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

Model Number	1804275-18
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Material Deformation (2976)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/06/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Medwatch mw5162648 received which states: the stent was prepared to load onto the wire and visualized.When the stent got through the catheter to the coronary the stent was visibly damaged.The physician pulled the stent delivery system out the of the system and noted the stent was not on the system.Stent was not identified.Physician removed product, except the sheath.He inserted a diagnostic catheter to take fluro guided images of the upper body (excluding head and neck) and lower extremities.No stent was visualized.Product retained and kept for review.Physician aborted intervening on that vessel.Case was finished and patient was taken to post-op area.Imaging orders placed to evaluate for retained object.
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
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.A conclusive cause for the reported difficulties and patient effects, and the relationship to the product, if any, cannot be determined; however, the subsequent treatment appears to be related to the operational context of the procedure.It was reported that the stent delivery system's (sds) stent was observed to be deformed after advancement.The physician removed the sds and noted the stent was not on the system.Factors that may contribute to material deformation or stent dislodgement include, but are not limited to, interaction with accessory devices, product damage during handling/ preparation of device, or interaction with a challenging lesion.Based on the information provided and because the device was not returned for analysis, it is unknown what may have caused the reported material deformation or stent dislodgement.The dislodged stent remains within the anatomy.There is no indication of a product quality issue with respect to manufacture, design, or labeling; therefore, no product-related corrective action will be implemented in this case.

• 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 ; EI
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 20964330
• Report Number: 2024168-2024-14937
• Device Sequence Number: 18212590
• Product Code: NIQ
• UDI-Device Identifier: 08717648233166
• UDI-Public: (01)08717648233166(17)270208(10)4021441
• Combination Product (Y/N): Y
• 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: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/14/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 1804275-18
• Device Catalogue Number: 1804275-18
• Device Lot Number: 4021441
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/09/2024
• Supplement Date Received by Manufacturer: 01/13/2025
• Initial Report FDA Received Date: 12/18/2024
• Supplement Report FDA Received Date: 01/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/09/2024
• 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: Other
• Patient Age: 57 YR
• Patient Sex: Female
• Patient Weight: 56 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White