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

Model Number	1203350-38
Medical Device Problem Codes	Peeled/Delaminated (1454); Deformation Due to Compressive Stress (2889); Difficult to Advance (2920); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/13/2025
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 performed was to treat a posterior tibial artery.An unspecified esprit btk scaffold over a 0.014" guide wire was deployed.A 3.50x38mm esprit btk resorbable scaffold system, was advanced when it was observed that the unspecified 0.014" guidewire was no longer at the posterior tibial artery.The guide wire was adjusted and the esprit btk pulled back.An attempt was made to advance the esprit btk; however, unsuccessful.The esprit btk was removed and the shaft was observed to be kinked.The failure to advance was noted to be due to the kink in the delivery system of the esprit btk.There were no adverse patient effects and no clinically significant delay in the procedure.Returned device analysis observed shredding noted at the distal balloon folds and the guide wire exit notch was torn distally for a length of 5 mm.No additional information was provided.
Additional Manufacturer Narrative
Visual inspection and functional testing were performed on the returned device.The reported shaft kink was confirmed.The reported failure to advance could not be confirmed due to the condition of the device when returned.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 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: 23598242
• Report Number: 2024168-2025-11611
• Device Sequence Number: 13083965
• Product Code: NXW
• UDI-Device Identifier: 08717648357091
• UDI-Public: (01)08717648357091(11)250313(17)270312(10)5031361
• Combination Product (Y/N): Y
• Initial Reporter State: PA
• 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): 02/20/2026

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: 1203350-38
• Device Catalogue Number: 1203350-38
• Device Lot Number: 5031361
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/29/2025
• Supplement Date Received by Manufacturer: 02/11/2026
• Initial Report FDA Received Date: 11/19/2025
• Supplement Report FDA Received Date: 02/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/13/2025
• 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
• Patient Weight: 62 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White