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

Model Number	1804450-23
Medical Device Problem Codes	Leak/Splash (1354); Improper or Incorrect Procedure or Method (2017); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/11/2026
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 guiding catheter / sheath selection.H6: medical device problem code: 2017 / 2017 excessive force.
Event or Problem Description
It was reported that the procedure was a 90% stenosed lesion in the right coronary artery (rca) with moderate calcification and moderate tortuosity.The 4.5 x 23 mm xience skypoint stent delivery system (sds) was advanced to the target lesion, but resistance was met with the anatomy.Therefore, a guide extension catheter was used.However, as the guide extension catheter was not in specification for compatibility with the sds, force was applied the push the stent through the guide extension catheter.Then at the target lesion, the balloon was attempted to be inflated to deploy the stent; however, the balloon would not inflate, and no pressure was able to be held.A leak was noted to be at the proximal end.The sds was removed from the patient and a 4.0 mm xience skypoint stent was used to continue the procedure.There was no adverse patient effect and no clinically significant delay reported in the procedure.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: 24747065
• Report Number: 2024168-2026-01316
• Device Sequence Number: 15744690
• Product Code: NIQ
• UDI-Device Identifier: 08717648233579
• UDI-Public: (01)08717648233579(17)270929(10)4100841
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/22/2026

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: 1804450-23
• Device Catalogue Number: 1804450-23
• Device Lot Number: 4100841
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/11/2026
• Supplement Date Received by Manufacturer: 05/01/2026
• Initial Report FDA Received Date: 03/31/2026
• Supplement Report FDA Received Date: 05/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/30/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: MEDTRONIC TELESCOPE GUIDE EXTENSION.
• Patient Sex: Unknown