XIENCE ALPINE 1125225-18Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 08717648199080), received between Aug 17, 2016 and Oct 9, 2019 — classified as 1 death, 13 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (5 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.

• InjuryOct 9, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2017, THREE XIENCE ALPINE STENTS WERE IMPLANTED IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY AND DIAGONAL BIFURCATION LESIONS. ON (B)(6) 2019, THE PATIENT PRESENTED, SYMPTOMATIC, AND WAS DIAGNOSED WITH ST-ELEVATION MYOCARDIAL INFARCTION (STEMI). ANGIOGRAPHY REVEALED THROMBOSIS IN ALL 3 STENTS. BALLOON ANGIOPLASTY WAS PERFORMED TO TREAT THE THROMBOSIS AND FLOW WAS RESTORED. NO ADDITIONAL TREATMENT WAS PERFORMED, AND THE PATIENT HAD A GOOD OUTCOME. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina; Myocardial Infarction; Thrombosis

  MAUDE report 9173211 ↗
• MalfunctionNov 27, 2018Inflation Problem; Activation Failure; Inflation Problem; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A DISTAL RIGHT CORONARY ARTERY. A 2.50 X18 MM XIENCE ALPINE STENT DELIVERY SYSTEM (SDS) WAS DILATED AT 10 ATMOSPHERES BUT THE STENT-BALLOON ONLY PARTIALLY INFLATED. THE SDS WAS REMOVED. THE STENT-BALLOON WAS CHECKED IF A RUPTURE HAD OCCURRED, BUT CANNOT BE CONFIRMED. THE DEVICE WAS REMOVED AND NO ADDITIONAL TREATMENT WAS PROVIDED. 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 8107883 ↗
• MalfunctionNov 1, 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 A HEAVILY TORTUOUS CIRCUMFLEX ARTERY. A 2.25X18MM XIENCE ALPINE STENT DELIVERY SYSTEM FAILED TO CROSS THE LESION, WHEN IT WAS NOTED THAT THE SHAFT BECAME KINKED. THE DEVICE WAS BEING REMOVED WHEN FURTHER RESISTANCE WITH THE ANATOMY WAS FELT. IT WAS UNSPECIFIED HOW THE PROCEDURE WAS COMPLETED. THE PATIENT IS DOING FINE. 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 8028248 ↗
• DeathJun 12, 2018Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS ADMITTED WITH ST ELEVATION MYOCARDIAL INFARCTION (MI). THE CORONARY PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE LEFT ANTERIOR DESCENDING ARTERY. NITROGLYCERIN WAS ADMINISTERED DUE TO VESSEL SPASM. PRE-DILATATION WAS PERFORMED AT THE TARGET LESION. A 2.25 X 18 MM XIENCE ALPINE STENT WAS IMPLANTED FIRST IN THE DISTAL PORTION OF THE LESION AND A 2.75 X 23 MM XIENCE ALPINE WAS THEN IMPLANTED IN THE PROXIMAL TO MID PORTION OF THE LESION. NITROGLYCERIN WAS ADMINISTERED DUE TO CONTINUED VESSEL SPASM. POST-DILATATION WAS PERFORMED AND THE STENTS WERE WELL APPOSED TO THE VESSEL WALL. GOOD BLOOD FLOW WAS NOTED. ONE DAY POST-PROCEDURE, THE PATIENT WAS PENDING DISCHARGE, BUT DID NOT FEEL WELL. A PAUSE WAS NOTED ON TELEMETRY. CARDIOPULMONARY RESUSCITATION WAS STARTED AND THE PATIENT WAS TRANSFERRED TO THE CATH LAB. THROMBUS WAS NOTED WITHIN THE ENTIRE STENTED PORTION OF THE LAD. DESPITE RESUSCITATION ATTEMPTS, THE PATIENT DIED ON (B)(6) 2018. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Arrhythmia; Death; Fatigue; Thrombosis; Vasoconstriction

