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

Catalog Number 1012015-150

Device Problems Stretched (1601); Malposition of Device (2616); Mechanical Jam (2983); Activation Failure (3270)

Patient Problem Foreign Body In Patient (2687)

Event Date 11/10/2020

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.The investigation determined that the reported difficulties and subsequent treatment were likely due to case circumstances.It is likely that the distal shaft was bent or restricted in the anatomy (possibly at the aortic bifurcation which was reported to be extremely calcified) preventing the shaft lumens from moving freely and preventing the thumbwheel from rotating.The additional reported difficulties of the stent stretching, and malposition of the stent was likely the result of manipulation to the delivery system in order to manually deploy the stent.The additional treatment and foreign body in patient were related to case circumstances.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

Event Description

It was reported that the procedure was performed to treat a de novo lesion with heavy calcification, moderate tortuosity, and 75% stenosis in the mid to distal left superior femoral artery (sfa).A non-abbott guide wire was placed and pre-dilatation was performed with a 4.0 x 80 mm armada 35 balloon.A non-abbott 6fr sheath was also placed from the contralateral groin.The aortic bifurcation was extremely calcified so the sheath could only just be advanced into the left common iliac artery.A 6.0x150 mm absolute pro self-expanding stent system was then advanced; however, on deployment of the stent, the thumbwheel stopped turning and the stent could only be partially deployed.The stent handle was broken apart to expose the inner mechanism and the stent was able to be deployed in something like a "pin/pull" fashion.This resulted in elongation of the stent and the stent being deployed in the proximal left common iliac artery instead of mid to distal left superficial artery (sfa) which was the location of the target lesion.The elongated stent was dilated with a 6.0 x 150 mm armada balloon, and flow was maintained throughout the stented segment.The physician suspected that the issue was the sheath was not over far enough and the calcification stopped the sheath from retracting and preventing the thumbwheel to roll.There was no adverse patient sequela and no clinically significant delay in the procedure.No additional information was provided.

Event Description

Subsequent to the original filing, 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

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.

• 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: 10897182
• MDR Text Key: 218940780
• Report Number: 2024168-2020-09867
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: 06/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/24/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2023
• Device Catalogue Number: 1012015-150
• Device Lot Number: 0032462
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/11/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/24/2020
• 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
• Treatment: GUIDE WIRE: 260CM ZIPWIRE BOSTON SCIENTIFIC.; INTRODUCER SHEATH: 6FR ANL.
• Patient Outcome(s): Required Intervention