XIENCE Sierra™ 1550300-08Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 08717648227233), received between Mar 11, 2019 and Sep 3, 2021 — classified as 6 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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.

• MalfunctionSep 3, 2021Difficult to Remove; Failure to Advance; Difficult to Remove; Failure to Advance

  IT WAS REPORTED THIS WAS A PROCEDURE TO TREAT A MODERATELY CALCIFIED AND MODERATELY TORTUOUS LEFT CIRCUMFLEX. A 3.0X8MM XIENCE SIERRA DRUG ELUTING STENT (DES) WAS INSERTED. HOWEVER, PRIOR TO REACHING THE LESION, HEAVY RESISTANCE WAS FELT. THEREFORE, THE PHYSICIAN DECIDED TO REMOVE THE DEVICE. IT WAS NOTED THAT DUE TO THE ANATOMY, RESISTANCE WAS FELT DURING REMOVAL. ONCE REMOVED, NO DEVICE DAMAGE WAS OBSERVED. A NEW DEVICE WAS INSERTED, AND THE PROCEDURE WAS SUCCESSFULLY PERFORMED. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12422689 ↗
• InjuryNov 13, 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 3.0 X 08 MM AND A 3.5 X 23 MM XIENCE SIERRA STENT WERE IMPLANTED IN THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY, IN OVERLAPPING FASHION, WITH THE 3.0 X 8 MM XIENCE SIERRA IMPLANTED DISTAL TO THE 3.5 X 23 MM XIENCE SIERRA. ON (B)(6) 2020, THE PATIENT WAS RE-HOSPITALIZED WITH CHEST PAIN. CORONARY ANGIOGRAPHY NOTED LESIONS IN THE PROXIMAL AND MID LAD AND A LESION IN THE POSTERIOR DESCENDING ARTERY (PDA). A DRUG ELUTING STENT WAS IMPLANTED IN THE PDA. ON (B)(6) 2020, A STAGED PROCEDURE WAS PERFORMED IN THE LAD, WITH IN-STENT RESTENOSIS NOTED IN THE 3.0 X 8 MM XIENCE SIERRA STENT. BALLOON DILATATION WAS PERFORMED AND AN ADDITIONAL DRUG ELUTING STENT WAS IMPLANTED TO TREAT THE RESTENOSIS. MEDICATION WAS ADMINISTERED AND ADJUSTED. THE ADVERSE EVENT RESOLVED ON (B)(6) 2020. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina; Stenosis

  MAUDE report 10840899 ↗
• InjurySep 21, 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) 2020 TWO XIENCE SIERRA STENTS (3.0X8, 3.0X23) WERE IMPLANTED IN THE FIRST DIAGONAL (D1) CORONARY ARTERY. ON (B)(6) 2020 THE PATIENT HAD CHEST PAIN. THE STENT WAS PATENT, BUT BOTH STENTS WERE PINCHING THE LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY. ACCORDING TO THE PHYSICIAN, THIS WAS NOT AN OCCLUSION. ANGIOPLASTY WAS PERFORMED WITH A KISSING BALLOON TECHNIQUE TO THE LAD AND D1. THE PATIENT HAD GOOD RESULTS AND THE CONDITION RESOLVED THE SAME DAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina; Vasoconstriction

  MAUDE report 10560242 ↗
• InjuryAug 6, 2020Improper or Incorrect Procedure or Method; Failure to Advance; Device Dislodged or Dislocated; Improper or Incorrect Procedure or Method; Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION WITH HEAVY CALCIFICATION AND MILD TORTUOSITY IN THE MID RIGHT CORONARY ARTERY (MRCA). DURING ADVANCEMENT OF A 3.0 X 8MM XIENCE SIERRA STENT DELIVERY SYSTEM (SDS), RESISTANCE MET WITH THE HEAVY CALCIFICATION AND THE STENT COULD NOT CROSS THE TARGET LESION. THEREFORE, THE SDS WAS REMOVED; HOWEVER, THE STENT WAS NOT ON THE BALLOON. THE STENT HAD DISLODGED IN THE PATIENT¿S BODY. A SNARE WAS USED TO RETRIEVE THE DISLODGED STENT, AND AN UNSPECIFIED SDS WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10373810 ↗
• MalfunctionApr 8, 2020Difficult to Insert; Material Separation; Deformation Due to Compressive Stress; Difficult to Insert; Material Separation; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN UNSPECIFIED LESION. A 3.0X08MM XIENCE SIERRA HAD DIFFICULTY BEING INSERTED ONTO THE GUIDE WIRE. THE TIP WAS NOTED AS BENT THEN BROKE OFF. ANOTHER SAME SIZE XIENCE SIERRA WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAYS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9934340 ↗
• 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 3.0X08MM XIENCE SIERRA WAS IMPLANTED. ON (B)(6) 2019 THE PATIENT WAS RE-ADMITTED WITH OTHER CARDIOVASCULAR SYMPTOMS. 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 9441136 ↗
• 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 3.0X08MM XIENCE SIERRA WAS IMPLANTED. ON (B)(6) 2019 AND (B)(6) 2019 THE PATIENT WAS RE-ADMITTED WITH HYPOGLYCEMIA AND BACTEREMIA. IT IS UNKNOWN WHAT TREATMENT WAS PERFORMED AND THE FINAL PATIENT OUTCOME IS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9439243 ↗
• MalfunctionNov 4, 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 THE LEFT MAIN. A 3.0 X 8 MM XIENCE SIERRA STENT WAS IMPLANTED WITHOUT ISSUES; HOWEVER, THE DEVICE HAD ALREADY EXPIRED. 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 9272647 ↗
• InjuryOct 1, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBSEQUENT TO THE PREVIOUS MEDWATCH REPORT, THE ADDITIONAL INFORMATION WAS RECEIVED: ON (B)(6) 2020, THE PATIENT PRESENTED TO THE EMERGENCY ROOM WITH CHEST PAIN AND SHORTNESS OF BREATH. IMAGING WAS PERFORMED REVEALING AN OCCLUDED LAD, CX, AND RCA. THE LIMA TO THE LAD WAS PATENT AND THE RAMUS HAD IN-STENT RESTENOSIS TREATED WITH BALLOON ANGIOPLASTY. THE EVENT RESOLVED THAT SAME DAY AND THE PATIENT WAS DISCHARGED HOME.

  Patient problems: Angina; Dyspnea; Stenosis

  MAUDE report 9142228 ↗
• MalfunctionMar 11, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE OBTUSE MARGINAL ARTERY. A 3.0X08MM XIENCE SIERRA STENT DELIVERY SYSTEM (SDS) WAS ADVANCED THROUGH AN 8F GUIDING CATHETER WITHOUT RESISTANCE; HOWEVER, IT WAS DECIDED THAT PRE-DILATATION WAS NEEDED SO THE SDS HAD TO BE REMOVED. NO RESISTANCE REMOVING THE SDS WAS FELT, BUT THE STENT DISLODGED RIGHT OUTSIDE THE GUIDE CATHETER BY THE GROIN AREA. THE DISLODGED STENT WAS SIMPLY REMOVED BY HAND. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A NEW 3.0X08MM XIENCE SIERRA 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 8408190 ↗