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

Catalog Number 82086-01

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Intracranial Hemorrhage (1891); Neurological Deficit/Dysfunction (1982)

Event Date 07/10/2017

Event Type  Injury  

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 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.

Manufacturer Narrative

Internal file number - (b)(4).Outcomes attributed to adverse event.

• Brand Name: XACT CAROTID STENT SYSTEM
• Type of Device: CAROTID STENT SYSTEM
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR, TEMECULA, CA USA REG# 2024168; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• Manufacturer Contact: connie speck ; abbott vascular; 26531 ynez road; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 6749399
• MDR Text Key: 81228759
• Report Number: 2024168-2017-06252
• Device Sequence Number: 1
• Product Code: NIM
• UDI-Device Identifier: 08717648010224
• UDI-Public: 08717648010224
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P040038
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 08/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 82086-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/28/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention