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

Catalog Number 1012010-150

Device Problems Mechanical Jam (2983); Activation Failure (3270)

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

Event Date 09/08/2021

Event Type  malfunction  

Manufacturer Narrative

The device was returned for analysis.The reported activation failure and mechanical jam were unable to be replicated in a testing environment due to the condition of the returned device.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 incidents from this lot.It is likely that the distal sheath of the delivery system was entrapped/bent in the heavily calcified anatomy and/or inadvertent mishandling resulted in the noted multiple outer member and stabilizer jacket bends and separated strain relief such that the ratchet was unable to properly engage the stent; thus resulting in reported mechanical jam (reported problem with the thumbwheel) and the reported activation failure/ deployment failure.Although the difficulties encountered appear to be related to procedural circumstances, on (b)(6) 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 a heavily calcified vessel in the superficial femoral artery (sfa).The 7.0x150mm absolute pro self-expanding stent system (sess) completely failed to deploy and it was noted that there was a problem with the thumbwheel.There was no adverse patient effect and there was no clinically significant delay in the procedure.Another stent was used to complete the procedure.No additional information was provided.Subsequent to the initial report, on (b)(6) 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; therefore, this event has been upgraded to reportable.

• 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: 14549859
• MDR Text Key: 292997049
• Report Number: 2024168-2022-05792
• 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
• Report Date: 05/31/2022

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: 09/30/2023
• Device Catalogue Number: 1012010-150
• Device Lot Number: 0100561
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/20/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/11/2022
• Initial Date FDA Received: 05/31/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/05/2020
• 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