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

Model Number	1011342-20
Medical Device Problem Codes	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
Event or Problem Description
For reporting purposes, the date of event/procedure is estimated as (b)(6) 2025 as it is the first date of the month of the av alert date.It was reported that the procedure was to treat an unspecified lesion.Pre-dilatation was performed with a 4.0 mm balloon.The acculink self expanding stent system (sess) was advanced to the lesion and deployment was attempted.The lever was stiff but it was thought that the stent was deployed.When the delivery system was removed, the stent was unable to be found on the delivery system or in the patient.The device was cut open and the stent was found inside the system.Another same size acculink sess was used to complete the procedure.There were no adverse patient effects.There was a small delay in the procedure but no harm to the patient.No additional information was provided.
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.B3: estimated date.
Additional Manufacturer Narrative
The device was not returned for analysis.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, it is possible that interaction with the anatomy prevented the shaft lumens from moving freely; thus, resulting in the reported mechanical jam and the reported activation/deployment failure; however, this cannot be confirmed.The investigation was unable to determine a conclusive cause for the reported difficulties.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
For reporting purposes, the date of event/procedure is estimated as (b)(6) 2025, as it is the first date of the month of the av alert date.It was reported that the procedure was to treat an unspecified lesion.Pre-dilatation was performed with a 4.0 mm balloon.The acculink self expanding stent system (sess) was advanced to the lesion and deployment was attempted.The lever was stiff but it was thought that the stent was deployed.When the delivery system was removed, the stent was unable to be found on the delivery system or in the patient.The device was cut open and the stent was found inside the system.Another same size acculink sess was used to complete the procedure.There were no adverse patient effects.There was a small delay in the procedure but no harm to the patient.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: 23851432
• Report Number: 2024168-2025-12173
• Device Sequence Number: 18534712
• Product Code: NIM
• UDI-Device Identifier: 08717648076336
• UDI-Public: (01)08717648076336(17)260131(10)4022961
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/09/2026

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 Expiration Date: 01/31/2026
• Device Model Number: 1011342-20
• Device Catalogue Number: 1011342-20
• Device Lot Number: 4022961
• 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: 12/05/2025
• Supplement Date Received by Manufacturer: 01/16/2026
• Initial Report FDA Received Date: 12/19/2025
• Supplement Report FDA Received Date: 02/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/29/2024
• 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