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U.S. Department of Health and Human Services

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

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AV-TEMECULA-CT ABSOLUTE PRO LL SELF-EXPANDING STENT SYSTEM; SELF EXPANDING STENT SYSTEM Back to Search Results
Catalog Number 1012015-150
Device Problems Break (1069); 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 10/10/2018
Event Type  Injury  
Manufacturer Narrative
(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The device is expected to be returned for evaluation.It has not yet been received.A follow up report will be submitted with all relevant information.
 
Event Description
It was reported that the procedure was performed to treat a stenosed lesion in the superficial femoral artery.A 6x150mm absolut pro ll self-expanding stent system (sess) was advanced; however, when attempting to deploy the stent friction was felt.The stent could not be pulled forward or backwards as it was stuck in the vessel.The thumbwheel was blocked and could not be rotated.An attempt to remove the stent was made and after a while the delivery system could be removed.Angiography was performed and it showed that part of the stent remained in the vessel wall.It could not be confirmed because part of the intervention was not filed; however, a possible stent fracture could have occurred.An unspecified stent was advanced and used to press the disintegrated absolute pro ll stent against the vessel wall.Final angiography showed good flow and the patients leg is well supplied with blood.The patient is doing fine.There was no clinically significant delay in the procedure.No additional information was provided.
 
Event Description
Subsequent to the previously filed report, additional information was received: the stent did not break as previously reported.The distal end of the delivery system (tip and inner member) of the 6x150mm absolut pro ll sess separated.The separated portion was embedded against the vessel wall with an unspecified stent.The stent was removed from the anatomy.No additional information was provided.
 
Manufacturer Narrative
Device codes: 1562 labeled.(b)(4).Device code 1069 was removed.Evaluation summary: visual inspection was performed on the returned device.The tip separation was confirmed.The failure to deploy, difficulty to remove and mechanical jam were unable to be confirmed due to the condition of the device.The reported physical resistance was unable to be replicated in a testing environment as it was based on operational circumstances.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.Based on the review of similar incident(s) there is no indication of a lot specific product quality issue.Potential factors for difficulty deploying the stent and/or rotating the thumbwheel include, but are not limited to, manufacturing, anatomical conditions, coagulation of blood, or deployment technique and/or damage to the device deployment mechanisms (handle components/shaft lumens).The investigation was unable to determine a conclusive cause for the reported difficulties.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
 
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Brand Name
ABSOLUTE PRO LL 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
MDR Report Key8043777
MDR Text Key126353278
Report Number2024168-2018-08531
Device Sequence Number1
Product Code NIO
Combination Product (y/n)N
PMA/PMN Number
P110028
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Remedial Action Other
Type of Report Initial,Followup
Report Date 02/25/2019
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 Number1012015-150
Device Lot Number8041861
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/09/2018
Initial Date Manufacturer Received 10/15/2018
Initial Date FDA Received11/06/2018
Supplement Dates Manufacturer Received02/19/2019
Supplement Dates FDA Received02/25/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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