MAUDE Adverse Event Report: ABBOTT VASCULAR XACT CAROTID; SELF EXPANDING PERIPHERAL STENT SYSTEM

Catalog Number 82090-01

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

Patient Problems Stroke/CVA (1770); Neurological Deficit/Dysfunction (1982)

Event Date 12/10/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).The customer reported the device was discarded.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.The emboshiled nav6 referenced is being filed under a separate medwatch report number.

Event Description

It was reported that the procedure was performed to treat a lesion in the right internal carotid artery.An emboshield nav6 embolic protection system (eps) was used along with a 9x30x136 xact stent delivery system (sds) and a 8x40x136 xact sds.All devices were deployed successfully, however it was reported that the filter of the eps moved distally in the vessel, and the filter faced resistance during removal with the anatomy.The vessel had a spasm, which was treated with an unspecified micro-catheter and 10 units of verapamil were administered.A 3x20mm unspecified balloon dilatation catheter was used, and a dissection was noted.The patient developed a cerebrovascular accident, so the patient was transported to another account.The patient was slowly improving, so a second intervention was deemed unnecessary.The patient was diagnosed with hyperperfusion syndrome, and the occlusion was tight.There was a clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

G9: exemption number e2019001-permits numbering sequence to begin with 10000, to avoid duplication of report numbers due to process transition.There may be gaps in numbering for reports submitted during the transition period.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 case information, a conclusive cause for the reported patient effect(s), and the relationship to the product, if any, cannot be determined.The delay in procedure and additional hospitalization were related to case circumstances.The reported patient effects of neurological deficit/dysfunction and stroke are listed in the xact instructions for use as known potential patients effect potentially associated with carotid stents and embolic protection systems.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• Brand Name: XACT CAROTID
• Type of Device: SELF EXPANDING PERIPHERAL STENT SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 9520129
• MDR Text Key: 175089818
• Report Number: 2024168-2019-14975
• Device Sequence Number: 1
• Product Code: NIM
• UDI-Device Identifier: 08717648010262
• UDI-Public: 08717648010262
• Combination Product (y/n): N
• PMA/PMN Number: P040038
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 01/17/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2022
• Device Catalogue Number: 82090-01
• Device Lot Number: 9041661
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/10/2019
• Initial Date FDA Received: 12/26/2019
• Supplement Dates Manufacturer Received: 01/09/2020
• Supplement Dates FDA Received: 01/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 9 X 30 MM XACT STENT
• Patient Outcome(s): Hospitalization
• Patient Age: 68 YR
• Patient Weight: 45