XIENCE Sierra™ 1550275-18Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 08717648227189), received between Mar 5, 2019 and Nov 15, 2021 — classified as 17 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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• InjuryNov 15, 2021Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE 99% STENOSED, MODERATELY CALCIFIED, MODERATELY TORTUOUS MID LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY. ON (B)(6) 2021, A 2.5X38 MM AND A 2.75X18 MM XIENCE SIERRA STENT WERE IMPLANTED. ON (B)(6) 2021, THE PATIENT RETURNED DUE TO ST ELEVATED MYOCARDIAL INFARCTION (STEMI) AND THEN OPTICAL COHERENCE TOMOGRAPHY (OCT) WAS PERFORMED. THIS REVEALED THAT THE STENTS WERE UNDER EXPANDED AND MALAPPOSED AS THE PHYSICIAN DID NOT ADEQUATELY POST DILATE THE OVERLAP OF THE STENTS. ADDITIONALLY THERE WAS IN-STENT THROMBOSIS. THROMBECTOMY WAS PERFORMED AND POST DILATATION WAS PERFORMED WITH A 3.25X15 MM NC TREK BALLOON. OCT WAS AGAIN PERFORMED AND SHOWED (B)(6) OF EXPANSION IN THE VESSEL AND WELL APPOSED STENT STRUTS. THERE WERE NO REPORTED ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Myocardial Infarction; Thrombosis/Thrombus

  MAUDE report 12814140 ↗
• 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 NON-ST-ELEVATION MYOCARDIAL INFARCTION AND A 2.75X18MM XIENCE SIERRA STENT WAS IMPLANTED. ON (B)(6) 2021, THE PATIENT WAS RE-ADMITTED WITH UNSPECIFIED CARDIOVASCULAR SYMPTOMS AND CHEST PAIN. UNSPECIFIED TREATMENT WAS PROVIDED AND THE FINAL PATIENT OUTCOME IS NOT KNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina

  MAUDE report 12394996 ↗
• InjuryAug 18, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON 05/17/2021 THE PATIENT HAD 6 XIENCE SIERRA STENTS (2.75X18MM, 2.75X23, 3X8MM, 3.25X33MM, 3.5X33MM, AND 3.5X8MM) IMPLANTED. ON (B)(6) 2021, THE PATIENT WAS RE-HOSPITALIZED DUE TO OTHER CARDIOVASCULAR SYMPTOMS INCLUDING CHEST PAIN. THE TYPE OF TREATMENT WAS UNSPECIFIED AND THE FINAL PATIENT OUTCOME IS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina

  MAUDE report 12337114 ↗
• MalfunctionAug 4, 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 THE LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY WITH HIGH LEVELS OF CIRCUMFERENTIAL CALCIFICATION. THE 2.75X18 MM XIENCE SIERRA STENT DELIVERY SYSTEM (SDS) WAS ADVANCED BUT COULD NOT REACH THE LESION DUE TO THE ANATOMY. WHEN REMOVING THE SDS THERE WAS RESISTANCE NOTED WITH THE ANATOMY AND THE PROXIMAL END OF THE STENT BECAME FLARED. ONCE THE SDS WAS REMOVED, A CUTTING BALLOON WAS USED AND THE LESION WAS DILATED WITH 2 NON-COMPLIANT BALLOONS. THEN TWO XIENCE SIERRA STENTS WERE ABLE TO BE SUCCESSFULLY IMPLANTED. THERE WERE NO ADVERSE PATIENT EFFECTS AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12275327 ↗
• 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 PRESENTED WITH A NON-ST-ELEVATION MYOCARDIAL INFARCTION AND TWO (2.75X18MM AND 3.5X33MM) XIENCE SIERRA STENTS WERE IMPLANTED. ON (B)(6) 2021, THE PATIENT WAS RE-ADMITTED WITH UNSPECIFIED CARDIOVASCULAR SYMPTOMS AND SYNCOPE AND COLLAPSE. UNSPECIFIED TREATMENT WAS PROVIDED AND THE FINAL PATIENT OUTCOME IS NOT KNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Syncope/Fainting

  MAUDE report 11914671 ↗
• 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 2.75X18 MM XIENCE SIERRA STENT IMPLANTED. THE PATIENT HAD PREVIOUSLY PRESENTED WITH NON ST ELEVATED MYOCARDIAL INFARCTION (NSTEMI). ON (B)(6) 2021 THE PATIENT WAS RE-ADMITTED TO THE HOSPITAL DUE TO ATHEROSCLEROTIC HEART DISEASE. UNSPECIFIED TREATMENT WAS PERFORMED AND THE FINAL PATIENT OUTCOME IS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Unspecified Heart Problem

