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

Model Number	1804400-28
Medical Device Problem Codes	Material Rupture (1546); Difficult to Advance (2920); Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/28/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.
Event or Problem Description
It was reported that the procedure performed was to treat a de novo, heavily calcified, moderately tortuous distal right coronary artery that is 90% stenosed.Pre-dilation was performed using a 3.5x15mm non-abbott coronary cutting balloon.During advancement of the 4.0x28mm xience skypoint drug-eluting stent (des), resistance was noted due to anatomy but ultimately crossed the lesion.The xience skypoint des ruptured at 6 atmospheres during the first inflation and failed to deploy.The xience skypoint was removed along with the balloon.Additional dilation was performed using a 4.0x10mm non-abbott balloon.A 4.0x15mm xience skypoint des and 4.0x18mm xience skypoint des were successfully deployed.Post-dilation with a 4.0x10mm non-abbott balloon was used concluding the procedure.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
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 difficulty to advance and activation failure of the stent appears to be related to operational context of the procedure.Additionally, a definitive cause for the reported material rupture of the balloon could not be determined.Factors that may contribute to material ruptures include, but are not limited to, inflation technique, interactions with other devices, lesion calcification and tortuosity or insufficient preparation prior to use.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 UNK ; EI UNK
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 22055072
• Report Number: 2024168-2025-05252
• Device Sequence Number: 4251444
• Product Code: NIQ
• UDI-Device Identifier: 08717648233500
• UDI-Public: (01)08717648233500(17)260125(10)3020141
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• 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: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/11/2025

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: 01/25/2026
• Device Model Number: 1804400-28
• Device Catalogue Number: 1804400-28
• Device Lot Number: 3020141
• 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: 04/28/2025
• Supplement Date Received by Manufacturer: 05/27/2025
• Initial Report FDA Received Date: 05/20/2025
• Supplement Report FDA Received Date: 06/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/26/2023
• 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
• Patient Sex: Unknown