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

Model Number	1203300-38
Medical Device Problem Codes	Difficult to Remove (1528); Material Separation (1562); Improper or Incorrect Procedure or Method (2017); Failure to Advance (2524); Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/24/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that that the procedure was to treat a 95% stenosed de novo lesion in the tibioperineal trunk (tpt).The 3x38mm esprit btk rx scaffold system device was to be advanced, but resistance was felt with the bifurcation when the device came out of the sheath.The shaft became kinked and the esprit device could no longer be advanced or retracted despite multiple attempts.The physician pulled hard on the esprit device, and the distal portion of the esprit device became separated.Therefore, a snared was used to remove the separated portion and the remainder of the device was pulled out, ending the procedure.No additional information was provided.
Additional Manufacturer Narrative
A visual inspection was performed on the returned device.The reported shaft deformation and shaft separation were confirmed.The reported failure to advance and difficulty to remove could not be replicated in a testing environment as they were related to operational circumstances.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.Based on the reported information and the observations from the returned analysis, the investigation determined that the reported issue appears to be related to circumstances of the procedure as it is likely the device interacted with the mildly tortuous, mildly calcified and 95% stenosed anatomy during advancement causing the reported failure to advance and subsequent shaft kink.During removal it is likely the reported shaft kink caused and/or contributed to the reported difficulty to remove.The device was pulled hard against the reported resistance to remove the delivery system causing the shaft to separate.A snare was used to successfully remove the distal portion of the esprit btk device.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.C3: 1 per year was entered; however, the frequency is 1 dose per implant.H6: 2017 - improper or incorrect procedure or method - excessive force.

• 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: 50797485
• Report Number: 2024168-2026-03588
• Device Sequence Number: 10529417
• Product Code: NXW
• UDI-Device Identifier: 08717648357015
• UDI-Public: (01)08717648357015(11)260612(17)280611(10)6061262
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 09/16/2026

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: 1203300-38
• Device Catalogue Number: 1203300-38
• Device Lot Number: 6061262
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/01/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/25/2026
• Initial Report FDA Received Date: 09/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/12/2026
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown