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

Catalog Number 82096-01

Device Problem Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/15/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device was not returned for analysis.The investigation was unable to determine a conclusive cause for the reported difficulties; however the treatment appears to be related to the circumstances of the procedure.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history identified no other incidents from this lot.Based on the information reviewed, 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 the xact stent delivery system was prepared per instructions for use and then advanced to the target site.A syringe was connected to the manifold and the manifold was connected with tubing to the rotating hemostatic valve (rhv).The xact stent delivery system was advanced through the rhv.All connections were noted to be tight.The physician pulled negative on the syringe and air was noted in the syringe.The air was removed and only blood was noted during negative pull back.The stent was deployed without issue and there was no adverse patient effect.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: 5904156
• MDR Text Key: 52999147
• Report Number: 2024168-2016-05691
• Device Sequence Number: 1
• Product Code: NIM
• UDI-Device Identifier: 08717648010323
• UDI-Public: (01)08717648010323(17)170831(10)4090261
• 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
• Report Date: 08/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2017
• Device Catalogue Number: 82096-01
• Device Lot Number: 4090261
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/15/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2014
• 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
• Treatment: RHV: TUOHY
• Patient Outcome(s): Required Intervention