  MAUDE report 7592585 ↗
• InjuryMay 17, 2018Improper or Incorrect Procedure or Method; Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN ECCENTRIC DE NOVO LESION LOCATED IN THE RIGHT CORONARY ARTERY (RCA ATRIOVENTRICULAR) THAT WAS MILDLY TORTUOUS, MILDLY CALCIFIED AND 90% STENOSED. THE LESION WAS PRE-DILATED WITH A NON-ABBOTT BALLOON. THE XIENCE ALPINE 2.25 X 18 MM STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TOWARDS THE LESION BUT FAILED TO CROSS A PREVIOUSLY IMPLANTED STENT IN THE PROXIMAL RIGHT CORONARY ARTERY (RCA). ALTHOUGH THE PROXIMAL PART WAS DILATED WITH THE NON-ABBOTT BALLOON, THE SDS FAILED TO CROSS AGAIN. WHEN THE SDS WAS REMOVED, THE STENT IMPLANT WAS FOUND TO HAVE DISLODGED. UNDER FLUOROSCOPY, IT WAS DISCOVERED THAT THE DISLODGED STENT WAS CAUGHT IN THE STENT STRUT LOCATED IN THE PROXIMAL RCA. A 3.0 X 15 XIENCE ALPINE STENT WAS THEN DEPLOYED TO CRUSH THE DISLODGED STENT. IVUS WAS PERFORMED AND STENOSIS IN THE ATRIOVENTRICULAR WENT FROM 90% TO 25%. WITH THIS CONFIRMED, THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Vessel Or Plaque, Device Embedded In

  MAUDE report 7522712 ↗
• InjuryJan 2, 2018Positioning Failure; Difficult To Position; Unstable

  IT WAS REPORTED THAT ON (B)(6)2017, THE PATIENT PRESENTED WITH A NON ST ELEVATION MYOCARDIAL INFARCTION AND UNSTABLE ANGINA. A 2.25X18 MM XIENCE ALPINE STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TO THE NON-CALCIFIED LESION IN THE DISTAL OBTUSE MARGINAL (OM) CORONARY ARTERY AND DIRECT STENTING WAS PERFORMED AT 14 ATMOSPHERES FOR 20 SECONDS, BUT DUE TO THE TIGHTNESS OF THE LESION, THE STENT MOVED 3 MM PROXIMALLY ON THE BALLOON. AFTER STENT DEPLOYMENT, THE PROXIMAL SEGMENT OF THE STENT WAS NOT EXPANDED AND WHEN THE SDS WAS RETRACTED FROM THE ANATOMY, THE STENT MOVED PROXIMAL INTO THE PROXIMAL OM, BUT THE SDS WAS SUCCESSFULLY REMOVED FROM THE PARTIALLY DEPLOYED STENT. A 2.25X20 TREK DILATATION CATHETER WAS ADVANCED THROUGH THE STENT, FULLY DEPLOYING IT, BUT THE STENT MOVED INTO HEALTHY TISSUE IN THE MID OM. A 3.5X20 TREK DILATATION CATHETER WAS INSERTED AND POST DILATED THE STENT. ANOTHER 2.25X18 XIENCE ALPINE SDS WAS INSERTED TO BE USED IN THE DISTAL OM LESION, BUT WAS UNABLE TO CROSS THROUGH THE IMPLANTED STENT AND WAS REMOVED FROM THE ANATOMY, UNDEPLOYED. ON THE MORNING OF (B)(6) 2017 THE PATIENT EXPERIENCED CHEST PAIN AND A MINOR, INSIGNIFICANT RISE IN TROPONIN. NO TREATMENT WAS GIVE

  Patient problems: Angina; Cardiac Enzyme Elevation; Foreign Body In Patient

  MAUDE report 7158705 ↗
• InjuryDec 13, 2017Break

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A PROXIMAL LEFT ANTERIOR DESCENDING ARTERY. ON (B)(6) 2015 THE PATIENT PRESENTED WITH STABLE ANGINA AND A 2.25 X 18 MM XIENCE ALPINE STENT WAS DEPLOYED. ON (B)(6) 2017 THE PATIENT PRESENTED WITH ANGINA AND A STENT FRACTURE OF THE XIENCE ALPINE WAS CONFIRMED. BALLOON ANGIOPLASTY WAS PERFORMED AND A NON-ABBOTT STENT WAS IMPLANTED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT SEQUELA REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina

  MAUDE report 7113146 ↗
• InjuryOct 18, 2017Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2017, 3 XIENCE ALPINE STENTS (2.25X18, 2.50X23 AND 2.25X18 MM) AND TWO NON-ABBOTT STENTS WERE SUCCESSFULLY IMPLANTED; HOWEVER, ALMOST IMMEDIATELY POST IMPLANTATION, THE PATIENT EXPERIENCED INTERMITTENT CHEST PAIN WITH SYMPTOMS INCREASING WHILE EATING AND WHILE PERFORMING STRENUOUS ACTIVITY. THIS WAS TREATED WITH NITROGLYCERIN AND ANTI-DEPRESSANTS, BUT THE ISSUE WAS NOT RESOLVED. ON (B)(6) 2017, THE PATIENT CONSULTED AN ALLERGIST WHO REQUESTED A LIST OF DEVICE COMPONENTS. ALLERGIC, SYSTEMIC SYMPTOMS WERE NOT REPORTED. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: Angina; Hypersensitivity/Allergic reaction

