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

Model Number	S-55-120-120-P6
Medical Device Problem Codes	Material Separation (1562); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/22/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device was not returned for evaluation.The supera instruction for use (ifu) states: 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, failing to retract and lock the thumbslide into place appears to be the likely cause for the reported tip detachment.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 incidents and/or complaints from this lot.Based on the information provided, the reported difficulties appear to be user/case related.Failing to retract and lock the thumbslide into place appears to be the likely cause for the reported difficulties.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.Attachment: user facility medwatch report #(b)(4).
Event or Problem Description
It was reported that the procedure was performed to treat a heavily calcified lesion in the superficial femoral artery.A 5.5x120mm supera self-expanding stent system (sess) was advanced and the stent was deployed.Post-deployment the removal steps were inadvertently not followed and the system was pulled back without pulling the thumb lever.The nose cone detached; however, the detached nose cone remained on the wire.The sess and wire with the nose cone were removed together.The patient is stable.The deployed stent was still in place and successfully treated the target lesion.There were no adverse patient effects and no clinically significant delay in the procedure.User facility medwatch report received that states: the supera stent was placed across the occlusion and post-dilated with a 6mm balloon.The 6x100 balloon was then used to treat the native distal sfa (superficial femoral artery).Notably, after the stent deployment a piece of the stent delivery system came off on the wire but was easily removed in its entirety.No additional information was provided.

• Brand Name: SUPERA SELF-EXPANDING STENT SYSTEM
• Common Device Name: SELF EXPANDING PERIPHERAL STENT SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 11499521
• Report Number: 2024168-2021-02079
• Device Sequence Number: 4266818
• Product Code: NIP
• UDI-Device Identifier: 08717648226144
• UDI-Public: 08717648226144
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: P120020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2022
• Device Model Number: S-55-120-120-P6
• Device Catalogue Number: S-55-120-120-P6
• Device Lot Number: 0081361
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/22/2021
• Initial Report FDA Received Date: 03/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 64 YR
• Patient Weight: 67