MAUDE Adverse Event Report: ABBOTT VASCULAR INC. ACCULINK¿; STENT, CAROTID

Model Number	1011343-40
Medical Device Problem Codes	Break (1069); Mechanical Jam (2983); Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned for analysis.The reported activation failure and mechanical jam was unable to be replicated in a testing environment due to returned device condition.Production record and corrective and preventive actions (capa) reviews were performed and revealed no indication of a product quality issue.Additionally, a review of the complaint handling database identified no other incidents from this lot.As there was no damage noted to the device during the inspection prior to use, it is possible that interaction with the anatomy resulted in compromising the device thus preventing the shaft lumens from moving freely; resulting in the reported mechanical jam and activation failure; however this cannot be confirmed.Inadvertent mishandling of the compromised device during attempts to deploy the stent resulted in the noted device damages (shaft separation, bunched shaft, and bent shaft) contributing to the reported difficulties.The investigation determined a conclusive cause for the reported difficulties cannot be determined.Based on the reported information and results of the complaint investigation there is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
Event or Problem Description
It was reported that the procedure performed was to treat an internal carotid artery.Once at the lesion, the handle slide of the 6-8x40mm acculink carotid self-expanding stent system over a 0.14 guidewire was pulled; however, the stent completely failed to deploy.An xact carotid stent was used to complete the procedure.There were no adverse patient effects and no clinically significant delay in the procedure.Subsequently, returned device analysis observed the shaft was separated at the distal end of the handle slider.The shaft at the separation was bunched and the hypotube was still intact holding both pieces together.No additional information was provided.

• Brand Name: ACCULINK¿
• Common Device Name: STENT, CAROTID
• Manufacturer (Section D): ABBOTT VASCULAR INC.; 3200 lakeside drive; santa clara CA 95054 2807
• 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: 24404130
• Report Number: 2024168-2026-00721
• Device Sequence Number: 8269892
• Product Code: NIM
• UDI-Device Identifier: 08717648076374
• UDI-Public: (01)08717648076374(17)270531(10)5062561
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P040012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/20/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 1011343-40
• Device Catalogue Number: 1011343-40
• Device Lot Number: 5062561
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/10/2026
• Initial Report FDA Received Date: 02/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/25/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown