XIENCE ALPINE 1125250-08Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 08717648199141), received between Sep 23, 2016 and Sep 18, 2018 — classified as 4 injuries, 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 18, 2018Improper or Incorrect Procedure or Method; Adverse Event Without Identified Device or Use Problem; Improper or Incorrect Procedure or Method; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A LESION IN THE LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY. WHEN THE 2.5X08 MM XIENCE ALPINE STENT DELIVERY SYSTEM (SDS) WAS ADVANCED IN THE ANATOMY, IT WAS NOTED ON THE PACKAGING THAT THE DEVICE EXPIRED ON (B)(6)2018. THE PHYSICIAN WAS NOTIFIED THAT THE STENT WAS EXPIRED, HOWEVER THE SDS WAS CONTINUED TO BE USED AND WAS IMPLANTED. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7886786 ↗
• InjuryFeb 14, 2018Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 2.5X08MM XIENCE ALPINE STENT WAS IMPLANTED ON (B)(6) 2017. ON (B)(6) 2018 THE PATIENT WAS RE-ADMITTED WITH ANGINA. MEDICATIONS WERE ADMINISTERED AND THE PATIENT WAS DISCHARGED. FINAL PATIENT OUTCOME IS REPORTEDLY UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina

  MAUDE report 7271324 ↗
• InjuryDec 12, 2017Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A STENOSED, NON-TORTUOUS AND HEAVILY CALCIFIED LESION IN THE DISTAL RIGHT CORONARY ARTERY. A 2.25X12MM XIENCE ALPINE STENT DELIVERY SYSTEM (SDS) FAILED TO CROSS THE LESION DUE TO THE HEAVY CALCIFICATION. A 2.50X08MM XIENCE ALPINE (SDS) WAS THEN ADVANCED IN AN ATTEMPT TO CROSS THE LESION; HOWEVER, THE STENT DISLODGED BEFORE REACHING THE LESION SITE DUE TO THE HEAVY CALCIFICATION. A 2.50X08MM XIENCE ALPINE STENT WAS DEPLOYED OVER THE DISLODGED STENT CRUSHING IT AGAINST THE VESSEL WALL. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A 2.75X12 AND 3.0X15 XIENCE ALPINE STENTS. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND NO ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Vessel Or Plaque, Device Embedded In

  MAUDE report 7110195 ↗
• InjuryAug 30, 2017Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 2.5X8MM XIENCE ALPINE STENT WAS IMPLANTED ON (B)(6) 2017. ON (B)(6) 2017 THE PATIENT WAS RE-ADMITTED WITH HYPERTENSION AND OTHER UNSPECIFIED CARDIOVASCULAR SYMPTOMS. UNSPECIFIED TREATMENT WAS ADMINISTERED TO THE PATIENT. FINAL PATIENT OUTCOME IS REPORTEDLY UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: High Blood Pressure/ Hypertension

  MAUDE report 6832803 ↗
• MalfunctionApr 10, 2017Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 75% STENOSED, MILDLY TORTUOUS, AND MILDLY CALCIFIED LESION IN THE DISTAL CIRCUMFLEX ARTERY. A NON-ABBOTT GUIDE WIRE CROSSED THE LESION AND AN INTRAVASCULAR ULTRASOUND WAS PERFORMED. A 2.25X23MM XIENCE ALPINE STENT WAS IMPLANTED IN THE TARGET LESION. A 2.5X8MM XIENCE ALPINE STENT WAS ADVANCED TO THE LESION; HOWEVER, THE STENT WAS NOT CONFIRMED WITH ANGIOGRAPHY. IT WAS THEN NOTICED THAT THE 2.5X8MM XIENCE ALPINE STENT DISLODGED INSIDE THE Y-CONNECTOR. THE DISLODGED STENT WAS REMOVED FROM THE Y-CONNECTOR AND A 2.25X8MM XIENCE ALPINE WAS ADVANCED TO THE LESION USING THE SAME Y-CONNECTOR. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6478418 ↗
• MalfunctionDec 29, 2016Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A PROCEDURE OF THE UNSPECIFIED VESSEL THE XIENCE ALPINE STENT DELIVERY SYSTEM (SDS) WAS BEING INSERTED WHEN THE STENT WAS DISLODGED. THERE WAS NO REPORTED PATIENT EFFECT. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6213712 ↗
• InjurySep 23, 2016Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ON (B)(6) 2016 A 2.5X8 MM XIENCE ALPINE STENT, A 2.5X23 MM XIENCE ALPINE STENT AND A 3.0X12 MM XIENCE ALPINE STENT WERE IMPLANTED IN AN UNSPECIFIED CORONARY ARTERY. ON (B)(6) 2016, THE PATIENT WAS RE-ADMITTED FOR OTHER CARDIOVASCULAR SYMPTOMS, GASTROINTESTINAL BLEED, UNSPECIFIED TREATMENT WAS PERFORMED. THE FINAL PATIENT OUTCOME WAS REPORTED AS UNKNOWN; HOWEVER, THE PATIENT WAS DISCHARGED TO HOME. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 5975495 ↗