XIENCE ALPINE 1125300-12Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 08717648199332), received between Aug 10, 2016 and Jun 27, 2019 — classified as 1 death, 14 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Difficult To Position” (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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• DeathJun 27, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2018 TWO XIENCE ALPINE STENTS, SIZES 3.0X12 AND 2.5X33 MM WERE IMPLANTED IN THE PROXIMAL LEFT CIRCUMFLEX CORONARY ARTERY. ON (B)(6) 2018 THE PATIENT EXPIRED AT HOME FROM A SUDDEN DEATH. THERE WAS NO MEDICAL INTERVENTION. THE DEATH CERTIFICATE LISTS CARDIAC ARREST AS THE CAUSE OF DEATH. IN THE OPINION OF THE PHYSICIAN, THIS IS POSSIBLY RELATED TO THE STENT, BUT THERE IS NO WAY OF KNOWING THE CAUSE OF DEATH AS THE PATIENT EXPIRED AT HOME. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Death

  MAUDE report 8740344 ↗
• InjuryJun 14, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 3.0X12MM AND 3.50X23MM XIENCE ALPINE STENTS WERE IMPLANTED ON (B)(6) 2019. THE PATIENT PRESENTED WITH ST-ELEVATION MYOCARDIAL INFARCTION (STEMI) BEFORE THE PROCEDURE. ON (B)(6) 2019 AND (B)(6) 2019, THE PATIENT WAS READMITTED WITH PNEUMONIA AND HEART FAILURE. TREATMENT PERFORMED WAS UNSPECIFIED AND THE FINAL PATIENT OUTCOME IS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Heart Failure; Unspecified Infection

  MAUDE report 8700966 ↗
• InjurySep 13, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ON (B)(6) 2018, A 3.0X12MM AND A 2.50X33MM XIENCE ALPINE STENT WERE IMPLANTED. ON (B)(6) 2018 THE PATIENT WAS RE-ADMITTED WITH CARDIOVASCULAR SYMPTOMS AND CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD). ON AND (B)(6) 2018 THE PATIENT WAS RE-ADMITTED WITH CARDIOVASCULAR SYMPTOMS AND TYPE 2 DIABETES. THE TYPE OF INTERVENTION WAS NOT BEEN REPORTED AND FINAL PATIENT OUTCOME IS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7875124 ↗
• InjuryAug 28, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE LEFT ANTERIOR DESCENDING ARTERY THAT WAS APPROXIMATELY 80% STENOSED. ON (B)(6) 2016, A 3.0 X 12 MM XIENCE ALPINE STENT WAS IMPLANTED; HOWEVER, THE PATIENT BEGAN EXPERIENCING A RASH SHORTLY AFTER THE PROCEDURE, WHICH HAS WORSENED OVER TIME. THE RASH IS FELT ON THE UNDERARMS, UPPER THIGHS, BOTTOM PART OF THE LEGS AND BACK AND OCCASIONALLY ON THE LEFT SIDE OF THE FACE. THE PATIENT STATED THAT THE RASH AND ITCHY FEELING IS SPORADIC. SHE HAS BEEN TAKING GABAPENTIN AND ANOTHER UNSPECIFIED MEDICATION FOR THE RASH WHICH MAKE HER FEEL TIRED. THE PATIENT HAS BEEN CONSULTING HER DERMATOLOGIST AND ALLERGIST TO CONFIRM WHAT IS CAUSING THE RASH. AT THIS TIME, THE CAUSE IS UNDETERMINED. ON (B)(6) 2016, SHE WAS RE-HOSPITALIZED AND IT WAS CONFIRMED THAT THE STENT HAD NOT MIGRATED FROM THE TARGET LESION. THE PHYSICIAN STATED THAT TWO SMALLER STENTS MAY NEED TO BE IMPLANTED; HOWEVER, THE PATIENT WILL CONFIRM THIS WITH THE PHYSICIAN IN TWO WEEKS. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 7823124 ↗
• InjuryJun 13, 2018Adverse Event Without Identified Device or Use Problem

