XIENCE ALPINE 1125325-23Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 08717648199455), received between Nov 21, 2016 and Dec 19, 2019 — classified as 1 death, 6 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. 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryDec 19, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A XIENCE ALPINE STENT WAS IMPLANTED ON (B)(6) 2019. ON (B)(6) 2019, THE PATIENT PRESENTED WITH UPPER EXTREMITY SWELLING, TINGLING AND THE INABILITY TO RAISE THEIR ARMS ABOVE THEIR HEAD, THOUGHT TO BE A POSSIBLE ALLERGIC REACTION. THE STATIN WAS CHANGED, AND STEROIDS GIVEN. A BLOOD PANEL CAME BACK NORMAL WITH NORMAL EJECTION FRACTION. THE PATIENT CONTINUES TO HAVE SYMPTOMS AND MAY BE TESTED FOR AN ALLERGIC REACTION TO THE STENT AT A FUTURE DATE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Hypersensitivity/Allergic reaction; Numbness; Swelling

  MAUDE report 9499802 ↗
• InjuryMay 23, 2019Difficult to Remove; Difficult to Advance; Device Dislodged or Dislocated; Difficult to Remove; Difficult to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THE PROCEDURE WAS PERFORMED TO TREAT A LESION WITH HEAVY CALCIFICATION AND HEAVY TORTUOSITY IN THE PROXIMAL CIRCUMFLEX AND PROXIMAL LEFT ANTERIOR DESCENDING CORONARY ARTERY. THE 3.25 X 23 MM XIENCE ALPINE STENT DELIVERY SYSTEM (SDS) WAS ADVANCED WITH RESISTANCE AND BECAME STUCK IN THE OSTIAL CIRCUMFLEX/LEFT MAIN ARTERY. THE SDS WAS WITHDRAWN, BUT THE STENT REMAINED LODGED IN CALCIUM. A SMALL BALLOON CATHETER WAS ADVANCED UP TO THE DISLODGED STENT AND THE BALLOON WAS PUT THROUGH THE DISLODGED STENT AND WAS ABLE TO REMOVE THE DISLODGED STENT FROM THE CALCIFICATION. HOWEVER, WHEN THE SDS WAS BEING RETRIEVED THE STENT BECAME LOST IN THE LEFT MAIN. FLUOROSCOPY COULD NOT LOCATE THE DISLODGED STENT. IT WAS UNCERTAIN IF THE DISLODGED STENT REMAINED FREE FLOATING IN THE PATIENT ANATOMY. THE PROCEDURE WAS ABORTED DUE TO THE HEAVILY CALCIFIED VESSEL. THE PATIENT REMAINED STABLE DURING AND AFTER THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 8636403 ↗
• DeathAug 30, 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 A ST ELEVATED MYOCARDIAL INFARCTION WITH CONFIRMED MULTI VESSEL DISEASE (PROXIMAL AND MID LEFT ANTERIOR DESCENDING (LAD), CIRCUMFLEX AND OBTUSE MARGINAL CORONARY ARTERIES). FOLLOWING PRE-DILATATION WITH THREE UNSPECIFIED BALLOONS, DUAL ANTI-PLATELET MEDICATION WAS GIVEN. THE ACTIVATED CLOTTING TIME (ACT) WAS NOTED TO BE OUT OF NORMAL RANGE. A 3.00X23 MM XIENCE ALPINE STENT WAS DEPLOYED IN THE MID LAD AND A 3.25X23 MM XIENCE ALPINE STENT WAS DEPLOYED IN THE PROXIMAL LAD. HAZINESS OF UNKNOWN CAUSE WAS NOTED AT THE OSTIUM OF THE LAD AND CIRCUMFLEX. FOLLOWING PRE-DILATATION OF THE CIRCUMFLEX WITH A 3.0X15 BALLOON, FURTHER DUAL ANTIPLATELET THERAPY WAS GIVEN. A 3.25X18 MM XIENCE ALPINE STENT WAS DEPLOYED IN THE CIRCUMFLEX. BLOOD FLOW TO THE LAD AND CIRCUMFLEX WAS LOST. VASODILATOR MEDICATION WAS GIVEN. A 4.00X18 MM XIENCE ALPINE STENT WAS DEPLOYED IN THE LEFT MAIN; HOWEVER, BLOOD FLOW WAS NOT ABLE TO BE RE-ESTABLISHED. THE PATIENT ARRESTED. AN ASPIRATION CATHETER WAS UNABLE TO BE ADVANCED AND CARDIOPULMONARY RESUSCITATION WAS ATTEMPTED. THE PATIENT EXPIRED DURING THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Cardiac Arrest; Occlusion

