XIENCE Sierra™ 1550225-28Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 08717648227042), received between Nov 26, 2018 and Sep 21, 2021 — classified as 10 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 21, 2021Difficult to Remove; Improper or Incorrect Procedure or Method; Failure to Advance; Material Deformation; Difficult to Remove; Improper or Incorrect Procedure or Method; Failure to Advance; Material Deformation

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A LESION IN THE RIGHT CORONARY ARTERY. THE 2.25X28 MM XIENCE SIERRA STENT DELIVERY SYSTEM (SDS) FAILED TO CROSS THE TARGET LESION DUE TO THE ANATOMY. WHEN RETRACTING THE SDS, RESISTANCE WAS FELT WITH THE GUIDE WIRE AND THE GUIDE CATHETER AND THE STENT STRUTS FLARED. ALL DEVICES WERE REMOVED TOGETHER AS A SINGLE DEVICE. ADDITIONALLY, IT WAS NOTED THAT THE 2.25X28 SIERRA WAS USED PAST EXPIRATION. A NEW SAME SIZE SIERRA CROSSED WITHOUT FURTHER ISSUES AND WAS IMPLANTED. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12508549 ↗
• InjuryJun 2, 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 2.25X28 MM XIENCE SIERRA STENT WAS IMPLANTED. THE PATIENT HAD PREVIOUSLY PRESENTED WITH NON ST ELEVATED MYOCARDIAL INFARCTION (NSTEMI). ON (B)(6) 2021 THE PATIENT WAS READMITTED FOR UNSPECIFIED CIRCULATORY AND RESPIRATORY SYMPTOMS. TREATMENT WAS UNSPECIFIED AND THE FINAL PATIENT OUTCOME IS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Myocardial Infarction; Unspecified Respiratory Problem

  MAUDE report 11921949 ↗
• InjuryJan 12, 2021Improper or Incorrect Procedure or Method; Failure to Advance; Improper or Incorrect Procedure or Method; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A MILDLY CALCIFIED, MILDLY TORTUOUS, DE NOVO MID RAMUS THAT WAS 100% STENOSED. PRE-DILATATION WAS DONE WITH A 1.2X12MM TREK BALLOON, A 2X15MM TREK BALLOON, AND A 2.5X15MM TREK BALLOON. THE 2.25X28MM XIENCE SIERRA STENT DELIVERY SYSTEM (SDS) WAS ADVANCED USING A GUIDING CATHETER BUT FAILED TO CROSS DUE TO THE ANATOMY. USING A NEW GUIDE SUPPORT CATHETER, A SECOND ATTEMPT WAS MADE TO CROSS BUT FAILED AGAIN DUE TO THE ANATOMY. A PERFORATION WAS THEN OBSERVED. ADDITIONAL DILATATION WAS DONE AND THE SDS WAS REATTEMPTED BUT DID NOT CROSS. THE XIENCE SIERRA SDS WAS REPLACED WITH A 2.25X26MM NON-ABBOTT SDS. THE REPLACEMENT DEVICE CROSSED IMMEDIATELY AND WAS DEPLOYED. POST-DILATATION WAS DONE WITH LONG INFLATIONS TO SUCCESSFULLY TREAT THE PERFORATION. THERE WAS NO ADVERSE PATIENT SEQUELA REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Perforation

  MAUDE report 11156581 ↗
• InjuryMay 5, 2020Failure to Advance; Material Deformation; Failure to Advance; Material Deformation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A DE NOVO LESION LOCATED IN THE MID-LEFT ANTERIOR DESCENDING CORONARY ARTERY THAT WAS MILDLY CALCIFIED, NON-TORTUOUS AND 90% STENOSED. AFTER PRE-DILATATION, A 2.25X28 XIENCE SIERRA FAILED TO CROSS THE LESION TWICE AND WHEN REMOVED, THE STRUTS WERE FLARED. A DISSECTION MAY HAVE OCCURRED. ANOTHER XIENCE SIERRA WAS SUCCESSFULLY IMPLANTED IN THE LESION AND AFTER POST-DILATATION, THE PROCEDURE WAS NOTED TO BE COMPLETED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Intimal Dissection; No Consequences Or Impact To Patient

  MAUDE report 10027261 ↗
• InjuryMar 6, 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 UNSTABLE ANGINA THEREFORE THE 2.25X28MM XIENCE SIERRA WAS IMPLANTED. ON (B)(6) 2019, (B)(6) 2019 AND (B)(6) 2019 THE PATIENT WAS RE-ADMITTED WITH DIABETES (KETOACIDOSIS), CHEST PAIN, HYPERTENSIVE HEART AND OTHER CARDIOVASCULAR SYMPTOMS. IT IS UNKNOWN WHAT TREATMENT WAS PERFORMED AND FINAL PATIENT OUTCOME IS UNKNOWN.

