XIENCE Sierra™ 1550325-15Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 08717648227332), received between Dec 10, 2018 and Mar 8, 2020 — classified as 10 injuries, 1 malfunction.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (1 report).

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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• 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 ST ELEVATED MYOCARDIAL INFARCTION (STEMI), TWO (3.25X15MM, 3.50X08MM) XIENCE SIERRA STENTS WERE IMPLANTED. ON (B)(6) 2020 THE PATIENT WAS RE-HOSPITALIZED WITH THROMBOSIS. PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY WAS PERFORMED. THE FINAL PATIENT OUTCOME IS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Thrombosis

  MAUDE report 9803847 ↗
• InjuryMar 4, 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) THEREFORE THE 3.25X15MM, 3.25X38MM, AND 3.50X38MM XIENCE SIERRA STENTS WERE IMPLANTED. ON (B)(6) 2019 THE PATIENT WAS RE-ADMITTED WITH OTHER [UNSPECIFIED] CARDIOVASCULAR SYMPTOMS AND ARTERY COMPLICATIONS. PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) WAS PERFORMED HOWEVER THE FINAL PATIENT OUTCOME IS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 9787768 ↗
• 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 ST ELEVATED MYOCARDIAL INFARCTION (STEMI) THEREFORE THE 3.25X15MM XIENCE SIERRA WAS IMPLANTED. ON (B)(6) 2019, (B)(6) 2019, AND (B)(6) 2019 THE PATIENT WAS RE-ADMITTED WITH SHORTNESS OF BREATH, HYPERTENSIVE HEART, STENOSIS LARYNX. IT IS UNKNOWN WHAT TREATMENT WAS PERFORMED AND THE FINAL PATIENT OUTCOME IS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Dyspnea; No Code Available

  MAUDE report 9439333 ↗
• InjurySep 5, 2019Adverse 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) 2019. ON (B)(6) 2019, THE PATIENT WAS RE-ADMITTED WITH GASTROPARESIS AND OTHER CARDIOVASCULAR SYMPTOMS. UNSPECIFIED TREATMENT WAS ADMINISTERED TO THE PATIENT. FINAL PATIENT OUTCOME IS REPORTEDLY UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8965966 ↗
• InjuryJun 14, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 3.25X15MM XIENCE SIERRA STENT WAS IMPLANTED ON (B)(6) 2018. THE PATIENT PRESENTED WITH VENTRICULAR FIBRILLATION BEFORE THE PROCEDURE. ON (B)(6) 2019, THE PATIENT WAS READMITTED WITH CARDIOVASCULAR SYMPTOMS INCLUDING A NON-DISPLACED TYPE 2 FRACTURE. TREATMENT PERFORMED WAS UNSPECIFIED AND THE FINAL PATIENT OUTCOME IS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8700473 ↗
• InjuryApr 18, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2019, A PERCUTANEOUS CORONARY INTERVENTION WAS PERFORMED. A 3.25X15MM XIENCE SIERRA STENT WAS SUCCESSFULLY IMPLANTED IN THE MID LEFT ANTERIOR DESCENDING (LAD) LESION. THERE WERE NO PROCEDURE COMPLICATIONS. ON (B)(6) 2019, THE PATIENT EXPERIENCED CHEST PAIN AND SHORTNESS OF BREATH. ELEVATED TROPONIN WAS NOTED. AS TREATMENT, MEDICATIONS WERE PROVIDED AND REQUIRED PROLONGED HOSPITALIZATION. THE EVENT RESOLVED WITHOUT SEQUELA. THERE WAS NO DEVICE MALFUNCTION. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THIS ISSUE.

  Patient problems: Angina; Cardiac Enzyme Elevation; Dyspnea

  MAUDE report 8528240 ↗
• InjuryMar 8, 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) 2018 DURING WHICH A 3.25 X 15 MM XIENCE SIERRA STENT WAS IMPLANTED FOR TREATMENT OF AN UNSPECIFIED VESSEL. THE PATIENT WAS READMITTED TO THE HOSPITAL ON (B)(6) 2019 FOR CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD) 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: No Code Available

  MAUDE report 8404130 ↗
• InjuryFeb 27, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 3.25X15MM XIENCE SIERRA STENT WAS IMPLANTED ON (B)(6) 2018. ON (B)(6) 2018, THE PATIENT WAS RE-ADMITTED FOR A CHEST PAIN AND OTHER UNSPECIFIED CARDIO VASCULAR SYMPTOMS. UNSPECIFIED TREATMENT WAS ADMINISTERED TO THE PATIENT. FINAL PATIENT OUTCOME IS REPORTEDLY UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina

  MAUDE report 8374641 ↗
• InjuryFeb 25, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 3.25 X 15 MM XIENCE SIERRA STENT WAS IMPLANTED ON (B)(6) 2018. ON (B)(6) 2018 THE PATIENT WAS READMITTED WITH UNSPECIFIED CARDIOVASCULAR SYMPTOMS IN ADDITION TO ACUTE CYSTITIS WITH HEMATURIA. THE TREATMENT PERFORMED FOR THE UNSPECIFIED CARDIOVASCULAR SYMPTOMS WAS NOT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8367924 ↗
• MalfunctionFeb 22, 2019Unsealed Device Packaging; Improper or Incorrect Procedure or Method; Unsealed Device Packaging; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A 90% STENOSED, MILDLY TORTUOUS, MILDLY CALCIFIED, AND CONCENTRIC LESION IN THE MID LEFT ANTERIOR DESCENDING ARTERY. THE TYVEK INNER POUCH OF A 3.25X15MM XIENCE SIERRA STENT DELIVERY SYSTEM WAS NOT SEALED. THE OUTER FOIL POUCH WAS SEALED. THE STENT WAS SUCCESSFULLY DEPLOYED. 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 8362821 ↗
• InjuryDec 10, 2018Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MILDLY CALCIFIED LEFT ANTERIOR DESCENDING CORONARY ARTERY. PRE-DILATATION WAS PERFORMED WITH A NON-ABBOTT BALLOON DILATATION CATHETER AND A 3.25X15 MM XIENCE SIERRA STENT WAS IMPLANTED AT 12 ATMOSPHERES. A CORONARY ARTERY DISSECTION WAS NOTED AFTER IMPLANTATION. THE PHYSICIAN FELT THAT THE STENT DELIVERY BALLOON GREW TOO MUCH OUTSIDE THE STENT, LIKE AN OVERHANG OUTSIDE THE LENGTH OF THE STENT ON THE PROXIMAL END OF THE BALLOON, RESULTING IN THE DISSECTION. ANOTHER XIENCE SIERRA STENT WAS IMPLANTED TO TREAT THE DISSECTION. THERE WAS NO ADVERSE PATIENT SEQUELA AN NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Intimal Dissection

  MAUDE report 8146807 ↗