XIENCE Sierra™ 1550275-33Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 08717648227219), received between Feb 4, 2019 and Apr 14, 2022 — classified as 1 death, 10 injuries, 1 malfunction.

The most frequently reported specific device problem is “Defective Device” (1 report).

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.

• InjuryApr 14, 2022Adverse 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 CHRONIC OCCLUSION IN THE MID RIGHT CORONARY ARTERY (RCA). ATHERECTOMY WAS PERFORMED USING A NON-ABBOTT DEVICE FOLLOWED BY PLACEMENT OF FOUR OVERLAPPING XIENCE SIERRA STENTS (2.75X33, 2.75X15, 3.0X38 AND 3.5X33MM). ALL WERE INFLATED TO 18 ATMOSPHERES FOR 20 SECONDS. AN EDGE DISSECTION WAS NOTED AND A 3.5X26MM GRAFTMASTER WAS ATTEMPTED TO TREAT THE DISSECTION; HOWEVER, FAILED TO CROSS DUE TO ANATOMY. THE DISSECTION WAS TREATED WITH BALLOON ANGIOPLASTY. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Vascular Dissection

  MAUDE report 14114227 ↗
• InjurySep 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 THE PATIENT PRESENTED WITH AN ST ELEVATION MYOCARDIAL INFARCTION. A 2.75X33MM XIENCE SIERRA STENT WAS IMPLANTED. ON (B)(6) 2021 THE PATIENT WAS RE-HOSPITALIZED WITH SYNCOPE, COLLAPSE AND OTHER CARDIOVASCULAR SYMPTOMS. TREATMENT WAS NOT SPECIFIED NOR WAS THE FINAL PATIENT OUTCOME. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Syncope/Fainting

  MAUDE report 12417877 ↗
• InjuryMar 4, 2021Adverse 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 ON (B)(6) 2020, TREATING A TARGET LESION IN THE PROXIMAL CIRCUMFLEX (CX) ARTERY. THE 2.75 X 33 MM XIENCE SIERRA STENT WAS IMPLANTED. ON (B)(6) 2021, CARDIAC ENZYMES WERE ELEVATED AND A MYOCARDIAL INFARCTION (MI) WAS DIAGNOSED. STENOSIS WAS NOTED IN THE LEFT ANTERIOR DESCENDING ARTERY, THE RAMUS ARTERY AND THE CX ARTERY. CORONARY ARTERY BYPASS GRAFT (CABG) SURGERY WAS PERFORMED ON (B)(6) 2021. POST SURGICAL PROCEDURE, THE PATIENT EXPERIENCED AN ACUTE KIDNEY INJURY (AKI), ATRIAL FIBRILLATION AND POSTPERICARDIOTOMY SYNDROME. NO INTERVENTION WAS PERFORMED FOR THE AKI. MEDICATION WAS ADMINISTERED TO TREAT THE ATRIAL FIBRILLATION AND ORAL STEROIDS WERE ADMINISTERED FOR THE POSTPERICARDIOTOMY SYNDROME. PER STUDY PHYSICIAN, THE AKI, ATRIAL FIBRILLATION AND POSTPERICARDIOTOMY SYNDROME WERE NOT RELATED TO THE IMPLANTED XIENCE SIERRA STENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina; Myocardial Infarction; Stenosis

  MAUDE report 11418619 ↗
• InjuryJul 29, 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) 2020, THE PATIENT PRESENTED WITH A RECENT NON-ST ELEVATED MYOCARDIAL INFARCTION (NSTEMI), ELEVATED TROPONIN, AND A PERCUTANEOUS CORONARY INTERVENTION WAS PERFORMED. PRE-DILATATION WAS PERFORMED ON THE MID LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY LESION AND A 2.75X33MM XIENCE SIERRA STENT (1550275-33, 0011041) WAS IMPLANTED. AN EDGE DISSECTION WAS OBSERVED, TREATED WITH A 3.0X33MM XIENCE SIERRA STENT (1550300-33, 0021841). POST-DILATATION WAS PERFORMED ON THE 3.0X33MM XIENCE SIERRA STENT WHEN A PLAQUE SHIFT WITH 100% OCCLUSION OCCURRED IN THE PROXIMAL DIAGONAL CORONARY ARTERY. ADDITIONAL ANGIOPLASTY WAS PERFORMED AS TREATMENT. REPORTEDLY, THERE WAS NO DEVICE MALFUNCTION AND THE EVENT RESOLVED. POST-PROCEDURE RESULTS WERE ACCEPTABLE, 0% RESIDUAL DIAMETER STENOSIS AND TIMI FLOW III. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THIS ISSUE.

  Patient problems: Intimal Dissection

  MAUDE report 10338703 ↗
• DeathMar 5, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  N/A.

  Patient problems: Death

  MAUDE report 9794197 ↗
• InjuryAug 30, 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 UNDERWENT A CORONARY STENTING PROCEDURE, WITH IMPLANTATION OF A 2.75 X 33 MM XIENCE SIERRA STENT, A 3.0 X 18 MM XIENCE SIERRA STENT AND A 4.0 X 12 MM XIENCE SIERRA STENT. ON (B)(6) 2019, THE PATIENT WAS RE-ADMITTED WITH DRESSLER¿S SYNDROME AND MEDICATION WAS ADMINISTERED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Pericardial Effusion

  MAUDE report 8952750 ↗
• InjuryJul 29, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  STUDY PATIENT ID: (B)(6). IT WAS REPORTED THAT ON (B)(6) 2018, A 2.75X33MM XIENCE SIERRA STENT WAS IMPLANTED IN THE MID LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY LESION. AN ABNORMAL STRESS TESTS OCCURRED FOLLOWING A SCHEDULED FOLLOW-UP. ON (B)(6) 2019, PERCUTANEOUS CATHETERIZATION WAS PERFORMED AND IN-STENT RESTENOSIS OF THE 2.75X33MM XIENCE SIERRA STENT WAS OBSERVED. THERE WAS NO DEVICE MALFUNCTION. AS TREATMENT, ANOTHER STENT WAS IMPLANTED IN THE MID LAD. THE EVENT RESOLVED. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THIS ISSUE.

