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

Model Number	1804225-12
Medical Device Problem Codes	Material Rupture (1546); Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/14/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned for evaluation.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.A conclusive 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, materials, 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 (inflation issues) include, but are not limited to, inflation technique, contrast concentration, loose connection with the indeflator, contamination in the inflation lumen or damage to the guide wire and/or inflation lumen.In this case, it is possible that the device may have interacted with the mildly calcified, mildly tortuous lesion during advancement, causing the reported material rupture, ultimately contributing the reported activation failure; however, 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 the diagonal coronary artery with mild calcification and mild tortuosity.The 2.25x12 mm xience skypoint stent delivery system (sds) was advanced to the lesion and deployment was attempted but the balloon partially inflated before it ruptured and the stent failed to deploy.The stent was removed on the delivery system and a non-abbott device was used to complete the procedure.There were no adverse patient effects and there was 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: 21877000
• Report Number: 2024168-2025-04126
• Device Sequence Number: 12737456
• Product Code: NIQ
• UDI-Device Identifier: 08717648232985
• UDI-Public: (01)08717648232985(17)271121(10)4112841
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• 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): 04/21/2025

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: 1804225-12
• Device Catalogue Number: 1804225-12
• Device Lot Number: 4112841
• 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: 04/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/22/2024
• 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