XIENCE Sierra™ 1550250-08Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 08717648227073), received between Feb 1, 2019 and Jun 2, 2021 — classified as 6 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (5 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryJun 2, 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 PRESENTED WITH HYPERTENSIVE HEART AND A 2.50X08MM XIENCE SIERRA STENT WAS IMPLANTED. ON (B)(6) 2021 AND (B)(6) 2021, THE PATIENT WAS RE-ADMITTED WITH UNSPECIFIED CARDIOVASCULAR SYMPTOMS AND HYPERTENSIVE HEART. UNSPECIFIED TREATMENT WAS PROVIDED AND THE FINAL PATIENT OUTCOME IS NOT KNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: High Blood Pressure/ Hypertension

  MAUDE report 11921897 ↗
• MalfunctionMar 25, 2021Difficult to Remove; Failure to Advance; Difficult to Remove; Failure to Advance

  IT WAS REPORTED THAT A 2.5X08MM XIENCE SIERRA FAILED TO CROSS DUE TO RESISTANCE WITH ANATOMY. DURING REMOVAL OF THE XIENCE SIERRA RESISTANCE WAS NOTED WITH ANATOMY AS WELL. THE PROCEDURE WAS COMPLETED WITH A DILATATION CATHETER BALLOON. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11568362 ↗
• MalfunctionFeb 22, 2021Difficult to Remove; Failure to Advance; Material Deformation; Difficult to Remove; Failure to Advance; Material Deformation

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

  Patient problems: Insufficient Information

  MAUDE report 11362934 ↗
• MalfunctionMay 5, 2020Break; Failure to Advance; Material Deformation; Break; Failure to Advance; Material Deformation

  IT WAS REPORTED THAT DURING A CORONARY INTERVENTION, THE 2.5 X 8MM XIENCE SIERRA STENT DELIVERY SYSTEM (SDS) FAILED TO CROSS THE LESION AND WHEN REMOVED, IT WAS NOTED THAT THE SOME OF THE STENT STRUTS WERE SEPARATED AND FLATTENED. IT WAS CONFIRMED, NOTHING WAS LEFT IN THE PATIENT ANATOMY. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. ANOTHER UNSPECIFIED XIENCE STENT WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10027281 ↗
• MalfunctionMar 27, 2020Unintended System Motion; Unintended System Motion

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 75% STENOSED, MILDLY TORTUOUS, CONCENTRIC, AND MILDLY CALCIFIED DE NOVO LESION IN THE MID LEFT ANTERIOR DESCENDING ARTERY. A 2.50X8MM XIENCE SIERRA STENT WAS IMPLANTED. ANGIOGRAM AND INTRAVASCULAR ULTRASOUND INDICATED THE STENT SHIFTED DURING DEPLOYMENT, PARTIALLY IN HEALTHY TISSUE. A 2.5X9MM NON-ABBOTT STENT WAS IMPLANTED, IN THE UNCOVERED PORTION OF THE LESION. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH POST-DILATATION. THERE WAS 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 9892042 ↗
• InjuryOct 7, 2019Material Separation; Failure to Advance; Device Dislodged or Dislocated; Material Separation; Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A TARGET LESION IN THE HEAVILY CALCIFIED RIGHT CORONARY ARTERY. ONE UNSPECIFIED XIENCE SIERRA STENT WAS IMPLANTED WITHOUT ISSUE. A SECOND 2.50X08MM XIENCE SIERRA WAS ADVANCED; HOWEVER, DUE TO THE PATIENT ANATOMY, THE STENT DELIVERY SYSTEM WAS UNABLE TO CROSS. IT IS UNSURE IF THE DEVICE WAS TRYING TO CROSS THROUGH THE PREVIOUSLY IMPLANTED STENT. THE DEVICE WAS PULLED BACK TO BE REMOVED AND THE STENT DISLODGED IN THE AORTA. THE DISLODGED STENT WAS ABLE TO BE SNARED AND PULLED BACK TO THE RADIAL ARTERY; HOWEVER, THE STENT FRACTURED, IN TWO PIECES. A PORTION OF THE FRACTURED STENT WAS ABLE TO BE REMOVED FROM THE PATIENT ANATOMY; HOWEVER, A PORTION REMAINED IN THE RADIAL ARTERY. AT THIS TIME, IT IS UNKNOWN IF THE SEPARATED PORTION WAS REMOVED OR IF IT REMAINS IN THE ANATOMY. THE PATIENT WAS IN STABLE CONDITION AT THE END OF THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 9161837 ↗
• MalfunctionAug 12, 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 DIAGONAL ARTERY. A 2.50X08MM XIENCE SIERRA STENT WAS IMPLANTED AT THE LESION. IT WAS ONLY AFTER THE IMPLANTATION DID THE PHYSICIAN REALIZE THAT THE STENT IMPLANT HAD EXPIRED ON (B)(6) 2019. THE PATIENT IS FINE. 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 8885620 ↗
• InjuryJul 31, 2019Difficult to Remove; Improper or Incorrect Procedure or Method; Failure to Advance; Device Dislodged or Dislocated; Difficult to Remove; Improper or Incorrect Procedure or Method; Failure to Advance; Device Dislodged or Dislocated

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

  Patient problems: Foreign Body In Patient

  MAUDE report 8846566 ↗
• InjuryJun 14, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 2.5X8MM AND 3.5X12MM XIENCE SIERRA STENTS WERE IMPLANTED ON (B)(6) 2019. THE PATIENT PRESENTED WITH NON-ST-ELEVATION MYOCARDIAL INFARCTION (NSTEMI) BEFORE THE PROCEDURE. ON (B)(6) 2019, THE PATIENT WAS READMITTED WITH CARDIOVASCULAR SYMPTOMS INCLUDING CHRONIC OBSTRUCTIVE PULMONARY DISEASE. TREATMENT PERFORMED WAS UNSPECIFIED AND THE FINAL PATIENT OUTCOME IS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8700723 ↗
• InjuryMar 2, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 2.50 X 08 MM XIENCE SIERRA STENT WAS IMPLANTED ON (B)(6) 2018. ON (B)(6) 2018 AND (B)(6) 2018 THE PATIENT WAS READMITTED WITH UNSPECIFIED CARDIOVASCULAR SYMPTOMS IN ADDITION TO A HEMORRHAGING DUODENAL ULCER AND NEOPLASM OF THE COLON FOR WHICH SURGICAL INTERVENTION WAS PERFORMED. THE TREATMENT PERFORMED FOR THE UNSPECIFIED CARDIOVASCULAR SYMPTOMS WAS NOT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8384346 ↗
• InjuryFeb 1, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2018 THE 2.5X8 MM XIENCE SIERRA STENT WAS IMPLANTED IN THE MID LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY AND THE 3.0X8 MM XIENCE SIERRA STENT WAS IMPLANTED IN THE FIRST OBTUSE MARGINAL (OM1) CORONARY ARTERY. ON (B)(6) 2019 THE PATIENT HAD MODERATE, GRADUAL ONSET, RIGHT-SIDED, PRESSURE-LIKE CHEST PAIN THAT OCCASIONALLY RADIATED TO THE LEFT SIDE. THE PAIN WAS RELIEVED WITH NITROGLYCERIN. IN-STENT RESTENOSIS WAS FOUND IN THE LAD AND PERCUTANEOUS REVASCULARIZATION WAS PERFORMED IN THE LAD ON (B)(6) 2019. A NEW STENT WAS IMPLANTED IN THE LAD. THE PATIENT WAS DISCHARGED HOME DOING WELL ON (B)(6) 2019. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina; Stenosis

  MAUDE report 8298448 ↗