XIENCE Sierra™ 1550300-12Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 08717648227240), received between Nov 5, 2018 and Sep 3, 2021 — classified as 15 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (3 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 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 3, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT WHEN A XIENCE 3X12MM DRUG ELUTING STENT (DES) WAS OPENED, IT WAS OBSERVED THE STENT WAS DISLOCATED ON THE BALLOON. THE DEVICE WAS NOT USED AND REPLACED. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12422618 ↗
• MalfunctionJul 16, 2021Difficult 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 HEAVILY CALCIFIED LEFT MAIN TO LEFT ANTERIOR DESCENDING BIFURCATED LESION. AFTER PRE-DILATATION WITH AN NC BALLOON, A 3X12MM XIENCE SIERRA WAS BEING ADVANCED WHEN THE DISTAL PART OF THE STENT GOT STUCK ON CALCIFIED PLAQUE AND THE DISTAL END OF THE STENT IMPLANT STARTED TO DEPLOY [FLARED STRUTS]. IT WAS DECIDED TO SIMPLY WITHDRAW THE DEVICE. AFTER SEVERAL ADDITIONAL DILATATIONS, ANOTHER SAME SIZE XIENCE SIERRA STENT 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 12182185 ↗
• InjuryMay 27, 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 (STEMI) BEFORE THE INITIAL PROCEDURE. TWO XIENCE SIERRA STENTS (3X12MM AND 3X8MM) WERE IMPLANTED ON (B)(6) 2021. ON (B)(6) 2021, THE PATIENT WAS RE-ADMITTED WITH DYSPNEA. UNSPECIFIED TREATMENT WAS PERFORMED, AND THE FINAL PATIENT OUTCOME IS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Dyspnea

  MAUDE report 11893883 ↗
• MalfunctionApr 20, 2021Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE LEFT ANTERIOR DESCENDING ARTERY. A 3.0X12MM XIENCE SIERRA STENT WAS DEPLOYED SUCCESSFULLY WITHOUT ISSUES; HOWEVER, POST-DEPLOYMENT IT WAS NOTED THAT THE STENT WAS EXPIRED. 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 11693832 ↗
• MalfunctionFeb 22, 2021Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A MODERATELY CALCIFIED AND TORTUOUS RIGHT CORONARY ARTERY. PRIOR TO IMPLANTING THE XIENCE SIERRA STENT, IT WAS NOTED THAT THE STENT WAS EXPIRED. THE STENT WAS IMPLANTED WITHOUT ISSUE. 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 11362835 ↗
• InjuryJan 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT ID: (B)(4). IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED ON 03/11/2019, TREATING A TARGET LESION IN THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY. A 3.0 X 12 MM XIENCE SIERRA STENT WAS IMPLANTED WITHOUT ISSUE. ON (B)(6) 2020, THE PATIENT WAS RE-HOSPITALIZED WITH CHEST PAIN. RESTENOSIS WAS NOTED AND AN ADDITIONAL STENT WAS IMPLANTED. THE PATIENT CONDITION RESOLVED ON (B)(6) 2020. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina; Stenosis

  MAUDE report 11136283 ↗
• InjuryJul 31, 2020Migration; Migration

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A MODERATELY CALCIFIED, NON-TORTUOUS PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE 3.0X12MM XIENCE SIERRA STENT WAS DEPLOYED AT 14ATM. A NON-ABBOTT NC BALLOON WAS THEN DELIVERED TO THE STENT FOR POST DILATATION, BUT THE STENT MOVED TO THE MIDDLE PORTION OF THE LAD BEFORE INFLATION. THE STENT WAS APPOSED TO HEALTHY TISSUE. A NEW 3.5X12MM XIENCE SIERRA STENT WAS DEPLOYED IN THE PROXIMAL LAD. THERE WAS NO ADVERSE PATIENT SEQUELA REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Vessel Or Plaque, Device Embedded In

