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U.S. Department of Health and Human Services

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

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AV-TEMECULA-CT XACT CAROTID STENT SYSTEM Back to Search Results
Device Problem Migration (4003)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/01/2018
Event Type  Injury  
Manufacturer Narrative
(b)(4).Udi#: in the absence of a reported part number, the udi cannot be calculated.The device was not returned for analysis.The lot history record (lhr) for this product could not be reviewed and a similar incident query could not be performed because the part and lot numbers were not reported.The investigation was unable to determine a conclusive cause for the reported stent migration.It may be possible that the stent was undersized for the vessel; however, this could not be confirmed.The additional surgical procedure to remove the stent was due to case circumstances.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
 
Event Description
It was reported that the xact stent moved from the target lesion in the carotid artery due to an unknown reason.Surgery was performed and the stent was successfully explanted and no longer remains in the patient.There was no reported adverse patient sequela.No additional information was provided.
 
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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 Key7720206
MDR Text Key115059010
Report Number2024168-2018-05763
Device Sequence Number1
Product Code NIM
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
P040038
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Physician
Remedial Action Other
Type of Report Initial
Report Date 07/25/2018
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
Device Operator Health Professional
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 07/17/2018
Initial Date FDA Received07/25/2018
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 Number1
Patient Outcome(s) Required Intervention;
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