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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 Problems Break (1069); Inaccurate Delivery (2339)
Patient Problem Foreign Body In Patient (2687)
Event Date 03/25/2013
Event Type  Injury  
Event Description
It was reported that on (b)(6) 2013, the index procedure was to treat a heavily calcified lesion in the internal carotid artery.During deployment of the 9.0x40x136 xact, the stent jumped forward and was deployed partially in healthy tissue and partially in the target lesion.An unplanned 9.0x30x136 xact stent was deployed overlapping to treat the remainder of the target lesion.The procedure was completed without any adverse patient sequela or clinically significant delay in the procedure.On (b)(6) 2014, during regular angiographic check-up, it was noted that the overlapping portion of the two deployed stents had fractured struts.A non-abbott balloon dilatation catheter (bdc) was successfully advanced; however, the balloon ruptured during inflation.As the patient is non-symptomatic and the vessel is not blocked, the decision was made to abort further treatment and continue regular monitoring.The procedure was completed without any adverse patient sequela or clinically significant delay in the procedure.There was no additional information provided.
 
Manufacturer Narrative
(b)(4).The 9.0 x 30 x 136 xact carotid stent mentioned is being filed under a separate manufacturer report number.It is indicated that the device is not returning for evaluation; therefore a failure analysis of the complaint device could not be completed.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.Based on the reviewed information, no product deficiency was identified.
 
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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 Key3812968
MDR Text Key4526381
Report Number2024168-2014-03068
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 05/01/2014
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? Yes
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 05/01/2014
Initial Date FDA Received05/15/2014
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) Hospitalization; Required Intervention;
Patient Age69 YR
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