  (B)(6) STUDY REPORT. IT WAS REPORTED THAT ON (B)(6) 2018, A 3.0X12MM XIENCE ALPINE STENT WAS SUCCESSFULLY IMPLANTED AT THE MID LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY, 90% STENOSED LESION. STARTING ON (B)(6) 2018, THE PATIENT WAS HOSPITALIZED FOR INITIAL ABDOMINAL PAIN, DYSPNEA, NAUSEA/VOMITING, AND DIAPHORESIS. AN ST ELEVATED MYOCARDIAL INFARCTION (STEMI) WAS DIAGNOSED, ELEVATED CARDIAC ENZYMES WERE NOTED, AND MID LAD THROMBUS WERE OBSERVED. AS TREATMENT, BALLOON ANGIOPLASTY AND A THROMBECTOMY WERE PERFORMED AT THE MID LAD. MEDICATIONS WERE ALSO PROVIDED. ON (B)(6) 2018, THE EVENT RESOLVED WITHOUT SEQUELA AND THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THIS ISSUE.

  Patient problems: Angina; Diaphoresis; Dyspnea; Myocardial Infarction; Nausea; Thrombosis

  MAUDE report 7598057 ↗
• InjuryMay 29, 2018Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 3.0 X 12MM, 3.25 X 15MM, AND A 2.25 X 18MM XIENCE ALPINE STENTS WERE IMPLANTED ON (B)(6) 2018. ON (B)(6) 2018, THE PATIENT WAS READMITTED WITH CARDIOVASCULAR SYMPTOMS AND COLOSTOMY (INTESTINAL) INFECTION. TREATMENT PERFORMED WAS UNSPECIFIED AND THE FINAL PATIENT OUTCOME IS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7550852 ↗
• MalfunctionDec 19, 2017Difficult To Position; Difficult to Remove

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE CIRCUMFLEX ARTERY. A SION BLUE GUIDE WIRE WAS ADVANCED THROUGH THE ANATOMY WITHOUT ISSUE. AFTER INSERTING THE 3.0 X 12 MM XIENCE ALPINE STENT DELIVERY SYSTEM (SDS) ON THE PROXIMAL END OF THE GUIDE WIRE, IT BECAME STUCK. THE DECISION WAS MADE TO USE THE SAME GUIDE WIRE SO THAT VESSEL ACCESS WOULD NOT BE LOST; THEREFORE, THE PROXIMAL END OF THE SION BLUE GUIDE WIRE WAS CUT LEAVING THE PROXIMAL END INSIDE THE DELIVERY SYSTEM. ANOTHER XIENCE ALPINE SDS WAS USED WITHOUT ISSUE WITH THE SAME SION BLUE GUIDE WIRE. NO ADVERSE PATIENT EFFECTS OR CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE WERE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7131888 ↗
• InjuryJul 26, 2017Difficult To Position; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MILDLY CALCIFIED, RESTENOSED LESION IN THE MID LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY. AN ATTEMPT WAS MADE TO CROSS A RESTENOSED LESION WITH A 3.0X12MM RX XIENCE ALPINE STENT DELIVERY SYSTEM (SDS), BUT THE SDS FAILED TO CROSS DUE TO INTERACTION WITH THE GUIDING CATHETER AND ANOTHER PREVIOUSLY IMPLANTED STENT; NOT DUE TO PATIENT ANATOMY. THE SDS WAS WITHDRAWN WITHOUT RESISTANCE AND THERE WAS NO DAMAGE CAUSED TO THE PREVIOUSLY IMPLANTED STENT. THERE WERE NO OTHER DEVICE ISSUES NOTED, HOWEVER, A DISSECTION OCCURRED DUE TO THE FAILURE TO CROSS. THE LAD DISSECTION AND STENOSIS WERE SUCCESSFULLY TREATED WITH BALLOON ANGIOPLASTY WITH AN UNSPECIFIED 3.0X12MM BALLOON FOLLOWED BY PLACEMENT OF AN UNSPECIFIED STENT. THERE WAS NO OCCURRENCE OF A CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Intimal Dissection

