MAUDE Adverse Event Report: ABBOTT VASCULAR INC. ESPRIT BTK; Scaffold,infrapopliteal,absorbable

Model Number	1203300-38
Medical Device Problem Codes	Deformation Due to Compressive Stress (2889); Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/12/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the procedure was to treat a lesion in the left anterior tibial artery.The 3x38mm esprit btk scaffold was advanced to the target lesion; however, the shaft kinked during a deployment attempt.Therefore, the device was removed from the patient.Another 3x38mm esprit device was used to continue the procedure.There was no adverse patient effect and no clinically significant delay reported 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.Based on the information received, the investigation determined that the reported issue appears to be related to operational context as it is likely handling and/or manipulation of the device during use resulted in the reported shaft kink.The kinked shaft likely caused a pinched/reduced inflation lumen causing the reported activation failure of the stent.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.

• Brand Name: ESPRIT BTK
• 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: 50525616
• Report Number: 2024168-2026-03391
• Device Sequence Number: 15909744
• Product Code: NXW
• UDI-Device Identifier: 08717648357015
• UDI-Public: (01)08717648357015(11)260113(17)280112(10)6011361
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 08/31/2026

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: 1203300-38
• Device Catalogue Number: 1203300-38
• Device Lot Number: 6011361
• 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: 08/06/2026
• Initial Report FDA Received Date: 08/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/13/2026
• 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
• Patient Sex: Unknown