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

Model Number	1203300-38
Medical Device Problem Codes	Break (1069); Difficult to Advance (2920)
Health Effect - Clinical Codes	Pain (1994); Thrombosis/Thrombus (4440)
Date of Event	08/08/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported the initial procedure on (b)(6) 2026 was to treat a lesion in the anterior tibial artery (ata).Four esprit btk scaffolds (2.50x38 and three 3.0x38mm) were implanted.Optical frequency domain imaging (ofdi) performed immediately after implantation confirmed good apposition of the scaffolds.The patient had relatively high adl despite chronic limb-threatening ischemia (clti) and reportedly massaged the lower leg because of pain and frequently walked to improve blood flow.The patient returned to the hospital on (b)(6) 2026 and although the great toe wound was healing and showed almost no deterioration, angiography revealed occlusion beginning around the middle of the four implanted esprit scaffolds.Passage of the guidewire was difficult; however, after crossing the lesion, ofdi demonstrated disruption of the 3.0x38mm esprit structure and a fracture.A portion of the guidewire was observed outside the esprit.Although images were not immediately available, the central portion appeared substantially disrupted.The findings were similar to coronary bioresorbable stent thrombosis associated with loss of scaffold support during the resorption process, resulting in protrusion into the vessel lumen and subsequent thrombosis.Following dilation with a 3.0 mm balloon, blood flow improved without issue.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 thrombosis and pain are listed in the esprit btk everolimus eluting resorbable scaffold systems instructions for use as known patient effects of scaffolding procedures.Based on the information received, the investigation determined that the reported issue appears to be related to operational context as it is likely the advancing guide wire interacted with the implanted esprit btk scaffold causing the reported difficulty to advance (crossability) and subsequent scaffold break.A conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined; however, the subsequent treatment appears 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.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: 50454617
• Report Number: 2024168-2026-03309
• Device Sequence Number: 10377626
• Product Code: NXW
• UDI-Device Identifier: 08717648357015
• UDI-Public: (01)08717648357015(11)251120(17)271119(10)5112061
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P230036
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• 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,Followup
• Report Date (Section B): 10/01/2026

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 1203300-38
• Device Catalogue Number: 1203300-38
• Device Lot Number: 5112061
• 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: 08/11/2026
• Supplement Date Received by Manufacturer: 09/29/2026
• Initial Report FDA Received Date: 08/26/2026
• Supplement Report FDA Received Date: 10/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/20/2025
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown