MAUDE Adverse Event Report: ABBOTT VASCULAR ACCULINK CAROTID STENT SYSTEM

Catalog Number 1010132-40

Device Problem Material Separation (1562)

Patient Problem No Patient Involvement (2645)

Event Date 10/13/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that while flushing the 6-8x40mm acculink self-expanding stent system, the white tip separated from the distal end of the shaft.There was no patient involvement.A new acculink was used to successfully complete the procedure.There were no adverse patient effects, and no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

Visual analysis was performed on the returned device.The reported tip separation was confirmed.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 complaints reported from this lot.The investigation determined that the reported tip separation was related to circumstances of the procedure.It is likely that during removal of the stylet, the tip was inadvertently grasped causing the tip to separate.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.Na.

• Brand Name: ACCULINK CAROTID STENT SYSTEM
• Type of Device: CAROTID STENT
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 10759555
• MDR Text Key: 213870313
• Report Number: 2024168-2020-09052
• Device Sequence Number: 1
• Product Code: NIM
• Combination Product (y/n): N
• PMA/PMN Number: P040012
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 11/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2021
• Device Catalogue Number: 1010132-40
• Device Lot Number: 9072961
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2020
• Date Manufacturer Received: 11/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1