XIENCE ALPINE 1125400-08Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 08717648199592), received between Apr 19, 2017 and Dec 11, 2018 — classified as 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Difficult to Remove” (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.

• InjuryDec 11, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2018 A 4.0X08 MM XIENCE ALPINE STENT WAS IMPLANTED. ON (B)(6) 2018 THE PATIENT WAS RE-ADMITTED WITH UNSTABLE ANGINA. THE TYPE OF INTERVENTION WAS NOT REPORTED AND FINAL PATIENT OUTCOME IS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina

  MAUDE report 8152990 ↗
• InjuryDec 6, 2017Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 4.0 X 8 MM XIENCE ALPINE STENT WAS IMPLANTED ON (B)(6) 2017. ON (B)(6) 2017, THE PATIENT WAS RE-ADMITTED WITH CARDIOVASCULAR SYMPTOMS INCLUDING SEPSIS. ALTHOUGH THE TREATMENT PERFORMED IS UNSPECIFIED, THE FACT THAT REHOSPITALIZATION OCCURRED INDICATES THAT SOME FORM OF TREATMENT WAS PERFORMED. THE FINAL PATIENT OUTCOME IS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Sepsis

  MAUDE report 7088659 ↗
• InjuryJun 16, 2017Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2017, A 3.0 X 15 MM, A 2.5 X 33 MM, A 2.5 X 15 MM AND A 4.0 X 08 MM XIENCE ALPINES STENTS WERE IMPLANTED. ON 06/04/17, THE PATIENT WAS RE-ADMITTED WITH INCREASED DIFFICULTY BREATHING. UNKNOWN MEDICAL TREATMENT WAS PERFORMED. THE PATIENT WAS DISCHARGED HOME. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Dyspnea

  MAUDE report 6648802 ↗
• InjuryMay 30, 2017Difficult to Remove; Failure to Advance; Device Damaged by Another Device; Device Dislodged or Dislocated; Material Deformation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE LEFT MAIN CORONARY ARTERY THAT WAS MILDLY TORTUOUS, HEAVILY CALCIFIED AND 90% STENOSED. AFTER PRE-DILATING THE LESION WITH A NON-ABBOTT BALLOON CATHETER, THE XIENCE ALPINE (XA) 4.0 X 8 MM STENT DELIVERY SYSTEM (SDS) WAS ADVANCED, HOWEVER, GOT STUCK WITH A PREVIOUSLY DEPLOYED STENT IN THE PROXIMAL LEFT ANTERIOR DESCENDING CORONARY ARTERY. WHEN THE XIENCE ALPINE WAS BEING PULLED BACK, THE STENT IMPLANT DISLODGED. AN ADDITIONAL GUIDE WIRE WAS ADVANCED IN THE LESION USING THE BUDDY WIRE TECHNIQUE, AND A NON-ABBOTT BALLOON CATHETER WAS ADVANCED DISTALLY AND INFLATED TO WITHDRAW THE XA STENT, HOWEVER THE STENT BECAME DEFORMED AND COULD NOT BE REMOVED. A SNARE DEVICE WAS ADVANCED OVER THE SECOND GUIDE WIRE, HOWEVER THE SNARE GOT CAUGHT WITH THE FIRST GUIDE WIRE INSIDE THE DISLODGED STENT. FINALLY, A SNARE DEVICE WAS ABLE TO SNARE THE DISLODGED STENT AND SUCCESSFULLY RETRIEVE IT INTO THE SHEATH THAT WAS AT THE PUNCTURE SITE. THE PROCEDURE WAS COMPLETED WITH A 4.0 X 12 MM XIENCE ALPINE STENT BEING DEPLOYED. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED. ADDITIONAL TIME WAS REQUIRED TO RETRIEVE THE DISLODGED STENT HOWEV

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6597840 ↗
• MalfunctionApr 19, 2017Difficult to Remove; Unstable

  IT WAS REPORTED THAT DURING PREPARATION OF THE 4.0 X 8 MM XIENCE ALPINE STENT DELIVERY SYSTEM, THE PROTECTIVE SHEATH AND MANDREL WERE DIFFICULT TO REMOVE; HOWEVER, THEY WERE ABLE TO BE REMOVED. UPON REMOVAL OF THE SHEATH, THE STENT WAS NOTED TO BE LOOSE. THE PHYSICIAN TOUCHED THE STENT WITH A FINGER AND THE STENT EASILY DISLODGED FROM THE BALLOON. THE DEVICE WAS NOT USED AND A 3.5 X 8 MM XIENCE ALPINE WAS USED INSTEAD. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 6505367 ↗