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	Ischemia (1942); Pain (1994); Stenosis (2263)
Date of Event	08/27/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient id: (b)(6).It was reported the initial procedure was to treat the proximal right anterior tibial (at) artery on (b)(6) 2025.A 3.0x38mm esprit btk scaffold was implanted without issue.On (b)(6) 2026, the patient returned with acute limb ischemia and pain in both legs however the left leg pain was more severe.Bilateral angiography showed left superficial femoral artery (sfa) chronic total occlusion (cto) with 70% popliteal stenosis and occluded tibial vessels.The angiography showed 90% sfa, popliteal, and proximal at stenosis with in-stent restenosis noted within the esprit scaffold.Attempted intervention of the left sfa was unsuccessful as the balloon catheter was unable to cross the lesion.No right leg intervention was performed.No additional information was provided.
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 query of the complaint handling database for the reported lot revealed there is no indication of a lot specific issue.The reported patient effects of ischemia, stenosis and pain are listed in the esprit btk everolimus eluting resorbable scaffold systems instructions for use as known patient effects of scaffold procedures.A conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined.There is no indication of a product quality issue with respect to manufacture, design or labeling.C3: 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: 50853996
• Report Number: 2024168-2026-03642
• Device Sequence Number: 18655318
• Product Code: NXW
• UDI-Device Identifier: 08717648357015
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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
• Report Date (Section B): 09/22/2026

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 Model Number: 1203300-38
• Device Catalogue Number: 1203300-38
• Device Lot Number: 412116A
• 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: 08/28/2026
• Initial Report FDA Received Date: 09/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/11/2024
• 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
• Patient Age: 59 YR
• Patient Sex: Male
• Patient Weight: 202 LB
• Patient Race: White