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

Model Number	1203250-28
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/22/2026
Type of Reportable Event	Malfunction

• 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: 25846461
• Report Number: 2024168-2026-02823
• Device Sequence Number: 16108202
• Product Code: NXW
• UDI-Device Identifier: 08717648357237
• UDI-Public: (01)08717648357237(11)240620(17)260619(10)406206A
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P230036
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/16/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/19/2026
• Device Model Number: 1203250-28
• Device Catalogue Number: 1203250-28
• Device Lot Number: 406206A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/24/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/22/2026
• Initial Report FDA Received Date: 07/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/20/2024
• 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
• Patient Sex: Unknown