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); Ambient Temperature Problem (2878)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/06/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the procedure was to treat the right anterior tibial artery.The 2.50 x 28 mm esprit btk scaffold was successfully implanted.After deployment, it was observed that the thermoalert tag was noted to be tripped.It is unknown when the tag alert sensor was triggered as the device was not stored in a temperature monitored room.There were no adverse patient effects and no clinically significant delay in the procedure.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.It was reported that the esprit btk scaffold was successfully implanted, after which the thermoalert tag was noted to be tripped.It should be noted that the esprit btk everolimus eluting resorbable scaffold system instruction for use (ifu) states: a non-sterile temperature monitor included in the package is for the shipping and storage of the esprit btk system.Before use of the esprit btk system, check the temperature monitor located through window in the back of the product box.The indicator should only show a check mark as indicate.If any other screen is present, do not use the product.Based on the information provided, a definitive cause for the reported issue could not be determined.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.H6 medical device problem code: 2017: failure to follow steps/instructions.

• 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: 24491646
• Report Number: 2024168-2026-00858
• Device Sequence Number: 10681915
• Product Code: NXW
• UDI-Device Identifier: 08717648357237
• UDI-Public: (01)08717648357237(11)250213(17)270212(10)5021361
• Combination Product (Y/N): Y
• Initial Reporter State: MI
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/02/2026

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 Model Number: 1203250-28
• Device Catalogue Number: 1203250-28
• Device Lot Number: 5021361
• 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: 02/06/2026
• Initial Report FDA Received Date: 03/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/13/2025
• 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
• Patient Age: 78 YR
• Patient Sex: Female
• Patient Weight: 61 KG
• Patient Ethnicity: Non Hispanic