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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 XRX04009T
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Stroke/CVA (1770); Thrombosis (2100)
Event Date 01/03/2019
Event Type  Injury  
Manufacturer Narrative
(b)(4): during processing of this complaint, attempts were made to obtain complete event, patient and device information.The stent remains in the patient.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 performed to treat an 85% stenosed, moderately tortuous, and heavily calcified lesion in the left inner carotid artery.A 40x9-7mm x-act freestyle stent was deployed; however, the patient suffered a stroke some hours later.An angiogram was performed and thrombosis in the stent was confirmed.The patient was treated with antiplatelet therapy and was discharged home.No additional information was provided.
 
Event Description
Subsequent to the previously filed report, additional information was received: the patient did not suffer a stoke.The patient was transferred to another hospital and unspecified treatment was performed.No additional information was provided.
 
Manufacturer Narrative
Internal file number - (b)(4).Corrections: outcomes attributed to adverse event: the patient did not suffer a disability or permanent damage.Patient code 1770 was removed.The device was not returned for evaluation.The reported patient effect of thrombosis is listed in the xact instructions for use, as a known possible complication associated with carotid stenting procedures.A review of the lot history record and corrective action tracking system for the web revealed no exceptions associated with this lot.Based on the case information and related record review, 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 issue with respect to manufacture, design or labeling.
 
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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
MDR Report Key8408838
MDR Text Key138415915
Report Number2024168-2019-01899
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,foreig
Remedial Action Other
Type of Report Initial,Followup
Report Date 03/15/2019
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? No
Device Operator Health Professional
Device Expiration Date01/31/2021
Device Catalogue NumberXRX04009T
Device Lot Number8021461
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 02/14/2019
Initial Date FDA Received03/11/2019
Supplement Dates Manufacturer Received03/12/2019
Supplement Dates FDA Received03/15/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention; Disability;
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