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

Model Number	1804350-15
Medical Device Problem Codes	Difficult to Remove (1528); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/13/2025
Type of Reportable Event	Malfunction
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 could not be determined.Factors which may contribute to difficulty advancing the device in the guiding catheter include, but are not limited to, manufacturing, damage to the stent, damage to the guiding catheter, guiding catheter size selection or procedural technique (devices not properly supported or coaxially aligned).Factors that can contribute to difficult to remove include, but are not limited to, kinks, bends, procedural technique, insufficient support, guiding catheter size selection, or interactions with other devices.In this case, it is possible that although the correct size 5f guide extension catheter was used during the procedure, the inner diameter (id) of the guideplus 5f may have been smaller than the 5f (0.056¿ / 1.42 mm id) as specified in the skypoint instructions for use, as resistance was noted, causing the reported difficult to advance and difficult to remove; however, without the device to examine, this cannot be confirmed.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.
Event or Problem Description
It was reported that the procedure was to treat a de novo lesion in the distal right coronary artery (drca) with moderate calcification and moderate tortuosity.The 3.5x15mm xience skypoint stent delivery system (sds) was attempted to be advanced into a 5f guide extension catheter; however, the sds became stuck with the extension guide catheter.Therefore, the sds and guide catheter had to be removed as a single unit.A 6f extension guide catheter and another same size xience sds were used to continue the procedure.There was no adverse patient effect and no clinically significant delay reported in 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 UNK ; EI UNK
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 22170228
• Report Number: 2024168-2025-05936
• Device Sequence Number: 21145938
• Product Code: NIQ
• UDI-Device Identifier: 08717648233395
• UDI-Public: (01)08717648233395(17)280209(10)5021441
• 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): 06/09/2025

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: 1804350-15
• Device Catalogue Number: 1804350-15
• Device Lot Number: 5021441
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/16/2025
• Initial Report FDA Received Date: 06/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/10/2025
• 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: 5F GUIDEPLUS EXTENSION CATHETER
• Patient Sex: Unknown