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

Model Number	1203350-38
Medical Device Problem Codes	Break (1069); Difficult to Flush (1251); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/27/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the tech could not flush the 3.5x38 mm esprit btk delivery system during prep.No patient was involved.The tech did not see heparinized saline coming out of the monorail port during prep.The tech removed the stylet from the delivery system and attached the syringe to the yellow cover (sheath covers scaffold).The tech tried to flush, but the fluid was not seen exiting.When that did not work, then they removed the sheath and tried to flush, but it still did not flush.They used another esprit btk to complete the procedure and that one flushed properly.Analysis of the returned device identified a break on the support/skive/wire/bayonet 5.6 cm distal to the outer member to hypotube seal but remained in the inflation lumen of the outer member.No additional information was provided.
Additional Manufacturer Narrative
A visual inspection and functional testing were performed on the returned device, which identified that the support/skive/wire/bayonet was separated 5.6cm distal to the outer member to hypotube seal.The reported difficulty flushing the device was not confirmed.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.It should be noted that the esprit btk everolimus eluting resorbably scaffold system instruction for use lists the dual layer sheath removal to be performed prior to the guide wire lumen flush.In this case, the initial difficulty appears to be related to the incorrect prep; however, the difficulty continued after the sheath/stylet removal.It is unknown if the instruction for use (ifu) deviation related to incorrect stent preparation caused the reported event.Based on the reported information and the observations from the returned analysis, a definitive cause for the reported issue could not be determined.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.H6 medical device problem code: 2017 - incorrect prep.

• Brand Name: ESPRIT¿
• Common Device Name: STENT,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: 21861302
• Report Number: 2024168-2025-03976
• Device Sequence Number: 18122078
• Product Code: NXW
• UDI-Device Identifier: 08717648357091
• UDI-Public: (01)08717648357091(11)240712(17)250711(10)4071261
• 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
• Report Date (Section B): 04/17/2025

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: 07/11/2025
• Device Model Number: 1203350-38
• Device Catalogue Number: 1203350-38
• Device Lot Number: 4071261
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/26/2025
• Initial Report FDA Received Date: 04/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/12/2024
• 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