XIENCE Sierra™ 1550275-23Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 08717648227196), received between Jun 22, 2018 and Mar 15, 2024 — classified as 1 death, 18 injuries, 2 malfunctions.

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. 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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 15, 2024Stretched; Failure to Advance; Device Dislodged or Dislocated; Stretched; Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE LEFT ANTERIOR DESCENDING CORONARY ARTERY THAT WAS MODERATELY CALCIFIED AND MILDLY TORTUOUS. REPORTEDLY, THE XIENCE SIERRA DES 2.75X23 RX STENT DELIVERY SYSTEM (SDS) MET RESISTANCE WITH ANOTHER NON-ABBOTT STENT DURING CROSSING. THE STENT DISLODGED; HOWEVER, WAS RETRIEVED WITH THE SDS BALLOON WHICH WAS STILL IN THE ANATOMY. THE STENT WAS REMOVED ELONGATED WITH THE SDS BALLOON. THE LESION WAS DILATED AND A DIFFERENT STENT WAS DEPLOYED TO COMPLETE THE PROCEDURE. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18914557 ↗
• InjuryJun 2, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON THE PATIENT HAD A 2.75X23 MM XIENCE SIERRA STENT IMPLANTED ON (B)(6) 2021. THE PATIENT HAD PREVIOUSLY PRESENTED WITH HYPERTENSIVE HEART AND HEART FAILURE. THE PATIENT WAS HOSPITALIZED ON (B)(6) 2021 AND (B)(6) 2021 WITH HYPERTENSIVE HEART / HEART FAILURE. SURGERY WAS PERFORMED. THE FINAL PATIENT OUTCOME IS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

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

  MAUDE report 11921142 ↗
• InjuryMay 27, 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 PRESENTED WITH NON-ST ELEVATED MYOCARDIAL INFARCTION (NSTEMI) THEREFORE THE 2.75X23MM XIENCE SIERRA STENT WAS IMPLANTED. ON (B)(6) 2021 THE PATIENT WAS RE-ADMITTED WITH CHEST PAIN. IT IS UNKNOWN WHAT TREATMENT WAS PERFORMED AND THE FINAL PATIENT OUTCOME IS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina

  MAUDE report 11898812 ↗
• InjuryMay 27, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2021 A XIENCE SIERRA STENT WAS IMPLANTED IN A PATIENT WHO HAD A PRIOR HISTORY OF ACUTE RESPIRATORY FAILURE. ON (B)(6) 2021 THE PATIENT WAS RE-ADMITTED TO THE HOSPITAL AGAIN WITH ST SEGMENT ELEVATION MYOCARDIAL INFARCTION (STEMI). A BALLOON PUMP WAS USED AS TREATMENT. FINAL PATIENT OUTCOME IS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Myocardial Infarction

  MAUDE report 11897965 ↗
• InjuryMar 11, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 2.75X23MM XIENCE SIERRA STENT WAS IMPLANTED ON (B)(6) 2020. THE PATIENT PRESENTED WITH A NON-ST ELEVATED MYOCARDIAL INFARCTION (STEMI) BEFORE THE PROCEDURE. ON (B)(6) 2020, THE PATIENT WAS RE-ADMITTED WITH ATHEROSCLEROTIC HEART DISEASE. UNSPECIFIED TREATMENT WAS PERFORMED, AND THE FINAL PATIENT OUTCOME IS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Myocardial Infarction; Unspecified Heart Problem

  MAUDE report 11467825 ↗
• MalfunctionFeb 3, 2021Break; Off-Label Use; Difficult to Remove; Failure to Advance; Break; Off-Label Use; Difficult to Remove; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A CALCIFIED LESION IN THE POPLITEAL ARTERY. A 2.75X23MM XIENCE SIERRA STENT DELIVERY SYSTEM (SDS) FAILED TO CROSS DUE TO RESISTANCE WITH THE ANATOMY. THE SDS WAS BEING REMOVED AND RESISTANCE WITH THE ANATOMY WAS ALSO FELT AND THE SHAFT OF BROKE. THE SDS WAS SIMPLY WITHDRAWN. ACCESS WAS LOST SO THE PROCEDURE WAS COMPLETED. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11276685 ↗
• InjuryDec 7, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 2.75X23MM XIENCE SIERRA STENT WAS IMPLANTED ON (B)(6) 2020. THE PATIENT PRESENTED WITH COVID-19. ON (B)(6) 2020, THE PATIENT WAS RE-ADMITTED WITH CARDIOVASCULAR SYMPTOMS INCLUDING CARDIAC ARREST. TREATMENT PERFORMED WAS UNSPECIFIED AND THE FINAL PATIENT OUTCOME IS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Cardiac Arrest

