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

Model Number	1804350-48
Medical Device Problem Codes	Off-Label Use (1494); Difficult to Remove (1528); Difficult to Advance (2920); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/06/2025
Type of Reportable Event	Malfunction
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, factors that can contribute to difficult to advance/remove include, but are not limited to, kinks, bends, procedural technique, insufficient support, patient anatomical morphology, patient disease state, 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, and interaction with patent anatomy or accessory devices.In this case, it is possible the device may have interacted with accessory devices (reportedly, the xience skypoint became snagged on the guide wire) in addition to the challenging anatomy during advancement, causing the reported difficult to advance.Further interaction with the challenging anatomy (heavily calcified) during retraction of the device may have contributed to the reported difficult to remove, ultimately causing the reported stent dislodgement; however, without the device to examine, this cannot be confirmed.In addition, it was reported that the procedure was to treat a lesion in the posterior tibial artery.It should be noted that the xience skypoint, electronic instructions for use (eifu), states: the xience skypoint stent system is indicated for improving coronary artery luminal diameter in patients, including those with diabetes mellitus, with symptomatic heart disease due to de novo native coronary artery lesions (length equal or less than 32 mm) with reference vessel diameters of greater than or equal to 2.25 mm and equal or less than 4.25 mm.The xience skypoint stent system is indicated for treating de novo chronic total coronary occlusions.It is unknown if the instructions for use (ifu) deviation contributed to the reported event.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.H6 medical device problem code: 1494 - incorrect anatomy.
Event or Problem Description
It was reported that the procedure was to treat a lesion in the posterior tibial artery with heavy calcification.The 3.5x48mm xience skypoint stent delivery system (sds) was being advanced to the target lesion when the sds became snagged on the guide wire (gw).Therefore, the sds was removed from the patient; however, during removal the stent came off the balloon and as a result , the dislodged stent and the delivery system gw were removed as a single unit.There was no adverse patient effect and no clinically significant delay reported 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: 23684146
• Report Number: 2024168-2025-11811
• Device Sequence Number: 9754078
• Product Code: NIQ
• UDI-Device Identifier: 08717648231308
• UDI-Public: (01)08717648231308(17)270703(10)5070941
• Combination Product (Y/N): Y
• Initial Reporter State: TN
• 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): 12/01/2025

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: 1804350-48
• Device Catalogue Number: 1804350-48
• Device Lot Number: 5070941
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/06/2025
• Initial Report FDA Received Date: 12/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/04/2025
• 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
• Patient Sex: Unknown