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

Model Number	1804300-23
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	08/21/2025
Type of Reportable Event	Malfunction
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, a definitive cause for the reported difficulties could not be determined.In this case, it is possible that interaction between the device and the patient's heavily calcified, moderately tortuous anatomy and 90% stenosed lesion contributed to the difficulty in advancing the device, resulting in the reported balloon material rupture and subsequent stent activation failure.However, because the device was not returned for analysis, this cannot be confirmed.There was no damage noted to the device during the inspection prior to use which suggests a product quality issue with respect to manufacture, design or labeling did not contribute to the reported difficulties.
Event or Problem Description
It was reported that the procedure was to treat a heavily calcified, moderately tortuous right coronary artery that is 90% stenosed.The lesion was pre-dilated with a 2.5x15mm non-abbott balloon.The 3.0x23mm xience skypoint stent delivery system was advanced to the target lesion with resistance felt with anatomy.When attempting to deploy the stent the balloon on the stent delivery system ruptured at 6 atmospheres.As the stent remained mounted on the delivery system the device was simply removed.The lesion was pre-dilated again with another 3.0x15mm non-abbott balloon and a 2.75x23mm xience skypoint was deployed and post dilatated without issue.There was no adverse patient effects and no clinically significant delay in the procedure.No additioanl 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: 23043205
• Report Number: 2024168-2025-09796
• Device Sequence Number: 18662545
• Product Code: NIQ
• UDI-Device Identifier: 08717648233258
• UDI-Public: (01)08717648233258(17)271126(10)4120441
• 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
• Report Date (Section B): 09/12/2025

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 Model Number: 1804300-23
• Device Catalogue Number: 1804300-23
• Device Lot Number: 4120441
• 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: 08/21/2025
• Initial Report FDA Received Date: 09/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/27/2024
• 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
• Patient Sex: Unknown