XIENCE Sierra™ 1550225-33Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08717648227059), received between Mar 8, 2020 and Apr 8, 2022 — classified as 2 injuries, 1 malfunction.

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

• InjuryApr 8, 2022Adverse 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, THE PATIENT UNDERWENT A CORONARY STENTING PROCEDURE, WITH IMPLANT OF A 2.25 X 33 MM XIENCE SIERRA STENT IN THE MID LEFT ANTERIOR DESCENDING CORONARY ARTERY (MLAD). ON (B)(6) 2019, THE PATIENT WAS RE-HOSPITALIZED WITH CHEST PAIN AND SHORTNESS OF BREATH. CARDIAC ENZYMES WERE ELEVATED. CARDIAC CATHETERIZATION SHOWED 70% STENOSIS IN THE MLAD. A REVASCULARIZATION PROCEDURE WAS PERFORMED ON (B)(6) 2019, WITH IMPLANT OF AN ADDITIONAL STENT IN THE MLAD, RESOLVING THE EVENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina; Cardiac Enzyme Elevation; Dyspnea; Stenosis

  MAUDE report 14060007 ↗
• MalfunctionFeb 22, 2021Material Separation; Migration; Material Separation; Migration

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MILDLY CALCIFIED, HEAVILY TORTUOUS LEFT ANTERIOR DESCENDING ARTERY (LAD). ON (B)(6) 2020, A 2.25X33MM XIENCE SIERRA WAS IMPLANTED AT THE LESION WITHOUT ISSUE. DURING THE FOLLOW UP VISIT ON (B)(6) 2021, THE PHYSICIAN NOTED THAT THE STENT IMPLANT WAS FRACTURED IN TWO SEPARATE PIECES AND HAD MIGRATED A BIT DISTALLY, STILL REMAINING ON THE LAD TARGET LESION. NO TREATMENT HAS BEEN PERFORMED. NO DISTAL FLOW INTERRUPTION WAS NOTED. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11362658 ↗
• 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 NON-ST ELEVATED MYOCARDIAL INFARCTION (NSTEMI). A 2.25X33MM XIENCE SIERRA STENT WAS IMPLANTED. ON (B)(6) 2019 THE PATIENT WAS RE-HOSPITALIZED WITH RIGHT SHOULDER PAIN. IT IS UNKNOWN WHAT TREATMENT WAS PERFORMED AND WHAT THE FINAL PATIENT OUTCOME WAS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Pain

  MAUDE report 9803948 ↗