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

Model Number	1804225-23
Medical Device Problem Codes	Difficult to Remove (1528); Failure to Advance (2524); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/22/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the procedure was to treat the right coronary artery (rca) with heavy calcification.After an initial unspecified stent was implanted, the 2.25x23mm xience skypoint stent delivery system (sds) was attempted to be advance to the target lesion; however, the sds failed to advance to the mid rca due to the anatomy.Therefore, the sds was removed with resistance due to the anatomy and then the stent became dislodged from the delivery system.A non-compliant balloon was used to implant the stent in the proximal rca partially in the initially implanted stent.This ended the procedure without further issue.There was no adverse patient sequela and no clinically significant delay reported 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.
Additional Manufacturer Narrative
A visual inspection analysis was performed on the returned device.The reported failure to advance and difficult to remove could not be tested as it was based on operational context.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.The investigation determined the reported difficulties and subsequent treatment appear to be related to the operational context of the procedure.It was reported that the stent delivery system (sds) was advanced toward the lesion but failed to cross due to challenging anatomy.As a result, the sds was withdrawn with resistance, during which the stent became dislodged from the delivery system.Analysis of the returned device confirmed the stent dislodgement.In this case, it is likely that the device encountered a heavily calcified lesion during advancement, leading to resistance and the reported failure to advance.Continued resistance during device retraction likely contributed to the reported difficulty to remove and the subsequent stent dislodgement.Additionally, it was reported that a non-compliant balloon was used to implant the stent in the anatomy.There is no indication of a product quality issue related to manufacturing, design, or labeling.Therefore, no product-related corrective action will be implemented.

• 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: 22038402
• Report Number: 2024168-2025-05154
• Device Sequence Number: 8160488
• Product Code: NIQ
• UDI-Device Identifier: 08717648233012
• UDI-Public: (01)08717648233012(17)260920(10)3092841
• 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
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/12/2025

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 Expiration Date: 09/20/2026
• Device Model Number: 1804225-23
• Device Catalogue Number: 1804225-23
• Device Lot Number: 3092841
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/06/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/22/2025
• Supplement Date Received by Manufacturer: 05/22/2025
• Initial Report FDA Received Date: 05/16/2025
• Supplement Report FDA Received Date: 06/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/21/2023
• 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 Age: 76 YR
• Patient Sex: Female
• Patient Weight: 74 KG