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

Model Number	S-45-120-120-P6
Medical Device Problem Code	Difficult or Delayed Activation (2577)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/15/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned for analysis.Production record and corrective and preventive 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.As there was no damage noted to the device during the inspection prior to use, it is likely that the distal sheath of the delivery system was entrapped or bent in the mildly calcified, mildly tortuous and 80% stenosed anatomy such that the ratchet was unable to completely deploy the stent resulting in the reported difficult or delayed activation.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.
Event or Problem Description
It was reported was that the procedure was to treat an 80% stenosed de novo lesion in the popliteal artery with mild calcification and mild tortuosity.The 4.5x120mm supera self-expanding stent system (sess) was advanced to the target lesion and the thumbslide was pushed and the stent was released; however, the stent failed to detach from the delivery system.The thumbslide was moved multiple times and the system relocked and unlocked.Ultimately, the stent was detached by gently shaking the delivery system.The stent was implanted to treat the target lesion.There was no adverse patient effect and no clinically significant delay reported 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: 24211816
• Report Number: 2024168-2026-00410
• Device Sequence Number: 20217303
• Product Code: NIP
• UDI-Device Identifier: 08717648226007
• UDI-Public: (01)08717648226007(17)260831(10)4091261
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P120020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• 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): 01/29/2026

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 Expiration Date: 08/31/2026
• Device Model Number: S-45-120-120-P6
• Device Catalogue Number: S-45-120-120-P6
• Device Lot Number: 4091261
• 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: 01/15/2026
• Initial Report FDA Received Date: 01/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/12/2024
• 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: .018 COMMAND GUIDE WIRE; 6FR INTRODUCER SHEATH 40CM
• Patient Sex: Unknown