MAUDE Adverse Event Report: AV-TEMECULA-CT XACT CAROTID STENT SYSTEM

Catalog Number 82097-01

Device Problems Premature Activation (1484); Failure to Advance (2524)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/15/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The device was received.The investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.The additional xact carotid device referenced is being filed under a separate medwatch report.

Event Description

It was reported that the procedure was performed to treat a 90% stenosed, heavily tortuous, and calcified artery in the distal right carotid artery.During advancement of a 10tx40x136mm xact carotid self-expanding stent system (sess), resistance was met with the anatomy.The sess jumped due to the tortuosity and the stent slightly deployed/flowered.The physician did not feel comfortable deploying the stent, so the device was removed without any issue.An attempt was made to advance a 10tx30x136mm xact sess, but the same issues occurred, so the device was removed.The procedure was successfully completed with the deployment of a 9x7x30mm xact stent.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

Internal file number (b)(4).Evaluation summary: visual, dimensional and functional inspection was performed on the returned device.The failure to advance was unable to be confirmed as it was based on case circumstances.The premature deployment 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 of the reported lot revealed no other incidents.The investigation determined the reported difficulties were due to case circumstances.The resistance during advancement was due to the anatomy, which was described as 90% stenosed, heavily tortuous, and calcified.The premature/partial deployment of the stent likely occurred when the distal sheath met resistance with the anatomy.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

• Brand Name: XACT CAROTID STENT SYSTEM
• Type of Device: CAROTID STENT SYSTEM
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• MDR Report Key: 8318553
• MDR Text Key: 135538255
• Report Number: 2024168-2019-00964
• Device Sequence Number: 1
• Product Code: NIM
• 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
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 02/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2021
• Device Catalogue Number: 82097-01
• Device Lot Number: 8050961
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/25/2019
• Date Manufacturer Received: 02/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 78 YR