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

Model Number	1804350-23
Medical Device Problem Codes	Break (1069); Failure to Advance (2524); Difficult to Advance (2920); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/08/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the procedure was to treat a right coronary artery (rca) lesion.The xience skypoint stent delivery system (sds) was advanced but the stent came off the balloon and got stuck in the guide liner.Unknown how the procedure was completed.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.D4: the udi number is ¿ni¿ as the part and lot number were not provided.
Additional Manufacturer Narrative
A visual inspection was performed on the returned stent.The reported stent dislodgement was confirmed.The reported stent break was not confirmed.The reported failure to advance could not be tested, as only the stent was returned.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 failure 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.Factors contributing to a stent break include, but are not limited to, over expansion of the stent, interaction with accessory devices, inadvertent mishandling or anatomy characteristics.In this case, it is possible that the device may have interacted with the challenging anatomy during advancement, causing the reported failure to advance.Further interaction with accessory devices (guide extension catheter) during retraction may have contributed to the reported stent dislodgement, ultimately causing the observed material deformation (bent and flared stent struts), which the account interpreted as the reported stent break; however, without the stent delivery system to analyze, this cannot be confirmed.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.Correction: h6: medical device problem code 2920 removed.
Event or Problem Description
Subsequent to the initially filed report, the following information was provided: several attempts to cross the rca with the 3.5 x 23 mm xience skypoint stent delivery system (sds) were made during the percutaneous coronary intervention.After multiple unsuccessful attempts, the physician removed the undeployed sds from the body when it was noted that the stent was no longer on the sds.After the undeployed stent was not found in the patient under fluoroscopy, the non-abbott guide catheter extension was removed and the undeployed stent was found inside the tip of the non-abbott guide catheter extension.The stent was removed from the non-abbott guide catheter extension and was found to have a small fracture on the stent itself.The procedure was aborted.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: 23944060
• Report Number: 2024168-2026-00013
• Device Sequence Number: 10758632
• Product Code: NIQ
• UDI-Device Identifier: 08717648233418
• UDI-Public: (01)08717648233418(17)280625(10)5063041
• Combination Product (Y/N): Y
• Initial Reporter State: FL
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/03/2026

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: 1804350-23
• Device Catalogue Number: 1804350-23
• Device Lot Number: 5063041
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/10/2025
• Supplement Date Received by Manufacturer: 02/06/2026
• Initial Report FDA Received Date: 01/02/2026
• Supplement Report FDA Received Date: 03/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/26/2025
• 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