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

Model Number	1011344-30
Medical Device Problem Codes	Difficult or Delayed Activation (2577); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/31/2022
Type of Reportable Event	Malfunction
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.The investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely that interaction with the calcified anatomy and/or other devices prevented the shaft lumens from moving freely; thus, resulting in resistance when pulling back the handle and the difficulty deploying the stent.There is no indication of a product quality issue with respect to manufacture, design or labeling.
Event or Problem Description
It was reported that the procedure was to treat the right common carotid artery with mild calcification.A 7.0-10 x 30mm acculink self expanding stent system (sess) was advanced to the target lesion.However, after unlocking the sess, resistance was noted when pulling back the handle during deployment of the stent.The stent was successfully deployed without further issue.There was no adverse patient effect and no clinically significant delay in the procedure.No additional information was provided.

• 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: 14190740
• Report Number: 2024168-2022-04397
• Device Sequence Number: 4481995
• Product Code: NIM
• UDI-Device Identifier: 08717648076381
• UDI-Public: 08717648076381
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P040012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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): 04/22/2022

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: 04/30/2023
• Device Model Number: 1011344-30
• Device Catalogue Number: 1011344-30
• Device Lot Number: 1052561
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/31/2022
• Initial Report FDA Received Date: 04/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/25/2021
• 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: Male