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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AV-TEMECULA-CT RX ACCULINK CAROTID STENT SYSTEM

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AV-TEMECULA-CT RX ACCULINK CAROTID STENT SYSTEM Back to Search Results
Catalog Number 1011344-40
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Stenosis (2263)
Event Date 11/04/2015
Event Type  Injury  
Manufacturer Narrative
(b)(4).There was no reported device malfunction, and the product was not returned.A review of the lot history record revealed no non-conformances or exceptions that would have contributed to the reported event.The investigation concluded that a definitive cause for the reported patient effect could not be determined.The reported patient effect of restenosis is a known observed and potential patient effect as listed in the rx acculink domestic, instructions for use.Although a conclusive cause for the reported patient effect 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.
 
Event Description
It was reported that on (b)(6) 2013 the 7-10x40 rx acculink was implanted in the left internal carotid artery (lica).The patient was re-admitted to the hospital on (b)(6) 2015 with carotid artery disease.Magnetic resonance angiogram (mra) found stenosis in the lica.Carotid angiogram on (b)(6) 2015 found 15% in-stent restenosis in the lica.Treatment was an increase in the daily aspirin dose to 325 mg/day.No additional information.
 
Manufacturer Narrative
(b)(4).The reported patient effects of angina, visual disturbances and arrhythmia are known observed and potential patient effects as listed in the rx acculink domestic instructions for use.
 
Event Description
Subsequent to the previously filed report, additional information was received that the percentage of stenosis in the left internal carotid artery was 75% via the magnetic resonance angiogram, not 15% as previously reported.The patient also had chest pain, dizziness, transient vision loss, substernal pressure and palpitations.The patient was referred to the cardiologist for follow-up.No additional information was provided.
 
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Brand Name
RX ACCULINK 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 Key5265388
MDR Text Key32660942
Report Number2024168-2015-07246
Device Sequence Number1
Product Code NIM
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P040012
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,Followup
Report Date 01/15/2016
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 Date12/31/2014
Device Catalogue Number1011344-40
Device Lot Number3012361
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 11/11/2015
Initial Date FDA Received12/03/2015
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received01/15/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/01/2013
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;
Patient Age62 YR
Patient Weight77
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