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

Model Number	1804225-18
Medical Device Problem Codes	Difficult to Remove (1528); Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/18/2026
Type of Reportable Event	Serious Injury
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.A conclusive cause for the reported stent migration and difficulty to remove could not be determined; however, the subsequent unexpected medical intervention (additional therapy / non-surgical treatment) and hospitalization appear to be related to the operational context of the procedure.Factors that may contribute to stent migration include, but are not limited to, patient anatomical morphology, patient disease state, non-uniform or partial stent apposition, procedural / deployment technique, or under-sizing of the vessel.Factors that can contribute to difficult to remove include, but are not limited to, anatomical conditions, guiding catheter lumen obstructions, kinks, bends, procedural / deployment technique, insufficient support, or interactions with other devices.In this case, it is possible the balloon may have not been fully deflated while attempting to retract the device following stent deployment, contributing to the reported difficult to remove, ultimately causing the reported stent migration; however, based on the information provided and without the device to examine, this cannot be confirmed.The stent was post-dilated and appears to match the vessel size.The patient remained stable and pain free throughout the procedure and they were monitored overnight.There was no adverse patient sequela.There is no indication of a product quality issue with respect to manufacture, design, or labeling; therefore, no product-related corrective action will be implemented in this case.
Event or Problem Description
It was reported that the procedure was to treat the saphenous vein graft (svg) to diagonal coronary artery anastomosis with mild calcification and heavy tortuosity.The lesion was pre-dilated with an nc balloon and a guide extension catheter was used to deliver the 2.25x18 mm xience skypoint stent delivery system (sds).The stent was deployed and upon removal of the delivery system balloon.The stent was pulled back from the lesion site into the svg where it remains and it is partially inside the target lesion.The stent was post-dilated and appears to match the vessel size.The patient remained stable and pain free throughout the procedure and they were monitored overnight.There were no adverse patient sequela.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: 24580203
• Report Number: 2024168-2026-01002
• Device Sequence Number: 21414029
• Product Code: NIQ
• UDI-Device Identifier: 08717648233005
• UDI-Public: (01)08717648233005(17)280629(10)5070741
• Combination Product (Y/N): Y
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: P110019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• 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): 03/11/2026

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: 1804225-18
• Device Catalogue Number: 1804225-18
• Device Lot Number: 5070741
• 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: 02/18/2026
• Initial Report FDA Received Date: 03/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/30/2025
• 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: GUIDELINER
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 65 YR
• Patient Sex: Male
• Patient Weight: 83 KG
• Patient Race: White