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

Model Number	1804350-28
Medical Device Problem Codes	Material Rupture (1546); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/12/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that procedure was to treat a de novo, heavily calcified moderately tortuous mid and distal right coronary artery (rca)lesion with 90% stenosis.A 3.50 x 28mm xience skypoint des was prepared according to the instructions for use.Pre-dilation was conducted several times using a wolverine 3.0x15 mm balloon.Although some resistance was felt while passing through the calcified lesion, the des successfully crossed the lesion and was expanded.However, during the initial inflation at approximately 6 atmospheres, a balloon rupture occurred.Since the des stent remained mounted and the system was retrieved without issue, no complications arose.Additional dilations were performed several times using a tasuki 3.5x15 mm balloon.The procedure was completed with another 3.0x28mm xience skypoint.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 provided and without the device to examine, a definitive cause for the reported difficulties could not be determined; however, factors that could contribute to difficult to advance include, but are not limited to, patient anatomical morphology, patient disease state, pre-dilatation strategy, device placement technique, interaction with previously placed stents or accessory devices.Factors that may contribute to material ruptures include, but are not limited to, material damage, inflation technique, interaction with other devices, lesion calcification and tortuosity or insufficient preparation prior to use.In this case, it is possible the device may have interacted with the heavily calcified, moderately tortuous, 90% stenosed lesion during advancement and positioning of the stent, as resistance was noted, contributing to the reported difficult to advance, ultimately causing the reported material rupture; however, based on the information provided and without the device to examine, this cannot be confirmed.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: 23009164
• Report Number: 2024168-2025-09000
• Device Sequence Number: 10502423
• Product Code: NIQ
• UDI-Device Identifier: 08717648233425
• UDI-Public: (01)08717648233425(17)261019(10)3102641
• 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): 08/25/2025

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: 1804350-28
• Device Catalogue Number: 1804350-28
• Device Lot Number: 3102641
• 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: 08/12/2025
• Initial Report FDA Received Date: 09/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/20/2023
• 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