  MAUDE report 11913900 ↗
• InjuryJun 12, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 2.75X18MM XIENCE SIERRA STENT WAS IMPLANTED ON (B)(6) 2020. THE PATIENT PRESENTED WITH ANGINA BEFORE THE PROCEDURE. ON (B)(6) 2020, THE PATIENT WAS RE-ADMITTED WITH CARDIOVASCULAR SYMPTOMS INCLUDING CHEST PAIN. TREATMENT PERFORMED WAS UNSPECIFIED AND THE FINAL PATIENT OUTCOME IS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina

  MAUDE report 10149091 ↗
• InjuryMar 13, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE THIS WAS A PERCUTANEOUS CORONARY INTERVENTION TREATING THE LEFT ANTERIOR DESCENDING (LAD), HEAVILY CALCIFIED LESION. FOLLOWING PRE-DILATATION PER IFU, A 2.75X18MM XIENCE SIERRA STENT DELIVERY SYSTEM (SDS) ADVANCED WITHOUT ANY UNUSUAL RESISTANCE TO THE LESION SITE. DURING STENT DEPLOYMENT, THE XIENCE SIERRA DELIVERY BALLOON BURST AT 10 ATMOSPHERES. THE DELIVERY SYSTEM WAS REMOVED WITHOUT ISSUE AND AS ADDITIONAL TREATMENT, A DILATATION CATHETER ADVANCED, DILATING THE STENT. THE STENT WAS FULLY APPOSED AT THE INTENDED LESION SITE. THERE WAS NO ADVERSE PATIENT SEQUELA AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THIS ISSUE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9832161 ↗
• 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). TWO (2.75X18MM, 2.50X15MM) XIENCE SIERRA STENTS WERE IMPLANTED. ON (B)(6) 2019 THE PATIENT WAS RE-HOSPITALIZED WITH CHEST PAIN AND OTHER CARDIOVASCULAR SYMPTOMS. IT IS UNKNOWN WHAT TREATMENT WAS PERFORMED AND WHAT THE FINAL PATIENT OUTCOME WAS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina

  MAUDE report 9803961 ↗
• InjuryMar 6, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON 12/29/2019 THE PATIENT PRESENTED WITH ATHEROSCLEROTIC HEART DISEASE AND UNSTABLE ANGINA THEREFORE THE 3.50X23MM AND 2.75X18MM XIENCE SIERRA STENTS WERE IMPLANTED. ON 1/1/2020 THE PATIENT WAS RE-ADMITTED WITH CHEST PAIN AND OTHER CARDIOVASCULAR SYMPTOMS. IT IS UNKNOWN WHAT TREATMENT WAS PERFORMED AND THE FINAL PATIENT OUTCOME IS UNKNOWN.

  Patient problems: Angina

  MAUDE report 9799963 ↗
• 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 2.75X18MM XIENCE SIERRA WAS IMPLANTED. ON (B)(6) 2019 THE PATIENT WAS RE-ADMITTED WITH HYPERTENSIVE HEART DISEASE WITH FAILURE. SURGERY WAS PERFORMED HOWEVER THE FINAL PATIENT OUTCOME IS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Heart Failure

  MAUDE report 9441195 ↗
• 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 NON-ST ELEVATED MYOCARDIAL INFARCTION (NSTEMI) THEREFORE THE 2.75X18MM XIENCE SIERRA WAS IMPLANTED. ON (B)(6) 2019 THE PATIENT WAS RE-ADMITTED WITH CONGESTIVE HEART FAILURE. IT IS UNKNOWN WHAT TREATMENT WAS PERFORMED AND THE FINAL PATIENT OUTCOME IS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Heart Failure

  MAUDE report 9440077 ↗
• 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 2.75X18MM, 3.0X23MM, AND 3.50X28MM XIENCE SIERRA STENTS WERE IMPLANTED. ON (B)(6) 2019 THE PATIENT WAS RE-ADMITTED WITH HEART DISEASE. IT IS UNKNOWN WHAT TREATMENT WAS PERFORMED AND THE FINAL PATIENT OUTCOME IS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 9438155 ↗
• InjuryOct 18, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBSEQUENT TO THE INITIAL MEDWATCH REPORT, THE ADDITIONAL INFORMATION WAS OBTAINED: PER PHYSICIAN, THE STENT THROMBOSIS WAS DUE TO THE PATIENT'S NON-COMPLIANCE WITH MEDICATION.

