XIENCE Sierra™ 1550400-38Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 08717648227547), received between Sep 13, 2018 and Aug 3, 2021 — classified as 12 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (3 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• InjuryAug 3, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PERCUTANEOUS CORONARY INTERVENTION (PCI) WAS PERFORMED ON THE LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY WITH HEAVY CALCIFICATION. REPORTEDLY, MULTIPLE, UNSPECIFIED BALLOON CATHETERS HAD DIFFICULTY CROSSING AND RUPTURED ON THE CALCIFICATION. ON (B)(6) 2021, THE PATIENT PRESENTED FOR ANOTHER PCI ON THE HEAVILY CALCIFIED, PROXIMAL TO MID LAD WITH 80-90% STENOSIS. A NON-ABBOTT WIRE (ROTAFLOPPY) AND ATHERECTOMY DEVICE (ROTA PRO 1.75MM) PERFORMED ROTATIONAL ATHERECTOMY IN THE LAD. A 3.0X20M NC BALLOON PERFORMED PRE-DILATATION TO THE PROXIMAL LAD. ATTEMPT TO DELIVERY AN UNSPECIFIED STENT DELIVERY SYSTEM WAS UNSUCCESSFUL. USING A 6 FRENCH GODZILLA EXTENSION CATHETER, A 4.0X38MM XIENCE SIERRA STENT WAS PLACED FROM THE OSTIAL LAD TO THE MID LAD WITHOUT A DEVICE ISSUE. DUE TO THE HEAVY CALCIFICATION, AGGRESSIVE POST-DILATATION WAS PERFORMED USING A 4.0X12MM TREK NC BALLOON. FOLLOWING, A FOCAL MID LAD PERFORATION WAS NOTED. THE EXISTING 4.0X12MM TREK NC BALLOON ADVANCED TO THE PERFORATION AND DILATATION WAS PERFORMED, HOWEVER THE PERFORATION PERSISTED. PER TRANSTHORACIC ECHOCARDIOGRAM, CARDIAC TAMPONADE WAS NOTED, TREATED WITH PERICARDIOCENTESIS. A PERICARDIAL DRAIN

  Patient problems: Cardiac Tamponade; Low Blood Pressure/ Hypotension; Perforation of Vessels; Thrombosis/Thrombus; Ventricular Fibrillation

  MAUDE report 12270525 ↗
• MalfunctionFeb 26, 2021Failure to Advance; Device Dislodged or Dislocated; Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A HEAVILY CALCIFIED, MODERATELY TORTUOUS, DE NOVO MID RIGHT CORONARY ARTERY. THE 4.0X38MM XIENCE SIERRA STENT DELIVERY SYSTEM FAILED TO CROSS DUE TO THE ANATOMY THEN THE STENT BECAME PARTIALLY STRIPPED FROM THE BALLOON. THE DELIVERY CATHETER AND STENT WERE REMOVED TOGETHER AS A SINGLE UNIT. TWO NEW XIENCE SIERRA STENTS (4.0 X 23MM, 4.0 X 15MM) WERE 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 11387857 ↗
• InjuryJan 16, 2021Adverse 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 THE RIGHT CORONARY ARTERY. THE PATIENT PRESENTED WITH A MYOCARDIAL INFARCTION. ON (B)(6) 2020, TWO XIENCE XPEDITION STENTS (4X38MM & 4X18MM) WERE IMPLANTED WITHOUT ISSUE. ON (B)(6) 2021 DURING THE BEGINNING OF A DIFFERENT PROCEDURE, THROMBOSIS WAS IDENTIFIED IN THE STENTS DESPITE THE PATIENT SHOWING NO SYMPTOMS. MEDICATION WAS GIVEN AS TREATMENT, AND THE PATIENT IS FINE. THERE WERE NO ADVERSE PATIENT SEQUELAE AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Thrombosis

  MAUDE report 11182622 ↗
• InjuryDec 8, 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 4.0X38 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 UNSTABLE ANGINA. TREATMENT WAS GIVEN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina

  MAUDE report 10969890 ↗
• MalfunctionOct 20, 2020Difficult to Remove; Failure to Advance; Difficult to Remove; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A 90% STENOSED, HEAVILY TORTUOUS, AND HEAVILY CALCIFIED LESION IN THE DISTAL RIGHT CORONARY ARTERY. A 4.0X38MM XIENCE SIERRA STENT DELIVERY SYSTEM (SDS) FAILED TO CROSS DUE TO RESISTANCE WITH THE ANATOMY. THE SDS WAS REMOVED; HOWEVER, RESISTANCE WITH THE ANATOMY WAS FELT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH AN UNSPECIFIED DEVICE. 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 10708857 ↗
• InjurySep 9, 2020Off-Label Use; Patient-Device Incompatibility; Off-Label Use; Patient-Device Incompatibility

