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

Model Number	S-50-060-120-P6
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/02/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the procedure was to treat the superficial femoral artery (sfa) with heavy calcification and 90% stenosis.The lesion was pre-dilated with a 5x100 mm armada balloon.The 5x60 mm supera self expanding stent system (sess) was advanced to the lesion and the stent was deployed.When the delivery system was removed over the wire, the stent was attached to the nose cone and came out with the delivery system.Another supera sess was used to complete the procedure.There were no reported adverse patient effects.No additional information was provided.
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.

• 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: 25586555
• Report Number: 2024168-2026-02486
• Device Sequence Number: 5442796
• Product Code: NIP
• UDI-Device Identifier: 08717648211744
• UDI-Public: (01)08717648211744(17)270930(10)5102261
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P120020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/07/2026

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 Model Number: S-50-060-120-P6
• Device Catalogue Number: S-50-060-120-P6
• Device Lot Number: 5102261
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/20/2026
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/02/2026
• Supplement Date Received by Manufacturer: 07/30/2026
• Initial Report FDA Received Date: 06/22/2026
• Supplement Report FDA Received Date: 08/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/22/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 014 COMMAND ST; 6F SHEATH
• Patient Sex: Unknown