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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT VASCULAR GUIDANT RX VIATRAC 18 PERIPHERAL DILATATION CATHETER PEREIPHERAL DILATATION CATHETER

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ABBOTT VASCULAR GUIDANT RX VIATRAC 18 PERIPHERAL DILATATION CATHETER PEREIPHERAL DILATATION CATHETER Back to Search Results
Catalog Number UNK RX VIATRAC
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Stroke/CVA (1770); Transient Ischemic Attack (2109); Stenosis (2263); Obstruction/Occlusion (2422)
Event Date 06/01/2015
Event Type  Injury  
Manufacturer Narrative
Estimated date of event. The device was discarded. The device will not be returned for evaluation. Investigation is not yet complete. A follow-up report will be submitted with all additional relevant information. The accunet and acculink referenced are being filed under separate medwatch report numbers. Literature attachment: "impact of cerebral blood perfusion and cognitive function of carotid artery stenting combined with medical therapy for patients with severe internal carotid stenosis. ".
 
Event Description
It was reported through a research article identifying that the accunet embolic system, acculink stent and viatrac balloon may be related to the following: occlusion, restenosis, cerebral ischemic stroke, transient ischemic attack, medication, and rehospitalization. This article summarizes clinical outcomes of 62 patients that were treated with an accunet filter, acculink stent and viatrac balloon. Details are listed in the attached article, titled "impact of cerebral blood perfusion and cognitive function of carotid artery stenting combined with medical therapy for patients with severe internal carotid stenosis. ".
 
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Brand NameGUIDANT RX VIATRAC 18 PERIPHERAL DILATATION CATHETER
Type of DevicePEREIPHERAL DILATATION CATHETER
Manufacturer (Section D)
ABBOTT VASCULAR
26531 ynez rd.
temecula CA 92591 4628
Manufacturer (Section G)
ABBOTT VASCULAR, REG # 2024168
26531 ynez road
temecula CA 92591 4628
Manufacturer Contact
lindsey bell
26531 ynez rd.
temecula, CA 92591-4628
9519143996
MDR Report Key12387967
MDR Text Key268811998
Report Number2024168-2021-07637
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K072798
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type literature
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/13/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/30/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNK RX VIATRAC
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/31/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 08/30/2021 Patient Sequence Number: 1
Treatment
ACCULINK STENT; ACCUNET EMBOLIC SYSTEM
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