XIENCE Sierra™ 1550275-12Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 08717648227165), received between Dec 13, 2018 and Aug 18, 2021 — classified as 1 death, 12 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (1 report).

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 18, 2026.

Most reported problems

Recent adverse event reports

The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• InjuryAug 18, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH A NON-ST ELEVATED MYOCARDIAL INFARCTION (NSTEMI) BEFORE THE INITIAL PROCEDURE. THREE XIENCE SIERRA STENTS (2.75X12MM, 3X12MM, AND 3X28MM) WERE IMPLANTED ON (B)(6) 2021. ON (B)(6)2021, THE PATIENT WAS RE-ADMITTED WITH NSTEMI. UNSPECIFIED TREATMENT WAS PERFORMED, AND THE FINAL PATIENT OUTCOME IS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Myocardial Infarction

  MAUDE report 12338182 ↗
• InjuryJun 1, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2021 THE PATIENT HAD A 2.75X12 MM XIENCE SIERRA STENT IMPLANTED. THE PATIENT HAD PREVIOUSLY PRESENTED WITH ACUTE PULMONARY EDEMA. ON (B)(6) 2021 THE PATIENT WAS READMITTED TO THE HOSPITAL DUE TO HYPERTENSIVE HEART FAILURE AND HEART DISEASE. TREATMENT WAS UNSPECIFIED AND THE FINAL PATIENT OUTCOME IS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Heart Failure/Congestive Heart Failure; High Blood Pressure/ Hypertension

  MAUDE report 11915640 ↗
• MalfunctionJan 28, 2021Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE 2.75X12 MM XIENCE SIERRA STENT WAS EXPIRED WHEN IT WAS IMPLANTED IN THE FIRST OBTUSE MARGINAL CORONARY ARTERY ON (B)(6) 2021. THERE WERE NO ADVERSE PATIENT EFFECTS AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 11244629 ↗
• InjuryDec 9, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2020, THREE XIENCE SIERRA STENTS WERE SUCCESSFULLY IMPLANTED (2.75X12MM, 3.0X12MM, 3.25X33MM). ON (B)(6) 2020, THE PATIENT WAS RE-ADMITTED WITH HYPERTENSION AND OTHER CARDIOVASCULAR SYMPTOMS. IT IS UNKNOWN WHAT TREATMENT WAS PERFORMED AND THE FINAL PATIENT OUTCOME IS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: High Blood Pressure/ Hypertension

  MAUDE report 10977773 ↗
• InjurySep 14, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2020 A XIENCE SIERRA STENT WAS IMPLANTED ON (B)(6) 2020. ON (B)(6) 2020, THE PATIENT WAS RE-ADMITTED WITH OTHER CARDIOVASCULAR (CV) SYMPTOMS; AND ACUTE CYSTITIS. UNSPECIFIED TREATMENT WAS ADMINISTERED TO THE PATIENT. THE FINAL PATIENT OUTCOME IS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 10532591 ↗
• InjurySep 8, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2020 THE PATIENT PRESENTED WITH NON-ST ELEVATED MYOCARDIAL INFARCTION (NSTEMI). A 2.75X12MM XIENCE SIERRA DRUG ELUTING STENT (DES) WAS IMPLANTED. ON (B)(6) 2020 THE PATIENT WAS RE-ADMITTED WITH NSTEMI AND OTHER CARDIOVASCULAR SYMPTOMS. CARDIAC CATHETERIZATION WAS PERFORMED; HOWEVER, THE FINAL PATIENT OUTCOME IS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Myocardial Infarction

  MAUDE report 10505153 ↗
• InjurySep 4, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2020 THE PATIENT PRESENTED WITH A NON-ST-ELEVATION MYOCARDIAL INFARCTION AND TWO (2.75X12MM AND 3.0X28MM) XIENCE SIERRA STENTS WERE IMPLANTED. ON (B)(6) 2020, THE PATIENT WAS RE-ADMITTED WITH UNSPECIFIED CARDIOVASCULAR SYMPTOMS AND CONGESTIVE HEART FAILURE. UNSPECIFIED TREATMENT WAS PROVIDED AND THE FINAL PATIENT OUTCOME IS NOT KNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Heart Failure

