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

Model Number	1804300-28
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	10/13/2025
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 and without the device to examine, a definitive cause for the reported difficulties could not be determined; however, factors that may contribute to material ruptures include, but are not limited to, material damage, inflation technique, interactions with other devices, lesion calcification and tortuosity or insufficient preparation prior to use.Factors that may contribute to an activation failure including expansion failures include, but are not limited to, inflation technique, contrast concentration, loose connection with the indeflator, anatomical conditions, contamination in the inflation lumen or damage to the guide wire and/or inflation lumen.Difficult to advance/position may be attributed to several factors including, but are not limited to, product placement technique, guiding catheter support, anatomical conditions, condition of the guide wire, interaction with accessory devices, damage to the catheter, patient disease state, or interaction with previously placed stents.In this case, it is possible the device may have interacted with the heavily calcified, moderately tortuous, 90% stenosed lesion during advancement, as resistance was noted, causing the reported difficult to advance.Further interaction with the challenging anatomy during positioning of the stent may have contributed to the reported material rupture; ultimately causing the reported activation failure; 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.
Event or Problem Description
It was reported that the procedure was to treat a heavily calcified, moderately left anterior descending artery that is 90% stenosed.The lesion was pre-dilated with a 2.75x15mm non-abbott balloon.A 3.0x28mm 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 delivery system ruptured at 6 atmospheres.The stent remained mounted on delivery system; therefore, simply withdrawn.A 3.0x15mm was used to further dilate and a 2.75x28mm xience skypoint stent was deployed without issue.Post-dilatation was performed with a 3.0x15mm non-abbott balloon.There was no adverse patient effects 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: 23480476
• Report Number: 2024168-2025-11382
• Device Sequence Number: 13344588
• Product Code: NIQ
• UDI-Device Identifier: 08717648233265
• UDI-Public: (01)08717648233265(17)280512(10)5052041
• 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): 11/05/2025

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: 1804300-28
• Device Catalogue Number: 1804300-28
• Device Lot Number: 5052041
• 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: 10/14/2025
• Initial Report FDA Received Date: 11/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/13/2025
• 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