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

Catalog Number 1010131-40

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

Patient Problems Stroke/CVA (1770); Thrombosis/Thrombus (4440)

Event Date 01/07/2022

Event Type  Injury  

Event Description

It was reported that the procedure was to treat a left carotid artery.Pre-dilatation was performed with a 7x20mm viatrac balloon.A non-abbott guide wire was advanced to the lesion, although difficulty was noted.Then an emboshield nav6 was placed.A 7-10/40mm acculink stent was placed in the left internal carotid.Then a 10x40mm acculink stent was placed (overlapping) at the junction of the previous acculink stent.Several hours post stent implantation, the patient suffered a stroke but no treatment was performed.There was also suspicion of ischemia due to a blood clot that has migrated into the brain (physician noted blood clots in the syringe while rinsing the non-abbott sheath).The procedure was prolonged.The patient is doing fine.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 effects of cerebrovascular accident and thrombosis are listed in the rx acculink carotid stent system instructions for use as possible adverse events associated with 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 additional acculink device referenced is filed under a separate medwatch report number.

• 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: 13258846
• MDR Text Key: 283953152
• Report Number: 2024168-2022-00516
• 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: 01/14/2022

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 Expiration Date: 02/28/2023
• Device Catalogue Number: 1010131-40
• Device Lot Number: 1033161
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/07/2022
• Initial Date FDA Received: 01/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/31/2021
• 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: 4-7 MM EMBOSHIELD; RX.014 ACCULINK 7-10/40 CE; TERUMO GUIDE WIRE; TERUMO INTRODUCER 90CM
• Patient Outcome(s): Disability