XIENCE ALPINE 1125325-15Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 08717648199431), received between Sep 18, 2016 and Feb 23, 2021 — classified as 1 death, 16 injuries, 1 malfunction.

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

• InjuryFeb 23, 2021Inflation Problem; Improper or Incorrect Procedure or Method; Inflation Problem; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 90% STENOSED LEFT ANTERIOR DESCENDING CORONARY ARTERY. AFTER LESION PRE-DILATATION, A 3.25X15MM XIENCE ALPINE STENT WAS GUIDED ACROSS THE LESION. DURING BALLOON INFLATION AT 24 ATMOSPHERES (ATM) FOR 15 SECONDS TO IMPLANT THE STENT, THE BALLOON APPEARED TO HAVE WAIST IN THE MIDDLE OF THE STENT. ADDITIONAL POST-DILATATION WAS PERFORMED, AND THE WAIST RESOLVED, FULLY EXPANDING THE STENT. PLEASE SEE ARTICLE FOR ADDITIONAL INFORMATION.

  Patient problems: Insufficient Information

  MAUDE report 11366799 ↗
• InjuryMar 21, 2019Failure to Advance; Device Dislodged or Dislocated; Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT A 3.25X15MM XIENCE ALPINE STENT DELIVERY SYSTEM (SDS) FAILED TO CROSS. THE SDS WAS REMOVED; HOWEVER, THE STENT WAS NOT ON THE BALLOON. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 8442213 ↗
• InjurySep 5, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 3.25 X 15MM 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 HEMORRHAGIC DISORDER. TREATMENT PERFORMED WAS UNSPECIFIED AND THE FINAL PATIENT OUTCOME IS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 7848147 ↗
• InjurySep 5, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2018, THE PATIENT UNDERWENT A CORONARY STENTING PROCEDURE, WITH IMPLANTATION OF TWO XIENCE ALPINE STENTS - A 3.25 X 15 MM AND A 2.5 X 23 MM. ON (B)(6) 2018, THE PATIENT WAS RE-HOSPITALIZED WITH IN-STENT THROMBOSIS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Thrombosis

  MAUDE report 7844876 ↗
• InjuryJun 6, 2018Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE 3.25X15MM AND 3.25X23MM XIENCE ALPINE STENTS WERE 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 MYOCARDIAL INFARCTION. THE TYPE OF TREATMENT PERFORMED WAS NOT REPORTED AND THE FINAL PATIENT OUTCOME IS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Myocardial Infarction

  MAUDE report 7576113 ↗
• InjuryDec 6, 2017Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 3.25 X 15 MM AND A 3.5 X 23 MM XIENCE ALPINE STENTS WERE IMPLANTED ON (B)(6) 2017. ON (B)(6) 2017, THE PATIENT WAS RE-ADMITTED WITH CARDIOVASCULAR SYMPTOMS. IT WAS FURTHER REPORTED THAT THE PATIENT HAD AN INFARCTION OF SPLEEN. SURGERY WAS PERFORMED. THE FINAL PATIENT OUTCOME IS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7088959 ↗
• InjuryOct 17, 2017Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6), A 3.25X15MM XIENCE ALPINE STENT WAS SUCCESSFULLY IMPLANTED. ON (B)(6), THE PATIENT WAS RE-HOSPITALIZED FOR CHEST PAIN. LABS WERE DRAWN AND AN ELECTROCARDIOGRAM WAS PERFORMED. THE PATIENT WAS DIAGNOSED AS HAVING AN EXACERBATION OF CONGESTIVE OBSTRUCTION PULMONARY DISEASE AND WAS DISCHARGED HOME. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: Angina

  MAUDE report 6955259 ↗
• InjuryOct 5, 2017Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 3.25X15 MM XIENCE ALPINE STENT WAS IMPLANTED ON (B)(6) 2017. ON (B)(6) 2017 THE PATIENT WAS RE-ADMITTED FOR THROMBOSIS. UNSPECIFIED TREATMENT WAS ADMINISTERED TO THE PATIENT. THE FINAL PATIENT OUTCOME IS REPORTEDLY NO PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Thrombosis

