XIENCE Sierra™ 1550275-28Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 08717648227202), received between Aug 14, 2018 and Dec 9, 2020 — classified as 1 death, 10 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjuryDec 9, 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 A ST-ELEVATION MYOCARDIAL INFARCTION AND A 2.75X28MM XIENCE SIERRA STENT WAS IMPLANTED. ON (B)(6) 2020, THE PATIENT WAS RE-ADMITTED WITH UNSPECIFIED CARDIOVASCULAR SYMPTOMS AND NON ST-ELEVATION MYOCARDIAL INFARCTION. UNSPECIFIED TREATMENT WAS PROVIDED AND THE FINAL PATIENT OUTCOME IS NOT KNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Myocardial Infarction

  MAUDE report 10979982 ↗
• DeathAug 25, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY. A 2.75X28 XIENCE SIERRA STENT WAS DEPLOYED AT 12 ATMOSPHERES (ATMS) WITHOUT ISSUE. STANDARD POST-DILATATION WITH A 3.5X10MM NON-ABBOTT CUTTING BALLOON WAS PERFORMED AT 14 ATMS. AFTER THE INFLATION, THE PATIENT BECAME HYPOTENSIVE WITH LOW CARDIAC OUTFLOW. VIA ANGIOGRAM A PERFORATION AT THE LESION WAS NOTED. EMERGENT PERICARDIOCENTESIS WAS PERFORMED. A PERICARDIAL DRAIN WAS PLACED AND USED TO INTERMITTENTLY REMOVE AND AUTO-TRANSFUSE THE PATIENT. PATIENT WAS PLACED ON LEVOPHED DRIP. BALLOON TAMPANADE WAS ATTEMPTED WITH A 3.5X12MM NC TREK BUT THE PERFORATION KEPT LEAKING. A 2.80X19MM RX GRAFMASTER STENT WAS INSERTED AND DEPLOYED AT 14 ATM. THERE WAS STILL NOTED LEAKING INTO THE PERICARDIAL SPACE LEADING TO CARDIAC TAMPONADE. EMERGENT PERIOCARDIOCENTESIS AND AUTO-TRANSFUSION WERE REPEATED MULTIPLE TIMES. AFTER POST-DILATATION OF THE COVERED STENT, THE PERFORATION SEEMED TO HAVE WORSENED. BALLOON TAMPONADE USING A 3.5X12MM NC TREK WAS PERFORMED AT 18 ATM. ONCE THE DEVICE WAS REMOVED, THE PATIENT BECAME INCREASINGLY HYPOXIC (LACKING OXYGEN) AND WAS EMERGENTLY INTUBATED. THE NC TREK BA

  Patient problems: Cardiac Tamponade; Death; Hematoma; Ischemia; Low Blood Pressure/ Hypotension; Perforation; Respiratory Distress; Shock

  MAUDE report 10448840 ↗
• InjuryJun 18, 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 A NON-ST ELEVATED MYOCARDIAL INFARCTION (NSTEMI) THEREFORE THE 2.75X28MM XIENCE ALPINE WAS IMPLANTED. ON (B)(6) 2020 THE PATIENT WAS RE-ADMITTED DUE TO ATRIAL FIBRILLATION, 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: Atrial Fibrillation

  MAUDE report 10169342 ↗
• 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 THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE MID LEFT ANTERIOR DESCENDING (LAD) ARTERY. A 2.75 X 28 MM XIENCE SIERRA STENT WAS IMPLANTED AND PLAQUE SHIFT OCCURRED, CAUSING A DISSECTION IN THE DIAGONAL BRANCH. AN ADDITIONAL DRUG ELUTING STENT WAS IMPLANTED AND THE PATIENT CONDITION RESOLVED THE SAME DAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Intimal Dissection; Prolapse

  MAUDE report 9826547 ↗
• MalfunctionJan 13, 2020Difficult to Remove; Failure to Advance; Material Deformation; Difficult to Remove; Failure to Advance; Material Deformation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A DE NOVO LESION LOCATED IN THE DISTAL RIGHT CORONARY ARTERY THAT WAS HEAVILY CALCIFIED, HEAVILY TORTUOUS AND 90% STENOSED. PRE-DILATATION WAS PERFORMED. A 2.75 X 28 MM XIENCE SIERRA STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TOGETHER WITH A GUIDELINER; HOWEVER, THE SDS FAILED TO CROSS DUE TO INTERACTION WITH CALCIFICATION. AFTER THE SDS WAS REMOVED WITH RESISTANCE, THE STENT IMPLANT WAS NOTED TO BE FLARED. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT OR A CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. ADDITIONAL DILATATION WAS PERFORMED AND A NEW XIENCE SIERRA STENT WAS DEPLOYED, FOLLOWED BY POST DILATATION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9582826 ↗
• InjuryDec 20, 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 AN ST ELEVATION MYOCARDIAL INFARCTION. A XIENCE SIERRA STENT WAS IMPLANTED IN THE LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY. A TIGHT LESION WAS NOTED IN DISTAL RIGHT CORONARY ARTERY (RCA); HOWEVER, THIS WAS LEFT UNTREATED AT THE TIME. ON (B)(6) 2019, THE PATIENT PRESENTED WITH CHEST PAIN, HYPOTENSION AND THROMBOSIS WAS NOTED IN BOTH THE LAD AND RCA, CONFIRMED BY ANGIOGRAPHY. IT WAS THOUGHT THAT THE TIGHT LESION IN THE RCA WAS THE CAUSE OF THE ISSUES. THE RCA WAS STENTED, AND THE LAD BALLOONED, RESOLVING THE ISSUE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina; Low Blood Pressure/ Hypotension; Thrombosis

  MAUDE report 9507385 ↗
• InjuryNov 18, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2019, A 2.75X28MM XIENCE SIERRA STENT WAS IMPLANTED IN THE DISTAL RIGHT CORONARY ARTERY AND RIGHT POSTERIOR ATRIOVENTRICULAR SEGMENT TO TREAT AN ACUTE MYOCARDIAL INFARCTION, CARDIOGENIC SHOCK, AND CARDIAC ARREST. ON (B)(6) 2019, THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE CIRCUMFLEX (CX) CORONARY ARTERY, BUT IN-STENT THROMBOSIS IN THE PREVIOUSLY IMPLANTED STENT WAS OBSERVED AND CONFIRMED THROUGH ANGIOGRAPHY. THE STENT WAS DILATED WITH A 3X15MM NON-ABBOTT BALLOON DILATATION CATHETER (BDC). THE THROMBUS WAS ATTEMPTED TO BE REMOVED WITH A NON-ABBOTT THROMBUS ASPIRATION CATHETER BUT WAS UNSUCCESSFUL. THE STENT WAS DILATED TWO MORE TIMES WITH A 3X13MM NON-ABBOTT BDC AND A 2.5X10MM NON-ABBOTT BDC. THE STENT WAS CONSIDERED SUFFICIENTLY DILATED, AND THE PROCEDURE CONTINUED TO TREAT THE CX ARTERY. THE PATIENT IS RECOVERING IN THE HOSPITAL. THERE WERE NO ADVERSE PATIENT SEQUELAE AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Thrombosis

  MAUDE report 9336905 ↗
• MalfunctionSep 6, 2019Difficult 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 PERFORMED TO TREAT A LESION IN THE HEAVILY CALCIFIED PROXIMAL LEFT ANTERIOR DESCENDING CORONARY ARTERY. PRE-DILATATION WAS PERFORMED WITH AN NC TREK. THE 2.75 X 28 MM XIENCE SIERRA STENT DELIVERY SYSTEM (SDS) WAS ADVANCED BUT FAILED TO CROSS DUE TO THE ANATOMY. THE SDS WAS REMOVED WITHOUT ISSUE. A GUIDE LINER AND A CUTTING BALLOON WERE USED, BUT BOTH DEVICES BECAME STUCK AND WERE REMOVED. THE SAME SDS WAS RE-INSERTED BUT FAILED TO CROSS DUE TO THE ANATOMY AGAIN. DURING REMOVAL, THE SDS GOT STUCK IN AN UNSPECIFIED GUIDE CATHETER FOR A BRIEF MOMENT BUT WAS SUBSEQUENTLY REMOVED INDEPENDENTLY. UPON REMOVAL, THE STENT STRUTS WERE NOTED TO BE FLARED AND A BIG NOTCH WAS NOTED ON THE GUIDE CATHETER. A NEW GUIDE CATHETER AND A NEW XIENCE SIERRA STENT WERE 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 8970371 ↗
• InjurySep 5, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 2.75X28MM XIENCE SIERRA STENT WAS IMPLANTED ON (B)(6) 2019. THE PATIENT PRESENTED WITH ANGINA BEFORE THE PROCEDURE. ON (B)(6) 2019, THE PATIENT WAS RE-ADMITTED WITH CHEST PAIN. UNSPECIFIED TREATMENT WAS PERFORMED, AND THE FINAL PATIENT OUTCOME IS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina

  MAUDE report 8967785 ↗
• InjurySep 4, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT FOUR XIENCE SIERRA STENTS, SIZES 2.75X28, 3.5X33, 3.5X38, 4.0X12, WERE IMPLANTED IN THE CORONARY ARTERY ON (B)(6) 2019. THE PATIENT WAS RE-ADMITTED TO THE HOSPITAL ON (B)(6) 2019 WITH CAROTID ARTERY OCCLUSION. SURGERY WAS PERFORMED. THE OUTCOME IS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8960364 ↗
• InjuryJul 15, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE LEFT ANTERIOR DESCENDING CORONARY ARTERY (LAD). A 2.5X30 NON-ABBOTT STENT WAS IMPLANTED IN THE DIAGONAL LAD, A 2.75X28 XIENCE SIERRA STENT WAS IMPLANTED DISTALLY IN THE MID LAD, AND A 2.75X23 XIENCE SIERRA STENT WAS IMPLANTED IN THE PROXIMAL LAD, WHICH COVERED THE NON-ABBOTT STENT. THE PROCEDURE WAS COMPLETED; HOWEVER, THE PATIENT FELT PAIN IN THE BIFURCATION LESION, SO THE PATIENT WENT BACK ON THE TABLE. A CLOT WAS NOTED WHERE THE NON-ABBOTT STENT WAS LOCATED. THROMBUS WAS NOTED IN THE TWO XIENCE SIERRA STENTS IN THE LAD, BUT WITH GOOD FLOW. AN ATTEMPT TO BALLOON THE LESIONS WAS MADE. A 2.5X15MM NC TREK BALLOON DILATATION CATHETER WAS ADVANCED WITHOUT RESISTANCE, BUT WHEN ANOTHER 2.5X15MM NC TREK BDC WAS ADVANCED THROUGH AN UNSPECIFIED 6F GUIDING CATHETER AT THE SAME TIME AS THE FIRST BALLOON, RESISTANCE WAS FELT BETWEEN THE TWO BDCS. DURING REMOVAL, THE PROXIMAL SHAFT OF THE FIRST BDC SEPARATED. THE SEPARATED BDC WAS SIMPLY REMOVED WITHOUT ISSUES. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina; Thrombosis

  MAUDE report 8791669 ↗
• InjuryFeb 27, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 2.75X28MM XIENCE SIERRA STENT WAS IMPLANTED ON (B)(6) 2018. ON (B)(6) 2018, THE PATIENT WAS RE-ADMITTED FOR A CEREBRAL INFARCTION. ON (B)(6) 2018, THE PATIENT WAS RE-ADMITTED FOR NON-ST-ELEVATION MYOCARDIAL INFARCTION (NSTEMI) 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: Myocardial Infarction; Stroke/CVA

  MAUDE report 8374659 ↗
• InjuryAug 14, 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 2.75 X 28 MM XIENCE SIERRA STENT WAS IMPLANTED IN THE MID LEFT ANTERIOR DESCENDING (LAD) ARTERY. ON (B)(6) 2018, THE PATIENT PRESENTED WITH CHEST PAIN AND WAS RE-ADMITTED TO THE HOSPITAL. ON (B)(6) 2018 IN-STENT THROMBOSIS WAS CONFIRMED VIA ANGIOGRAPHY AND BALLOON ANGIOPLASTY WAS PERFORMED, RESOLVING THE EVENT AND RESTORING FLOW TO TIMI3. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Thrombosis

  MAUDE report 7781483 ↗