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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 Problems Positioning Failure (1158); Difficult to Remove (1528)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/06/2013
Event Type  Injury  
Event Description
It was reported via a (b)(4) event report that a 6/8 x 40 acculink ii stent did not fully deploy and upon removal the stent stuck on the end of the shuttle sheath.The stent was explanted on (b)(6) 2013.No additional information was provided.
 
Manufacturer Narrative
(b)(4): during processing of this complaint, attempts were made to obtain complete event, patient and device information.The device is not going to be returned for investigation.A follow-up report will be submitted with all additional relevant information.(b)(4).
 
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.A query of the complaint handling database revealed no other incidents for failure to deploy or difficult to remove reported for this lot.Based on the reviewed information, no product deficiency was identified.
 
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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 Key3682179
MDR Text Key4293066
Report Number2024168-2014-01551
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 Other,Health Professional,Company Representative
Reporter Occupation Health Professional
Remedial Action Other
Type of Report Initial,Followup
Report Date 02/18/2014
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? Yes
Device Operator Health Professional
Device Expiration Date02/28/2015
Device Catalogue Number1011343-40
Device Lot Number3030461
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 03/25/2014
Initial Date FDA Received03/16/2014
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received03/31/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/01/2013
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; Required Intervention;
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