MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 REFLEX CATHETER; CATHETER, PERCUTANEOUS

Model Number UNK-NV-RFX

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

Patient Problems Stroke/CVA (1770); Intracranial Hemorrhage (1891)

Event Date 03/29/2018

Event Type  Injury  

Event Description

Grossberg, j.A., haussen, d.C., bouslama, m., <(>&<)> nogueira, r.G.(2018).Stent-retriever thrombectomy across circle of willis.World neurosurgery, 115, 47¿53.Https://doi.Org/10.1016/j.Wneu.2018.03.212 medtronic review of the literature article found case review of 3 patients who underwent thrombectomy treatment of endovascular stroke.The first two cases discussed in the article used non-medtronic devices in the treatment procedures.In the third case reviewed in the article, three solitaire stent retrievers (6mm x 30mm and two 4mm x 40mm respectively) and a navien 072 catheter were used off label for endovascular treatment; it was noted that the navien intra-cranial support catheter was required due to the patient vessel tortuosity.The middle aged male patient was admitted to the hospital with transient left-sided weakness.The next morning the patient was found to have a right mca syndrome and was transferred to our tertiary care center.The nihss score on arrival was 17.Ncct aspects was 9.Computed tomography perfusion revealed a large mismatch.Cta outside the hospital revealed a right distal cervical dissection and right ica-terminus occlusion.The solitaire 6 x 30 was used first and deployed across the occlusion and reviewed under constant aspiration with the occlusion balloon inflated.Angiography revealed recanalization the accessory middle cerebral artery (mca) and persistent occusion of the mca-m1 segment and azygous anterior cerebral artery (aca) a2 segment occlusion.The solitaire 4 x 40 stent retriever when then used in the right mca with recanalization of the majority of the territory with the exception of the inferior m3.After reperfusion of the mca was achieved, the decision was made to approach the azygous aca-a2 occlusion.However, it was observed that the distal cervical carotid dissection had worsened and the catheter would not cross.Accordingly, the balloon catheter was taken to the left ica.A solitaire 4 x 40 stent retriever was deployed across the occlusion and removed under constant aspiration with recanalization of the azygous aca-a2 achieved.The total procedure time was 229 minutes.Post-procedure ct did not show any hemorrhage.2 hours post-operative, the patient had an acute decline in mental status.Head ct revealed a large ich in the mca territory.The patient was taken to surgery for hemicraniectomy.Post-operative mri revealed a large right mca and aca territories stroke with no evidence of infarct in the left hemisphere.The patient was discharged to rehabilitation on post-operative day 22.The 90-day modified rankin scale (mrs) was 4.

Manufacturer Narrative

Associated with mdr #: 2029214-2023-00368.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: REFLEX CATHETER
• Type of Device: CATHETER, PERCUTANEOUS
• 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: 16449402
• MDR Text Key: 310328437
• Report Number: 2029214-2023-00369
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161152
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/27/2023

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-RFX
• Device Catalogue Number: UNK-NV-RFX
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/01/2023
• Initial Date FDA Received: 02/27/2023
• 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; Other
• Patient Sex: Male