XIENCE ALPINE 1125350-08Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 08717648199509), received between Sep 22, 2017 and Apr 26, 2018 — classified as 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 26, 2018Improper or Incorrect Procedure or Method; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN A SAPHENOUS VEIN GRAFT TO THE OBTUSE MARGINAL. AFTER IMPLANTING THE XIENCE ALPINE STENT, IT WAS NOTED TO BE EXPIRED. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7466204 ↗
• InjuryApr 4, 2018Difficult to Remove; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 99% STENOSED AND HEAVILY CALCIFIED LESION IN THE OSTIUM ARTERY. FOLLOWING PRE-DILATATION, A 3.5X12MM XIENCE ALPINE STENT WAS BEING DEPLOYED; HOWEVER, THE STENT MIGRATED FORWARD DURING DEPLOYMENT AND WAS DEPLOYED OUTSIDE OF THE TARGET LESION. A 3.5X8MM XIENCE ALPINE STENT DELIVERY SYSTEM (SDS) WAS BEING ADVANCED TO BE PLACED PROXIMAL TO THE 3.5X12MM XIENCE ALPINE STENT; HOWEVER, THE SDS WAS ADVANCED FURTHER THAN NEEDED AND WHEN ATTEMPTING TO PULL BACK THE STENT TO THE TARGET LESION THE STENT GOT STUCK ON THE STRUTS OF THE PREVIOUSLY DEPLOYED STENT AND THE 3.5X8MM XIENCE ALPINE STENT DISLODGED. AN ATTEMPT TO RETRIEVE THE STENT WITH AN ADDITIONAL GUIDE WIRE UTILIZING A GUIDE LINER FOR SUPPORT WAS MADE BUT FAILED. AN UNKNOWN 1.5MM BALLOON CATHETER WAS USED TO SLIGHTLY EXPAND THE STENT SO THAT AN UNKNOWN 3.5MM BALLOON CATHETER COULD BE USED TO SUCCESSFULLY DEPLOY THE STENT INSIDE THE PREVIOUSLY IMPLANTED 3.5X12MM XIENCE ALPINE STENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A NEW 3.5X8MM XIENCE ALPINE DEPLOYED AT THE TARGET LESION. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 7398053 ↗
• InjuryDec 1, 2017Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 3.5 X 8 MM, 3.5 X 15 MM AND A 3.5 X 18 MM XIENCE ALPINE STENTS WERE IMPLANTED ON (B)(6) 2017. ON (B)(6) 2017, THE PATIENT WAS RE-ADMITTED WITH HEART FAILURE INCLUDING OTHER CARDIOVASCULAR SYMPTOMS. ALTHOUGH THE TREATMENT PERFORMED IS UNSPECIFIED, THE FACT THAT RE-HOSPITALIZATION OCCURRED INDICATES THAT SOME FORM OF TREATMENT WAS PERFORMED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Heart Failure

  MAUDE report 7076410 ↗
• MalfunctionOct 27, 2017Unstable; Failure to Advance

  IT WAS REPORTED THAT DURING A HEAVILY CALCIFIED AND TORTUOUS MID LEFT CIRCUMFLEX CORONARY ARTERY INTERVENTION, RESISTANCE WAS MET WITH THE ANATOMY WHILE ADVANCING THE 3.5 X 08 MM XIENCE ALPINE STENT DELIVERY SYSTEM (SDS) TO THE LESION AND THE STENT MOVED PROXIMALLY ON THE SDS BALLOON, BUT REMAINED ON THE SDS BALLOON. THE DEVICE WAS REMOVED WITHOUT ISSUE. THERE WAS NO 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 6984418 ↗
• MalfunctionSep 22, 2017Device Expiration Issue; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THE PROCEDURE WAS PERFORMED ON (B)(6) 2017, TO TREAT A LESION IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE 3.5 X 8 MM XIENCE ALPINE STENT WAS IMPLANTED WITHOUT ISSUE. AFTER THE PROCEDURE, IT WAS FOUND THAT THE STENT HAD EXPIRED ON 08/17/2017. 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 6888646 ↗