XIENCE XPEDITION 1074325-18Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08717648162442), received between Jun 14, 2018 and Oct 17, 2019 — classified as 2 injuries.

The most frequently reported specific device problem is “Difficult to Remove” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryOct 17, 2019Difficult to Remove; Material Separation; Difficult to Remove; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED LESION IN THE MODERATELY TORTUOUS PROXIMAL LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY. THERE WAS NO RESISTANCE NOTED DURING ADVANCEMENT OF THE 3.25X18 MM XIENCE XPEDITION STENT DELIVERY SYSTEM (SDS); HOWEVER, THE SDS SEPARATED IN THE GUIDE. THERE WAS RESISTANCE DURING REMOVAL AND THE SEPARATED PORTION HAD TO BE SNARED. NOTHING REMAINS IN THE PATIENT. ANOTHER XIENCE STENT WAS IMPLANTED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT SEQUELA AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9204186 ↗
• InjuryJun 14, 2018Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING INFORMATION WAS REPORTED FROM AN ARTICLE TITLED: `DIFFERENT OUTCOMES OF THE TWO XIENCE STENT IMPLANTS DEPLOYED IN THE SAME BRANCHES OF CORONARY CONFIRMED BY OFDI.' IN (B)(6) 2014, THE PATIENT UNDERWENT A CARDIAC ULTRASOUND WHICH REVEALED AN INFERIOR OLD MYOCARDIAL INFARCTION. IT WAS REPORTED THAT ON (B)(6) 2014, A PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE FIRST MARGINAL BRANCH OF THE LEFT CIRCUMFLEX CORONARY ARTERY (LCX) WITH 90% STENOSIS. A 3.0X23 MM XIENCE XPEDITION STENT WAS DEPLOYED AND REVASCULARIZATION WAS CONFIRMED. POST PROCEDURE, AN ACUTE STENT THROMBOSIS WAS SUSPECTED WITH ST ELEVATION. CORONARY ANGIOGRAPHY CONFIRMED A THROMBUS IN THE DISTAL LCX NOT WITHIN 5MM OF THE DEPLOYED 3.0X23 MM XIENCE XPEDITION IN THE FIRST MARGINAL BRANCH. A 3.25X18 MM XIENCE XPEDITION STENT WAS DEPLOYED TO TREAT THE LESION IN THE DISTAL LCX AND THE PATIENT WAS PUT ON DUAL ANTIPLATELET THERAPY FOLLOWING. ON (B)(6) 2017, A COMPUTED TOMOGRAPHY SCAN CONFIRMED 99% RE-STENOSIS IN THE 3.25X18 MM XIENCE XPEDITION STENT. IN (B)(6) 2017, THE PATIENT UNDERWENT AN UNSPECIFIED PERCUTANEOUS CORONARY INTERVENTION WHICH CONFIRMED THAT THE 3.25X18 MM XIENCE XPEDITION STENT WAS SUFFICIENTLY D

  Patient problems: Stenosis

  MAUDE report 7601639 ↗