MAUDE Adverse Event Report: ABBOTT VASCULAR INC. SUPERA; STENT, SUPERFICIAL FEMORAL ARTERY

Model Number	S-50-120-120-P6
Medical Device Problem Codes	Mechanical Jam (2983); Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/16/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.
Event or Problem Description
It was reported that the procedure was to treat a lower limb artery with 80% stenosis.The 5.0x120 mm supera self expanding stent system (sess) was advanced to the lesion and deployment was attempted.The roller became stuck and the stent could not be fully released.The stent was manually retracted back into the sheath and removed from the body.A drug coated balloon was used to complete the procedure.There were no adverse patient effects and there was no clinically significant delay in the procedure.No additional information was provided.Subsequent to the initially filed china report it was reported the stent only partially deployed.
Additional Manufacturer Narrative
The device was not returned for analysis.A corrective and preventive actions (capa) review was performed and revealed no indication of a product quality issue.Additionally, a production record review and a review of the complaint handling database was not performed because the lot number was not reported.As there was no damage noted to the device during the inspection prior to use, it is possible that interaction with the anatomy and/or other devices resulted in preventing the shaft lumens from moving freely; thus resulting in the reported mechanical jam (lever to unlock was hard to push down) and the reported mechanical jam (thumbwheel would not turn) and the reported activation/deployment failure; however this cannot be confirmed.The investigation was unable to determine a conclusive cause for the reported difficulties.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.B5: describe event or problem: updated, removed "subsequent to the initially filed china report it was reported the stent only partially deployed.".
Event or Problem Description
It was reported that the procedure was to treat a lower limb artery with 80% stenosis.The 5.0x120 mm supera self expanding stent system (sess) was advanced to the lesion and deployment was attempted.The roller became stuck and the stent could not be fully released.The stent was manually retracted back into the sheath and removed from the body.A drug coated balloon was used to complete the procedure.There were no adverse patient effects and there was no clinically significant delay in the procedure.No additional information was provided.

• Brand Name: SUPERA
• Common Device Name: STENT, SUPERFICIAL FEMORAL ARTERY
• Manufacturer (Section D): ABBOTT VASCULAR INC.; 3200 lakeside drive; santa clara CA 95054 2807
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 2024168; 26531 ynez road; temecula CA 92591 4628
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 23960790
• Report Number: 2024168-2026-00062
• Device Sequence Number: 13129923
• Product Code: NIP
• UDI-Device Identifier: 08717648211775
• UDI-Public: (01)08717648211775(17)270228(10)5032661
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/19/2026

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-50-120-120-P6
• Device Catalogue Number: S-50-120-120-P6
• Device Lot Number: 5032661
• 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: 12/16/2025
• Supplement Date Received by Manufacturer: 01/05/2026
• Initial Report FDA Received Date: 01/05/2026
• Supplement Report FDA Received Date: 01/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/26/2025
• 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: 6F 90CM SHEATH
• Patient Sex: Unknown