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

Catalog Number 82091-01

Device Problem Difficult to Remove (1528)

Patient Problem Intimal Dissection (1333)

Event Date 08/01/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).The product was not returned for analysis.The lot history record for this product could not be reviewed and a similar incident query could not be performed because the lot number was not reported.The investigation was unable to determine a cause for the reported difficulties and subsequent patient effect.Vessel dissection is listed in the xact instruction for use as an adverse event potentially associated with carotid stents and embolic protection systems.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

Event Description

It was reported that after successful deployment of the xact stent, the stent system could not be removed from the anatomy.A shuttle sheath was advanced over the device, and the devices were able to be retracted together.During the attempts to remove the device, a dissection was noted under the stent.No treatment was performed.There was no clinically significant delay in the procedure and no adverse patient sequela.No additional information was provided.

• 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: 7765527
• MDR Text Key: 116522849
• Report Number: 2024168-2018-06113
• Device Sequence Number: 1
• Product Code: NIM
• UDI-Device Identifier: 08717648010279
• UDI-Public: 08717648010279
• 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: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 08/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 82091-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/01/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Outcome(s): Required Intervention