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Adverse Event Report

ABBOTT VASCULAR - VASCULAR SOLUTIONS XACT CAROTID STENT SYSTEM   back to search results
Catalog Number 82090-01
Device Problem Unknown (for use when the device problem is not known)
Event Date 06/03/2007
Event Type  Injury   Patient Outcome  Hospitalization; Required Intervention Disability
Manufacturer Narrative

The device remains in the patient. The lot number was provided. A review of the device history record did not produce any findings relevant to this report.

 
Event Description

Device malfunction: none. Symptoms/ae: stroke. Time of symptoms: after the procedure. It was reported that ten days post an uneventful, right internal carotid artery (rica) stenting procedure, the patient experienced a stroke and was rehospitalized for four days. It was reported that the patient "continues with right sided weakness, facial droop and slurring of words". Ten days post stenting procedure, the patient had a seizure lasting about 1 minute which was due to hypotension and was treated with medication. Three weeks post procedure, the patient had a follow-up consult where it was reported that she continues to have right sided facial droop and right sided weakness. Additionally, it was stated that she has 80-99% left sided carotid stenosis. Although requested, there is no additional information available. Study event.

 
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Brand NameXACT CAROTID STENT SYSTEM
Baseline Device 510(K) Number
Baseline Device PMA Number
Manufacturer (Section F)
ABBOTT VASCULAR - VASCULAR SOLUTIONS
abbott vascular galway
mervue buisness park
mervue, galway
IRELAND
Manufacturer (Section D)
ABBOTT VASCULAR - VASCULAR SOLUTIONS
abbott vascular galway
mervue buisness park
mervue, galway
IRELAND
Manufacturer (Section G)
ABBOTT VASCULAR GALWAY
mervue business park
mervue, galway
IRELAND
Manufacturer Contact
bob shokoohi
26531 ynez road
temecula , CA 92591-4628
(951) 914 -1738
Device Event Key906873
MDR Report Key933018
Event Key834191
Report Number9616695-2007-00147
Device Sequence Number1
Product CodeNIM
Report Source Manufacturer
Source Type Study,Health Professional,Company Representative
Reporter Occupation Physician
Remedial Action Other
Type of Report Initial
Report Date 06/29/2007
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/25/2007
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device EXPIRATION Date06/01/2009
Device Catalogue Number82090-01
Device LOT Number403884
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Was The Report Sent To Manufacturer? No
Date Manufacturer Received10/05/2007
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured07/01/2006
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Is the Device an Implant? Yes
Is this an Explanted Device?
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 10/25/2007 Patient Sequence Number: 1
#TreatmentTreatment Date
1,EMBOSHIELD PART # E6190-01,
2,HEPARIN,

Database last updated on January 30, 2009

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