  MAUDE report 7834621 ↗
• InjuryJul 2, 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 A LESION IN THE LEFT ANTERIOR DESCENDING CORONARY ARTERY. ON (B)(6) 2018, THE 3.25X23MM XIENCE ALPINE WAS IMPLANTED. THE PATIENT WAS COMPLIANT WITH THE ANTIPLATELET DRUG. ON (B)(6) 2018, THE PATIENT RETURNED WITH CHEST PAIN, ANGIOGRAPHY WAS PERFORMED AND IN-STENT THROMBOSIS OF THE IMPLANTED XIENCE ALPINE STENT WAS CONFIRMED. THE PATIENT WAS TREATED WITH AN UNSPECIFIED BALLOON DILATATION CATHETER. ON AN UNSPECIFIED DATE, THE PATIENT FAILED A STRESS TEST, THUS ON (B)(6) 2018, THE PATIENT WAS BROUGHT BACK FOR RE-CATHETERIZATION. THE XIENCE ALPINE WAS CONFIRMED TO HAVE REMAINED PATENT. THE PATIENT IS STABLE. THERE WAS NO ADVERSE PATIENT SEQUELAE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina; Test Result; Thrombosis

  MAUDE report 7655460 ↗
• InjuryJul 23, 2017Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2017, THE PATIENT UNDERWENT A CORONARY PROCEDURE, WITH IMPLANTATION OF A 3.0 X 18 MM ABSORB GT1 BIORESORBABLE VASCULAR SCAFFOLD (BVS) IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY AND A 3.25 X 23MM XIENCE ALPINE STENT IN THE RIGHT CORONARY ARTERY (RCA). THE PATIENT WAS PRESCRIBED DUAL ANTI-PLATELET THERAPY (DAPT) OF ASPIRIN AND CLOPIDOGREL AND WAS DISCHARGED TO HOME. ON (B)(6) 2017, THE PATIENT WAS RE-HOSPITALIZED WITH ANGINA. CORONARY ANGIOGRAPHY WAS PERFORMED AND NOTED THROMBOSIS IN BOTH THE ABSORB BVS AND IN THE XIENCE STENT. THE PATIENT REPORTED BEING NON-COMPLIANT WITH DAPT. THROMBECTOMY WAS PERFORMED. TWO ADDITIONAL XIENCE ALPINE STENTS WERE IMPLANTED; ONE IN THE ABSORB SCAFFOLD IN THE LAD AND ONE IN THE XIENCE ALPINE STENT IN THE RCA. THE CLOPIDOGREL WAS CHANGED TO TICAGRELOR AND THE PATIENT WAS DISCHARGED TO HOME IN STABLE CONDITION. ON (B)(6) 2017, THE PATIENT WAS RE-HOSPITALIZED AGAIN, WITH ANGINA, AND THROMBOSIS WAS NOTED IN BOTH LOCATIONS (LAD AND RCA). THE PATIENT WAS ADMITTED IN CARDIOGENIC SHOCK WITH BLOOD PRESSURE OF 80/59. AN INTRA-AORTIC BALLOON PUMP AND A TEMPORARY PACEMAKER WERE PLACED AND THE BLOOD PRESSURE INCREASED TO THE 150-160

