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

Model Number	1804275-15
Medical Device Problem Codes	Failure to Advance (2524); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Angina (1710); Foreign Body In Patient (2687)
Date of Event	01/12/2026
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.Based on the information provided, a definitive cause for the reported difficulties and reported patient effects in relationship to the product, if any, cannot be determined; however, the subsequent hospitalization, surgical intervention and foreign body in patient appear to be related to the operational context of the procedure.Factors that could contribute to failure 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.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 stents or accessory devices.In this case, it is possible the device may have interacted with previously implanted stents during advancement, causing the reported failure to advance.Further interaction with the previously implanted stents during retraction of the device, as resistance was noted, may have contributed to the reported stent dislodgement; however, this cannot be confirmed.The patient was sent to bypass, and the stent remains in the anatomy.The reported patient effect of angina is listed in the xience skypoint, everolimus eluting coronary stent system (eecss), electronic instructions for use as a known patient effect of coronary stenting procedures.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 left anterior descending (lad) coronary artery but the 2.75x15 mm xience skypoint stent delivery system (sds) device became stuck in the left main.There were 2 unspecified stents in the anatomy from a previous procedure that the device became stuck with.The physician yanked the device and the stent came off of the delivery system and is lodged between the two previously implanted stents.The patient experienced chest pain during the procedure.The patient was sent to bypass.The patient was discharged and is doing well.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: 24307361
• Report Number: 2024168-2026-00548
• Device Sequence Number: 21245698
• Product Code: NIQ
• UDI-Device Identifier: 08717648233159
• UDI-Public: (01)08717648233159(17)280707(10)5071641
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• 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): 02/10/2026

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: 1804275-15
• Device Catalogue Number: 1804275-15
• 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: 01/19/2026
• Initial Report FDA Received Date: 02/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/08/2025
• 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: UNSPECIFIED PREVIOUSLY IMPLANTED STENTS
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Unknown