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U.S. Department of Health and Human Services

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

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COVIDIEN SPIDER FX; CATHETER, CAROTID, TEMPORARY, FOR EMBOLIZATION CAPTURE Back to Search Results
Device Problem Off-Label Use (1494)
Patient Problem Vascular Dissection (3160)
Event Date 01/01/2015
Event Type  Injury  
Manufacturer Narrative
Event date: month and year valid: date of article publication.Endovascular recanalization of nonacute symptomatic vertebral ostial occlusion performed using a distal embolic protection device world neurosurgery (2020) 135; 316-323 10.1016/j.Wneu.2019.12.132.If information is provided in the future, a supplemental report will be issued.
 
Event Description
In the literature article "endovascular recanalization of nonacute symptomatic vertebral ostial occlusion performed using a distal embolic protection device", a retrospective study was conducted from a database, from january 2015 and february 2019, that contained consecutive patients with symptomatic total vertebral ostial occlusion on digital subtraction angiography who had undergone stenting with the protection of epds.The patients were selected to undergo stenting based on the following conditions: 1)recurrent tia, stroke, or progressive stroke in the vertebrobasilar territory despite best medical treatment (including dual antiplatelet therapy, aggressive statins, and optimized glucose control); 2) severe ischemic symptoms not explained by corresponding infarct shown on diffusion-weighted magnetic resonance image (mri); 3) atherosclerosis as the primary etiology, confirmed on the basis of the following clinical and imaging evidence; a) presence of at least 2 vascular atherosclerotic risk factors (i.E.Hypertension, diabetes mellitus, dyslipidaemia, smoking); and b) absence of any clinical, laboratory, or imaging findings suspicious for other potential causes, such as vasculitis, moyamoya disease, or dissection; and 4) digital subtraction angiography findings of a) nondominant, hypoplastic, or severer stenotic or occlusive contralateral va; b) collateral supply from the posterior communicating artery (pcoma), thyrocervical trunks, costocervical trunks, and external carotid artery could not fill the ipsilateral territory of cerebellum sufficiently; c) favourable patency of the distal segment of the occlusive lesions and the basilar artery (ba); and d) the distal segment of the occlusive lesions was thick enough (diameter >3mm ) for the deployment of epds.Patients were selected with a good and straight pathway that can stabilize the guiding catheter, which is the key to recovery of the epd in addition to provide a stable platform for performing procedures.The diameter of distal va at the site of the filter basket placement should be >3.0 mm.The patients or their authorized family members provided consent to the endovascular treatment of the occluded vertebral artery, off-label use of the epds.All procedures were performed using the transfemoral or trans-radial approach under local anaesthesia.Intravenous heparin boluses were administered to maintain the activate clotting time between 250 and 300 seconds during the procedure.A 6- or 8- french guiding catheter was positioned in the aortic arch for 1 patient or the subclavian artery for the other patients in proximity to the va origin.A non-medtronic micro-guidewire was assisted by a non-medtronic microcatheter was introduced into the lesion to the distal segment.After withdrawing the micro-guidewire, the location of the microcatheter tip in the free lumen, the length of the occlusion, and the distal lumen of the lesion were confirmed through the microcatheter angiography.Next, a spider fx epd or a non-medtronic filter was navigated through the occlusive segment and placed at the v2 segment of the va.When the epd could not be navigated distally due to a tight stenosis, a micro-balloon was used to predilate the stenosis, allowing the epd delivery catheter to pass through.After epd placement, predilation using a non-medtronic balloon was performed.A non-medtronic balloon-expanded stent, an ev3 or a non-medtronic drug-eluting stent, or a ev3 protégé rx self-expanding stent was subsequently deployed across the lesion with minimal protrusion to the subclavian artery to minimize distal migration of the stent and to properly cover the atherosclerotic lesion in the occluded segment.During the procedure, the stent was selected mainly according the occlusive length, va diameter, and risk of in-stent restenosis depending on the operator's decision.The stent was selected to provide ~= 3mm coverage on the distal side of the lesion and 1-2 mm coverage on proximal side.Post-stenting angioplasty was performed if there was residual stenosis.The postprocedural antegrade flow was graded using the thrombolysis in cerebral ischemia grading system.Technical success was defined as successful deployment of a distal epd and stent at the target lesion followed by successful retrieval of the device and a final residual stenosis of <(><<)>30% with thrombolysis in cerebral ischemia grade >2b.Preoperatively, the patients were required to take dual anti-platelet therapy (100 mg/day aspirin and 75 mg/day clopidogrel) for at least 5 days.All patients were tested for thromboelastography platelet mapping to assess the effectiveness of clopidogrel, and responder to clopidogrel was defined as the inhibition of platelet aggregation induced by adenosine diphosphate >30%.If the patient was responsive to the clopidogrel aspiring and clopidogrel were required to be taken for 6 months after the procedure, then either 1 of the 2 drugs should be continued over their lifetime.Patients were also prescribed statins and educated on controlling other risk factors.All patients were intensively monitored after the intervention including continuous and strict control of blood pressure and neurologic symptoms/signs monitoring.Blood pressure was maintained at 120130/60-80 mm hg to prevent cerebral hyper-fusion syndrome (chs).Patients exhibiting new neurologic symptoms/signs were required to undergo cranial computed tomography (ct) scan to identify a potential intracranial haemorrhage or new infarction.All patients with successfully recanalization were followed up clinically at 1, 3, and 6 months in the outpatient clinic to evaluate the functional outcome and rates or recurrent tia, stroke, and death.The clinical stroke severity and function outcome were measure using the national institutes of health stoke scale (nihss) and modified rankin scale (mrs).The mrs applied in our study is a 7-point scale ranging from 0 (no symptoms) to 6 (death).A favorable clinical outcome was defined as a mrs score of 0-1 at 3 months.They were also scheduled for repeat vascular imaging examination at 6 months.In-stent restenosis (isr) was defined as a diameter of the stenosis >50%.All but 1 patients had occluded arteries originate from the subclavian artery.Endovascular recanalization was successful in all patients.Additional dilation of stenosis after installing the epd was performed in 5 out of 7 patients.Balloon-expandable drug eluting stents (dess) and bare metal stents were used in 1 and 5 patients respectively.One patient had a mild headache for 1 hour after the procedure, and right cerebellar hemorrhage was seen on the postprocedural ct images; it was considered as mild chs resulting from insufficient postprocedural blood pressure control.After dehydration, the headache gradually resolved and his neurologic symptoms improved at 24 hours after the procedure with the nihss score decreased to 2 from the preprocedural score of 5.Preprocedural symptoms of 3 patients resolved after the procedure; therefore an imaging examination was not performed.A vessel imaging examination was performed 6-8 months, where cerebral angiography was performed in 4 patients and 1 was assessed via ct angiography.One (20%) artery was found to have asymptomatic isr of approximately 60%.Patient #4 procedural-related details: time intervals between symptoms to treatment (days): 16; time intervals between occlusion confirmed to treatment (days): 9; no residual stenosis; considered successful; spider fx epd used; no pre-dilation before epds deployment; no embolism in protection; intraprocedural complications: dissection.
 
Manufacturer Narrative
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.
 
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Brand Name
SPIDER FX
Type of Device
CATHETER, CAROTID, TEMPORARY, FOR EMBOLIZATION CAPTURE
Manufacturer (Section D)
COVIDIEN
4600 nathan lane north
plymouth MN 55442
MDR Report Key9805737
MDR Text Key196411211
Report Number2183870-2020-00073
Device Sequence Number1
Product Code NTE
Combination Product (y/n)N
PMA/PMN Number
K063204
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,literature
Type of Report Initial,Followup
Report Date 05/14/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/09/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Was Device Available for Evaluation? No
Date Manufacturer Received05/12/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age67 YR
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