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

Model Number 1011339-40

Device Problems Material Separation (1562); Difficult to Advance (2920)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/14/2022

Event Type  malfunction  

Manufacturer Narrative

The device was received.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event 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.

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
• Type of Device: 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
• MDR Text Key: 306884403
• Report Number: 2024168-2023-00188
• Device Sequence Number: 1
• Product Code: NIM
• UDI-Device Identifier: 08717648076268
• UDI-Public: 08717648076268
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P040012
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 01/25/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/10/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1