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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 1010133-40
Device Problem Detachment Of Device Component (1104)
Patient Problem No Patient Involvement (2645)
Event Date 04/21/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.Evaluation summary: visual inspections were performed on the returned device.The reported separation was confirmed.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 identified no other incidents from this lot.The investigation determined the reported separation appears to be related to circumstances of the procedure.Based on the information reviewed, there is no indication of a product quality issue with respect to manufacture, design or labeling.
 
Event Description
It was reported that the inner member of the 7-10x40mm acculink stent system was separated 9mm proximal to the base of the tip after removal from the package.The device was not used in the patient and the procedure was successfully completed with a new unknown device.There were no adverse patient effects 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 Key7567502
MDR Text Key110047303
Report Number2024168-2018-04128
Device Sequence Number1
Product Code NIM
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
P040012
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Reporter Occupation Health Professional
Remedial Action Other
Type of Report Initial
Report Date 06/04/2018
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 Date06/30/2019
Device Catalogue Number1010133-40
Device Lot Number7071361
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/11/2018
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 05/16/2018
Initial Date FDA Received06/04/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/01/2017
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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