XIENCE XPEDITION 1074250-12Recalls & reported problems
Abbott Vascular Inc. · XIENCE Xpedition Everolimus Eluting Coronary Stent System 2.50 mm x 12 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
- 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 08717648162121), received between Mar 30, 2018 and Mar 30, 2018 — classified as 1 injury.
The most frequently reported specific device problem is “Failure to Advance” (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
- Failure to Advance1
Patient problems
- Intimal Dissection1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMar 30, 2018Failure to Advance
IT WAS REPORTED THAT THE PATIENT WAS HOSPITALIZED IN THE INTENSE CARE UNIT (ICU) WITH ST SEGMENT ELEVATION MYOCARDIAL INFARCTION (STEMI) FROM THE DIFFUSED MID-PROXIMAL AND NEARLY OCCLUDED MID RIGHT CORONARY ARTERY (RCA). AFTER PRE-DILATATION WITH AN UNSPECIFIED BALLOON CATHETER, THE 2.5 X 33 MM XIENCE XPEDITION STENT DELIVERY SYSTEM (SDS) WAS ADVANCED BUT FAILED TO CROSS THE LESION DUE TO THE ANATOMY. THE DEVICE WAS REMOVED AND A SHORTER 2.5 X 12 MM XIENCE XPEDITION SDS WITH A GUIDELINER WAS ATTEMPTED; HOWEVER, PROXIMAL TO THE TARGET LESION A VESSEL DISSECTION OCCURRED. A 2.25 X 8 MM XIENCE XPEDITION STENT WAS SUCCESSFULLY IMPLANTED PROXIMAL TO THE TARGET LESION. THE DISSECTION WAS TREATED WITH BALLOON ANGIOPLASTY AND THE PATIENT WAS PUT ON MEDICAL MANAGEMENT. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Intimal Dissection
MAUDE report 7387183 ↗
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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