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

Model Number	1203350-38
Medical Device Problem Codes	Stretched (1601); Device Damaged by Another Device (2915)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/24/2025
Type of Reportable Event	Malfunction
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.Based on the information received, the investigation determined that the reported issue appears to be related to operational context of the procedure as it is likely the reported interaction with guide wire (or any other procedural accessory) contributed to the reported stretched scaffold.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 that the procedure was to treat a totally occluded lesion in the right anterior tibial artery.A non-abbott balloon was used for pre-dilatation up and down the lesion but a part of it did not open.The jade balloon was used to open the lesion some more and an orbital atherectomy system (oas) was also used.Three esprit btk stents were implanted to the distal portion of the right anterior tibial artery without issues.The 3.5x38mm esprit btk stent was then implanted to the proximal portion successfully.However, guidewire access was lost.A new non-abbott guidewire was attempted to gain access but failed even with the aid of a.018 support catheter.During this time, the implanted scaffold was noted to have stretched still within the target lesion upon fluoroscopy, and the markers were intact.It was noted that either unspecified guidewire or the micro catheter damaged the scaffold.No intervention was performed, and the procedure was aborted since guidewire access could not be re-established.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: 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: 23843500
• Report Number: 2024168-2025-12162
• Device Sequence Number: 9816851
• Product Code: NXW
• UDI-Device Identifier: 08717648357091
• UDI-Public: (01)08717648357091(11)250910(17)270909(10)5091061
• Combination Product (Y/N): Y
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: P230036
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/18/2025

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 Model Number: 1203350-38
• Device Catalogue Number: 1203350-38
• Device Lot Number: 5091061
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/24/2025
• Initial Report FDA Received Date: 12/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/10/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 0.018 QUICKCROSS SUPPORT CATHETER.; CHOICE PT FLOPPY GUIDEWIRE, 0.018 QUICKCROSS SUPPO.
• Patient Sex: Unknown