XIENCE ALPINE 1125325-38Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 08717648199486), received between Sep 23, 2016 and Dec 21, 2017 — classified as 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 21, 2017Positioning Failure; Inflation Problem; Leak/Splash

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A LESION IN AN UNSPECIFIED ARTERY. THE 3.25X38 MM XIENCE ALPINE STENT DELIVERY SYSTEM (SDS) WAS ADVANCED WITHOUT RESISTANCE IN THE PATIENT ANATOMY. HOWEVER, THE BALLOON FAILED TO INFLATE; THE STENT DID NOT DEPLOY. A LEAK WAS SUSPECTED. THE SDS WAS REMOVED FROM THE PATIENT ANATOMY. A NEW XIENCE ALPINE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7140085 ↗
• MalfunctionSep 27, 2017Unstable

  IT WAS REPORTED THAT THE 3.25X38 MM XIENCE ALPINE STENT DELIVERY SYSTEM WAS REMOVED FROM THE COIL WHEN IT WAS NOTED THAT THE STENT WAS NOT BETWEEN THE MARKERS. THIS DEVICE WAS NOT USED IN THE PATIENT. A NON-ABBOTT STENT WAS USED TO COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 6898521 ↗
• InjuryAug 29, 2017Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT TWO XIENCE ALPINE STENTS (3.25X38MM AND 3.5X08MM) WERE IMPLANTED ON (B)(6) 2017. ON (B)(6) 2017 THE PATIENT WAS RE-ADMITTED FOR ANGINA AND OTHER UNSPECIFIED CARDIOVASCULAR SYMPTOMS. UNSPECIFIED TREATMENT WAS ADMINISTERED TO THE PATIENT. FINAL PATIENT OUTCOME IS REPORTEDLY UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina

  MAUDE report 6829060 ↗
• MalfunctionNov 14, 2016Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING REMOVAL OF THE PROTECTIVE SHEATH FROM THE 3.25 X 38 MM XIENCE ALPINE STENT DELIVERY SYSTEM, THE STENT IMPLANT DISLODGED AND WAS LOCATED INSIDE THE SHEATH. THE DEVICE COULD NOT BE USED ON THE PATIENT. THERE WAS NO REPORTED RESISTANCE DURING REMOVAL FROM THE DISPENSER OR PROTECTIVE SHEATH, NOR WAS FORCE APPLIED OR ANY MANIPULATION OF THE STENT IMPLANT. THERE WAS NO PATIENT INVOLVEMENT. ANOTHER STENT DELIVERY SYSTEM WAS ABLE TO BE USED SUCCESSFULLY FOR THE CASE. NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE WAS REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 6100736 ↗
• InjurySep 23, 2016Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 3.25 X 38 MM XIENCE ALPINE STENT WAS IMPLANTED ON (B)(6) 2016. ON (B)(6) 2016, THE PATIENT WAS RE-ADMITTED WITH ANGINA. THE PATIENT WAS DISCHARGED WITHOUT TREATMENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina

  MAUDE report 5975538 ↗