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

Model Number	1804400-18
Medical Device Problem Codes	Difficult to Advance (2920); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/14/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the procedure was to treat a lesion in the right coronary artery (rca) with calcification.After pre-dilatation and intravascular lithotripsy, a 2.5x28mm unspecified xience stent, a 3.5x48 unspecified stent and a 4x18 unspecified xience stent were in implanted.Then, a 4x18mm xience skypoint stent delivery system (sds) was being advance to the proximal rca with resistance due to the anatomy when the stent became dislodged from the delivery system.Therefore, a 1.5mm unspecified balloon was used to implant the stent at the target lesion.Another 4x18mm xience stent was used to continue the procedure.There was no adverse patient effect and no clinically significant delay reported 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, a definitive cause for the reported difficulties could not be determined; however, the subsequent unexpected medical intervention appears to be related to circumstances of the procedure.A cine was received and reviewed by an abbott vascular clinical specialist who concluded the provided media shows an image of the rca post stenting of the vessel.While a malfunction of a xience stent is noted by the dislodgement of the stent from the delivery system upon advancement into the artery, a cause for this cannot be determined by the provided media.There was no damage noted to the stent delivery system (sds) during the inspection prior to use which suggests a product quality issue did not contribute to the reported difficulties.Factors that can contribute to difficult to advance include, but are not limited to, kinks, bends, procedural technique, insufficient support, patient anatomical morphology, patient disease state, previously implanted stent(s) or interactions with accessory devices.Stent dislodgement may be attributed to several factors including, but not limited to, positive pressure during preparation, forced sheath removal, handling of the stent during preparation, interaction with patent anatomy, previously implanted stent(s) or accessory devices.In this case, it is possible the device may have interacted with the previously implanted stent(s) in addition to the challenging anatomy during advancement, as resistance was noted, causing the reported difficult to advance.Further interaction with the previously implanted stent(s) in addition to the challenging anatomy may have contributed to the reported stent dislodgement; however, without the device to examine, this cannot be confirmed.A 1.5mm unspecified balloon was used to implant the stent at the target lesion.Another 4x18mm xience stent was used to continue the procedure.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: 23760441
• Report Number: 2024168-2025-11917
• Device Sequence Number: 13245214
• Product Code: NIQ
• UDI-Device Identifier: 08717648233487
• UDI-Public: (01)08717648233487(17)280708(10)5071641
• Combination Product (Y/N): Y
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P110019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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): 12/09/2025

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?: No
• Operator of Device: Health Professional
• Device Model Number: 1804400-18
• Device Catalogue Number: 1804400-18
• Device Lot Number: 5071641
• 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: 11/14/2025
• Initial Report FDA Received Date: 12/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/09/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 2.5X28MM XIENCE STENT; 3.5X48MM STENT; 4X18MM XIENCE STENT
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown