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XIENCE ALPINE 1145350-28Recalls & reported problems

Abbott Vascular Inc. · XIENCE Alpine Everolimus Eluting Coronary Stent System 3.50 mm x 28 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
0
Injuries reported
2
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08717648200274), received between Feb 2, 2018 and Apr 22, 2021 — classified as 2 injuries.

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 or Delayed Activation1
  • Failure to Advance1
  • Material Rupture1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1
  • No Consequences Or Impact To Patient1

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • InjuryApr 22, 2021Material Rupture; Difficult or Delayed Activation; Material Rupture; Difficult or Delayed Activation

    IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A MODERATELY CALCIFIED LESION IN THE RIGHT CORONARY ARTERY (RCA). TWO XIENCE ALPINE STENT SYSTEMS WERE USED. WITH EACH STENT DELIVERY SYSTEM, THE BALLOON WAS INFLATED AND THE STENT WAS DEPLOYED. EACH BALLOON LOST PRESSURE AND DEFLATED ALMOST IMMEDIATELY. A BALLOON RUPTURE WAS SUSPECTED IN EACH DEVICE. THE STENT DELIVERY SYSTEMS WERE REMOVED WITHOUT RESISTANCE AND THE STENTS REMAINED AT THE TARGET LESION. POST DILATATION WAS PERFORMED WITH EACH STENT, AS IT COULD NOT BE DETERMINED IF THE STENTS WERE FULLY APPOSED TO THE VESSEL WALL. THERE WAS NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11711989 ↗
  • InjuryFeb 2, 2018Failure to Advance; Device Dislodged or Dislocated

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED LESION IN THE RIGHT CORONARY ARTERY. FOLLOWING PRE-DILATATION, A 3.5X28MM XIENCE ALPINE OTW STENT DELIVERY SYSTEM (SDS) FAILED TO CROSS DUE TO THE ANATOMY. THE SDS WAS PULLED OUT AND THE STENT DISLODGED ON THE WIRE. AN ATTEMPT WAS MADE TO SNARE THE STENT, BUT UNABLE TO RETRIEVE. THE PATIENT WAS THEN TRANSFERRED TO (B)(6) MEDICAL CENTER WHERE ANOTHER ATTEMPT TO SNARE WAS PERFORMED. THE STENT WAS SUCCESSFULLY SNARED AND THE PATIENT IS DOING FINE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 7236088 ↗

Other Coronary drug-eluting stent devices

All Coronary drug-eluting stent devices →

Sources and updates

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