MAUDE Adverse Event Report: ABBOTT VASCULAR XACT CAROTID; SELF EXPANDING PERIPHERAL STENT SYSTEM

Model Number 82098-01

Device Problems Component Missing (2306); Activation Failure (3270)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/21/2019

Event Type  malfunction  

Manufacturer Narrative

Exemption number e2019001.The device was received.The 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 performed to treat a 95% stenosed lesion in the right common carotid artery.A 10x30mm xact self-expanding stent system (sess) was prepared per the instructions for use.Following pre-dilatation, the sess was advanced and the deployment actuator was advanced without issues to deploy the stent; however, no stent came out.The sess was removed without issues and an attempt to deploy the stent outside the patient anatomy was made, but again no stent came out.It was reported that it seemed as though the stent was missing.The procedure was successfully completed with a 10x8mm unspecified tapered stent.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.The return device analysis identified that the stent implant was partially exposed from the distal sheath and not expanded.

Manufacturer Narrative

Visual and functional analysis was performed on the returned device.The distal end of the stent implant was located approximately 0.7mm from the distal end of the sheath; therefore, the reported missing stent was not confirmed.However, the deployment mechanism did not function properly.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 deployment failure appears to be related to a potential product quality issue.The issue is being addressed per internal operating procedures.Abbott vascular will continue to trend the performance of these devices.

• Brand Name: XACT CAROTID
• Type of Device: SELF EXPANDING PERIPHERAL STENT SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 9446193
• MDR Text Key: 177939690
• Report Number: 2024168-2019-14349
• Device Sequence Number: 1
• Product Code: NIM
• UDI-Device Identifier: 08717648010347
• UDI-Public: 08717648010347
• Combination Product (y/n): N
• PMA/PMN Number: P040038
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 02/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2019
• 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 Model Number: 82098-01
• Device Catalogue Number: 82098-01
• Device Lot Number: 8072461
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/24/2019
• Date Manufacturer Received: 01/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SHEATH: 6FRX80CM COOK
• Patient Age: 66 YR
• Patient Weight: 86