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

Model Number	1804250-15
Medical Device Problem Codes	Deflation Problem (1149); Difficult to Remove (1528); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/20/2025
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.It was reported that the contrast mix used was 40 contrast/60 saline.It should be noted that the xience skypoint, everolimus eluting coronary stent system (eecss), electronic instructions for use (ifu) states: contrast diluted 1:1 with heparinized normal saline.It is unknown if the ifu deviation directly caused or contributed to the reported event.Based on the information provided, a definitive cause for the reported difficulties could not be determined.Factors that may contribute to deflation problems include, but are not limited to, deflation technique, contrast concentration, contamination in the inflation lumen, damage to the guide wire and/or inflation lumen.Factors that can contribute to difficult to remove include, but are not limited to, kinks, bends, procedural technique, anatomical conditions, insufficient support, guiding catheter size selection, or interactions with other devices.In this case, it is possible the balloon did not have adequate time to fully deflate once the stent was deployed and negative pressure was held prior to retraction and/or contrast concentration, causing the reported deflation problem.In addition, it is also possible the device may have interacted with the mildly calcified, mildly tortuous lesion during removal of the device, as resistance was noted, ultimately causing the reported difficult to remove; however, based on the information provided and without the device to examine, this cannot be confirmed.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 that the procedure was performed to treat a mildly calcified and tortuous lesion in the ramus branch.After deploying a 2.5x15mm xience skypoint drug-eluting stent (des) it was noted that the balloon on the delivery catheter could not be fully deflated when negative pressure was applied for 30sec.Causing resistance during withdrawal attempts.Following multiple attempts to deflate the balloon with an indelfator, the balloon was ultimately fully deflated with another syringe and the procedure was completed.There were no adverse patient effects nor clinical delay.No additional information was provided.

• 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: 22332254
• Report Number: 2024168-2025-06514
• Device Sequence Number: 12869233
• Product Code: NIQ
• UDI-Device Identifier: 08717648233074
• UDI-Public: (01)08717648233074(17)271120(10)4112741
• Combination Product (Y/N): Y
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: P110019
• 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
• Report Date (Section B): 06/25/2025

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: 1804250-15
• Device Catalogue Number: 1804250-15
• Device Lot Number: 4112741
• 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: 06/04/2025
• Initial Report FDA Received Date: 06/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/21/2024
• 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 Age: 78 YR
• Patient Sex: Female
• Patient Weight: 96 KG