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

Model Number S-50-100-120-P6

Device Problems Difficult to Remove (1528); Material Separation (1562); Improper or Incorrect Procedure or Method (2017); Migration (4003)

Patient Problem Insufficient Information (4580)

Event Date 02/13/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).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 the reported that the procedure was performed to treat a moderately calcified, non-tortuous left superficial femoral artery.Atherectomy was not done.Using a 6f sheath, the 5.0x100mm 6f supera self-expanding stent system was advanced to the target lesion without issue.It was confirmed via fluoroscopy that the stent had been fully released without issue.The thumbslide was not pulled back and the two locks were not locked.During removal of the delivery catheter, the tip separated and the stent became entangled with the ratchet.The stent was moved into the iliac bifurcation.A snare device was used to remove the tip and stent.A new supera was used to successfully complete the procedure without issue.There was no adverse patient sequela reported.No additional information was provided.

Manufacturer Narrative

Visual analysis was performed on the returned device.The difficulty removing and stent migration were not tested as it was based on case circumstances.The tip detachment was confirmed.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 complaints.The supera instruction for use (ifu) instructs: following confirmed implantation of the supera stent, retract the thumb slide in a single motion to the starting position on the handle and rotate the system lock and deployment lock into the locked position, in line with the thumb slide.In this case, it is likely that failing to retract the tip prior to removal contributed to the tip detachment.The investigation determined that the reported difficulties and subsequent treatment to retrieve the separated tip and stent were user related.The difficulty removing and tip detachment were due to not retracting the thumbslide and locking the system lock prior to removal resulting in the tip catching in the stent and separating, resulting in the stent migrating into the iliac bifurcation.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: 11401530
• MDR Text Key: 234411025
• Report Number: 2024168-2021-01630
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 08717648211768
• UDI-Public: 08717648211768
• 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,health
• Type of Report: Initial,Followup
• Report Date: 04/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2022
• Device Model Number: S-50-100-120-P6
• Device Catalogue Number: S-50-100-120-P6
• Device Lot Number: 0092861
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2021
• Date Manufacturer Received: 04/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 6FR DESTINATION SHEATH
• Patient Outcome(s): Required Intervention