XIENCE ALPINE 1145300-08Recalls & reported problems
Abbott Vascular Inc. · XIENCE Alpine Everolimus Eluting Coronary Stent System 3.00 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
- 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 08717648200045), received between Sep 27, 2019 and Sep 27, 2019 — classified as 1 injury.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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
- Device Dislodged or Dislocated1
- Difficult to Remove1
- Failure to Advance1
- Improper or Incorrect Procedure or Method1
Patient problems
- Foreign Body In Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjurySep 27, 2019Difficult to Remove; Improper or Incorrect Procedure or Method; Failure to Advance; Device Dislodged or Dislocated; Difficult to Remove; Improper or Incorrect Procedure or Method; Failure to Advance; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION WITH HEAVY TORTUOSITY AND MODERATE CALCIFICATION IN THE OBTUSE MARGINAL CORONARY ARTERY. THE XIENCE ALPINE STENT DELIVERY SYSTEM (SDS) WAS ADVANCED WITH RESISTANCE FROM THE ANATOMY AND BEFORE REACHING THE TARGET LESION, THE SDS WAS UNABLE TO ADVANCE FURTHER. RESISTANCE WAS NOTED DURING REMOVAL OF THE SDS; THEREFORE, FORCE WAS USED TO REMOVE THE DEVICE. DURING REMOVAL, THE STENT DISLODGED FROM THE BALLOON. THE DISLODGED STENT MIGRATED AND REMAINS IN THE PROXIMAL CIRCUMFLEX ARTERY. THE PHYSICIAN DECIDED TO ADVANCE A 3.0 X 12 MM XIENCE ALPINE SDS TO COMPRESS THE DISLODGED STENT TO THE VESSEL WALL. THE PROCEDURE WAS ENDED. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Foreign Body In Patient
MAUDE report 9130838 ↗
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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