XIENCE Sierra™ 1550325-18Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 08717648227349), received between Jul 17, 2019 and May 27, 2021 — classified as 7 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryMay 27, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A XIENCE SIERRA STENT WAS IMPLANTED ON (B)(6) 2021. THE PATIENT HAD PREVIOUSLY PRESENTED WITH HYPERTENSIVE HEART DISEASE/HEART FAILURE. ON (B)(6) 2021, THE PATIENT WAS RE-ADMITTED WITH OTHER CARDIOVASCULAR SYMPTOMS INCLUDING DIZZINESS AND GIDDINESS. TREATMENT PERFORMED WAS UNSPECIFIED AND THE FINAL PATIENT OUTCOME IS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Dizziness

  MAUDE report 11894850 ↗
• MalfunctionDec 17, 2020Improper or Incorrect Procedure or Method; Failure to Advance; Improper or Incorrect Procedure or Method; Failure to Advance

  THE RETURN GOODS LAB RECEIVED A CHIPBOARD BOX OF A 3.25X18MM XIENCE SIERRA WITH A NOTE STATING DEVICE FAILED TO CROSS; HOWEVER, DEVICE WAS NOT RETURNED. NO PATIENTS EFFECTS WERE REPORTED AND NO CLINICALLY SIGNIFICANT DELAY WAS REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. ANALYSIS OF THE RETURNED BOX, IDENTIFIED THE DEVICE WAS USED AFTER THE EXPIRATION DATE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11032590 ↗
• InjurySep 5, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 3.25X18MM XIENCE SIERRA STENT WAS IMPLANTED ON (B)(6) 2020. THE PATIENT PRESENTED WITH NON-ST ELEVATED MYOCARDIAL INFARCTION BEFORE THE PROCEDURE. ON (B)(6) 2020, THE PATIENT WAS RE-ADMITTED WITH PULMONARY EMBOLISM. UNSPECIFIED TREATMENT WAS PERFORMED, AND THE FINAL PATIENT OUTCOME IS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Pulmonary Embolism

  MAUDE report 10498061 ↗
• InjuryJul 22, 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 3.25X18MM XIENCE SIERRA STENT WAS IMPLANTED IN THE PROXIMAL LEFT CIRCUMFLEX (LCX) CORONARY ARTERY LESION AND A 3.0X18MM XIENCE SIERRA STENT WAS IMPLANTED IN THE 1ST OBTUSE MARGINAL LESION. STENT PLACEMENT ANGIOGRAPHIC APPEARANCE WAS DEEMED ACCEPTABLE WITH 0% DIAMETER STENOSIS AND NO COMPLICATION. ON (B)(6) 2020, THE PATIENT WAS HOSPITALIZED FOR CHEST PRESSURE/PAIN, EXPERIENCING SINCE (B)(6) 2020. IMAGING WAS PERFORMED AND IN-STENT RESTENOSIS WAS OBSERVED WITHIN THE LCX 3.25X18MM XIENCE SIERRA STENT. THERE WAS NO DEVICE MALFUNCTION. ANOTHER PERCUTANEOUS INTERVENTION WAS PERFORMED AS TREATMENT AND THE EVENT RESOLVED. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THIS ISSUE.

  Patient problems: Angina; Stenosis

  MAUDE report 10311578 ↗
• InjuryJun 12, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN AN UNSPECIFIED VESSEL. THE 3.25 X 18 MM XIENCE SIERRA STENT WAS IMPLANTED. FOUR DAYS POST STENTING PROCEDURE, THE PATIENT WAS RE-HOSPITALIZED WITH MYOCARDIAL INFARCTION. UNSPECIFIED TREATMENT WAS PROVIDED AND THE FINAL PATIENT OUTCOME IS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Myocardial Infarction

  MAUDE report 10151143 ↗
• MalfunctionApr 24, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING PREPARATION OF THE 3.25X18MM XIENCE SIERRA STENT DELIVERY SYSTEM (SDS), IT WAS NOTED THAT THE STENT WAS OFF CENTER [DISLODGED]. THE DEVICE WAS NOT USED AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A NON-ABBOTT STENT. THERE WAS NO REPORT OF CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 9998065 ↗
• InjuryMar 3, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT US (B)(6). IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED ON (B)(6) 2020, TREATING A TARGET LESION IN THE PROXIMAL AND MID LEFT ANTERIOR DESCENDING (LAD) ARTERY. A 2.5 X 38 MM XIENCE SIERRA STENT AND A 3.25 X 18 MM XIENCE SIERRA STENT WERE IMPLANTED WITHOUT ISSUE. ON (B)(6) 2020, THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT (ED) WITH LEFT SHOULDER PAIN AND A NON-ST ELEVATION MYOCARDIAL INFARCTION WAS DIAGNOSED. MEDICATION WAS ADMINISTERED. THE PATIENT REMAINED IN OBSERVATION WHILE IN THE ED, BUT WAS NEVER RE-HOSPITALIZED. THE EVENT RESOLVED ON (B)(6) 2020. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina; Myocardial Infarction

  MAUDE report 9782332 ↗
• InjuryJan 2, 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 3.25X18 MM XIENCE SIERRA STENT WAS IMPLANTED IN THE FIRST OBTUSE MARGINAL CORONARY ARTERY. ON (B)(6) 2019 THE PATIENT HAD CHEST PAIN AND WAS NOTED TO HAVE IN-STENT RESTENOSIS. ANOTHER STENT WAS PLACED TO TREAT THE RESTENOSIS. THE CONDITION RESOLVED AND THE PATIENT WAS DISCHARGED THE NEXT DAY ON (B)(6) 2019 IN STABLE CONDITION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina; Stenosis

  MAUDE report 9538375 ↗
• InjuryOct 28, 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 3.25X18MM XIENCE SIERRA STENT WAS SUCCESSFULLY IMPLANTED IN THE 1ST OBTUSE MARGINAL (OM) CORONARY ARTERY LESION. THERE WERE NO PROCEDURE COMPLICATIONS. ON (B)(6) 2019, THE PATIENT STARTED EXPERIENCING CHEST PAIN. ON (B)(6) 2019, PRESENTED TO THE EMERGENCY ROOM WITH CHEST PAIN AND WAS HOSPITALIZED. IN-STENT RESTENOSIS WAS OBSERVED. ANOTHER PERCUTANEOUS INTERVENTION WAS PERFORMED AT THE TARGET LESION SITE AS TREATMENT. THE EVENT RESOLVED. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THIS ISSUE.

  Patient problems: Angina; Stenosis

  MAUDE report 9246498 ↗
• MalfunctionJul 17, 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 PERFORMED TO TREAT A NON-TORTUOUS, NON-CALCIFIED, LEFT ANTERIOR DESCENDING LESION. WHILE THE 3.25X18MM XIENCE SIERRA STENT DELIVERY SYSTEM (SDS) WAS IN THE PATIENT, THE EXPIRATION DATE WAS NOTED AS EXPIRED (EXPIRATION DATE: 06/10/2019). THE SDS WAS REMOVED WITHOUT BEING DEPLOYED. A NEW SAME SIZE XIENCE SIERRA 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 8800130 ↗