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U.S. Department of Health and Human Services

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

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ABBOTT VASCULAR XACT CAROTID; SELF EXPANDING PERIPHERAL STENT SYSTEM Back to Search Results
Catalog Number XRX03007S
Device Problems Material Separation (1562); Deformation Due to Compressive Stress (2889)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/19/2019
Event Type  malfunction  
Manufacturer Narrative
The device was received.The investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
 
Event Description
It was reported that the procedure was to treat a moderately tortuous internal carotid artery.During the procedure, it was noted that a x-act freestyle straight 30x7 carotid stent system suffered warping (bend) at the guide wire exit notch.Another stent was used to successfully complete the procedure.There was no adverse patient effects or clinically significant delay.No additional information was reported.1/3/2020: device analysis noted that the support wire was separated at 3.7cm from noted torn shaft.No additional information was provided.
 
Manufacturer Narrative
Visual analysis was performed on the returned device which identified the support wire was separated.The reported kink was confirmed.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no other incidents.The investigation determined that the kink likely occurred during use.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
 
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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 Key9637769
MDR Text Key177389703
Report Number2024168-2020-00931
Device Sequence Number1
Product Code NIM
Combination Product (y/n)N
PMA/PMN Number
P040038
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Type of Report Initial,Followup
Report Date 02/25/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date12/31/2019
Device Catalogue NumberXRX03007S
Device Lot Number7011661
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/26/2019
Initial Date Manufacturer Received 01/03/2020
Initial Date FDA Received01/28/2020
Supplement Dates Manufacturer Received02/07/2020
Supplement Dates FDA Received02/26/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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