MAUDE Adverse Event Report: COVIDIEN SPIDER FX; CATHETER, CAROTID, TEMPORARY, FOR EMBOLIZATION CAPTURE

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

Patient Problems Stroke/CVA (1770); Paresis (1998)

Event Date 05/01/2020

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

A representative case is reported of a plaque with acute intraplaque hemorrhage.Images were obtained from a (b)(6) man with asymptomatic carotid artery stenosis.This patient experienced amaurosis fugax after carotid artery stenting.Acute intraplaque hemorrhage appears hyperintense on hyper t1-weighted images and isointense to hypointense on t2-weighted multicontrast atherosclerosis characterization images.A small quantity of hemorrhagic debris was captured.Preoperative diffusion-weighted imaging showed no ipsilateral acute infarction in parietal lobe.Two new diffusion-weighted imaging lesions were observed in the same transverse plane.The purpose of this retrospective study was to identify which stage of intraplaque hemorrhage (iph) is an independent risk factor for ipsilateral new ischemic lesions (nils) after carotid artery stenting (cas).Two antiplatelet agents were administered for at least 7 days before cas.All the procedures were performed under local anaesthesia via the percutaneous transfemoral route.An intravenous heparin bolus based on the patient¿s weight was given for intraoperative anticoagulation.Two different types of embolic protection device (epd) were used one of which was the spiderfx.Pre-dilation was performed with a percutaneous transluminal angioplasty balloon catheter placed across the stenosis before deploying the stent.Two types of non-medtronic stents were placed in the stenotic lesion: open cell or closed cell.Post-dilation was performed to ensure that the residual stenosis was <(> <<)>30%.All the patients received neurologic evaluation during and after the procedures.The intraoperative evaluation consisted of consciousness and contralateral limb function tests during the steps including common carotid artery cannulation, epd lesion crossing, stent crossing, stent implantation, pre-dilation, and post-dilation.The debris captured by the epds was also observed after the procedures.Mri examinations were performed 3 days before the operation.All mris were independently reviewed by 2 radiologists with 3- and 6-years¿ experience in carotid mri who were blinded to the patients¿ clinical history and results of other diagnostic tests.If there was reviewer discrepancy, a consensus decision was made.

• Brand Name: SPIDER FX
• Type of Device: CATHETER, CAROTID, TEMPORARY, FOR EMBOLIZATION CAPTURE
• Manufacturer (Section D): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; IE ; 091708734
• MDR Report Key: 10181396
• MDR Text Key: 201037630
• Report Number: 2183870-2020-00187
• Device Sequence Number: 1
• Product Code: NTE
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K063204
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/04/2020
• 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
• Patient Age: 78 YR