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

Catalog Number	82086-01
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Syncope (1610); Transient Ischemic Attack (2109)
Date of Event	07/18/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Exemption number e2019001permits 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 evaluation.The lot history record (lhr) for this product could not be reviewed and a similar incident query could not be performed because the product was not returned for evaluation and the lot number was not reported.The reported patient effects of transient ischemic attacks (tias) and syncope are listed in the xact instruction for use adverse events as potentially associated with carotid stents and embolic protection systems.Based on the information provided, a conclusive cause for the reported stent fracture and subsequent patient effects could not be determined.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.Na.
Event or Problem Description
It was reported that on (b)(6) 2018, an xact stent was successfully implanted, without any device issues, in the right internal carotid, across a bifurcation.On (b)(6) 2019, the patient presented with transient ischemic symptoms and syncope.Imaging was performed and the xact stent had partially fractured.The physician is unsure if the tia symptoms and syncope are related to the xact stent or if they are related to the patient's pre-existing atrial fibrillation.There was still good blood flow through the stent so no treatment was deemed necessary.The event did not required hospitalization and no treatment was provided.No additional information was provided regarding this issue.

• Brand Name: XACT CAROTID
• Common Device Name: SELF EXPANDING PERIPHERAL STENT SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 8876165
• Report Number: 2024168-2019-10689
• Device Sequence Number: 2389973
• Product Code: NIM
• UDI-Device Identifier: 08717648010224
• UDI-Public: 08717648010224
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 08/08/2019

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 Catalogue Number: 82086-01
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/18/2019
• Initial Report FDA Received Date: 08/08/2019
• 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