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

Model Number	1804350-15
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	04/27/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the procedure was to treat the left anterior descending (lad) artery with moderate calcification.The 3.5x15mm xience skypoint stent delivery system (sds) was being advanced when the device had resistance with a non-abbott hemostatic rotating hemostatic valve (rhv) and the stent came off inside the rhv.The dislodged stent was simply removed from the rhv and another xience skypoint stent was used to complete the procedure.There was no adverse patient effect and there was no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
A visual inspection was performed on the returned device.The reported stent dislodgement was confirmed.The reported difficult to advance could not be tested due to the condition of the returned device.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 analysis of the returned stent, a definitive cause for the reported difficulties could not be determined; however, 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 or accessory devices.Factors that could contribute to difficult to advance include, but are not limited to, patient anatomical morphology, inner lumen obstruction, patient disease state, pre-dilatation strategy, device placement technique, interaction with previously placed stents or accessory devices.In this case, it is possible the device may have interacted with accessory devices (rotating hemostatic valve) during insertion/advancement, as resistance was noted, causing the reported difficult to advance, ultimately contributing to the reported stent dislodgement; however, based on the information provided and analysis of the returned device, this cannot be confirmed.The dislodged stent was simply removed from the rhv and another xience skypoint stent was used to complete the procedure.There was no adverse patient effect and there was no clinically significant delay in the procedure.

• 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: 25376976
• Report Number: 2024168-2026-02253
• Device Sequence Number: 13414302
• Product Code: NIQ
• UDI-Device Identifier: 08717648233395
• UDI-Public: (01)08717648233395(17)280824(10)5082941
• 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: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 06/03/2026

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 1804350-15
• Device Catalogue Number: 1804350-15
• Device Lot Number: 5082941
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/19/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/13/2026
• Initial Report FDA Received Date: 06/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/25/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown