XIENCE XPEDITION 1074275-18Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08717648162244), received between Apr 2, 2020 and Apr 2, 2020 — classified as 1 death.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• DeathApr 2, 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, THE PATIENT PRESENTED WITH A RECENT NON-ST ELEVATED MYOCARDIAL INFARCTION (NSTEMI). NO PRE-DILATATION WAS PERFORMED. A 2.75X33MM AND 2.75X18MM XIENCE STENT WERE IMPLANTED IN THE LEFT ANTERIOR DESCENDING (LAD), CORONARY ARTERY LESION. A 2.75X18 AND A 2.75X8MM XIENCE STENT WERE IMPLANTED IN THE DIAGONAL CORONARY ARTERY, 80% STENOSED LESION. REPORTEDLY, STENT PLACEMENTS ANGIOGRAPHIC APPEARANCE WAS ACCEPTABLE AND POST-DILATATION WAS PERFORMED. THE END RESULT WAS TIMI FLOW 3 AND 0% DIAMETER STENOSIS. POST-PROCEDURE, THE PATIENT'S TROPONIN INCREASED AND A NEW MYOCARDIAL INFARCTION (MI) WAS DIAGNOSED. THE PATIENT HAD AN INTRACRANIAL BLEED WITH HERNIATION WORSENED BY MEDICAL THERAPY FOR MI AND HAD BECOME UNRESPONSIVE. ON (B)(6) 2020, THE PATIENT EXPIRED. PER PHYSICIAN, THE EVENT WAS UNRELATED TO THE DEVICE AND UNRELATED TO THE PROCEDURE. THERE WAS NO DEVICE MALFUNCTION. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THIS ISSUE.

  Patient problems: Death; Intracranial Hemorrhage; Myocardial Infarction; Neurological Deficit/Dysfunction

  MAUDE report 9917838 ↗