  MAUDE report 6959677 ↗
• InjuryOct 17, 2017Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6), A 2.25X18MM XIENCE ALPINE STENT WAS SUCCESSFULLY IMPLANTED. ON (B)(6), THE PATIENT WAS REHOSPITALIZED FOR ANGINA. AN ELECTROCARDIOGRAM WAS PERFORMED AND LABS WERE DRAWN. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: Angina

  MAUDE report 6955226 ↗
• InjurySep 14, 2017Difficult to Remove; Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY TORTUOUS AND HEAVILY CALCIFIED DISTAL LEFT ANTERIOR DESCENDING (LAD) ARTERY. A 2.25 X 18 MM XIENCE ALPINE STENT FAILED TO CROSS THE LESION DUE TO THE ANATOMY AND DISLODGED FROM THE BALLOON IN THE LEFT MAIN ARTERY. AN ATTEMPT WAS THEN MADE TO REMOVE THE STENT BUT IT BECAME STUCK ON AN UNSPECIFIED GUIDELINER. THEREFORE, AN UNSPECIFIED STENT WAS IMPLANTED TO TREAT THE ALPINE STENT. THE ALPINE STENT WAS CRUSHED AND EMBEDDED IN HEALTHY TISSUE IN THE LEFT MAIN ARTERY. THEN ANOTHER UNSPECIFIED STENT WAS IMPLANTED IN THE DISTAL LAD TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT SEQUELA REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Vessel Or Plaque, Device Embedded In

  MAUDE report 6867228 ↗
• InjuryApr 11, 2017Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2016, A 2.25X18 RX XIENCE ALPINE DRUG-ELUTING STENT WAS IMPLANTED FOR TREATMENT OF AN UNSPECIFIED VESSEL. ON (B)(6) 2016, THE PATIENT WAS REHOSPITALIZED DUE TO OTHER UNSPECIFIED CARDIOVASCULAR SYMPTOMS, INCLUDING WEAKNESS. UNSPECIFIED TREATMENT WAS ADMINISTERED AND THE FINAL PATIENT OUTCOME IS REPORTEDLY UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Weakness

  MAUDE report 6482113 ↗
• InjuryNov 7, 2016Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING THE PROCEDURE TO TREAT A MODERATELY CALCIFIED LESION IN THE MODERATELY TORTUOUS PROXIMAL 1ST OBTUSE MARGINAL (OM1) CORONARY ARTERY, A 2.25X18 RX XIENCE ALPINE STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TOWARD THE LESION. WHEN ATTEMPTING TO CROSS THE LESION, RESISTANCE WAS FELT AGAINST THE LESION, THE SDS FAILED TO CROSS, AND, WHILE NO FORCE WAS APPLIED, THE STENT DISLODGED PROXIMALLY ONTO THE SDS. THE DISLODGED STENT WAS SNARED BY AN UNSPECIFIED SNARE DEVICE AND PULLED BACK INTO THE LEFT MAIN ARTERY. AN UNSPECIFIED STENT WAS THEN ADVANCED AND DEPLOYED IN THE LEFT MAIN, CRUSHING THE DISLODGED XIENCE ALPINE STENT AGAINST THE NON-DISEASED LEFT MAIN ARTERIAL WALL, COMPLETELY OUTSIDE OF THE TARGET LESION. THE TARGET LESION IN THE OM1 WAS LEFT UNTREATED AND WILL BE ADDRESSED VIA MEDICAL MANAGEMENT. WHILE THIS ISSUE CAUSED A CLINICALLY SIGNIFICANT DELAY, THERE WERE NO ADVERSE PATIENT SEQUELAE AND THE PATIENT IS REPORTEDLY DOING WELL. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Vessel Or Plaque, Device Embedded In

  MAUDE report 6083446 ↗
• InjuryOct 4, 2016Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 2.25 X 18 MM XIENCE ALPINE STENT WAS IMPLANTED ON (B)(6) 2015. ON (B)(6) 2015 THE PATIENT WAS RE-ADMITTED FOR A STROKE. IT IS UNKNOWN WHAT TREATMENT WAS PERFORMED. THE PATIENT WAS DISCHARGED TO A NURSING HOME. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Stroke/CVA

