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

Model Number	1804400-12
Medical Device Problem Codes	Deflation Problem (1149); Difficult to Remove (1528); Improper or Incorrect Procedure or Method (2017); Device Dislodged or Dislocated (2923); Activation Failure (3270)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/04/2025
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.It was reported that during removal of the xience skypoint partially deflated balloon, resistance was met with anatomy and the stent came off the shaft.It should be noted that the xience skypoint everolimus eluting coronary stent system instruction for use (ifu) states: deflate the balloon by pulling negative on the inflation device.Confirm balloon deflation under fluoroscopy and wait 10-15 seconds longer.In this case, it is unknown if the reported issue with activation of the stent and likely loss of pressure may have prevented the deflation of the balloon prior to removal.Based on the information provided, a definitive cause for the reported activation failure could not be determined.The reported deflation problem, difficulty to remove and stent dislodgment with the reported foreign body in patient and treatment appear to be related to operational context 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.H6: medical device problem code: 2017, incorrect removal.
Event or Problem Description
It was reported that the procedure was to treat a moderately calcified, proximal left anterior descending coronary artery.An attempt to inflate the balloon of a 4.00x12mm xience skypoint drug-eluting stent (des) was made twice, and both times only reached 2 atmospheres.During removal of the xience skypoint partially deflated balloon, resistance was met with anatomy and the stent came off the shaft.An unspecified balloon was used to deploy the dislodged stent in the radial artery.A 4.00x12mm non-abbott device was used to complete the procedure.There was no adverse patient sequela and no clinically significant delay in 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: 21943862
• Report Number: 2024168-2025-04542
• Device Sequence Number: 15662406
• Product Code: NIQ
• UDI-Device Identifier: 08717648233463
• UDI-Public: (01)08717648233463(17)260212(10)3021641
• Combination Product (Y/N): Y
• Initial Reporter State: NC
• 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): 05/01/2025

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: 02/12/2026
• Device Model Number: 1804400-12
• Device Catalogue Number: 1804400-12
• Device Lot Number: 3021641
• 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: 05/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/13/2023
• 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 Age: 52 YR
• Patient Sex: Female