MAUDE Adverse Event Report: ABBOTT VASCULAR INC. ESPRIT¿; SCAFFOLD,INFRAPOPLITEAL,ABSORBABLE

Model Number	1203375-38
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Obstruction/Occlusion (2422)
Date of Event	04/23/2025
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 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 system instructions for use as a known patient effect of coronary scaffolding procedures.A conclusive cause for the reported patient effect, 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
(b)(4).It was reported that on (b)(6) 2025 one 3.75x38 mm esprit btk scaffold was implanted in the proximal left anterior tibial artery (ata).On (b)(6) 2025, duplex ultrasound showed the scaffold was occluded.Balloon angioplasty was performed in the ata, tibioperoneal trunk and left popliteal arteries on (b)(6) 2025.No additional information was provided.
Additional Manufacturer Narrative
Correction: b3 - date of event: updated from (b)(6) 2025 to (b)(6) 2025.B5 - describe event or problem: updated based on additional information received.
Event or Problem Description
Subsequent to the previously filed report, additional information was received that the scaffold was found occluded via the duplex ultrasound on (b)(6) 2025.No additional information was provided.

• 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: 22959112
• Report Number: 2024168-2025-09405
• Device Sequence Number: 8453379
• Product Code: NXW
• UDI-Device Identifier: 08717648357176
• UDI-Public: (01)08717648357176(11)240611(17)250610(10)4061161
• 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
• Report Date (Section B): 10/29/2025

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: 06/10/2025
• Device Model Number: 1203375-38
• Device Catalogue Number: 1203375-38
• Device Lot Number: 4061161
• 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: 08/13/2025
• Supplement Date Received by Manufacturer: 10/10/2025
• Initial Report FDA Received Date: 09/03/2025
• Supplement Report FDA Received Date: 10/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/11/2024
• 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; Required Intervention
• Patient Age: 78 YR
• Patient Sex: Female
• Patient Weight: 48 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American