  MAUDE report 10497742 ↗
• InjuryJul 29, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE HEAVILY TORTUOUS PROXIMAL CIRCUMFLEX ARTERY THAT WAS HEAVILY CALCIFIED AND 99% STENOSED. AFTER LESION PREPARATION, A XIENCE SIERRA WAS DELIVERED BUT DURING DEPLOYMENT, THE DELIVERY BALLOON RUPTURED AT 10 ATMOSPHERES. AS THE STENT WAS NOT EXPANDED ENOUGH, POST-DILATATION WAS PERFORMED WITH A NON-ABBOTT BALLOON TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10341713 ↗
• InjuryJun 15, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 2.75X12MM XIENCE SIERRA STENT WAS IMPLANTED ON (B)(6) 2020. ON (B)(6) 2020, THE PATIENT WAS RE-ADMITTED FOR ATRIAL FIBRILLATION AND OTHER UNSPECIFIED CARDIO VASCULAR SYMPTOMS. UNSPECIFIED TREATMENT WAS ADMINISTERED TO THE PATIENT. FINAL PATIENT OUTCOME IS REPORTEDLY UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Atrial Fibrillation

  MAUDE report 10155628 ↗
• MalfunctionMar 18, 2020Difficult to Remove; Failure to Advance; Material Deformation; Difficult to Remove; Failure to Advance; Material Deformation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A DE NOVO LESION LOCATED IN THE DISTAL LEFT ANTERIOR DESCENDING CORONARY ARTERY THAT WAS BOTH HEAVILY CALCIFIED AND TORTUOUS. PRE-DILATATION WAS PERFORMED WITH A NON-ABBOTT BALLOON. THE XIENCE SIERRA STENT DELIVERY SYSTEM (SDS) WAS ADVANCED, BUT FAILED TO CROSS THE LESION AND THE DISTAL EDGE OF THE STENT WAS FLARED. RESISTANCE WAS NOTED DURING REMOVAL OF THE SDS. ANOTHER SAME SIZE XIENCE SIERRA STENT WAS SUCCESSFULLY IMPLANTED. THERE WAS NO ADVERSE PATIENT EFFECT OR CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9850977 ↗
• InjuryDec 9, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2019 THE PATIENT PRESENTED WITH ATHEROSCLEROTIC HEART DISEASE WITH ANGINA THEREFORE THE 2.75X12MM XIENCE SIERRA WAS IMPLANTED. ON (B)(6) 2019 THE PATIENT WAS RE-ADMITTED WITH ATHEROSCLEROTIC HEART DISEASE WITH ANGINA. IT IS UNKNOWN WHAT TREATMENT WAS PERFORMED AND THE FINAL PATIENT OUTCOME IS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina; No Code Available

  MAUDE report 9439089 ↗
• DeathSep 3, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH A HISTORY OF A NON ST ELEVATED MYOCARDIAL INFARCTION AND A 2.75 X 12 MM XIENCE SIERRA STENT WAS IMPLANTED ON (B)(6) 2019. THE PATIENT WAS READMITTED ON (B)(6) 2019 WITH AN ATRIAL FLUTTER. THE TYPE OF INTERVENTION WAS NOT REPORTED AND THE PATIENT EXPIRED ON AN UNKNOWN DATE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Atrial Flutter

  MAUDE report 8957685 ↗
• InjuryAug 26, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A XIENCE SIERRA STENT WAS IMPLANTED ON (B)(6) 2019. ON (B)(6) 2019, THE PATIENT WAS RE-HOSPITALIZED DUE TO UNSTABLE ANGINA AND OTHER CARDIOVASCULAR SYMPTOMS. TREATMENT WAS ADMINISTERED. FINAL PATIENT OUTCOME WAS NOT PROVIDED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina

  MAUDE report 8932376 ↗
• InjuryJun 14, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2019 THE PATIENT PRESENTED WITH NON-ST-ELEVATION MYOCARDIAL INFARCTION (NSTEMI) AND WAS TREATED WITH 2.75 X 12 MM AND 3.00 X 12 MM XIENCE SIERRA STENTS. ON (B)(6) 2019 THE PATIENT WAS RE-ADMITTED FOR ANGINA, HEART FAILURE, AND OTHER CARDIOVASCULAR SYMPTOMS. THE TYPE OF TREATMENT PERFORMED AT THAT TIME IS UNKNOWN. THE PATIENT WAS ALSO RE-ADMITTED ON (B)(6) 2019 AND MEDICAL INTERVENTION, PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) WAS PERFORMED. THE FINAL PATIENT OUTCOME IS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina; Heart Failure

  MAUDE report 8702027 ↗
• 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, THE 2.75X12MM XIENCE SIERRA AND 3.0X15MM XIENCE SIERRA STENTS WERE IMPLANTED. ON (B)(6) 2018 THE PATIENT WAS RE-ADMITTED WITH CEREBRAL INFARCTION. THE TREATMENT PERFORMED AND THE FINAL PATIENT OUTCOME IS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Stroke/CVA

  MAUDE report 8161288 ↗