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

Model Number	S-55-150-120-P6
Medical Device Problem Codes	Stretched (1601); Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/03/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned for analysis.Production record and corrective and preventative actions (capa) reviews were performed and revealed no indication of a product quality issue.Additionally, a review of the complaint handling database revealed no indication of a lot specific product quality issue.As there was no damage noted to the device during the inspection prior to use, it is possible that during stent deployment, interaction with the heavily calcified, heavily torturous anatomy contributed to the reported stretched/elongated stent, ultimately resulting in the reported activation/deployment failure; 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.The additional devices referenced in b5 are being filed under a separate medwatch report numbers.
Event or Problem Description
It was reported that the procedure was to treat a heavily calcified, heavily tortuous superficial femoral artery and popliteal artery lesion.The 5.5x150 mm supera self-expanding stent (ses) was advanced to the target lesion and fully deployed.However, during removal of the ses, elongation occurred and the stent was removed.This also occurred with the second 5.5x150 mm supera ses and the third 5.5x120 mm supera ses.A fourth 5.5x150 mm supera ses and a non-abbott stent were used to complete the procedure.There were no adverse patient effects and there was 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: 25524239
• Report Number: 2024168-2026-02426
• Device Sequence Number: 10731888
• Product Code: NIP
• UDI-Device Identifier: 08717648226168
• UDI-Public: (01)08717648226168(17)270731(10)5081461
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/16/2026

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-55-150-120-P6
• Device Catalogue Number: S-55-150-120-P6
• Device Lot Number: 5081461
• 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: 06/04/2026
• Supplement Date Received by Manufacturer: 06/26/2026
• Initial Report FDA Received Date: 06/16/2026
• Supplement Report FDA Received Date: 07/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/14/2025
• 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