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

Model Number	1804350-08
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Angina (1710); Dizziness (2194); Obstruction/Occlusion (2422)
Date of Event	09/01/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.B3: date of event estimated as 9/1/2025.D6: date of implant estimated as (b)(6) 2022 the additional devices referenced in b5 are filed under separate medwatch report numbers.
Event or Problem Description
It was reported that in (b)(6) 2022, once 2.5x08mm xience skypoint was implanted in the proximal diagonal, 3.5x23mm, 3.5x12mm, 3.5x15mm xience skypoints implanted in proximal and mid right coronary artery (rca).Another 3.0x23, 3.0x12mm and 3.5x08mm xience skypoints were implanted in the mid left anterior descending artery (lad) without issue.However, in (b)(6) 2025, the patient began to experience chest pain and dizziness.Therefore, a stress test and angiogram revealed the mid rca and mid lad are occluded.Patient is awaiting bypass surgery.No additional information was provided.
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 their relationship to the product, if any, cannot be determined.The reported patient effects of obstruction/occlusion, dizziness and angina are listed in the xience skypoint instruction for use as a known patient effects of coronary stenting procedures.There is no indication of a product quality issue with respect to manufacture, design, or labeling.

• 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: 23270463
• Report Number: 2024168-2025-11061
• Device Sequence Number: 13135716
• Product Code: NIQ
• UDI-Device Identifier: 08717648233371
• UDI-Public: (01)08717648233371(17)230830(10)1082441
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P110019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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): 11/03/2025

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: 08/30/2023
• Device Model Number: 1804350-08
• Device Catalogue Number: 1804350-08
• Device Lot Number: 1082441
• 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: 09/17/2025
• Supplement Date Received by Manufacturer: 10/10/2025
• Initial Report FDA Received Date: 10/10/2025
• Supplement Report FDA Received Date: 11/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/31/2021
• 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
• Outcome Attributed to Adverse Event: Disability; Hospitalization
• Patient Age: 54 YR
• Patient Sex: Unknown
• Patient Weight: 69 KG