XIENCE ALPINE 1125300-15Recalls & reported problems

Summary

The FDA's MAUDE database contains 36 adverse event reports that list this exact device (DI 08717648199349), received between Sep 2, 2016 and Apr 23, 2021 — classified as 1 death, 26 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (6 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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 36 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 23, 2021Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT A 3.0X15MM XIENCE ALPINE STENT WAS DEPLOYED WITHOUT ISSUES; HOWEVER, DURING REMOVAL OF THE STENT DELIVERY SYSTEM (SDS) RESISTANCE WITH THE GUIDE WIRE WAS FELT. THE SDS AND GUIDE WIRE HAD TO BE REMOVED AS A UNIT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. RETURN DEVICE ANALYSIS NOTED THAT THE STENT WAS STATIONARY ON THE BALLOON AND WAS NOT DEPLOYED AS REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11717870 ↗
• InjurySep 12, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE INDEX PROCEDURE TOOK PLACE ON (B)(6) 2018 DURING WHICH A 3.0 X 15 MM XIENCE ALPINE STENT WAS IMPLANTED FOR TREATMENT OF AN UNSPECIFIED VESSEL. THE PATIENT WAS READMITTED TO THE HOSPITAL ON (B)(6) 2018 FOR NON-SEGMENT ELEVATED MYOCARDIAL INFARCTION. MEDICAL INTERVENTION WAS PERFORMED AND FINAL PATIENT OUTCOME IS REPORTEDLY UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Myocardial Infarction

  MAUDE report 7870404 ↗
• InjurySep 11, 2018Off-Label Use; Adverse Event Without Identified Device or Use Problem; Off-Label Use; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2017, A 3.0X18MM XIENCE ALPINE STENT WAS IMPLANTED. ON (B)(6) 2018, THE PATIENT WAS RE-ADMITTED WITH STENT RESTENOSIS. A 3.0X15MM XIENCE ALPINE STENT WAS DEPLOYED TO TREAT THE RESTENOSIS. ON (B)(6) 2018, THE PATIENT WAS RE-ADMITTED WITH CHEST PAIN 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 7866558 ↗
• InjurySep 4, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 3.0X15 MM XIENCE ALPINE STENT WAS IMPLANTED ON (B)(46) 2018. ON (B)(6) 2018, THE PATIENT WAS RE-ADMITTED WITH GASTROINTESTINAL BLEEDING 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: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 7843130 ↗
• InjuryJul 26, 2018Adverse 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 (3.0X15MM, 3.0X12MM) WERE IMPLANTED IN AN UNSPECIFIED VESSEL. ON (B)(6) 2018, THE PATIENT WAS RE-HOSPITALIZED FOR TREATMENT OF A NON-ST ELEVATION MYOCARDIAL INFARCTION (NSTEMI). MEDICATION WAS ADMINISTERED AND THE PATIENT WAS DISCHARGED HOME. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Myocardial Infarction

  MAUDE report 7724975 ↗
• InjuryJun 5, 2018Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 3.0 X 15MM XIENCE ALPINE CORONARY STENT SYSTEM WAS IMPLANTED ON (B)(6) 2018. ON (B)(6) 2018 THE PATIENT WAS RE-ADMITTED WITH GASTROESOPHOGEAL LACERATION SYNDROME AND CARDIOVASCULAR SYMPTOMS. ALTHOUGH THE TREATMENT PERFORMED IS UNSPECIFIED, THE FACT THAT HOSPITALIZATION OCCURRED INDICATES THAT SOME FORM OF TREATMENT WAS PERFORMED. THE FINAL PATIENT OUTCOME IS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7571939 ↗
• MalfunctionApr 24, 2018Difficult To Position; Difficult to Remove

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE LEFT ANTERIOR DESCENDING CORONARY ARTERY. DURING ADVANCEMENT OF THE XIENCE ALPINE 3 X 15 MM STENT DELIVERY SYSTEM (SDS), MID-WAY UP, THE SDS MET RESISTANCE WITH THE GUIDING CATHETER AND WOULD NOT ADVANCE FURTHER. WHILE REMOVING THE SDS, THERE WAS ALSO RESISTANCE MET WITH THE GUIDING CATHETER AND BOTH WERE REMOVED AS A SINGLE UNIT. WHEN REMOVED, IT WAS NOTICED THAT THE GUIDING CATHETER WAS KINKED. ANOTHER UNSPECIFIED STENT DELIVERY SYSTEM WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7454445 ↗
• InjuryMar 6, 2018Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 3.0 X 15 MM XIENCE ALPINE WAS IMPLANTED ON (B)(6)2017. ON (B)(6) 2017 THE PATIENT WAS RE-ADMITTED WITH CARDIOVASCULAR SYMPTOMS AND VASCULAR DISORDER OF THE INTESTINE. ALTHOUGH THE TREATMENT PERFORMED IS UNSPECIFIED, THE FACT THAT HOSPITALIZATION OCCURRED, INDICATES THAT SOME FORM OF TREATMENT WAS PERFORMED. THE FINAL PATIENT OUTCOME IS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7316999 ↗
• InjuryDec 6, 2017Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 3.0 X 15 MM XIENCE ALPINE STENTS WERE IMPLANTED ON (B)(6) 2017. ON (B)(6) 2017, THE PATIENT WAS RE-ADMITTED WITH CARDIOVASCULAR SYMPTOMS INCLUDING HYPERTENSIVE HEART DISEASE WITH HEART FAILURE. 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: Heart Failure; High Blood Pressure/ Hypertension

