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XIENCE ALPINE 1145350-23Recalls & reported problems

Abbott Vascular Inc. · XIENCE Alpine Everolimus Eluting Coronary Stent System 3.50 mm x 23 mm / Over-The-Wire · Class 3 · Implant

All models of XIENCE ALPINE (72)

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

Adverse event reports
3
Deaths reported
0
Injuries reported
2
Recalls naming it
0

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08717648200267), received between Mar 13, 2017 and Dec 9, 2022 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Markings/Labelling 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 18, 2026.

Most reported problems

Device problems

  • Adverse Event Without Identified Device or Use Problem1
  • Device Markings/Labelling Problem1
  • Difficult or Delayed Activation1
  • Material Rupture1

Patient problems

  • Angina1
  • No Clinical Signs, Symptoms or Conditions1
  • No Patient Involvement1
  • Stenosis1

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

  • InjuryDec 9, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT ON (B)(6) 2019 THE PATIENT PRESENTED WITH UNSTABLE ANGINA; THEREFORE A 3.50X23MM XIENCE ALPINE STENT WAS IMPLANTED IN THE 90% STENOSED PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY WITH MODERATE CALCIFICATION. ON (B)(6) 2022 THE PATIENT WAS RE-HOSPITALIZED DUE TO ANGINA AND ANGIOGRAPHY CONFIRMED THE PREVIOUSLY IMPLANTED STENT HAD BECOME 90% RESTENOSED. THEREFORE THE LESION WAS RETREATED WITH BALLOON DILATATION, ROTATIONAL ATHERECTOMY SYSTEM AND STENT IMPLANTATION. IN ADDITION THE PATIENT WAS GIVEN ASPIRIN AND PLAVIX. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO ADDITIONAL INFORMATION WAS PROVIDED.

    Patient problems: Angina; Stenosis

    MAUDE report 15954937 ↗
  • 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 11712009 ↗
  • MalfunctionMar 13, 2017Device Markings/Labelling Problem

    IT WAS REPORTED THAT A 3.5 X 23 MM XIENCE ALPINE STENT DELIVERY SYSTEM (SDS) WAS TO BE USED FOR THE PROCEDURE; HOWEVER, THE DEVICE INSIDE THE BOX WAS A 3.5 X 18 MM XIENCE ALPINE SDS. THE DEVICE WAS NOT USED, NO PATIENT INVOLVEMENT. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Patient problems: No Patient Involvement

    MAUDE report 6401513 ↗

Other Coronary drug-eluting stent devices

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Sources and updates

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