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XIENCE ALPINE 1125275-08Recalls & reported problems

Abbott Vascular Inc. · XIENCE Alpine Everolimus Eluting Coronary Stent System 2.75 mm x 08 mm / Rapid-Exchange · Class 3 · Implant

All models of XIENCE ALPINE (72)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
2
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08717648199233), received between Apr 11, 2017 and Aug 21, 2017 — classified as 1 injury, 1 malfunction.

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 18, 2026.

Most reported problems

Device problems

  • Adverse Event Without Identified Device or Use Problem1
  • Improper or Incorrect Procedure or Method1
  • Material Rupture1

Patient problems

  • No Consequences Or Impact To Patient1
  • Thrombosis1

Recent adverse event reports

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

  • MalfunctionAug 21, 2017Material Rupture; Improper or Incorrect Procedure or Method

    IT WAS REPORTED THAT DURING DEVICE PREPARATION, AIR ASPIRATION WAS PERFORMED IN THE ANATOMY. THE PROCEDURE WAS TO TREAT A MILDLY CALCIFIED AND ECCENTRIC DE NOVO PROXIMAL LEFT ANTERIOR DESCENDING ARTERY THAT WAS 85% STENOSED. PRE-DILATATION WAS PERFORMED AND A 2.75 X 08 MM XIENCE ALPINE STENT DELIVERY SYSTEM WAS ADVANCED TO THE LESION. AN ATTEMPT WAS MADE TO PRESSURIZE THE BALLOON WHEN CONTRAST COULD BE SEEN LEAKING FROM THE BALLOON WHEN IT WAS INFLATED TO 4 ATMOSPHERES. THE STENT IMPLANT HAD NOT DEPLOYED YET, SO THE DEVICE WAS REMOVED WITHOUT ISSUE. ANOTHER 2.75 X 08 MM XIENCE ALPINE STENT WAS SUCCESSFULLY DEPLOYED TO COMPLETE THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE AND NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 6809303 ↗
  • InjuryApr 11, 2017Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT ON (B)(6) 2016, A 2.75X8 RX XIENCE ALPINE, A 3.0X15 RX XIENCE ALPINE, AND A 3.0X12 RX XIENCE ALPINE DRUG-ELUTING STENT WERE IMPLANTED FOR TREATMENT OF AN UNSPECIFIED CORONARY VESSEL. ON (B)(6) 2016, THE PATIENT WAS REHOSPITALIZED DUE TO OTHER UNSPECIFIED CARDIOVASCULAR SYMPTOMS, INCLUDING THROMBOSIS. MEDICAL INTERVENTION WAS PERFORMED VIA ANGIOPLASTY AND STENT PLACEMENT. THE FINAL PATIENT OUTCOME IS REPORTEDLY UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Patient problems: Thrombosis

    MAUDE report 6482423 ↗

Other Coronary drug-eluting stent devices

All Coronary drug-eluting stent devices →

Sources and updates

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