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

Model Number	1804350-38
Medical Device Problem Codes	Difficult to Advance (2920); Device Dislodged or Dislocated (2923); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/15/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.
Event or Problem Description
It was reported that the procedure was to treat a lesion in the mid left anterior descending (mlad) artery with moderate calcification and moderate tortuosity.The 3.5x38mm xience skypoint stent delivery system (sds) was attempted to be advanced to the target lesion; however, the sds met with resistance with the guide catheter and the stent became deformed and displaced on the balloon.The stent was removed via a femoral approach.A non-abbott balloon was used to complete the procedure.There was no adverse patient effect and no clinically significant delay reported in the procedure.No additional information was provided.
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 issues could not be determined.It was reported that the stent delivery system (sds) met with resistance with the guide catheter and the stent became deformed and displaced on the balloon.Factors that may contribute to difficulty advancing the sds through guide catheter include, but are not limited to, inner diameter of the catheter, system profile, guidewire movement (im collapse), inadequate deliverability, or challenging anatomy.Based on the information provided and because the device was not returned for analysis, it is unknown what may have caused the reported difficulties during advancement.Additionally, it was reported that the sds became deformed and displaced.In this case, it is possible the manipulation of the sds when resistance was met, with the guide catheter contributed to the reported material deformation and device dislodged or dislocated.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: 20884554
• Report Number: 2024168-2024-14428
• Device Sequence Number: 9043391
• Product Code: NIQ
• UDI-Device Identifier: 08717648233449
• UDI-Public: (01)08717648233449(17)260608(10)3061941
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• 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: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/08/2025

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 Expiration Date: 06/08/2026
• Device Model Number: 1804350-38
• Device Catalogue Number: 1804350-38
• Device Lot Number: 3061941
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/18/2024
• Supplement Date Received by Manufacturer: 01/02/2025
• Initial Report FDA Received Date: 12/09/2024
• Supplement Report FDA Received Date: 01/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/09/2023
• 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
• Patient Sex: Unknown