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

Model Number	1203250-18
Medical Device Problem Codes	Difficult to Remove (1528); Material Separation (1562); Improper or Incorrect Procedure or Method (2017); Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/15/2025
Type of Reportable Event	Serious Injury
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 the physician pulled hard to remove the system; however it separated at the shaft.It should be noted that the esprit btk everolimus eluting resorbable scaffold system instruction for use states: applying excessive force to the delivery system can potentially result in the loss of or damage to the delivery system components.In this case, it is unknown if the instruction for use (ifu) deviation related to excessive force caused the reported difficulties.Based on the information received, the investigation determined that the reported issue appears to be related to operational context.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.H6 medical device problem code: 2017 - excessive force.
Event or Problem Description
It was reported that the procedure was to treat the calcified lesion in the posterior tibial artery.Pre-dilatation was performed and the vessel diameter after pre-dilatation was 2.5 mm.The 2.50x18mm esprit btk system was advanced through a short 6fr sheath up and over but there was not enough support and the device became stuck.The physician pulled hard to remove the system; however it separated at the shaft.The patient was sent to surgery to remove the separated portion.There were no adverse patient sequela and no clinically significant delay in the procedure.No additional information was provided.

• 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: 21880796
• Report Number: 2024168-2025-04151
• Device Sequence Number: 8632149
• Product Code: NXW
• UDI-Device Identifier: 08717648357213
• UDI-Public: (01)08717648357213(11)241016(17)260415(10)4101661
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• 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): 04/22/2025

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 04/15/2026
• Device Model Number: 1203250-18
• Device Catalogue Number: 1203250-18
• Device Lot Number: 4101661
• 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: 04/15/2025
• Initial Report FDA Received Date: 04/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/16/2024
• 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: SHORT 6FR SHEATH
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 65 YR
• Patient Sex: Male