XIENCE ALPINE 1125325-18Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 08717648199448), received between Oct 28, 2016 and May 7, 2019 — classified as 2 deaths, 10 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• InjuryMay 7, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2018, A XIENCE ALPINE 3.25X18MM STENT WAS SUCCESSFULLY IMPLANTED IN THE RAMUS CORONARY ARTERY LESION. ON (B)(6) 2018, THE PATIENT WAS HOSPITALIZED FOR STABLE VENTRICULAR TACHYCARDIA. AS TREATMENT, AN IMPLANTABLE CARDIOVERTER-DEFIBRILLATOR (ICD) WAS PLACED. THE EVENT RESOLVED WITHOUT SEQUELA. PER PHYSICIAN, THE EVENT WAS POSSIBLY RELATED TO THE DEVICE. THERE WAS NO DEVICE MALFUNCTION. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THIS EVENT.

  Patient problems: Ventricular Tachycardia

  MAUDE report 8588619 ↗
• InjuryNov 13, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2018, A 3.25X18MM XIENCE ALPINE STENT WAS SUCCESSFULLY IMPLANTED IN THE RAMUS CORONARY ARTERY LESION. ON (B)(6) 2018, THE PATIENT WAS HOSPITALIZED FOR ANGINA AND A NON-ST ELEVATED MYOCARDIAL INFARCTION (MI) WAS DIAGNOSED. ANOTHER PERCUTANEOUS INTERVENTION WITH THROMBECTOMY/THROMBOLYSIS WAS PERFORMED ON THE RAMUS VESSEL, OUTSIDE THE LESION SITE. REPORTEDLY, THERE WAS NO RESTENOSIS NOR THROMBUS IN OR WITHIN 5MM OF THE XIENCE ALPINE STENT. PER PHYSICIAN, THE EVENT WAS POSSIBLY RELATED TO THE DEVICE. THE EVENT RESOLVED. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THIS ISSUE.

  Patient problems: Angina; Myocardial Infarction; Thrombosis

  MAUDE report 8066835 ↗
• 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 7834688 ↗
• DeathJun 6, 2018Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE 3.25X18MM XIENCE ALPINE STENT WAS IMPLANTED ON (B)(6) 2018. ON (B)(6) 2018, THE PATIENT WAS READMITTED WITH HYPO-OSMOLALITY, HYPONATREMIA AND OTHER CARDIOVASCULAR SYMPTOMS. ON (B)(6) 2018 WITH GASTROINTESTINAL BLEED. THE TREATMENT PERFORMED WAS NOT REPORTED AND THE PATIENT DIED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Death; No Code Available

  MAUDE report 7576035 ↗
• MalfunctionApr 6, 2018Difficult to Remove; Device Damaged by Another Device; Material Deformation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED, ECCENTRIC DE NOVO LESION IN THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY THAT WAS 99% STENOSED. AN UNSPECIFIED GUIDE WIRE (GW) WAS ADVANCED TO THE FIRST DIAGONAL ARTERY. THEN A 3.25 X 18MM XIENCE ALPINE WAS DEPLOYED AT THE PROXIMAL LAD. AFTER THE STENT WAS DEPLOYED, THE GW WAS ATTEMPTED TO BE REMOVED, BUT FAILED. ANOTHER ATTEMPT WAS MADE TO REMOVE THE GW, WITH A NON-ABBOTT CATHETER, WHEN STRONG RESISTANCE WAS MET AND IT WAS NOTED THAT THE STENT GOT DEFORMED. THE GW WAS ABLE TO BE SIMPLY REMOVED TOGETHER WITH THE NON-ABBOTT CATHETER; HOWEVER, THE XIENCE ALPINE STENT WAS CAUGHT ON THE GW AND CATHETER AND WAS EXPLANTED. ANOTHER XIENCE ALPINE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. 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 7403856 ↗
• InjuryMar 6, 2018Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT TWO XIENCE ALPINE STENTS (3.25 X 18 MM, 3.25 X 08 MM) WERE IMPLANTED (B)(6) 2017. ON (B)(6) 2017 THE PATIENT WAS RE-ADMITTED WITH CARDIOVASCULAR SYMPTOMS INCLUDING ABNORMAL ELECTROCARDIOGRAM (EKG). 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: Non specific EKG/ECG Changes

  MAUDE report 7317242 ↗
• MalfunctionDec 1, 2017Difficult to Remove; Unstable; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MILDLY TORTUOUS, MILDLY CALCIFIED ECCENTRIC DISTAL RIGHT CORONARY ARTERY THAT WAS 75% STENOSED. AFTER A GUIDE WIRE CROSSED THE LESION, A 3.25 X 18MM XIENCE ALPINE STENT DELIVERY SYSTEM WAS ADVANCED BUT WAS UNABLE TO CROSS DUE TO THE TORTUOUSITY OF THE VESSEL SO IT WAS THEN PULLED BACK INTO THE GUIDING CATHETER. THE STENT MOVED DISTALLY FROM THE BALLOON DUE TO RESISTANCE FELT WITH THE GUIDING CATHETER TIP DURING REMOVAL. THE DEVICE WAS REMOVED FROM THE ANATOMY AS A SINGLE UNIT. A NON-ABBOTT STENT WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. 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 7075882 ↗
• InjuryNov 30, 2017Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2017 THE 3.25 X 18 MM XIENCE ALPINE STENT WAS IMPLANTED FOR TREATMENT OF A LESION OF AN UNSPECIFIED VESSEL. ON (B)(6) 2017, THE PATIENT WAS RE-HOSPITALIZED WITH HYPERTENSION, HEART FAILURE AND OTHER CARDIOVASCULAR (CV) SYMPTOMS. UNSPECIFIED TREATMENT WAS ADMINISTERED AND THE FINAL PATIENT OUTCOME IS REPORTEDLY UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Heart Failure; High Blood Pressure/ Hypertension