  MAUDE report 10959051 ↗
• InjuryDec 5, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH NON-ST ELEVATED MYOCARDIAL INFARCTION ON (B)(6) 2020 AND A XIENCE SIERRA STENT WAS IMPLANTED. ON (B)(6) 2020, THE PATIENT WAS RE-HOSPITALIZED WITH OTHER CARDIOVASCULAR SYMPTOMS. THE FINAL PATIENT OUTCOME IS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 10954009 ↗
• InjurySep 10, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON 5/6/20 THE PATIENT PRESENTED WITH A ST ELEVATED MYOCARDIAL INFARCTION (STEMI). A 2.75X23MM XIENCE SIERRA STENT WAS IMPLANTED. ON 5/10/20 THE PATIENT WAS RE-HOSPITALIZED WITH HEMOPTYSIS AND OTHER CARDIOVASCULAR SYMPTOMS. IT IS UNKNOWN WHAT TREATMENT WAS PERFORMED AND FINAL PATIENT OUTCOME WAS UNKNOWN. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Code Available

  MAUDE report 10517833 ↗
• InjuryAug 26, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT ID: (B)(6). IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT PRESENTED WITH A RECENT NON-ST ELEVATED MYOCARDIAL INFARCTION AND A 70% STENOSED LESION WITHIN THE MID RIGHT CORONARY ARTERY (RCA). PRE-DILATATION WAS PERFORMED WITHIN THE MID RCA AND A 2.5X38MM (1550250-38, 9020841) AND A 2.75X23MM (1550275-23, 8091141) XIENCE SIERRA STENT WERE IMPLANTED. POST-DILATATION WAS PERFORMED. 0% RESIDUAL STENOSIS WAS NOTED WITHOUT A DEVICE ISSUE REPORTED. ON (B)(6) 2020, DURING A FOLLOW-UP, THE PATIENT REPORTED EXPERIENCING ONGOING, INTERMITTENT CHEST PAIN THAT WAS RELIEVED WITH REST. AS TREATMENT, THE PATIENTS MEDICATION (NITROGLYCERINE) WAS PROVIDED/ADJUSTED. ON (B)(6) 2020, DURING A FOLLOW-UP, THE PATIENT PRESENTED WITH WORSENING CHEST PAIN. PER NUCLEAR STRESS TEST, ST SEGMENT DEPRESSION WAS OBSERVED. ON (B)(6) 2020, THE PATIENT CONTINUED TO HAVE CHEST PAIN. THE PATIENT WAS HOSPITALIZED AND IN-STENT RESTENOSIS WAS OBSERVED IN BOTH RCA, XIENCE SIERRA STENTS. AS TREATMENT, ANGIOPLASTY WAS PERFORMED ON THE 99% OCCLUDED LESION WITHIN THE RCA. THE EVENT RESOLVED. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THIS ISSUE.

  Patient problems: Angina; Stenosis; Test Result

  MAUDE report 10454754 ↗
• InjuryJun 15, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT TWO XIENCE SIERRA STENTS (2.75X23MM AND 3.5X28MM) WERE IMPLANTED ON (B)(6) 2020. ON (B)(6) 2020, THE PATIENT WAS RE-ADMITTED WITH UNSTABLE ANGINA 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: Angina

  MAUDE report 10155866 ↗
• InjuryFeb 26, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT ID: (B)(6). IT WAS REPORTED THAT ON (B)(6) 2019, A PERCUTANEOUS CORONARY INTERVENTION (PCI) WAS PERFORMED. A 3.0X28MM XIENCE SIERRA STENT WAS SUCCESSFULLY IMPLANTED IN THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY LESION AND A 2.75X23MM XIENCE SIERRA STENT (1550275-23, 8103041) WAS SUCCESSFULLY IMPLANTED IN THE MID LAD. REPORTEDLY, THERE WERE NO PROCEDURAL COMPLICATIONS. STARTING ON (B)(6) 2020, THE PATIENT STARTED EXPERIENCING DYSPNEA. ON (B)(6) 2020, THE PATIENT WAS HOSPITALIZED. IMAGING WAS PERFORMED AND 80% STENOSIS WAS OBSERVED IN THE MID LAD, 2.75X23MM XIENCE SIERRA STENT. THE PROXIMAL 3.0X28MM XIENCE SIERRA STENT REMAINED PATENT. ELEVATED CARDIAC ENZYMES WERE NOTED; HOWEVER, THE PATIENT HAD NOT HAD A MYOCARDIAL INFARCTION. BALLOON ANGIOPLASTY WAS PERFORMED AND MEDICATIONS WERE PROVIDED. THE EVENT RESOLVED WITHOUT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THIS ISSUE.

