XIENCE Skypoint™ 1804325-33Recalls & reported problems
Abbott Vascular Inc. · XIENCE Skypoint™ Everolimus Eluting Coronary Stent System 3.25 mm x 33 mm / Rapid-Exchange · Class 3 · Implant
All models of XIENCE Skypoint (69)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08717648233357), received between Mar 24, 2023 and Mar 24, 2023 — classified as 1 injury.
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 16, 2026.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Angina1
- Cardiac Arrest1
- Diaphoresis1
- Low Blood Pressure/ Hypotension1
- Myocardial Infarction1
- Thrombosis/Thrombus1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMar 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT LESIONS IN THE IN THE PROXIMAL LEFT ANTERIOR DESCENDING (PLAD) ARTERY AND PROXIMAL RAMUS INTERMEDIUS (PRI) CORONARY ARTERY. ACTIVATED CLOTTING TIME (ACT) WAS NOTED TO BE 303 SECONDS; THEREFORE, ANOTHER 2000 UNITS OF IV HEPARIN WERE ADMINISTERED. ADDITIONALLY, 180MG OF BRILINTA WAS ADMINISTERED. THE 3.25X33MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TO THE TARGET LESION IN THE PLAD AND THE STENT WAS DEPLOYED AT 18 ATM FOR 12 SECONDS. ANGIOGRAPHY WAS PERFORMED AND THERE WAS NO ISSUE WITH THE IMPLANTED STENT. NEXT THE 2.25X15MM XIENCE SKYPOINT SDS WAS ADVANCED TO THE TARGET LESION IN THE PRI AND DEPLOYED AT 12 ATM FOR 15 SECONDS. THE PHYSICIAN TOOK ANGIOGRAPHIC VIEWS POST STENT IMPLANTATION. THERE WAS NO REPORTED ISSUE WITH THE SECOND IMPLANTED STENT. POST PROCEDURE THE PATIENT NOTED CHEST PAIN OF A 2 ON A SCALE OF 10. SOMETIME POST PROCEDURE IN THE HOLDING AREA, BLOOD PRESSURE WAS NOTED TO BE CRITICALLY LOW AND THE PATIENT WAS DIAPHORETIC WITH SEVERE CHEST PAIN. ELECTROCARDIOGRAM (EKG/ECG) NOTED AN ST-ELEVATION MYOCARDIAL INFARCTION (STEMI). THE PATIENT WAS BROUGHT BACK, EMERGENTLY, TO THE CATH LAB. AT SOME POINT, THE PA
Patient problems: Angina; Cardiac Arrest; Diaphoresis; Low Blood Pressure/ Hypotension; Myocardial Infarction; Thrombosis/Thrombus
MAUDE report 16613426 ↗
Other Coronary drug-eluting stent devices
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- SYNERGY™ H7493926016300Boston Scientific Corporation · Coronary drug-eluting stent7 deaths106 reports
- SYNERGY™ H7493926020300Boston Scientific Corporation · Coronary drug-eluting stent9 deaths90 reports
- XIENCE Sierra™ 1550350-33Abbott Vascular Inc. · Coronary drug-eluting stent1 recall32 reports
- SYNERGY™ H7493926016250Boston Scientific Corporation · Coronary drug-eluting stent6 deaths82 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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