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

Model Number	1804300-15
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/03/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the procedure was to treat a moderately calcified, heavily tortuous right coronary artery.The 3.0x28mm xience skypoint stent delivery system (sds) failed to cross due to anatomy and the stent was observed to become flared.A 3.0x23mm xience skypoint sds was attempted to be advanced; however, failed to cross due to anatomy and was removed.The stent was observed to flared.Therefore, a 3.0x15mm xience skypoint stent was advanced and implanted in the distal lesion; however, the stent moved from the lesion site and was removed from the anatomy with a balloon.A new unspecified stent was implanted successfully.A 3.0x18mm xience skypoint stent delivery system was attempted to be advanced to treat the proximal portion of the lesion; however, failed to cross due to anatomy and the stent became flared.Therefore, a new 3.0x28mm xience skypoint was attempted to be advanced; however, failed to cross due to anatomy and the stent dislodged.The stent traveled to the aorta of the patient.A snare was used to remove the stent and the lesion was left untreated.There was no adverse patient sequela and clinically significant delay was noted.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.The additional device referenced in b5 is filed under a separate medwatch report number.
Additional Manufacturer Narrative
A visual inspection was performed on the returned device.The reported stent migration could not be evaluated as the exact anatomical conditions encountered by the device used during the procedure could not be replicated in the test laboratory.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 could not be determined; however, the subsequent unexpected medical intervention and delay to treatment/therapy 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 or under-sizing of the vessel.In this case, it is possible the device may have interacted with the moderately calcified, heavily tortuous lesion during stent placement/deployment, causing the reported stent migration; however, based on the information provided, a definitive cause for the reported stent migration cannot be confirmed.There is no indication of a product quality issue with respect to manufacture, design, or labeling.

• 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: 23202924
• Report Number: 2024168-2025-10696
• Device Sequence Number: 13277238
• Product Code: NIQ
• UDI-Device Identifier: 08717648233234
• UDI-Public: (01)08717648233234(17)271008(10)4101641
• Combination Product (Y/N): Y
• PMA/510(K) Number: P110019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/28/2025

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?: No
• Operator of Device: Health Professional
• Device Model Number: 1804300-15
• Device Catalogue Number: 1804300-15
• Device Lot Number: 4101641
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/19/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/10/2025
• Supplement Date Received by Manufacturer: 10/03/2025
• Initial Report FDA Received Date: 10/02/2025
• Supplement Report FDA Received Date: 10/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/09/2024
• 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