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

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.

• 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 Key: 8043777
• MDR Text Key: 126353278
• Report Number: 2024168-2018-08531
• Device Sequence Number: 1
• Product Code: NIO
• Combination Product (y/n): N
• PMA/PMN Number: P110028
• Number of Events Reported: 1
• 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 Date: 03/31/2021
• Device Catalogue Number: 1012015-150
• Device Lot Number: 8041861
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2018
• Initial Date Manufacturer Received: 10/15/2018
• Initial Date FDA Received: 11/06/2018
• Supplement Dates Manufacturer Received: 02/19/2019
• Supplement Dates FDA Received: 02/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention