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

Catalog Number	82086-01
Health Effect - Clinical Codes	Intracranial Hemorrhage (1891); Neurological Deficit/Dysfunction (1982)
Date of Event	07/10/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).There was no reported device malfunction and the product was not returned.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.The reported patient effects of intracranial hemorrhage and neurological deficit/dysfunction, as listed in the xact instructions for use, are known adverse events associated with the use of a carotid device in native carotid arteries.Based on the case information and related record review, a conclusive cause for the reported patient effects and the relationship to the product, if any, cannot be determined and 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 procedure, on (b)(6) 2017, was to treat the right internal carotid artery.The emboshield nav6 was placed followed by successful implantation of the 9-7x40 xact stent.After the xact stent was implanted, there was no flow distal to the stent and the patient was noted to have slurred speech.Medication (tpa) was administered to break up any potential clot and an aspiration catheter was used to remove debris from the emboshield nav6.The filter was then removed and distal flow was restored.The slurred speech improved, but was still present.Visual examination of the filter identified the debris that was in the filter appeared to be calcium rather than clot.The procedure was completed and the patient was sent for a ct scan.An intracranial bleed was noted.On an unknown date, the patient was unable to speak and was in a vegetative state.No additional information was provided.
Additional Manufacturer Narrative
Internal file number - (b)(4).Outcomes attributed to adverse event.

• 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: 6749399
• Report Number: 2024168-2017-06252
• Device Sequence Number: 1538875
• Product Code: NIM
• UDI-Device Identifier: 08717648010224
• UDI-Public: 08717648010224
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P040038
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/02/2017

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 82086-01
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/10/2017
• Supplement Date Received by Manufacturer: 07/28/2017
• Initial Report FDA Received Date: 07/27/2017
• Supplement Report FDA Received Date: 08/02/2017
• 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: Other; Required Intervention