MAUDE Adverse Event Report: ABBOTT VASCULAR INC. Esprit¿; Scaffold,infrapopliteal,absorbable

Model Number	1203350-38
Medical Device Problem Codes	Difficult to Remove (1528); Difficult to Advance (2920); Material Deformation (2976); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/19/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the procedure was to treat a lesion in an unspecified artery.The 3.5x38mm esprit btk would not advance onto the 0.014" command es guidewire.The device did not enter sheath and would not go further.Scaffold and balloon were noted to be bunched up and deformed.Then the esprit could not be removed from the guidewire either.The guidewire was cut just before the balloon tip to proceed.The same guidewire with another esprit was used with no issue to complete the procedure.There was no adverse patient effect and there was no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.C3: 1 per year was entered; however, the frequency is 1 dose per implant.The additional device referenced in b5 & d10 is filed under separate medwatch report number.

• Brand Name: Esprit¿
• Common Device Name: Scaffold,infrapopliteal,absorbable
• Manufacturer (Section D): ABBOTT VASCULAR INC.; 3200 lakeside drive; santa clara CA 95054 -280
• Manufacturer (Section G): ABBOTT VASCULAR, Reg # 2024168; 26531 ynez road; temecula CA 92591 -462
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591--462 ; +1(951)914-5259
• MDR Report Key: 50758254
• Report Number: 2024168-2026-03531
• Device Sequence Number: 18440469
• Product Code: NXW
• UDI-Device Identifier: 08717648357091
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/14/2026

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 1203350-38
• Device Catalogue Number: 1203350-38
• Device Lot Number: 5101461
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/20/2026
• Initial Report FDA Received Date: 09/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/14/2025
• 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: 0.014" Command ES
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown