XIENCE Sierra™ 1550250-18Recalls & reported problems

Summary

The FDA's MAUDE database contains 38 adverse event reports that list this exact device (DI 08717648227103), received between Aug 22, 2018 and Mar 4, 2022 — classified as 2 deaths, 28 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (5 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 25 most recent of 38 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 4, 2022Difficult to Remove; Failure to Advance; Deformation Due to Compressive Stress; Difficult to Remove; Failure to Advance; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE DISTAL RIGHT CORONARY ARTERY (DRCA) WITH MODERATE CALCIFICATION AND MILD TORTUOSITY. A 2.50 X 18 XIENCE SIERRA STENT DELIVERY SYSTEM (SDS) WAS ATTEMPTED TO BE ADVANCED TO THE TARGET LESION; HOWEVER, RESISTANCE WAS FELT DUE TO ANATOMICAL CHALLENGES, AND THE STENT COULD NOT CROSS THE TARGET LESION. THEN THE SHAFT OF THE SDS BECAME KINKED. THEREFORE, THE SDS WAS REMOVED AND RESISTANCE WAS NOTED DURING REMOVAL DUE TO ANATOMICAL CHALLENGES. AN UNSPECIFIED STENT WAS IMPLANTED TO SUCCESSFULLY TREAT THE TARGET LESION. THERE WERE NO ADVERSE PATIENT EFFECTS AND THERE WERE NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13667302 ↗
• InjuryDec 14, 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 2.5X18MM XIENCE SIERRA DRUG ELUTING STENT (DES) WAS IMPLANTED. ON (B)(6) 2021 THE PATIENT WAS RE-ADMITTED WITH CHEST PAIN AND WAS TREATED WITH MEDICATIONS. THE PATIENT WAS DISCHARGED TO HOME. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina

  MAUDE report 13003253 ↗
• InjuryDec 13, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2021, THREE XIENCE SIERRA STENTS (2.5X18, 2.5X25, 3.0X28MM) WERE IMPLANTED WITHOUT REPORTED ISSUE. ON (B)(6) 2021 THE PATIENT WAS RE-HOSPITALIZED DUE TO VENTRICULAR TACHYCARDIA AND CORONARY ARTERY BYPASS SURGERY WAS PERFORMED. THE PATIENT WAS DISCHARGED TO HOME. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Tachycardia

  MAUDE report 12991836 ↗
• InjuryDec 13, 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 2.50X18MM XIENCE SIERRA DRUG ELUTING STENT (DES) WAS IMPLANTED. ON (B)(6) 2021, THE PATIENT WAS RE-ADMITTED WITH A MYOCARDIAL INFARCTION. THE PATIENT WAS GIVEN MEDICATIONS AND DISCHARGED TO HOME. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Myocardial Infarction

  MAUDE report 12988785 ↗
• InjuryDec 10, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAS A HISTORY OF NON-ST ELEVATED MYOCARDIAL INFARCTION AND HAD A 2.5X18 MM AND 2.75X28 MM XIENCE SIERRA STENTS IMPLANTED ON (B)(6) 2021. ON (B)(6) 2021 THE PATIENT WAS READMITTED TO THE HOSPITAL DUE TO NSTEMI AND WAS SENT TO THE CATH LAB; HOWEVER, NOTHING WAS DONE. FINAL PATIENT OUTCOME IS LISTED AS UNKNOWN.

  Patient problems: Myocardial Infarction

  MAUDE report 12980573 ↗
• InjuryDec 9, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A HISTORY OF ST ELEVATED MYOCARDIAL INFARCTION (STEMI) AND HAD A 2.5X18 MM XIENCE SIERRA IMPLANTED ON( B)(6) 2021. THE PATIENT RETURNED ON (B)(6) 2021 DUE TO ATRIAL FLUTTER AND HAD A DEFIBRILLATOR INSERTED. FINAL PATIENT OUTCOME IS FINE AND PATIENT WAS DISCHARGED WITH HOME HEALTH. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Atrial Flutter

  MAUDE report 12970038 ↗
• InjuryAug 31, 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 A ST ELEVATED MYOCARDIAL INFARCTION (STEMI) AND THE 2.50X18MM XIENCE SIERRA STENT WAS IMPLANTED. ON (B)(6) 2021, THE PATIENT WAS RE-ADMITTED WITH UNSPECIFIED CARDIOVASCULAR SYMPTOMS AND STEMI. UNSPECIFIED TREATMENT WAS PROVIDED AND THE FINAL PATIENT OUTCOME IS NOT KNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Myocardial Infarction

  MAUDE report 12391990 ↗
• 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 THIS PATIENT WHO HAD A NON ST ELEVATION MYOCARDIAL INFARCTION (NSTEMI). ON (B)(6) 2021 THE PATIENT WAS RE-ADMITTED TO THE HOSPITAL AGAIN WITH A NSTEMI. MEDICAL INTERVENTION WAS REQUIRED, ALTHOUGH NOT SPECIFIED. THE FINAL PATIENT OUTCOME WAS NOT PROVIDED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Myocardial Infarction

  MAUDE report 11898129 ↗
• 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 PATIENT WITH ATHEROSLEROTIC HEART DISEASE WITHOUT ANGINA WAS IMPLANTED WITH A XIENCE SIERRA STENT. THE PATIENT WAS RE-ADMITTED WITH CHEST PAIN AND OTHER CARDIOVASCULAR SYMPTOMS ON (B)(6) 2021. UNSPECIFIED TREATMENT WAS PERFORMED, AND THE FINAL PATIENT OUTCOME IS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina

  MAUDE report 11894638 ↗
• InjuryApr 6, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT ID: (B)(6). IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED ON (B)(6) 2020 TO TREAT A TARGET LESION IN THE DISTAL TO MID LEFT ANTERIOR DESCENDING (LAD) ARTERY. FOUR XIENCE SIERRA STENTS WERE IMPLANTED: 2.5 X 23, 2.5 X 18, 3.0 X 38 AND 3.25 X 28. THE PATIENT WAS RE-HOSPITALIZED ON (B)(6) 2021 WITH COMPLAINTS OF CHEST PAIN. TROPONIN LEVELS WERE ELEVATED. MEDICATION WAS ADMINISTERED. A CORONARY ANGIOGRAM WAS PERFORMED ON (B)(6) 2021. THE DISTAL LAD WAS NOTED TO BE 95% OCCLUDED AND REVASCULARIZATION WAS PERFORMED, TREATING IN-STENT RESTENOSIS IN THE 2.5 X 23 MM XIENCE SIERRA STENT AND THE 2.5 X 18 MM XIENCE SIERRA STENT. THE EVENT RESOLVED ON (B)(6) 2021. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina; Cardiac Enzyme Elevation; Stenosis

  MAUDE report 11624060 ↗
• MalfunctionMar 19, 2021Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THIS WAS A PROCEDURE TO TREAT A DE NOVO LESION IN THE PROXIMAL OBTUSE MARGINAL ARTERY WITH NO CALCIFICATION AND NO TORTUOSITY. A 2.50X18 MM XIENCE SIERRA STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TO THE TARGET LESION AND THE STENT WAS SUCCESSFULLY DEPLOYED. HOWEVER, POST DEPLOYMENT IT WAS NOTED THAT THE STENT HAD EXPIRED. THE PATIENT IS STABLE. 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 11529869 ↗
• InjuryMar 11, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 2.5X18MM 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 SEPSIS. UNSPECIFIED TREATMENT WAS PERFORMED, AND THE FINAL PATIENT OUTCOME IS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Sepsis

  MAUDE report 11467801 ↗
• InjuryDec 8, 2020Adverse 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 BEFORE THE INITIAL PROCEDURE. A 2.5X18MM XIENCE SIERRA STENT WAS IMPLANTED ON (B)(6) 2020. ON (B)(6) 2020, THE PATIENT WAS RE-ADMITTED WITH CHEST PAIN. UNSPECIFIED TREATMENT WAS PERFORMED, AND THE FINAL PATIENT OUTCOME IS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina

  MAUDE report 10969863 ↗
• InjuryDec 8, 2020Adverse 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 BEFORE THE INITIAL PROCEDURE. A 2.5X18MM XIENCE SIERRA STENT WAS IMPLANTED ON (B)(6) 2020. ON (B)(6) 2020, THE PATIENT WAS RE-ADMITTED WITH VENTRICULAR FIBRILLATION. UNSPECIFIED SURGERY WAS PERFORMED AS TREATMENT, AND THE FINAL PATIENT OUTCOME IS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Ventricular Fibrillation

  MAUDE report 10969515 ↗
• MalfunctionOct 1, 2020Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A DISTAL LEFT CIRCUMFLEX ARTERY. A 2.5X18MM XIENCE SIERRA WAS OPENED AND THE NURSE FELT SOMETHING WAS WRONG BUT HANDED THE DEVICE TO THE PHYSICIAN TO USE IN THE PROCEDURE. AFTER THE XIENCE SIERRA WAS DEPLOYED, IT WAS NOTED THAT THE STERILE POUCH (CLEAR TYVEK) OF THE XIENCE SIERRA WAS NOT SEALED. THERE WERE NO ADVERSE PATIENT EFFECTS OR CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10616876 ↗
• InjurySep 14, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH A MYOCARDIAL INFARCTION AND ON (B)(6) 2020 THREE XIENCE SIERRA STENTS (2.5 X 18, 3.0 X 38, 3.5 X 28) WERE IMPLANTED. ON (B)(6) 2020, THE PATIENT WAS RE-HOSPITALIZED WITH CHRONIC GASTROJEJUNAL ULCER WITH HEMORRHAGE. TREATMENT INCLUDED PLACEMENT OF A PACEMAKER. THE FINAL PATIENT OUTCOME IS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 10532357 ↗
• InjurySep 14, 2020Material Rupture; Difficult or Delayed Activation; Material Rupture; Difficult or Delayed Activation

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED LESION IN THE DISTAL RIGHT CORONARY ARTERY (RCA). THE 2.5X18MM RX XIENCE SIERRA STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TO THE LESION WITHOUT ISSUE. DURING INFLATION, THE BALLOON RUPTURED AND THE STENT WAS ONLY PARTIALLY DEPLOYED. THE SDS WAS REMOVED AND ANOTHER BALLOON CATHETER WAS ADVANCED INSIDE THE STENT AND INFLATED TO FULLY APPOSE THE STENT TO THE VESSEL WALL. 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 10532273 ↗
• InjurySep 10, 2020Adverse 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-ELEVATION MYOCARDIAL INFARCTION. TWO XIENCE SIERRA STENTS (2.50X18MM AND 2.50X33MM) WERE IMPLANTED ON (B)(6) 2020. ON (B)(6) 2020, THE PATIENT WAS RE-ADMITTED WITH CARDIOVASCULAR SYMPTOMS INCLUDING EPISTAXIS. TREATMENT PERFORMED WAS UNSPECIFIED AND THE FINAL PATIENT OUTCOME IS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 10516197 ↗
• 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 A ST-ELEVATION MYOCARDIAL INFARCTION AND TWO XIENCE SIERRA STENTS (2.5X18MM AND 3.0X23MM) WERE IMPLANTED. ON (B)(6) 2020, THE PATIENT WAS RE-ADMITTED WITH UNSPECIFIED CARDIOVASCULAR SYMPTOMS AND CHEST PAINS. UNSPECIFIED TREATMENT WAS PROVIDED AND THE FINAL PATIENT OUTCOME IS NOT KNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina

  MAUDE report 10505017 ↗
• MalfunctionSep 7, 2020Difficult to Remove; Material Rupture; Difficult to Advance; Difficult to Remove; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED, 75% STENOSED, DE NOVO LESION INT THE LEFT ANTERIOR DESCENDING ARTERY (LAD). A 2.5X18MM XIENCE SIERRA DRUG ELUTING STENT (DES) WAS ADVANCED BUT MET RESISTANCE WITH THE ANATOMY AND WAS UNABLE TO REACH THE TARGET LESION. DILATATION WAS PERFORMED A SECOND TIME AND THE DES REACHED THE LESION, BUT IT WAS NOTED THAT BLOOD WAS OBSERVED IN THE INFLATION DEVICE AND A BALLOON RUPTURE WAS SUSPECTED. THE DES WAS REMOVED WITH RESISTANCE NOTED WITH THE ANATOMY. A NON-ABBOTT DEVICE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10500241 ↗
• InjurySep 1, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT ID: (B)(6). IT WAS REPORTED THAT THIS WAS A CORONARY INTERVENTION IN THE MID LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY. DURING THE PROCEDURE, AFTER POST DILATATION OF THE 2.5X18 MM XIENCE SIERRA STENT, A SMALL PERFORATION WAS NOTED. BALLOON TAMPONADE SUCCESSFULLY TREATED THE PERFORATION. THREE OTHER XIENCE SIERRA STENTS WERE ALSO IMPLANTED DURING THIS PROCEDURE. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: Perforation

  MAUDE report 10478536 ↗
• InjuryJun 18, 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 STENOSIS OF CORONARY STENT THEREFORE, THE 2.5X18MM XIENCE SIERRA WAS IMPLANTED. ON (B)(6) 2020 THE PATIENT WAS RE-ADMITTED DUE TO UNSTABLE ANGINA. IT IS UNKNOWN WHAT TREATMENT WAS PERFORMED AND THE FINAL PATIENT OUTCOME IS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina

  MAUDE report 10171702 ↗
• InjuryApr 8, 2020Failure to Advance; Device Dislodged or Dislocated; Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN UNSPECIFIED LESION DURING ADVANCEMENT, A 2.5X18 XIENCE SIERRA STENT MET RESISTANCE WITH THE ANATOMY AND BECAME DISLODGED. THE STENT WAS CRUSHED AND EMBEDDED WITH ANOTHER STENT. NOTHING FURTHER WAS DONE AND THE PATIENT IS FINE. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Vessel Or Plaque, Device Embedded In

  MAUDE report 9936249 ↗
• InjuryMar 13, 2020Difficult or Delayed Activation; Difficult or Delayed Activation

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A 99% STENOSED LESION IN THE MID LEFT ANTERIOR DESCENDING ARTERY (LAD). ON (B)(6) 2020, THE PATIENT PRESENTED WITH ST-ELEVATION MYOCARDIAL INFARCTION. FOLLOWING PRE-DILATATION, A 2.5X18MM XIENCE SIERRA STENT WAS DEPLOYED; HOWEVER, THE STENT WAS UNDERSIZED FOR THE VESSEL DIAMETER AND LOOKED UNDER EXPANDED/IRREGULAR. NO POST-DILATATION WAS PERFORMED, AND THE PROCEDURE WAS COMPLETED. ON (B)(6) 2020, THE PATIENT WENT BACK TO THE CATH LAB DUE TO THE LAD BEING OCCLUDED. AN ANGIOGRAM WAS PERFORMED AND CONFIRMED THE OCCLUSION TO BE THROMBOSIS. THE LESION WAS DILATED, AND THE FLOW WAS RESTORED. THE PATIENT IS DOING WELL. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Thrombosis

  MAUDE report 9831258 ↗
• InjuryMar 13, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2019, TWO XIENCE SIERRA STENTS WERE IMPLANTED IN AN UNSPECIFIED CORONARY ARTERY. SINCE THE PROCEDURE, THE PATIENT HAS EXPERIENCED PAIN IN HER MOUTH, WHICH SHE SUSPECTED AS AN ALLERGIC REACTION. THE PATIENT WENT TO THE PHYSICIAN REGARDING THIS ISSUE AND THE PHYSICIAN RECOMMENDED BENADRYL TO SEE IF THAT WOULD HELP. THERE WAS NO ADDITIONAL HOSPITALIZATION AND THERE WAS NO DEVICE ISSUE REPORTED. THERE WAS NO ADDITIONAL ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THIS ISSUE.

  Patient problems: Hypersensitivity/Allergic reaction; Pain

  MAUDE report 9829687 ↗