  MAUDE report 6745802 ↗
• InjuryJun 22, 2017Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE INITIAL PROCEDURE THAT TOOK PLACE ON (B)(6) 2017 WAS TO TREAT A LESION LOCATED IN THE NON-TORTUOUS, NON-CALCIFIED MID LEFT ANTERIOR DESCENDING ARTERY. TWO XIENCE ALPINE STENTS (3.0 X 12 MM AND 3.0 X 15 MM) WERE DEPLOYED VIA DIRECT STENTING FOR TREATMENT OF THE LESION, FOLLOWED BY POST-DILATATION OF THE STENTS. THE STENTS WERE CONFIRMED TO BE FULLY APPOSED TO THE VESSEL WALL ON ANGIOGRAPHY. ON (B)(6) 2017, THE PATIENT WAS REHOSPITALIZED EXPERIENCING CHEST PAIN. ANGIOGRAPHY REVEALED THROMBUS IN THE DEPLOYED STENTS. A BALLOON CATHETER WAS USED TO TREAT THE THROMBOSIS SUCCESSFULLY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina; Thrombosis

  MAUDE report 6662210 ↗
• MalfunctionApr 24, 2017Device Damaged by Another Device

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE HEAVILY CALCIFIED CIRCUMFLEX. THE 3.0 X 12 MM XIENCE ALPINE STENT WAS DEPLOYED WITHOUT ISSUE AT THE LESION. DURING RETRACTION OF THE NON-ABBOTT GUIDE WIRE IT BECAME CAUGHT ON THE STENT IMPLANT, PULLING THE STENT IMPLANT OUT INTO THE GUIDING CATHETER. ANOTHER STENT WAS ABLE TO BE DEPLOYED SUCCESSFULLY FOR TREATMENT OF THE LESION. NO ADVERSE PATIENT EFFECTS OR CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE WERE REPORTED DUE TO THE EXPLANTATION OF THE STENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6516868 ↗
• InjuryApr 18, 2017Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE INDEX PROCEDURE TOOK PLACE ON (B)(6) 2016 DURING WHICH THE FOLLOWING 3.0 X 12 MM, 3.0 X 23 MM, 3.0 X 08 MM AND 3.5 X 12 MM XIENCE ALPINE STENTS WERE PLACED FOR TREATMENT. THE PATIENT WAS READMITTED TO THE HOSPITAL ON (B)(6) 2016 EXPERIENCING AN ST MYOCARDIAL INFARCTION. THE PATIENT UNDERWENT A SURGICAL PROCEDURE DURING WHICH A PACEMAKER WAS IMPLANTED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Myocardial Infarction

  MAUDE report 6501548 ↗
• InjuryApr 11, 2017Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2016, A 2.75X8 RX XIENCE ALPINE, A 3.0X15 RX XIENCE ALPINE, AND A 3.0X12 RX XIENCE ALPINE DRUG-ELUTING STENT WERE IMPLANTED FOR TREATMENT OF AN UNSPECIFIED CORONARY VESSEL. ON (B)(6) 2016, THE PATIENT WAS REHOSPITALIZED DUE TO OTHER UNSPECIFIED CARDIOVASCULAR SYMPTOMS, INCLUDING THROMBOSIS. MEDICAL INTERVENTION WAS PERFORMED VIA ANGIOPLASTY AND STENT PLACEMENT. THE FINAL PATIENT OUTCOME IS REPORTEDLY UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Thrombosis

