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	Obstruction/Occlusion (2422); Unspecified Tissue Injury (4559)
Date of Event	11/06/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.
Event or Problem Description
Patient id: (b)(6).It was reported that on (b)(6) 2025, one 3.0x38 mm esprit btk scaffold was implanted across the left, distal tibio-peroneal trunk and proximal peroneal arteries.The patient was seen in the clinic for a wound care follow-up on (b)(6) 2025.An ulcer at the left first toe progressed to gangrene at the toe tip.Arterial duplex scan of the left lower limb showed early re-occlusion of left peroneal artery with pre-existing chronic occlusion of left anterior and posterior tibial arteries.The patient was re-admitted to the hospital for a surgical bypass procedure.Angiogram, performed on (b)(6) 2026, showed distal occlusion with insufficient collaterals to support surgical bypass; therefore, the planned surgical intervention was not completed.The patient was discharged on (b)(6) 2026.No further intervention was performed during this hospitalization.The patient will follow-up with the clinic next week for further treatment options.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 effect of occlusion is listed in the esprit btk everolimus eluting resorbable scaffold systems instructions for use as a known patient effect of coronary stenting procedures.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.There is no indication of a product quality issue with respect to manufacture, design or labeling; therefore, no product-related corrective action will be implemented in this case.
Event or Problem Description
N/a.
Event or Problem Description
Subsequent to the previously filed report, additional information was received that on 03/27/2026 the patient underwent a limb salvage procedure on the left limb using the great saphenous vein to bypass the occlusion in the popliteal artery.The patient was admitted on (b)(6) 2026 and discharged on (b)(6) 2026.No additional information was provided.
Additional Manufacturer Narrative
B5 - describe event or problem: updated as additional information was received.

• Brand Name: ESPRIT¿
• Common Device Name: SCAFFOLD,INFRAPOPLITEAL,ABSORBABLE
• 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: 24166067
• Report Number: 2024168-2026-00357
• Device Sequence Number: 9112964
• Product Code: NXW
• UDI-Device Identifier: 08717648357015
• UDI-Public: (01)08717648357015(11)241202(17)260601(10)4120261
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• 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,Followup
• Report Date (Section B): 04/29/2026

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: 06/01/2026
• Device Model Number: 1203300-38
• Device Catalogue Number: 1203300-38
• Device Lot Number: 4120261
• 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: 12/31/2025
• Supplement Date Received by Manufacturer: 01/26/2026; 04/07/2026
• Initial Report FDA Received Date: 01/23/2026
• Supplement Report FDA Received Date: 02/16/2026; 04/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/02/2024
• 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: Required Intervention; Hospitalization
• Patient Age: 64 YR
• Patient Sex: Female
• Patient Weight: 64 KG
• Patient Race: Black Or African American