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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AV-TEMECULA-CT ABSOLUTE PRO VASCULAR SELF-EXPANDING STENT SYSTEM; SELF EXPANDING STENT SYSTEM

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AV-TEMECULA-CT ABSOLUTE PRO VASCULAR SELF-EXPANDING STENT SYSTEM; SELF EXPANDING STENT SYSTEM Back to Search Results
Catalog Number 1012530-100
Device Problems Difficult to Remove (1528); Material Separation (1562); Difficult to Advance (2920); Mechanical Jam (2983); Activation Failure (3270)
Patient Problem Vessel Or Plaque, Device Embedded In (1204)
Event Date 08/27/2018
Event Type  Injury  
Manufacturer Narrative
(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.Evaluation summary: the device was returned.Visual inspection and functional inspection was performed on the returned device.The difficulties could not be replicated due to the condition of the returned device.It was noted that the outer member was separated at two locations (outer member was separated 1.3cm proximal to the proximal end of distal outer sheath and the inner braiding and the outer member was separated 2mm distal to the proximal end of the rack).A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history of the reported lot revealed no other incidents.The investigation determined that the reported difficulties and subsequent treatment were likely due to operational circumstances of the procedure.Kinks were noted on the distal sheath which suggest that the sheath was likely bent/restricted in the anatomy and caused restriction between the shaft lumens, resulting in difficulty rotating the thumbwheel and deployment failure due to the outer member separation.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 the procedure was to treat a heavily calcified lesion in the right common iliac.The 8.0x100mm absolute pro vascular self expanding stent system (sess) was advanced with resistance noted due to the anatomy.During attempted deployment, the thumbslide failed to completely deploy the stent.Resistance was met during retraction and a piece of the stent separated in the patient anatomy.A covered stent was used to embed the separated portion of the absolute pro stent.There was no clinically significant delay in the procedure and no adverse patient sequela.No additional information was provided.
 
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Brand Name
ABSOLUTE PRO VASCULAR SELF-EXPANDING STENT SYSTEM
Type of Device
SELF EXPANDING 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 Key7878242
MDR Text Key120335709
Report Number2024168-2018-07193
Device Sequence Number1
Product Code NIO
UDI-Device Identifier08717648175732
UDI-Public08717648175732
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P110028
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 09/14/2018
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 Date03/31/2021
Device Catalogue Number1012530-100
Device Lot Number8040361
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/04/2018
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 08/28/2018
Initial Date FDA Received09/14/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/01/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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