XIENCE Sierra™ 1550225-08Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 08717648226991), received between Aug 5, 2019 and Dec 6, 2021 — classified as 6 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryDec 6, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE INDEX PROCEDURE ON (B)(6) 2020, WAS TO TREAT A MILDLY TORTUOUS, MILDLY CALCIFIED MID LEFT ANTERIOR DESCENDING ARTERY (LAD) . A 2.25X08MM XIENCE SIERRA STENT DELIVERY SYSTEM WAS IMPLANTED WITHOUT ISSUE. ONE MONTH AFTER THE INDEX PROCEDURE THE TWO DUAL ANTIPLATELET DRUG THERAPY WAS DISCONTINUED AND ONE DIRECT ORAL ANTICOAGULANT (DOAC) WAS PRESCRIBED. AT THE 12 MONTH FOLLOW-UP THE ONE DOAC WAS CONTINUED. ON (B)(6) 2021, REVASCULARIZATION WAS PERFORMED [IN-STENT RESTENOSIS]. A CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE WAS NOT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Stenosis

  MAUDE report 12934735 ↗
• InjuryMar 2, 2021Adverse 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 HAD A 2.25X8 MM XIENCE SIERRA STENT IMPLANTED. ON (B)(6) 2020 THE PATIENT WAS RE-HOSPITALIZED DUE TO OTHER CARDIOVASCULAR SYMPTOMS INCLUDING SEPSIS. THE TYPE OF TREATMENT WAS UNSPECIFIED AND THE FINAL PATIENT OUTCOME IS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Sepsis

  MAUDE report 11401844 ↗
• InjuryJan 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(6). IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED ON (B)(6) 2020, TREATING TARGET LESIONS IN THE RAMUS ARTERY AND THE OBTUSE MARGINAL ARTERY. TWO XIENCE SIERRA STENTS, A 2.25 X 8 MM STENT AND A 3.0 X 8 MM STENT, WERE IMPLANTED IN THE RAMUS AND A 3.0 X 8 MM STENT WAS IMPLANTED IN THE OBTUSE MARGINAL. ON (B)(6) 2020, THE PATIENT PRESENTED WITH ANGINA. CARDIAC CATHETERIZATION WAS PERFORMED ON (B)(6) 2020 AND SHOWED IN-STENT RESTENOSIS IN THE RAMUS, AT THE SITE WHERE THE 2.25 X 8 MM XIENCE SIERRA WAS IMPLANTED. REVASCULARIZATION WAS PERFORMED, WITH IMPLANT OF A 2.5 X 8 MM XIENCE SIERRA STENT. ADDITIONALLY, THE PROXIMAL CIRCUMFLEX (CX) ARTERY STENOSIS WAS NOTED TO HAVE WORSENED AND A 3.5 X 8 MM UNSPECIFIED STENT WAS IMPLANTED. THE PATIENT CONDITION RESOLVED ON (B)(6) 2020. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: Angina; Stenosis

