MAUDE Adverse Event Report: ABBOTT VASCULAR ACCUNET EMBOLIC PROTECTION SYSTEM

Catalog Number UNK RX ACCUNET

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 unique device identifier (udi) is unknown because the part and lot number were not provided.The device was not returned for evaluation.A review of the lot history record of the reported lot could not be conducted because the part and lot number were not provided.The reported patient effects of stenosis, cerebrovascular accident and occlusion are listed in the rx accunet embolic protection system instructions for use as known patient effects associated with the use of this device.A conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined.However, the treatment appears to be related to the operational context of the procedure.There is no indication of a product quality issue with respect to manufacture, design or labeling of the device.The acculink and viatrac devices referenced are being filed under separate medwatch mfr numbers.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."na.

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: ACCUNET EMBOLIC PROTECTION SYSTEM
• Type of Device: EMBOLIC PROTECTION SYSTEM
• 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: 12350158
• MDR Text Key: 267558632
• Report Number: 2024168-2021-07358
• Device Sequence Number: 1
• Product Code: NTE
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K081549
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK RX ACCUNET
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/11/2021
• Initial Date FDA Received: 08/20/2021
• 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 Sequence Number: 1
• Treatment: ACCULINK STENT; VIATRAC BALLOON
• Patient Outcome(s): Hospitalization; Required Intervention; Disability
• Patient Age: 65 YR