XIENCE ALPINE 1145350-38Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08717648200298), received between Aug 11, 2017 and Mar 28, 2024 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (3 reports).

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

Recent adverse event reports

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

• MalfunctionMar 28, 2024Off-Label Use; Stretched; Improper or Incorrect Procedure or Method; Device Dislodged or Dislocated; Off-Label Use; Stretched; Improper or Incorrect Procedure or Method; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE LEFT ANTERIOR TIBIAL ARTERY. THE 3.5X38MM XIENCE ALPINE STENT DELIVERY SYSTEM (SDS) WAS PREPARED PER INSTRUCTIONS FOR USE (IFU) AND WAS ADVANCED TO THE LESION WHEN IT WAS NOTED THAT THE STENT WAS NOT ON THE BALLOON. THE DEVICE WAS REMOVED. THE STENT WAS FOUND INSIDE THE PROTECTIVE SHEATH AND WAS NOTED TO BE STRETCHED; HOWEVER, THERE WAS NO RESISTANCE DURING REMOVAL OF THE PROTECTIVE SHEATH. IMPROPER OR INCORRECT PROCEDURE OF NOT INSPECTING DEVICE UPON USE OCCURRED. ANOTHER SAME SIZE XIENCE ALPINE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18990041 ↗
• MalfunctionApr 21, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING PREPARATION, IT WAS NOTED THAT THE STENT IMPLANT OF THE 3.50X38MM XIENCE ALPINE HAD MOVED, STILL REMAINING ON THE DELIVERY SYSTEM. THERE WAS NO RESISTANCE WHEN REMOVING THE DEVICE FROM THE DISPENSER HOOP COIL, OR WHEN THE PROTECTIVE SHEATH WAS REMOVED. THERE WAS NO DAMAGE NOTED TO THE CHIPBOARD BOX OR DISPENSER HOOP COIL. ANOTHER XIENCE DEVICE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11704162 ↗
• MalfunctionAug 11, 2017Improper or Incorrect Procedure or Method; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING DEVICE PREPARATION, WHEN REMOVING THE STYLET, THE STENT DISLODGED FROM THE BALLOON; HOWEVER, THE DEVICE WAS NOT INSPECTED PRIOR TO USE AND THE STENT DELIVERY SYSTEM WAS ADVANCED THROUGH THE NON-TORTUOUS VESSEL TO THE MODERATELY CALCIFIED, ANTERIOR TIBIAL ARTERY LESION. IT WAS THEN NOTED THAT THE STENT WAS NOT ON THE BALLOON AND WAS FOUND ON THE BACK TABLE ATTACHED TO THE STYLET. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA OR A CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6790048 ↗