MAUDE Adverse Event Report: ABBOTT VASCULAR XIENCE SKYPOINT DRUG ELUTING CORONARY STENT DELIVERY SYSTEM

Catalog Number	1804350-28
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	05/20/2024
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.The investigation determined the reported difficulties appear to be related to the operational context of the procedure.In this case, it was reported that the stent delivery system (sds) interacted with the edge of the guiding catheter during advancement, resulting in material deformation.Material deformation would impact the wires maneuverability through the catheter, contributing to the difficulty encountered during advancement.Additionally, it was reported that interaction with catheter contributed to the reported stent dislodgement.The dislodged stent was successfully removed from the anatomy as a single unit with the sds.There is no indication of a product quality issue with respect to manufacture, design, or labeling.
Event or Problem Description
It was reported that the procedure was to treat a lesion in the mid right coronary artery (mrca) with moderate calcification and more tortuosity.The 3.5x28mm xience skypoint stent delivery system (sds) was being advanced repeatedly being pushed and pulled around the guide catheter when the stent became deformed due to interaction with the edge of the guide catheter.The stent dislodged and the physician approached from the femoral artery using the same sds retrieving the stent.The stent was removed as a single unit with the sds.Another 3.5x28mm non-abbott stent was used to complete the procedure.There was no adverse patient effect and there was no clinically significant delay in the procedure.No additional information was provided.

• Brand Name: XIENCE SKYPOINT DRUG ELUTING CORONARY STENT DELIVERY SYSTEM
• Common Device Name: DRUG ELUTING CORONARY STENT DELIVERY SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• 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: 19512447
• Report Number: 2024168-2024-06911
• Device Sequence Number: 20696039
• Product Code: NIQ
• UDI-Device Identifier: 08717648233425
• UDI-Public: (01)08717648233425(17)250712(10)2070241
• 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): 06/11/2024

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: 07/12/2025
• Device Catalogue Number: 1804350-28
• Device Lot Number: 2070241
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/20/2024
• Initial Report FDA Received Date: 06/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/13/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 6F GUIDING CATHETER
• Patient Sex: Unknown