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

Model Number	1804350-33
Medical Device Problem Codes	Difficult to Remove (1528); Failure to Advance (2524); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/25/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned for analysis.A review of the production records and corrective or preventive actions (capa) was performed and revealed no indication of a product quality issue.Additionally, a query of the complaint handling database for the reported lot revealed 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) failed to cross due to the anatomy and the sds became stuck, resulting in reported failure to advance.When attempting to remove the sds from patient, resistance was noted and the device kinked.Based on the information provided and because the device was not returned for analysis, it is unknown what may have caused the reported issues.Additionally, it is possible that manipulation of the sds, when resistance was encountered, contributed to the reported kink.Based on the result of the complaint investigation, there is no indication of a product quality issue with the respect to manufacture, design or labeling.
Event or Problem Description
It was reported that the procedure was to treat a 90% de novo lesion in the distal right coronary artery (drca) with mild calcification and moderate tortuosity.The 3.5x33 xience skypoint stent delivery system (sds) was attempted to be advanced to the target lesion; however, failed to cross due to the anatomy and the sds became stuck.Therefore, the sds was removed from the patient and resistance was also noted.After, removal, a kink was noted approximately 15cm from the tip of the sds.There was no adverse patient effect and no clinically significant delay reported in the procedure.Another xience stent was used to complete the procedure.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 ; EI
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 20466327
• Report Number: 2024168-2024-12214
• Device Sequence Number: 15360889
• Product Code: NIQ
• UDI-Device Identifier: 08717648233432
• UDI-Public: (01)08717648233432(17)260424(10)3050241
• 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
• Report Date (Section B): 10/16/2024

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: 04/24/2026
• Device Model Number: 1804350-33
• Device Catalogue Number: 1804350-33
• Device Lot Number: 3050241
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/25/2024
• Initial Report FDA Received Date: 10/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/25/2023
• 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