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

Catalog Number 1010132-40

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

Patient Problems Transient Ischemic Attack (2109); Obstruction/Occlusion (2422)

Event Date 06/27/2023

Event Type  Injury  

Event Description

It was reported that the procedure was to treat a lesion in the left internal carotid artery (atheromatous stenosis).An emboshield nav 6 was put in place above the lesion and position was verified by angiogram.The 6.0-8.0x40mm acculink stent was deployed and implanted successfully with a normal opening and a little portion in the common carotid artery.Post dilatation was performed with a viatrac balloon and under imaging blood flow was good.The emboshield filter was captured without issues.However, the physician observed that the internal carotid artery had no flow at all.A fibrinolytic medication was administered (actilyse) as the physician suspected a spasm of the internal carotid explaining the no flow.The physician believes the spasm was due to the filter.The spasm spontaneously resolved with routine medication.Immediately after the procedure, the patient woke up confused and it was then decided to do a new procedure the next day.On (b)(6), the patient had an intervention to remove the acculink stent to remove the atheroma that was retained in the stent struts and found to be obstructed.It was confirmed that the lesion was well covered by the stent.The procedure was performed under angiography.There was no thrombosis found per the physician.A carotid endarterectomy was performed and the artery wall was closed with a polyurethane patch.No additional information was provided.

Manufacturer Narrative

The device was not returned for evaluation.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.The reported patient effect of occlusion is listed in the rx acculink carotid stent system instructions for use as a known patient effect associated with the use of a stent in carotid arteries.A conclusive cause for the reported patient effect, 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.

• 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: 17346661
• MDR Text Key: 319372719
• Report Number: 2024168-2023-07675
• Device Sequence Number: 1
• Product Code: NIM
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P040012
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/18/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 1010132-40
• Device Lot Number: 2101061
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/10/2022
• 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: VIATRAC BALLOON
• Patient Outcome(s): Required Intervention; Hospitalization