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

Model Number	1804250-18
Medical Device Problem Codes	Difficult to Remove (1528); Device Damaged by Another Device (2915); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/09/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the procedure was to treat the mid left anterior descending (lad) coronary artery with calcification.The area intended to be treated was an unstented gap between two unspecified previously implanted stents.An activated clotting time (act) test was performed and then an unspecified 1.4 mm laser was used for in stent restenosis in the proximal stent.The 2.5x18 mm xience skypoint stent was then implanted at 9 atmospheres in the gap and overlapping areas were expanded with the stent balloon.A non-abbott scoring balloon was advanced to the distal stent for angioplasty.However, upon removal, the balloon caught on the xience skypoint stent and the stent became deformed and shortened.The patient was sent for open heart surgery to remove the balloon and the deformed stent.There were no adverse patient sequela during the procedure and the patient is stable following the surgery.No additional information was provided.
Additional Manufacturer Narrative
The device was not returned for analysis.A review of the production records and the corrective and preventive actions (capa) database 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 and treatment appear to be related to the operational context of the procedure.It was reported that the xience skypoint stent was implanted in the gap between two previously implanted stents.Subsequent to implantation, a balloon was passed through the skypoint stent.During removal of the balloon, an interaction between the balloon and stent occurred.In this case, it is likely that the balloon and implanted stent were not coaxially aligned during the balloon removal, resulting in the interaction between the devices.Additionally, it was reported that the interaction between the devices resulted in stent deformation.The damaged stent was removed via surgery.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.

• 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: 21912860
• Report Number: 2024168-2025-04344
• Device Sequence Number: 17958692
• Product Code: NIQ
• UDI-Device Identifier: 08717648233081
• UDI-Public: (01)08717648233081(17)271113(10)4112041
• Combination Product (Y/N): Y
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P110019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• 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): 04/25/2025

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?: No
• Operator of Device: Health Professional
• Device Model Number: 1804250-18
• Device Catalogue Number: 1804250-18
• Device Lot Number: 4112041
• 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: 04/09/2025
• Initial Report FDA Received Date: 04/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/14/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ANGIOSCULP BALLOON.
• Outcome Attributed to Adverse Event: Hospitalization; Disability; Required Intervention
• Patient Age: 78 YR
• Patient Sex: Male
• Patient Weight: 126 KG