  MAUDE report 10349965 ↗
• MalfunctionJul 16, 2020Material Rupture; Improper or Incorrect Procedure or Method; Difficult to Advance; Material Rupture; Improper or Incorrect Procedure or Method; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED LESION IN THE MODERATELY TORTUOUS LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY. A ROTABLATOR WAS USED AND BALLOON ANGIOPLASTY WAS PERFORMED. THE 3.00X12 MM XIENCE SIERRA STENT DELIVERY SYSTEM (SDS) FAILED TO CROSS SO PRE-DILATATION WAS PERFORMED WITH A CUTTING BALLOON. THE XIENCE SIERRA SDS WAS REINSERTED AND THE STENT WAS IMPLANTED AT 16 ATMOSPHERES. UPON REMOVAL, BLOOD WAS NOTED INSIDE THE BALLOON, INDICATING A RUPTURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10284928 ↗
• InjuryJul 15, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH ACUTE MYOCARDIAL INFARCTION. THE VESSEL WAS PREPPED WITH A COMPLIANT BALLOON AND THE 3.0X12 MM XIENCE SIERRA STENT WAS IMPLANTED. NO POST DILATATION WAS PERFORMED AND THERE WERE NO ISSUES NOTED WITH DEPLOYMENT OF THE STENT. THERE WAS RESIDUAL STENOSIS NOTED ANGIOGRAPHICALLY, WHICH THE PHYSICIAN STATED WAS THE STENT CLOTTING OFF. THE THROMBOSIS WAS TREATED MEDICALLY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Thrombosis

  MAUDE report 10276840 ↗
• InjuryJun 15, 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 3.0X12 MM XIENCE ALPINE STENT WAS IMPLANTED IN THE PATIENT WITH A HISTORY OF NON ST ELEVATION MYOCARDIAL INFARCTION. ON (B)(6) 2020 THE PATIENT WAS RE-ADMITTED TO THE HOSPITAL WITH A CEREBRAL INFARCTION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Stroke/CVA

  MAUDE report 10153751 ↗
• 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). TWO (3.0X12MM, 3.50X23MM) XIENCE SIERRA STENTS WERE IMPLANTED. ON (B)(6) 2020 THE PATIENT WAS RE-HOSPITALIZED WITH HYPOTENSION. IT IS UNKNOWN WHAT TREATMENT WAS PERFORMED AND WHAT THE FINAL PATIENT OUTCOME WAS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Low Blood Pressure/ Hypotension

  MAUDE report 9803929 ↗
• 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 UNSTABLE ANGINA. A 3.0X12MM XIENCE SIERRA STENT WAS IMPLANTED. ON (B)(6) 2019 THE PATIENT WAS RE-ADMITTED WITH ATHEROSCLEROSIS. PLAIN OLD BALLOON ANGIOPLASTY (POBA) WAS PERFORMED; HOWEVER, THE FINAL PATIENT OUTCOME IS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 9803884 ↗
• InjuryMar 5, 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) THEREFORE THE 3.00X12MM XIENCE SIERRA WAS IMPLANTED. ON (B)(6) 2020 THE PATIENT WAS RE-ADMITTED WITH NSTEMI. PLAIN OLD BALLOON ANGIOPLASTY (POBA) WAS PERFORMED HOWEVER THE FINAL PATIENT OUTCOME IS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Myocardial Infarction