  Patient problems: Angina; Cardiogenic Shock; Low Blood Pressure/ Hypotension

  MAUDE report 6734919 ↗
• InjuryJul 23, 2017Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2017, THE PATIENT UNDERWENT A CORONARY PROCEDURE, WITH IMPLANTATION OF A 3.0 X 18 MM ABSORB GT1 BIORESORBABLE VASCULAR SCAFFOLD (BVS) IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY AND A 3.25 X 23MM XIENCE ALPINE STENT IN THE RIGHT CORONARY ARTERY (RCA). THE PATIENT WAS PRESCRIBED DUAL ANTI-PLATELET THERAPY (DAPT) OF ASPIRIN AND CLOPIDOGREL AND WAS DISCHARGED TO HOME. ON (B)(6) 2017, THE PATIENT WAS RE-HOSPITALIZED WITH ANGINA. CORONARY ANGIOGRAPHY WAS PERFORMED AND NOTED THROMBOSIS IN BOTH THE ABSORB BVS AND IN THE XIENCE STENT. THE PATIENT REPORTED BEING NON-COMPLIANT WITH DAPT. THROMBECTOMY WAS PERFORMED. TWO ADDITIONAL XIENCE ALPINE STENTS WERE IMPLANTED; ONE IN THE ABSORB SCAFFOLD IN THE LAD AND ONE IN THE XIENCE ALPINE STENT IN THE RCA. THE CLOPIDOGREL WAS CHANGED TO TICAGRELOR AND THE PATIENT WAS DISCHARGED TO HOME IN STABLE CONDITION. ON (B)(6) 2017, THE PATIENT WAS RE-HOSPITALIZED AGAIN, WITH ANGINA, AND THROMBOSIS WAS NOTED IN BOTH LOCATIONS (LAD AND RCA). THE PATIENT WAS ADMITTED IN CARDIOGENIC SHOCK WITH BLOOD PRESSURE OF 80/59. AN INTRA-AORTIC BALLOON PUMP AND A TEMPORARY PACEMAKER WERE PLACED AND THE BLOOD PRESSURE INCREASED TO THE 150-160

  Patient problems: Angina; Cardiogenic Shock; Low Blood Pressure/ Hypotension; Thrombosis

  MAUDE report 6734918 ↗
• 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 3.25 X 23 MM XIENCE ALPINE WAS PLACED FOR TREATMENT. THE PATIENT WAS READMITTED TO THE HOSPITAL ON (B)(6) 2016 WITH ABNORMAL EKG/ECG AND EXPERIENCING SYMPTOMS OF ATRIAL FIBRILLATION. 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: Atrial Fibrillation; Non specific EKG/ECG Changes

  MAUDE report 6501443 ↗
• MalfunctionJan 23, 2017Improper or Incorrect Procedure or Method; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE 3.25 X 23 MM XIENCE ALPINE STENT DELIVERY SYSTEM WAS PREPARED FOR USE. THERE WAS NO DIFFICULTY NOTED DURING REMOVAL OF THE SHEATH AND STYLET. THE DEVICE WAS ADVANCED INTO THE PATIENT ANATOMY, TO THE TARGET LESION, AND NO DIFFICULTY WAS NOTED. THE PHYSICIAN INFLATED THE BALLOON TO DEPLOY THE STENT, AND THEN REMOVED THE STENT DELIVERY SYSTEM WITHOUT DIFFICULTY. AN UNSPECIFIED DILATATION CATHETER WAS ADVANCED FOR POST-DILATATION OF THE STENT; HOWEVER, IT WAS NOTED THAT THERE WAS NO STENT AT THE TARGET LESION. IT WAS THEN NOTED THAT THE STENT WAS ON THE BACK TABLE, WHERE THE DEVICE WAS PREPARED FOR USE. THE STENT HAD DISLODGED FROM THE STENT DELIVERY SYSTEM DURING PREPARATION OF THE DEVICE, BUT WAS NOT NOTICED. THE STENT DID NOT DISLODGE IN THE PATIENT ANATOMY AND THERE WAS NO ADVERSE PATIENT EFFECT. A SECOND XIENCE ALPINE WAS THEN USED WITHOUT ISSUE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6271045 ↗
• MalfunctionNov 21, 2016Collapse; Difficult to Remove

  IT WAS REPORTED THAT THERE WAS NO RESISTANCE NOTED WHEN ADVANCING THE 3.25X23 XIENCE ALPINE STENT DELIVERY SYSTEM (SDS) OVER THE NON-ABBOTT GUIDE WIRE (GW). THE XIENCE ALPINE WAS PRESSURIZED ONE TIME AT 18 ATMS AND THE STENT WAS DEPLOYED WITHOUT ISSUES. HOWEVER,AS THE XIENCE ALPINE SDS WAS PULLED OUT OF THE DEPLOYED STENT, THE SION GW ALSO CAME OUT UNEXPECTEDLY, AS THE SDS AND GW WERE STUCK TOGETHER. THUS, THE DEVICES WERE REMOVED OUT OF THE ANATOMY AS A SINGLE UNIT. THERE WAS NO RESISTANCE MET BETWEEN THE DEPLOYED STENT AND THE SDS WHEN THE SDS WAS REMOVED. THE PHYSICIAN COMMENTS THAT THE GW LUMEN ON THE SDS MAY HAVE COLLAPSED AFTER THE SINGLE INFLATION. NO SIGNIFICANT DELAY IN THE PROCEDURE WAS REPORTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6117932 ↗