XIENCE Skypoint™ 1804500-18Recalls & reported problems
Abbott Vascular Inc. · XIENCE Skypoint™ Everolimus Eluting Coronary Stent System 5.00 mm x 18 mm / Rapid-Exchange · Class 3 · Implant
All models of XIENCE Skypoint (69)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 1
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08717648233647), received between Mar 30, 2026 and Mar 30, 2026 — classified as 1 death.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- High Blood Pressure/ Hypertension1
- Pericardial Effusion1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
DeathMar 30, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT ON (B)(6) 2025, THE PATIENT, WITH A HISTORY OF CORONARY ARTERY DISEASE AND ST ELEVATION MYOCARDIAL INFARCTION (STEMI), HAD ONE 5.0X18 MM XIENCE SKYPOINT STENT IMPLANTED. THE PATIENT WAS RE-ADMITTED ON (B)(6) 2025 WITH CHRONIC ISCHEMIC HEART DISEASE, HYPERTENSIVE HEART, CHRONIC KIDNEY DISEASE WITH HEART FAILURE AND STAGE 1 THROUGH STAGE 4 CHRONIC KIDNEY DISEASE. THE PATIENT WAS RE-ADMITTED AGAIN ON (B)(6) 2025 WITH CHRONIC ISCHEMIC HEART DISEASE AND HEMOPERICARDIUM AS A CURRENT COMPLICATION FOLLOWING ACUTE MYOCARDIAL INFARCTION. DRAINAGE OF THE PERICARDIAL CAVITY WAS PERFORMED DURING THE LATTER RE-ADMISSION; HOWEVER, THE PATIENT EXPIRED ON (B)(6) 2026. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: High Blood Pressure/ Hypertension; Pericardial Effusion
MAUDE report 24713081 ↗
Other Coronary drug-eluting stent devices
- SYNERGY™ H7493926038300Boston Scientific Corporation · Coronary drug-eluting stent8 deaths124 reports
- SYNERGY™ H7493926016300Boston Scientific Corporation · Coronary drug-eluting stent7 deaths106 reports
- SYNERGY™ H7493926020300Boston Scientific Corporation · Coronary drug-eluting stent9 deaths90 reports
- SYNERGY™ H7493926016250Boston Scientific Corporation · Coronary drug-eluting stent6 deaths82 reports
- XIENCE Sierra™ 1550350-33Abbott Vascular Inc. · Coronary drug-eluting stent1 recall32 reports
- Resolute Onyx™ RONYX30022UXMedtronic, Inc. · Coronary drug-eluting stent6 deaths76 reports
- SYNERGY™ H7493926024300Boston Scientific Corporation · Coronary drug-eluting stent3 deaths75 reports
- Resolute Onyx™ RONYX30015UXMedtronic, Inc. · Coronary drug-eluting stent3 deaths73 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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