XIENCE XPEDITION 1074225-08Recalls & reported problems
Abbott Vascular Inc. · XIENCE Xpedition SV Everolimus Eluting Coronary Stent System 2.25 mm x 8 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
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08717648162015), received between Mar 2, 2017 and Sep 25, 2017 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Device Expiration Issue” (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
- Device Expiration Issue1
- Improper or Incorrect Procedure or Method1
Patient problems
- Angina1
- No Consequences Or Impact To Patient1
- Stenosis1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 25, 2017Device Expiration Issue; Improper or Incorrect Procedure or Method
IT WAS REPORTED THAT A 2.25X08 MM XIENCE XPEDITION STENT IMPLANT WAS SUCCESSFULLY IMPLANTED ON (B)(6) 2017. IT WAS LATER DETERMINED THE STENT HAD EXPIRED. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND NO ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6891361 ↗InjuryMar 2, 2017Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THREE XIENCE XPEDITION STENTS (2.25 X 18 MM. 2.25 X 08 MM AND 3.0 X 12 MM) WERE IMPLANTED IN THE RIGHT CORONARY ARTERY ON (B)(6) 2014. ON (B)(6) 2017, THE PATIENT WAS RE-ADMITTED WITH CHEST PAIN AND RESTENOSIS IN THE STENTS WAS FOUND WHICH WAS TREATED WITH TWO NON-ABBOTT STENTS. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. THE PATIENT IS DOING GOOD. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Angina; Stenosis
MAUDE report 6374756 ↗
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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