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

Model Number	S-50-100-120-P6
Medical Device Problem Codes	Difficult to Remove (1528); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/24/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It is reported that the procedure was to treat a 70% stenosed de novo lesion in the superficial femoral artery (sfa) with moderate calcification and mild tortuosity.The 5x100mm supera peripheral self-expanding stent system (sess) was attempted to be advanced on a 0.018 unspecified guide wire (gw); however, the sess became stuck during advancement and removal.Therefore, the sheath, guide catheter and sess were removed as a single unit.The procedure was continued with an unspecified same size device.There was no adverse patient effect and no clinically significant delay reported in the procedure.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.
Additional Manufacturer Narrative
The device was returned for analysis.The reported difficult to advance and the reported difficult to remove through the guide wire were unable to be confirmed.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 possible that a coagulation of blood and/or contrast on the guidewire resulted in the reported difficult to advance and reported difficult to remove along the guide wire; however this cannot be confirmed.The investigation determined a conclusive cause for the reported difficulties cannot be determined.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.

• 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: 24328977
• Report Number: 2024168-2026-00611
• Device Sequence Number: 13272279
• Product Code: NIP
• UDI-Device Identifier: 08717648211768
• UDI-Public: (01)08717648211768(17)270630(10)5072961
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/31/2026

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-50-100-120-P6
• Device Catalogue Number: S-50-100-120-P6
• Device Lot Number: 5072961
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/24/2026
• Supplement Date Received by Manufacturer: 03/11/2026
• Initial Report FDA Received Date: 02/12/2026
• Supplement Report FDA Received Date: 03/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/29/2025
• 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
• Patient Sex: Unknown