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

Model Number	1804350-18
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Dyspnea (1816); Hypersensitivity/Allergic reaction (1907); Dizziness (2194)
Date of Event	12/25/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the procedure was to treat a lesion in the left anterior descending (lad) coronary artery.The 3.5x18 mm xience skypoint stent was implanted on (b)(6) 2024 and on (b)(6) 2024 the patient experienced minor sinus pressure, heaviness in the chest with slight difficulty in breathing, hoarse or strained voice, clear post nasal drip, and dizziness or light headed feeling.The patient was discharged without further treatment and was instructed to wait an additional 7 days for symptoms to resolve.The patient was taking brilinta, and rosuvastatin 10 mg.The brilinta gave him a rash and they stopped the medication on (b)(6) 2025, and was switched to plavix on (b)(6) 2025.Rosuvastatin was increased from 10 mg to 20 mg.The patient went to urgent care around (b)(6) 2025 and they diagnosed him with sinusitis and prescribed claritin and a nasal spray.The patient is concerned about an allergic reaction.They have an appointment with their cardiologist in 4 weeks and plan to see an allergist.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 the reported patient effects of dizziness and hypersensitivity are listed in the xience skypoint everolimus eluting coronary stent systems instructions for use as a known patient effects of coronary stenting procedures.A conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined.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: 21210602
• Report Number: 2024168-2025-00769
• Device Sequence Number: 4045684
• Product Code: NIQ
• UDI-Device Identifier: 08717648233401
• UDI-Public: (01)08717648233401(17)270812(10)4081541
• Combination Product (Y/N): Y
• Initial Reporter State: FL
• 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: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/22/2025

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 Model Number: 1804350-18
• Device Catalogue Number: 1804350-18
• Device Lot Number: 4081541
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/07/2025
• Initial Report FDA Received Date: 01/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/13/2024
• 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: Other
• Patient Age: 59 YR
• Patient Sex: Male