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

Catalog Number 1012008-150

Device Problems Difficult to Remove (1528); Material Separation (1562); Improper or Incorrect Procedure or Method (2017); Mechanical Jam (2983); Activation Failure (3270)

Patient Problem Foreign Body In Patient (2687)

Event Date 05/19/2022

Event Type  Injury  

Manufacturer Narrative

The device was not returned for analysis.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 other complaints reported from this lot.Because it was reported that an attempt was made to force the thumbwheel and it broke, it should be noted that the absolute pro ll instruction for use 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.Failure to follow these instructions could result in failure to deploy, difficulties with deployment and partial stent deployment or deployment in an unintended location.It could not be determined if the use of force caused or contributed to the difficulties encountered the investigation determined that the reported difficulties resulting serious injury/ illness/ impairment and foreign body in the patient were related to circumstances of the procedure.It may be possible that the distal shaft was bent or restricted in the anatomy (possibly at the aortic bifurcation) preventing the shaft lumens from moving freely, causing resistance with the thumbwheel and with continued force applied, damage to the system components occurred.The additional difficulties of resistance during removal and stent separation are likely the result of manipulation of the delivery system to remove the device with the stent partially deployed.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.

Event Description

It was reported that the procedure was to treat an unspecified lesion in the superficial femoral artery (sfa).A 5x150mm absolute pro self-expanding stent system (sess) was advanced to the target lesion without issue.Halfway through the deployment the thumbwheel became stuck.An attempt was made to force the thumbwheel and it broke.The stent partially deployed in the target sfa, but when an attempt was made to retrieve the system, the stent separated, and a small piece of stent remained in the sfa.The rest of the stent was in the introducer; however, it was not able to be removed, so it was deployed in the iliac artery.The sess was removed.There was no adverse patient sequela and no clinically significant delay in the procedure.Another absolute pro was implanted to successfully complete the procedure.No additional information was provided.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.

Manufacturer Narrative

Visual and functional analysis was performed on the returned device.The reported partial deployment, thumbwheel jam, stent separation and difficult to remove were unable to be confirmed due to the condition of the returned device.The investigation determined that the reported difficulties resulting in serious injury/ illness/ impairment, and foreign body in the patient were related to circumstances of the procedure.It may be possible that restriction to the distal shaft lumens occurred in the anatomy (likely over the aortic bifurcation), preventing further movement of the shaft lumens, and causing the thumbwheel to lock up resulting in partial deployment.Further attempts to rotate the thumbwheel against resistance likely caused the noted outer member separation at the distal end of the shuttle preventing any further transmission between the thumbwheel and retractable sheath.The additional difficulties of resistance during removal and stent separation are likely the result of manipulation of the delivery system to remove the device with the stent partially deployed.D9, h3 - device was available for evaluation.H6 - type of investigation code 4117 - removed.H10 - addtl mfg narrative.

• 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: 14516068
• MDR Text Key: 292743572
• Report Number: 2024168-2022-05640
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: P110028
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date: 07/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1012008-150
• Device Lot Number: 2012561
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/11/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/25/2022
• 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
• Patient Outcome(s): Other