XIENCE Sierra™ 1550225-12Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 08717648227004), received between Jun 19, 2018 and Apr 1, 2022 — classified as 2 deaths, 11 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (4 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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 1, 2022Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THIS WAS A PROCEDURE TO TREAT A LESION IN THE DIAGONAL ARTERY. A 2. 5 X 12 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. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13973096 ↗
• MalfunctionMay 28, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING PREP OF THE 2.25X12 MM XIENCE SIERRA STENT DELIVERY SYSTEM (SDS), THE STENT WAS NOTED TO HAVE BEEN DISLODGED FROM THE SDS. THERE WAS NO RESISTANCE REMOVING THE SDS FROM THE DISPENSER COIL. THE DEVICE WAS NOT USED AND THERE WAS NO PATIENT INVOLVEMENT. A NEW, SAME SIZE XIENCE SIERRA WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11901376 ↗
• InjuryMar 26, 2021Failure to Advance; Device Dislodged or Dislocated; Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS REPORTED TO TREAT A RE-STENOSED LESION IN THE LEFT MAIN CORONARY ARTERY. A NON-ABBOTT STENT WAS IMPLANTED ON (B)(6) 2021. ON (B)(6) 2021, THE PREVIOUSLY DEPLOYED STENT WAS RE-STENOSED, SO ANOTHER NON-ABBOTT STENT WAS ATTEMPTED TO BE USED BUT FAILED TO CROSS. A 2.25X12MM XIENCE SIERRA STENT DELIVERY SYSTEM (SDS) WAS ATTEMPTED BUT FAILED TO CROSS DUE TO INTERACTION WITH THE PREVIOUSLY DEPLOYED STENT, AND THE STENT DISLODGED. A SNARE WAS ATTEMPTED, BUT FAILED TO REMOVE THE DISLODGED STENT. A NON-ABBOTT BALLOON AND NON-ABBOTT STENT WERE USED TO EMBED THE STENT, AND THE PATIENT IS FINE. THERE WERE NO ADVERSE PATIENT SEQUELAE AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 11577615 ↗
• MalfunctionSep 21, 2020Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE MODERATELY CALCIFIED, DISTAL RIGHT CORONARY ARTERY. THE BALANCE MIDDLE WEIGHT (BMW) GUIDE WIRE AND THE 2.25X12MM XIENCE SIERRA STENT DELIVERY SYSTEM (SDS) SUCCESSFULLY CROSSED THE TARGET LESION. THE SIERRA STENT WAS IMPLANTED WITHOUT ISSUE. HOWEVER, RESISTANCE WAS FELT WITH THE GUIDE WIRE DURING REMOVAL. THE GUIDEWIRE AND THE SDS WERE REMOVED TOGETHER AS A SINGLE UNIT. A BURR COULD BE FELT ON THE RADIOPAQUE TIP OF THE GUIDE WIRE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND NO ADVERSE PATIENT EFFECT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10563565 ↗
• InjurySep 3, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT TWO XIENCE SIERRA STENTS (4X12MM AND 2.25X12MM) WERE IMPLANTED IN THE LEFT ANTERIOR DESCENDING CORONARY ARTERY (LAD) ON (B)(6) 2020. THE PATIENT PRESENTED WITH UNSTABLE ANGINA AND ATHEROSCLEROTIC HEART DISEASE BEFORE THE PROCEDURE. ON (B)(6) 2020, THE PATIENT WAS RE-ADMITTED WITH ANTERIOR NON-ST ELEVATED MYOCARDIAL INFARCTION AND PALPITATIONS. TWO MORE XIENCE SIERRA STENTS (2.75X38MM AND 3X18MM) WERE IMPLANTED OVER THE PREVIOUS STENTS IN THE LAD ON (B)(6) 2020. ON (B)(6) 2020, THE PATIENT WAS RE-ADMITTED WITH ANTERIOR NON-ST ELEVATED MYOCARDIAL INFARCTION AND PALPITATIONS AGAIN. UNSPECIFIED BALLOONS WERE USED AS TREATMENT, AND THE FINAL PATIENT OUTCOME IS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Arrhythmia; Myocardial Infarction

  MAUDE report 10491550 ↗
• DeathJul 9, 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 2.25X12 MM XIENCE SIERRA STENT WAS IMPLANTED IN THE FIRST DIAGONAL ARTERY AND THE 2.5X15 MM XIENCE SIERRA STENT WAS IMPLANTED IN THE DISTAL RIGHT CORONARY ARTERY. ON (B)(6) 2020 THE PATIENT HAD A MYOCARDIAL INFARCTION AND EXPIRED. NO TREATMENT WAS GIVEN. THERE IS A POSSIBLE DEVICE RELATIONSHIP. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Death; Myocardial Infarction; No Consequences Or Impact To Patient

  MAUDE report 10254096 ↗
• MalfunctionApr 8, 2020Inflation Problem; Leak/Splash; Inflation Problem; Leak/Splash

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

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9935324 ↗
• InjuryMar 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) 2020 THE 2.25X12 MM XIENCE SIERRA STENT WAS IMPLANTED IN THE RIGHT POSTERIOR DESCENDING CORONARY ARTERY. ON (B)(6) 2020 THE PATIENT HAD THROAT TIGHTNESS, LEFT ARM PAIN, DYSPNEA, AND OCCASIONAL CHEST PRESSURE. THE SYMPTOMS WORSENED, THUS THE PATIENT WENT TO THE EMERGENCY ROOM. THE PATIENT WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2020. AN ECHOCARDIOGRAM WAS THE ONLY DIAGNOSTIC PERFORMED AND THERE WERE NO CHANGES ON THE (B)(6) 2020 ECHOCARDIOGRAM COMPARED TO THE (B)(6) 2020 ECHOCARDIOGRAM. THE CONDITION RESOLVED AND THE PATIENT WAS DISCHARGED ON (B)(6) 2020. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina; Dyspnea

  MAUDE report 9884363 ↗
• InjuryMar 8, 2020Adverse 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 ELEVATED MYOCARDIAL INFARCTION (NSTEMI). A 2.25X12MM XIENCE SIERRA STENT WAS IMPLANTED. ON (B)(6) 2019 THE PATIENT WAS RE-HOSPITALIZED WITH INFECTION, INFLAMMATION AND OTHER CARDIOVASCULAR SYMPTOMS. SURGERY WAS PERFORMED; HOWEVER, THE FINAL PATIENT OUTCOME IS UNKNOWN. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: Inflammation; Unspecified Infection

  MAUDE report 9803963 ↗
• InjuryMar 8, 2020Adverse 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). A 2.25X12MM XIENCE SIERRA STENT WAS IMPLANTED. ON (B)(6) 2019 THE PATIENT WAS RE-HOSPITALIZED WITH ATHEROSCLEROTIC HEART DISEASE. IT IS UNKNOWN WHAT TREATMENT WAS PERFORMED AND WHAT THE FINAL PATIENT OUTCOME WAS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 9803949 ↗
• InjuryFeb 17, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE CIRCUMFLEX ARTERY. ON (B)(6) 2019, A 2.25X12MM (DISTAL), 2.25X23MM (MIDDLE), AND 2.50X28MM (PROXIMAL) XIENCE SIERRA STENTS WERE DEPLOYED. ON (B)(6) 2020, THE PATIENT WAS RE-ADMITTED FOR IN-STENT RESTENOSIS. BALLOONING WAS PERFORMED TO TREAT THE STENOSIS; HOWEVER, WHILE BALLOONING THE 2.25X23MM IMPLANTED STENT, THE STENT FRACTURED. A 2.5X15MM NON-ABBOTT STENT WAS DEPLOYED TO TREAT THE FRACTURE, BUT THIS CAUSED A PERFORATION. A SECOND NON-ABBOTT STENT WAS USED TO SUCCESSFULLY TREAT THE PERFORATION. THERE WERE NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Stenosis

  MAUDE report 9717874 ↗
• MalfunctionJan 2, 2020Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A LESION IN THE OBTUSE MARGINAL. THE 2.25X12MM XIENCE SIERRA WAS STENT WAS IMPLANTED WHEN IT WAS NOTED THE DEVICE WAS USED PAST THE EXPIRATION DATE OF 12/10/2019. 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 9539049 ↗
• InjuryDec 20, 2019Entrapment of Device; Device Damaged by Another Device; Entrapment of Device; Device Damaged by Another Device

