XIENCE Sierra™ 1550275-38Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 08717648227226), received between Sep 17, 2018 and May 27, 2021 — classified as 12 injuries, 1 malfunction.

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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjuryMay 27, 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 NON-ST ELEVATED MYOCARDIAL INFARCTION (NSTEMI); THEREFORE, THE 2.75X38MM XIENCE SIERRA WAS IMPLANTED. ON 2/09/2021 THE PATIENT WAS RE-ADMITTED WITH HEART DISEASE AND OTHER CARDIOVASCULAR SYMPTOMS. IT IS UNKNOWN WHAT TREATMENT WAS PERFORMED AND THE FINAL PATIENT OUTCOME IS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Ischemic Heart Disease

  MAUDE report 11897806 ↗
• InjuryMar 12, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2020 A XIENCE SIERRA STENT WAS SUCCESSFULLY IMPLANTED. ON (B)(6) 2020, THE PATIENT WAS RE-ADMITTED WITH HYPERTENSION AND OTHER CARDIOVASCULAR SYMPTOMS. IT IS UNKNOWN WHAT TREATMENT WAS PERFORMED AND THE FINAL PATIENT OUTCOME IS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: High Blood Pressure/ Hypertension

  MAUDE report 11475441 ↗
• InjuryMar 8, 2021Adverse 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 PRESENTED WITH NON-ST ELEVATED MYOCARDIAL INFARCTION (NSTEMI). TWO (2.75X38MM, 3.0X15MM) XIENCE SIERRA DRUG ELUTING STENTS (DES) WERE IMPLANTED. ON (B)(6) 2021, 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 11439322 ↗
• InjuryDec 1, 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) 2018, THE PATIENT PRESENTED WITH A MID-LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY, 70% STENOSED LESION. A 2.75X33MM XIENCE SIERRA STENT WAS IMPLANTED WITH ACCEPTABLE RESULTS AND WITHOUT COMPLICATION. ON (B)(6) 2019, A XIENCE SIERRA STENT 2.75X38MM WAS IMPLANTED TO TREAT RESTENOSIS IN THE PREVIOUSLY IMPLANTED, MID LAD 2.75X33MM XIENCE SIERRA STENT (PREVIOUSLY REPORTED UNDER ANOTHER MANUFACTURER MFR#). ON (B)(6) 2020, THE PATIENT WAS HOSPITALIZED FOR CHEST PAIN. PER IMAGING, THE MID LAD HAD 95% OCCLUSION WITH RESTENOSIS. ADDITIONAL ANGIOPLASTY WAS PERFORMED AS TREATMENT, PLACING A NON-ABBOTT STENT IN THE MID LAD. THERE WAS NO DEVICE MALFUNCTION AND THE EVENT RESOLVED. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THIS ISSUE.

  Patient problems: Angina; Stenosis

  MAUDE report 10928622 ↗
• InjuryNov 20, 2020Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON (B)(6) 2018, THE PROCEDURE WAS PERFORMED TO TREAT THE RIGHT CORONARY ARTERY. TWO XIENCE SIERRA STENTS (2.75X38MM AND 3.0X28MM) WERE IMPLANTED. ON (B)(6) 2020, THE PATIENT UNDERWENT A HEART CATHERIZATION DUE TO CHEST PAIN AND TROUBLE BREATHING. IT WAS THEN CONFIRMED THAT BOTH STENTS HAD COLLAPSED. THE STENTS WERE OPENED WITH ANGIOPLASTY AND TWO NEW XIENCE SIERRA STENTS (3.5X12MM AND 3.5X28MM). THERE WAS NO ADVERSE PATIENT SEQUELA REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. AS THE IMPLANT DATE WAS NOT CONFIRMED, THE LAST DATE PROVIDED ((B)(6) 2018) WILL BE USED AS THE ESTIMATED DATE.

  Patient problems: Angina; Occlusion; Respiratory Distress

  MAUDE report 10879778 ↗
• MalfunctionOct 14, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING USE OF A 2.75X38MM XIENCE SIERRA STENT DELIVERY SYSTEM (SDS), THE STENT CAME OFF IN AN UNSPECIFIED GUIDE CATHETER. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10680919 ↗
• InjurySep 14, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2020 A XIENCE SIERRA STENT WAS IMPLANTED. ON (B)(6) 2020, THE PATIENT WAS RE-ADMITTED WITH OTHER CV SYMPTOMS, AND ACUTE KIDNEY FAILURE. UNSPECIFIED TREATMENT WAS ADMINISTERED TO THE PATIENT. THE FINAL PATIENT OUTCOME IS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 10532624 ↗
• InjurySep 3, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT TWO XIENCE SIERRA STENTS (4X12MM AND 2.25X12MM) WERE IMPLANTED IN THE LEFT ANTERIOR DESCENDING CORONARY ARTERY (LAD) ON (B)(6) 2020. THE PATIENT PRESENTED WITH UNSTABLE ANGINA AND ATHEROSCLEROTIC HEART DISEASE BEFORE THE PROCEDURE. ON (B)(6) 2020, THE PATIENT WAS RE-ADMITTED WITH ANTERIOR NON-ST ELEVATED MYOCARDIAL INFARCTION AND PALPITATIONS. TWO MORE XIENCE SIERRA STENTS (2.75X38MM AND 3X18MM) WERE IMPLANTED OVER THE PREVIOUS STENTS IN THE LAD ON (B)(6) 2020. ON (B)(6) 2020, THE PATIENT WAS RE-ADMITTED WITH ANTERIOR NON-ST ELEVATED MYOCARDIAL INFARCTION AND PALPITATIONS AGAIN. UNSPECIFIED BALLOONS WERE USED AS TREATMENT, AND THE FINAL PATIENT OUTCOME IS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Arrhythmia; Myocardial Infarction

