XIENCE XPEDITION 1074350-23Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08717648162558), received between Dec 30, 2016 and Jan 31, 2020 — classified as 1 injury, 2 malfunctions.

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

• InjuryJan 31, 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) /2019, THE PATIENT PRESENTED WITH ELEVATED CARDIAC ENZYMES AND A PERCUTANEOUS CORONARY INTERVENTION (PCI) WAS PERFORMED. PRE-DILATATION WAS PERFORMED ON THE PROXIMAL RIGHT CORONARY ARTERY (RCA), 100% STENOSED LESION AND A 3.5X23MM (1074350-23 9053141) XIENCE XPEDITION STENT WAS SUCCESSFULLY IMPLANTED. PRE-DILATATION WAS ALSO PERFORMED ON THE MID CIRCUMFLEX (CX) CORONARY ARTERY, 100% STENOSED LESION AND A 2.5X28MM (1074250-28 9031141) XIENCE XPEDITION STENT WAS SUCCESSFULLY IMPLANTED. REPORTEDLY EXCELLENT RESULTS WERE OBSERVED WITH 0% DIAMETER STENOSIS, TIMI FLOW III, AND NO COMPLICATIONS. POST-PROCEDURE, THE PATIENT EXPERIENCED CHEST PAIN, CARDIAC ENZYMES REMAINED ELEVATED AND A NEW MYOCARDIAL INFARCTION WAS DIAGNOSED. MEDICATION WAS PROVIDED AS TREATMENT. PER PHYSICIAN, THE EVENT WAS UNKNOWN IF DEVICE RELATED. THERE WAS NO DEVICE MALFUNCTION. NO ADDITIONAL TREATMENT WAS PROVIDED. THE EVENT WAS CONSIDERED RESOLVED ON (B)(6) 2019. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THIS ISSUE.

  Patient problems: Angina; Myocardial Infarction

  MAUDE report 9655788 ↗
• MalfunctionApr 13, 2017Device Expiration Issue; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT A 3.50 X 23 MM XIENCE XPEDITION STENT WAS SUCCESSFULLY IMPLANTED ON (B)(6) 2017. IT WAS LATER DETERMINED THAT THE EXPIRATION DATE FOR THE XIENCE XPEDITION WAS IN (B)(6) 2017 AND SHOULD NOT HAVE BEEN USED IN THE PROCEDURE. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6490209 ↗
• MalfunctionDec 30, 2016Improper or Incorrect Procedure or Method; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE LEFT ANTERIOR DESCENDING CORONARY ARTERY. THE 3.5X23MM XIENCE XPEDITON STENT DELIVERY SYSTEM WAS ADVANCED TO THE LESION; HOWEVER, IT WAS NOTED THAT THE STENT WAS NOT ON THE BALLOON. THE STENT HAD DISLODGED DURING PREPPING AND WAS FOUND OUTSIDE THE PATIENT ON THE TABLE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER DEVICE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6215891 ↗