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

Model Number	1804350-38
Medical Device Problem Codes	Break (1069); Improper or Incorrect Procedure or Method (2017); Defective Device (2588); Material Deformation (2976); Activation Failure (3270); Noise, Audible (3273); Migration (4003); Failure to Deflate (4060)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/12/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the procedure was to treat a de novo, mildly calcified, mildly tortuous mid-right coronary artery lesion with 50% stenosis.A 3.5x38 mm xience skypoint drug-eluding stent (des) was advanced to the target lesion.However, a scraping/grinding sound was heard.The stent was removed and inspected, but no damage was noted.The stent was advanced to the target lesion again.During inflation at 6 atm, only the distal portion of the balloon inflated due to a crack in the shaft.Therefore, the stent was partially deployed, and the balloon was unable to be deflated.The delivery system was slowly removed and the stent moved back to the proximal section of the lesion.The delivery system was removed, but the stent remained in the anatomy and had shortened to 30 mm.A 4 mm balloon dilation catheter was used to fully deploy the stent.The stent was deployed in part of the lesion site and a healthy segment, and the stent struts appeared to be overlapped in two layers.A new 4x23 mm xience des was used to complete the procedure.There were no adverse patient effects and there was no clinically significant delay in the procedure.No additional information was provided.
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 - re-insertion.

• 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--462 ; +1(951)914-5259
• MDR Report Key: 25722677
• Report Number: 2024168-2026-02629
• Device Sequence Number: 12168956
• Product Code: NIQ
• UDI-Device Identifier: 08717648233449
• UDI-Public: (01)08717648233449(17)281202(10)5120541
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• PMA/510(K) Number: P110019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• 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): 09/23/2026

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: 1804350-38
• Device Catalogue Number: 1804350-38
• Device Lot Number: 5120541
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/09/2026
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/15/2026
• Supplement Date Received by Manufacturer: 09/04/2026
• Initial Report FDA Received Date: 07/06/2026
• Supplement Report FDA Received Date: 09/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/03/2025
• 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