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

Model Number	1203350-28
Medical Device Problem Codes	Break (1069); Failure to Advance (2524); Difficult to Advance (2920); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/05/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the procedure was to treat a lesion in the tibial artery.The 3.50 x 28 mm esprit btk system was advanced however the steep aortic bifurcation caused the sheath to back out of the contralateral side and resistance during advancement.The esprit failed to cross the lesion.Once removed it was noted the guide wire exit notch was torn and the support skive/wire/bayonet was separated 1 cm distal to the outer member to hypotube seal, however, was held by the outer member.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.
Event or Problem Description
It was reported the procedure was to treat a lesion in the tibial artery.The 3.50x28mm esprit btk system was advanced however the steep aortic bifurcation caused the sheath to back out of the contralateral side and resistance during advancement.The esprit failed to cross the lesion.Once removed it was noted the guide wire exit notch was torn and the support skive/wire/bayonet was separated 1 cm distal to the outer member to hypotube seal, however, was held by the outer member.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
Visual inspection, functional testing and dimensional analysis were performed on the returned device.The reported notch and shaft break were confirmed.The reported difficulty/failure to advance 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 was reported that when the device was advanced towards the lesion the sheath backed out due to the difficult anatomy.It is likely the device interacted with the introducer sheath due to this movement causing the reported difficulty to advance.Continued interaction with the difficult anatomy likely resulted in the reported failure to advance.After removal it was observed that the guide wire notch was torn likely due to interaction with the procedural guide wire during the difficult advancement.Additionally, a skive break was identified, held together by the outer member.It is likely the skive was bent and/or torqued due to handling during the difficult advancement, ultimately causing the skive to bend to the point of breaking.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.

• Brand Name: ESPRIT¿
• Common Device Name: SCAFFOLD,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: 24764539
• Report Number: 2024168-2026-01348
• Device Sequence Number: 9349016
• Product Code: NXW
• UDI-Device Identifier: 08717648357077
• UDI-Public: (01)08717648357077(11)250806(17)270805(10)5080661
• Combination Product (Y/N): Y
• Initial Reporter State: GA
• 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,Followup
• Report Date (Section B): 04/07/2026

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: 1203350-28
• Device Catalogue Number: 1203350-28
• Device Lot Number: 5080661
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/05/2026
• Supplement Date Received by Manufacturer: 04/03/2026
• Initial Report FDA Received Date: 04/02/2026
• Supplement Report FDA Received Date: 04/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/06/2025
• 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 Age: 63 YR
• Patient Sex: Male