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

Catalog Number	82092-01
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/13/2018
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 product was not returned for analysis.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 revealed no other incidents.The investigation determined that the reported difficulty to remove appears to be related to circumstance of the procedure.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.The emboshield nav6 referenced is being filed under a separate medwatch report.
Event or Problem Description
It was reported the procedure was performed to treat a lesion in the common carotid artery.The emboshield nav 6 embolic protection system (eps) was advanced with resistance and tension noted due to the anatomy, but reached the desired location.An xact stent delivery system (sds) was advanced to the target lesion and the stent was implanted successfully.During withdrawal of the xact sds, the device became stuck with a kink in the nav 6 barewire.The distal end of the 6fr sheath was advanced up to the filter and all devices were removed as one whole system.There was no adverse patient effect and no clinically significant delay in the procedure.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: 7375048
• Report Number: 2024168-2018-02234
• Device Sequence Number: 1373170
• Product Code: NIM
• UDI-Device Identifier: 08717648010286
• UDI-Public: 08717648010286
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P040038
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 03/27/2018

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: 11/30/2020
• Device Catalogue Number: 82092-01
• Device Lot Number: 7121361
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/13/2018
• Initial Report FDA Received Date: 03/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 74 YR
• Patient Weight: 95