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A CORONARY STENTING PROCEDURE, TREATING A TARGET LESION IN THE DIAGONAL ARTERY. THE 2.25 X 12 MM XIENCE SIERRA STENT WAS IMPLANTED WITHOUT ISSUE. THERE WAS NO DIFFICULTY NOTED DURING ADVANCEMENT OR WITHDRAWAL OF THE STENT DELIVERY SYSTEM. HOWEVER, RESISTANCE WAS NOTED DURING REMOVAL OF THE EXTRA S'PORT GUIDE WIRE, AS THE GUIDE WIRE WAS CAUGHT ON THE DISTAL END OF THE STENT. THE GUIDE WIRE COILS STRETCHED INTO THE AORTA. A GUIDE LINER WAS ADVANCED INTO THE GUIDE CATHETER, IN AN ATTEMPT TO PUSH THE COILS BACK INTO THE VESSEL. A SECOND EXTRA S'PORT GUIDE WIRE WAS ADVANCED TO ASSIST REMOVAL OF THE FIRST GUIDE WIRE. THE SECOND GUIDE WIRE ALSO GOT STUCK ON THE STENT. IN THE ATTEMPT TO REMOVE BOTH GUIDE WIRES, THE STENT WAS EXPLANTED WITH THE GUIDE WIRES. THE LEFT ANTERIOR DESCENDING (LAD) ARTERY WAS DAMAGED DURING THE REMOVAL ATTEMPTS AND AN ADDITIONAL STENT WAS IMPLANTED. THE DIAGONAL ARTERY WAS NOT TREATED WITH ADDITIONAL STENTING AND NO VESSEL DAMAGE WAS NOTED FROM THE STENT EXPLANTATION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Tissue Damage

  MAUDE report 9508070 ↗
• InjuryAug 13, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE CIRCUMFLEX ARTERY. THE PATIENT WAS EXPOSED TO 26 GY (GRAY) OF RADIATION. A 2.25 X 12 MM XIENCE SIERRA STENT DELIVERY SYSTEM WAS USED AND A STENT DISLODGEMENT WAS REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 8888172 ↗
• InjuryApr 29, 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 WAS ADMITTED WITH ST ELEVATION MYOCARDIAL INFARCTION, THROMBUS AND CARDIAC ARREST. A 2.25 X 18 MM XIENCE SIERRA STENT (8120341) AND A 2.5 X 28 MM XIENCE SIERRA STENT (8102441) WERE IMPLANTED IN THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY. SLUGGISH FLOW WAS NOTED AFTER STENT DEPLOYMENT; HOWEVER, NO ADDITIONAL INTERVENTION WAS PERFORMED. ON (B)(6) 2019, THE PATIENT EXPERIENCED VENTRICULAR TACHYCARDIA AND WAS TAKEN BACK TO THE CATH LAB. CORONARY ANGIOGRAPHY NOTED THROMBUS IN THE STENTED SEGMENT. A 2.5 X 33 MM XIENCE SIERRA STENT AND A 2.25 X 12 MM XIENCE SIERRA STENT (8090341) WERE IMPLANTED TO TREAT THE THROMBUS. POST DILATATION WAS PERFORMED USING AN UNSPECIFIED NC DILATATION CATHETER. A NON-FLOW LIMITING EDGE DISSECTION WAS NOTED AT THE 2.25 X 12 MM XIENCE SIERRA STENT. NO ADDITIONAL INTERVENTION WAS PERFORMED TO TREAT THE DISSECTION. POST PROCEDURE, THE PATIENT WAS IN STABLE CONDITION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Intimal Dissection

  MAUDE report 8561593 ↗
• InjuryFeb 27, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2018 A 2.25X12MM XIENCE SIERRA STENT WAS IMPLANTED. ON (B)(6) 2018 THE PATIENT WAS RE-ADMITTED WITH CHEST PAIN AND OTHER UNSPECIFIED CARDIO VASCULAR SYMPTOMS. THE TREATMENT PERFORMED AND PATIENT OUTCOME IS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina

