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

Model Number	1804300-15
Medical Device Problem Codes	Break (1069); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/11/2025
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.D4: a partial udi is being reported because the lot number was not provided.
Event or Problem Description
It was reported that upon opening the 3.0x15 mm xience skypoint stent delivery system (sds), the device was noted to be defective.The distal tip was floppy, had no support and the distal portion of the stent was not on the shaft of the device.The device was not used and there was no patient involvement.Another xience sds was used to complete the procedure.There was no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
A visual inspection was performed on the returned device.The reported tip break was not confirmed; however, it is possible the account was referring to the observed outer member break and/or stretched inner/outer member.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 break could not be determined.Factors contributing to a break include, but are not limited to, interaction with the anatomy, interaction with accessory devices or inadvertent mishandling during unpackaging, sheath/stylet removal or during preparation of the device.Stretched material may be attributed to several factors including, but not limited to, forced sheath removal, inadvertent mishandling during unpackaging or preparation of the device or use of force while removing the device.In this case, it is possible that inadvertent mishandling during sheath/stylet removal may have contributed to the observed stretched inner/outer member, ultimately causing the observed outer member break; however, 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.H6:correction medical device problem code 2923 was removed.
Event or Problem Description
Subsequent to the initially filed report it was stated it seems the outer member was not extruded to the entire length of the catheter.The stent is on the device.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: 22632337
• Report Number: 2024168-2025-07788
• Device Sequence Number: 20871675
• Product Code: NIQ
• UDI-Device Identifier: 08717648233234
• UDI-Public: (01)08717648233234(17)280408(10)5041641
• Combination Product (Y/N): Y
• Initial Reporter State: KY
• 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): 08/27/2025

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: 1804300-15
• Device Catalogue Number: 1804300-15
• Device Lot Number: 5041641
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/11/2025
• Supplement Date Received by Manufacturer: 08/07/2025
• Initial Report FDA Received Date: 07/28/2025
• Supplement Report FDA Received Date: 08/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/09/2025
• 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
• Patient Sex: Unknown