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

Model Number	1011344-40
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/05/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the procedure was to treat a 70% stenosed de novo lesion in the internal carotid artery with mild calcification and mild tortuosity.The 7-10x40mm acculink self expanding stent system (sess) was advanced on a barewire to the target lesion and an attempt was made to release the stent; however, the stent was not able to be released and completely failed to deploy.Therefore, the sess was removed from the patient and another acculink sess was used to continue the procedure.There was no adverse patient effect and no clinically significant delay reported in the procedure.Return device analysis found the distal end of the 7-10x40mm acculink self expanding stent was extending distally from distal end of stent sheath for a length of 0.5mm (millimeters).No additional information was provided.
Additional Manufacturer Narrative
Visual inspection and functional testing were performed on the returned device.The reported activation failure was confirmed.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 history identified no other similar complaints from this lot.Based on the reported information and the observations from the returned analysis, the investigation determined that the reported complaint appears to be related to operational context.There was no damage noted to the device during the inspection prior to use which suggests a product quality issue did not contribute to the reported difficulty.Return device analysis noted the stent sheath was bunched distally from proximal end of sheath and there were multiple bends noted across the length of the shaft.The stent implant was not deployed and remained in the sheath.The distal end of the stent was extending distally from distal end of stent sheath.The stent was not flowered.In this case, it is likely that distal sheath was restricted within the 70% stenosed lesion preventing movement of the distal sheath.Additional attempts to retract the slider likely contributed to the noted bunching resulting in deployment failure.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

• 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: 21971867
• Report Number: 2024168-2025-04731
• Device Sequence Number: 12797417
• Product Code: NIM
• UDI-Device Identifier: 08717648076398
• UDI-Public: (01)08717648076398(17)260131(10)4021661
• 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): 05/06/2025

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: 1011344-40
• Device Catalogue Number: 1011344-40
• Device Lot Number: 4021661
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/04/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/14/2025
• Initial Report FDA Received Date: 05/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/16/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: BAREWIRE
• Patient Sex: Unknown