XIENCE ALPINE 1125225-08Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 08717648199059), received between Oct 26, 2016 and Aug 11, 2020 — classified as 3 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (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.

• InjuryAug 11, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT ID: (B)(6). IT WAS REPORTED THAT THE PATIENT WAS REGISTERED FOR THE (B)(6) STUDY AND PRESENTED WITH UNSTABLE ANGINA. A 2.25X08 MM XIENCE ALPINE HAD ALSO BEEN IMPLANTED IN THE DISTAL LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY ON (B)(6) 2017. AN ABDOMINAL AORTIC ANEURYSM PROCEDURE WAS SCHEDULED AND DURING THE CT OF THE CORONARY ARTERY ON (B)(6) 2020, RESTENOSIS WAS SUSPECTED. NO SYMPTOMS WERE NOTED BUT AN ANGIOGRAPHY WAS PERFORMED AND RESTENOSIS OF THE DISTAL LAD WAS CONFIRMED. THE AREA WAS TREATED WITH A DRUG ELUTING BALLOON AND THE CONDITION IMPROVED. THE PATIENT WAS COMPLIANT WITH DUAL ANTIPLATELET DRUG THERAPY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Stenosis

  MAUDE report 10394189 ↗
• InjuryAug 16, 2018Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MILDLY TORTUOUS, MILDLY CALCIFIED LESION IN THE 1ST OBTUSE MARGINAL (OM) CORONARY ARTERY AND LEFT CIRCUMFLEX ARTERY (LCX). A 2.25X8MM XIENCE ALPINE STENT WAS IMPLANTED IN THE 1ST OM; HOWEVER, A PORTION OF THE STENT STRUTS WERE NOTED TO BE IN THE LCX ARTERY AND WERE NOT FULLY EXPANDED. POST DILATATION WAS PERFORMED TO FULLY APPOSE THE STENT TO THE VESSEL WALL. A 3.0X25MM XIENCE ALPINE STENT WAS IMPLANTED IN THE LCX. A HT-BMW UNIVERSAL GUIDE WIRE WAS ADVANCED; HOWEVER, RESISTANCE WAS MET WITH THE STENT STRUTS OF THE 2.25X8 MM XIENCE ALPINE STENT. THE GUIDE WIRE WAS PULLED BACK TO RE-POSITION AND WAS NOTED TO HAVE GOT CAUGHT ON THE STENT STRUTS OF THE 2.25X8 MM XIENCE ALPINE STENT. THE HT BMW UNIVERSAL GUIDE WIRE STARTED TO UNRAVEL DURING REMOVAL FROM THE PATIENT ANATOMY AND THE UNRAVELED PORTION WAS NOTED TO HAVE SEPARATED IN THE PATIENT ANATOMY. A SNARE DEVICE WAS USED TO RETRIEVE THE MAJORITY OF THE SEPARATED PORTION; HOWEVER, THE TIP WAS UNABLE TO BE RETRIEVED. THERE WAS NO DAMAGE NOTED TO THE 2.25X8 MM XIENCE ALPINE STENT. A 3.25X23MM XIENCE ALPINE STENT WAS IMPLANTED IN THE OM TO EMBED THE SEPARATED TIP AND TREAT THE TARGET LESIO

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7791058 ↗
• MalfunctionAug 8, 2018Difficult to Remove; Failure to Advance; Difficult to Remove; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY TORTUOUS AND HEAVILY CALCIFIED POSTERIOR DESCENDING ARTERY. AN ATTEMPT WAS MADE TO ADVANCE A 2.25 X 8 MM XIENCE ALPINE STENT DELIVERY SYSTEM (SDS) TO THE LESION; HOWEVER, THE DEVICE FAILED TO CROSS THE LESION DUE TO THE ANATOMY. THEN, DURING REMOVAL, IT MET RESISTANCE WITH A GUIDE LINER AND WAS NOT ABLE TO BE PULLED BACK INSIDE IT. THEREFORE, ALL THE DEVICES WERE REMOVED AS A SINGLE UNIT WITH THE STENT STILL ON THE SDS BALLOON. THE DEVICE WAS REPLACED WITH ANOTHER 2.25 X 8 MM XIENCE ALPINE SDS TO SUCCESSFULLY COMPLETE THE PROCEDURE. IT WAS NOTED THAT THE STENT FROM THE FIRST SDS LATER DISLODGED FROM THE BALLOON WHEN ALL THE DEVICES WERE PULLED APART ON THE TABLE. 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 7764458 ↗
• InjuryJul 3, 2017Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED LESION IN THE LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY. THE VESSEL WAS PRE-DILATED WITH AN UNSPECIFIED BALLOON DILATION CATHETER. THE 2.25X08 MM XIENCE ALPINE STENT DELIVERY SYSTEM (SDS) FAILED TO CROSS A PREVIOUSLY IMPLANTED STENT. THE SDS WAS REMOVED AND IT WAS NOTED THAT THE STENT HAD DISLODGED IN THE LAD. AN UNSPECIFIED STENT WAS USED TO CRUSH THE STENT AGAINST THE VESSEL WALL. AN ATTEMPT WAS MADE TO ADVANCE A 2.5X12 MM XIENCE ALPINE SDS IN THE PATIENT ANATOMY, HOWEVER THE SDS FAILED TO CROSS THE SAME PREVIOUSLY IMPLANTED STENT AND THE STENT DISLODGED IN THE LAD. ANOTHER STENT WAS USED TO CRUSH THE STENT AGAINST THE VESSEL WALL. NO ADDITIONAL TREATMENT WAS REQUIRED; THE PROCEDURE WAS COMPLETE AT THIS TIME. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Vessel Or Plaque, Device Embedded In

  MAUDE report 6684787 ↗
• MalfunctionOct 26, 2016Break

  IT WAS REPORTED THAT BEFORE USE, WHEN THE XIENCE ALPINE 2.25 X 8 MM STENT DELIVERY SYSTEM WAS REMOVED FROM THE HOOP, A BROKEN HUB ON THE DELIVERY SHAFT WAS NOTICED. THE DEVICE WAS NOT USED. ANOTHER XIENCE ALPINE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 6057565 ↗