  Patient problems: Stenosis; Test Result

  MAUDE report 8837203 ↗
• InjuryJul 25, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A 2.75 X 33 MM XIENCE SIERRA STENT WAS IMPLANTED ON (B)(6) 2019, TO TREAT A LESION IN THE MID LEFT ANTERIOR DESCENDING (LAD) ARTERY. ON (B)(6) 2019, THE PATIENT WAS RE-HOSPITALIZED WITH MYOCARDIAL INFARCTION AND IN-STENT THROMBOSIS WAS NOTED WITHIN THE IMPLANTED STENT. MEDICATION WAS ADMINISTERED, AND A REVASCULARIZATION PROCEDURE WAS PERFORMED ON (B)(6) 2019, RESOLVING THE EVENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Myocardial Infarction; Thrombosis

  MAUDE report 8828862 ↗
• InjuryMar 8, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE INDEX PROCEDURE TOOK PLACE ON (B)(4) 2018 DURING WHICH A 2.75 X 33 MM XIENCE SIERRA STENT WAS IMPLANTED FOR TREATMENT OF AN UNSPECIFIED VESSEL. THE PATIENT WAS READMITTED TO THE HOSPITAL ON (B)(6) 2018 FOR ACUTE PANCREATITIS AND OTHER UNSPECIFIED CARDIOVASCULAR SYMPTOMS. UNSPECIFIED TREATMENT WAS ADMINISTERED TO THE PATIENT. FINAL PATIENT OUTCOME IS REPORTEDLY UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Unspecified Infection

  MAUDE report 8404056 ↗
• InjuryMar 6, 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 CAME IN WITH ANGINA AND WAS TREATED WITH TWO XIENCE SIERRA STENTS (2.75X33, 2.75X38) IN THE LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY. AFTER POST DILATATION OF THE LAD, THE DIAGONAL ARTERY SIDE BRANCH BECAME OCCLUDED PRESUMABLY DUE TO PLAQUE SHIFTING AND A MYOCARDIAL INFARCTION WITH CHEST PAIN OCCURRED. A BOLUS OF AGGRASTAT MEDICATION WAS GIVEN. THE CHEST PAIN RESOLVED AND THE PATIENT WAS DISCHARGED ON (B)(6) 2019. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina; Myocardial Infarction; Prolapse

  MAUDE report 8396898 ↗
• MalfunctionMar 1, 2019Improper or Incorrect Procedure or Method; Device Dislodged or Dislocated; Improper or Incorrect Procedure or Method; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A CONCENTRIC LESION IN THE PROXIMAL TO MID LEFT ANTERIOR DESCENDING CORONARY ARTERY WITH MILD TORTUOSITY, MILD CALCIFICATION AND 99% STENOSIS. A 2.75 X 33 MM XIENCE SIERRA STENT DELIVERY SYSTEM (SDS) WAS ATTEMPTED TO BE ADVANCED WITH NO REPORTED RESISTANCE; HOWEVER, ON ANGIOGRAPHY IT WAS NOTED THAT THE STENT WAS NOT MOUNTED ON THE BALLOON AND HAD DISLODGED IN THE GUIDING CATHETER. THE DISLODGED STENT WAS RETRIEVED BY SIMPLY REMOVING THE GUIDING CATHETER, AND THE PROCEDURE SUCCESSFULLY COMPLETED WITH A NEW 2.75 X 33MM XIENCE SIERRA SDS. ON REVIEW OF ANGIOGRAPHY ONE DAY POST PROCEDURE, IT WAS NOTED THAT THE SDS HAD INADVERTENTLY BEEN DILATED DURING THE PROCEDURE, AND THE STENT WAS NO LONGER MOUNTED ON THE BALLOON DURING ADVANCEMENT TO THE LESION. 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 8383943 ↗
• InjuryFeb 4, 2019Defective Device; Device Damaged by Another Device; Defective Device; Device Damaged by Another Device

  IT WAS REPORTED THAT DURING A PROCEDURE OF THE HEAVILY TORTUOUS, NON-CALCIFIED, MID LEFT ANTERIOR DESCENDING (LAD) ARTERY AND THE DIAGONAL ARTERY, THE XIENCE SIERRA STENT WAS IMPLANTED WITHOUT ISSUE. WHILE ATTEMPTING TO REMOVE THE NON-ABBOTT GUIDE WIRE IN THE LAD, RESISTANCE WAS MET AS THE WIRE WAS JAILED UNDER THE STENT. THE WIRE BECAME DETACHED; THE STENT WAS FORESHORTENED AND GROSSLY DEFORMED IN THE VESSEL. THE PATIENT WAS TRANSFERRED TO SURGERY, PLACED ON A BALLOON PUMP AND CORONARY ARTERY BYPASS WAS PERFORMED. THE PATIENT WAS REPORTED TO BE IN CRITICAL CONDITION, BUT WAS BEING WEANED FROM THE BALLOON PUMP. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8303525 ↗