XIENCE Sierra™ 1550400-15Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 08717648227493), received between Dec 10, 2018 and Feb 16, 2022 — classified as 10 injuries, 5 malfunctions.

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

• InjuryFeb 16, 2022Migration; Migration

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A SAPHENOUS VEIN GRAFT (SVG) IN THE DISTAL RIGHT CORONARY ARTERY (RCA). THE 4.0X15MM XIENCE SIERRA STENT WAS DEPLOYED AT 14 ATMOSPHERES WITHOUT ISSUE. A DILATATION BALLOON CATHETER (BDC) WAS ADVANCED TO POST DILATE THE STENT WHEN IT WAS NOTED THE SIERRA STENT HAD MIGRATED FROM THE DISTAL TO THE MID RCA (APPROXIMATELY 10-15MM). THE BDC POST DILATED THE SIERRA TO ENSURE IT WOULD NOT MIGRATE ANY FURTHER. A NON-ABBOTT STENT WAS THEN IMPLANTED AT THE TARGET LESION. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 13541074 ↗
• 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 ATHEROSCLEROTIC HEART DISEASE AND UNSTABLE ANGINA. ON (B)(6) 2021 TWO XIENCE SIERRA STENTS WERE IMPLANTED (3.00X38MM AND A 3.50X38MM). THE PATIENT WAS RE-HOSPITALIZED ON B)(6) 2021 WITH CARDIOVASCULAR SYMPTOMS INCLUDING ATHEROSCLEROTIC HEART DISEASE AND UNSTABLE ANGINA. TWO ADDITIONAL 4.00X15MM XIENCE SIERRA STENTS WERE IMPLANTED ON B)(6) 2021. THE PATIENT WAS RE-HOSPITALIZED AGAIN ON B)(6) 2021 WITH CARDIOVASCULAR SYMPTOMS INCLUDING ACUTE KIDNEY FAILURE. UNSPECIFIED MEDICAL INTERVENTION WAS PERFORMED AND THE FINAL PATIENT OUTCOME IS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 11894749 ↗
• 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 UNSTABLE ANGINA AND ATHEROSCLEROTIC HEART DISEASE BEFORE THE INITIAL PROCEDURE. TWO XIENCE SIERRA STENTS (4X15MM AND 3.25X18MM) WERE IMPLANTED ON (B)(6) 2021. ON (B)(6) 2021, THE PATIENT WAS RE-ADMITTED WITH UNSTABLE ANGINA. UNSPECIFIED TREATMENT WAS PERFORMED, AND THE FINAL PATIENT OUTCOME IS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina

  MAUDE report 11894115 ↗
• InjuryMar 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 A 4.00X15 MM XIENCE SIERRA STENT WAS SUCCESSFULLY IMPLANTED. ON (B)(6) 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. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina

  MAUDE report 11485273 ↗
• MalfunctionOct 14, 2020Break; Leak/Splash; Break; Leak/Splash

  IT WAS REPORTED THAT A 4.0X15MM XIENCE SIERRA STENT DELIVERY SYSTEM (SDS) WAS PREPARED (AIR ASPIRATED) PRIOR TO USE WITHOUT ISSUES. THE SDS WAS ADVANCED; HOWEVER, A LEAK AT THE HUB WAS NOTED. UPON FURTHER INSPECTION, IT WAS NOTED THAT THERE WAS A CRACK ON THE HUB. THE SDS WAS REMOVED, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A NEW UNSPECIFIED XIENCE SIERRA STENT. 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 10678969 ↗
• InjurySep 14, 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 PATIENT PRESENTED WITH NON-ST ELEVATED MYOCARDIAL INFARCTION AND A 4.00X15MM XIENCE SIERRA STENT WAS IMPLANTED. ON (B)(6) 2020, THE PATIENT WAS RE-ADMITTED WITH A PULMONARY EMBOLISM. UNSPECIFIED TREATMENT WAS PROVIDED AND THE FINAL PATIENT OUTCOME IS NOT KNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Pulmonary Embolism

  MAUDE report 10528899 ↗
• InjurySep 1, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBSEQUENT TO THE PREVIOUS MEDWATCH REPORT, THE ADDITIONAL INFORMATION WAS OBTAINED: ON (B)(6)2020, THE PATIENT PRESENTED FOR A RENAL TRANSPLANT EVALUATION. A CARDIAC CATHETERIZATION WAS PERFORMED REVEALING OSTIAL LEFT ANTERIOR DESCENDING (LAD) AND DISTAL LEFT MAIN (LM) STENOSIS. THERE WAS A KNOWN OSTIAL LAD IN-STENT RESTENOSIS OF AN UNSPECIFIED STENT. REPORTEDLY, THE PROXIMAL LAD 4.0X15MM XIENCE SIERRA STENT REMAINED PATENT WITHOUT A DEVICE MALFUNCTION. THIS NEW INFORMATION REVEALED THAT THERE WAS NO COMPLAINT AGAINST THIS DEVICE.

