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

Model Number	1804250-15
Medical Device Problem Codes	Material Separation (1562); Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/24/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A visual inspection was performed on the returned device.The reported deformation due to compressive stress was confirmed.The observed material separation was confirmed.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 deformation due to compressive stress could not be determined.Factors that could contribute to deformation due to compressive stress include, but are not limited to, inadvertent mishandling during unpackaging of the device, sheath/stylet removal, preparation, or during use of the device, interaction with accessory devices, patient anatomical morphology, or patient disease state.Potential causes for a material separation include, but are not limited to, inadvertent mishandling during unpackaging, during preparation or use of the device, interaction with the anatomy and/or accessory devices.In this case, it is possible that inadvertent mishandling during unpackaging of the device may have caused the observed packaging problem (kinked coil), contributing to the reported deformation due to compressive stress (kinked hypotube); however, this cannot be confirmed.Additional follow up with the account noted the observed material separation did not occur during the procedure and was likely due to handling/packaging for device return to abbott vascular.There is no indication of a product quality issue with respect to manufacture, design, or labeling.
Event or Problem Description
It was reported that upon opening the package of a 2.50x15mm xience skypoint drug-eluting stent, the hoop dispenser and proximal shaft were noted to be kinked.An unspecified device was used to complete the procedure.There was no device use or patient involvement, and no clinically significant delay in the procedure.Subsequently, returned device analysis observed the hypotube was kinked and separated distal to the strain relief tubing.The hypotube fracture faces were oval shaped and the material at the noted separations were jagged.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: 23661073
• Report Number: 2024168-2025-11774
• Device Sequence Number: 9123384
• Product Code: NIQ
• UDI-Device Identifier: 08717648233074
• UDI-Public: (01)08717648233074(17)280629(10)5070441
• Combination Product (Y/N): Y
• Initial Reporter State: NE
• 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
• Report Date (Section B): 11/26/2025

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: 1804250-15
• Device Catalogue Number: 1804250-15
• Device Lot Number: 5070441
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/11/2025
• Initial Report FDA Received Date: 11/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/30/2025
• 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