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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
Catalog Number 82086-01
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Neurological Deficit/Dysfunction (1982)
Event Date 08/20/2014
Event Type  Injury  
Event Description
It was reported that on (b)(6) 2014, an xact stent was placed in a carotid artery without noted issue.Post-procedure, the patient was noted in good condition.On (b)(6) 2014, the patient showed signs of a stroke and received an magnetic resonance imaging (mri) on (b)(6) 2014.A transient ischemic attack was diagnosed and the patient experienced facial deficiencies.There was no treatment reported.There was no additional information provided.
 
Manufacturer Narrative
(b)(4).It is indicated that the device is not returning and there was no report of a device malfunction.The reported patient effect of a neurological event is a known observed and potential patient effect as listed in the xact carotid stent system instruction for use.Although a conclusive cause for the reported patient effect, and the relationship to the product, if any, cannot be determined, there is no indication of a product quality deficiency.
 
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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 462
Manufacturer (Section G)
ABBOTT VASCULAR, TEMECULA, CA USA REG# 2024168
abbott vascular
26531 ynez road
temecula CA 92591 462
Manufacturer Contact
connie speck
abbott vascular
26531 ynez road
temecula, CA 92591-4628
9519143996
MDR Report Key4086435
MDR Text Key4827392
Report Number2024168-2014-05868
Device Sequence Number1
Product Code NIM
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P040038
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Health Professional
Remedial Action Other
Type of Report Initial
Report Date 08/21/2014
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 Catalogue Number82086-01
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 08/21/2014
Initial Date FDA Received09/12/2014
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) Other;
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