XIENCE ALPINE 1145400-08Recalls & reported problems
Abbott Vascular Inc. · XIENCE Alpine Everolimus Eluting Coronary Stent System 4.00 mm x 08 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
- 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 08717648200311), received between Mar 6, 2019 and Oct 11, 2021 — classified as 1 death, 1 malfunction.
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 16, 2026.
Most reported problems
Device problems
- Failure to Advance1
- Improper or Incorrect Procedure or Method1
- Leak/Splash1
- Material Split, Cut or Torn1
Patient problems
- Death1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 11, 2021Leak/Splash; Improper or Incorrect Procedure or Method; Material Split, Cut or Torn; Leak/Splash; Improper or Incorrect Procedure or Method; Material Split, Cut or Torn
IT WAS REPORTED THIS WAS A PROCEDURE TO TREAT DE NOVO OSTIAL LEFT MAIN. A XIENCE ALPINE 4.0X8 DRUG ELUTING STENT (DES) WAS INSERTED. HOWEVER, WHEN FLUSHING THE DEVICE, A HOLE IN THE SIDE OF THE CATHETER SHAFT WAS OBSERVED. IT WAS NOTED THE DEVICE WAS ATTEMPTED TO BE PREPARED WHILE IN THE ANATOMY. DUE TO THIS, THE STENT WAS REMOVED AND REPLACED WITH A SAME SIZE DEVICE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12605924 ↗DeathMar 6, 2019Failure to Advance; Failure to Advance
IT WAS REPORTED THAT DURING A PROCEDURE OF THE PROXIMAL CIRCUMFLEX ARTERY, THE 4.0 X 08 MM XIENCE ALPINE STENT DELIVERY SYSTEM (SDS) FAILED TO CROSS THE LESION FOR AN UNSPECIFIED REASON. A NON-ABBOTT STENT WAS USED IN THE PROCEDURE WITHOUT REPORTED ISSUE. IT WAS NOTED, HOWEVER, THAT THE PATIENT DIED DURING THE PROCEDURE OF 'NATURAL CAUSE' NOT RELATED TO THE DEVICE. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Death
MAUDE report 8396765 ↗
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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