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

Model Number	1203350-18
Medical Device Problem Codes	Difficult to Remove (1528); Material Separation (1562); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/08/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.H6 - medical device problem code 2017 clarifier: excessive force.
Event or Problem Description
It was reported the procedure was to treat a lesion in the proximal anterior tibial artery.The esprit btk system was advanced and the scaffold deployed in the target lesion.During removal of the system outside of the patient anatomy, the shaft became stuck on the guide wire.Force was applied in the attempts to remove the catheter and the shaft separated on the guide wire.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
A visual inspection was performed on the returned device.The reported difficulty to remove and shaft separation were 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 specific issue.Based on the reported information and the observations from the returned analysis, a definitive cause for the reported difficulty to remove from the guide wire could not be determined.Factors that may contribute to difficulty removing the guide wire include, but are not limited to, patient¿s disease state, patient¿s anatomical morphology, interaction with an accessory device, and/or damage to the guide wire.In this case, it is possible that an interaction between the guide wire in combination with procedural contaminants (blood/contrast) may have contributed to the reported difficulty to remove; however, this cannot be confirmed.Force was used against the reported resistance causing the reported shaft separation.It should be noted that the esprit btk instructions for use states: after successful withdrawal of the balloon from the deployed scaffold, should any resistance be felt at any time when withdrawing the scaffold delivery system remove the entire system as a single unit.Applying excessive force to the delivery system can potentially result in loss of or damage to the delivery system components.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 proximal anterior tibial artery.The esprit btk system was advanced and the scaffold deployed in the target lesion.During removal of the system outside of the patient anatomy, the shaft became stuck on the guide wire.Force was applied in the attempts to remove the catheter and the shaft separated on the guide wire.There were no adverse patient effects 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: 20824964
• Report Number: 2024168-2024-14153
• Device Sequence Number: 8928344
• Product Code: NXW
• UDI-Device Identifier: 08717648357053
• UDI-Public: (01)08717648357053(17)260331(10)4100161
• Combination Product (Y/N): Y
• Initial Reporter Country: CA
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/30/2025

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: 03/31/2026
• Device Model Number: 1203350-18
• Device Catalogue Number: 1203350-18
• Device Lot Number: 4100161
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/12/2024
• Supplement Date Received by Manufacturer: 01/17/2025
• Initial Report FDA Received Date: 12/02/2024
• Supplement Report FDA Received Date: 01/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/01/2024
• 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
• Patient Sex: Unknown