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U.S. Department of Health and Human Services

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

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ABBOTT VASCULAR XACT CAROTID STENT SYSTEM; SELF EXPANDING PERIPHERAL STENT SYSTEM Back to Search Results
Model Number 82091-01
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Stroke/CVA (1770); Thrombosis/Thrombus (4440)
Event Date 05/13/2021
Event Type  Injury  
Manufacturer Narrative
The device was not returned for analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.The reported patient effects of stroke and thrombosis are listed in the xact instructions for use as a known potential adverse effects associated with carotid stents and embolic protection systems.Based on the case information, a conclusive cause for the reported patient effects, 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.Na.
 
Event Description
It was reported that this was a procedure to treat a lesion in the heavily calcified, mildly tortuous internal carotid artery.An emboshield nav 6 embolic protection system was advanced and deployed.A 4x20 mm viatrac dilatation catheter was used for pre-dilatation.A xact 8tx30x136 carotid stent system was advanced and deployed without any issue in the internal carotid artery.A 5x20 mm viatrac dilatation catheter was used for post dilatation and the emboshield nav 6 was retrieved without issue.Approximately, twenty-five minutes after the procedure, when the patient was in intensive care unit (icu); the patient experienced left side facial drooping and left side leg weakness.The patient had a stroke, no flow was observed in the internal carotid artery where the xact stent was implanted.The patient was transferred to a neighboring hospital that treats acute stroke patients.Tissue plasminogen activator and acute stroke intervention was performed, a clot was removed from xact stent with a non-abbott catheter and additional ballooning was performed with 6.0 x 20 viatrac balloon.The patient was kept overnight in the icu.No additional information was provided.
 
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Brand Name
XACT CAROTID STENT SYSTEM
Type of Device
SELF EXPANDING PERIPHERAL STENT SYSTEM
Manufacturer (Section D)
ABBOTT VASCULAR
26531 ynez rd.
temecula CA 92591 4628
Manufacturer (Section G)
ABBOTT VASCULAR, REG # 2024168
26531 ynez road
temecula CA 92591 4628
Manufacturer Contact
lindsey bell
26531 ynez rd.
temecula, CA 92591-4628
9519143996
MDR Report Key11936351
MDR Text Key254521821
Report Number2024168-2021-04660
Device Sequence Number1
Product Code NIM
UDI-Device Identifier08717648010279
UDI-Public08717648010279
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 company representative,health
Reporter Occupation Physician
Type of Report Initial
Report Date 06/03/2021
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 Date02/28/2023
Device Model Number82091-01
Device Catalogue Number82091-01
Device Lot Number0031861
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 05/13/2021
Initial Date FDA Received06/03/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/18/2020
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; Disability;
Patient Age65 YR
Patient Weight63
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