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

Catalog Number	82086-01
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/26/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The other xact referenced is filed under a separate medwatch report number.Evaluation summary: visual, dimensional and functional inspections were performed on the returned device.Analysis of the returned device revealed the blockage was material from the inner member of the catheter.It is likely that improper loading of the nav6 barewire most likely scratched the interior of the xact guidewire lumen and the shavings formed a blockage that prevented further advancement of the xact unit over the wire.The difficulty advancing over the guide wire 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 did not reveal a lot specific product issue.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 procedure was to treat a mildly calcified internal carotid artery.A barewire would not advance through the guide wire lumen of a 9.0 x 40 mm xact self-expanding stent system.A new 9.0 x 40 mm xact was going to be used; however, the guide wire could not advance through the lumen of the second xact either.Outside the anatomy a command guide wire also could not advance through the inner member of the xact stent systems.It appeared that the guide wire lumen of the two xact delivery systems was plugged.A non-abbott stent delivery system was successfully used to complete the procedure.There was no clinically significant delay in procedure and no adverse patient effects.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: 6541881
• Report Number: 2024168-2017-03886
• Device Sequence Number: 16388938
• Product Code: NIM
• UDI-Device Identifier: 08717648010224
• UDI-Public: (01)08717648010224(17)190531(10)6060361
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: P040038
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 05/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2019
• Device Catalogue Number: 82086-01
• Device Lot Number: 6060361
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/21/2017
• Initial Report FDA Received Date: 05/03/2017
• 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: EMBOSHIELD NAV6