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

Model Number	1011339-40
Medical Device Problem Codes	Material Separation (1562); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/14/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was received.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that the procedure was to treat an unknown carotid artery.The 7x40mm acculink self-expanding stent system was attempted to be advanced through the unspecified guide catheter; however, the tip separated as it met resistance with the unspecified guide catheter.It is noted that the acculink never made into the patient, but the guide catheter was already in the patient.A new same size device was used to successfully complete the procedure.There was no adverse patient effects and no clinically significant delay.No additional information was provided.
Additional Manufacturer Narrative
The device was returned for analysis.The reported material separation-tip was able to be confirmed.The reported difficult to advance was unable to be replicated in a testing environment due to the condition of the returned device.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 during advancement interaction with the guiding catheter resulted in the reported difficult to advance.Manipulation of the device resulted in the observed wrinkled sheath.The noted exposed stent ultimately resulted in the reported material separation-tip.The noted multiple bends throughout the shaft likely occurred due to handling or during packing for return analysis.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: 16105969
• Report Number: 2024168-2023-00188
• Device Sequence Number: 15367170
• Product Code: NIM
• UDI-Device Identifier: 08717648076268
• UDI-Public: 08717648076268
• Combination Product (Y/N): N
• Initial Reporter State: NE
• 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): 02/10/2023

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: 01/31/2024
• Device Model Number: 1011339-40
• Device Catalogue Number: 1011339-40
• Device Lot Number: 2021062
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/29/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/15/2022
• Supplement Date Received by Manufacturer: 01/25/2023
• Initial Report FDA Received Date: 01/05/2023
• Supplement Report FDA Received Date: 02/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/10/2022
• 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