  MAUDE report 11133743 ↗
• MalfunctionNov 24, 2020Improper or Incorrect Procedure or Method; Difficult to Advance; Device Dislodged or Dislocated; Improper or Incorrect Procedure or Method; Difficult to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A NARROW DIAGONAL ARTERY. A 2.25X08MM UNSPECIFIED XIENCE SIERRA WAS ADVANCED PAST A NEWLY DEPLOYED XIENCE SIERRA IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY WITH SOME RESISTANCE. IT WAS ATTEMPTED TO DEPLOY THE STENT; HOWEVER THE STENT DID NOT APPEAR IN THE ANGIOGRAM ONCE THE BALLOON WAS INFLATED. DURING REMOVAL OF THE STENT DELIVERY SYSTEM, RESISTANCE WAS MET WITH THE PREVIOUSLY IMPLANTED XIENCE SIERRA. ALL DEVICES, GUIDE CATHETER, GUIDE WIRE AND STENT DELIVERY SYSTEM WERE REMOVED. ONCE OUTSIDE OF THE ANATOMY THE DEVICES WERE FLUSHED AND THE STENT WAS RECOVERED. IT WAS NOTED THE STENT HAD DISLODGED FROM THE BALLOON. 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 10891271 ↗
• MalfunctionOct 23, 2020Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE MID SECOND DIAGONAL CORONARY ARTERY. A 2.25X8MM XIENCE SIERRA STENT WAS IMPLANTED ON (B)(6) 2020, AND AFTER THE PROCEDURE, IT WAS NOTED THAT THE EXPIRATION DATE WAS (B)(6) 2020. 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 10730471 ↗
• InjuryDec 10, 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 FOUR XIENCE SIERRA STENTS WERE IMPLANTED (2.25X08MM, 2.50X08MM, 2.50X15MM, 2.75X15MM). ON 8/22/2019 THE PATIENT WAS RE-ADMITTED WITH ATHEROSCLEROTIC HEART DISEASE. PLAIN OLD BALLOON ANGIOPLASTY (POBA) WAS PERFORMED HOWEVER THE FINAL PATIENT OUTCOME IS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 9447118 ↗
• MalfunctionNov 13, 2019Difficult 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 OSTIAL LEFT CIRCUMFLEX ARTERY WITH MODERATE TORTUOSITY AND MILD CALCIFICATION. AFTER A FAILED ATTEMPT TO CROSS, WHEN THE STENT DELIVERY SYSTEM WAS BEING REMOVED, IT MET RESISTANCE WITH THE GUIDING CATHETER. BOTH DEVICES WERE REMOVED TOGETHER AS A SINGLE UNIT. UPON REMOVAL, THE STENT STRUTS WERE OBSERVED TO BE FLARED. DILATATION WITH A BALLOON WAS PERFORMED TO COMPLETE THE PROCEDURE. THERE WERE NO REPORTED 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 9319275 ↗
• InjurySep 13, 2019Improper or Incorrect Procedure or Method; Failure to Advance; Device Dislodged or Dislocated; Improper or Incorrect Procedure or Method; Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A TORTUOUS AND CALCIFIED LESION OF THE FIRST DIAGONAL CORONARY ARTERY. POST THE DEPLOYMENT OF A 2.25 X 18 MM XIENCE SIERRA STENT, A DISTAL EDGE DISSECTION WAS NOTED. A 2.25 X 08 XIENCE SIERRA STENT DELIVERY SYSTEM (SDS) WAS ATTEMPTED TO BE ADVANCED THROUGH THE DEPLOYED STENT TO TREAT THE DISSECTION; HOWEVER, RESISTANCE WAS MET AND THE 2.25 X 08 XIENCE SIERRA STENT DISLODGED FROM THE SDS AT THE PROXIMAL PART OF THE DEPLOYED STENT. NEGATIVE PRESSURE HAD BEEN APPLIED TO THE SDS. THE GUIDE WIRE WAS INADVERTENTLY PULLED OUT OF THE DIAGONAL AND ON RE-WIRING THE LESION, THE WIRE PASSED BEHIND THE DISLODGED STENT STRUTS NOT THROUGH THE STENT. THE STENT WAS THEREFORE CRUSHED INTO THE PROXIMAL SEGMENT OF THE STENTED VESSEL WITH AN UNSPECIFIED BALLOON CATHETER. THE PATIENT REPORTEDLY TOLERATED THE PROCEDURE WELL. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Vessel Or Plaque, Device Embedded In

  MAUDE report 9050798 ↗
• InjuryAug 5, 2019Adverse 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) 2019, A 2.25X8MM XIENCE SIERRA STENT WAS IMPLANTED IN THE PROXIMAL CIRCUMFLEX (CX) LESION WITHOUT A DEVICE DEFICIENCY. DURING STENT DEPLOYMENT, A PLAQUE SHIFT OCCURRED FROM THE PROXIMAL CX TO THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY. BALLOON ANGIOPLASTY WAS PERFORMED AS TREATMENT AND THE EVENT RESOLVED. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL THAT SAME DAY. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THIS ISSUE.

  Patient problems: Prolapse

  MAUDE report 8860243 ↗