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

Model Number	1804225-18
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Stroke/CVA (1770); Vascular Dissection (3160)
Date of Event	06/10/2024
Type of Reportable Event	Death
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 patient effect(s), and the relationship to the product, if any, cannot be determined; however, the subsequent treatment appears to be related to the operational context of the procedure.The reported patient effect(s) of death, stroke and dissection are listed in the xience skypoint everolimus eluting coronary stent systems instructions for use as a known patient effect(s) of coronary stenting procedures.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
Patient id: (b)(6).On (b)(6) 2024 percutaneous coronary intervention (pci) was performed to treat lesions in the left main trunk (lmt) and left anterior descending (lad) arteries with mild tortuosity and moderate calcification.Prior to stent implantation, the lesions were treated with intravascular lithotripsy (ivl) and pre-dilated with a non-compliant balloon.Then, a 2.25x18mm, 3x33mm and 3.5x28mm xience skypoint stents were implanted followed by post dilatation.At some point during the procedure a coronary artery dissection occurred; however was covered with stents.Then, on (b)(6) 2024 the patient experienced difficulty walking and was hospitalized.An mri revealed ischemic stroke.On (b)(6) 2024 the patient was transferred to another hospital, where on (b)(6) 2024 an ablation procedure was performed during which reported bleeding occurred in the right femoral puncture site.The patient was discharged a few days later.During the 1 year follow-up call it was reported that on (b)(6) 2025 the patient died during hospitalization.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: 22170979
• Report Number: 2024168-2025-05945
• Device Sequence Number: 13111850
• Product Code: NIQ
• UDI-Device Identifier: 08717648233005
• UDI-Public: (01)08717648233005(17)241017(10)110084A
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• PMA/510(K) Number: P110019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Study,Health Professional,Company Representative
• 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?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 10/17/2024
• Device Model Number: 1804225-18
• Device Catalogue Number: 1804225-18
• Device Lot Number: 110084A
• 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: 10/18/2021
• 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: XIENCE SKYPOINT DES 3.00 X 33 RX US; XIENCE SKYPOINT DES 3.50 X 28 RX US
• Outcome Attributed to Adverse Event: Death
• Patient Age: 82 YR
• Patient Sex: Female
• Patient Weight: 50 KG