MAUDE Adverse Event Report: ABBOTT VASCULAR RX ACCULINK CAROTID STENT SYSTEM

Catalog Number	1011340-40
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/28/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the procedure was to treat a right internal carotid lesion.During deployment of an 8x40mm acculink stent, the stent jumped forward and did not cover the entire target lesion.An 8x30mm acculink stent was deployed to successfully complete the procedure.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
The device was not returned for analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no other similar incidents from this lot.It is possible that as the stent was being deployed interaction with the 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 forward and did not cover the entire lesion) however, this could not be confirmed.The investigation determined a conclusive cause for the reported difficulties cannot be determined.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• Brand Name: RX ACCULINK CAROTID STENT SYSTEM
• Common Device Name: CAROTID STENT
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• 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: 18727602
• Report Number: 2024168-2024-01928
• Device Sequence Number: 6235274
• Product Code: NIM
• UDI-Device Identifier: 08717648076299
• UDI-Public: 08717648076299
• 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
• Device Implanted Year: 2024
• 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): 02/16/2024

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: 08/31/2024
• Device Catalogue Number: 1011340-40
• Device Lot Number: 2092761
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/29/2024
• Initial Report FDA Received Date: 02/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/27/2022
• 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