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE TIBIAL ARTERY BELOW THE KNEE. AN UNSPECIFIED GUIDE WIRE WAS ADVANCED AND ATHERECTOMY WAS PERFORMED. AN UNSPECIFIED BALLOON CATHETER WAS ADVANCED AND THE LESION WAS DILATED; HOWEVER, A PERFORATION WAS NOTED. FIVE NON-ABBOTT STENTS WERE DEPLOYED AND TREATED THE PERFORATION IN THE ANTERIOR TIBIAL ARTERY. IN THE POSTERIOR TIBIAL ARTERY (PTA) FIVE XIENCE SIERRA STENTS (3.5X28MM, 3.5X38MM, 4.0X33MM, 4.0X38MM, AND 4.0X38MM) WERE DEPLOYED OVERLAPPING EACH OTHER. THREE OF THE STENTS SEALED THE AREA OF THE PERFORATION SUCCESSFULLY; HOWEVER, TWO OF THE STENTS (4.0X33MM AND 4.0X38MM) DID NOT. PROLONGED BALLOON INFLATION WAS DONE FOR 10 MINUTES AND THE PERFORATION WAS NOT SEALED AND THE PATIENT CONTINUED BLEEDING. A 4.0X19MM GRAFTMASTER COVERED STENT AND A 3.5X19MM GRAFTMASTER COVERED STENT WERE DEPLOYED ON TOP OF THE DEPLOYED 4.0X33MM AND 4.0X38MM XIENCE SIERRA STENTS TO SUCCESSFULLY TREAT THE LONG PERFORATION IN THE PTA. DUE TO THE LONG PERFORATION AND EXCESSIVE BLEEDING DURING TREATMENT THE PATIENT SUFFERED FROM COMPARTMENT SYNDROME AND WAS SENT TO SURGERY FOR A FASCIOTOMY ON THE SAME DAY. NO ADDITIONAL INFORMATION WAS

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10512304 ↗
• InjuryAug 21, 2020Difficult to Remove; Material Rupture; Device Dislodged or Dislocated; Difficult to Remove; Material Rupture; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HIGH GRADE STENOSIS IN THE PROXIMAL THROUGH MID RIGHT CORONARY ARTERY (RCA). WHILE THE 4.0X38 MM XIENCE SIERRA STENT WAS BEING DEPLOYED THE BALLOON RUPTURED AT 8 ATMOSPHERES AND THE STENT DISLODGED. THE PROXIMAL END OF THE STENT WAS EXPANDED ABOUT 1 MM. THE DELIVERY SYSTEM WAS ABLE TO BE REMOVED AFTER SOME WORK AND MULTIPLE BALLOONS WERE USED TO DILATE THE SEVERELY UNDER-EXPANDED STENT IN THE TARGET LESION. AT THIS POINT THE PATIENT WENT ASYSTOLIC, BUT WAS ABLE TO BE RESUSCITATED. ONCE STABLE, THE 4.00X38 MM XIENCE SIERRA WAS OVERLAPPED WITH ANOTHER 4.0X18 MM XIENCE SIERRA. A 4.00MM NON COMPLIANT NON-ABBOTT BALLOON WAS USED TO COMPLETE POST-DILATATION OF BOTH OF THE STENTS. THERE WERE NO ISSUES REPORTED WITH THE 4.0X18 MM XIENCE SIERRA STENT. THE PATIENT IS INTUBATED AND IS IN THE INTENSIVE CARE UNIT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Cardiac Arrest; Respiratory Failure

  MAUDE report 10438155 ↗
• InjuryJun 18, 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 TWO (4.00X38 MM AND 3.50X38 MM) XIENCE SIERRA STENTS IMPLANTED. ON (B)(6) 2020, THE PATIENT WAS RE-ADMITTED WITH ANGINA. UNSPECIFIED TREATMENT WAS PROVIDED AND THE FINAL PATIENT OUTCOME IS NOT KNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina

  MAUDE report 10171863 ↗
• MalfunctionDec 13, 2019Contamination /Decontamination Problem; Difficult to Advance; Contamination /Decontamination Problem; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE RIGHT CORONARY ARTERY THAT WAS BOTH HEAVILY CALCIFIED AND TORTUOUS. WHILE LOADING THE XIENCE SIERRA STENT DELIVERY SYSTEM ON THE GUIDE WIRE, THE GUIDE WIRE DIDN'T COME OUT THE RAPID EXCHANGE PORT. THE PHYSICIAN KEPT PUSHING AND IT FINALLY CAME OUT, BUT A SMALL PIECE OF PLASTIC CAME OUT OF WHERE THE WIRE CAME OUT. THE DELIVERY SYSTEM WAS WITHDRAWN AND ANOTHER XIENCE SIERRA WAS USED TO COMPLETE THE PROCEDURE WITH NO DELAY OR ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9468042 ↗
• MalfunctionNov 20, 2019Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT AN EXPIRED 4.0 X 38 MM XIENCE SIERRA STENT WAS DEPLOYED IN THE PATIENT. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9348492 ↗
• InjuryOct 31, 2019Adverse 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 DISTAL RIGHT CORONARY ARTERY (RCA). A 4.0 X 38 MM XIENCE SIERRA STENT WAS IMPLANTED. DURING STENT DEPLOYMENT, A MARGINAL SIDE BRANCH WAS BLOCKED. ADDITIONAL BALLOON ANGIOPLASTY WAS PERFORMED TO OPEN THE VESSEL. SEVERAL HOURS POST STENTING PROCEDURE, LEFT SIDED WEAKNESS AND FACIAL DROOP WERE NOTED. COMPUTED TOMOGRAPHY, ANGIOGRAPHY AND MAGNETIC RESONANCE IMAGING WERE PERFORMED. A SMALL EMBOLIC STROKE WAS DIAGNOSED IN THE RIGHT HEMISPHERE. THE PATIENT WAS KEPT OVERNIGHT FOR OBSERVATION. NO TREATMENT WAS PROVIDED.

  Patient problems: Occlusion; Stroke/CVA; Weakness

  MAUDE report 9262288 ↗
• MalfunctionSep 18, 2019Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A DE NOVO LESION LOCATED IN THE MID-RIGHT CORONARY ARTERY THAT WAS HEAVILY CALCIFIED. DURING BACKLOADING OF THE BALLOON CATHETER ON THE GUIDE WIRE, THE GUIDE WIRE POKED THE BALLOON AND CAUSED A TEAR. THIS OCCURRED WHEN ENTERING THE GUIDE CATHETER OUTSIDE OF THE BODY. A NON-ABBOTT STENT WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9084112 ↗
• InjuryAug 29, 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 A ST ELEVATED MYOCARDIAL INFARCTION (STEMI) THEREFORE THE 4.0X38MM XIENCE SIERRA WAS IMPLANTED. ON (B)(6) 2019 THE PATIENT WAS RE-ADMITTED WITH ANGINA. IT IS UNKNOWN WHAT TREATMENT WAS PERFORMED AND THE FINAL PATIENT OUTCOME IS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina

  MAUDE report 8946521 ↗
• InjuryJul 31, 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 PATIENT UNDERWENT A CORONARY PROCEDURE, TREATING A TARGET LESION IN THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD). A 4.0 X 38 MM XIENCE SIERRA STENT WAS IMPLANTED, AND A PROXIMAL EDGE DISSECTION WAS NOTED. NO TREATMENT WAS REPORTED. ON (B)(6) 2019, THE PATIENT REPORTED EXPERIENCING DYSPNEA ON EXERTION. PHARMOCOLOGIC STRESS TESTING WAS PERFORMED AND REVEALED A MODERATE TO SEVERE PERFUSION DEFECT WITH EXTENSIVE ISCHEMIA. ON (B)(6) 2019, THE PATIENT WAS RE-HOSPITALIZED, WITH DYSPNEA ON EXERTION. RESTENOSIS WAS NOTED AT THE PROXIMAL STENT EDGE AND A REVASCULARIZATION PROCEDURE WAS PERFORMED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Dyspnea; Intimal Dissection; Ischemia; Stenosis

