MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 SOLITAIRE RD; CATHETER, THROMBUS RETRIEVER

Model Number UNK-NV-SRD

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

Patient Problems Stenosis (2263); Vascular Dissection (3160)

Event Date 04/21/2017

Event Type  Death  

Event Description

Junji uno, katsuharu kameda, ryosuke otsuj,i nice ren, shintaro nagaoka , kazushi maeda, yoshiaki ikai, hidefuku gi; cerebrovascualr diseases; 2017; 44:217-224; mechanical thrombectomy for acute basilar artery occlusion in early therapeutic time window; doi: 10.1159/000479939.Medtronic received information in a literature article that patients potentially treated with launcher guiding catheter, marksman catheter and solitaire fr stent had complications.The purpose of the article was to analyze consecutive cases of basilar artery (ba) occlusion (bao) treated with mechanical thrombectomy (mt) to evaluate its safety and efficacy and to deter[1]mine factors associated with the prognosis.Thirty-four consecutive patients who were admitted to our hospital between (b)(6) 2011 and (b)(6) 2016, who were treated with mt for bao, were enrolled.They assessed patients at admission extensive acute cerebral infarction in posterior circulation was de[1]fined as significant cerebellar infarction with a mass effect and/or bilateral extended brainstem infarction on a non-contrast ct scan.When a major artery occlusion was detected with cta and a per[1]fusion defect in cerebral blood flow (cbf) was observed with ctp, mt was performed.Procedure: endovascular treatment was performed under sedation using diazepam and pentazocine.An 8f long sheath was inserted into the right femoral artery under local anesthesia and the largest possible medtronic guiding catheter, 6¿8f (launcher), was introduced into the dominant or most accessible vertebral artery.When the penumbra system was used, depending on the diameter of the occluded vessel, the 054 or 041 catheter in the early stage or the 5max, 5max ace, or 4max catheter in the later stage was used as an aspiration catheter and advanced to immediately before the site of the occlusion using the 3max or pxslim as an intermediate catheter with the 0.014 microguidewire.The catheter was inserted into the thrombus to aspirate for 90 sec using an aspiration pump.As a stent retriever, the solitaire fr or the trevoprovue was used.When a stent retriever was used as a microcatheter, the rapidtransit or the marksman was initially placed, passing the site of occlusion with the transend ex microguidewire.After confirming that the microcatheter has passed the thrombus via angiography through the microcatheter, we advanced and deployed the stent retriever.The period of stent deployment was 2.5 min.In the case of incomplete recanalization, the procedure was repeated 2 or 3 times.When the presence of residual stenosis was detected, percutaneous transluminal angioplasty was performed as appropriate.As for postoperative antithr ombotic drugs, antiplatelet drugs or anticoagulants were selected, depending on the cause of cerebral infarction.Results: successful recanalization (tici = 2b) was achieved in all patients.A favorable prognosis (mrs = 2) at 90 days was observed in 56% of patients.The mortality rate was 12% ( n = 4).No symptomatic intracerebral hemorrhage (sich) was observed.Of 34 patients, the penumbra system was used as first-line treatment in 30, while a stent retriever was used in 4 patients.Percutaneous transluminal angioplasty was performed for residual stenosis in 5 patients with atherothrombotic occlusion.Stenting was performed for vertebral artery dissection in one patient.Assessable ctp images were obtained in 31 of 34 patients, and cbf/cbv mismatch was observed in 27 of 31 patients.They did not exclude any patients by ctp and had no pc-aspect limit.

Manufacturer Narrative

Event related to regulatory report: 2029214-2023-00445.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: SOLITAIRE RD
• 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: 16523473
• MDR Text Key: 311078545
• Report Number: 2029214-2023-00446
• Device Sequence Number: 1
• Product Code: NRY
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 03/10/2023

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-SRD
• Device Catalogue Number: UNK-NV-SRD
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/03/2023
• Initial Date FDA Received: 03/10/2023
• 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