XIENCE Sierra™ 1550350-08Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 08717648227394), received between Jun 26, 2019 and Mar 15, 2021 — classified as 1 death, 4 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• DeathMar 15, 2021Adverse 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 HAD A 3.5X8 MM XIENCE SIERRA STENT IMPLANTED. ON (B)(6) 2020 THE PATIENT EXPERIENCED NSTEMI AND OTHER CARDIOVASCULAR SYMPTOMS AND WAS RE-ADMITTED TO THE HOSPITAL. REPORTEDLY, SURGERY WAS PERFORMED. THE PATIENT WAS ADMITTED AGAIN ON (B)(6) 2020 FOR THROMBOSIS. IT IS NOT SPECIFIED WHAT TREATMENT WAS PERFORMED. THE PATIENT EXPIRED ON THE SAME DAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Myocardial Infarction; Thrombosis/Thrombus

  MAUDE report 11485412 ↗
• MalfunctionJul 29, 2020Difficult to Remove; Device Dislodged or Dislocated; Difficult to Remove; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING DEVICE PREPARATION OF THE XIENCE SIERRA STENT SYSTEM, THERE WAS AN UNUSUAL FEELING WHEN REMOVING THE PROTECTIVE SHEATH AND STYLET; HOWEVER, THE DEVICE WAS USED IN THE ANATOMY TO TREAT A LESION LOCATED IN THE MILDLY CALCIFIED AND 90% STENOSED RIGHT CORONARY ARTERY. WHEN DELIVERED TO THE LESION, IT WAS NOTED THAT A STENT WAS NOT ON THE BALLOON AND WAS LATER FOUND STUCK ON THE PROTECTIVE SHEATH. THERE WAS NO ADVERSE PATIENT EFFECT OR CLINICALLY SIGNIFICANT DELAY. A SAME SIZE NON-ABBOTT STENT WAS USED TO COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10340895 ↗
• MalfunctionJun 1, 2020Difficult to Remove; Material Separation; Failure to Advance; Difficult to Remove; Material Separation; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A RE-STENOSED LESION LOCATED IN THE LEFT ANTERIOR DESCENDING CORONARY ARTERY THAT WAS HEAVILY CALCIFIED AND MODERATELY TORTUOUS. AFTER THE XIENCE SIERRA STENT DELIVERY SYSTEM (SDS) FAILED TO CROSS THE HEAVILY CALCIFIED ANATOMY, WHEN THE SDS WAS REMOVED WITH RESISTANCE, THE PROXIMAL SHAFT SEPARATED OUTSIDE THE PATIENT BUT WAS EASILY REMOVED. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. DIFFERENT GUIDE WIRES AND BALLOONS WERE USED TO BETTER PREPARE THE VESSEL. THEN, ANOTHER 3.5 X 8 MM XIENCE SIERRA STENT WAS USED TO COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10106937 ↗
• InjuryMar 12, 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 PATIENT PRESENTED WITH ELEVATED TROPONIN. A 3.0X8MM AND 3.5X8MM XIENCE SIERRA STENTS WERE IMPLANTED IN THE RAMUS CORONARY ARTERY WITH ACCEPTABLE RESULTS. ON 09/11/2019, THE PATIENT PRESENTED WITH CHEST PAIN. PER IMAGING, THE LEFT ANTERIOR DESCENDING (LAD) AND RIGHT CORONARY ARTERY (RCA) HAD AN OCCLUSION. THE RAMUS CORONARY ARTERY 3.0X8MM XIENCE SIERRA STENT WAS OBSERVED WITH IN-STENT RESTENOSIS. AS TREATMENT, ANOTHER PERCUTANEOUS CORONARY INTERVENTION (PCI) WAS PERFORMED. THE RAMUS WAS TREATED WITH A HIGH-PRESSURE BALLOON CATHETER. THE PRE-EXISTING CORONARY ARTERY BYPASS GRAFT TO THE LAD WAS PATENT. THE PATIENT WAS DISCHARGED HOME WITH CONTINUED DUAL ANTIPLATELET THERAPY (DAPT). THERE WAS NO DEVICE MALFUNCTION. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THIS ISSUE. ON (B)(6) 2020, THE PATIENT EXPERIENCED CHEST PAIN. CORONARY ANGIOGRAPHY REVEALED AN OCCLUDED LAD, CIRCUMFLEX AND RCA ARTERIES. THE LIMA WAS PATENT TO THE LAD. BOTH XIENCE SIERRA STENTS IMPLANTED IN THE RAMUS HAD RESTENOSED, TREATED WITH LASER AND HIGH PRESSURE BALLOON. MEDICATIONS WERE PROVIDED. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THIS ISSUE

  Patient problems: Angina; Dyspnea; Stenosis

  MAUDE report 9826324 ↗
• 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 (3.25X15MM, 3.50X08MM) XIENCE SIERRA STENTS WERE IMPLANTED. ON (B)(6) 2020 THE PATIENT WAS RE-HOSPITALIZED WITH THROMBOSIS. PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY WAS PERFORMED. THE FINAL PATIENT OUTCOME IS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Thrombosis