  MAUDE report 9793797 ↗
• MalfunctionJan 2, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT WHEN PULLING THE STENT DELIVERY SYSTEM (SDS) FROM THE OUT OF THE HOOP WITHOUT RESISTANCE, THE HUB WAS NOTED TO BE SEPARATED. THEREFORE, A NEW SDS WAS OPENED, BUT THE SECOND SDS DISPENSER COIL WAS NOTED TO KINKED. THE SDS WAS WITHDRAWN FROM THE HOOP AND THE PROXIMAL SHAFT WAS NOTED TO HAVE A SMALL KINK AS WELL. THE PHYSICIAN DECIDED TO USE THE SDS ANYWAYS IN THE PROCEDURE. THE SDS WAS USED SUCCESSFULLY TO TREAT A LESION IN THE CIRCUMFLEX CORONARY ARTERY. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 9539710 ↗
• InjuryDec 10, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 3.0X12MM XIENCE SIERRA STENT WAS IMPLANTED ON (B)(6) 2019. THE PATIENT DEVELOPED AN ALLERGIC REACTION. THE PATIENT IS EXTREMELY ITCHY EVERYWHERE EXCEPT FOR THE LOWER EXTREMITIES. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 9448692 ↗
• InjurySep 4, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THREE XIENCE SIERRA STENTS, SIZES 3.0X12, 3.25X15, 3.5X15, WERE IMPLANTED IN THE CORONARY ARTERY ON (B)(6) 2019. THE PATIENT WAS RE-ADMITTED TO THE HOSPITAL ON (B)(6) 2019 WITH GASTRO-INTESTINAL REFLUX. TREATMENT WAS GIVEN. THE OUTCOME IS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8960505 ↗
• InjurySep 3, 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 UNDERWENT A CORONARY STENTING PROCEDURE, WITH IMPLANTATION OF A 3.0 X 12 MM XIENCE SIERRA STENT. ON (B)(6) 2019, THE PATIENT WAS RE-ADMITTED WITH HYPERTENSIVE HEART. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: High Blood Pressure/ Hypertension

  MAUDE report 8958325 ↗
• MalfunctionMay 2, 2019Difficult to Remove; Failure to Advance; Difficult to Remove; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY TORTUOUS, HEAVILY CALCIFIED DISTAL LEFT ANTERIOR DESCENDING ARTERY THAT WAS 99% STENOSED. A 3.0X12MM XIENCE SIERRA STENT DELIVERY SYSTEM (SDS) FAILED TO CROSS DUE TO THE ANATOMY. SOME RESISTANCE WAS MET WITH THE ANATOMY DURING REMOVAL. THE PROCEDURE WAS COMPLETED WITHOUT FURTHER TREATMENT. 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 8575299 ↗
• InjuryFeb 25, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 3.00 X 12 MM XIENCE SIERRA STENT WAS IMPLANTED ON (B)(6) 2018. ON (B)(6) 2018 AND (B)(6) 2018 THE PATIENT WAS READMITTED WITH ORTHOSTATIC HYPOTENSION AND SYNCOPE/ COLLAPSE. THE TREATMENT PROVIDED WAS NOT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Low Blood Pressure/ Hypotension; Syncope

  MAUDE report 8368063 ↗
• InjuryDec 1, 2018Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED THAT THIS WAS A CORONARY PROCEDURE, PERFORMED ON (B)(6) 2018, TO TREAT A LESION IN THE RAMUS ARTERY. OPTICAL COHERENCE TOMOGRAPHY WAS PERFORMED DURING THE PROCEDURE AND A 3.0 X 12 MM XIENCE SIERRA STENT WAS IMPLANTED. ADDITIONAL POST-DILATATION WAS PERFORMED, AS IT WAS NOTED THAT THE STENT WAS UNDER EXPANDED. ON (B)(6) 2018, THE PATIENT PRESENTED TO THE EMERGENCY ROOM WITH CHEST PAIN. CORONARY ANGIOGRAPHY WAS PERFORMED AND NOTED OCCLUSION IN THE MID RAMUS AND DISTAL CLOSURE DUE TO DISSECTION. TWO ADDITIONAL XIENCE STENTS WERE IMPLANTED AND THE EVENT RESOLVED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina; Intimal Dissection; Occlusion

