XIENCE ALPINE 1145400-38Recalls & reported problems
Abbott Vascular Inc. · XIENCE Alpine Everolimus Eluting Coronary Stent System 4.00 mm x 38 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 08717648200380), received between Aug 30, 2017 and Aug 30, 2017 — classified as 1 injury.
The most frequently reported specific device problem is “Deflation Problem” (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
- Deflation Problem1
- Device Operates Differently Than Expected1
- Difficult to Remove1
- Improper or Incorrect Procedure or Method1
Patient problems
- Atrial Fibrillation1
- Myocardial Infarction1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryAug 30, 2017Deflation Problem; Difficult to Remove; Improper or Incorrect Procedure or Method; Device Operates Differently Than Expected
IT WAS REPORTED THAT THE PATIENT PRESENTED WITH AN ST ELEVATED MYOCARDIAL INFARCTION (STEMI) AND A THROMBOSED PROXIMAL RIGHT CORONARY ARTERY (RCA)). THE CULPRIT VESSEL (RCA) WAS TREATED WITH SUCCESSFUL ADVANCEMENT (VIA FEMORAL ACCESS) AND DEPLOYMENT OF A 4.0X38MM OTW XIENCE ALPINE DRUG-ELUTING STENT (DES). WHEN DEPLOYING THE STENT, A TRANSLUCENT GAP (WITH NO CONTRAST) WAS NOTED IN THE CENTER OF THE BALLOON, BUT INFLATION AND DEPLOYMENT WERE COMPLETED WITHOUT DIFFICULTY. DURING AN ATTEMPT TO THEN DEFLATE THE STENT DELIVERY SYSTEM (SDS) BALLOON USING AN INDEFLATOR, THE BALLOON WOULD NOT DEFLATE AT ALL AND WAS UNABLE TO BE RETRACTED FROM THE DEPLOYED STENT. THE GUIDE CATHETER WAS PUSHED FORWARD TO THE EDGE OF THE STENT, THEN MULTIPLE ATTEMPTS WERE MADE TO PUNCTURE THE BALLOON USING BOTH ENDS OF VARIOUS UNSPECIFIED GUIDE WIRES, BUT THE BALLOON WAS UNABLE TO BE PUNCTURED AFTER ATTEMPTING FOR 30 MINUTES. GENTLE, CONSISTENT FORCE WAS THEN APPLIED TO THE SDS AND THE INFLATED BALLOON WAS ABLE TO BE WITHDRAWN FROM THE STENT (WITH NO DAMAGE TO THE STENT) AND THE BALLOON WAS WEDGED BACK INTO THE GUIDE CATHETER. THE INFLATED BALLOON AND GUIDE CATHETER WERE WITHDRAWN FROM THE ANATOMY AS A SINGLE
Patient problems: Atrial Fibrillation; Myocardial Infarction
MAUDE report 6832240 ↗
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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