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

Model Number	1203300-18
Medical Device Problem Codes	Difficult to Advance (2920); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/14/2025
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 treat the ostium of the anterior tibial artery.A 3.0x18mm esprit below the knee (btk) was implanted without issue; however, the 3.0x18mm was a smaller stent than what the physician wanted to use but was only size available and planned for re-intervention on a later date.On (b)(6) 2025, when advancing a 4fr x 90cm angled guide catheter attempting to cross the previously implanted esprit resistance was met and the scaffold accordioned and folded up on itself.It was observed angiographically as the platinum markers went from 18mm apart to about 2mm apart.There was no adverse patient effect and no clinically significant delay in the procedure no additional information was provided.
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 the esprit btk 3.0 x 18 mm scaffold was implanted two weeks prior to the reported event.During advancement of a procedural guide catheter interaction occurred with the implanted scaffold causing the reported difficulty to advance and subsequent material deformation of the implanted 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.

• 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: 22932729
• Report Number: 2024168-2025-09333
• Device Sequence Number: 16010230
• Product Code: NXW
• UDI-Device Identifier: 08717648356971
• UDI-Public: (01)08717648356971(11)240409(17)260408(10)404096A
• Combination Product (Y/N): Y
• Initial Reporter State: WI
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/24/2025

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: 04/08/2026
• Device Model Number: 1203300-18
• Device Catalogue Number: 1203300-18
• Device Lot Number: 404096A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/14/2025
• Supplement Date Received by Manufacturer: 10/01/2025
• Initial Report FDA Received Date: 09/02/2025
• Supplement Report FDA Received Date: 10/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/09/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 4FR X 90CM ANGLED QUICKCROSS
• Patient Age: 67 YR
• Patient Sex: Unknown
• Patient Weight: 97 KG
• Patient Race: White