XIENCE ALPINE 1145250-23Recalls & reported problems
Abbott Vascular Inc. · XIENCE Alpine Everolimus Eluting Coronary Stent System 2.50 mm x 23 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 08717648199905), received between Apr 13, 2017 and Apr 13, 2017 — classified as 1 injury.
The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (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
- Improper or Incorrect Procedure or Method1
- Physical Resistance1
Patient problems
- Angina1
- Intimal Dissection1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryApr 13, 2017Improper or Incorrect Procedure or Method; Physical Resistance
IT WAS REPORTED THAT THE PATIENT UNDERWENT A CORONARY STENTING PROCEDURE TO TREAT A TARGET LESION IN THE RIGHT CORONARY ARTERY (RCA). A 2.5 X 23 MM XIENCE ALPINE WAS ADVANCED TOWARD THE LESION, BUT COULD NOT CROSS, SO IT WAS REMOVED AND ADDITIONAL DILATATION WAS PERFORMED. IT WAS RE-INSERTED AND IMPLANTED IN THE DISTAL HALF OF THE MID RCA. A SMALL DISSECTION WAS NOTED AT THE PROXIMAL EDGE. A 2.75 X 28 MM XIENCE ALPINE WAS DEPLOYED IN THE PROXIMAL TO MID RCA, TO COVER THE TARGET LESIONS IN THE MID TO DISTAL RCA AND TREAT THE DISSECTION. THE PATIENT WAS HEMODYNAMICALLY STABLE, BUT HAD COMPLAINTS OF CHEST PAIN. A 3.0 X 15 MM NON-ABBOTT DILATATION CATHETER WAS INFLATED IN THE MID RCA AND A BALLOON RUPTURE OCCURRED, CAUSING A PERFORATION IN THE MID RCA. A 2.8 X 19 MM GRAFTMASTER STENT WAS ADVANCED; HOWEVER, THE DEVICE WAS NOT ABLE TO CROSS TO THE PERFORATION. AFTER MULTIPLE ATTEMPTS, THE GRAFTMASTER STENT DELIVERY SYSTEM WAS REMOVED FROM THE ANATOMY, WITH THE STENT UNDEPLOYED. A 3.0 X 20 MM NC TREK WAS RE-INSERTED INTO THE MID RCA AND INFLATED. THE PATIENT WAS MONITORED AND MEDICATION WAS ADMINISTERED. MONITORING WAS CONTINUED AND REPEAT ANGIOGRAPHY NOTED A MILD CORONARY LEAK. A MILD PE
Patient problems: Angina; Intimal Dissection
MAUDE report 6491216 ↗
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- XIENCE Sierra™ 1550350-33Abbott Vascular Inc. · Coronary drug-eluting stent1 recall32 reports
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- 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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