XIENCE Sierra™ 1550325-28Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 08717648227363), received between Dec 20, 2018 and Jun 1, 2021 — classified as 4 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryJun 1, 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 HAD A 3.25X28 MM XIENCE SIERRA STENT IMPLANTED. THE PATIENT HAD PREVIOUSLY PRESENTED WITH NON ST ELEVATED MYOCARDIAL INFARCTION (NSTEMI). ON (B)(6) 2021 THE PATIENT WAS READMITTED TO THE HOSPITAL DUE TO NSTEMI AND OTHER CARDIOVASCULAR SYMPTOMS. BALLOON ANGIOPLASTY WAS REPORTED AS TREATMENT AND FINAL PATIENT OUTCOME IS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Myocardial Infarction

  MAUDE report 11917093 ↗
• InjuryMay 12, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT ID: (B)(6). IT WAS REPORTED THAT ON 10/18/2019, THE PATIENT PRESENTED FOR A PERCUTANEOUS CORONARY INTERVENTION. A 3.25X28MM XIENCE SIERRA STENT WAS IMPLANTED IN THE MID TO DISTAL LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY, 50% STENOSED LESION WITH ACCEPTABLE RESULTS. THERE WAS 0% RESIDUAL STENOSIS AND NO COMPLICATIONS. ON (B)(6) 2021, THE PATIENT PRESENTED WITH A POSITIVE STRESS TEST, EXERTIONAL DYSPNEA, AND 20% IN-STENT RESTENOSIS OF THE TARGET LESION, 3.25X28MM XIENCE SIERRA STENT. AS TREATMENT, ADDITIONAL ANGIOPLASTY WAS PERFORMED THAT DAY. THE EVENT DID NOT REQUIRE HOSPITALIZATION. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THIS ISSUE.

  Patient problems: Dyspnea; Stenosis

  MAUDE report 11815349 ↗
• MalfunctionMar 9, 2021Difficult to Remove; Failure to Advance; Material Deformation; Difficult to Remove; Failure to Advance; Material Deformation

  IT WAS REPORTED THAT PROCEDURE WAS PERFORMED TO TREAT A LESION WITH HEAVY CALCIFICATION AND MODERATE TORTUOSITY IN THE RIGHT CORONARY ARTERY (RCA). THE 3.25 X 28 MM XIENCE SIERRA STENT DELIVERY SYSTEM (SDS) WAS ADVANCED BUT THERE WAS RESISTANCE DUE TO THE HEAVY CALCIFICATION; THEREFORE, IT WAS DECIDED TO REMOVE THE SDS. WHEN THE SDS WAS BEING REMOVED THERE WAS ALSO RESISTANCE AND IT WAS NOTED THAT THE PROXIMAL STENTS WERE FLARED. A NEW SDS WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11446048 ↗
• MalfunctionFeb 16, 2021Improper 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 LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY. A 3.25 X 28 MM XIENCE SIERRA STENT DELIVERY SYSTEM (SDS) WAS ADVANCED WITHOUT ISSUE TO THE TARGET LESION AND THE STENT WAS IMPLANTED SUCCESSFULLY. ON (B)(6) 2021, IT WAS NOTED THAT THE STENT WAS EXPIRED. THE PATIENT IS DOING WELL. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11333345 ↗
• InjuryJan 23, 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, THE PATIENT UNDERWENT A CORONARY STENTING PROCEDURE TO TREAT A LESION IN THE PROXIMAL RIGHT CORONARY ARTERY (RCA). A 3.25 X 28 MM XIENCE SIERRA STENT WAS IMPLANTED WITHOUT ISSUE. ON (B)(6) 2020, THE PATIENT PRESENTED TO THE EMERGENCY ROOM WITH LIGHTHEADEDNESS AND STATED THEY HAD BEEN FEELING WEAK AND LIGHTHEADED SINCE THE STENTING PROCEDURE. ADDITIONALLY, BLOOD PRESSURE WAS LOW AND CARDIAC ENZYMES WERE ELEVATED. MYOCARDIAL INFARCTION WAS DIAGNOSED. MEDICATIONS WERE ADMINISTERED. CARDIOLOGY WAS CONSULTED AND ANGIOGRAPHY WAS PERFORMED, REVEALING SEVERE IN-STENT RESTENOSIS AND THROMBOSIS. INTRAVENOUS ULTRASOUND (IVUS) NOTED PROLAPSED CALCIFIC PLAQUE THROUGH THE STENT STRUTS. REVASCULARIZATION WAS PERFORMED ON (B)(6) 2020, WITH ANGIOPLASTY, STENT IMPLANTATION AND ASPIRATION THROMBECTOMY. THE EVENT RESOLVED ON (B)(6) 2020. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Dizziness; Low Blood Pressure/ Hypotension; Myocardial Infarction; Prolapse; Stenosis; Thrombosis