  MAUDE report 9803848 ↗
• InjuryOct 11, 2019Difficult to Remove; Failure to Advance; Device Dislodged or Dislocated; Difficult to Remove; Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT RESTENOSIS OF 3 XIENCE STENTS THAT WERE IMPLANTED IN (B)(6) 2018. THE STENTS WERE LOCATED IN THE LEFT ANTERIOR DESCENDING (LAD), CIRCUMFLEX AND LEFT MAIN CORONARY ARTERIES. THE PATIENT WAS SYMPTOMATIC ON (B)(6) 2019, WITH CHEST TIGHTNESS AND SHORTNESS OF BREATH. AN ANGIOGRAPHY WAS DONE TO CONFIRM RESTENOSIS AND INTERVENTION WAS PERFORMED TODAY, (B)(6) 2019. THE 3.50X8 MM XIENCE SIERRA WAS ADVANCED WITH RESISTANCE NOTED WITH THE PREVIOUSLY IMPLANTED STENTS AND ONCE IT WAS LOCATED IN THE PROXIMAL CIRCUMFLEX CORONARY ARTERY IT BECAME STUCK ON ONE OF THE STENTS AND COULD NOT BE ADVANCED OR WITHDRAWN. FINALLY THE STENT DELIVERY SYSTEM (SDS) WAS ABLE TO BE REMOVED; HOWEVER, THE STENT WAS NOT LOCATED ON THE SDS WHEN IT CAME OUT OF THE ANATOMY. IT WAS CONFIRMED THAT THE STENT REMAINED IN THE LEFT MAIN CORONARY ARTERY AND BALLOON ANGIOPLASTY WAS USED TO CRUSH THE STENT TO THE VESSEL. THE PATIENT REMAINS HOSPITALIZED WITH A HEART PUMP. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Vessel Or Plaque, Device Embedded In

  MAUDE report 9182917 ↗
• MalfunctionAug 7, 2019Difficult to Remove; Difficult to Advance; Material Deformation; Difficult to Remove; Difficult to Advance; Material Deformation

  IT WAS REPORTED THE PROCEDURE WAS PERFORMED TO TREAT A LESION WITH MODERATE CALCIFICATION AND TORTUOSITY IN THE LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY WITH A 4.0 X 18 MM XIENCE SIERRA STENT DELIVERY SYSTEM (SDS). THE 4.0 XIENCE SIERRA SDS WAS ADVANCED BUT MET RESISTANCE WITH THE 6FR GUIDING CATHETER. THEREFORE, IT WAS DECIDED TO REMOVE THE 4.0 XIENCE SIERRA AND RESISTANCE WAS MET AS WELL WITH THE GUIDING CATHETER DURING WITHDRAWAL. OUTSIDE THE PATIENT ANATOMY, IT WAS NOTED THAT THE PROXIMAL END STENT STRUTS WERE FLARED. A 3.5 X 8 MM XIENCE SIERRA SDS WAS ADVANCED AND ENCOUNTERED THE SAME RESISTANCE DURING ADVANCING AND WITHDRAWAL. THE PROXIMAL END STENT STRUTS WERE FLARED AS WELL. A NEW GUIDING CATHETER WAS ADVANCED AND A NEW 4.0 XIENCE SIERRA WAS ADVANCES SUCCESSFULLY TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8870412 ↗
• InjuryJul 24, 2019Unintended System Motion; Unintended System Motion

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE PROXIMAL RIGHT CORONARY ARTERY. A 3.5X8MM XIENCE SIERRA STENT DELIVERY SYSTEM (SDS) WAS ADVANCED WITHOUT RESISTANCE, AND THE STENT DEPLOYED; HOWEVER, THE STENT MOVED DURING DEPLOYMENT, AND ENVELOPED AROUND AN UNSPECIFIED GUIDING CATHETER. AN UNSPECIFIED GUIDE WIRE AND AN UNSPECIFIED BALLOON DILATATION CATHETER WERE USED TO KEEP THE STENT FROM SLIDING OFF THE GUIDING CATHETER AS IT WAS BEING PULLED BACK INTO THE RIGHT BRACHIAL ARTERY. ONCE THERE, THE STENT WAS EMBEDDED, AND THE PROCEDURE WAS COMPLETE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED. USER FACILITY MEDWATCH REPORT RECEIVED THAT STATES: "CORONARY STENT DEPLOYED OSTIAL RIGHT CORONARY ARTERY AND MIGRATED UP AROUND GUIDE CATHETER. STENT PULLED BACK AND RELOCATED AND DEPLOYED IN RIGHT BRACHIAL ARTERY. FDA SAFETY REPORT ID # (B)(4)."

  Patient problems: Vessel Or Plaque, Device Embedded In

  MAUDE report 8824052 ↗
• MalfunctionJun 26, 2019Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MILDLY TORTUOUS AND MILDLY CALCIFIED PROXIMAL LEFT ANTERIOR DESCENDING ARTERY. A 3.5 X 8 MM XIENCE SIERRA STENT WAS USED; HOWEVER, IT WAS NOTED THAT IT WAS 10 DAYS EXPIRED. 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 8733211 ↗