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

Model Number	1203350-38
Medical Device Problem Code	Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/14/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A visual inspection was performed on the returned device.The reported difficulty to advance on the procedural guide was confirmed.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 of specific issue.Based on the reported information and the observations from the returned analysis, 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.
Event or Problem Description
It was reported the procedure was to treat a lesion in the right anterior tibial artery.The 3.50x38mm rx esprit btk system was advanced over a 0.014 command guide wire however resistance was met outside the patient.Another same size device was used to complete the procedure with a mailman 0.014 wire.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.Return device analysis noted the inner member was separated within the outer member.

• Brand Name: ESPRIT¿
• Common Device Name: STENT,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: 21772852
• Report Number: 2024168-2025-03500
• Device Sequence Number: 8220426
• Product Code: NXW
• UDI-Device Identifier: 08717648357091
• UDI-Public: (01)08717648357091(11)241007(17)260406(10)4100761
• 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
• 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): 04/04/2025

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 Expiration Date: 04/06/2026
• Device Model Number: 1203350-38
• Device Catalogue Number: 1203350-38
• Device Lot Number: 4100761
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/21/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/28/2025
• Initial Report FDA Received Date: 04/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/07/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 0.014 COMMAND GUIDE WIRE.
• Patient Age: 53 YR
• Patient Sex: Male