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

Model Number 1011344-40

Device Problem Migration (4003)

Patient Problem Foreign Body In Patient (2687)

Event Date 06/07/2022

Event Type  Injury  

Manufacturer Narrative

The device was not returned for analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no other incidents from this lot.A cine was received and reviewed by an abbott vascular clinical specialist who provided the following summary: this incident concerns an rx acculink carotid stent (7-10x40mm) implanted (b)(6) 2021.The provided media (photos) shows the acculink stent successfully implanted with the distal half of the stent clearly covering the lesion while the proximal half of the stent is in healthy tissue.From the provided photos it cannot be determined how well opposed the proximal half of the stent is within the artery, contrast injection would be needed.On 07 june 2022 it was discovered that the acculink stent in question had migrated proximally to the point where most of the stent is no longer within the lesion.The provided photos confirm this proximal migration and that only a couple millimeters of the distal stent are located at the site of the lesion, providing no clinical benefit.It is difficult to determine a probable cause of the stent migration without more clinical information, specifically contrast injections displaying the anatomy of the entire artery.It is possible that anatomical conditions and/or repetitive movement over time contributed to the reported stent migration; however this cannot be confirmed.The investigation determined a conclusive cause for the reported migration cannot be determined.The treatment appears to be related to the operational context of the procedure as reportedly a non-abbott stent was used to overlap and treat the lesion.There is no indication of a product quality issue with respect to manufacture, design or labeling.

Event Description

It was reported that the procedure was to treat the carotid artery with mild tortuosity and moderate calcification and 70% stenosis.On (b)(6) 2021 the 7-10x40 mm acculink carotid stent system (css) was implanted without issue.On 06/07/2022 it was discovered that the stent had migrated for an unknown reason.The stent is completely out of the target lesion.A non-abbott stent was used to overlap and treat the lesion.

• 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: 14877420
• MDR Text Key: 295069206
• Report Number: 2024168-2022-07082
• Device Sequence Number: 1
• Product Code: NIM
• UDI-Device Identifier: 08717648076398
• UDI-Public: 08717648076398
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: P040012
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2023
• Device Model Number: 1011344-40
• Device Catalogue Number: 1011344-40
• Device Lot Number: 1032461
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/24/2021
• 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
• Patient Outcome(s): Hospitalization; Required Intervention