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

Catalog Number 1012014-120

Device Problems Entrapment of Device (1212); Material Separation (1562); Mechanical Jam (2983); Activation Failure (3270)

Patient Problems Stenosis (2263); Vascular Dissection (3160); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/09/2021

Event Type  Injury  

Manufacturer Narrative

The device will not be returned for evaluation; the device was reportedly discarded.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.The additional device referenced is being filed under a separate medwatch report number.

Event Description

It was reported that the procedure was performed to treat a de novo lesion in the heavily calcified, heavily tortuous, 100% stenosed superfiical femoral artery and popliteal artery.On (b)(6) 2021, a non-abbott sheath was advanced when a dissection was noted.Pre-dilatation was performed with multiple unspecified balloons and a command guide wire.A 5x150mm absolute pro ll self-expanding stent system (sess) was advanced, and the stent was deployed; however, dilatation was performed over this stent to prepare the lumen to receive a second stent as they observed some residual stenosis due to recoil.A 5x120mm absolute pro ll sess was advanced with a non-abbott 6f sheath, and no resistance was noted.The stent was partially deployed overlapping the first stent when the thumbwheel stopped rotating, and the rest of the stent was unable to be deployed.The sess was attempted to be removed, but significant resistance was noted with the previously deployed stent.The second stent was retrieved partially to the sheath when the shaft separated.The separated portion of the shaft in the sheath was removed by inflating an unspecified balloon within the sheath and removing everything together.The stent remained in the common femoral artery until it was surgically removed the following day on (b)(6) 2021.A 5x150 absolute pro ll stent was used to successfully complete the initial procedure.No more adverse advents were observed and the patient is currently recovering.However, there was a clinically significant delay in the procedure.No additional information was provided.

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 incidents.Based on the information provided, the investigation was unable to determine a conclusive cause for the reported activation failure, and mechanical jam.In this case, based on the reported information, it may be possible that the anatomical conditions induced a constriction in the shaft sheath during the insertion process or during the activation, causing resistance with the thumbwheel, partial deployment and the inability to release the stent from the delivery system however, this could not be confirmed.The entrapment of the device and material separation likely occurred due to the partially deployed stent becoming entrapped with the previously deployed stent resulting in separation of the shaft.Additionally, the unexpected medical intervention, foreign body removal, surgical intervention, treatment delay and hospitalization were due to the case circumstances.There is no indication of a product quality issue with respect to manufacture, design, or labeling.

Event Description

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.

Manufacturer Narrative

Updated mfg narrative: the investigation determined that the reported difficulties were likely related to circumstances of the procedure.In this case, based on the reported information, it may be possible that the anatomical conditions induced a constriction in the shaft sheath during the insertion process or during the activation, causing resistance with the thumbwheel, partial deployment and the inability to release the stent from the delivery system however, this could not be confirmed.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.H6: investigation conclusions code 67 removed.

• 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: 11396410
• MDR Text Key: 234210991
• Report Number: 2024168-2021-01584
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: PO
• 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: 01/31/2023
• Device Catalogue Number: 1012014-120
• Device Lot Number: 0021761
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/10/2021
• Initial Date FDA Received: 03/01/2021
• Supplement Dates Manufacturer Received: 03/05/2021; 05/11/2022
• Supplement Dates FDA Received: 03/26/2021; 06/02/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/17/2020
• 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: 5X150 ABSOLUTE PRO LL STENT; 6F DESTINATION SHEATH; COMMAND GUIDE WIRE
• Patient Outcome(s): Hospitalization; Required Intervention