XIENCE Sierra™ 1550225-23Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 08717648227035), received between Jul 30, 2018 and Oct 26, 2021 — classified as 12 injuries, 3 malfunctions.

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

• InjuryOct 26, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE MODERATELY CALCIFIED, MILDLY TORTUOUS PROXIMAL LEFT ANTERIOR DESCENDING CORONARY ARTERY. A 2.25X23MM XIENCE SIERRA STENT DELIVERY SYSTEM (SDS) WAS BEING ADVANCED WITHOUT RESISTANCE WHEN THE STENT DISLODGED, SO A SNARE WAS USED TO RETRIEVE THE DISLODGED STENT WITHOUT ISSUE. A 2.25X24MM NON-ABBOTT STENT WAS 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 12698914 ↗
• InjuryJul 21, 2021Adverse 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 LOCATED IN THE LEFT ANTERIOR DESCENDING CORONARY ARTERY. POST IMPLANT OF THE STENT, ACUTE STENT THROMBOSIS WAS CONFIRMED WITH ANGIOGRAPHY. PATIENT WAS SUCCESSFULLY TREATED WITH A BALLOON. THERE WAS NO ADVERSE PATIENT SEQUELA OR A CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 12203706 ↗
• InjuryJul 12, 2021Difficult to Remove; Failure to Advance; Device Dislodged or Dislocated; Difficult to Remove; Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY TORTUOUS, MODERATELY CALCIFIED CIRCUMFLEX ARTERY. A 2.25X23MM XIENCE SIERRA STENT DELIVERY SYSTEM (SDS) FAILED TO CROSS. DURING REMOVAL OF THE SDS RESISTANCE WAS MET WITH THE UNSPECIFIED GUIDE LINER AND THE STENT DISLODGED. IT IS UNCLEAR WHETHER THE STENT WAS BEING PULLED BACK INTO THE GUIDE LINER, OR IF THE GUIDE LINER WAS BEING ADVANCED OVER THE STENT. THE STENT WAS CRUSHED INTO THE VESSEL WALL BETWEEN THE LEFT MAIN AND CIRCUMFLEX WITH TWO ADDITIONAL XIENCE SIERRA STENTS. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 12150070 ↗
• MalfunctionJul 5, 2021Difficult to Remove; Failure to Advance; Difficult to Remove; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE LEFT CIRCUMFLEX ARTERY THAT WAS MILDLY CALCIFIED AND HEAVILY TORTUOUS. AFTER LESION PRE-DILATATION, THE XIENCE SIERRA DEVICE WAS ATTEMPTED TO BE ADVANCED BUT DID NOT CROSS DUE TO THE PATIENT¿S ANATOMY. DURING REMOVAL, RESISTANCE WAS MET. THERE WAS NO ADVERSE PATIENT EFFECT OR A CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. A DRUG COATED BALLOON (DCB) WAS USED TO COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12119312 ↗
• InjuryDec 8, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2020, A 2.25X23MM XIENCE SIERRA STENT WAS IMPLANTED. ON (B)(6) 2020, THE PATIENT WAS READMITTED FOR HYPERTENSIVE HEART DISEASE AND UNSPECIFIED TREATMENT WAS PROVIDED. THE DEVICE RELATIONSHIP TO THE EVENT WAS NOT PROVIDED. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THIS ISSUE.

  Patient problems: High Blood Pressure/ Hypertension

  MAUDE report 10969991 ↗
• InjuryMar 24, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED AND MILDLY TORTUOUS LESION IN THE MID LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE 2.25X23MM XIENCE SIERRA STENT WAS IMPLANTED WITHOUT ISSUE. POST PROCEDURE, WHEN LEAVING THE CATH LAB, THE PATIENT EXPERIENCED CHEST PAIN. THE PATIENT WAS BROUGHT BACK AND ANGIOGRAPHY REVEALED THROMBOSIS INSIDE THE SIERRA STENT. ANGIOPLASTY WAS PERFORMED WITH A 2.75MM BALLOON AS TREATMENT. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND NO ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina; Thrombosis