  MAUDE report 8122638 ↗
• InjuryNov 5, 2018Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A HEAVILY CALCIFIED LESION AT THE BIFURCATION OF THE LEFT ANTERIOR DESCENDING AND DIAGONAL CORONARY ARTERIES. POST ATHERECTOMY AND PRE-DILATATION WITH A NON ABBOTT BALLOON, A 3.00 X 12 MM XIENCE SIERRA STENT WAS SUCCESSFULLY DEPLOYED IN THE DIAGONAL CORONARY ARTERY. POST DEPLOYMENT THE BIFURCATION PROXIMAL TO THE IMPLANTED STENT WAS FURTHER DILATED USING A KISSING BALLOON TECHNIQUE WITH TWO NON-ABBOTT BALLOONS. POST BALLOON ANGIOPLASTY, A PLAQUE SHIFT WAS NOTED AND AN ADDITIONAL 3.00 X 12 MM XIENCE SIERRA STENT WAS DEPLOYED TO SUCCESSFULLY TREAT THE PLAQUE SHIFT, WITH SOME OVERLAP OF THE PREVIOUSLY DEPLOYED STENT. NO POST DILATATION WAS PERFORMED. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. TEN MINUTES POST PROCEDURE, THE PATIENT COMPLAINED OF CHEST PAIN AND CHANGES TO THE PATIENT'S BLOOD PRESSURE [DROP] AND EKG WERE NOTED. ANGIOGRAPHY CONFIRMED IN STENT THROMBOSIS. THE PATIENT WAS FITTED WITH A NON-ABBOTT TEMPORARY HEART PUMP AND AN INTRAVASCULAR ULTRASOUND WAS PERFORMED. STENT UNDER EXPANSION WAS NOTED AND FURTHER BALLOON ANGIOPLASTY WITH A 3.0 X 5 MM NON ABBOTT BALLOON DILATATION CATHETER WAS PERFORMED. PO

  Patient problems: Angina; Low Blood Pressure/ Hypotension; Non specific EKG/ECG Changes; Thrombosis

  MAUDE report 8039220 ↗
• InjuryNov 5, 2018Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A HEAVILY CALCIFIED LESION AT THE BIFURCATION OF THE LEFT ANTERIOR DESCENDING AND DIAGONAL CORONARY ARTERIES. POST ATHERECTOMY AND PRE-DILATATION WITH A NON ABBOTT BALLOON, A 3.00 X 12 MM XIENCE SIERRA STENT WAS SUCCESSFULLY DEPLOYED IN THE DIAGONAL CORONARY ARTERY. POST DEPLOYMENT THE BIFURCATION PROXIMAL TO THE IMPLANTED STENT WAS FURTHER DILATED USING A KISSING BALLOON TECHNIQUE WITH TWO NON-ABBOTT BALLOONS. POST BALLOON ANGIOPLASTY, A PLAQUE SHIFT WAS NOTED AND AN ADDITIONAL 3.00 X 12 MM XIENCE SIERRA STENT WAS DEPLOYED TO SUCCESSFULLY TREAT THE PLAQUE SHIFT, WITH SOME OVERLAP OF THE PREVIOUSLY DEPLOYED STENT. NO POST DILATATION WAS PERFORMED. TEN MINUTES POST PROCEDURE, THE PATIENT COMPLAINED OF CHEST PAIN AND CHANGES TO THE PATIENT'S BLOOD PRESSURE [DROP] AND EKG WERE NOTED. ANGIOGRAPHY CONFIRMED IN STENT THROMBOSIS. THE PATIENT WAS FITTED WITH A NON-ABBOTT TEMPORARY HEART PUMP AND AN INTRAVASCULAR ULTRASOUND WAS PERFORMED. STENT UNDER EXPANSION WAS NOTED AND FURTHER BALLOON ANGIOPLASTY WITH A 3.0 X 5 MM NON ABBOTT BALLOON DILATATION CATHETER WAS PERFORMED. POST ANGIOPLASTY, THE EXPANDED STENTS WERE CONFIRMED TO BE PAT

  Patient problems: Angina; Low Blood Pressure/ Hypotension; Non specific EKG/ECG Changes; Thrombosis

  MAUDE report 8039141 ↗