MAUDE Adverse Event Report: ABBOTT VASCULAR INC. XIENCE Skypoint¿; Coronary Drug-Eluting Stent

Model Number	1804350-18
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/09/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the procedure was to treat the circumflex coronary artery.The 3.5x18 mm xience skypoint stent dislodged from the delivery system prior to reaching the target lesion.There was no resistance.The stent went down into the aorta and is undeployed.A snare was attempted but was unsuccessful.A non-abbott stent was used to treat the target lesion and the patient was discharged as planned.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 provided, a definitive cause for the reported issue could not be determined.Stent dislodgement can be influenced by several factors, including, but not limited to, improper or inadequate stent crimping during manufacturing, incorrect sheath sizing, positive pressure applied during device preparation, forced sheath removal, mishandling of the stent during preparation, and interactions with patient anatomy and/or other interventional devices.An attempt to retrieve the dislodged stent using a snare was unsuccessful, and an additional stent was subsequently implanted to treat the target lesion.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.C3: 1 per year was entered; however, the frequency is 1 dose per implant.

• Brand Name: XIENCE Skypoint¿
• Common Device Name: Coronary Drug-Eluting Stent
• Manufacturer (Section D): ABBOTT VASCULAR INC.; 3200 lakeside drive; santa clara CA 95054 -280
• Manufacturer (Section G): ABBOTT VASCULAR, Reg # 3005718570 (P099); cashel road; clonmel tipperary UNK ; EI UNK
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591--462 ; +1(951)914-5259
• MDR Report Key: 50935930
• Report Number: 2024168-2026-03753
• Device Sequence Number: 13161239
• Product Code: NIQ
• UDI-Device Identifier: 08717648233401
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P110019
• 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): 09/29/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 1804350-18
• Device Catalogue Number: 1804350-18
• Device Lot Number: 5052641
• 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: 09/09/2026
• Initial Report FDA Received Date: 09/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/19/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown
• Patient Weight: 214 LB