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); Myocardial Infarction (1969); Transient Ischemic Attack (2109); Stenosis (2263); Obstruction/Occlusion (2422); Unspecified Tissue Injury (4559)

Event Date 01/01/2014

Event Type  Injury  

Event Description

It was reported through the post market clinical follow-up (pmcf) report, that the acculink stent may be related to the adverse patient effects of death, myocardial infarction, access site complications, surgical intervention, transient ischemic attack, stroke, occlusion, re-stenosis, revascularization and re-hospitalization.Details are listed in the attached pmcf, titled post market clinical follow-up evaluation report abbott carotid stent and embolic protection systems.Please see the attached pmcf evaluation report for specific information.

Manufacturer Narrative

Age - average.Date of event ¿ estimated.The unique device identifier (udi) is unknown because the part number and lot number were not provided.Date of implant ¿ estimated.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 was not provided.The reported patient effects of myocardial infarction, transient ischemic attack, cerebrovascular accident, occlusion, stenosis are listed in the rx acculink carotid stent system instructions for use (ifu) as possible adverse events associated with use of these devices.A conclusive cause for the reported myocardial infarction, tissue damage, transient ischemic attack, cerebrovascular accident, occlusion, stenosis, and the relationship to the product, if any, cannot be determined.The treatments appear 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.The patient deaths and the other adverse events reported in the pmcf are filed under separate medwatch report numbers.Attachment: title ¿post market clinical follow-up evaluation report abbott carotid stent and embolic protection systems¿na.

• 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: 15643480
• MDR Text Key: 302160259
• Report Number: 2024168-2022-10885
• Device Sequence Number: 1
• Product Code: NIM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P040012
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2022
• 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
• Date Manufacturer Received: 09/29/2022
• 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): Hospitalization; Disability; Required Intervention