  MAUDE report 8376139 ↗
• InjuryFeb 19, 2019Failure to Advance; Device Dislodged or Dislocated; Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED LESION IN THE NON TORTUOUS DISTAL RIGHT CORONARY ARTERY (RCA). THE 2.25X12 MM XIENCE SIERRA STENT DELIVERY SYSTEM (SDS) COULD NOT CROSS THE LESION AND THE SDS WAS REMOVED DUE TO THE RESISTANCE. IT WAS NOTICED WHEN THE SDS WAS REMOVED THAT THE STENT WAS NOT LOCATED ON THE SDS. THE STENT COULD NOT BE LOCATED AND IT WAS ASSUMED TO BE UNDEPLOYED AND FREE FLOATING IN THE PROXIMAL RCA. NO ATTEMPT WAS MADE TO RETRIEVE THE STENT AS IT COULD NOT BE LOCATED ON THE ANGIOGRAM. THE PROCEDURE WAS COMPLETED WITH BALLOON ANGIOPLASTY AT THE TARGET LESION. THE PATIENT HAS NOT BEEN BROUGHT BACK TO LOCATE OR RETRIEVE THE STENT AND THERE ARE NO PLANS TO BRING THE PATIENT BACK. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 8352362 ↗
• DeathDec 26, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MILDLY TORTUOUS AND MILDLY CALCIFIED OBTUSE MARGINAL BRANCH, THE DIAGONAL BRANCH AND THE LEFT ANTERIOR DESCENDING ARTERY. A 2.25 X 12 MM XIENCE SIERRA STENT WAS IMPLANTED IN THE OBTUSE MARGINAL BRANCH, A 2.25 X 18 MM XIENCE SIERRA STENT WAS IMPLANTED IN THE DIAGONAL BRANCH AND A 2.5 X 38 MM XIENCE SIERRA STENT WAS IMPLANTED IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY WITHOUT ANY ISSUES. HOWEVER, THE PATIENT COMPLAINED OF DISCOMFORT AND THEN BECAME HYPOTENSIVE AND EXPERIENCED CARDIAC ARREST. THEREFORE, CARDIOPULMONARY RESUSCITATION (CPR) WAS STARTED AND THE PATIENT WAS INTUBATED. IT WAS NOTED THAT THERE WAS NO FLOW IN THE VESSELS THAT WERE STENTED DUE TO THROMBUS. THEREFORE, BALLOON ANGIOPLASTY WAS PERFORMED IN THE PROXIMAL CIRCUMFLEX, DIAGONAL AND LAD ARTERIES. ASPIRATION WAS PERFORMED TO REMOVE THE THROMBUS AND A 2.5 X 38 MM XIENCE SIERRA STENT WAS IMPLANTED IN THE DISTAL LAD. CPR CONTINUED; HOWEVER, THE PATIENT EXPIRED THAT SAME DAY ON (B)(6) 2018. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina; Cardiac Arrest; Low Blood Pressure/ Hypotension; Respiratory Failure; Thrombosis

  MAUDE report 8197825 ↗
• MalfunctionJun 19, 2018Deflation Problem; Difficult to Remove; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY TORTUOUS PROXIMAL LEFT ANTERIOR DESCENDING ARTERY. A 2.25 X 12 MM XIENCE SIERRA STENT WAS IMPLANTED AND DID NOT MEET ANY RESISTANCE DURING ADVANCEMENT. THE STENT DELIVERY SYSTEM (SDS) WAS INFLATED ONCE AT 15 ATMOSPHERES. HOWEVER, THE STENT DELIVERY BALLOON BECAME STUCK WITH THE DEPLOYED STENT DURING REMOVAL. IT WAS REPORTED THAT THE BALLOON WAS DEFLATED FOR 2-3 SECONDS. THEREFORE, MORE NEGATIVE PRESSURE WAS APPLIED AND THE BALLOON WAS REMOVED FULLY DEFLATED. ADDITIONALLY, SLIGHT FORCE WAS USED TO REMOVE THE SDS FROM THE ANATOMY TO SUCCESSFULLY COMPLETE THE PROCEDURE. THE STENT WAS FULLY APPOSED TO THE LESION. 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 7613893 ↗