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

Model Number	1212350-38
Medical Device Problem Code	Difficult or Delayed Activation (2577)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/23/2026
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.A cine was received and reviewed by an abbott clinical specialist.The lesion was not fully prepared prior to implantation of the esprit scaffold system.The waist indicates that the calcification in that area was unable to be properly expanded.The ifu indicates that the user should fully pretreat the lesion confirming that the lesion is expandable prior to implantation of the esprit btk scaffold system.The pretreatment with the atherectomy likely debulked the calcification but further pretreatment of the area was needed.Based on the information received, the investigation determined that the reported issue appears to be related to operational context as it is likely the patients calcified anatomy resulted in the reported difficulty to deploy.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 the procedure was to treat a calcified lesion in the right anterior tibial (at) artery.The lesion was prepared with a diamondback atherectomy device and balloon inflations.A non-abbott guide wire was advanced to the lesion with resistance noted due to the calcium.The 3.50x38mm otw esprit btk system was advanced to the target lesion and the balloon inflated to 16 atmospheres (atm) however under angio it was noted there was a portion of the middle of the balloon that did not inflate.Inflation was increased to 20 atm however the middle still did not inflate.The scaffold was deployed therefore the esprit btk system was retracted.The physician wanted to test the balloon therefore it was inflated in another part of the lesion and the balloon was able to fully inflate with no waist.The esprit btk system was removed and the lesion post dilated with a non-compliant balloon.In the physicians opinion, the waist was due to calcium in the lesion and not a balloon issue.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: 24531836
• Report Number: 2024168-2026-00936
• Device Sequence Number: 8894827
• Product Code: NXW
• UDI-Device Identifier: 08717648353703
• UDI-Public: (01)08717648353703(11)251117(17)271116(10)5111761
• 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
• Device Implanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/06/2026

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: 1212350-38
• Device Catalogue Number: 1212350-38
• Device Lot Number: 5111761
• 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: 02/23/2026
• Initial Report FDA Received Date: 03/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/17/2025
• 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: 81 YR
• Patient Sex: Female
• Patient Weight: 65 KG