MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 SOLITAIRE AB STENT; INTRACRANIAL NEUROVASCULAR STENT

Model Number UNK-NV-SAB

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

Patient Problem Intracranial Hemorrhage (1891)

Event Date 01/17/2019

Event Type  Death  

Manufacturer Narrative

Event related to regulatory report: 2029214-2023-00074.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

Byung moon kim, jang-hyun baek, ji hoe heo, dong joon kim, hyo suk nam, young dae kim, hyo suk nam, and young dae kim; american heart association; 2019; 50:1178-1183; effect of cumulative case volume on procedural and clinical outcomes in endovascular thrombectomy; doi: 10.1161/strokeaha.119.024986.Medtronic received information in a literature article that patients potentially treated with cello balloon catheter, solitaire ab stents and solitaire fr stents had complication.The aim of this study was to test whether or not procedural and clinical outcomes would improve with increased endovascular thrombectomy (evt) cumulative case volume (evt-ccv) in a large cohort treated with stent retriever (sr) or contact aspiration (ca) thrombectomy as a first-line modality.Because those studies did not access individual patient data, the only outcome analyzed was mortality.A total of 1032 patients underwent evt for acute stroke caused by large vessel occlusion (lvo) in the participating hospitals during the study period.Among them, 955 patients (mean age= 67.8.M:f=507:448).Evt procedure: patients eligible for intravenous tpa (tissue-type plasminogen activator) treatment had the full dose of tpa (0.9 mg/kg).All evt procedures were performed under local anesthesia with or without conscious sedation.A 6f shuttle sheath or an 8f to 9f balloon guide catheter (cello or optimo) was used as a guide catheter.The use of a balloon guide catheter depended on the protocol of each site.Two types of srs (solitaire ab/fr or trevo stryker) were used for sr thrombectomy, and the penumbra system was predominantly used for ca thrombectomy.Results: recanalization and good outcome rates positively correlated with evt-ccv group.782 had a good outcome.  61 had symptomatic intracranial hemorrhage and mortality was 93.

• Brand Name: SOLITAIRE AB STENT
• Type of Device: INTRACRANIAL NEUROVASCULAR STENT
• 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: 16187848
• MDR Text Key: 307521742
• Report Number: 2029214-2023-00075
• Device Sequence Number: 1
• Product Code: NJE
• 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: 01/17/2023

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-SAB
• Device Catalogue Number: UNK-NV-SAB
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/12/2023
• Initial Date FDA Received: 01/17/2023
• 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: 68 YR
• Patient Sex: Male