XIENCE XPEDITION 1074300-33Recalls & reported problems
Abbott Vascular Inc. · XIENCE Xpedition LL Everolimus Eluting Coronary Stent System 3.00 mm x 33 mm / Rapid-Exchange · Class 3 · Implant
All models of XIENCE XPEDITION (41)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 1
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08717648162374), received between Aug 5, 2016 and May 2, 2023 — classified as 1 death, 1 injury.
The most frequently reported specific device problem is “Off-Label Use” (1 report).
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.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem2
- Off-Label Use1
Patient problems
- Death1
- Dyspnea1
- Hypersensitivity/Allergic reaction1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryMay 2, 2023Off-Label Use; Adverse Event Without Identified Device or Use Problem; Off-Label Use; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN AN UNSPECIFIED ARTERY. THE 3.0X33MM XIENCE XPEDITION STENT DELIVERY SYSTEM (SDS) WAS IMPLANTED ON (B)(6) 2014. AN ALLERGIC REACTION OCCURRED AS THE PATIENT NOTICED SHORTNESS OF BREATH BUT HAD NO OTHER ADVERSE REACTIONS. THE PATIENT THOUGHT THIS IS SOMEWHAT NORMAL AS THE PATIENT IS ALLERGIC TO THINGS LIKE NICKEL, LATEX, BEES, STITCHES, AND AMONG OTHER THINGS. TREATMENT, IF ANY, WAS NOT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Dyspnea; Hypersensitivity/Allergic reaction
MAUDE report 16853440 ↗DeathAug 5, 2016Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT SOMETIME IN 2014 A 3.0 X 33 MM XIENCE XPEDITION STENT WAS BEING USED IN A PROCEDURE WHERE THE PATIENT EXPIRED. IT IS UNKNOWN IF THE STENT WAS IMPLANTED. THE CAUSE OF DEATH IS UNKNOWN. THERE IS NO ADDITIONAL INFORMATION PROVIDED.
Patient problems: Death
MAUDE report 5851592 ↗
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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