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

Model Number	1011343-40
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/17/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned for analysis.Production record and corrective and preventative 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, the investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely that interaction with the 94% stenosed anatomy resulted in preventing the shaft lumens from moving freely; thus resulting in the reported activation failure.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 was to treat a de novo lesion in the internal carotid artery with mild calcification, mild tortuosity and 94% stenosis.The acculink self expanding stent system (sess) was advanced to the lesion but the stent could not be deployed.There was no problem with the deployment mechanism.Another same size device was used to complete the procedure.There were no adverse patient effects.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: 25718475
• Report Number: 2024168-2026-02610
• Device Sequence Number: 21482365
• Product Code: NIM
• UDI-Device Identifier: 08717648076374
• UDI-Public: (01)08717648076374(17)271231(10)6011261
• 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: Other,Foreign,Company Representative,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/13/2026

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: 6011261
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/17/2026
• Supplement Date Received by Manufacturer: 07/06/2026
• Initial Report FDA Received Date: 07/06/2026
• Supplement Report FDA Received Date: 07/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/12/2026
• 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