XIENCE Sierra™ 1550300-33Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 08717648227295), received between Nov 16, 2018 and Aug 25, 2021 — classified as 8 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (6 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• InjuryAug 25, 2021Adverse 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 PATIENT PRESENTED WITH IN-STENT RESTENOSIS IN THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY WITH 70% STENOSIS. A CUTTING/SCORING BALLOON PREPPED THE LESION. FOLLOWING, A 3.0X33MM XIENCE SIERRA STENT WAS IMPLANTED WITHOUT A DEVICE MALFUNCTION REPORTED. AN EDGE DISSECTION WAS NOTED POST STENT IMPLANTATION. POST-DILATATION WAS PERFORMED WITH TIMI FLOW 3 AND 0% RESIDUAL STENOSIS OBSERVED FOLLOWING. NO ADDITIONAL TREATMENT WAS PROVIDED. ON (B)(6) 2021, THE PATIENT HAD PRESENTED WITH RECURRENT CHEST PAIN. PER IMAGING, 70% ISR OF THE PROXIMAL LAD, AND STENOSIS OF THE LEFT CIRCUMFLEX (LCX) WAS NOTED. REPORTEDLY, THERE WAS NO DEVICE MALFUNCTION. AS TREATMENT, ANGIOPLASTY WAS PERFORMED ON THE PROXIMAL LAD AND LCX. THE EVENT RESOLVED WITHOUT SEQUELA THAT SAME DAY. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THIS ISSUE.

  Patient problems: Angina; Stenosis; Vascular Dissection

  MAUDE report 12366166 ↗
• MalfunctionAug 24, 2021Difficult to Remove; Failure to Advance; Material Deformation; Difficult to Remove; Failure to Advance; Material Deformation

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE RIGHT CORONARY ARTERY. A 3X33 MM XIENCE SIERRA STENT DELIVERY SYSTEM (SDS) FAILED TO CROSS DUE TO THE ANATOMY, AND THE STENT STRUTS BECAME FLARED. THE SDS FACED RESISTANCE DURING REMOVAL WITH THE ANATOMY AS WELL. AN UNSPECIFIED 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 12360054 ↗
• InjuryMar 9, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 3.0X33MM XIENCE SIERRA STENT WAS IMPLANTED ON (B)(6) 2020. THE PATIENT HAD PREVIOUSLY PRESENTED WITH ATHEROSCLEROTIC HEART DISEASE. ON (B)(6) 2020, THE PATIENT WAS READMITTED WITH OTHER CARDIOVASCULAR SYMPTOMS INCLUDING DIZZINESS. TREATMENT PERFORMED WAS UNSPECIFIED AND THE FINAL PATIENT OUTCOME IS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Dizziness

  MAUDE report 11445599 ↗
• MalfunctionOct 30, 2020Difficult to Remove; Failure to Advance; Difficult to Remove; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE DISTAL RIGHT CORONARY ARTERY THAT WAS BOTH HEAVILY CALCIFIED AND TORTUOUS. THE XIENCE SIERRA STENT DELIVERY SYSTEM FAILED TO CROSS AND THERE WAS RESISTANCE DURING REMOVAL FROM THE ANATOMY. THE PROCEDURE WAS COMPLETED WITH BALLOON ANGIOPLASTY. THERE WERE NO REPORTED 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 10760173 ↗
• InjuryJul 29, 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 PATIENT PRESENTED WITH A RECENT NON-ST ELEVATED MYOCARDIAL INFARCTION (NSTEMI), ELEVATED TROPONIN, AND A PERCUTANEOUS CORONARY INTERVENTION WAS PERFORMED. PRE-DILATATION WAS PERFORMED ON THE MID LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY LESION AND A 2.75X33MM XIENCE SIERRA STENT (1550275-33, 0011041) WAS IMPLANTED. AN EDGE DISSECTION WAS OBSERVED, TREATED WITH A 3.0X33MM XIENCE SIERRA STENT (1550300-33, 0021841). POST-DILATATION WAS PERFORMED ON THE 3.0X33MM XIENCE SIERRA STENT WHEN A PLAQUE SHIFT WITH 100% OCCLUSION OCCURRED IN THE PROXIMAL DIAGONAL CORONARY ARTERY. ADDITIONAL ANGIOPLASTY WAS PERFORMED AS TREATMENT. REPORTEDLY, THERE WAS NO DEVICE MALFUNCTION AND THE EVENT RESOLVED. POST-PROCEDURE RESULTS WERE ACCEPTABLE, 0% RESIDUAL DIAMETER STENOSIS AND TIMI FLOW III. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THIS ISSUE.

