MAUDE Adverse Event Report: ABBOTT VASCULAR ABSOLUTE PRO .035 SELF EXPANDING STENT SYSTEM; SELF EXPANDING PERIPHERAL STENT SYSTEM

Catalog Number 1011917-040

Device Problems Difficult to Remove (1528); Material Separation (1562); Improper or Incorrect Procedure or Method (2017); Activation Failure (3270)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 11/16/2022

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.(b)(4).

Event Description

It was reported that the procedure was to treat the left external iliac artery with low calcification and low tortuosity via cross over access from the right side.A non-abbott 6fr 45 cm sheath was placed and pre-dilatation was performed.The 8x40 mm absolute pro self expanding stent (ses) was deployed without resistance and the delivery system was then attempted to be removed.During removal there was resistance and some force was applied to remove the system and it was seen that the stent was still attached to the delivery system tip.During removal the distal part of the stent separated and was released in the primitive iliac artery.The delivery system was removed with the proximal portion of the stent still in the delivery system.The distal portion of the stent was left in the anatomy and secured to the vessel with a new stent.A non-abbott stent was used to treat the initial target lesion.There were no adverse patient sequela.No additional information was provided.

Manufacturer Narrative

The device was returned for analysis.The reported difficult to remove was unable to be replicated in a testing environment as it was based on operational circumstances.The reported material separation stent and the reported activation/deployment failure were unable to be replicated in a testing environment due to the condition of the returned device/stent not returned.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.Reportedly, during removal there was resistance and some force was applied to remove the system.It should be noted that the absolute pro.035 peripheral self-expanding stent system instructions for use (ifu) states: should unusual resistance be felt at any time during lesion or stricture access or delivery system removal, the introducer sheath / guiding catheter and stent system should be removed as a single unit.Applying excessive force to the stent delivery system can potentially result in loss or damage to the stent and delivery system components.Although resistance was noted during removal, the force applied during removal of the device seemed to be a reasonable clinical response to the difficulties.The investigation determined the reported/noted difficulties appear to be related to circumstances of the procedure as it is likely that during removal the delivery system tip inadvertently was caught with the deployed stent; thus resulting in the reported difficult to remove.Manipulation of the compromised device ultimately resulted in the reported stent material separation; thus resulting in the reported activation/deployment failure.Manipulation of the device likely resulted in the noted multiple distal sheath kinks/chatter marks.As reported, the distal portion of the stent was left in the anatomy and secured to the vessel with a new stent.The reported treatment(s) appear to be related to the operational context of the procedure as reportedly the distal portion of the stent was left in the anatomy and secured to the vessel with a new stent.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• Brand Name: ABSOLUTE PRO .035 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: 15946348
• MDR Text Key: 305140256
• Report Number: 2024168-2022-12426
• Device Sequence Number: 1
• Product Code: FGE
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K072708
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1011917-040
• Device Lot Number: 2081761
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/01/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/17/2022
• 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
• Treatment: 6FR 45 CM SHEATH
• Patient Outcome(s): Required Intervention