  MAUDE report 8848971 ↗
• InjuryNov 19, 2018Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2018, THE PATIENT PRESENTED WITH ANGINA. THE PROCEDURE WAS TO TREAT A LESION LOCATED IN A MODERATELY TORTUOUS, MODERATELY CALCIFIED CONCENTRIC MID TO DISTAL RIGHT CORONARY ARTERY (RCA) A 4.0X23MM XIENCE SIERRA STENT AND A 4.0X38MM XIENCE SIERRA STENT WERE DEPLOYED IN AN OVERLAPPED MANNER. TIMI FLOW CHANGED FROM 2 TO 3. INTRAVASCULAR ULTRASOUND (IVUS) WAS CONFIRMED TO SUCCESSFULLY COMPLETE THE PROCEDURE. IT WAS CONFIRMED THAT THE PATIENT WAS COMPLIANT WITH DUAL ANTIPLATELET DRUG THERAPY AFTER THE PROCEDURE. ON (B)(6) 2018, THE PATIENT WAS RE-HOSPITALIZED DUE TO CHEST PAIN. IN-STENT THROMBUS WAS CONFIRMED VIA ANGIOGRAPHY. THE STENT WAS RECOILED. BALLOON ANGIOPLASTY WAS PERFORMED WITH A 4.0X12MM UNSPECIFIED BALLOON. ON (B)(6) 2018, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina; Thrombosis

  MAUDE report 8086961 ↗
• InjurySep 18, 2018Difficult or Delayed Positioning; Difficult or Delayed Positioning

  IT WAS REPORTED THAT THE PATIENT HAD A PREVIOUSLY PLACED STENT IN A SAPHENOUS VEIN GRAFT (SVG) TO THE OSTIAL POSTERIOR DESCENDING ARTERY 10 YEARS PRIOR. THIS WAS ANOTHER PERCUTANEOUS CORONARY INTERVENTION TO TREAT THE SAME AREA. THE LESION WAS A LITTLE ECCENTRIC WITH ONE FOCAL STENOSIS AT THE OSTIUM. DURING DEPLOYMENT OF THE XIENCE SIERRA 4 X 38 MM STENT AT 10 ATMOSPHERES, THE STENT SLIPPED BACK PROXIMAL TOWARD THE GUIDE INTO THE AORTA. THE OSTIAL FOCAL LESION WAS COVERED, HOWEVER ROUGHLY 10MM OF STENT IS NOW HANGING OUTSIDE THE SVG INTO THE AORTA. THE STENT BALLOON CATHETER WAS THEN RE-ADVANCED AND INFLATED ONE MORE TIME TO COMPLETE THE PROCEDURE AFTER TAKING A FINAL ANGIOGRAM. THIS WAS DONE TO REINFORCE THE STENT TO THE VESSEL WALL. THE PHYSICIAN PLANS TO KEEP PATIENT ON DUAL ANTIPLATELET THERAPY FOR THE REMAINDER OF HIS LIFE. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7887265 ↗
• InjurySep 13, 2018Stretched; Device Dislodged or Dislocated; Stretched; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE OSTIUM OF THE PROXIMAL RIGHT CORONARY ARTERY (RCA). A NON-ABBOTT AL TYPE GUIDING CATHETER WAS ADVANCED TO THE LESION. A 4.0X38MM XIENCE SIERRA STENT DELIVERY SYSTEM (SDS) WAS THEN ADVANCED TO THE LESION WITHOUT RESISTANCE; HOWEVER, THE GUIDING CATHETER MOVED DURING THE SDS BALLOON INFLATION TO DEPLOY THE STENT, AND THE PROXIMAL END OF THE PARTIALLY EXPANDED STENT ENTERED THE GUIDING CATHETER. THE SDS BALLOON INFLATION HAD STOPPED AT APPROXIMATELY 5-6 ATMOSPHERES, AND THE PARTIALLY EXPANDED STENT DISLODGED FROM THE SDS BALLOON AND THE PROXIMAL END OF THE STENT REMAINED IN THE GUIDING CATHETER. THE SDS WAS REMOVED AND THE DISLODGED STENT WAS RETRIEVED FROM THE PATIENT ANATOMY WITH A SNARE DEVICE. AFTER REMOVAL, THE STENT WAS NOTED TO BE STRETCHED/MANGLED AND TWINED WITH THE SNARE DEVICE AND THE STENT STRUTS. A NEW SAME SIZE XIENCE SIERRA STENT WAS IMPLANTED AT THE LESION AND THE PROCEDURE WAS COMPLETED. A CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE WAS REPORTED; HOWEVER THERE WAS NO PATIENT SEQUELA. THE PHYSICIAN THINKS THE EVENT WAS CAUSED DUE TO OPERATIONAL FACTORS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7874612 ↗