XIENCE XPEDITION 1074350-18Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08717648162541), received between Jan 12, 2017 and Sep 25, 2018 — classified as 1 death, 2 injuries.

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.

• DeathSep 25, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A 3.5 X 18 MM XIENCE XPEDITION STENT IMPLANTED ON (B)(6) 2014. HOWEVER, HE EXPERIENCED ANGINA, LOW KIDNEY FUNCTION AND LOW OXYGEN ON (B)(6) 2018 AND EXPIRED THAT SAME DAY IN THE HOSPITAL. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina; Dyspnea; Renal Failure

  MAUDE report 7907397 ↗
• InjuryJul 10, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2015 THE 3.5X18MM XIENCE XPEDITION STENT WAS IMPLANTED IN THE 13MM, VESSEL DIAMETER 3.5MM, 75% STENOSIS IN THE MID LEFT ANTERIOR DESCENDING CORONARY ARTERY (LAD) AND THE 2.25X18 MM XIENCE XPEDITION STENT WAS IMPLANTED IN THE ATRIO-VENTRICULAR (AV) ARTERY. ON 04/18/2017, 75% IN-STENT RESTENOSIS (ISR) WAS FOUND IN THE MID LAD. ON (B)(6) 2017, PERCUTANEOUS REVASCULARIZATION WAS PERFORMED WITH A DRUG ELUTING STENT IN THE MID LAD. THE CONDITION RESOLVED ON (B)(6) 2017. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Stenosis

  MAUDE report 7674273 ↗
• InjuryJan 12, 2017Adverse Event Without Identified Device or Use Problem

  SUBSEQUENT TO THE INITIAL 30-DAY MEDICAL DEVICE REPORT, THE FOLLOWING INFORMATION WAS RECEIVED: ON (B)(6) 2016, THE PATIENT EXPERIENCED SILENT ISCHEMIA. ON (B)(6) 2017, THE PATIENT WAS HOSPITALIZED AND ON (B)(6) 2017, PERCUTANEOUS CORONARY INTERVENTION WAS PERFORMED IN THE DISTAL RIGHT CORONARY ARTERY. THE CONDITION RESOLVED AND ON (B)(6) 2017 THE PATIENT WAS DISCHARGED. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: Stenosis

  MAUDE report 6248256 ↗