  Patient problems: Cardiac Enzyme Elevation; Dyspnea; Stenosis

  MAUDE report 9757385 ↗
• InjuryFeb 26, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT ID: (B)(6). IT WAS REPORTED THAT ON (B)(6) 2019 THE 2.75X23 MM XIENCE SIERRA STENT WAS IMPLANTED IN THE MID LEFT ANTERIOR DESCENDING CORONARY ARTERY. ON (B)(6) 2020 THE PATIENT REPORTED HAVING HAD CHEST DISCOMFORT/PAIN AND SHORTNESS OF BREATH ON EXERTION FOR APPROXIMATELY 3 TO 4 WEEKS PRIOR TO THE (B)(6) APPOINTMENT. A CARDIAC CATHETERIZATION WAS PERFORMED ON (B)(6) 2020 AND 95% IN-STENT RESTENOSIS WAS FOUND IN THE DISTAL END OF THE XIENCE SIERRA STENT. ANOTHER XIENCE STENT WAS IMPLANTED TO TREAT THE RESTENOSIS WITH GOOD RESULTS. THE CONDITION RESOLVED ON (B)(6) 2020. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina; Dyspnea; Stenosis

  MAUDE report 9756302 ↗
• 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 ST ELEVATED MYOCARDIAL INFARCTION (STEMI) THEREFORE THE 2.75X23MM XIENCE SIERRA WAS IMPLANTED. ON (B)(6) 2019 THE PATIENT WAS RE-ADMITTED WITH CARDIAC FUNCTIONAL DISTURBANCES. PLAIN OLD BALLOON ANGIOPLASTY (POBA) WAS PERFORMED HOWEVER THE FINAL PATIENT OUTCOME IS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Arrhythmia

  MAUDE report 9438491 ↗
• InjurySep 6, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 2.75X23MM XIENCE SIERRA STENT WAS IMPLANTED ON (B)(6) 2019. THE PATIENT PRESENTED WITH NON ST-ELEVATION MYOCARDIAL INFARCTION (NSTEMI) BEFORE THE PROCEDURE. ON (B)(6) 2019, THE PATIENT WAS READMITTED WITH CARDIOVASCULAR SYMPTOMS INCLUDING ABDOMINAL PAIN. TREATMENT PERFORMED WAS UNSPECIFIED AND THE FINAL PATIENT OUTCOME IS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8970875 ↗
• InjuryJul 15, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE LEFT ANTERIOR DESCENDING CORONARY ARTERY (LAD). A 2.5X30 NON-ABBOTT STENT WAS IMPLANTED IN THE DIAGONAL LAD, A 2.75X28 XIENCE SIERRA STENT WAS IMPLANTED DISTALLY IN THE MID LAD, AND A 2.75X23 XIENCE SIERRA STENT WAS IMPLANTED IN THE PROXIMAL LAD, WHICH COVERED THE NON-ABBOTT STENT. THE PROCEDURE WAS COMPLETED; HOWEVER, THE PATIENT FELT PAIN IN THE BIFURCATION LESION, SO THE PATIENT WENT BACK ON THE TABLE. A CLOT WAS NOTED WHERE THE NON-ABBOTT STENT WAS LOCATED. THROMBUS WAS NOTED IN THE TWO XIENCE SIERRA STENTS IN THE LAD, BUT WITH GOOD FLOW. AN ATTEMPT TO BALLOON THE LESIONS WAS MADE. A 2.5X15MM NC TREK BALLOON DILATATION CATHETER WAS ADVANCED WITHOUT RESISTANCE, BUT WHEN ANOTHER 2.5X15MM NC TREK BDC WAS ADVANCED THROUGH AN UNSPECIFIED 6F GUIDING CATHETER AT THE SAME TIME AS THE FIRST BALLOON, RESISTANCE WAS FELT BETWEEN THE TWO BDCS. DURING REMOVAL, THE PROXIMAL SHAFT OF THE FIRST BDC SEPARATED. THE SEPARATED BDC WAS SIMPLY REMOVED WITHOUT ISSUES. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina; Thrombosis

