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 04/30/2023

Event Type  Injury  

Manufacturer Narrative

B3: date estimated.D4: the udi is unknown as the part/lot number was not provided.D6a: date of implant is 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 stenosis, transient ischemic attacks, cerebrovascular accident, myocardial infarction, occlusion are listed in the rx acculink carotid stent system information for prescribers as adverse events potentially associated with use of carotid stents and embolic protection systems.A conclusive cause for the reported stenosis, transient ischemic attack, cerebrovascular accident, myocardial infarction, occlusion and tissue injury, and the relationship to the product, if any, cannot be determined.The treatments 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.The additional patient of death reported in the article is captured under a separate medwatch report.

Event Description

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

• 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: 17451145
• MDR Text Key: 320307103
• Report Number: 2024168-2023-08398
• 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: 08/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2023
• 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: 07/14/2023
• 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; Other; Disability; Required Intervention
• Patient Age: 70 YR
• Patient Sex: Male
• Patient Race: White