XIENCE V 1009541-15Recalls & reported problems
Abbott Vascular Inc. · XIENCE V Everolimus Eluting Coronary Stent System 3.00 mm x 15 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 08717648064098), received between Nov 21, 2017 and Nov 21, 2017 — 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
- Hypersensitivity/Allergic reaction1
- Inflammation1
- Rash1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryNov 21, 2017Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT ON 04/20/2010 A 3.0X15 MM XIENCE V STENT WAS IMPLANTED IN THE RIGHT CORONARY ARTERY. ON AN UNSPECIFIED DATE, SOMETIME IN (B)(6) 2017, AFTER EATING PORK AND BEEF THE PATIENT BEGAN TO EXPERIENCE SWELLING OF THE CHIN AND CHEST. THE PATIENT THEN BROKE INTO A RASH IN THE STOMACH, LEG AND FACE. THE PATIENT SAW AN ALLERGIST WHICH INFORMED HIM HE WAS HAVING AN ALLERGIC REACTION. CREAMS WERE GIVEN TO THE PATIENT AND HE WAS INFORMED TO DISCONTINUE EATING PORK AND BEEF. THE PATIENT WAS INFORMED HE IS ALLERGIC TO GOLD AMONG OTHER THINGS (NOT SPECIFIED) AND WAS CONCERNED HE MAY BE ALLERGIC TO THE STENT. THE PATIENT IS DOING GREAT. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Hypersensitivity/Allergic reaction; Inflammation; Rash
MAUDE report 7050488 ↗
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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