  MAUDE report 7088352 ↗
• InjuryAug 31, 2017Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 3.0 X 15 MM XIENCE ALPINE STENT WAS IMPLANTED ON (B)(6) 2017. ON (B)(6) 2017 THE PATIENT WAS RE-ADMITTED FOR ABDOMINAL PAIN 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: No Code Available

  MAUDE report 6834139 ↗
• InjuryAug 30, 2017Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 3.0X15MM XIENCE ALPINE STENT WAS IMPLANTED ON (B)(6) 2017. ON (B)(6) 2017 THE PATIENT WAS RE-ADMITTED WITH HEART FAILURE 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: Heart Failure

  MAUDE report 6832852 ↗
• InjuryAug 30, 2017Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 3.0X15 MM XIENCE ALPINE STENT WAS IMPLANTED ON (B)(6) 2017. ON (B)(6) 2017 THE PATIENT WAS RE-ADMITTED WITH CHEST PAIN 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 6832770 ↗
• InjuryAug 11, 2017Failure to Advance; Device Dislodged or Dislocated

  SUS VOLUNTARY EVENT REPORT #MW5070899 WAS RECEIVED REPORTING THE FOLLOWING: DURING A PERCUTANEOUS CORONARY INTERVENTION A STENT BECAME DISLODGED OFF THE DELIVERY SYSTEM. THE DELIVERY SYSTEM WAS ADVANCED AND REMOVED MULTIPLE ATTEMPTING TO CROSS THE LESION. THE STENT WAS SUCCESSFULLY RETRIEVED WITH A SNARE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6789068 ↗
• InjuryJul 26, 2017Failure to Advance

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH ELEVATED TROPONIN LEVELS AND MYOCARDIAL INFARCTION. THE PROCEDURE WAS TO TREAT HEAVILY CALCIFIED, DE NOVO LESIONS IN THE MILDLY TORTUOUS PROXIMAL DIAGONAL ARTERY AND THE MILDLY TORTUOUS PROXIMAL LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY. AN ATTEMPT WAS MADE TO CROSS THE LESION IN THE DIAGONAL ARTERY WITH A 2.25X12MM RX XIENCE ALPINE STENT DELIVERY SYSTEM (SDS), BUT THIS DEVICE FAILED TO CROSS DUE TO PATIENT ANATOMY AND WAS WITHDRAWN. THERE WERE NO OTHER DEVICE ISSUES, NO ADVERSE PATIENT EFFECTS, AND NO DELAY RELATED TO USE OF THIS DEVICE. AN ATTEMPT WAS MADE TO CROSS THE LAD LESION WITH A 3.0X15MM RX XIENCE ALPINE SDS, BUT THIS DEVICE ALSO FAILED TO CROSS DUE TO PATIENT ANATOMY AND A DISSECTION OCCURRED DURING THE ATTEMPT TO CROSS THE LAD. NO ADDITIONAL ATTEMPTS TO CROSS WERE MADE WITH STENT SYSTEMS. THE DIAGONAL AND LAD LESIONS, AND THE LAD DISSECTION, WERE SUCCESSFULLY TREATED VIA BALLOON ANGIOPLASTY. THERE WERE NO ADVERSE PATIENT SEQUELAE. THE PATIENT WAS DISCHARGED HOME THE FOLLOWING DAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Intimal Dissection

  MAUDE report 6745829 ↗
• InjuryJul 7, 2017Device Dislodged or Dislocated

  DURING A PERCUTANEOUS CORONARY INTERVENTION A STENT BECAME DISLODGED OFF THE DELIVERY SYSTEM. THE DELIVERY SYSTEM WAS ADVANCED AND REMOVED MULTIPLE TIMES ATTEMPTING TO CROSS THE LESION. THE STENT WAS SUCCESSFULLY RETRIEVED WITH A SNARE.

