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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 1011343-40
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Death (1802)
Event Date 06/11/2013
Event Type  Death  
Event Description
Although requested, there was no additional information provided.
 
Event Description
It was reported that on (b)(6) 2012, the patient underwent a stenting procedure with placement of a 6-8 x 40 mm rx acculink stent in the mildly calcified left internal carotid artery.On (b)(6) 2013, the patient collapsed and passed away at home.Cause of death is not known and no autopsy was performed.Additional information has been requested.
 
Manufacturer Narrative
(b)(4).The stent remains in the patient.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
 
Manufacturer Narrative
(b)(4).It is indicated that the device is not returning for evaluation; therefore, a failure analysis of the complaint device could not be completed.A review of the lot history record revealed no non-conformances that would have contributed to the reported event.The results of the query of similar incidents in the complaint handling database for this lot did not indicate a manufacturing issue.The reported patient effect of death is listed in the rx acculink, domestic, instructions for use.A query of the electronic complaint handling database indicated there had been no similar incidents reported for this lot.Based on the information reviewed, there is no indication of a product deficiency.
 
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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 462
Manufacturer (Section G)
ABBOTT VASCULAR, TEMECULA, CA USA REG# 2024168
abbott vascular
26531 ynez road
temecula CA 92591 462
Manufacturer Contact
connie speck
abbott vascular
26531 ynez road
temecula, CA 92591-4628
9519143996
MDR Report Key3595870
MDR Text Key4134343
Report Number2024168-2014-00459
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 Study,Health Professional
Reporter Occupation Health Professional
Remedial Action Other
Type of Report Initial,Followup
Report Date 01/06/2014
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 Date05/31/2014
Device Catalogue Number1011343-40
Device Lot Number2061961
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 02/07/2014
Initial Date FDA Received01/28/2014
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received02/12/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/01/2012
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) Death;
Patient Age66 YR
Patient Weight60
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