XIENCE XPEDITION 1074350-28Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08717648162565), received between Sep 27, 2018 and Oct 11, 2019 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Deformation Due to Compressive Stress” (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.

• MalfunctionOct 11, 2019Material Separation; Tear, Rip or Hole in Device Packaging; Deformation Due to Compressive Stress; Packaging Problem; Material Separation; Tear, Rip or Hole in Device Packaging; Deformation Due to Compressive Stress; Packaging Problem

  IT WAS REPORTED THAT DURING UNPACKING OF A 3.50X28MM XIENCE XPEDIITION STENT DELIVERY SYSTEM, THE OUTER PACKAGING WAS NOTED WITH A SLIGHT DENT. AS THE DEVICE WAS BEING UNPACKED FURTHER DAMAGE WAS NOTED (DISPENSER HOOP COIL DENTED, DELIVERY SYSTEM (SHAFT) WAS KINKED AND THE STENT IMPLANT [BROKEN] IN TWO PIECES). THE DEVICE WAS NEVER USED AND THERE WAS NO PATIENT INVOLVEMENT. ANOTHER XIENCE XPEDITION WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED. (B)(6) 2019: PER REASSESSMENT OF THE EVENT DETAILS, IT WAS CONFIRMED THAT THE HYPOTUBE SEPARATED IN TWO PIECES, NOT THE STENT IMPLANT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 9182666 ↗
• InjurySep 27, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2013, THE PATIENT UNDERWENT A CORONARY PROCEDURE TO TREAT THE TARGET LESION IN THE PROXIMAL RIGHT CORONARY ARTERY (RCA). A XIENCE XPEDITION STENT WAS IMPLANTED. ON (B)(6) 2018, THE PATIENT WAS SEEN WITH COMPLAINTS OF CHEST PAIN. AS THE PATIENT HAD BEEN NON-COMPLIANT WITH ASPIRIN ADMINISTRATION SINCE (B)(6) 2018, THE ASPIRIN WAS DISCONTINUED. CORONARY ANGIOGRAPHY WAS PERFORMED ON (B)(6) 2018 AND NOTED 50% RE-STENOSIS IN THE TARGET LESION AND 90% STENOSIS IN THE MID RCA. MEDICATION WAS ADMINISTERED ON (B)(6) 2018 AND THE ANGINA RESOLVED ON (B)(6) 2018. CORONARY ANGIOGRAPHY WAS PERFORMED ON (B)(6) 2018 AND NOTED THAT THE STENOSIS WAS WITHIN 5 MM OF THE IMPLANTED STENT. REVASCULARIZATION WITH ADDITIONAL STENT IMPLANTATION WAS PERFORMED AND THE EVENT RESOLVED ON (B)(6) 2018. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina; Stenosis

  MAUDE report 7916502 ↗