XIENCE ALPINE 1125400-33Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08717648199653), received between Sep 8, 2016 and Dec 5, 2017 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (2 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. How this data works · Data updated Oct 13, 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.

• InjuryDec 5, 2017Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 4.0 X 33 MM XIENCE ALPINE STENT WAS IMPLANTED ON (B)(6) 2017. ON (B)(6)2017, THE PATIENT WAS RE-ADMITTED WITH CARDIOVASCULAR SYMPTOMS INCLUDING PRECORDIAL PAIN. ALTHOUGH THE TREATMENT PERFORMED IS UNSPECIFIED, THE FACT THAT REHOSPITALIZATION OCCURRED INDICATES THAT SOME FORM OF TREATMENT WAS PERFORMED. THE FINAL PATIENT OUTCOME IS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina

  MAUDE report 7084622 ↗
• MalfunctionDec 7, 2016Improper or Incorrect Procedure or Method; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING PREPARATION OF THE 4.00 X 33 MM XIENCE ALPINE STENT DELIVERY SYSTEM (SDS) THE STENT IMPLANT BECAME DISLODGED FROM THE BALLOON AND WAS FOUND INSIDE THE PROTECTIVE SHEATH. THERE WAS NO RESISTANCE FELT DURING REMOVAL OF THE SDS FROM THE HOOP/COIL. THE SDS WAS PREPPED (AIR ASPIRATION) PRIOR TO THE REMOVAL OF THE PRODUCT MANDREL AND STENT SHEATH AND THERE WAS NO RESISTANCE FELT DURING THEIR REMOVAL. THE XIENCE ALPINE SDS WAS NOT USED IN THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 6153487 ↗
• InjurySep 28, 2016Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 4.00 X 33 MM XIENCE ALPINE RX WAS IMPLANTED ON (B)(6) 2016. ON (B)(6) 2016 THE PATIENT WAS RE-ADMITTED FOR OTHER CARDIOVASCULAR SYMPTOMS, DIZZINESS AND SYNCOPE. IT IS UNKNOWN WHAT TREATMENT WAS PERFORMED. THE PATIENT WAS DISCHARGED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Dizziness; Syncope

  MAUDE report 5985641 ↗
• MalfunctionSep 8, 2016Improper or Incorrect Procedure or Method; Device Dislodged or Dislocated

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A LESION WITH MODERATE TORTUOSITY AND MODERATE CALCIFICATION IN THE RIGHT CORONARY ARTERY (RCA). THE XIENCE ALPINE WAS ADVANCED TO THE TARGET LESION; HOWEVER, THE STENT WAS NOT VISIBLE UNDER FLUOROSCOPY. THE DISLODGED STENT WAS FOUND INSIDE THE PROTECTIVE SHEATH ON THE PREP TABLE. THERE HAD BEEN NO RESISTANCE NOTED DURING REMOVAL OF THE PROTECTIVE SHEATH. A NEW 4.0 XIENCE ALPINE WAS ADVANCED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5937261 ↗