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

Model Number	1011344-40
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/04/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the procedure was performed to treat a lesion in the moderately to heavily tortuous and heavily calcified lesion in the left carotid artery.The emboshield nav6 embolic protection system (ebs) was advanced; however, resistance with the anatomy was felt.The ebs lost canulation with the catheter and the vessel had to be re-canulated.Next a 4.0x30mm viatrac plus ballon catheter was advanced and the lesion was dilated without issues.A 10tx40x136mm xact self expanding stent system (ses) was being advanced, but resistance with the anatomy was felt therefore it was removed.A 7x10x40mm acculink ses was advanced without issues; however, during deployment the stent jumped and the stent deployed but missed about 20% of the lesion.The previously used 10tx40x136mm xact ses was advanced and deployed at the rest of the 20% of the lesion overlapping with the acculink stent.An angiogram was performed and flow was noted.Went in to retrieve the nav6 filter and it was removed without incident.Repeated angiogram and it was discovered there was no flow and the patient had a spasm which led to a stroke.Medicine and nuro intervention was performed to try and pull out the clot that had formed.The lesion regained some flow.The right carotid artery was canulated and angio taken again and it was noted that there was a clot around the area where the nav6 filter had been during the procedure.The physician does not believe anything came off the filter.Patient woke up from anesthesia and was unable to move their right side.The patient was taken back to the lab later that evening and a clot was confirmed and removed.The patient suffered a stroke.Per the physician, the abbott devices used did not cause or contribute to the reported patient effects.No additional information was provided.
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 to use, the investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely that as the stent was being deployed interaction with the moderately to heavily tortuous and heavily calcified anatomy resulted in preventing the shaft lumens from moving freely resulting in the stent to jump in a spring like release; thus resulting in the reported malposition of device (stent jumped and the stent deployed but missed about 20% of the lesion).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.

• 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: 23817449
• Report Number: 2024168-2025-12077
• Device Sequence Number: 10067084
• Product Code: NIM
• UDI-Device Identifier: 08717648076398
• UDI-Public: (01)08717648076398(17)270831(10)5091161
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: P040012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/16/2025

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 Model Number: 1011344-40
• Device Catalogue Number: 1011344-40
• Device Lot Number: 5091161
• 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: 12/04/2025
• Initial Report FDA Received Date: 12/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/11/2025
• 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