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

Catalog Number	82087-01
Health Effect - Clinical Code	Low Blood Pressure/ Hypotension (1914)
Date of Event	02/22/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The device 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.Based on the similar incident review, there is no indication of a lot specific product quality issue.The reported patient effect of hypotension is listed in the xact carotid stent systems instructions for use as a known patient effect of the stenting procedure.The investigation was unable to determine a conclusive cause for the reported difficult to deploy and hypotension.There is no indication of a product quality issue with respect to design, manufacture or labeling of the device.
Event or Problem Description
It was reported that the patient underwent a carotid procedure on (b)(6) 2018, treating a target lesion in the lightly calcified right common carotid artery.The 9.0 x 30 mm xact stent was deployed, but a delay was encountered while attempting to separate the stent from the delivery system.Eventually, the stent fully deployed in the lesion and the delivery system successfully removed; however, during the delay, the patient experienced severe hypotension, which was treated with neosynephrine.The physician felt the delay was clinically significant.The patient condition resolved.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: 7364552
• Report Number: 2024168-2018-02104
• Device Sequence Number: 1235854
• Product Code: NIM
• UDI-Device Identifier: 08717648010231
• UDI-Public: 08717648010231
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): 03/22/2018

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: 01/31/2020
• Device Catalogue Number: 82087-01
• Device Lot Number: 7021661
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/01/2018
• Initial Report FDA Received Date: 03/22/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 61 YR
• Patient Weight: 93