  MAUDE report 6918278 ↗
• MalfunctionOct 4, 2017Difficult to Remove; Material Deformation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A NEW LESION LOCATED IN THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY (LAD). THE PATIENT PRESENTED EXPERIENCING A MYOCARDIAL INFARCTION. THERE WAS AN OLDER STENT DEPLOYED DURING A PREVIOUS PROCEDURE LOCATED IN THE VESSEL THAT WAS OBSERVED TO BE PATENT. THROMBUS ASPIRATION WAS PERFORMED PRIOR TO THE ATTEMPT TO STENT. DURING POSITIONING OF THE 3.25 X 15 MM XIENCE ALPINE STENT DELIVERY SYSTEM (SDS), THE STENT STRUTS CAUGHT ON THE PROXIMAL END OF THE PREVIOUSLY DEPLOYED STENT. RESISTANCE FELT DURING RETRACTION OF THE SDS CAUSED THE STENT STRUTS TO FLARE. ANOTHER SDS WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. 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 6914443 ↗
• InjuryJun 15, 2017Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2017, A 3.25 X 15 MM XIENCE ALPINE STENT WAS IMPLANTED AND ON (B)(6) 2017 A 3.5 X 15 MM XIENCE ALPINE STENT WAS IMPLANTED. ON (B)(6) 2017, THE PATIENT RETURNED WITH CHEST PAIN. PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) WAS PERFORMED AND MEDICATIONS WERE OPTIMIZED. NO ADDITIONAL INFORMATION WAS PROVIDED

  Patient problems: Angina

  MAUDE report 6645584 ↗
• InjuryApr 19, 2017Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE INDEX PROCEDURE TOOK PLACE ON (B)(6) 2016 DURING WHICH A 3.25 X 25 MM XIENCE ALPINE WAS PLACED FOR TREATMENT. THE PATIENT WAS READMITTED TO THE HOSPITAL ON (B)(6) 2016 FOR THE ONSET OF SEPSIS. ALTHOUGH THE TREATMENT PERFORMED IS UNSPECIFIED, THE FACT THAT REHOSPITALIZATION OCCURRED INDICATES THAT SOME FORM OF TREATMENT WAS PERFORMED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Sepsis

  MAUDE report 6503646 ↗
• 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 3 XIENCE ALPINE STENTS (3.25 X 15 MM (X2), 3.25 X 18 MM) WERE IMPLANTED FOR TREATMENT. THE PATIENT WAS READMITTED TO THE HOSPITAL ON (B)(6) 2017 EXPERIENCING SYMPTOMS OF MYOPATHY. ALTHOUGH THE TREATMENT PERFORMED IS UNSPECIFIED, THE FACT THAT REHOSPITALIZATION OCCURRED INDICATES THAT SOME FORM OF TREATMENT WAS PERFORMED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 6501602 ↗
• DeathMar 21, 2017Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN ECCENTRIC LESION LOCATED IN THE PROXIMAL RIGHT CORONARY ARTERY (RCA) WITH MILD TORTUOSITY AND MILD CALCIFICATION THAT WAS 90% STENOSED. PRE-DILATATION WAS PERFORMED USING TWO NON-ABBOTT BALLOON DILATATION CATHETERS (BDC) FOLLOWED BY THE SUCCESSFUL IMPLANTATION OF A 3.25 X 15 MM XIENCE ALPINE RX DRUG ELUTING STENT AT 10 ATMOSPHERES (ATM). THE PROXIMAL PART WAS ADDITIONALLY DILATED TO 18 ATM USING THE STENT DELIVERY SYSTEM CATHETER. INTRAVASCULAR ULTRASOUND (IVUS) CONFIRMED THAT THE STENT IMPLANT WAS WELL APPOSED TO THE VESSEL WALL. THE PROCEDURE WAS SUCCESSFULLY COMPLETED AND THE PATIENT WAS DISCHARGED FROM THE HOSPITAL WITHOUT ISSUES. ON (B)(6) 2017, THE PATIENT EXPIRED AT HOME. IT WAS REPORTED THAT THE REASON FOR THE PATIENT DEATH IS UNKNOWN. AN AUTOPSY WAS NOT PERFORMED. THE PHYSICIAN INDICATED THAT IT IS UNKNOWN IF THE DEATH IS RELATED TO THE DEVICE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Death

