XIENCE Sierra™ 1550400-12Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 08717648227486), received between Nov 2, 2018 and Oct 15, 2024 — classified as 1 death, 9 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 15, 2024Improper or Incorrect Procedure or Method; Failure to Advance; Improper or Incorrect Procedure or Method; Failure to Advance

  IT WAS REPORTED THE 2.75X18MM RX XIENCE SIERRA STENT DELIVERY SYSTEM (SDS) AND THE 4.0X12MM RX XIENCE SIERRA SDS BOTH FAILED TO CROSS THE LESION. THE PROCEDURE WAS COMPLETED USING A NON-ABBOTT DEVICE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED. IT WAS NOTED THE 4.0X12 RX XIENCE SIERRA WAS USED PAST THE EXPIRATION DATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20450834 ↗
• MalfunctionMar 8, 2024Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MILDLY CALCIFIED PROXIMAL LEFT ANTERIOR DESCENDING ARTERY. THE 4.0X12MM XIENCE SIERRA STENT DELIVERY SYSTEM WAS USED FOR POST-DILATATION AT 14 ATMOSPHERES. IT WAS DILATATED FOR A SECOND TIME AND WHEN REMOVING FROM THE ANATOMY IT BECAME STUCK. THEREFORE, IT WAS DILATATED AGAIN TO 10 ATMOSPHERES AND THEN WAITED FOR 15 SECONDS FOR DEFLATION. THE DELIVERY BALLOON WAS REMOVED WITH HEAVY RESISTANCE NOTED. THE XIENCE SIERRA WAS DETAINED [DEPLOYED]. THERE WAS NO ADVERSE PATIENT EFFECTS REPORTED AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18867936 ↗
• InjuryAug 30, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2021 A XIENCE SIERRA STENT WAS IMPLANTED. ON (B)(6) 2021, THE PATIENT WAS RE-ADMITTED DUE TO CARDIAC FUNCTIONAL DISTURBANCE. BALLOON ANGIOPLASTY OF THE STENT WAS PERFORMED AS TREATMENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Arrhythmia

  MAUDE report 12389259 ↗
• InjuryMay 27, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2021 A XIENCE SIERRA STENT WAS SUCCESSFULLY IMPLANTED IN A PATIENT WHO PREVIOUSLY PRESENTED WITH NON-ST SEGMENT ELEVATION MYOCARDIAL INFARCTION. ON (B)(6) 2021, 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. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina

  MAUDE report 11898724 ↗
• MalfunctionDec 1, 2020Difficult to Remove; Failure to Advance; Deformation Due to Compressive Stress; Difficult to Remove; Failure to Advance; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY TORTUOUS DISTAL LEFT ANTERIOR DESCENDING ARTERY (DLAD). A 4.0X12MM XIENCE SIERRA STENT DELIVERY SYSTEM WAS ATTEMPTED TO CROSS; HOWEVER THE SHAFT BECAME KINKED DUE TO RESISTANCE WITH ANATOMY DURING ADVANCEMENT. IT WAS NOTED DURING REMOVAL RESISTANCE WAS ALSO MET WITH ANATOMY. ANOTHER UNSPECIFIED STENT WAS USED TO SUCCESSFULLY COMPLETE PROCEDURE ALONG WITH NON-ABBOTT GUIDE EXTENSION CATHETER. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10930983 ↗
• InjuryNov 10, 2020Difficult to Remove; Device Dislodged or Dislocated; Difficult to Remove; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THIS WAS A TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE, TREATING AORTIC STENOSIS. STENT DELIVERY SYSTEMS WERE PLACED IN THE LEFT MAIN AND RIGHT CORONARY ARTERY AS A PRECAUTION IF THE VESSELS WERE TO BECOME OCCLUDED DURING THE TAVR PROCEDURE. A 4.0 X 12 MM XIENCE SIERRA STENT PLACED IN THE LEFT MAIN. THE TAVR PROCEDURE WAS COMPLETED AND THE STENT DELIVERY SYSTEM WAS REMOVED; HOWEVER, DURING REMOVAL, THE XIENCE SIERRA STENT BECAME CAUGHT ON THE TAVR DEVICE AND DISLODGED. THE STENT SEEMED TO BE WELL TRAPPED BETWEEN THE VESSEL WALL AND THE TAVR DEVICE; THEREFORE, NO ADDITIONAL INTERVENTION WAS PERFORMED TO RETRIEVE THE STENT. THE PATIENT WAS IN STABLE CONDITION AT THE END OF THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 10816881 ↗
• 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 WAS 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 10491573 ↗
• MalfunctionApr 29, 2020Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY TORTUOUS, MODERATELY CALCIFIED DISTAL RIGHT CORONARY ARTERY (DRCA) THAT WAS 90% STENOSED. ONCE THE LESION WAS PRE-DILATED A 4.0X12MM XIENCE SIERRA WAS ADVANCED AND RESISTANCE WAS FELT WITH ANATOMY. THE DEVICE WAS INFLATED ONCE AT 8 ATMOSPHERES (ATM) WHEN THE BALLOON RUPTURED, THE STENT IMPLANT WAS NOT DEPLOYED. ANOTHER NON-ABBOTT DEVICE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE NO WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10011783 ↗
• MalfunctionApr 17, 2020Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT OUT OF PACKAGING, THE 4.0X12MM XIENCE SIERRA STENT DELIVERY SYSTEM TIP WAS NOTED TO BE TORN. THERE WAS NO PATIENT INVOLVEMENT. THE XIENCE SIERRA WAS REPLACED WITH A NEW UNSPECIFIED STENT 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 Patient Involvement

  MAUDE report 9973131 ↗
• InjuryJan 16, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT ON (B)(6) 2019, A PERCUTANEOUS CORONARY INTERVENTION WAS PERFORMED ON THE MID RIGHT CORONARY ARTERY (RCA) LESION. A 4.0X12MM XIENCE SIERRA STENT WAS DIRECTLY IMPLANTED IN THE MILDLY CALCIFIED MID RCA. USING THE XIENCE SIERRA DILATATION BALLOON, DILATATION WAS PERFORMED AT 12 ATMOSPHERES FOR 15 SECONDS AND THEN 16 ATMS FOR 25 SECONDS. DURING THAT SECOND INFLATION, THE BALLOON HAD RUPTURED. THE DELIVERY SYSTEM WAS REMOVED WITHOUT RESISTANCE AND ANOTHER BALLOON CATHETER WAS USED TO PERFORM ADDITIONAL DILATATION. THE STENT REMAINED FULLY APPOSED TO THE MID RCA SITE. THERE WAS NO ADVERSE PATIENT SEQUELA AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THIS ISSUE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9598306 ↗
• 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 SUPRAVENTRICULAR TACHYCARDIA THEREFORE THE 4.0X12MM XIENCE SIERRA WAS IMPLANTED. ON (B)(6) 2019 AND (B)(6) 2019 THE PATIENT WAS RE-ADMITTED WITH SUPRAVENTRICULAR TACHYCARDIA AND HYPERTENSIVE HEART DISEASE. SURGERY WAS PERFORMED HOWEVER THE FINAL PATIENT OUTCOME IS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available; Ventricular Tachycardia

  MAUDE report 9439164 ↗
• 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 4.0X12MM XIENCE SIERRA WAS IMPLANTED. ON (B)(6) 2019 THE PATIENT WAS RE-ADMITTED WITH CHEST PAIN. IT IS UNKNOWN WHAT TREATMENT WAS PERFORMED AND THE FINAL PATIENT OUTCOME IS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina

  MAUDE report 9438104 ↗
• DeathNov 8, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE, THE LEFT MAIN BECAME OCCLUDED. A 4.0 X 12 MM XIENCE SIERRA STENT WAS IMPLANTED WITHOUT ISSUE TO OPEN THE VESSEL. THE PATIENT HAD BEEN LOADED WITH HEPARIN FOR THE TAVR PROCEDURE, BUT THE HEPARIN WAS REVERSED AT THE END, PER FACILITY PROTOCOL, TO SUTURE THE ACCESS SITE. AFTER THE PROCEDURE WAS COMPLETED, THE PATIENT WAS NOT ADMINISTERED AN ANTI-PLATELET MEDICATION. THE PATIENT WAS TAKEN TO THE INTENSIVE CARE UNIT, BUT CODED AND WAS THEN TAKEN BACK TO THE CATH LAB. CORONARY ANGIOGRAPHY NOTED THROMBUS IN THE STENT. A SECOND 4.0 X 8 MM XIENCE SIERRA STENT WAS IMPLANTED, PROXIMAL AND OVERLAPPING THE FIRST SIERRA STENT. THE PATIENT WAS TAKEN BACK TO THE ICU, BUT LATER THE SAME DAY, DIED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Cardiac Arrest; Thrombosis

  MAUDE report 9301613 ↗
• InjuryJun 14, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 4.0 X 12 MM XIENCE SIERRA STENT WAS IMPLANTED ON(B)(6) 2019. ON (B)(6) 2019, THE PATIENT WAS RE-ADMITTED WITH ANGINA AND OTHER UNSPECIFIED CARDIO VASCULAR SYMPTOMS. UNSPECIFIED TREATMENT WAS ADMINISTERED TO THE PATIENT. FINAL PATIENT OUTCOME IS REPORTEDLY UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina

  MAUDE report 8701954 ↗
• InjuryMar 5, 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 TWO XIENCE SIERRA STENTS WERE IMPLANTED. ON (B)(6) 2018 THE PATIENT WAS RE-HOSPITALIZED FOR A SURGICAL SITE INFECTION AND OTHER CARDIOVASCULAR SYMPTOMS. TREATMENT AND PATIENT OUTCOME WERE NOT PROVIDED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8392079 ↗
• MalfunctionNov 2, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A CONCENTRIC DE NOVO LESION LOCATED IN THE PROXIMAL RIGHT CORONARY ARTERY THAT WAS NON TORTUOUS, MILDLY CALCIFIED AND 80% STENOSED. AFTER PRE-DILATATION AND INTRAVASCULAR ULTRASOUND (IVUS) WERE PERFORMED, A 4.0 X 12MM XIENCE SIERRA STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TO THE TARGET LESION. THE PHYSICIAN COMMENTED THAT THE STENT LOOKED LIKE IT HAD SHIFTED PROXIMALLY WITH IVUS, SO THE SDS WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A 4.0 X 12MM NON-ABBOTT STENT. THERE WAS NO REPORT OF A CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND NO PATIENT EFFECT CAUSED BY THE DEVICE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8032796 ↗