  MAUDE report 9624121 ↗
• InjurySep 3, 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 WAS TREATED WITH A 3.25X28 MM XIENCE SIERRA STENT. ON (B)(6) 2019, THE PATIENT WAS RE-ADMITTED WITH ATHEROSCLEROSIS AND OTHER CARDIOVASCULAR SYMPTOMS. THE TYPE OF TREATMENT WAS UNSPECIFIED AND THE FINAL PATIENT OUTCOME IS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8958051 ↗
• MalfunctionJan 30, 2019Failure to Advance; Device Dislodged or Dislocated; Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED LESION LOCATED IN THE CORONARY ARTERY. THE 3.25X28 MM XIENCE SIERRA STENT DELIVERY SYSTEM (SDS) MET RESISTANCE DURING ADVANCEMENT AND FAILED TO CROSS THE LESION DUE TO THE CALCIFICATION. AFTER SOME MANIPULATION, THE IMAGE SUGGESTED THAT THE STENT WAS NOT ON THE PROPER POSITION ON THE BALLOON OF THE SDS. THE SDS WAS REMOVED FROM THE ANATOMY WITHOUT RESISTANCE AND IT WAS NOTED THAT THE STENT WAS NOT ON THE PROPER POSITION ON THE BALLOON. THE STENT WAS CONFIRMED TO HAVE MOVED, BUT REMAINED TIGHTLY CRIMPED. THE SDS WAS REPLACED WITH ANOTHER XIENCE STENT TO CONTINUE TO COMPLETE THE PROCEDURE. 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 8288842 ↗
• MalfunctionDec 20, 2018Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY TORTUOUS RIGHT CORONARY ARTERY. A 3.25 X 28 MM XIENCE SIERRA STENT WAS IMPLANTED ALONG WITH 3 OTHER UNSPECIFIED XIENCE SIERRA STENTS WITHOUT ANY DEVICE ISSUES. AS A GAP WAS NOTED BETWEEN 2 STENTS, A 2.25 X 15 MM XIENCE SIERRA STENT WAS ADVANCED TO THE LESION; HOWEVER, THE STENT BECAME CAUGHT WITH THE 3.25 X 28 MM SIERRA STENT. IT WAS NOTED UNDER ANGIOGRAPHY THAT THE 3.25 X 28 MM SIERRA STENT WAS NOT DAMAGED. THE 2.25 X 15 MM SIERRA STENT DELIVERY SYSTEM (SDS) WAS THEN MOVED BACK AND FORTH TO REMOVE THE STENT, AND IT DISLODGED. THEREFORE, AN UNSPECIFIED TREK AND A 1.5 X 12 MM MINI TREK BALLOON CATHETER WERE USED TO CRUSH THE STENT TO THE 3.25 X 28 MM STENT. POST-DILATATION WAS THEN PERFORMED WITH A 3.5 X 15 MM NC TREK BALLOON CATHETER TO SUCCESSFULLY COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8184322 ↗