XIENCE ALPINE 1125275-38Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08717648199301), received between Oct 3, 2016 and Aug 29, 2017 — classified as 2 injuries, 2 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 18, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryAug 29, 2017Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 2.75X38 MM XIENCE ALPINE STENT WAS IMPLANTED ON (B)(6) 2017. ON (B)(6) 2017 THE PATIENT WAS RE-ADMITTED FOR UNSPECIFIED CARDIOVASCULAR SYMPTOMS AND SEPSIS. UNSPECIFIED TREATMENT WAS ADMINISTERED TO THE PATIENT. FINAL PATIENT OUTCOME IS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Sepsis

  MAUDE report 6828725 ↗
• MalfunctionApr 13, 2017Difficult to Remove; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING UNPACKING. OF A 2.75 X 38 MM XIENCE ALPINE STENT DELIVERY SYSTEM THERE WAS SLIGHT RESISTANCE REMOVING THE PROTECTIVE SHEATH AND THE STENT DISLODGED INSIDE THE SHEATH. THE DEVICE WAS NOT USED. A SECOND 2.75 X 38 MM XIENCE ALPINE STENT WAS SUCCESSFULLY DEPLOYED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE AND NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 6491048 ↗
• MalfunctionJan 26, 2017Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE MID LEFT ANTERIOR DESCENDING CORONARY ARTERY THAT WAS MODERATELY TORTUOUS AND HEAVILY CALCIFIED. ROTABLATION AND GUIDELINERS WERE USED. THE 2.75 X 38 XIENCE ALPINE STENT CROSSED THE LESION BUT WHEN IT WAS ATTEMPTED TO BE INFLATED, IT WAS LEAKING AT THE JUNCTION OF THE HYPOTUBE. IT WAS CONFIRMED THAT NO AIR WAS IN THE PATIENT FROM THE LEAKY SHAFT. THE PROCEDURE WAS COMPLETED BY DEPLOYING A NON-ABBOTT 2.75 X 30 MM STENT AND A 2.75 X 23 MM XIENCE ALPINE STENT. THERE WERE NO REPORTED 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 6281189 ↗
• InjuryOct 3, 2016Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 2.75 X 38 MM AND A 3.50 X 33 MM XIENCE ALPINE STENT WERE IMPLANTED ON (B)(6) 2016. ON (B)(6) 2016, THE PATIENT WAS RE-ADMITTED WITH OTHER CARDIOVASCULAR SYMPTOMS INCLUDING PERICARDIUM DISEASE. ANTI-INFLAMMATORIES WERE GIVEN; THERE WERE NO ADVERSE PATIENT SEQUELA. THE PATIENT WAS DISCHARGED TO HOME. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 5993785 ↗