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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 1010132-30
Device Problem Improper or Incorrect Procedure or Method (2017)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/14/2016
Event Type  Injury  
Manufacturer Narrative
(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.Concomitant products: guide wire: boston journey; embolic protection: emboshield nav6.(b)(4) - failure to follow steps/instructions: delivered on wrong wire.(b)(4).The device was not returned for analysis.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history of the reported lot revealed no other incidents.The emboshield nav 6 instruction for use (ifu) instructs to: perform the required interventions over the barewire filter delivery wire.The investigation determined that the difficulties appear to be due to user error and there is no indication the issue was caused by or related to the design, manufacture or labeling.The emboshield nav6 referenced is filed under a separate medwatch report.
 
Event Description
It was reported that during a procedure of a restenosed patch treatment of the external carotid artery, the emboshield nav6 embolic protection device (epd) was positioned in the vessel without issue.A non-abbott guide wire was used next to the epd to advance and deploy the acculink stent; however, this jailed the epd and guide wire and the filter could not be retrieved.Surgical intervention was used to remove the epd and the acculink stent.The patient was reported to be fine.There was no reported clinically significant delay in the procedure.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 Key5564338
MDR Text Key42326780
Report Number2024168-2016-02285
Device Sequence Number1
Product Code NIM
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
P040012
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Health Professional
Remedial Action Other
Type of Report Initial
Report Date 04/08/2016
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 Date08/31/2017
Device Catalogue Number1010132-30
Device Lot Number5092361
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 03/15/2016
Initial Date FDA Received04/08/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/01/2015
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;
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