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

Catalog Number 82096-01

Device Problems Positioning Failure (1158); Device Contamination with Chemical or Other Material (2944)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/30/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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 a xact stent delivery system (sds) advanced to the left internal carotid artery lesion without issue.During stent deployment attempt, the stent failed to deploy.There was no stent deployment at all.The device was removed without issue and another xact was successfully used.There were no adverse patient effects and there was no clinically significant delay.There was no additional information provided.The device returned with an unidentified stationary clear drop on the delivery system.

Manufacturer Narrative

(b)(4).Evaluation summary: the device was returned for analysis and the deployment issue was confirmed.A glue drop was found at the guide wire exit notch and was noted to be part of the normal manufacturing process.It would not have contributed to the reported deployment difficulty.Based on visual and functional analysis of the returned device, there is no indication of a product quality issue with respect to manufacture, design or labeling.A definitive cause for the deployment difficulty cannot be determined.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 incidents from this lot.Based on the reviewed information, there is no indication the issue was caused by or related 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
• Manufacturer (Section G): ABBOTT VASCULAR, TEMECULA, CA USA REG# 2024168; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• Manufacturer Contact: connie speck ; abbott vascular; 26531 ynez road; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 5268182
• MDR Text Key: 32870475
• Report Number: 2024168-2015-07288
• Device Sequence Number: 1
• Product Code: NIM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P040038
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 01/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2018
• Device Catalogue Number: 82096-01
• Device Lot Number: 5080561
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 11/09/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/07/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2015
• 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
• Patient Age: 75 YR