  MAUDE report 9875494 ↗
• InjuryFeb 17, 2020Break; Break

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE CIRCUMFLEX ARTERY. ON (B)(6) 2019, A 2.25X12MM (DISTAL), 2.25X23MM (MIDDLE), AND 2.50X28MM (PROXIMAL) XIENCE SIERRA STENTS WERE DEPLOYED. ON (B)(6) 2020, THE PATIENT WAS RE-ADMITTED FOR IN-STENT RESTENOSIS. BALLOONING WAS PERFORMED TO TREAT THE STENOSIS; HOWEVER, WHILE BALLOONING THE 2.25X23MM IMPLANTED STENT, THE STENT FRACTURED. A 2.5X15MM NON-ABBOTT STENT WAS DEPLOYED TO TREAT THE FRACTURE, BUT THIS CAUSED A PERFORATION. A SECOND NON-ABBOTT STENT WAS USED TO SUCCESSFULLY TREAT THE PERFORATION. THERE WERE NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Perforation; Stenosis

  MAUDE report 9717897 ↗
• InjuryFeb 6, 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) 2019, A 2.25X23MM XIENCE SIERRA STENT (1550225-23, 8091341) WAS SUCCESSFULLY IMPLANTED IN THE MID LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY. THERE WERE NO PROCEDURE COMPLICATIONS. ON (B)(6) 2019, THE PATIENT PRESENTED WITH DYSPNEA AND FOR DIAGNOSTIC IMAGING. IMAGING DISPLAYED 90% STENOSIS IN A MID- LAD VEIN GRAFT AND THE 2.25X23MM XIENCE SIERRA STENT HAD 5% STENOSIS. THE PATIENT WAS SENT FOR ANOTHER PERCUTANEOUS CORONARY INTERVENTION AND ANOTHER STENT WAS IMPLANTED IN THE MID LAD VEIN GRAFT AND WITHIN 5MM OF THE 2.25X23MM XIENCE SIERRA STENT. THE EVENT RESOLVED. PER PHYSICIAN, THE EVENT WAS UNRELATED TO THE XIENCE SIERRA STENT AND UNRELATED TO THE INDEX PROCEDURE. PER PHYSICIAN, THE DYSPNEA WAS RELATED TO THE PATIENTS AORTIC STENOSIS AND UNRELATED TO THE CORONARY ARTERY DISEASE. THERE WAS NO DEVICE MALFUNCTION. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THIS ISSUE.

  Patient problems: Stenosis

  MAUDE report 9678595 ↗
• InjurySep 5, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 2.25X23MM XIENCE SIERRA STENT WAS IMPLANTED ON (B)(6) 2019. THE PATIENT PRESENTED WITH NON-ST-ELEVATION MYOCARDIAL INFARCTION (NSTEMI) BEFORE THE PROCEDURE. ON (B)(6) 2019 AND (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 8967753 ↗
• InjurySep 5, 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)(6) 2019 DURING WHICH A 2.25 X 23 MM XIENCE SIERRA STENT WAS IMPLANTED FOR TREATMENT OF AN UNSPECIFIED VESSEL. THE PATIENT WAS READMITTED TO THE HOSPITAL ON (B)(6) 2019 FOR SEPSIS 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: Sepsis

  MAUDE report 8966944 ↗
• InjurySep 5, 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 A NON-ST-ELEVATION MYOCARDIAL INFARCTION AND THREE (2.25X23MM, 2.5X18MM AND 2.75X18MM) XIENCE SIERRA STENTS WERE IMPLANTED. ON (B)(6) 2019, THE PATIENT WAS RE-ADMITTED WITH UNSPECIFIED CARDIOVASCULAR SYMPTOMS AND MALAISE. UNSPECIFIED TREATMENT WAS PROVIDED AND THE FINAL PATIENT OUTCOME IS NOT KNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Pain

