XIENCE Sierra™ 1550325-12Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 08717648227325), received between Sep 20, 2018 and Dec 9, 2020 — classified as 1 death, 6 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (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.

• DeathDec 9, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2020 THE 3.25X12 MM XIENCE SIERRA STENT WAS IMPLANTED IN THIS PATIENT WHO HAD A NON ST ELEVATION MYOCARDIAL INFARCTION (NSTEMI). ON (B)(6) 2020 THE PATIENT WAS RE-ADMITTED TO THE HOSPITAL WITH HYPERTENSIVE HEART, CHRONIC KIDNEY DISEASE WITH HEART FAILURE (STAGE 5 END STAGE RENAL DISEASE). THE PATIENT HAD CHEST PAIN. THE PATIENT WAS TREATED WITH URINARY FILTRATION AND DISCHARGED TO HOME HEALTH ON (B)(6) 2020. ON (B)(6) 2020 THE PATIENT WAS RE-ADMITTED TO THE HOSPITAL WITH ACUTE RESPIRATORY FAILURE WITH HYPOXIA. THE PATIENT HAD CHEST DISCOMFORT. THE PATIENT WAS PLACED ON RESPIRATORY VENTILATION UNTIL THE PATIENT EXPIRED ON (B)(6) 2020. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina; Death; Heart Failure; High Blood Pressure/ Hypertension

  MAUDE report 10976569 ↗
• InjuryDec 2, 2020Adverse 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 3.25X12 MM XIENCE SIERRA STENT IMPLANTED. ON (B)(6) 2020 THE PATIENT WAS RE-HOSPITALIZED DUE TO OTHER CARDIOVASCULAR SYMPTOMS AND NON ST-ELEVATION MYOCARDIAL INFARCTION. THE TYPE OF TREATMENT WAS UNSPECIFIED AND THE FINAL PATIENT OUTCOME IS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Myocardial Infarction

  MAUDE report 10935527 ↗
• InjuryNov 19, 2020Adverse 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 TO TREAT A LESION IN THE MID RIGHT CORONARY ARTERY (RCA). THE 3.25 X 12 MM XIENCE SIERRA STENT DELIVERY SYSTEM WAS ADVANCED AND THE STENT WAS IMPLANTED WITHOUT ISSUE. POST IMPLANT OPTICAL COHERENCE TOMOGRAPHY SHOWED A DISTAL DISSECTION. NO TREATMENT WAS PROVIDED AND THE EVENT RESOLVED THE SAME DAY. THERE WAS NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Intimal Dissection

  MAUDE report 10872168 ↗
• MalfunctionSep 4, 2020Difficult to Remove; Failure to Advance; Difficult to Remove; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED, HEAVILY TORTUOUS DE NOVO DISTAL RIGHT CORONARY ARTERY THAT IS 90% STENOSED. AFTER PRE-DILATATION A 3.25X12MM XIENCE SIERRA WAS ATTEMPTED TO ADVANCE BUT FAILED DUE TO RESISTANCE WITH PATIENT'S ANATOMY. IT WAS ALSO NOTED RESISTANCE WAS MET DURING REMOVAL WITH THE LESION. ANOTHER NON-ABBOT STENT WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. 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 10494967 ↗
• InjuryMar 8, 2020Adverse 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 ATHEROSCLEROTIC HEART DISEASE. A 3.25X12MM XIENCE SIERRA STENT WAS IMPLANTED. ON (B)(6) 2019 THE PATIENT WAS RE-HOSPITALIZED WITH CHEST PAIN. IT IS UNKNOWN WHAT TREATMENT WAS PERFORMED AND WHAT THE FINAL PATIENT OUTCOME WAS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina

  MAUDE report 9803951 ↗
• InjuryMar 8, 2020Adverse 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 NON-ST ELEVATED MYOCARDIAL INFARCTION (NSTEMI). TWO (3.25X12MM AND 3.25X15MM) XIENCE SIERRA STENTS WERE IMPLANTED. ON (B)(6) 2020 THE PATIENT WAS RE-HOSPITALIZED WITH GASTRO-ESOPHAGEAL REFLUX DISEASE. IT IS UNKNOWN WHAT TREATMENT WAS PERFORMED AND WHAT THE FINAL PATIENT OUTCOME WAS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 9803857 ↗
• InjuryDec 9, 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 NON-ST ELEVATED MYOCARDIAL INFARCTION (NSTEMI) THEREFORE THE 3.25X12MM XIENCE SIERRA WAS IMPLANTED. ON (B)(6) 2019 THE PATIENT WAS RE-ADMITTED WITH ATHEROSCLEROTIC HEART DISEASE. IT IS UNKNOWN WHAT TREATMENT WAS PERFORMED AND THE FINAL PATIENT OUTCOME IS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 9438450 ↗
• MalfunctionMar 12, 2019Break; Inflation Problem; Break; Inflation Problem

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE MODERATELY TORTUOUS CIRCUMFLEX ARTERY. THE HUB OF THE XIENCE SIERRA WAS CRACKED AND WOULD NOT HOLD PRESSURE TO INFLATE THE BALLOON. THE DEVICE WAS REMOVED WITHOUT ISSUE AND THE LESION WAS TREATED WITH A NEW DEVICE TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT OR A CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8413004 ↗
• InjuryDec 14, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2018, THE PATIENT UNDERWENT A CORONARY STENTING PROCEDURE, WITH IMPLANTATION OF A 3.25 X 12 MM XIENCE SIERRA STENT AND A 3.5 X 18 MM XIENCE SIERRA STENT. ON (B)(6) 2018, THE PATIENT RE-ADMITTED WITH CHEST PAIN AND THROMBOSIS WAS NOTED WITHIN THE IMPLANTED STENTS. A REVASCULARIZATION PROCEDURE WAS PERFORMED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina; Thrombosis

  MAUDE report 8166433 ↗
• MalfunctionSep 20, 2018Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE 3.25X12 XIENCE SIERRA STENT WAS IMPLANTED IN THE PROXIMAL LEFT ANTERIOR DESCENDING CORONARY ARTERY. AFTER STENT DEPLOYMENT, THE STENT DELIVERY SYSTEM (SDS) APPEARED TO BE FULLY DEFLATED, BUT THE SDS WAS DIFFICULT TO REMOVE FROM THE WELL APPOSED STENT. 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 7895765 ↗