XIENCE ALPINE 1145300-38Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08717648200113), received between Mar 2, 2020 and Oct 5, 2022 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (2 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. How this data works · Data updated Oct 13, 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.

• MalfunctionOct 5, 2022Difficult to Remove; Failure to Advance; Difficult to Remove; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE TIBIAL ARTERY. ATHERECTOMY WAS PERFORMED SO THE VESSEL WAS FREE OF CALCIFICATION AND TORTUOSITY. THE XIENCE ALPINE STENT DELIVERY SYSTEM (SDS) WAS ATTEMPTED TO BE ADVANCED BUT IT COULD NOT CROSS THE LESION FOR AN UNKNOWN REASON. THE SDS WAS STUCK TO THE GUIDE WIRE DURING REMOVAL SO THEY WERE REMOVED TOGETHER AND A NEW XIENCE ALPINE SDS WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS 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 15544903 ↗
• MalfunctionOct 15, 2020Off-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 THE TIBIAL TRUNK. A 3X38 XIENCE ALPINE DRUG ELUTING STENT (DES) WAS REMOVED FROM ITS PACKAGING WITHOUT ISSUE AND ADVANCED INTO THE ANATOMY. WHEN THE BALLOON WAS INFLATED UNDER FLUOROSCOPY, IT WAS NOTED THAT THERE WAS NO STENT ATTACHED. THE STENT WAS FOUND STRETCHED ON THE STYLET OUTSIDE OF THE PATIENT ANATOMY. THE USER DID NOT CONFIRM THAT THERE WAS A STENT ON THE BALLOON PRIOR TO USE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10687507 ↗
• InjuryMar 2, 2020Device Dislodged or Dislocated; Activation Failure; Device Dislodged or Dislocated; Activation Failure

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A LESION IN THE RIGHT CORONARY ARTERY (RCA). TWO STENTS WERE SUCCESSFULLY DEPLOYED WITHOUT ISSUES. A 3.0X38MM OTW XIENCE ALPINE STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TO THE LESION. AN ATTEMPT WAS MADE TO INFLATE THE BALLOON HOWEVER A HISSING SOUND WAS HEARD AND THE BALLOON DID NOT INFLATE. IT WAS UNKNOWN IF THE HISSING WAS COMING FROM THE HUB OF THE SDS OR THE NON-ABBOTT INDEFLATOR THEREFORE THE DECISION WAS MADE TO REMOVE THE SDS HOWEVER DURING REMOVAL THE STENT DISLODGED AND EMBOLIZED TO THE RCA. NO INTERVENTION WAS PERFORMED AND THE STENT REMAINS IN THE RCA. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Embolism; Foreign Body In Patient

  MAUDE report 9777160 ↗