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 Code	Visual Disturbances (2140)
Date of Event	12/05/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Exemption number e2019001.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 effect visual disturbance is listed in the xact instruction for use as a known adverse event 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 effect could not be determined.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
Event or Problem Description
It was reported that the procedure was to treat a right internal carotid artery.In (b)(6) 2017, an xact stent was implanted without issue.On (b)(6) 2019, the patient then experienced vision loss.Therefore, the patient was sent for treatment the same day.Via angiography, it was noted that the xact stent was fractured (but not in two pieces).During preparation of an emboshield nav6, it was difficult to load the filter onto the delivery catheter (dc) pod.However, after some manipulation the filter was able to load onto the dc pod successfully and was used without issue.Then three unspecified stents were used to successfully treat the fractured stent.The patient is fine.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.

• 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: 9475167
• Report Number: 2024168-2019-14563
• Device Sequence Number: 11427997
• 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: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/16/2019

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: 12/05/2019
• Initial Report FDA Received Date: 12/16/2019
• 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: Required Intervention
• Patient Age: 85 YR