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

Model Number	1804275-12
Medical Device Problem Code	Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/27/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported resistance was met advancing the 2.75x12mm rx xience skypoint stent delivery system (sds) over a hi torque floppy guide wire.The sds was unable to advance through the copilot valve.The sds was removed and replaced with another same size skypoint.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
A visual inspection was performed on the returned device.The reported difficulty to advance could not be confirmed due to the condition the device was received 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.Based on the reported information and the observations from the returned analysis, the investigation determined that the reported issue appears to be related to circumstances of the procedure.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 ; EI
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 21264717
• Report Number: 2024168-2025-00999
• Device Sequence Number: 9511615
• Product Code: NIQ
• UDI-Device Identifier: 08717648233142
• UDI-Public: (01)08717648233142(17)260215(10)3022241
• Combination Product (Y/N): Y
• Initial Reporter State: OH
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/29/2025

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 Expiration Date: 02/15/2026
• Device Model Number: 1804275-12
• Device Catalogue Number: 1804275-12
• Device Lot Number: 3022241
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/20/2025
• Initial Report FDA Received Date: 01/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/16/2023
• 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: COPILOT; HI TORQUE FLOPPY GUIDE WIRE
• Patient Sex: Unknown