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

Model Number	1804250-23
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Angina (1710); Thrombosis/Thrombus (4440)
Date of Event	10/29/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient presented with st elevated myocardial infarction (stemi) and the procedure was to treat the 100% occluded left anterior descending (lad) coronary artery.The 2.5x23 mm xience skypoint stent was implanted on (b)(6) 2024.On (b)(6) 2024, the patient experienced angina and was emergently brought to the cath lab and acute stent thrombosis was detected via angiography.Three other xience skypoint stents (2.25x15 mm, 3.0x8 mm, 3.25x12 mm) were implanted and aggrastat was provided.The patient was discharged out of the cath lab in stable but serious condition and expired on (b)(6) 2024.In the physician's opinion, none of the xience skypoint stents caused or contributed to the patient death.No additional information was provided.
Additional Manufacturer Narrative
The reported patient effect(s) of thrombosis and angina is listed in the xience skypoint everolimus eluting coronary stent systems instructions for use as a known patient effect(s) of coronary stenting procedures.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.A conclusive cause for the reported patient effect(s), and the relationship to the product, if any, cannot be determined; however, the subsequent treatments appear to be related to the operational context of the procedure.In this case, it was reported that in the physician¿s opinion, none of the xience skypoint stents caused or contributed to the patient death.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.The additional devices referenced in b5 are filed under separate medwatch report numbers.

• 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 ; EI
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 20747082
• Report Number: 2024168-2024-13804
• Device Sequence Number: 8362595
• Product Code: NIQ
• UDI-Device Identifier: 08717648233098
• UDI-Public: (01)08717648233098(17)260511(10)3051841
• Combination Product (Y/N): Y
• 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: 2024
• 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): 11/21/2024

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: 05/11/2026
• Device Model Number: 1804250-23
• Device Catalogue Number: 1804250-23
• Device Lot Number: 3051841
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/29/2024
• Initial Report FDA Received Date: 11/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/12/2023
• 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: Hospitalization; Required Intervention
• Patient Age: 68 YR
• Patient Sex: Female