MAUDE Adverse Event Report: ABBOTT VASCULAR RX ACCULINK CAROTID STENT SYSTEM

Catalog Number UNKNOWN RX ACCULINK

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

Patient Problems Stroke/CVA (1770); Embolism (1829); Myocardial Infarction (1969); Neurological Deficit/Dysfunction (1982); Thrombosis (2100); Transient Ischemic Attack (2109); Prolapse (2475)

Event Date 01/01/2019

Event Type  Injury  

Manufacturer Narrative

Date of event: date is estimated.The device was not returned for analysis.The lot history record (lhr) for this product could not be reviewed because the product was not returned for evaluation and the part and lot numbers were not reported.In this case, there was no reported device malfunction associated with the rx acculink.The reported patient effects of myocardial infarction (mi), embolism, neurological deficit / dysfunction, cerebrovascular accident, transient ischemic attack, and thrombosis are listed in the rx acculink instructions for use as known potential patient effects associated with the use of a stent in carotid arteries.Based on the case information, a conclusive cause for the reported patient effect(s), and the relationship to the product, if any, cannot be determined.There is no indication of a product quality issue with respect to manufacture, design or labeling.Literature attached: "stenting of the carotid artery with cguard and acculink stents: interim results of a randomized trial.".

Event Description

It was reported through a research article an acculink stent may be related to acute impairment of cerebral circulation, myocardial infarction (mi), neurological deficit, ischemic foci, embolization, cerebral ischemia, and cerebral ischemic stroke.There was no device malfunction reported.Specific patient information is documented as unknown.Details provided in the attached article titled: "stenting of the carotid artery with cguard and acculink stents: interim results of a randomized trial.".

• Brand Name: RX ACCULINK CAROTID STENT SYSTEM
• Type of Device: CAROTID STENT
• 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: 11111539
• MDR Text Key: 225102024
• Report Number: 2024168-2021-00030
• Device Sequence Number: 1
• Product Code: NIM
• Combination Product (y/n): N
• Reporter Country Code: RS
• PMA/PMN Number: P040012
• 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: 01/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN RX ACCULINK
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/15/2020
• 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
• Patient Outcome(s): Disability
• Patient Age: 68 YR