XIENCE ALPINE 1125325-28Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 08717648199462), received between Sep 29, 2016 and Dec 13, 2018 — classified as 7 injuries.

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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryDec 13, 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 3.25X28MM XIENCE ALPINE AND A 3.50X08MM XIENCE SIERRA STENT WERE IMPLANTED. ON (B)(6) 2018 THE PATIENT WAS RE-ADMITTED WITH ST ELEVATED MYOCARDIAL INFARCTION (STEMI). PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) WAS PERFORMED; HOWEVER, THE FINAL PATIENT OUTCOME IS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Myocardial Infarction

  MAUDE report 8161217 ↗
• InjurySep 5, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A XIENCE ALPINE 3.25 X 28 MM STENT WAS IMPLANTED ON (B)(6) 2018. ON (B)(6) 2018, THE PATIENT WAS RE-ADMITTED WITH CHEST PAIN. IT IS UNKNOWN WHAT TREATMENT WAS PROVIDED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina

  MAUDE report 7847870 ↗
• InjuryJun 5, 2018Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 3.25 X 28 MM XIENCE ALPINE CORONARY STENT SYSTEM WAS IMPLANTED ON (B)(6) 2018. ON (B)(6) 2018 THE PATIENT WAS RE-ADMITTED WITH MYOCARDIAL INFARCTION AND CARDIOVASCULAR SYMPTOMS. ALTHOUGH THE TREATMENT PERFORMED IS UNSPECIFIED, THE FACT THAT HOSPITALIZATION OCCURRED INDICATES THAT SOME FORM OF TREATMENT WAS PERFORMED. THE FINAL PATIENT OUTCOME IS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Myocardial Infarction

  MAUDE report 7570740 ↗
• InjuryJun 5, 2018Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE 3.25 X 28 MM XIENCE ALPINE STENT WAS IMPLANTED ON (B)(6) 2018. THE PATIENT PRESENTED WITH NON ST-ELEVATION MYOCARDIAL INFARCTION BEFORE THE PROCEDURE. ON (B)(6) 2018, THE PATIENT WAS READMITTED WITH CARDIOVASCULAR SYMPTOMS, INCLUDING ARTERIOVENOUS MALFORMATION. SURGERY WAS PERFORMED HOWEVER THE FINAL PATIENT OUTCOME IS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Fistula

  MAUDE report 7569370 ↗
• InjuryAug 29, 2017Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 3.25X28 MM XIENCE ALPINE STENT WAS IMPLANTED ON (B)(6) 2017. ON (B)(6) 2017 THE PATIENT WAS RE-ADMITTED WITH ABNORMAL EKG/ECG AND EXPERIENCING SYMPTOMS OF ATRIAL FIBRILLATION. UNSPECIFIED TREATMENT WAS ADMINISTERED TO THE PATIENT. FINAL PATIENT OUTCOME IS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Atrial Fibrillation; Non specific EKG/ECG Changes

  MAUDE report 6828976 ↗
• InjurySep 29, 2016Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THREE XIENCE ALPINE STENTS (3.5 X 15 MM, 3.5 X 23 MM AND 3.5 X 38 MM) WERE IMPLANTED ON (B)(6) 2016. ON (B)(6) 2016, THE PATIENT WAS RE-ADMITTED WITH CARDIOVASCULAR SYMPTOMS INCLUDING ANGINA. IT IS UNKNOWN WHAT TREATMENT WAS PERFORMED. THE FINAL PATIENT OUTCOME IS UNKNOWN AND THE PATIENT WAS DISCHARGED HOME. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina

  MAUDE report 5988612 ↗
• InjurySep 29, 2016Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 3.25 X 28 MM XIENCE ALPINE, AND A 3.0 X 15 MM XIENCE ALPINE STENTS WERE IMPLANTED ON (B)(6) 2016. ON (B)(6) 2016, THE PATIENT WAS RE-ADMITTED WITH CARDIOVASCULAR SYMPTOMS INCLUDING ANGINA. IT IS UNKNOWN WHAT TREATMENT WAS PERFORMED. THE FINAL PATIENT OUTCOME IS UNKNOWN AND THE PATIENT WAS DISCHARGED HOME. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina

  MAUDE report 5988589 ↗