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 08/05/2020

Event Type  Death  

Event Description

Medtronic received information that a study was done to compare the differences between wingspan and neuroform stents in patients with middle cerebral artery stenosis involving echelon 10 microcatheters and navien intermediate catheters.Retrospectively analyzed consecutive patients with symptomatic mca stenosis who had been treated with either neuroform or wingspan from 1 january, 2018 to 1 january, 2021. the inclusion criteria were as follows: recurrence of transient ischemic attack (tia) or ischemic stroke (nihss <= 12; national institutes of health stroke scale) within the previous 180 days despite antiplatelet therapy; digital subtraction angiography-verified severe atherosclerotic stenosis (>=70%) or occlusion in the m1 segments of the middle cerebral artery (mca), using the method of the north american symptomatic carotid endarterectomy trial (nascet) or (if the distal vessel was not accessible) the wasid measurement; at least one atherosclerotic risk factor (hypertension, diabetes mellitus , hyperlipidemia, hyper-homocysteinemia, and smoking); the previous stroke occurring more than 7 days before stenting; age between 18 and 85 y; and a drop in cerebral blood flow by 30% or more compared to the contralateral mca circulation territory on computed tomography perfusion (ctp) imaging. of the 190 included patents, 113 were assigned to the wingspan group and 77 were assigned to the neuroform group.The baseline characteristics of the patients showed more males in the wingspan group (79.6vs.66.2%, p = 0.04).Meanwhile, higher nihss scores on admission (2.88 ± 3.19 vs.4.69 ± 3.74, p < 0.01), higher degrees of stenosis in the target artery (84.59 ± 8.60 vs.90.74 ± 10.78, p < 0.01), and more type-c in the mori classification (34.5 vs.66.2%, p < 0.01) were found in the neuroform group.Routine oral aspirin (100 mg/day) and clopidogrel (75 mg/day) were administered 3¿ 5 days before stenting.The risk factors hypertension, low density lipoprotein, homocysteine, and high blood glucose were controlled according published guidelines for the prevention of secondary ischemic stroke.Smoking and drinking were prohibited, and each patient¿s lifestyle was adjusted. three experienced n eurointerventionist with more than 100 cases of intracranial stent implantation performed the stenting procedure.After general anesthesia, the patients received 3,000u of unfractionated heparin intravenously for systemic heparinization.An echelon 10 microcathete r was navigated to the distal part of the stenosis. if the path was too tortuous to deliver the microcatheter to the target lesion, the intermediate catheter navien or a distal access catheter from another manufacturer was used.The stenting procedure was completeed as per study.  1 patient ultimately died of intracerebral hemorrhage, 1 patient experienced infarction in the perforating branch territory of the s tented artery confirmed by mri while the nihss returned to the baseline level when discharged, 1 patient had tia, 2 had asymptomatic hemorrhagic transformation after infarction and 1 had symptomatic hemorrhagic transformation resulting from hyper-reperfusion. in the neuroform group, no patient died during the perioperative period, 1 patient had tia, 1 patient experienced infarction the branch territory, 1 patient experienced guidewire perforation during the retreating of the delivery system (the patient was asymptomatic because the ruptured artery was successfully embolized by coil immediately), 1 patient experienced asymptomatic intracerebral hemorrhage, and 1 patient experienced symptomatic intracerebral hemorrhage.

Manufacturer Narrative

Kai zhou, yuan cao, xiao-hui he, zhong-ming qiu, shuai liu, zi-li gong, jie shuai and qing-wu yang; frontiers in neurology; 2021; volume 12, article 527541; a comparison of safety and effectiveness between wingspan and neuroform stents in patients with middle cerebral artery stenosis.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: 13233245
• MDR Text Key: 283657863
• Report Number: 2029214-2022-00037
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K110055
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2022
• 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
• Date Manufacturer Received: 01/06/2022
• 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): Hospitalization; Death
• Patient Sex: Male