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

Model Number	1804350-23
Medical Device Problem Codes	Difficult to Advance (2920); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/07/2025
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 provided and without the device to examine, a definitive cause for the reported difficulties could not be determined; however, the subsequent unexpected medical intervention appears to be related to circumstances of the procedure.Stent dislodgement may be attributed to several factors including, but not limited to, improper or inadequate crimping at the time of manufacture, incorrect sheath sizing, positive pressure during preparation, forced sheath removal, handling of the stent during preparation, and interaction with patent anatomy or accessory devices.Difficult to advance/position may be attributed to several factors including, but are not limited to, product placement technique, guiding catheter support, anatomical conditions, inner diameter of guide wire lumen, outer diameter of the guide wire, condition of the guide wire, interaction with accessory devices, damage to the catheter, patient disease state, interaction with previously placed stents or accumulation of blood or contrast.In this case, it is possible the device may have interacted with the guide catheter/accessory devices during advancement, as resistance was noted, contributing to the reported difficulty to advance, ultimately causing the reported stent dislodgement; however, without the device to examine, this cannot be confirmed.An unspecified balloon was inserted and inflated to be able to remove the stent with the guide 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.
Event or Problem Description
It was reported that the procedure was to treat a heavily calcified left anterior descending artery.When attempting to advance the 3.5x23mm xience skypoint stent delivery system, resistance was felt with the unspecified guideliner and stent dislodged.An unspecified balloon was inserted and inflated to be able to remove the stent with guideliner.A new guideliner and stent were used to successfully complete the procedure.There was no adverse patient sequela and no clinically significant delay 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: 21921954
• Report Number: 2024168-2025-04397
• Device Sequence Number: 9086487
• Product Code: NIQ
• UDI-Device Identifier: 08717648233418
• UDI-Public: (01)08717648233418(17)270929(10)4100841
• Combination Product (Y/N): Y
• Initial Reporter State: PA
• 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): 04/28/2025

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 Model Number: 1804350-23
• Device Catalogue Number: 1804350-23
• Device Lot Number: 4100841
• 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: 04/07/2025
• Initial Report FDA Received Date: 04/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown