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

Model Number	S-55-150-120-P6
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Impaired Healing (2378); Obstruction/Occlusion (2422); Unspecified Tissue Injury (4559)
Date of Event	08/09/2025
Type of Reportable Event	Serious Injury
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 identified no other similar incidents from this lot.The reported patient effect of obstruction/occlusion is listed in the absolute pro peripheral stent system instructions for use as a potential complication.A conclusive cause for the reported obstruction/occlusion and unspecified tissue injury and the relationship to the product, if any, cannot be determined.The treatments appear to be related to the operational context of the procedure.Based on the 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 device referenced in b5 is filed under a separate medwatch report number.
Event or Problem Description
Patient id: (b)(6).It was reported that on (b)(6) 2025, one 6.0x100 mm absolute pro stent and one 5.5x150 mm supera stent were implanted in the proximal right superficial femoral artery (sfa).On (b)(6) 2025, computed tomography angiography suggested multi vessel stenosis and occlusion in the lower limb artery.The degree of in-stent restenosis was 60% in both the supera and absolute pro stents.On (b)(6) 2025, balloon angioplasty of the right posterior tibial artery and popliteal artery was performed.Afterwards, the patient underwent hemodialysis.On (b)(6) 2025, the patient underwent a right second toe amputation secondary to diabetic foot gangrene.After the intervention, symptomatic treatment such as anti-infection, pain relief and rehydration was given.The patient was discharged from the hospital on (b)(6) 2025.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: 25364486
• Report Number: 2024168-2026-02236
• Device Sequence Number: 10679720
• Product Code: NIP
• UDI-Device Identifier: 08717648226168
• UDI-Public: (01)08717648226168(17)260630(10)4072461
• 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: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Study,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?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2026
• Device Model Number: S-55-150-120-P6
• Device Catalogue Number: S-55-150-120-P6
• Device Lot Number: 4072461
• 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: 05/18/2026
• Supplement Date Received by Manufacturer: 06/24/2026
• Initial Report FDA Received Date: 06/02/2026
• Supplement Report FDA Received Date: 07/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/24/2024
• 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: 5.5X150 MM SUPERA STENT
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization; Disability
• Patient Age: 60 YR
• Patient Sex: Male
• Patient Weight: 84 KG