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

Model Number	1203375-38
Medical Device Problem Codes	Peeled/Delaminated (1454); Material Separation (1562); Failure to Advance (2524); Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/07/2025
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.
Event or Problem Description
It was reported that the procedure was performed to treat a mildly calcified lesion in the left anterior tibial artery.Following pre-dilatation, a 3.0x38mm, 3.75x38mm, and 3.75x38mm esprit btk scaffold devices were attempted to be advanced to the lesion; however, all the devices were noted to fail to cross the lesion, with subsequent kinks along the delivery system being noted.At this point a fourth unspecified esprit btk device was used and was successfully able to cross the lesion be implanted; however, following its removal, kinks on the delivery system were noted.There were no adverse patient effects nor clinical delay.The 3.75 x 38mm esprit btk device return analysis revealed that there was balloon material shredding noted along the balloon, and a portion of the distal end of the scaffold was separated and not returned.The account confirmed the correct device was returned and noted that they were unaware of the separation of the scaffold and shredding of the balloon.No additional information was provide.
Additional Manufacturer Narrative
A visual inspection was performed on the returned device.The reported shaft deformation was confirmed.The reported failure to advance could not be replicated in a testing environment as it was related to operational context of the procedure.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 of failure to advance and shaft deformation appears to be related to circumstances of the procedure.Balloon shredding was observed during return analysis of the device.It is unclear when this damage occurred as the account did not report shredding.It is possible the balloon shredding occurred due to friction during transit post procedure; however, this cannot be confirmed.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: 23137232
• Report Number: 2024168-2025-10252
• Device Sequence Number: 18364911
• Product Code: NXW
• UDI-Device Identifier: 08717648357176
• UDI-Public: (01)08717648357176(11)240611(17)260610(10)406116A
• Combination Product (Y/N): Y
• Initial Reporter State: OH
• 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): 03/02/2026

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 Expiration Date: 06/10/2026
• Device Model Number: 1203375-38
• Device Catalogue Number: 1203375-38
• Device Lot Number: 406116A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/27/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/05/2025
• Supplement Date Received by Manufacturer: 02/10/2026
• Initial Report FDA Received Date: 09/24/2025
• Supplement Report FDA Received Date: 03/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/11/2024
• 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