XIENCE ALPINE 1145250-28Recalls & reported problems
Abbott Vascular Inc. · XIENCE Alpine Everolimus Eluting Coronary Stent System 2.50 mm x 28 mm / Over-The-Wire · Class 3 · Implant
All models of XIENCE ALPINE (72)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08717648199912), received between Jan 15, 2021 and Jan 15, 2021 — classified as 1 malfunction.
The most frequently reported specific device problem is “Difficult 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 16, 2026.
Most reported problems
Device problems
- Difficult to Advance1
- Difficult to Remove1
- No Apparent Adverse Event1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 15, 2021Difficult to Remove; Difficult to Advance; No Apparent Adverse Event
IT WAS REPORTED THAT THE PROCEDURE WAS TREAT A LEFT ANTERIOR DESCENDING ARTERY. A 2.5X28MM XIENCE ALPINE WAS ATTEMPTED TO ADVANCE OVER THE 014 BALANCE MIDDLEWEIGHT HYDRO GUIDE WIRE; HOWEVER, IT BECAME STUCK. BOTH DEVICES WERE SIMPLY REMOVED AS ONE UNIT. ANOTHER UNSPECIFIED STENT AND GUIDE WIRE WERE USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY. SUBSEQUENT TO FILING THE INITIAL REPORT, THE FOLLOWING CLARIFICATION WAS RECEIVED: THE 2.5X28MM XIENCE ALPINE WAS THE DEVICE USED TO SUCCESSFULLY COMPLETE THE PROCEDURE AND NOT THE DEVICE THAT BECAME STUCK ON THE BMW GUIDE WIRE. THE DEVICE THAT BECAME STUCK ON THE BMW GUIDE WIRE WAS A NON-ABBOTT STENT. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 11178874 ↗
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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