  MAUDE report 6420903 ↗
• InjuryOct 4, 2016Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A XIENCE ALPINE 3.25 X 15 MM STENT WAS IMPLANTED ON (B)(6) 2016 AND ON (B)(6) 2016 THE PATIENT WAS RE-ADMITTED WITH AN ANEURYSM IN THE RENAL ARTERY. IT WAS STATED THAT SURGERY WAS PERFORMED AS TREATMENT UPON RE-ADMISSION ALONG WITH INTERVENTIONAL EMBOLIZATION. THE PATIENT WAS DISCHARGED HOME. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Aneurysm

  MAUDE report 5998618 ↗
• InjuryOct 4, 2016Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 3.25 X 15 MM XIENCE ALPINE STENT WAS IMPLANTED ON (B)(6) 2015. ON (B)(6) 2015 THE PATIENT WAS RE-ADMITTED WITH CHEST PAIN. IT IS UNKNOWN WHAT TREATMENT WAS PERFORMED IN THE HOSPITAL. THE PATIENT WAS DISCHARGED HOME WITH MEDICATION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina

  MAUDE report 5996807 ↗
• InjurySep 28, 2016Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 3.25 X 15 MM XIENCE ALPINE STENT WAS IMPLANTED ON (B)(6) 2015. ON (B)(6) 2015 THE PATIENT WAS RE-ADMITTED WITH CHEST PAIN. IT IS UNKNOWN WHAT TREATMENT WAS PERFORMED. THE PATIENT WAS DISCHARGED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina

  MAUDE report 5985277 ↗
• InjurySep 23, 2016Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 3.25 X 15 MM XIENCE ALPINE STENT AND A 3.5 X 23 MM XIENCE ALPINE STENT WERE IMPLANTED ON (B)(6) 2016. ON (B)(6) 2016, THE PATIENT WAS RE-ADMITTED WITH SHORTNESS OF BREATH AND CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD). IT IS UNKNOWN WHAT TREATMENT WAS PERFORMED. THE FINAL PATIENT OUTCOME IS UNKNOWN AND THE PATIENT WAS DISCHARGED TO HOME. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Dyspnea

  MAUDE report 5975553 ↗
• InjurySep 18, 2016Kinked; Failure to Advance

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A CHRONIC TOTAL OCCLUDED LESION IN THE MID RIGHT CORONARY ARTERY. DURING ADVANCEMENT OF THE 3.25X18 MM XIENCE ALPINE STENT DELIVERY SYSTEM (SDS) RESISTANCE WAS FELT WITH THE PATIENT ANATOMY, FORCE WAS USED AND THE SHAFT KINKED. THE SDS WAS REMOVED. A 3.25X15 MM XIENCE ALPINE SDS WAS ADVANCED AND THE SAME ISSUE OCCURRED, HOWEVER THIS TIME A DISSECTION OCCURRED. THE 3.25X15 MM XIENCE ALPINE SDS WAS REMOVED. A 3.0X15 MM XIENCE ALPINE WAS USED TO TREAT THE DISSECTION AND A 3.0X12 MM NON-ABBOTT SDS WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT SEQUEL AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Intimal Dissection

  MAUDE report 5959190 ↗