XIENCE V 1009541-08Recalls & reported problems
Abbott Vascular Inc. · XIENCE V Everolimus Eluting Coronary Stent System 3.00 mm x 08 mm / Rapid-Exchange · Class 3 · Implant
Data updated Oct 13, 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 08717648064050), received between Aug 12, 2016 and Aug 12, 2016 — 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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Stenosis1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryAug 12, 2016Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT ON 10/18/2010, THREE XIENCE V STENTS WERE IMPLANTED IN THE PROXIMAL RIGHT CORONARY ARTERY, SIZES 2.5 X 28MM, 3.0 X 18MM, 3.0 X 08MM. ON (B)(6) 2011, RESTENOSIS WAS FOUND IN THE LESION. THE PATIENT WAS HOSPITALIZED AND WAS TREATED WITH PCI FOR RESTENOSIS IN THE 2.5X28 XIENCE V STENT ON (B)(6) 2011. THE PATIENT CONDITION IMPROVED AND WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2011. ON (B)(6) 2012, RESTENOSIS WAS FOUND AGAIN IN THE LESION. THE PATIENT WAS HOSPITALIZED AND WAS TREATED WITH A TRIPLE CORONARY ARTERY BYPASS GRAFT SURGERY IN THE DISTAL LEFT ANTERIOR DESCENDING CORONARY ARTERY, THE POSTERIOR-LATERAL BRANCH OF LEFT CIRCUMFLEX CORONARY ARTERY, AND THE ARTERIOVENOUS BRANCH OF THE RIGHT CORONARY ARTERY ON (B)(6) 2012. THE PATIENT CONDITION IMPROVED AND THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2012. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Stenosis
MAUDE report 5873612 ↗
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
- 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
- SYNERGY™ H7493926038250Boston Scientific Corporation · Coronary drug-eluting stent4 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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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