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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
Catalog Number XRX04008T
Device Problem Off-Label Use (1494)
Patient Problems Stroke/CVA (1770); Paresis (1998); Thrombosis/Thrombus (4440)
Event Date 04/28/2021
Event Type  Injury  
Manufacturer Narrative
(b)(4).The customer reported the device is not returning.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.Na.
 
Event Description
It was reported that the procedure was to treat a dissection flap/stenosis at the distal end of the bovine pericardium patch located in the internal carotid artery.A left carotid endarterectomy with patch repair was first performed on the patient.At the end of the procedure, it was decided to stent the patient with an x-act stent with no issues reported as the stent looked good via angiogram.Medication was provided to the patient but within 30 minutes after the primary procedure the patient started to experience stroke symptoms such as one-sided weakness and additional medication was provided to treat.Then a diagnostic selective carotid angiogram was performed which confirmed in-stent thrombus.Patient was taken back to the operation room and the stent implant was explanted via surgical procedure.Patient is recovering satisfactorily.No additional information was provided.
 
Event Description
It was reported that the procedure was to treat a dissection flap/stenosis at the distal end of the bovine pericardium patch located in the internal carotid artery.A left carotid endarterectomy with patch repair was first performed on the patient.At the end of the procedure, it was decided to stent the patient with an x-act stent with no issues reported as the stent looked good via angiogram.Medication was provided to the patient but within 30 minutes after the primary procedure the patient started to experience stroke symptoms such as one-sided weakness and additional medication was provided to treat.Then a diagnostic selective carotid angiogram was performed which confirmed in-stent thrombus.Patient was taken back to the operation room and the stent implant was explanted via surgical procedure.Patient is recovering satisfactorily.Subsequent to the initially filed mdr, the account confirmed a stroke.They sent the stent for histopathology which showed platelet aggregation.The stroke treated via medication and then stent was explanted.All stroke symptoms resolved post-surgery.No additional information was provided.
 
Manufacturer Narrative
The device was not returned for evaluation.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Based on the information reviewed, there is no indication of a product quality issue.It should be noted the xact cartoid stent system instructions for use (ifu) states: the safety and effectiveness of the xact carotid stent system has not yet been established in patients with the characteristics noted below: presence of carotid artery dissection prior to initiation of the procedure.Section 6.2 adverse events section also states: thrombosis and stroke or other neurological complications as foreseeable events.In this case, it is unknown if the ifu deviation directly caused or contributed to the reported event.A conclusive cause for the reported off-label use (indication for use) and patient effects and the relationship to the device, if any, cannot be determined.There is no indication of a product quality deficiency with respect to manufacture, design, or labeling and the treatment/ medication appears to be related to operational context of the procedure.
 
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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
MDR Report Key11863098
MDR Text Key251960765
Report Number2024168-2021-04298
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
Type of Report Initial,Followup
Report Date 06/08/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/21/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date06/30/2023
Device Catalogue NumberXRX04008T
Device Lot Number0072361
Was Device Available for Evaluation? No
Date Manufacturer Received06/01/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention; Disability;
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