  MAUDE report 8791703 ↗
• InjuryJun 20, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT TWO XIENCE SIERRA STENTS (2.75X23MM AND 3.5X15MM) WERE IMPLANTED ON (B)(6) 2019. ON (B)(6) 2019 AND (B)(6) 2019, THE PATIENT WAS RE-ADMITTED WITH SLURRED SPEECH AND TYPE 2 DIABETES AND UNSPECIFIED CARDIO VASCULAR SYMPTOMS. UNSPECIFIED TREATMENT WAS ADMINISTERED TO THE PATIENT. FINAL PATIENT OUTCOME IS REPORTEDLY UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8719902 ↗
• DeathJun 4, 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 A NON-ST-ELEVATION MYOCARDIAL INFARCTION (NSTEMI). THE PROCEDURE WAS TO TREAT THE MID LEFT ANTERIOR DESCENDING ARTERY. A 2.75 X 23MM XIENCE SIERRA STENT WAS IMPLANTED ON (B)(6) 2019. IT WAS CONFIRMED THAT THE PATIENT WAS COMPLIANT WITH DUAL ANTIPLATELET DRUG THERAPY. ON (B)(6) 2019, THE PATIENT WAS READMITTED DUE TO ENZYME ELEVATION AND CHEST PAIN. PERCUTANEOUS CORONARY INTERVENTION WAS ATTEMPTED BUT THE PATIENT WAS UNCOOPERATIVE AND THEREFORE PROCEDURE WAS ABORTED. THEN THE PATIENT DEVELOPED RESPIRATORY FAILURE AND WAS ADMITTED TO HOME HOSPICE. ON (B)(6) 2019, THE PATIENT DIED AT HOME. AN AUTOPSY WAS NOT PERFORMED. THE CAUSE OF DEATH IS UNKNOWN. PER THE PHYSICIAN THE DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE PATIENT DEATH. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina; Cardiac Enzyme Elevation; Respiratory Failure

  MAUDE report 8666587 ↗
• InjuryFeb 25, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 2.75 X 23 MM XIENCE SIERRA STENT WAS IMPLANTED ON (B)(6) 2018. ON (B)(6) 2018 THE PATIENT WAS READMITTED WITH UNSPECIFIED CARDIOVASCULAR SYMPTOMS IN ADDITIONAL TO ACUTE PANCREATITIS. THE TREATMENT PROVIDED WAS NOT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8368229 ↗
• InjuryDec 17, 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 PATIENT UNDERWENT A CORONARY STENTING PROCEDURE, WITH IMPLANTATION OF A 2.75 X 23 MM XIENCE SIERRA STENT. ON (B)(6) 2018, THE PATIENT RE-ADMITTED WITH MYOCARDIAL INFARCTION. INTERVENTION WAS PERFORMED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Myocardial Infarction

  MAUDE report 8171266 ↗
• InjuryJun 22, 2018Deflation Problem; Difficult or Delayed Positioning; Difficult to Remove

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A TORTUOUS AND CALCIFIED LESION IN THE OBTUSE MARGINAL (OM) TO LEFT CIRCUMFLEX (LX). THE 2.75X23MM RX XIENCE SIERRA STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TO THE LESION WITH NO RESISTANCE NOTED. THE STENT WAS DEPLOYED AT 15 ATMOSPHERES (ATM) FOR 15 SECONDS. DEFLATION WAS ATTEMPTED HOWEVER THE BALLOON DID NOT FULLY DEFLATE AS IT WAS CAUGHT ON THE MIDDLE PORTION OF THE STENT THAT WAS NOT FULLY APPOSED TO THE VESSEL WALL. RESISTANCE WAS MET DURING RETRACTION AS THE BALLOON WAS CAUGHT ON THE STENT, RESULTING IN THE GUIDE DEEP SEATING AND CAUSING A DISSECTION. THE SIERRA BALLOON WAS FINALLY DEFLATED AND REMOVED WITH NO ISSUE. POST DILATATION WAS PERFORMED WITH A NC BALLOON, FULLY APPOSING THE STENT. TWO ADDITIONAL SIERRA STENTS WERE DEPLOYED TO TREAT THE DISSECTION. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND NO ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Intimal Dissection

  MAUDE report 7630676 ↗