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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 1011340-30
Device Problems Difficult or Delayed Positioning (1157); Malposition of Device (2616)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/02/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.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 investigation was unable to determine a conclusive cause for the reported difficulties.It may be possible that the distal sheath was restricted or entrapped within the anatomy causing the stent to jump during deployment due to built-up tension within the shaft lumens of the delivery system resulting in a spring like release of the stent; however, this could not be confirmed.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
 
Event Description
It was reported that the procedure was performed to treat a moderately tortuous lesion in the internal carotid artery.An 8/30 acculink ii self expanding stent delivery system was advanced to the lesion with no resistance; however, the stent was difficult to visualize and appeared to jump on deployment.The stent was ultimately deployed partially inside the target lesion, leaving part of the lesion uncovered.A second unspecified acculink stent was deployed to treat the remainder of the lesion.There was no reported adverse patient sequela and no 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 Key8597646
MDR Text Key144702682
Report Number2024168-2019-03726
Device Sequence Number1
Product Code NIM
UDI-Device Identifier08717648076282
UDI-Public08717648076282
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 Physician
Remedial Action Other
Type of Report Initial
Report Date 05/09/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date06/30/2020
Device Catalogue Number1011340-30
Device Lot Number8073061
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 05/02/2019
Initial Date FDA Received05/09/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/01/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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