XIENCE XPEDITION 1074350-38Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 08717648162589), received between Feb 7, 2017 and Sep 19, 2022 — classified as 3 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (3 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjurySep 19, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT "THE XIENCE XPEDITION [3.50 X 38 MM] SDS WAS REMOVED AND THE SHAFT WAS SEPARATED. THE PATIENT HAS TO HAVE SURGERY REQUIRED TO HAVE THE REST OF THE DEVICE REMOVED." NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 15451200 ↗
• InjuryAug 12, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A MODERATELY CALCIFIED AND NON-TORTUOUS PROXIMAL LEFT ANTERIOR DESCENDING DE NOVO LESION THAT WAS 70% STENOSED. PRE-DILATATION WAS DONE WITH A 3.0X8MM NC TREK BALLOON DILATATION CATHETER AT 15 ATMOSPHERES (ATM) FOR 10 SECONDS FOLLOWED BY 8 ATM FOR 6 SECONDS TWICE. THE 3.50X38MM RX XIENCE XPEDITION STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TO THE TARGET LESION AND WHEN PRESSURIZED TO 16 ATM FOR 14 SECONDS, THE BALLOON RUPTURED. THE STENT WAS DEPLOYED IN THE TARGET LESION. POST-DILATATION WAS DONE WITH 4.0X9MM NON-ABBOTT BALLOON AT 16 ATM FOR 14 SECONDS, AT 20 ATM FOR 9 SECONDS, THEN AT 10 ATM FOR 8 SECONDS. 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 8884922 ↗
• MalfunctionFeb 9, 2018Difficult to Insert; Unstable; Material Deformation; Physical Property Issue

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN UNKNOWN LESION. AS THE XIENCE XPEDITION 3.5 X 38 MM STENT DELIVERY SYSTEM (SDS) WAS ADVANCED THROUGH THE CO-PILOT INTO THE GUIDE CATHETER, IT FELT GRITTY. THUS, THE SDS WAS REMOVED FROM THE CATHETER AND IT WAS OBSERVED THAT SOME OF THE DISTAL STRUTS WERE FLARED. THE SDS WAS NEVER ADVANCED INTO THE BODY OF THE PATIENT, ONLY ADVANCED A SMALL LENGTH OF THE GUIDE CATHETER OUTSIDE THE BODY. A NEW STENT DELIVERY SYSTEM WAS THEN OPENED AND DEPLOYED WITHOUT ISSUE. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED. BASED ON A PHOTO RECEIVED FROM THE ACCOUNT, THE STENT HAD MOVED DISTALLY ON THE BALLOON.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7260867 ↗
• MalfunctionSep 22, 2017Improper or Incorrect Procedure or Method; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE STENT OF A 3.5X38MM XIENCE XPEDITION STENT DELIVERY SYSTEM (SDS) DISLODGED DURING REMOVAL OF THE PROTECTIVE SHEATH. ADDITIONALLY, THE SDS WAS BEING PREPPED WITH A VERY BRIEF NEGATIVE PRESSURE BEING PULLED BUT NOT SUSTAINED BEFORE THE SHEATH/STYLET WERE REMOVED. THE DEVICE WAS NOT USED AND 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 Patient Involvement

  MAUDE report 6889039 ↗
• MalfunctionJul 3, 2017Difficult To Position; Difficult to Remove; Unstable; Device Dislodged or Dislocated; Material Deformation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY TORTUOUS AND HEAVILY CALCIFIED MID RIGHT CORONARY ARTERY. A 3.5 X 38 MM XIENCE XPEDITION STENT DELIVERY SYSTEM (SDS) WAS BEING ADVANCED THROUGH A GUIDELINER WHEN THE STENT GOT STUCK AND WAS DAMAGED. THE SDS WAS PULLED BACK THROUGH THE GUIDELINER, THE STENT BECAME LOOSE AND WHEN IT WAS PULLED INTO THE CO-PILOT, IT DISLODGED. THE STENT WAS EASILY REMOVED. A SECOND 3.5 X 38 MM XIENCE XPEDITION WAS BEING ADVANCED WHEN IT MET RESISTANCE WITH THE ANATOMY AND COULD NOT CROSS THE LESION. THE DEVICE WAS REMOVED AND A NON-ABBOTT STENT WAS SUCCESSFULLY DEPLOYED TO COMPLETE THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE AND NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6684596 ↗
• InjuryJun 26, 2017Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2014 THREE XIENCE XPEDITION STENTS WERE IMPLANTED, ONE IN THE PROXIMAL LEFT ANTERIOR DESCENDING (PLAD-3.5X38 MM), ONE IN THE LEFT MAIN (4.0X12 MM) AND ONE IN THE POSTERIOR DESCENDING CORONARY ARTERY (3.0X12 MM). ON (B)(6) 2015, CORONARY ARTERY STENOSIS WAS NOTED IN THE PLAD. ON (B)(6) 2015 CORONARY ARTERY BYPASS GRAFT SURGERY WAS PERFORMED AS FOLLOWS: LEFT INTERNAL THORACIC ARTERY TO LAD AND SAPHENOUS VEIN GRAFT TO OBTUSE MARGINAL ARTERY, RESOLVING THE EVENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Stenosis

  MAUDE report 6667267 ↗
• MalfunctionJun 22, 2017Detachment Of Device Component

  IT WAS REPORTED THAT THE SHAFT OF THE 3.5 X 38 MM XIENCE XPEDITION SEPARATED. THE DEVICE WAS NOT USED IN THE PATIENT AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER UNKNOWN DEVICE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 6660020 ↗
• MalfunctionFeb 7, 2017Improper or Incorrect Procedure or Method; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A DE NOVO LESION IN THE MODERATELY TORTUOUS, MILDLY CALCIFIED, SOFT PLAQUE, 99% STENOSED RIGHT CORONARY ARTERY (RCA). A 3.50 X 38 MM XIENCE XPEDITION STENT DELIVERY SYSTEM (SDS) WAS SELECTED FOR THE PROCEDURE. THE SDS WAS ADVANCED TO THE LESION, CROSSED AND WHILE TRYING TO POSITION THE STENT IMPLANT IN THE LESION, IT WAS OBSERVED THAT THERE WAS NO STENT IMPLANT ON THE SDS. THE SDS WAS REMOVED FROM THE ANATOMY AND IT WAS DISCOVERED THAT THE STENT IMPLANT HAD DISLODGED DURING PREPARATION AND WAS FOUND INSIDE THE PROTECTIVE SHEATH. A 3.50 X 23 MM XIENCE ALPINE STENT IMPLANT WAS SUCCESSFULLY DEPLOYED TO COMPLETE 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 6309163 ↗