MAUDE Adverse Event Report: ABBOTT VASCULAR ACCULINK; CAROTID STENT

Catalog Number 1011343-40

Device Problem Material Separation (1562)

Patient Problem No Patient Involvement (2645)

Event Date 09/09/2019

Event Type  malfunction  

Manufacturer Narrative

The device was not returned for evaluation.A review of the lot history record identified no manufacturing nonconformities that would have contributed to this event.Additionally, a review of the complaint history identified no other similar incidents and/or complaints from this lot.The investigation was unable to determine a conclusive cause for the reported material separation.Both, the delivery system tip and the supported mandrel tip are white, and they are next to each other at the distal end of the device.There is no indication of a product quality issue with respect to manufacture, design or labeling.Exemption number e2019001-permits numbering sequence to begin with 10000, to avoid duplication of report numbers due to process transition.There may be gaps in numbering for reports submitted during the transition period.

Event Description

It was reported that during unpacking of a rx.014 acculink 6-8/40, after taking out the stent from the dispenser hoop coil, as the stylet was being removed, the white cone [catheter tip] on top of the stent came off with the stylet.The device was not used and there was no patient involvement.A new device was replaced to successfully complete the procedure.There was no clinically significant delay or adverse patient effects.No additional information was provided.

• Brand Name: ACCULINK
• 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: 9130515
• MDR Text Key: 160497973
• Report Number: 2024168-2019-12162
• Device Sequence Number: 1
• Product Code: NIM
• UDI-Device Identifier: 08717648076374
• UDI-Public: 08717648076374
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/27/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2020
• Device Catalogue Number: 1011343-40
• Device Lot Number: 9011761
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/09/2019
• Initial Date FDA Received: 09/27/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/17/2019
• 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