MAUDE Adverse Event Report: ABBOTT VASCULAR INC. Esprit¿; Scaffold,infrapopliteal,absorbable

Model Number	1203300-38
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Impaired Healing (2378); Obstruction/Occlusion (2422)
Date of Event	07/01/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient id: (b)(6).It was reported the initial procedure was performed on (b)(6) 2025 to treat a heavily calcified lesion in the proximal right anterior tibial artery (ata).The 3.0 x 38mm esprit btk scaffold was implanted without issue.The patient returned on (b)(6) 2026 with a recurrent wound ulcer on the right foot and a lower limb angiogram revealed chronic total occlusion of the right proximal to mid ata, posterior tibial artery and of the right peroneal artery.Atherectomy and angioplasty were performed on (b)(6) 2026 as treatment.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.C3 - #1 frequency units: 1 per year was entered; however, the frequency is 1 dose per implant.

• Brand Name: Esprit¿
• Common Device Name: Scaffold,infrapopliteal,absorbable
• Manufacturer (Section D): ABBOTT VASCULAR INC.; 3200 lakeside drive; santa clara CA 95054 -280
• Manufacturer (Section G): ABBOTT VASCULAR, Reg # 2024168; 26531 ynez road; temecula CA 92591 -462
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591--462 ; +1(951)914-5259
• MDR Report Key: 50325868
• Report Number: 2024168-2026-03247
• Device Sequence Number: 9714867
• Product Code: NXW
• UDI-Device Identifier: 08717648357015
• UDI-Public: (01)08717648357015(11)240717(17)250716(10)4071761
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P230036
• 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: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/15/2026

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: 07/16/2025
• Device Model Number: 1203300-38
• Device Catalogue Number: 1203300-38
• Device Lot Number: 4071761
• 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: Not provided
• Supplement Date Received by Manufacturer: 08/26/2026
• Initial Report FDA Received Date: 08/19/2026
• Supplement Report FDA Received Date: 09/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/17/2024
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 36 YR
• Patient Sex: Male
• Patient Weight: 217 LB
• Patient Race: White