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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 82090-01
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Thrombosis (2100)
Event Date 05/15/2017
Event Type  Injury  
Manufacturer Narrative
(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.Thrombectomy was attempted with two non-abbott thrombectomy devices, but no clot was aspirated; only blood.A 2nd xact stent (8t x 40 x 136) was deployed proximally overlapping the 1st stent in an attempt to secure thrombus; but thrombus was not secured.Stroke symptoms continued.Tissue plasminogen activator (tpa) medication was given through the catheter, with no improvement to patient effects.The 3rd nav6 filter was retrieved and an accunet (1011649-65) filter was then deployed without difficulty.A 3rd stent (82092-01 xact) was deployed distal to the very 1st placed stent overlapping it, in attempt to secure thrombus, but it was not secured.The patient was still neurologically unresponsive.Integrilin (3 mg) was injected into the 3rd deployed xact stent; angiogram showed desired perfusion with no more vessel occlusion and an immediate subsequent computerized tomography (ct) scan showed no bleeding in the brain.Magnetic resonance imaging (mri) performed the next day ((b)(6) 2017) confirmed stroke had occurred on both sides of the brain (right side was much worse than left), as particles (debris) were noted on the scan.The patient was discharged (b)(6) 2017 to a stroke recovery therapy center with some returned neurological activity; there remains weakness to the left side and slurred speech.Reportedly, the patient experienced worsening of stroke symptoms (increased neurological deficit) throughout the entire procedure and it cannot be stated with certainty if the devices used worsened the stroke symptoms.No additional information was provided.Concomitant medical products: stent: 8t x 40 x 136 xact.Embolic protection: emboshield nav6.The device was not returned for evaluation.The lot history record (lhr) for this product could not be reviewed because the product was not returned for evaluation and the lot number was not reported.The reported patient effect of stroke is listed in the xact instruction for use as a known patient effect.Based on the case information and related record review, a conclusive cause for the reported patient effect(s), 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.The emboshield nav6 (x2) and additional xact stents referenced in describe event or problem are being filed under separate medwatch reports.
 
Event Description
It was reported that on (b)(6) 2017, the patient initially presented with some signs of stroke (blurred vision and slightly impaired speech), but symptoms resolved just prior to start of procedure to treat a heavily calcified, non-tortuous right internal carotid artery (rica).An emboshield nav6 lg 190 cm embolic protection system (eps) was advanced past the lesion without issue, but patient began to show signs of stroke again (same symptoms, but worse than pre-procedure).While there was no device issue, the barewire was inadvertently pulled back, which pulled the filter back to the lesion.The nav6 filter was retrieved without difficulty using the nav6 retrieval catheter (rc).A 2nd nav6 filter was deployed without issue, patient stroke symptoms (loss of speech, loss of vision) continued to worsen.An 8t x 40 x 136 xact self-expanding stent was deployed without difficulty.Angiography showed in-stent thrombosis which occluded the vessel.Patient experienced severe headache, became completely unresponsive neurologically (stroke worsened further).The 2nd nav6 was retrieved with nav6 rc without difficulty.A 3rd nav6 was deployed without difficulty.A 4.5 x 15 x 135 rx viatrac balloon was advanced and inflated to treat thrombus and open occluded vessel, but there was no improvement to the patient effects.
 
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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
Manufacturer (Section G)
ABBOTT VASCULAR, TEMECULA, CA USA REG# 2024168
abbott vascular
26531 ynez road
temecula CA 92591 4628
Manufacturer Contact
connie speck
abbott vascular
26531 ynez road
temecula, CA 92591-4628
9519143996
MDR Report Key6619785
MDR Text Key76943523
Report Number2024168-2017-04855
Device Sequence Number1
Product Code NIM
UDI-Device Identifier08717648010262
UDI-Public(01)08717648010262
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 Health Professional
Remedial Action Other
Type of Report Initial
Report Date 06/07/2017
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 Catalogue Number82090-01
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 05/15/2017
Initial Date FDA Received06/07/2017
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) Required Intervention;
Patient Age75 YR
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