  Patient problems: Prolapse

  MAUDE report 10338735 ↗
• MalfunctionJul 14, 2020Difficult to Remove; Device Dislodged or Dislocated; Difficult to Remove; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING PREPARATION OF A 3.0X33MM XIENCE SIERRA DRUG ELUTING STENT SYSTEM (DES), STRONG RESISTANCE WAS NOTED DURING REMOVAL OF THE PROTECTIVE SHEATH, AND IT WAS NOTED THAT THE STENT SHIFTED ON THE BALLOON. THE DEVICE WAS NOT USED. THERE WAS NO PATIENT INVOLVEMENT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. A NEW SAME SIZED XIENCE SIERRA DES WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 10274064 ↗
• MalfunctionMay 4, 2020Difficult to Remove; Improper or Incorrect Procedure or Method; Difficult to Remove; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROTECTIVE SHEATH OF A 3.0X33MM XIENCE SIERRA STENT DELIVERY SYSTEM (SDS) COULD NOT BE REMOVED. ADDITIONALLY, THE SDS WAS PREPPED PRIOR TO ATTEMPTING TO REMOVE THE PROTECTIVE SHEATH. THE SDS WAS NOT USED AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A NEW UNSPECIFIED XIENCE SIERRA. THERE WAS NO PATIENT INVOLVEMENT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 10022297 ↗
• MalfunctionApr 8, 2020Difficult to Remove; Failure to Advance; Material Deformation; Difficult to Remove; Failure to Advance; Material Deformation

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A MODERATELY CALCIFIED, MODERATELY TORTUOUS RIGHT CORONARY ARTERY. THE 3.0X33MM XIENCE SIERRA STENT DELIVERY CATHETER FAILED TO CROSS THE LESION DUE TO THE ANATOMY. DURING REMOVAL OF THE DEVICE, THE EDGE BECAME FLARED DUE TO INTERACTION WITH THE GUIDING CATHETER. A NEW SAME SIZE UNSPECIFIED 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 9939170 ↗
• MalfunctionApr 6, 2020Defective Device; Defective Device

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MID LEFT ANTERIOR DESCENDING ARTERY. AFTER CONFIRMING THE LESION WITH AN OPTICAL COHERENCE TOMOGRAPHY, A 3.0X33MM XIENCE SIERRA STENT WAS ADVANCED TO THE LESION BUT WAS NOTED AS TOO SHORT TO COVER THE LESION. THEREFORE, A 38MM LENGTH XIENCE STENT WAS USED INSTEAD TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS OR CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED. 3/16/2020: ADDITIONAL INFORMATION RECEIVED FROM THE ACCOUNT WHERE THE PHYSICIAN STATES UNCERTAINTY WHETHER THE STENT WAS UNDERSIZED THAN EXPECTED, OR BECAME SHORTER DURING THE PROCEDURE. 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 9929122 ↗
• InjuryNov 1, 2019Difficult to Remove; Difficult to Advance; Device Dislodged or Dislocated; Difficult to Remove; Difficult to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY TORTUOUS, HEAVILY CALCIFIED DE NOVO RIGHT CORONARY ARTERY THAT WAS 80% STENOSED. DURING ADVANCEMENT, A 3.0X33MM XIENCE SIERRA STENT MET RESISTANCE WITH THE ANATOMY BUT WAS ABLE TO REACH THE LESION. HOWEVER, DURING REPOSITIONING OF THE DEVICE RESISTANCE WAS MET AGAIN WITH THE ANATOMY, FORCE WAS APPLIED AND THE STENT DISLODGED. AN UNSPECIFIED BALLOON WAS USED TO DILATE/DEPLOY THE STENT IN PLACE AND WAS APPOSED TO THE VESSEL WALL, WITHIN THE TARGET LESION. THERE WAS NO ADVERSE PATIENT SEQUELA REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9268852 ↗
• InjurySep 5, 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 AND THREE (3.0X33MM, 3.25X23MM, AND 3.25X33) XIENCE SIERRA STENTS WERE IMPLANTED. ON (B)(6) 2019, THE PATIENT WAS RE-ADMITTED WITH UNSPECIFIED CARDIOVASCULAR SYMPTOMS AND A HYPERTENSIVE HEART. UNSPECIFIED TREATMENT WAS PROVIDED AND THE FINAL PATIENT OUTCOME IS NOT KNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: High Blood Pressure/ Hypertension

  MAUDE report 8967089 ↗
• InjuryApr 8, 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 MULTIPLE VESSEL CORONARY ARTERY DISEASE AND A 3.00 X 33 MM XIENCE SIERRA STENT WAS IMPLANTED IN THE RIGHT CORONARY ARTERY WITH NO TORTUOSITY AND NO CALCIFICATION. ON (B)(6) 2019, THE PATIENT DEVELOPED CHEST PAIN AND NAUSEA SYMPTOMS. MYOCARDIAL INFARCTION WAS NOT DIAGNOSED; HOWEVER, EKG CHANGES WERE NOTED AND MEDICATION WAS GIVEN. ON (B)(6) 2019 ANGIOGRAPHY WAS PERFORMED AND STENT THROMBOSIS WAS IDENTIFIED. MODERATE CLOT ASPIRATION WAS ACHIEVED WITH A NON-ABBOTT THROMBECTOMY DEVICE AND BALLOON ANGIOPLASTY WAS PERFORMED WITH A NC TREK BALLOON DILATATION CATHETER TO RESTORE FLOW. THE PATIENT WAS REPORTED TO BE DOING WELL POST PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina; Nausea; Non specific EKG/ECG Changes; Thrombosis

  MAUDE report 8492181 ↗
• 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 3.0X33MM XIENCE SIERRA STENT WAS IMPLANTED. ON (B)(6) 2018 THE PATIENT WAS RE-ADMITTED WITH AN ACUTE MYOCARDIAL INFARCTION AND OTHER UNSPECIFIED CARDIO VASCULAR SYMPTOMS. THE TREATMENT PERFORMED AND PATIENT OUTCOME IS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Myocardial Infarction

  MAUDE report 8376122 ↗
• InjuryDec 19, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2018, A XIENCE SIERRA STENT WAS IMPLANTED WITHOUT REPORTED ISSUES. ON (B)(6) 2018, THE PATIENT WAS RE-ADMITTED DUE TO AN ALLERGIC REACTION (ALLERGIC URTICARIAL) DUE TO AN UNSPECIFIED DRUG. IT IS UNKNOWN IF THIS IS RELATED TO THE DEVICE. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THIS ISSUE.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 8180475 ↗
• MalfunctionNov 16, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE RIGHT CORONARY ARTERY THAT WAS HEAVILY CALCIFIED. AFTER ROTABLATION WAS PERFORMED, BALLOONS WERE USED FOR PREDILATATION. THE 3.0 X 33 MM XIENCE SIERRA STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TO THE LESION WITHOUT RESISTANCE, HOWEVER, DURING THE FIRST INFLATION, THE STENT EXPANDED BUT CONTRAST WAS LEAKING AND IT WAS NOT POSSIBLE TO INFLATE THE BALLOON. THE XIENCE SIERRA WAS REMOVED FROM THE ANATOMY AND AN ATTEMPT WAS MADE TO INFLATE THE BALLOON. THE BALLOON EXPANDED; HOWEVER, THERE WERE MULTIPLE HOLES IN THE BALLOON. THEN, THE 2.25 X 15 MM XIENCE SIERRA WAS ADVANCED TO THE LESION BUT RUPTURED BELOW RATED BURST PRESSURE DURING THE FIRST INFLATION. BOTH SDS BALLOONS RUPTURED PREMATURELY POST-ROTABLATION. A 3 X 32 MM NON-ABBOTT STENT WAS DEPLOYED TO COMPLETE THE PROCEDURE. THE DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE AND AIR ASPIRATION WAS PERFORMED OUTSIDE THE ANATOMY PRIOR TO USE WITHOUT ANY ISSUE. 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 8080059 ↗