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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 82088-01
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Bradycardia (1751); Cardiac Arrest (1762)
Event Date 05/18/2020
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 bradycardia/arrhythmia are listed in the xact instructions for use as known potential patients effects associated with carotid stents and embolic protection systems.Based on the case information, a conclusive cause for the reported patient effect(s), and the relationship to the product, if any, cannot be determined.The additional therapy/non-surgical treatment and treatment with medication was related to case circumstances.There is no indication of a product quality issue with respect to manufacture, design or labeling.
 
Event Description
It was reported that the procedure was to treat a heavily calcified lesion in the heavily tortuous right common carotid artery.An emboshield nav6 embolic protection system (eps) was used and a viatrac 14 dilatation catheter was used for post dilatation.After the 9.0x9.0x30 mm xact stent was implanted, the patient experienced a drop in pulse and asystole.The patient was stabilized with cpr and medication and continued to be stable.The physician reported that this was a very difficult case due to the highly calcified area.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 Key10140841
MDR Text Key194756430
Report Number2024168-2020-04898
Device Sequence Number1
Product Code NIM
UDI-Device Identifier08717648010248
UDI-Public08717648010248
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 06/10/2020
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 Date06/30/2022
Device Model Number82088-01
Device Catalogue Number82088-01
Device Lot Number9070861
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 05/18/2020
Initial Date FDA Received06/10/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/08/2019
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) Life Threatening; Required Intervention;
Patient Age73 YR
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