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

Model Number	1804350-28
Medical Device Problem Codes	Break (1069); Failure to Advance (2524); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/19/2024
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 the right coronary artery (rca) with no calcification or tortuosity.The 3.5x28 mm xience skypoint stent struts became broken during the procedure.There were no adverse patient effects and there was no clinically significant delay in the procedure.No additional information was provided.
Event or Problem Description
Subsequent to the initially filed report it was stated the device failed to cross the lesion due to interaction with another unspecified stent.The stent struts were flared and bent, rather than broken.No additional information was provided.
Additional Manufacturer Narrative
A visual inspection and dimensional analysis were performed on the returned device.Material deformation was confirmed.The reported failure to advance could not be tested as it is operational context of the procedure.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 reported information and the observations from the returned analysis, the investigation determined that the reported failure to advance and material deformation appears to be related to circumstances of the procedure.It was reported the stent delivery system (sds) failed to cross the lesion due to interaction with another unspecified stent, resulting in failure to advance.The analysis of the returned device confirmed the crossing profile met specification.In addition, it was reported that the stent was bent, flared.In this case analysis of the device confirmed the reported material deformation on the stent.This type of damage can occur due to interaction with the previous implanted stent.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.B5: describe event or problem updated.H6: medical device problem code correction 1069 was removed, 2976 and 2524 were added.

• 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: 20698820
• Report Number: 2024168-2024-13575
• Device Sequence Number: 12401144
• Product Code: NIQ
• UDI-Device Identifier: 08717648233425
• UDI-Public: (01)08717648233425(17)270623(10)4062841
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• 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: Health Professional,Company Representative
• 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 Model Number: 1804350-28
• Device Catalogue Number: 1804350-28
• Device Lot Number: 4062841
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/19/2024
• Supplement Date Received by Manufacturer: 01/02/2025
• Initial Report FDA Received Date: 11/15/2024
• Supplement Report FDA Received Date: 01/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/24/2024
• 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
• Patient Sex: Unknown