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

Catalog Number	82096-01
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/15/2016
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: CAROTID STENT SYSTEM
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• MDR Report Key: 5904156
• Report Number: 2024168-2016-05691
• Device Sequence Number: 13600231
• Product Code: NIM
• UDI-Device Identifier: 08717648010323
• UDI-Public: (01)08717648010323(17)170831(10)4090261
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: P040038
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 08/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2017
• Device Catalogue Number: 82096-01
• Device Lot Number: 4090261
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/15/2016
• Initial Report FDA Received Date: 08/25/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: RHV: TUOHY
• Outcome Attributed to Adverse Event: Required Intervention