XIENCE XPEDITION 1074350-12Recalls & reported problems
Abbott Vascular Inc. · XIENCE Xpedition Everolimus Eluting Coronary Stent System 3.50 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
- 2
- Deaths reported
- 1
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08717648162527), received between Mar 7, 2017 and Jun 14, 2018 — classified as 1 death, 1 malfunction.
The most frequently reported specific device problem is “Break” (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 Problem1
- Break1
- Difficult To Position1
- Kinked1
Patient problems
- Death1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
DeathJun 14, 2018Adverse Event Without Identified Device or Use Problem
EXCEL STUDY REPORT. IT WAS REPORTED THAT ON (B)(6) 2013, A 4.0X18MM AND 3.5X12MM XIENCE XPEDITION STENTS WERE SUCCESSFULLY IMPLANTED IN THE LEFT MAIN CORONARY ARTERY (LM), PROXIMAL LEFT ANTERIOR DESCENDING (LAD), AND PROXIMAL CIRCUMFLEX (CX) CORONARY ARTERY LESIONS. IN THE YEAR 2015, A PERCUTANEOUS INTERVENTION WAS PERFORMED IN THE RIGHT CORONARY ARTERY (RCA). ON (B)(6) 2017, THE PATIENT PASSED AWAY DUE TO AN UNDETERMINED REASON. PER PHYSICIAN, THE DEVICE RELATIONSHIP TO THE DEATH WAS UNKNOWN. THERE WAS NO AUTOPSY PERFORMED. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THIS ISSUE.
Patient problems: Death
MAUDE report 7602850 ↗MalfunctionMar 7, 2017Break; Kinked; Difficult To Position
IT WAS REPORTED THAT THE 3.5X12MM XIENCE XPEDITION RX STENT DELIVERY SYSTEM (SDS) WAS INSERTED INTO THE GUIDE CATHETER, BUT MET RESISTANCE DUE TO AN IRREGULARITY (BUMP) IN THE SHAFT NEAR THE STENT. THE DEVICE WAS REMOVED AND ANOTHER DRUG ELUTING STENT WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED. RETURNED DEVICE ANALYSIS FOUND THAT THE INNER MEMBER WAS SEPARATED AND BUNCHED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6386228 ↗
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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