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

Model Number 1011344-40

Device Problems Difficult to Remove (1528); Difficult to Advance (2920); Mechanical Jam (2983); Activation Failure (3270)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/28/2023

Event Type  malfunction  

Manufacturer Narrative

Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.

Event Description

It was reported that the procedure was performed to treat a lesion in the internal carotid artery with moderate tortuosity.An emboshield nav6 filter was deployed.The 7-10 acculink carotid stent system was advanced and resistance was noted with the anatomy.During an attempt to deploy the stent, resistance was felt on the thumbslide.After several attempts the stent completely failed to deployed.During removal, resistance was noted with the anatomy.Another acculink was used to complete the procedure.There were no adverse patient effects and there was no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

The device was returned for analysis.The reported activation failure and the reported mechanical jam were able to be confirmed.The reported difficult to advance and the reported difficult to remove were unable to be replicated in a testing environment as they were based on operational circumstances.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 did not indicate a lot specific quality issue.The investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely that resistance was met with the moderate tortuosity anatomy resulting in the reported difficult to advance and the reported difficult to remove.Interaction with the moderate tortuosity anatomy/manipulation of the device and/or inadvertent mishandling likely resulted in the noted device damages (multiple bends in the entire length of the shaft) thus resulting in the reported/noted mechanical jam and ultimately resulting in the reported activation/deployment failure.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: 17364160
• MDR Text Key: 320020367
• Report Number: 2024168-2023-07786
• Device Sequence Number: 1
• Product Code: NIM
• UDI-Device Identifier: 08717648076398
• UDI-Public: 08717648076398
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1011344-40
• Device Catalogue Number: 1011344-40
• Device Lot Number: 2112261
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/08/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/22/2022
• 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: 014. BAREWIRE
• Patient Age: 81 YR
• Patient Sex: Female
• Patient Weight: 51 KG