  Patient problems: Ischemia; Stenosis; Test Result

  MAUDE report 10479619 ↗
• 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). A 4.0X15MM XIENCE SIERRA STENT WAS IMPLANTED. ON (B)(6) 2019 THE PATIENT WAS RE-HOSPITALIZED WITH THROMBOCYTOPENIC PURPURA. SURGERY WAS PERFORMED; HOWEVER, THE FINAL PATIENT OUTCOME IS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 9803869 ↗
• InjuryMar 6, 2020Malposition of Device; Difficult to Advance; Device Dislodged or Dislocated; Malposition of Device; Difficult to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT HEAVY TORTUOUS, HEAVY CALCIFIED AND 90% STENOSIS LESION IN THE MID RIGHT CORONARY ARTERY. IT WAS NOTED THAT PRE-DILATATION WAS NOT PERFORMED. A XIENCE SIERRA 4.00X15 RX WAS ADVANCED, BUT RESISTANCE WAS NOTED. THE STENT WAS CONTINUED TO BE ADVANCED; HOWEVER, THE STENT THEN DISLODGED. THE PHYSICIAN STATED THE DISLODGED STENT WAS DUE TO NOT PERFORMING PRE-DILATATION. A SMALL DIAMETER BALLOON WAS THEN INSERTED AND SHIFTED THE STENT TO THE PROXIMAL LESION. THE BALLOON DILATED THE STENT, BUT IT WAS NOTED THAT THE STENT WAS IMPLANTED AT A MORE PROXIMAL POSITION THEN PLANNED; THEREFORE, AN ADDITIONAL STENT WAS IMPLANTED. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9800185 ↗
• 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 4.0X15MM XIENCE SIERRA WAS IMPLANTED. ON (B)(6) 2019 THE PATIENT WAS RE-ADMITTED WITH NSTEMI. IT IS UNKNOWN WHAT TREATMENT WAS PERFORMED AND THE FINAL PATIENT OUTCOME IS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Myocardial Infarction

  MAUDE report 9440859 ↗
• MalfunctionDec 2, 2019Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT AFTER IMPLANTING THE XIENCE SIERRA STENT ON (B)(6) 2019, IT WAS NOTED TO BE EXPIRED. THE PATIENT IS DOING WELL. 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 9396036 ↗
• MalfunctionNov 5, 2019Difficult to Advance; Material Deformation; Difficult to Advance; Material Deformation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A DE NOVO LESION IN A MILDLY CALCIFIED PROXIMAL CIRCUMFLEX ARTERY THAT DID NOT HAVE ANY TORTUOSITY. A 4.0 X 15 MM XIENCE SIERRA STENT DELIVERY SYSTEM (SDS) WAS USED. HOWEVER, IT MET RESISTANCE WITH THE GUIDING CATHETER AND THE STENT STRUTS BECAME FLARED. THEREFORE, ANOTHER 4.0 X 15 MM XIENCE SIERRA SDS WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. RETURNED DEVICE ANALYSIS REVEALED THAT THERE WAS A TEAR AT THE GUIDE WIRE EXIT NOTCH. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9282137 ↗
• MalfunctionJun 17, 2019Improper or Incorrect Procedure or Method; Adverse Event Without Identified Device or Use Problem; Improper or Incorrect Procedure or Method; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PROCEDURE ON (B)(6) 2019 WAS TO TREAT A THROMBOTIC RIGHT CORONARY ARTERY. AN EXPIRED XIENCE SIERRA STENT WAS IMPLANTED IN A PATIENT. THE EXPIRATION DATE OF THE STENT WAS (B)(6) 2019. THERE WAS NO CLINICALLY SIGNIFICANT DELAY OR ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8704206 ↗
• MalfunctionApr 15, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT THE TIP OF A 4.00 X 15 MM XIENCE SIERRA STENT DELIVERY SYSTEM (SDS) WAS NOTED AS DAMAGED WHEN REMOVED FROM PACKAGING. THE SDS WAS NOT USED. THERE WAS NO RESISTANCE REMOVING THE SDS FROM THE DISPENSER COIL AND NO DAMAGE WAS NOTED TO THE PACKAGING COMPONENTS. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A NEW 4.00 X 15 MM XIENCE SIERRA SDS. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. THE RETURN DEVICE ANALYSIS IDENTIFIED THAT THE TIP WAS SEPARATED 2.5 MM DISTAL TO THE DISTAL BALLOON SEAL AND FOLLOW-UP WITH THE ACCOUNT CONFIRMED THE REPORTED DAMAGE. THE TIP SEPARATED PORTION WAS NOT RETURNED BECAUSE IT WAS DISCARDED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 8515450 ↗
• InjuryDec 10, 2018Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED MID RIGHT CORONARY ARTERY. PRE-DILATATION WAS PERFORMED WITH A NON-ABBOTT BALLOON DILATATION CATHETER AND A 4.00X15MM XIENCE SIERRA STENT WAS IMPLANTED AT 12 ATMOPSHERES. A CORONARY ARTERY DISSECTION WAS NOTED AFTER IMPLANTATION. THE PHYSICIAN FELT THAT THE STENT DELIVERY BALLOON GREW TOO MUCH OUTSIDE THE STENT, LIKE AN OVERHANG OUTSIDE THE LENGTH OF THE STENT ON THE PROXIMAL END OF THE BALLOON, RESULTING IN THE DISSECTION. ANOTHER XIENCE SIERRA STENT WAS IMPLANTED TO TREAT THE DISSECTION. THERE WAS NO ADVERSE PATIENT SEQUELA AN NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Intimal Dissection

  MAUDE report 8146751 ↗