  MAUDE report 7073135 ↗
• MalfunctionSep 22, 2017Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING PREPARATION OF A 3.25 X 18 MM XIENCE ALPINE STENT DELIVERY SYSTEM (SDS) THE STENT DISLODGED FROM THE BALLOON WHEN THE PROTECTIVE SHEATH WAS REMOVED. THE DEVICE WAS NOT USED AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A NEW XIENCE ALPINE SDS. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 6888987 ↗
• InjuryAug 30, 2017Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 3.25X18MM XIENCE ALPINE STENT WAS IMPLANTED ON (B)(6) 2017. ON (B)(6) 2017 THE PATIENT WAS RE-ADMITTED WITH ATRIAL FIBRILLATION 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: Atrial Fibrillation

  MAUDE report 6832787 ↗
• InjuryJun 22, 2017Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE INDEX PROCEDURE TOOK PLACE ON (B)(6) 2017 DURING WHICH A 3.25 X 18 MM XIENCE ALPINE STENT WAS IMPLANTED FOR TREATMENT OF AN UNSPECIFIED VESSEL. THE PATIENT WAS READMITTED TO THE HOSPITAL ON (B)(6)2017 FOR HYPOTENSION, HYPERKALEMIA, ACUTE RENAL FAILURE AND BRADYCARDIA. ANGIOTENSIN II RECEPTOR BLOCKERS MEDICATION WAS STOPPED AND SO WAS THE INTRAVENOUS FLUID OF POTASSIUM SUPPLEMENTAL MEDICATION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Bradycardia; Low Blood Pressure/ Hypotension; Renal Failure

  MAUDE report 6662028 ↗
• InjuryMay 24, 2017Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE INDEX PROCEDURE TOOK PLACE ON (B)(6) 2017 DURING WHICH A 3.25 X 18 MM XIENCE ALPINE WAS IMPLANTED FOR TREATMENT OF AN UNSPECIFIED VESSEL. THE PATIENT WAS READMITTED TO THE HOSPITAL ON (B)(6) 2017 FOR CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD) AND SHORTNESS OF BREATH. 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 6588381 ↗
• InjuryJan 5, 2017Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT WITHIN 30-DAYS POST-STENTING OF AN UNKNOWN CORONARY VESSEL WITH A XIENCE ALPINE THE PATIENT WAS RE-ADMITTED TO THE HOSPITAL WITH AN INFECTION 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: Unspecified Infection

  MAUDE report 6226382 ↗
• InjuryDec 30, 2016Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 3.25 X 18 MM XIENCE ALPINE STENT WAS IMPLANTED ON (B)(6) 2016. ON (B)(6) 2016 THE PATIENT WAS RE-ADMITTED DUE TO AN ACCIDENTAL OVERDOSE; HOWEVER, THERE WERE OTHER UNSPECIFIED 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 6216663 ↗
• InjuryOct 28, 2016Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE PATIENT THAT ON (B)(6) 2015 A 3.0X18 MM XIENCE ALPINE STENT WAS IMPLANTED IN THE MID LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY AND A 2.5X28 MM XIENCE ALPINE STENT WAS IMPLANTED IN THE SECOND DIAGONAL OF THE LAD. ON (B)(6) 2015 THE PATIENT RETURNED WITH CHEST PAIN AND HIGH BLOOD PRESSURE. A 3.25X18 MM XIENCE ALPINE STENT WAS IMPLANTED IN THE OBTUSE MARGINAL (OM) ARTERY AND A 3.5X33 MM XIENCE ALPINE WAS IMPLANTED IN THE PROXIMAL LAD ACROSS THE DISEASED SEGMENTS INTO THE PREVIOUSLY PLACED STENT. THE PATIENT HAS HAD SEVERAL ANGIOGRAMS PERFORMED DUE TO CONTINUED CHEST PAIN, ONE IN (B)(6) 2016, (DATE NOT SPECIFIED FOR (B)(6)) AND ON (B)(6) 2016, ANGIOGRAMS HAVE CONFIRMED ALL FOUR STENTS REMAIN PATENT. ROUTINE MEDICATION WAS GIVEN FOR ANGINA AND FOR HYPERTENSION. THE PATIENT IS CONCERNED THAT SHE IS POSSIBLY ALLERGIC TO THE STENTS WHICH COULD BE CAUSING THE CHEST PAIN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina; High Blood Pressure/ Hypertension; Hypersensitivity/Allergic reaction

  MAUDE report 6065104 ↗