.There were 33 female and 13 male patients with a mean age of 56.9 years.The treatment modality was coiling. meanwhile, 50 patients with 53 intracranial aneurysms who were treated with conventional-sized coils were selected as the control conventional-sized coil group, including 36 female and 14 male patients with a mean age of 54.6 years.The treatment modality was coiling alone in 29 aneurysms and stent-assisted coiling in 24 aneurysms.Inclusion criteria were age range of 18-80 years, with saccular aneurysms less than 15 mm in size ([width+ height or depth]/2) and h unt-hess grade of o-iii.The exclusion criteria were patients who had prolonged coagulation time, liver or kidney dysfunction, tortuous intracranial vasculature, severe cerebral vasospasm, hunt-hess grade iv and v, pseudoaneurysms, dissecting aneurysms, and traumatic subarachnoid hemorrhage.In the large stent group 2 out of 21 stents used were solitaire and in the conventional size group 2 out of 24 were solitaire. the procedure was performed with the patient under general anesthesia, with dual antiplatelet inhibition.  a microcatheter was intro duced into the aneurysm cavity under guidance of a microguidewire for embolization.All aneurysms were embolized to dense packing until no coils could be inserted into the aneurysm.Results: the complete occlusion rate was smaller in the large-sized coil group(84.3%) than in the conventional group (92.5%).In the large coil group during the follow-up, 44 (97.8%) aneurysms showed complete or stable occlusion.One aneurysm recurred in the aneurysm neck and was retreated with surgical clipping.In the conventional group at follow up forty aneurysms remained completely occluded or had a stable occlusion status.Five aneurysms recurred, including 2 medium and 3 large aneurysms, with a mean recurrence time of 12.9 months.The 2 medium aneurysms with recurrence were retreated with surgical clipping, and the other 3 larger ones were recoiled to complete occlusion.

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.

• 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: 16264870
• MDR Text Key: 308384205
• Report Number: 2029214-2023-00133
• 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,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/30/2023

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-SOLITAIRE
• Device Catalogue Number: UNK-NV-SOLITAIRE
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/24/2023
• Initial Date FDA Received: 01/30/2023
• 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