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

Model Number	1212250-38
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Obstruction/Occlusion (2422)
Date of Event	02/27/2026
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 over-the-wire (otw) 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.The other scaffolds referenced in b5 are being filed under separate medwatch report numbers.
Event or Problem Description
Patient id: (b)(6).It was reported that on (b)(6) 2025 three esprit otw scaffolds (sizes 2.5x38, 3.0x38 (x2) mm) were implanted in the proximal right anterior tibial artery.During a follow-up appointment on (b)(6) 2026, the patient had bilateral cyanosis and non-palpable pulses.The patient was scheduled for an angiogram to treat a lower limb arterial occlusion (stenosis) in all three index scaffolds.On (b)(6) 2026, he underwent successful percutaneous transluminal angioplasty of the target anterior tibial artery, which improved from 100% stenosis to restored patency and flow.The procedure restored perfusion without complication, and the patient was discharged in stable condition the same day.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: 24944456
• Report Number: 2024168-2026-01628
• Device Sequence Number: 12081831
• Product Code: NXW
• UDI-Device Identifier: 08717648353864
• UDI-Public: (01)08717648353864(11)250505(17)270504(10)5050561
• Combination Product (Y/N): Y
• Initial Reporter State: MA
• 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): 04/21/2026

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: 1212250-38
• Device Catalogue Number: 1212250-38
• Device Lot Number: 5050561
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/30/2026
• Initial Report FDA Received Date: 04/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/05/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: TWO ESPRIT OTW SCAFFOLDS, SIZED 3.0X38 MM
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Male
• Patient Weight: 74 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White