MAUDE Adverse Event Report: ABBOTT VASCULAR INC. XIENCE Skypoint¿; Coronary Drug-Eluting Stent

Model Number	1804350-15
Medical Device Problem Codes	Off-Label Use (1494); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Intracranial Hemorrhage (1891); Visual Disturbances (2140); Dyskinesia (2363); Nervous System Injury (2689)
Date of Event	07/02/2026
Type of Reportable Event	Death
Event or Problem Description
It was reported that the procedure was to treat a basilar artery.The lesion was pre-dilated with a 2.75 x 10mm sapphire ii pro balloon.The 3.50 x 15mm xience skypoint drug-eluting stent was implanted when suspected hyper fusion syndrome occurred.Post dilatation was not performed, and it was noted that hemostasis was achieved with a prostyle device.Subsequently, the patient was transferred to the intensive care unit for observation when left hand immobility, and right pupil dilation and right sided blindness were noted.A code blue was called, and it was determined that the patient was experiencing a right sided cerebral hemorrhage.The patient was stabilized and another code blue was called.Medication was provided and the patient transferred to another center for potential further intervention.Following the patient's transfer to another facility, no additional information from that facility is available.It was subsequently noted on (b)(6) 2026 that the patient died on (b)(6) 2026.No additional information was provided.
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.C3: 1 per year was entered; however, the frequency is 1 dose per implant.H6: medical device problem code: 1494 - incorrect anatomy.

• Brand Name: XIENCE Skypoint¿
• Common Device Name: Coronary Drug-Eluting Stent
• Manufacturer (Section D): ABBOTT VASCULAR INC.; 3200 lakeside drive; santa clara CA 95054 -280
• 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--462 ; +1(951)914-5259
• MDR Report Key: 50060973
• Report Number: 2024168-2026-02955
• Device Sequence Number: 13448215
• Product Code: NIQ
• UDI-Device Identifier: 08717648233395
• UDI-Public: (01)08717648233395(17)280708(10)5071541
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: P110019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• 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): 08/12/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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: 5071541
• 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: 07/02/2026
• Supplement Date Received by Manufacturer: 07/23/2026
• Initial Report FDA Received Date: 07/28/2026
• Supplement Report FDA Received Date: 08/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/09/2025
• 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
• Outcome Attributed to Adverse Event: Death
• Patient Age: 72 YR
• Patient Sex: Female
• Patient Weight: 127 LB
• Patient Race: White