  MAUDE report 6482453 ↗
• InjuryMar 14, 2017Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE MILDY TORTUOUS, MODERATELY CALCIFIED, MID LEFT ANTERIOR DESCENDING CORONARY ARTERY. ON (B)(6) 2017, THE PATIENT WAS EXPERIENCING ANGINA AND A 3.0X12 MM XIENCE ALPINE STENT WAS IMPLANTED. THE PATIENT DID NOT RECEIVE ANY ANTICOAGULATION (PLAVIX) DRUGS AFTER THE PROCEDURE OR DURING THE NIGHT OF THE PROCEDURE. THE NEXT MORNING ON (B)(6) 2017 THE PATIENT PRESENTED WITH ANGINA AND ENZYME ELEVATION. ANGIOGRAPHY WAS PERFORMED AND IN-STENT THROMBOSIS WAS CONFIRMED. THE PATIENT WAS TREATED WITH AN UNSPECIFIED BALLOON DILATATION CATHETER. IT IS THE PHYSICIAN'S OPINION THAT THROMBUS IS A RESULT OF THE PATIENT NOT BEING GIVEN ANY ANTICOAGULATION DRUGS, AND NOT AN ISSUE WITH THE DEVICE. THERE WERE NO ADVERSE PATIENT SEQUELAE AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina; Cardiac Enzyme Elevation; Thrombosis

  MAUDE report 6403835 ↗
• InjuryJan 11, 2017Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT WITHIN 30-DAYS POST-STENTING OF A CORONARY VESSEL WITH TWO XIENCE ALPINE STENTS, THE PATIENT WAS RE-ADMITTED TO THE HOSPITAL WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD) AND OTHER CARDIOVASCULAR SYMPTOMS. IT IS UNKNOWN WHAT TREATMENT WAS PERFORMED OR WHAT THE FINAL PATIENT OUTCOME WAS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 6244303 ↗
• 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 CHEST PAIN AND OTHER CARDIOVASCULAR SYMPTOMS. IT IS UNKNOWN WHAT TREATMENT WAS PERFORMED OR WHAT THE FINAL PATIENT OUTCOME WAS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina

  MAUDE report 6244251 ↗
• MalfunctionJan 9, 2017Material Rupture; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 90% STENOSED, MODERATELY TORTUOUS, AND HEAVILY CALCIFIED LESION IN THE DISTAL RIGHT CORONARY ARTERY. FOLLOWING PRE-DILATATION, A 3.0X38MM XIENCE ALPINE STENT DELIVERY SYSTEM WAS ADVANCED TO THE LESION. AIR ASPIRATION WAS PERFORMED WHILE THE DEVICE WAS INSIDE THE PATIENT. THE BALLOON RUPTURED AT 8 ATMOSPHERES (ATM) DURING THE FIRST INFLATION. THE STENT DELIVERY SYSTEM WAS REMOVED AND THE STENT WAS SUCCESSFULLY POST-DILATED WITH A NON-ABBOTT BALLOON DILATATION CATHETER AT 20 ATM. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6234478 ↗
• InjuryDec 30, 2016Physical Resistance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE 3.0X12 XIENCE ALPINE STENT DELIVERY SYSTEM (SDS) MET RESISTANCE DURING ADVANCEMENT TO THE SAPHENOUS VEIN GRAFT (SVG) FOR THE RIGHT CORONARY ARTERY. THE RESISTANCE WAS FELT NEAR ONE OF THE CLIPS ON THE SVG. THE SDS REACHED THE TARGET LESION AND WAS READY TO BE DEPLOYED, BUT A STENT WAS NOT ON THE SDS. THE SDS WAS REMOVED FROM THE ANATOMY. THE MISSING STENT WAS UNABLE TO BE LOCATED. THE BACK TABLE AND THE PATIENT WERE CHECKED, BUT THE STENT COULD NOT BE FOUND. ANOTHER XIENCE ALPINE STENT WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. THE PATIENT IS DOING FINE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 6216552 ↗
• InjuryAug 10, 2016Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A CORONARY ARTERY STENTING PROCEDURE, THE 3.0 X 12 MM XIENCE ALPINE STENT WAS SUCCESSFULLY IMPLANTED; HOWEVER, A PROXIMAL DISSECTION WAS NOTED. A 2.75 X 12 MM XIENCE ALPINE STENT WAS IMPLANTED AS TREATMENT WITHOUT ISSUE. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Intimal Dissection

  MAUDE report 5866954 ↗