XIENCE XPEDITION 1074300-18Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08717648162343), received between Aug 27, 2018 and Jul 18, 2019 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Deflation 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.

• MalfunctionJul 18, 2019Deflation Problem; Difficult to Remove; Improper or Incorrect Procedure or Method; Deflation Problem; Difficult to Remove; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN UNSPECIFIED LESION. AFTER STENT DEPLOYMENT OF A 3.0X18MM XIENCE XPEDITION, THE STENT-BALLOON FAILED TO DEFLATE. IT WAS DECIDED TO SIMPLY WITHDRAW THE STENT-BALLOON. NO HARM CAME TO THE PATIENT. REPORTEDLY, THE DEVICE WAS NOT PREPPED (AIR ASPIRATION) OUTSIDE THE ANATOMY PRIOR TO USE. 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 8803242 ↗
• InjuryAug 27, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IN (B)(6) 2018, THE PROCEDURE WAS PERFORMED USING TWO XIENCE XPEDITION STENTS TO TREAT A LESION IN THE MID RIGHT CORONARY ARTERY (RCA) WITH MILD CALCIFICATION. A 3.0 X 38 MM XIENCE XPEDITION STENT WAS IMPLANTED IN THE PROXIMAL RCA AND A 3.0 X 18 MM XIENCE XPEDITION STENT WAS IMPLANTED IN THE MID RCA. ON (B)(6) 2018, THE PATIENT PRESENTED WITH ACUTE CORONARY SYNDROME FROM A DE NOVO BLOCKAGE. ANGIOGRAPHY REVEALED THE STENTS HAD 70-80% RESTENOSIS IN THE RCA IN BOTH XIENCE XPEDITION STENTS. BALLOON ANGIOPLASTY WAS PERFORMED TO TREAT THE RESTENOSIS. PER THE PHYSICIAN, THE CAUSE OF THE RESTENOSIS WAS UNDER EXPANSION OF THE STENT. THE LEFT ANTERIOR ARTERY WAS ALSO TREATED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Stenosis

  MAUDE report 7820023 ↗