XIENCE XPEDITION 1074250-15Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08717648162138), received between Dec 16, 2016 and Nov 12, 2019 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Inflation Problem” (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.

• MalfunctionNov 12, 2019Inflation Problem; Material Separation; Inflation Problem; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A PROXIMAL RAMUS ARTERY. A 2.5X15MM XIENCE XPEDITION STENT WAS LOADED ONTO A SION GUIDE WIRE AND PLACED AT THE LESION. A PRIORITY PAK 20/30 INDEFLATOR WAS USED TO INFLATE THE XIENCE XPEDTION, AS INFLATION WAS INITIATED, BUT THE STENT-BALLOON FAILED TO INFLATE. ADDITIONALLY, THE INDEFLATOR SHOWED NO PRESSURE INCREASE ON THE DIAL. NEGATIVE PRESSURE WAS THEN APPLIED AND BLOOD WAS NOTED BACKING UP INTO THE INDEFLATOR PORT. IT WAS THEN NOTED THAT THE PROXIMAL SHAFT WAS BROKEN. THE ENTIRE DELIVERY SYSTEM WAS REMOVED AS A SINGLE UNIT. DEVICES WERE EXCHANGED WITH NEW ONES INCLUDING A 2.5X15MM XIENCE STENT TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9311026 ↗
• InjuryDec 16, 2016Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PROCEDURE ON (B)(6) 2014 WAS TO TREAT A MILDLY TORTUOUS AND MILDLY CALCIFIED LESION IN THE FIRST DIAGONAL ARTERY. THE PATIENT PRESENTED WITH ACUTE MYOCARDIAL INFARCTION (AMI) A 2.5X15MM XIENCE XPEDITION STENT WAS IMPLANTED. ON (B)(6) 2016 THE PATIENT WAS RE-ADMITTED AND PRESENTED WITH CHEST PAIN. THROMBOSIS WAS CONFIRMED WITH AN INTRAVASCULAR ULTRASOUND IN THE STENTED SEGMENT. THROMBUS ASPIRATION WAS PERFORMED AND AN UNKNOWN STENT WAS DEPLOYED, WHICH RECONSTRUCTED THE BLOOD FLOW. THE PHYSICIAN MADE A COMMENT STATING, "IT IS ASSUMED THERE IS NO ISSUE WITH THE STENT ITSELF. THE PATIENT HAS BEEN TAKING PLAVIX. HOWEVER, THERE ARE A CERTAIN NUMBER OF PATIENTS ON WHOM PLAVIX DOES NOT TAKE EFFECT. IT SEEMS PLAVIX IS NOT EFFECTIVE ON THIS PATIENT. PLAVIX WAS REPLACED WITH EFFIENT." THE OUTCOME WAS SUCCESSFUL AND THE PATIENT IS IN GOOD CONDITION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina; Thrombosis

  MAUDE report 6183505 ↗