  MAUDE report 10491614 ↗
• InjuryMar 13, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2019, TWO XIENCE SIERRA STENTS WERE IMPLANTED IN AN UNSPECIFIED CORONARY ARTERY. SINCE THE PROCEDURE, THE PATIENT HAS EXPERIENCED PAIN IN HER MOUTH, SHE SUSPECTED AS AN ALLERGIC REACTION. THE PATIENT WENT TO THE PHYSICIAN REGARDING THIS ISSUE AND THE PHYSICIAN RECOMMENDED BENADRYL TO SEE IF THAT WOULD HELP. THERE WAS NO ADDITIONAL HOSPITALIZATION AND THERE WAS NO DEVICE ISSUE REPORTED. THERE WAS NO ADDITIONAL ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THIS ISSUE.

  Patient problems: Hypersensitivity/Allergic reaction; Pain

  MAUDE report 9829931 ↗
• InjurySep 3, 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 AN INFERIOR WALL, MYOCARDIAL INFARCTION (MI). A 2.75X38MM XIENCE SIERRA STENT WAS IMPLANTED WITHOUT REPORTED ISSUES. ON (B)(6) 2019, THE PATIENT WAS READMITTED FOR ANGINA AND ATHEROSCLEROTIC DISEASE. THERE WAS NO UNSTABLE ANGINA. UNSPECIFIED TREATMENT WAS PROVIDED. NO OTHER ACTION WAS REPORTED. THE PATIENT WAS DISCHARGED HOME. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THIS ISSUE.

  Patient problems: Angina

  MAUDE report 8958253 ↗
• InjurySep 3, 2019Difficult to Remove; Material Rupture; Device Dislodged or Dislocated; Material Deformation; Difficult to Remove; Material Rupture; Device Dislodged or Dislocated; Material Deformation

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A MILDLY TORTUOUS, MID RIGHT CORONARY ARTERY. THE 2.75X38MM RX XIENCE SIERRA STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TO THE TARGET LESION WITHOUT RESISTANCE. THE BALLOON RUPTURED AT 10 ATMOSPHERES. THE STENT SLIGHTLY EXPANDED AND IT DISLODGED FROM THE BALLOON. IT WAS ATTEMPTED TO PULL THE SDS IN TO AN UNSPECIFIED GUIDING CATHETER (GC) BUT WAS UNSUCCESSFUL DUE TO THE PARTIALLY INFLATED PROXIMAL END OF THE BALLOON. THE SDS AND THE GC WERE REMOVED AS A SINGLE UNIT. THE STENT WAS SNARED VIA THE GROIN. THE STENT WAS STRETCHED DURING REMOVAL. THE DELIVERY SYSTEM WAS CUT INTENTIONALLY AFTER IT WAS REMOVED FROM THE ANATOMY TO REMOVE FROM THE GC. THE TARGET LESION WAS LEFT UNTREATED BUT WILL BE STENTED IN THE NEXT COUPLE OF WEEKS; THE EXACT DATE WAS NOT REPORTED. THERE WAS NO ADVERSE PATIENT SEQUELA REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8956497 ↗
• InjuryJul 10, 2019Difficult to Remove; Defective Device; Device Damaged by Another Device; Difficult to Remove; Defective Device; Device Damaged by Another Device

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE OSTIUM OF A LEFT INTERNAL MAMMARY ARTERY (LIMA) GRAFT LOCATED IN AN UNKNOWN ARTERY. AN UNSPECIFIED GUIDE WIRE WAS ADVANCED AND A 2.75 X 38 MM XIENCE SIERRA STENT WAS IMPLANTED. HOWEVER, WHEN THE GUIDE WIRE WAS BEING REMOVED, IT BECAME CAUGHT WITH THE STENT, AND THE STENT BECAME SHORTENED MORE THAN 10%. THE STENT REMAINED IN ONE PIECE AND WAS STILL WELL APPOSED TO THE VESSEL WALL, ACCORDING TO THE ANGIOGRAPHY. THE GUIDE WIRE WAS THEN REMOVED AND THERE WAS A FAILED ATTEMPT TO RE-ACCESS THE STENT; THEREFORE, THERE WAS NO FURTHER TREATMENT. THE STENT REMAINED IN THE LESION AND DID NOT MIGRATE TO HEALTHY TISSUE. THE PATIENT THEN EXPIRED ON (B)(6) 2019 DUE TO A STROKE. THE PHYSICIAN REPORTED THAT THE DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE DEATH. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8777067 ↗
• InjurySep 17, 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 2.75X38 MM XIENCE SIERRA STENT WAS IMPLANTED IN THE LEFT ANTERIOR DESCENDING CORONARY ARTERY WITHOUT INCIDENT. THE NEXT DAY, (B)(6) 2018 THE PATIENT HAD AN ST ELEVATION MYOCARDIAL INFARCTION WITH THROMBUS INSIDE THE XIENCE STENT. THE CONDITION WAS TREATED WITH THROMBECTOMY AND THE PATIENT IS NOW IN STABLE CONDITION. IT WAS SUSPECTED THAT THERE MAY HAVE BEEN A DISTAL STENT EDGE DISSECTION ON (B)(6) 2018 THAT WAS NOT IDENTIFIED DURING THE PROCEDURE, WHICH MAY HAVE LED TO THE STENT THROMBOSIS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Intimal Dissection; Myocardial Infarction; Thrombosis

  MAUDE report 7881139 ↗