  Patient problems: Angina; High Blood Pressure/ Hypertension

  MAUDE report 9799674 ↗
• InjuryMar 4, 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 UNSTABLE ANGINA THEREFORE THE 2.25X28MM AND 2.50X33MM XIENCE SIERRA STENTS WERE IMPLANTED. ON (B)(6) 2019 THE PATIENT WAS RE-ADMITTED WITH ATHEROSCLEROTIC HEART DISEASE 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: No Code Available; Stenosis

  MAUDE report 9788173 ↗
• InjuryOct 23, 2019Inflation Problem; Material Rupture; Difficult or Delayed Activation; Patient-Device Incompatibility; Migration; Inflation Problem; Material Rupture; Difficult or Delayed Activation; Patient-Device Incompatibility; Migration

  IT WAS REPORTED THAT THE 2.25 X 28 MM XIENCE SIERRA STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TO THE RIGHT CORONARY ARTERY SLIGHTLY MORE DISTAL THAN THE INTENDED AREA. THE STENT WAS READY TO BE DEPLOYED BUT THE SDS BALLOON WOULD NOT INFLATE WHEN A NORMAL RATE OF INFLATION WAS USED. THE INFLATION DEVICE WAS QUICKLY INFLATED TO 10 ATMOSPHERES WHICH ALLOWED THE STENT TO BE PARTIALLY DEPLOYED (DOG-BONED), BUT THE SDS WAS LOSING PRESSURE. THE DOG BONED STENT WAS DUE TO THE SLOW LEAK ON THE SDS BALLOON. DURING REMOVAL OF THE SDS, THE STENT WAS INADVERTENTLY PULLED BACK 10 MM. A 2.0 X 20 BALLOON DILATATION CATHETER WAS INSERTED THROUGH THE STENT TO MORE FULLY EXPAND IT AGAINST THE ARTERY. THE STENT WAS STILL COVERING THE INTENDED LESION. A 2.5 MM NON-COMPLIANT BDC WAS USED TO POST DILATE THE STENT. AFTER THE SDS WAS REMOVED FROM THE ANATOMY, THE BALLOON RUPTURE WAS NOTED. THE CUSTOMER BELIEVES THE BALLOON RUPTURE OCCURRED FROM THE STENT ITSELF AT THE MANUFACTURING SITE. THE PROCEDURE WAS COMPLETED. 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 9227361 ↗
• MalfunctionOct 9, 2019Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT DURING PREPARATION, THE 2.25X28MM XIENCE SIERRA STENT DELIVERY SYSTEM (SDS) KEPT BURPING AIR. THE SDS WAS NOT USED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH AN UNSPECIFIED DEVICE. 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 9173392 ↗
• InjurySep 5, 2019Failure to Advance; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A MODERATELY CALCIFIED LESION IN THE LEFT ANTERIOR DESCENDING ARTERY. A 2.25X28MM XIENCE SIERRA STENT DELIVERY SYSTEM (SDS) FAILED TO CROSS DUE TO THE ANATOMY; HOWEVER, DURING THE ATTEMPT TO CROSS A PERFORATION WAS NOTED. THE SDS WAS REMOVED AND AN UNSPECIFIED NON-ABBOTT BALLOON CATHETER WAS USED TO BALLOON THE PERFORATION UNTIL IT SEALED SUCCESSFULLY. THERE WERE NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Perforation

  MAUDE report 8967177 ↗
• InjuryMar 2, 2019Patient-Device Incompatibility; Difficult to Advance; Patient-Device Incompatibility; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED LESION IN THE OBTUSE MARGINAL CORONARY ARTERY. THE XIENCE SIERRA STENT WAS DEPLOYED, BUT THE PROXIMAL STENT WAS NOT FULLY APPOSED TO THE VESSEL WALL DUE TO THE CALCIFICATION. POST-DILATATION WAS ATTEMPTED, BUT THE BALLOON COULD NOT CROSS INTO THE STENT. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA OR A CLINICALLY SIGNIFICANT DELAY IN PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8384454 ↗
• InjuryDec 13, 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 2.25X28MM XIENCE SIERRA, 2.50X23MM XIENCE SIERRA, AND 3.50X28MM XIENCE SIERRA STENTS WERE IMPLANTED. ON (B)(6) 2018 THE PATIENT WAS RE-ADMITTED WITH VENTRICULAR TACHYCARDIA AND ELEVATED EKG/ECG. THE TREATMENT PERFORMED AND PATIENT OUTCOME IS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Non specific EKG/ECG Changes; Ventricular Tachycardia

  MAUDE report 8161605 ↗
• InjuryNov 26, 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 PROCEDURE WAS PERFORMED TO TREAT THE BIFURCATION OF THE LEFT ANTERIOR DESCENDING (LAD) AND 1ST DIAGONAL CORONARY ARTERIES. THE LESION WAS PRE-DILATED AND A 2.25 X 28 MM XIENCE SIERRA WAS SUCCESSFULLY DEPLOYED AT 11 ATMOSPHERES IN THE DIAGONAL ARTERY. POST DILATATION WAS PERFORMED AT 12 ATMOSPHERES AT THE LAD FOR DIAGONAL STENT CRUSHING. INTRAVASCULAR ULTRASOUND CONFIRMED REVASCULARIZATION WITH EXCELLENT RESULTS. THE PATIENT WAS PRESCRIBED ANTICOAGULANT THERAPY. ON (B)(6) 2018 THE PATIENT WAS RE-ADMITTED WITH ANGINA AND CHEST PAIN. STENT OCCLUSION AND EARLY STENT THROMBOSIS WERE CONFIRMED. THE VESSEL WAS RE-VASCULARIZED BY ASPIRATING THE THROMBUS AND FURTHER BALLOON ANGIOPLASTY OF THE DIAGONAL ARTERY. THE PATIENT WAS PRESCRIBED ANTICOAGULANT THERAPY AGAIN AND WAS REPORTED TO BE STABLE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina; Thrombosis

  MAUDE report 8102611 ↗