MAUDE Adverse Event Report: ABBOTT VASCULAR SUPERA SELF-EXPANDING STENT SYSTEM; SELF EXPANDING PERIPHERAL STENT SYSTEM

Catalog Number 42055150-120

Device Problems Entrapment of Device (1212); Material Separation (1562); Stretched (1601); Improper or Incorrect Procedure or Method (2017)

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

Event Date 05/07/2021

Event Type  Injury  

Manufacturer Narrative

The stent remains in patient.The device will not be returned for evaluation.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.(b)(4).

Event Description

It was reported that the procedure was performed to treat a de novo lesion in the 90% stenosed right superficial femoral artery.Pre-dilatation was performed with non-abbott balloons, and a 5.5x150mm supera self expanding stent system (sess) was implanted proximally.During removal, there was no resistance when the tip of the sess became entangled with the implanted stent and separated.A snare was used to retrieve the separated tip, but resistance was felt.Force was applied as the tip was entangled with the implanted stent, and the implanted stent became elongated.An unspecified balloon and 4.5x100mm supera stent were used to resolve the elongation and return the supera stent to its original position.There was no adverse patient sequelae and no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

The device was not returned for evaluation.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 similar complaints.It was reported that a snare was used to retrieve the separated tip, but resistance was felt.Force was applied as the tip was entangled with the implanted stent, and the implanted stent became elongated.It should be noted that the supera instruction for use states: ¿should unusual resistance be felt at any time during stent system advancement or stent deployment, the entire system should be removed together with the introducer sheath or guiding catheter as a single unit.¿ although it was reported that force was used to remove the separated tip that was entangled with the implanted stent, the excess force seemed to be a reasonable clinical response to the difficulties encountered.An abbott vascular medical affairs expert reviewed the details of the case and the angiographic images provided.The results are as follows: the cine images did provide evidence confirming the supera stent ce od 5.5x150 6f 120cm tip became entangled with the stent upon withdrawal.The images show a detached tip as well as tip/stent interaction that was not mitigated prior to the tip disengaging.It is unknown if the tip disengaged because it hung up on a wire or if it hung up on the introducer.Both are possible.Based on the reported information and review of the provided angiographic images, the investigation was unable to determine a cause for the reported difficulties resulting in unexpected medical intervention.It may be possible that the tip became entrapped with the stent wire during deployment causing detachment when the thumbslide was retracted; however, this could not be confirmed.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

• Brand Name: SUPERA SELF-EXPANDING STENT SYSTEM
• Type of Device: SELF EXPANDING PERIPHERAL STENT SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 11901143
• MDR Text Key: 253470271
• Report Number: 2024168-2021-04487
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• PMA/PMN Number: P120020
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 07/18/2021

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: 04/30/2022
• Device Catalogue Number: 42055150-120
• Device Lot Number: 0052061
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/11/2021
• Initial Date FDA Received: 05/28/2021
• Supplement Dates Manufacturer Received: 06/28/2021
• Supplement Dates FDA Received: 07/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 81 YR
• Patient Weight: 65