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

Model Number	1203250-38
Medical Device Problem Codes	Difficult to Remove (1528); 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	05/20/2025
Type of Reportable Event	Malfunction
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 procedure was to treat the posterior tibial artery.The 2.5x38mm esprit below the knee (btk) was not prepped and noted to feel resistance when removing the protective sheath.It should be noted that the esprit scaffold system instruction for use (ifu) lists the dual layer sheath removal to be performed prior to the delivery system preparation.In this case, it is unknown if the ifu deviation related to incorrect prep contributed to the reported event.Based on the information provided, a definitive cause for the reported issues 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.
Event or Problem Description
It was reported that the procedure was to treat the posterior tibial artery.The 2.5x38mm esprit below the knee (btk) was not prepped and noted to feel resistance when removing the protective sheath.The 300 non-abbott guide wire was already in place when the esprit was attempted to be advance; however, before it could advance in the anatomy the device became stuck with the guide wire.The device could not be removed independently; therefore, the guide wire and esprit were removed together.The case was aborted and no further treatment was provided.There was no adverse patient effect reported and no clinically significant delay reported.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: 22179875
• Report Number: 2024168-2025-05995
• Device Sequence Number: 9227597
• Product Code: NXW
• UDI-Device Identifier: 08717648357251
• UDI-Public: (01)08717648357251(11)241009(17)261008(10)410096A
• Combination Product (Y/N): Y
• Initial Reporter State: IL
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 06/10/2025

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: 1203250-38
• Device Catalogue Number: 1203250-38
• Device Lot Number: 410096A
• 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: 05/20/2025
• Initial Report FDA Received Date: 06/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/09/2024
• 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