MAUDE Adverse Event Report: ABBOTT VASCULAR INC. XIENCE SKYPOINT¿; CORONARY DRUG-ELUTING STENT

Model Number	1804300-12
Medical Device Problem Codes	Leak/Splash (1354); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/18/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the procedure was to treat the right coronary artery with mild tortuosity and 90% stenosis.The 3.0x12 mm xience skypoint stent delivery system (sds) was advanced to the lesion and air removal was attempted prior to positioning at the lesion.Negative pressure could not be properly applied and blood returned into the system.The device was not used and was replaced with a new same size xience skypoint sds.There were no adverse patient effects and there was no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
H6 medical device problem code: 2017, incorrect prep.Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.
Additional Manufacturer Narrative
A visual and functional inspection was performed on the returned device.The reported leak/splash was 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.Based on the reported information and the observations from the returned analysis, a definitive cause for the reported leak/splash could not be determined.Factors that may contribute to a leak include, but are not limited to, inflation technique, contrast concentration, loose connection with the indeflator, contamination in the inflation lumen, interaction with accessory devices, or damage to the balloon, guide wire and/or inflation lumen.In addition, it was reported the 3.0x12 mm xience skypoint stent delivery system (sds) was advanced to the lesion and air removal was attempted prior to positioning at the lesion.It should be noted that the xience skypoint, electronic instructions for use (eifu) states: prepare an inflation device / syringe with diluted contrast medium.Attach an inflation device / syringe to the stopcock; attach to the inflation port.With the tip down, orient the delivery system vertically.Open the stopcock to delivery system; pull negative for 30 seconds; release to neutral for contrast fill.Close the stopcock to the delivery system; purge the inflation device / syringe of all air.Repeat steps until all air is expelled.It is unknown if the eifu deviation(s) directly caused or contributed to the reported event.In this case, it is possible the device may have interacted with the mildly tortuous, 90% stenosed lesion and/or accessory devices causing the observed material damage to the inner/outer member, ultimately causing the reported leak/splash; however, based on the information received and analysis of the returned device, a conclusive cause for the reported leak/splash cannot 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.

• Brand Name: XIENCE SKYPOINT¿
• Common Device Name: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): ABBOTT VASCULAR INC.; 3200 lakeside drive; santa clara CA 95054 2807
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 3005718570 (P099); cashel road; clonmel tipperary UNK ; EI UNK
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 22964356
• Report Number: 2024168-2025-09423
• Device Sequence Number: 18407657
• Product Code: NIQ
• UDI-Device Identifier: 08717648233227
• UDI-Public: (01)08717648233227(17)280219(10)5022541
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/13/2025

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: 1804300-12
• Device Catalogue Number: 1804300-12
• Device Lot Number: 5022541
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/18/2025
• Supplement Date Received by Manufacturer: 09/29/2025
• Initial Report FDA Received Date: 09/04/2025
• Supplement Report FDA Received Date: 10/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/20/2025
• 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 Sex: Unknown