  Patient problems: Angina; Thrombosis

  MAUDE report 9209943 ↗
• 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 WAS TREATED WITH 2 2.75X18 MM XIENCE SIERRA STENTS. ON (B)(6) 2019 THE PATIENT WAS RE-ADMITTED WITH HYPERTENSION. THE TREATMENT WAS UNSPECIFIED AND THE FINAL PATIENT OUTCOME IS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: High Blood Pressure/ Hypertension

  MAUDE report 8958139 ↗
• InjuryJul 18, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH CORONARY ARTERY DISEASE AND THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE LEFT CIRCUMFLEX CORONARY ARTERY. A 2.5 X 15 MM TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED; HOWEVER, FAILED TO CROSS THE LESION DUE TO THE PATIENT ANATOMY. BALLOON DILATATION WAS PERFORMED WITH A NON-ABBOTT BDC PRIOR TO ATHERECTOMY BEING PERFORMED WITH A NON-ABBOTT ATHERECTOMY DEVICE. FOLLOWING FIVE PASSES OF THE ATHERECTOMY DEVICE, A PERFORATION AT THE BIFURCATION OF THE LEFT MAIN AND LEFT CIRCUMFLEX ARTERY WAS NOTED. BALLOON ANGIOPLASTY WAS PERFORMED WITH A 2.5 X 15 MM TREK BDC AND A 2.75 X 18 MM XIENCE SIERRA STENT WAS DEPLOYED IN THE PROXIMAL LEFT CIRCUMFLEX ARTERY. CONTINUED EXTRAVASATION WAS NOTED. FURTHER BALLOON ANGIOPLASTY WAS PERFORMED WITH A 4.0 X 15 MM TREK BDC; HOWEVER, ST ELEVATION OCCURRED DUE TO THE SIZE OF BALLOON USED AND PROLONGED INFLATIONS ONLY. A SMALLER 3.0 X 15 MM TREK BDC WAS USED AND REDUCED EXTRAVASATION WAS NOTED POST ANGIOPLASTY. THE PATIENT WAS DEEMED A POOR CANDIDATE FOR SURGICAL INTERVENTION DUE TO CO-MORBIDITIES AND THE SITE OF THE PERFORATION. AN ABBOTT IMAGING CATHETER WAS USED TO VIEW THE PERFORATION WHICH WAS N

  Patient problems: Angina; Low Blood Pressure/ Hypotension; Thrombosis

  MAUDE report 8804548 ↗
• InjuryJun 27, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT TWO XIENCE SIERRA STENTS (2.75X18MM AND 3.0X23MM) WERE IMPLANTED ON (B)(6) 2019. ON (B)(6) 2019, THE PATIENT WAS RE-ADMITTED WITH SEVERE ANGINA AND SEGMENT ELEVATION MYOCARDIAL INFARCTION. PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY WAS PERFORMED ON THE PATIENT. FINAL PATIENT OUTCOME IS NO PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina; Myocardial Infarction

  MAUDE report 8741353 ↗
• InjuryMar 8, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE INDEX PROCEDURE TOOK PLACE ON (B)(6) 2018 DURING WHICH A 2.75 X 18 MM XIENCE SIERRA STENT WAS IMPLANTED FOR TREATMENT OF AN UNSPECIFIED VESSEL. THE PATIENT WAS READMITTED TO THE HOSPITAL ON (B)(6) 2018 FOR DRESSLER SYMPTOM, PULMONARY EMBOLISM AND OTHER UNSPECIFIED CARDIOVASCULAR SYMPTOMS. UNSPECIFIED TREATMENT WAS ADMINISTERED TO THE PATIENT. FINAL PATIENT OUTCOME IS REPORTEDLY UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available; Pulmonary Embolism

  MAUDE report 8404151 ↗
• MalfunctionMar 5, 2019Difficult to Remove; Failure to Advance; Difficult to Remove; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN A MODERATELY TORTUOUS, HEAVILY CALCIFIED, 90% STENOSED, OBTUSE MARGINAL BRANCH OF THE CIRCUMFLEX ARTERY. AFTER PRE-DILATATION, THE 2.75 X 18 MM XIENCE SIERRA STENT DELIVERY SYSTEM (SDS) FAILED TO CROSS. DURING REMOVAL ANATOMICAL RESISTANCE WAS MET; THE SDS WAS REMOVED AND A DIFFERENT UNSPECIFIED DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT. 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 8391646 ↗