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

Model Number	1804250-18
Medical Device Problem Codes	Difficult to Remove (1528); Improper or Incorrect Procedure or Method (2017); Difficult to Advance (2920); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	06/06/2025
Type of Reportable Event	Serious Injury
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.Based on the information received, the investigation determined that the reported issue appears to be related to user error.The xience skypoint instructions for use (ifu) indicate, when treating multiple lesions within the same vessel, stent the distal lesion prior to stenting the proximal lesion.Stenting in this order obviates the need to cross the proximal stent during placement of the distal stent and reduces the chance of damaging or dislodging the proximal stent.It is likely the ifu violation of stenting the proximal lesion first caused interactions with the two stents during advancement to the more distal lesion.The advancing stent got stuck with the initially implanted stent during advancement and during removal resulting in the reported stent dislodgement.The stent was ultimately crushed with the initially implanted stent using a balloon catheter.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.H6 medical device problem code: 2017 - distal to stent.
Event or Problem Description
It was reported that the procedure was to treat a lesion in the left main coronary and ramus artery with mild to moderate calcification.An unspecified stent was implanted in the left main artery.Then, the physician directed an unspecified guide wire (gw) into the ramus artery and the lesion was ballooned successfully.The 2.5x18mm xience skypoint stent delivery system (sds) was then attempted to be advanced to the ramus artery; however, the sds met resistance when advancing through the first implanted stent and the sds became stuck with the implanted stent.An attempt was made to remove the sds, but the stent became dislodged and only the delivery system and gw were able to be removed from the patient.Therefore, the dislodged stent was crushed with a nc trek balloon against the initially implanted stent, ending the procedure.There was no adverse patient sequela 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: 22366684
• Report Number: 2024168-2025-06713
• Device Sequence Number: 21191233
• Product Code: NIQ
• UDI-Device Identifier: 08717648233081
• UDI-Public: (01)08717648233081(17)260620(10)3062841
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• 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): 06/30/2025

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/20/2026
• Device Model Number: 1804250-18
• Device Catalogue Number: 1804250-18
• Device Lot Number: 3062841
• 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: 06/09/2025
• Initial Report FDA Received Date: 06/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/21/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown