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

Catalog Number 1012014-150

Device Problems Entrapment of Device (1212); Mechanical Jam (2983); Activation Failure (3270)

Patient Problem Tissue Damage (2104)

Event Date 09/23/2020

Event Type  Injury  

Manufacturer Narrative

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.

Event Description

It was reported that the procedure was performed to treat a de novo lesion with heavy calcification, no tortuosity, and total occlusion in the left superior femoral artery to popliteal artery.The right side was punctured for cross over approach and a non-abbott 6f, 45cm sheath was placed.A 5mm unspecified balloon was used to pre-dilate the vessel; however, the balloon was not enough and a stent was needed.Then, a 5 x 150 mm absolute pro self-expanding stent system (sess) was prepared per instructions for use and advanced to the target lesion.While attempting to deploy the stent, the thumbwheel could be moved but nothing happened with the stent.Only 2-3 cm of the stent was able to be deployed.Therefore, the physician cut the handle and removed the outer and inner shaft separately.An unspecified balloon was used to remove the half-deployed stent from the patient's anatomy by dragging the stent back to the non-abbott introducer sheath.The stent got stuck inside of the non-abbott introducer sheath and both devices were removed together.Reportedly, the vessel was injured during the stent removal and the damage to the vessel was unknown.The procedure ended at this point.The final patient outcome was reported to be good flow.There was a clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

Visual analysis was performed on the returned device.The reported deployment issue, thumbwheel jam and entrapment of the device were unable to be confirmed 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 indication of a lot specific product quality issue.The reported patient effect of injury [tissue damage] to artery (rupture, perforation, dissection) is listed in the absolute pro ll instruction for use as a known possible complication that may occur with use of the device.The investigation was unable to determine a definitive cause for the reported difficulties.It may be possible that the distal shaft was bent or entrapped within the anatomy (possibly at the aortic bifurcation), preventing movement of the shaft lumens and causing the thumbwheel to lock up.Additional attempts to rotate the thumbwheel against resistance may have placed tension between the ribbon and the proximal spool causing the proximal spool to dislocate from the pivot web thumbwheel resulting in the ribbon spooling around the center handle pin and preventing further deployment as the transmission between the thumbwheel and retractable sheath was lost.The difficulty removing (entrapment), stent damage and reported vessel damage was likely the result of attempting remove the delivery system with the stent partially deployed.The additional damage noted to the returned unit was likely the result of manipulation to delivery system in the attempt to manually deploy the stent.The additional treatments to remove the partially deployed stent and delay in procedure were due to case circumstances.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

Manufacturer Narrative

Visual analysis was performed on the returned device.The reported deployment issue, thumbwheel jam and entrapment of the device were unable to be confirmed 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 indication of a lot specific product quality issue.The reported patient effect of injury [tissue damage] to artery (rupture, perforation, dissection) is listed in the absolute pro ll instruction for use as a known possible complication that may occur with use of the device.The investigation was unable to determine a definitive cause for the reported difficulties.It may be possible that the distal shaft was bent or entrapped within the anatomy (possibly at the aortic bifurcation), preventing movement of the shaft lumens and causing the thumbwheel to lock up.Additional attempts to rotate the thumbwheel against resistance may have placed tension between the ribbon and the proximal spool causing the proximal spool to dislocate from the pivot web thumbwheel resulting in the ribbon spooling around the center handle pin and preventing further deployment as the transmission between the thumbwheel and retractable sheath was lost.The difficulty removing (entrapment), stent damage and reported vessel damage was likely the result of attempting remove the delivery system with the stent partially deployed.The additional damage noted to the returned unit was likely the result of manipulation to delivery system in the attempt to manually deploy the stent.The additional treatments to remove the partially deployed stent and delay in procedure were due to case circumstances.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.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

Subsequent to the original filing, 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.

• 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: 10659324
• MDR Text Key: 216415721
• Report Number: 2024168-2020-08458
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: SW
• 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,Followup
• Report Date: 06/02/2022

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: 12/31/2022
• Device Catalogue Number: 1012014-150
• Device Lot Number: 0012361
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/24/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/23/2020
• Initial Date FDA Received: 10/09/2020
• Supplement Dates Manufacturer Received: 12/29/2020; 05/11/2022
• Supplement Dates FDA Received: 01/04/2021; 06/02/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/23/2020
• 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
• Patient Outcome(s): Required Intervention