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

Model Number	S-60-040-120-P6
Medical Device Problem Codes	Stretched (1601); Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/14/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the procedure was to treat a heavily calcified lesion in the superficial femoral artery (sfa).The lesion was pre-dilated with a 6mm non-compliant balloon.The 6.0x40mm supera self expanding stent system (ses) was advanced to the target lesion however during deployment significant elongation occurred after the start of deployment; therefore, deployment was aborted.The ses was removed from the patient without issue.Repeat ivus imaging showed significant recoil, with the lumen measuring approximately 5.3 mm.Per the physician, the supera stent did not cause or contribute to the vessel recoil.Balloon angioplasty was performed again followed by deployment of another supera stent.Good flow was obtained, and the procedure was completed uneventfully.Per the physician the elongation was considered likely due to greater than expected vessel recoil, resulting in inadequate luminal expansion during initial preparation.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
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.The investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely that the greater than expected vessel recoil resulted in the reported stretched stent.As reported, deployment was aborted resulting in the reported activation failure.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: 24303087
• Report Number: 2024168-2026-00542
• Device Sequence Number: 17428733
• Product Code: NIP
• UDI-Device Identifier: 08717648211799
• UDI-Public: (01)08717648211799(17)270430(10)5052761
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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
• Report Date (Section B): 02/10/2026

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-60-040-120-P6
• Device Catalogue Number: S-60-040-120-P6
• Device Lot Number: 5052761
• 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: 02/03/2026
• Initial Report FDA Received Date: 02/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/27/2025
• 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