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

Catalog Number 1012009-150

Device Problems Difficult to Remove (1528); Material Separation (1562); Activation Failure (3270)

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

Event Date 09/30/2022

Event Type  malfunction  

Event Description

It was reported that the procedure was to treat a totally occluded lesion in the superficial femoral artery (sfa) with moderate calcification.Pre-dilatation was performed with 3.00x15mm and 5.00x20mm balloons.A 6f sheath was used.The 6.00x150mm absolute pro self-expanding stent system (sess) was advanced to the target lesion; however, the stent only partially deployed.The delivery system became stuck with the stent and the stent was removed with the delivery system.There was no adverse patient effect and there was no clinically significant delay reported in the procedure.A non-abbott stent was used to complete the procedure.No additional information was provided.

Manufacturer Narrative

The device was received.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

Subsequent to initial report, the following information was received: it was reported that the stent implant separated distal to the proximal end while attempting to deploy the stent.The separated stent was able to be removed together with sheath.No part of the stent was left inside the patient.A non-abbott stent was used to complete the procedure.No additional information was provided.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.

Manufacturer Narrative

The device was returned for analysis.The reported material separation was able to be confirmed.The reported activation failure was unable to be replicated in a testing environment due to the condition of the returned device.The reported difficult to remove was unable to be replicated in a testing environment as it was based on operational circumstances.Additionally, it was noted that there were wrinkles sporadically through the length of the stent sheath.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.As there was no damage noted to the device during the inspection prior to use, it is possible that the distal shaft was bent in the moderately calcified, totally occluded anatomy preventing the shaft lumens from moving freely, resulting in the reported difficulty deploying the stent; however this cannot be confirmed.The investigation determined a conclusive cause for the reported activation failure cannot be determined.Manipulation of the device likely resulted in the noted wrinkles sporadically through the entire length of the stent sheath likely contributing to the reported difficulties and ultimately resulted in the reported material separation/noted stent separation.Interaction with the moderately calcified, totally occluded anatomy and/or other devices likely resulted in the reported difficult to remove the compromised 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.

• 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: 15664406
• MDR Text Key: 302428246
• Report Number: 2024168-2022-11025
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 12/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1012009-150
• Device Lot Number: 2082961
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/23/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/29/2022
• 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