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

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. ".

• Brand Name: GUIDANT RX VIATRAC 18 PERIPHERAL DILATATION CATHETER
• Type of Device: PEREIPHERAL 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 Key: 12387967
• MDR Text Key: 268811998
• Report Number: 2024168-2021-07637
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K072798
• Number of Events Reported: 1
• 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 Received: 08/30/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Catalogue Number: UNK 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 Received: 08/31/2021
• 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