MAUDE Adverse Event Report: ABBOTT VASCULAR INC. SUPERA; Stent, Superficial Femoral Artery

Model Number	S-50-120-120-P6
Medical Device Problem Codes	Material Separation (1562); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/28/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported this was a procedure to treat a heavily calcified, heavily tortuous, and 98% stenosed superficial femoral artery.A supera 5.0x120 was inserted and placed at the target lesion.However, after the stent was released and the delivery system was withdrawn from the body, the distal tip was found detached and trapped on the guide wire.It was noted the thumb slide was not fully retracted, and the system lock and deployment lock were not rotated into the locked position.A snare was inserted to retrieve the detached fragment.No additional information provided.
Additional Manufacturer Narrative
The device was not returned for analysis.Production record and corrective and preventative actions (capa) reviews were performed and revealed no indication of a product quality issue.Additionally, a review of the complaint handling database identified no other incidents from this lot.Reportedly, after the supera was released at the target lesion and the delivery system was withdrawn from the body, the distal tip of the stent was found detached and trapped on the guide wire.It was noted the thumb slide was not fully retracted, and the lock and the deployment lock were not rotated into the locked position.It should be noted that the supera peripheral stent system instructions 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.The investigation determined the reported difficulties appear to be related to deviation of the ifu and subsequent circumstances of the procedure as it is likely that failing to rotate the system lock and deployment lock into the locked position resulted in the tip of the supera to not be fully retracted back into the distal sheath, resulting in the tip of the device to be caught on the deployed stent struts; thus inadvertently detaching the distal tip from the delivery system and becoming trapped on the guide wire during withdrawal from the body, ultimately resulting in the reported material separation.As reported, a snare was inserted to retrieve the detached fragment.Based on the reported information and results of the complaint investigation there is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.H6 medical device problem code: 2017 - failure to follow steps / instructions.

• Brand Name: SUPERA
• Common Device Name: Stent, Superficial Femoral Artery
• Manufacturer (Section D): ABBOTT VASCULAR INC.; 3200 lakeside drive; santa clara CA 95054 -280
• Manufacturer (Section G): ABBOTT VASCULAR, Reg # 2024168; 26531 ynez road; temecula CA 92591 -462
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591--462 ; +1(951)914-5259
• MDR Report Key: 50214011
• Report Number: 2024168-2026-03140
• Device Sequence Number: 20358058
• Product Code: NIP
• UDI-Device Identifier: 08717648211775
• UDI-Public: (01)08717648211775(17)270831(10)5092561
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P120020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/11/2026

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
• Operator of Device: Health Professional
• Device Model Number: S-50-120-120-P6
• Device Catalogue Number: S-50-120-120-P6
• Device Lot Number: 5092561
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/28/2026
• Initial Report FDA Received Date: 08/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/25/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown