XIENCE V 1009541-12Recalls & reported problems
Abbott Vascular Inc. · XIENCE V Everolimus Eluting Coronary Stent System 3.00 mm x 12 mm / Rapid-Exchange · Class 3 · Implant
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 08717648064074), received between Mar 1, 2018 and Mar 1, 2018 — 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
- Stenosis1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMar 1, 2018Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT ON (B)(6) 2013 ONE 4.0X15 MM XIENCE V STENT WAS IMPLANTED IN THE LEFT MAIN (LM) CORONARY ARTERY AND THE 3.0X12 MM XIENCE V STENT WAS IMPLANTED IN THE DISTAL LEFT CIRCUMFLEX (DLCX) CORONARY ARTERY. ON (B)(6) 2017 THE PATIENT HAD UNSTABLE ANGINA AND A 90% RESTENOSIS WAS FOUND IN THE DLCX ON THE CORONARY ANGIOGRAM. ON (B)(6) 2017 PERCUTANEOUS CORONARY INTERVENTION WAS PERFORMED IN THE DLCX. THE CONDITION RESOLVED. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.
Patient problems: Angina; Stenosis
MAUDE report 7307876 ↗
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
- 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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