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

Catalog Number 1013015-150

Device Problems Entrapment of Device (1212); Improper or Incorrect Procedure or Method (2017); Mechanical Jam (2983); Activation Failure (3270)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/21/2023

Event Type  Injury  

Event Description

It was reported that the procedure was to treat an 80% stenosed de novo lesion in the superficial femoral artery (sfa) with mild calcification and mild tortuosity.The 5.00x150mm absolute pro self-expanding stent system (sess) was advanced on a command 18st guidewire to the target lesion; however, after partially releasing the stent the thumbwheel became stuck.Therefore, the physician opened the handle and attempted to advance the thumbwheel; however, the thumbwheel was still stuck.The sess could not be removed from the patient anatomy.Therefore, surgical cutdown of the sfa was performed to remove the absolute sess.No additional information was provided.

Manufacturer Narrative

Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.Device code 2017 - failure to follow steps / instructionsna.

Manufacturer Narrative

The device was returned for analysis.The reported mechanical jam and the reported activation failure was unable to be replicated in a testing environment due to the condition of the returned device.The reported entrapment of device was unable to be replicated in a testing environment as it was based on operational circumstances.It should be noted that the absolute pro ll peripheral self-expanding stent system instructions for use (ifu), states: should unusual resistance be felt during initial rotation of the thumbwheel, prior to any of the stent starting to deploy, the entire system should be removed together with the introducer sheath or guiding catheter as a single unit.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.The deviation of the instructions for use does not appear to have caused/contributed to the reported difficulties.Additionally, a review of the complaint history identified no other incidents from this lot and original lot.As there was no damage noted to the device during the inspection prior to use, the investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely that the distal shaft was bent by the heavily calcified, mildly tortuous and 80% stenosed anatomy preventing the shaft lumens from moving freely, resulting in resistance with the thumbwheel/ mechanical jam and the reported difficulty deploying the stent/ activation failure.Manipulation of the device during attempted removal, in conjunction with intentional opening of the handle and attempting to advance the thumbwheel, resulted in the multiple noted device damages.Interaction with the anatomy and/or other devices resulted in the reported entrapment of device.The treatment appears to be related to the operational context of the procedure as surgical cutdown of the superficial femoral artery was performed to remove the absolute self-expanding stent system.On may 11th, 2022, abbott determined that a field safety notice 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.

• 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: 16734302
• MDR Text Key: 313235441
• Report Number: 2024168-2023-03787
• 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
• Report Date: 06/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1013015-150
• Device Lot Number: 2110861
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/18/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/08/2022
• 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
• Treatment: COMMAND18ST
• Patient Outcome(s): Required Intervention