MAUDE Adverse Event Report: ABBOTT VASCULAR ABSOLUTE PRO LL SELF-EXPANDING STENT SYSTEM; SELF EXPANDING PERIPHERAL STENT SYSTEM

Catalog Number 1013015-150

Device Problems Difficult to Remove (1528); Material Separation (1562); Improper or Incorrect Procedure or Method (2017); Activation Failure (3270)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 10/25/2021

Event Type  Injury  

Event Description

It was reported that the procedure was to treat a stenosis with mild calcification in the superficial femoral artery (sfa).Pre-dilatation was performed using a 4.0x150 armada 35 balloon.The 5.0x150mm absolute pro self-expanding stent system (sess) had no resistance advancing to the lesion, however, after turning the thumbwheel without resistance only one third of the stent was released.The stent and the sess were pulled together with excessive force fracturing the stent and leaving part of the stent in the target lesion.Further dilatation of the lesion was again performed using a 4.0x150mm armada 35 balloon to advance another 5.0x150mm absolute pro sess.The stent had no resistance advancing to the lesion.The thumbwheel was turned without resistance, however, only about one fourth of the stent was released.Again, the stent and the sess were pulled together with excessive force fracturing the stent and leaving part of the stent in the target lesion.No attempts were made to retrieve the separated portions of the stent in the target lesion as they were noted to be embedded in the lesion.The patient reportedly had no discomfort and the procedure was finished with angioplasty of the lesion only.There was no reported clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

(b)(4).The device is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.The additional absolute pro ll device referenced is being filed under a separate medwatch report number.

Manufacturer Narrative

Visual analysis was performed on the returned device.The reported deployment issue, difficulty removing, and stent separation were unable to be confirmed due to the condition of the returned unit.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 identified no indication of a lot specific product quality issue.Because it was reported that the delivery catheter was removed forcefully against resistance, it should be noted that the absolute pro ll instruction for use states: ¿should unusual resistance be felt at any time during lesion or stricture access or delivery system removal, the introducer sheath / guiding catheter and stent system should be removed as a single unit.Applying excessive force to the stent delivery system can potentially result in loss or damage to the stent and delivery system components.¿ in this event, the removal against resistance does not appear to have contributed to the initial deployment difficulty and thumbwheel locking up.The investigation was unable to determine a definitive cause for the reported difficulties resulting in a portion of the stent embedded in the lesion.It may be possible that the distal shaft was kinked or entrapped within anatomy (possibly over the aortic arch) preventing movement of the shaft lumens and causing resistance with the thumbwheel preventing full deployment; however, this could not be confirmed.Additionally, it is likely that the difficulty removing, and separation of the stent was the result of retracting the delivery system with the stent partially deployed and apposed to the vessel wall.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

Manufacturer Narrative

Although the difficulties encountered appear to be related to procedural circumstances, on may 11th, 2022, abbott determined that a field safety notice (fsn) was required for the absolute pro ll peripheral self-expanding stent system (psess).Abbott has confirmed reports of mechanical locking, stent deployment and partial stent deployment failures, resulting from unintended excessive force used to deploy the stent.To reduce occurrences of deployment failures and associated outcomes, abbott is notifying all users of the potential causes and risks.H6: investigation conclusions code 4315 removed; 4307 added.

• Brand Name: ABSOLUTE PRO LL SELF-EXPANDING STENT SYSTEM
• Type of Device: SELF EXPANDING PERIPHERAL STENT SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 2024168; 26531 ynez road; temecula CA 92591 4628
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 12821766
• MDR Text Key: 284691384
• Report Number: 2024168-2021-10414
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P110028
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Remedial Action: Notification
• Type of Report: Initial,Followup,Followup
• Report Date: 05/29/2022

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: 05/31/2024
• Device Catalogue Number: 1013015-150
• Device Lot Number: 1062361
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/23/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/26/2021
• Initial Date FDA Received: 11/16/2021
• Supplement Dates Manufacturer Received: 12/30/2021; 05/11/2022
• Supplement Dates FDA Received: 01/12/2022; 05/29/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/23/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other