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

Model Number	1804250-15
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Stenosis (2263)
Date of Event	01/30/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient id: (b)(6).It was reported that (b)(6) 2022 the patient underwent stenting in the left main coronary artery with a 4.5x12 mm xience skypoint stent and in the first obtuse marginal (om1) coronary artery with a 2.5x15 mm xience skypoint stent (lot 1100541).The patient was on clopidogrel until (b)(6) 2023 when the prescription ran out needed to be requested again.The patient restarted clopidogrel medication on (b)(6) 2023.On (b)(6) 2024, the patient had an annual follow up visit with the cardiologist after she had a recent hypotensive syncopal episode due to metoprolol.During the visit there were no present symptoms, but because of her history of severe coronary artery disease, a stress test was recommended.The patient had an abnormal stress test on (b)(6) 2024 and was subsequently scheduled for a heart catheterization.The patient was re-admitted to the hospital on (b)(6) 2024.Heart catheterization found the patient had 80% in-stent restenosis in the om1.Revascularization (balloon angioplasty and angiosculpt) was only performed in the obtuse marginal coronary artery on (b)(6) 2024 and the condition resolved.There was no adverse patient sequelae.The patient was discharged on (b)(6) 2024.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 review of the complaint history identified no other similar complaints from this lot.The reported patient effect of stenosis is listed in the xience skypoint everolimus eluting coronary stent systems instructions for use as a known patient effect of coronary stenting procedures.A conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined; however, the subsequent treatment and hospitalization appear to be related to the operational context of the procedure.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 ; EI
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 21152065
• Report Number: 2024168-2025-00568
• Device Sequence Number: 15768639
• Product Code: NIQ
• UDI-Device Identifier: 08717648233074
• UDI-Public: (01)08717648233074(17)231011(10)1100541
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• 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: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/14/2025

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: 10/11/2023
• Device Model Number: 1804250-15
• Device Catalogue Number: 1804250-15
• Device Lot Number: 1100541
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/23/2024
• Initial Report FDA Received Date: 01/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/12/2021
• 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: Required Intervention; Hospitalization
• Patient Age: 75 YR
• Patient Sex: Female
• Patient Weight: 84 KG
• Patient Ethnicity: Hispanic
• Patient Race: White