XIENCE ALPINE 1125325-12Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 08717648199424), received between Nov 16, 2016 and Dec 1, 2021 — classified as 6 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryDec 1, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBSEQUENT TO THE INITIALLY FILED REPORT, THE FOLLOWING INFORMATION WAS RECEIVED: AFTER STENT IMPLANTATION, THE PATIENT WAS TAKING A LOW DOSE OF ASPIRIN AND BRILINTA. MEDICATION WAS INCREASED FOR TREATMENT OF ANGINA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina; Stenosis

  MAUDE report 12913645 ↗
• InjuryJan 28, 2021Off-Label Use; Off-Label Use

  IT WAS REPORTED THAT DURING A LEFT INTERNAL CAROTID ARTERY STENTING PROCEDURE, AFTER SUCCESSFUL IMPLANTATION OF THE XIENCE ALPINE STENT, A PERFORATION WAS NOTED. TWO COVERED STENTS WERE SUCCESSFULLY IMPLANTED, SEALING THE PERFORATION. THERE WAS NO ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Perforation

  MAUDE report 11244784 ↗
• MalfunctionNov 15, 2018Difficult to Remove; Failure to Advance; Deformation Due to Compressive Stress; Difficult to Remove; Failure to Advance; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN UNSPECIFIED CORONARY ARTERY. AN UNSPECIFIED BALANCE MIDDLEWEIGHT (BMW) GUIDE WIRE WAS ADVANCED TO THE LESION AND A 3.25 X 12 MM XIENCE ALPINE STENT DELIVERY SYSTEM (SDS) WAS USED. HOWEVER, THE SDS FAILED TO CROSS THE LESION AND THE SHAFT BECAME BROKEN (KINKED). THE SHAFT WAS STILL ON THE GUIDE WIRE. IT IS UNKNOWN AT THIS TIME IF ANY OTHER DEVICE CROSSED THE LESION. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED. AN UNKNOWN BALANCE MIDDLE WEIGHT (BMW) GUIDE WIRE WAS RETURNED FROZEN IN THE XIENCE ALPINE SDS. FOLLOW-UP WITH THE SITE WAS PERFORMED; HOWEVER, NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8075891 ↗
• InjurySep 12, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT WITHIN 30-DAYS POST-STENTING WITH A 3.25 X 12 MM XIENCE ALPINE STENT, THE PATIENT WAS RE-HOSPITALIZED FOR UNSTABLE ANGINA. TREATMENT WAS PROVIDED. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina

  MAUDE report 7869428 ↗
• InjurySep 5, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A XIENCE ALPINE 3.25 X 12 MM STENT WAS IMPLANTED ON (B)(6) 2018. ON (B)(6) 2018, THE PATIENT WAS RE-ADMITTED WITH ACUTE MYOCARDIAL INFARCTION. IT IS UNKNOWN WHAT TREATMENT WAS PROVIDED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Myocardial Infarction

  MAUDE report 7848472 ↗
• InjurySep 4, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 3.25 X 12 MM XIENCE ALPINE STENT WAS IMPLANTED ON (B)(6) 2018. THE PATIENT PRESENTED WITH NON-ST-ELEVATION MYOCARDIAL INFARCTION (NSTEMI) BEFORE THE PROCEDURE. ON (B)(6) 2018, THE PATIENT WAS READMITTED WITH CARDIOVASCULAR SYMPTOMS, INCLUDING CHEST PAIN. ON (B)(6) 2018, THE PATIENT WAS READMITTED AGAIN FOR CHEST PAIN. TREATMENT PERFORMED WAS UNSPECIFIED AND THE FINAL PATIENT OUTCOME IS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina

  MAUDE report 7844026 ↗
• MalfunctionJun 7, 2018Crack; Leak/Splash

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 90% STENOSED LESION IN THE MID LEFT ANTERIOR DESCENDING ARTERY. A 3.25X12MM XIENCE ALPINE STENT DELIVERY SYSTEM (SDS) WAS PREPPED WITHOUT ISSUES. THE SDS WAS ADVANCED; HOWEVER, WHEN THE DEVICE WAS BEING PRESSURIZED IT WAS NOTED THAT CONTRAST WAS LEAKING OUT OF THE HUB. THE PRESSURIZATION WAS STOPPED AND ALL CONNECTIONS WERE CONFIRMED TO BE TIGHT. THE CONNECTIONS WERE FINE; HOWEVER, THERE WAS A CRACK AT THE HUB. THE SDS WAS REMOVED FROM THE PATIENT ANATOMY WITHOUT ISSUES AND ONCE OUTSIDE THE ANATOMY, THE BALLOON APPEARED AS IF IT HAD NEVER BEEN INFLATED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A NEW 3.25X12MM XIENCE ALPINE SDS. 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 7579942 ↗
• MalfunctionFeb 28, 2017Difficult to Remove

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN ECCENTRIC DE NOVO LESION IN THE NON-TORTUOUS, HEAVILY CALCIFIED, 75% STENOSED, PROXIMAL RIGHT CORONARY ARTERY (RCA). A 3.25 X 12 MM XIENCE ALPINE STENT DELIVERY SYSTEM (SDS) WAS SELECTED FOR THE PROCEDURE. THE SDS WAS ADVANCED WITH NO RESISTANCE TO THE LESION AND THE STENT WAS SUCCESSFULLY IMPLANTED. TO ENSURE THAT THE STENT WAS FULLY APPOSED TO THE ARTERY WALL THE SDS BALLOON WAS INFLATED TO 10 ATMOSPHERES THREE TIMES. DURING REMOVAL OF SDS FROM THE ANATOMY, RESISTANCE WAS FELT WITH THE NON-ABBOTT GUIDE WIRE. IN ORDER TO FACILITATE THE REMOVAL OF THE SDS, THE GUIDE WIRE WAS PUSHED AND PULLED UNTIL THE SDS WAS INDEPENDENTLY REMOVED FROM THE ANATOMY. 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 6364868 ↗
• InjuryJan 11, 2017Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT WITHIN 30-DAYS POST-STENTING OF A CORONARY VESSEL WITH A XIENCE ALPINE, THE PATIENT WAS RE-ADMITTED TO THE HOSPITAL WITH A NON-ST ELEVATION MYOCARDIAL INFARCTION (NSTEMI) AND OTHER CARDIOVASCULAR SYMPTOMS. PERCUTANEOUS CORONARY ANGIOPLASTY WAS PERFORMED. THE FINAL PATIENT OUTCOME WAS NOT PROVIDED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Myocardial Infarction

  MAUDE report 6244218 ↗
• MalfunctionNov 16, 2016Deflation Problem; Difficult to Remove; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT IN-STENT RESTENOSIS OF A PREVIOUSLY DEPLOYED STENT LOCATED IN THE RIGHT CORONARY ARTERY. AFTER SUCCESSFUL PLACEMENT OF THE XIENCE ALPINE STENT IMPLANT INSIDE THE PREVIOUSLY DEPLOYED STENT, THE STENT DELIVERY SYSTEM BALLOON WOULD NOT DEFLATE AND IT BECAME CAUGHT ON THE PREVIOUSLY DEPLOYED STENT. THE INDEFLATOR WAS EXCHANGED FOR A SYRINGE THAT WAS USED SUCCESSFULLY TO FULLY DEFLATE THE BALLOON. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6107435 ↗