  MAUDE report 8965303 ↗
• MalfunctionMay 30, 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 WAS TO TREAT A DE NOVO, CHRONIC TOTAL OCCLUSION OF THE 1ST OBTUSE MARGINAL CORONARY ARTERY. THE 2.25X23 MM XIENCE SIERRA STENT WAS ADVANCED AND SUCCESSFULLY IMPLANTED. HOWEVER, AFTER THE PROCEDURE, IT WAS NOTED THAT THE EXPIRATION DATE OF THE DEVICE WAS 05/09/2019. THERE WERE NO ADVERSE PATIENT EFFECTS AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8656365 ↗
• InjuryMar 22, 2019Difficult to Remove; Failure to Advance; Device Damaged by Another Device; Device Dislodged or Dislocated; Difficult to Remove; Failure to Advance; Device Damaged by Another Device; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE MID CIRCUMFLEX CORONARY ARTERY WITH MODERATE TORTUOSITY AND MODERATE CALCIFICATION. A 2.25 X 23 MM XIENCE SIERRA STENT DELIVERY SYSTEM WAS ADVANCED; HOWEVER, COULD NOT CROSS THE LESION DUE TO MEETING RESISTANCE WITH A PREVIOUSLY CRUSHED STENT IN THE PROXIMAL CIRCUMFLEX ARTERY. ON ATTEMPTING TO REMOVE THE SDS, RESISTANCE WITH A NON-ABBOTT GUIDE CATHETER EXTENSION, A GUIDE CATHETER AND THE ANATOMY WAS MET AND THE STENT DISLODGED. AN UNSPECIFIED TREK BALLOON DILATATION CATHETER WAS ADVANCED TO CRUSH THE STENT INTO THE VESSEL WALL. THE TIP OF A NON-ABBOTT GUIDE WIRE BECAME TRAPPED BEHIND THE CRUSHED STENT AND WHEN THE GUIDE WIRE WAS ATTEMPTED TO BE REMOVED WITH NO REPORTED FORCE, A TIP SEPARATION OCCURRED. A NON-ABBOTT STENT WAS DEPLOYED TO EMBED THE DISLODGED STENT FURTHER INTO THE VESSEL WALL AND TRAP THE TIP OF THE SEPARATED GUIDE WIRE. THE PROCEDURE WAS COMPLETED WITH THE SUCCESSFUL DEPLOYMENT OF A 2.5 X 18 MM XIENCE SIERRA STENT AT THE TARGET LESION. INTRA- PROCEDURE ECHO WAS COMPLETED AND RESULTS INDICATED THE PATIENT HAD AN ECHO EJECTION FRACTION OF 50-55% AND A TRACE TO SMALL INFERIOR LATERAL PERICARDIAL

  Patient problems: Vessel Or Plaque, Device Embedded In

  MAUDE report 8445445 ↗
• InjuryDec 18, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD THREE XIENCE SIERRA STENTS (2.25X23 MM (X2), 2.50X12 MM) IMPLANTED IN AN UNSPECIFIED CORONARY ARTERY ON (B)(6) 2018 AND HAS NOT BEEN ABLE TO SLEEP, FEELING DIZZY AND LIGHT HEADED, SHORTNESS OF BREATH, CHEST PAIN AND ACCESS SITE TENDERNESS IN THE FEMORAL ARTERY SINCE THE PROCEDURE. THE PATIENT DOES NOT HAVE ANY KNOWN ALLERGIES TO METAL. ON (B)(6) 2018 THE PATIENT WENT TO THE EMERGENCY ROOM AND ECHOCARDIOGRAM WAS PERFORMED. NO FURTHER INTERVENTION WAS PERFORMED AS THE PAIN WAS REPORTED TO BE LIKELY FROM HEALING FROM THE STENTS BEING IMPLANTED. THE PATIENT WAS GIVEN NITROGLYCERIN FOR THE CHEST PAIN AND DISCHARGED FROM THE HOSPITAL ON (B)(6) 2018. AS OF (B)(6) 2018, THE PATIENT IS FEELING BETTER BUT STILL EXPERIENCING SHORTNESS OF BREATH. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina; Dizziness; Dyspnea; Pain

  MAUDE report 8175253 ↗
• MalfunctionJul 30, 2018Material Rupture; Improper or Incorrect Procedure or Method; Material Rupture; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A CONCENTRIC AND DE NOVO LESION IN THE DISTAL RIGHT CORONARY ARTERY WITH NO CALCIFICATION AND NO TORTUOSITY THAT WAS 90% STENOSED. AFTER PRE-DILATATION WAS PERFORMED, A 2.25 X 23 MM XIENCE SIERRA STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TO THE TARGET LESION. THE BALLOON WOULD NOT INFLATE WHEN A CONTRAST LEAK WAS OBSERVED [MATERIAL RUPTURE]. REPORTEDLY, AN ATTEMPT WAS MADE TO INFLATE THE BALLOON OUTSIDE THE PATIENT AND THE DISTAL PORTION OF THE BALLOON WAS LEAKING. THE SDS WAS RETRACTED WITH THE STENT AND A 2.25 X 24 MM NON-ABBOTT STENT WAS 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 7731300 ↗