XIENCE ALPINE 1145250-18Recalls & reported problems
Abbott Vascular Inc. · XIENCE Alpine Everolimus Eluting Coronary Stent System 2.50 mm x 18 mm / Over-The-Wire · Class 3 · Implant
Data updated Oct 13, 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 08717648199899), received between Feb 21, 2019 and Feb 21, 2019 — classified as 1 injury.
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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Stenosis1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryFeb 21, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT IN (B)(6) 2017, THE PATIENT PRESENTED WITH ISCHEMIC CARDIOMYELOPATHY AND UNDERWENT A CORONARY STENTING PROCEDURE FOR A LESION IN THE PROXIMAL TO MID LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY WITH 80-90% STENOSIS. A 2.50 X 18 MM XIENCE ALPINE STENT WAS DEPLOYED IN THE MID LAD AND A 2.75 X 12 MM XIENCE ALPINE STENT WAS DEPLOYED IN THE PROXIMAL TO MID LAD WITHOUT ISSUE. ON (B)(6) 2019, THE PATIENT UNDERWENT FURTHER PERCUTANEOUS CORONARY TRANSLUMINAL ANGIOPLASTY (PTCA) FOR UNSPECIFIED SYMPTOMS. IN STENT RE-STENOSIS OF THE ALPINE STENTS WAS DIAGNOSED BY ANGIOGRAM. A 3.00 X 28 MM XIENCE SIERRA STENT AND A 3.00 X 23 MM XIENCE SIERRA STENT WERE DEPLOYED IN THE PROXIMAL TO MID LAD TO TREAT THE RE-STENOSIS. THE PATIENT WAS REPORTED TO BE WELL POST PROCEDURE AND WAS THEREFORE DISCHARGED; HOWEVER 5 DAYS LATER THE PATIENT DEVELOPED CHEST PAIN AND LOW BLOOD PRESSURE AND WAS RE-ADMITTED (B)(6) 2019). ANGIOGRAM CONFIRMED IN STENT THROMBOSIS AND THE PATIENT WAS TREATED WITH MEDICATION AND ADDITIONAL BALLOON ANGIOPLASTY. A NON-ABBOTT HEART PUMP WAS USED DURING THE PROCEDURE. POST PROCEDURE THE STENTS WERE CONFIRMED TO BE PATENT AND THE PATIENT WAS REPORTED TO BE STABLE IN H
Patient problems: Stenosis
MAUDE report 8360396 ↗
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
- SYNERGY™ H7493926038250Boston Scientific Corporation · Coronary drug-eluting stent4 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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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