  MAUDE report 5997054 ↗
• InjurySep 28, 2016Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 2.25 X 18 MM XIENCE ALPINE, 2.50 X 33 MM XIENCE ALPINE, 2.50 X 12 MM XIENCE ALPINE, 2.25 X 12 MM XIENCE ALPINE, AND A 2.25 X 18 MM XIENCE ALPINE STENTS WERE IMPLANTED ON (B)(6) 2016. ON (B)(6)2016, THE PATIENT WAS RE-ADMITTED WITH CARDIOVASCULAR SYMPTOMS INCLUDING HEART FAILURE. IT IS UNKNOWN WHAT TREATMENT WAS PERFORMED. THE FINAL PATIENT OUTCOME IS UNKNOWN AND THE PATIENT WAS DISCHARGED TO A HOSPICE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Heart Failure

  MAUDE report 5985697 ↗
• MalfunctionSep 28, 2016Difficult To Position; Difficult to Remove

  IT WAS REPORTED DURING A PROCEDURE THE XIENCE ALPINE GOT STUCK WITH THE GUIDE WIRE DURING ADVANCEMENT TO THE TARGET LESION. THE DEVICES WERE REMOVED TOGETHER AS ONE UNIT WITHOUT ANY ISSUES. A NEW XIENCE ALPINE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5985005 ↗
• InjurySep 16, 2016Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 2.25X18MM XIENCE ALPINE STENT WAS IMPLANTED ON (B)(6) 2016. ON (B)(6) 2016, THE PATIENT WAS RE-ADMITTED WITH CARDIOVASCULAR SYMPTOMS AND ANGINA. A CATHETER PROCEDURE WAS PERFORMED TO TREAT THE ANGINA. THE PATIENT WAS DISCHARGED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina

  MAUDE report 5958323 ↗
• InjuryAug 24, 2016Difficult to Remove; Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A CORONARY PROCEDURE TO TREAT A TARGET LESION IN THE CALCIFIED, 90% STENOSED RIGHT CORONARY ARTERY. THE 2.25 X 18 MM XIENCE ALPINE STENT DELIVERY SYSTEM WAS ADVANCED INTO THE PATIENT ANATOMY AND RESISTANCE WAS NOTED ADVANCING TO THE LESION, DUE TO THE PATIENT ANATOMY. THE DEVICE WAS PULLED BACK FOR RE-POSITIONING AND RESISTANCE WAS NOTED DUE TO THE PATIENT ANATOMY. IT WAS NOTED THAT THE STENT DID NOT APPEAR TO BE ON THE STENT DELIVERY SYSTEM AND THE DEVICE WAS REMOVED. UPON REMOVAL, THE STENT WAS NOT ON THE STENT DELIVERY SYSTEM. THE GUIDE WIRE WAS REMOVED FROM THE PATIENT ANATOMY; HOWEVER, THE STENT WAS NOT ON THE GUIDE WIRE. THE STENT WAS NOT NOTED TO BE IN THE CORONARY ANATOMY. COMPUTED TOMOGRAPHY OF THE BRAIN WAS PERFORMED; HOWEVER, THE STENT WAS NOT SEEN. NO ADDITIONAL INTERVENTION HAS BEEN PERFORMED AND THE PATIENT IS UNDER OBSERVATION. AT THIS TIME, THE PATIENT IS IN STABLE CONDITION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 5900760 ↗
• MalfunctionAug 17, 2016Difficult to Remove; Device Misassembled During Manufacturing /Shipping

  IT WAS REPORTED THAT A LITTLE RESISTANCE WAS FELT DURING REMOVAL OF THE XIENCE ALPINE 2.25 X 18 MM STENT DELIVERY SYSTEM (SDS) FROM THE DISPENSER COIL. UPON REMOVAL OF THE SDS, THE STENT IMPLANT WAS FOUND TO NOT BE CRIMPED BETWEEN THE MARKERS; THE STENT WAS LOCATED PROXIMALLY. THERE WAS NO REPORTED RESISTANCE FELT OR FORCE APPLIED DURING THE REMOVAL OF THE PRODUCT MANDREL/STENT SHEATH AND NO MANIPULATION/HANDLING OF THE STENT AT ANY POINT. THE DEVICE WAS NOT USED FOR THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 5884384 ↗