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

Model Number	1804350-28
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); Material Deformation (2976); Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/03/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.H6 medical device problem code: 2017 - use after damage.
Event or Problem Description
T was reported that the procedure was to treat a heavily tortuous, moderately calcified right coronary artery.The vessel was predilated with a 2.5x15mm non-abbott balloon.The 3.5x28mm xience skypoint stent delivery system was opened, removed from packaging and a slight flare was already observed on the proximal side of the stent.The 3.5x28mm xience skypoint was inserted and attempted to be advanced; however, resistance was felt and the stent was not deployed.A new 3.5x28mm xience skypoint was used to successfully complete the procedure.There was no adverse patient effects and no clinically significant delay in the procedure.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.A conclusive cause for the reported difficulties could not be determined.Factors that could contribute to material deformation include, but are not limited to, inadvertent mishandling during sheath/stylet removal, preparation, during use of the device, or interaction with anatomy or accessory devices.Factors that may contribute to an activation failure including expansion failures include, but are not limited to, inflation technique, contrast concentration, loose connection with the indeflator, anatomical conditions, contamination in the inflation lumen or damage to the guide wire and/or inflation lumen.In this case, it is possible that inadvertent mishandling during unpackaging of the device or sheath/stylet removal may have contributed to the reported material deformation.Further interaction with accessory devices during advancement and attempted deployment, as resistance was noted, may have contributed to the reported activation failure; however, without the product to examine, this cannot be confirmed.It was reported that the 3.5x28mm xience skypoint stent delivery system (sds) was removed from the packaging and a slight flare was observed on the proximal side of the stent; however, the xience skypoint was inserted and attempted to be advanced.It should be noted that the xience skypoint, everolimus eluting coronary stent system (eecss), instructions for use (ifu), states to carefully remove the system from the package and inspect for bends, kinks, and other damage.Verify that the stent does not extend beyond the radiopaque balloon markers.Do not use if any defects are noted.It is unknown if the ifu deviation(s) directly caused or contributed to the reported event.There is no indication of a product quality issue with respect to manufacture, design, or labeling.

• 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: 23393859
• Report Number: 2024168-2025-11225
• Device Sequence Number: 13248223
• Product Code: NIQ
• UDI-Device Identifier: 08717648233425
• UDI-Public: (01)08717648233425(17)270829(10)4090641
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/18/2025

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: 1804350-28
• Device Catalogue Number: 1804350-28
• Device Lot Number: 4090641
• 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: 10/06/2025
• Supplement Date Received by Manufacturer: 10/30/2025
• Initial Report FDA Received Date: 10/27/2025
• Supplement Report FDA Received Date: 11/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/30/2024
• 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