  Patient problems: No Information

  MAUDE report 6701154 ↗
• MalfunctionJun 28, 2017Difficult To Position; Difficult to Remove; Material Deformation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY TORTUOUS, CONCENTRIC, MODERATELY CALCIFIED DE NOVO MID RIGHT CORONARY ARTERY. A 3.0 X 15 MM AND A 3.0 X 18 MM XIENCE ALPINE STENT CATHETER WAS USED BUT MET RESISTANCE WHEN ADVANCING THROUGH A NON-ABBOTT 5 FR GUIDING CATHETER EXTENSION. THE 3.0 X 15 MM STENT CATHETER BECAME STUCK ON THE GUIDING CATHETER EXTENSION, WHICH MADE IT DIFFICULT TO REMOVE. THE DISTAL END OF THE 3.0 X 15 MM STENT'S STRUT WAS ALSO FLARED. 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 6675527 ↗
• 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 6662213 ↗
• InjuryJun 16, 2017Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2017, A 3.0 X 15 MM, A 2.5 X 33 MM, A 2.5 X 15 MM AND A 4.0 X 08 MM XIENCE ALPINES STENTS WERE IMPLANTED. ON (B)(6) 2017, THE PATIENT WAS RE-ADMITTED WITH INCREASED DIFFICULTY BREATHING. UNKNOWN MEDICAL TREATMENT WAS PERFORMED. THE PATIENT WAS DISCHARGED HOME. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Dyspnea

  MAUDE report 6648791 ↗
• MalfunctionJun 15, 2017Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE STENT OF A 3.0X15MM RX XIENCE ALPINE DRUG-ELUTING STENT (DES) CAME OFF (DISLODGED) IN AN UNSPECIFIED GUIDING CATHETER, OUTSIDE OF PATIENT ANATOMY. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED. USER FACILITY MEDWATCH REPORT RECEIVED THAT STATES: STENT CAME OFF IN THE GUIDE CATHETER OUTSIDE OF PT'S BODY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6645480 ↗
• MalfunctionJun 14, 2017Material Rupture

  IT WAS REPORTED THAT THE 3.0 X 15 MM XIENCE ALPINE STENT DELIVERY SYSTEM BALLOON RUPTURED DURING USE; HOWEVER, THE DEVICE WAS ABLE TO BE REMOVED INTACT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6640576 ↗
• MalfunctionMay 18, 2017Material Rupture

  DURING PROCEDURE, BALLOON RUPTURED AND WAS REMOVED INTACT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6581395 ↗
• May 18, 2017Detachment Of Device Component

  STENT CAME OFF IN THE GUIDE CATHETER OUTSIDE OF PT'S BODY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6581392 ↗
• 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 A 3.0 X 15 MM XIENCE ALPINE WAS PLACED FOR TREATMENT. THE PATIENT WAS READMITTED TO THE HOSPITAL ON (B)(6) 2016 EXPERIENCING SYMPTOMS SYNCOPE. ALTHOUGH THE TREATMENT PERFORMED IS UNSPECIFIED, THE FACT THAT REHOSPITALIZATION OCCURRED INDICATES THAT SOME FORM OF TREATMENT WAS PERFORMED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Syncope

  MAUDE report 6501495 ↗
• InjuryApr 11, 2017Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2016, A 2.75 X 8 RX XIENCE ALPINE, A 3.0 X 15 RX XIENCE ALPINE, AND A 3.0 X 12 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 6482414 ↗
• MalfunctionApr 7, 2017Device Dislodged or Dislocated

  IT WAS REPORTED THAT AFTER PREPPING A 3.5X15MM RX XIENCE ALPINE STENT DELIVERY SYSTEM (SDS) WITHOUT ISSUE, THE SDS WAS ADVANCED WITHOUT RESISTANCE INTO A COPILOT ROTATING HEMOSTATIC VALVE (RHV), WHICH WAS CONNECTED TO THE PATIENT ACCESS SITE. HOWEVER, IMMEDIATELY AFTER ENTERING THE COPILOT RHV, IT WAS NOTED THAT THE XIENCE ALPINE STENT HAD DISLODGED PROXIMALLY ONTO THE SDS SHAFT OUTSIDE OF THE PATIENT ANATOMY. THE SDS WAS SIMPLY WITHDRAWN FROM THE COPILOT WITHOUT RESISTANCE. A NEW UNSPECIFIED XIENCE ALPINE WAS USED WITH THE SAME COPILOT WITHOUT ISSUE TO SUCCESSFULLY TREAT THE PATIENT. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO OCCURRENCE OF A CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6474149 ↗