XIENCE ALPINE 1125275-18Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 08717648199264), received between Aug 12, 2016 and Apr 8, 2020 — classified as 10 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (1 report).

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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryApr 8, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT ID: (B)(6). IT WAS REPORTED THAT A PERCUTANEOUS CORONARY INTERVENTION WAS PERFORMED ON (B)(6) 2019. A 2.75X18MM XIENCE ALPINE STENT WAS IMPLANTED IN THE PROXIMAL-MID LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY LESION AND A 2.5X12MM XIENCE ALPINE STENT WAS IMPLANTED IN THE MID LAD. THE PROCEDURE WAS PERFORMED WITHOUT COMPLICATIONS. STARTING ON (B)(6) 2019, THE PATIENT EXPERIENCED ACUTE ON CHRONIC HEART FAILURE. THE PATIENT WAS ADMITTED TO THE HOSPITAL WITH DYSPNEA, ORTHOPNEA, AND ANGINA. ELEVATED TROPONIN AND THE EJECTION FRACTION WAS OBSERVED AT 50-55%. REPORTEDLY, THE ELEVATED TROPONIN WAS RELATED TO DEMAND ISCHEMIA SECONDARY TO HEART FAILURE AND ATRIAL FIBRILLATION. MEDICATIONS WERE PROVIDED. ON (B)(6) 2019, A NON-ABBOTT STENT WAS IMPLANTED IN THE STENOSED PROXIMAL LAD, MORE PROXIMAL AND SLIGHTLY OVERLAPPING THE PREVIOUSLY IMPLANTED MID-PROXIMAL LAD 2.75X18MM XIENCE ALPINE STENT. MEDICATIONS WERE ALSO PROVIDED. PER PHYSICIAN, THE EVENTS WERE UNRELATED TO THE XIENCE ALPINE STENTS AND UNRELATED TO THE INDEX PROCEDURE. THERE WAS NO DEVICE MALFUNCTION. THE EVENT RESOLVED WITHOUT SEQUELA. THERE WAS NO ADDITIONAL INFORMATION PROVIDED REGARDING THIS ISSUE.

  Patient problems: Angina; Atrial Fibrillation; Cardiac Enzyme Elevation; Dyspnea; Heart Failure; Ischemia; Test Result

  MAUDE report 9935627 ↗
• InjurySep 11, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT 2.75 X18 MM XIENCE ALPINE STENTS WAS IMPLANTED ON (B)(6) 2018. ON (B)(6) 2018, THE PATIENT WAS RE-ADMITTED WITH CARDIOVASCULAR SYMPTOMS DUE TO ATHEROSCLEROSIS HEART DISEASE WHICH INCLUDED OTHER ANGIOGRAPHY PROCEDURES. 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: No Code Available

  MAUDE report 7866130 ↗
• InjurySep 4, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THREE XIENCE ALPINE STENTS (2.75X18MM, 2.5X23MM, AND 3.00X33MM) WERE IMPLANTED ON (B)(6) 2018. 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 7843159 ↗
• InjuryMar 9, 2018Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 2.75 X 18 MM XIENCE ALPINE STENT WAS IMPLANTED ON (B)(6) 2017. ON (B)(6) 2017 THE PATIENT WAS RE-ADMITTED WITH CARDIOVASCULAR SYMPTOMS AND SEPSIS. 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: Sepsis

  MAUDE report 7328960 ↗
• InjuryFeb 22, 2018Difficult to Remove; Improper or Incorrect Procedure or Method; Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MILDLY TORTUOUS, MILDLY CALCIFIED ECCENTRIC DE NOVO LESION IN THE MID LEFT ANTERIOR DESCENDING CORONARY ARTERY THAT WAS 90% STENOSED. A 2.5 X 12MM XIENCE ALPINE STENT WAS IMPLANTED AT THE LESION. A 2.75 X 18 XIENCE ALPINE STENT DELIVERY SYSTEM (SDS) WAS THEN ATTEMPTED TO CROSS THE LESION BUT WAS UNABLE DUE TO THE ANATOMY. ANOTHER ATTEMPT WAS PERFORMED AFTER IT HAD BEEN PRE-DILATATED TWICE BUT WAS UNABLE TO AND IT WAS THEN DECIDED TO BE REMOVED. DURING WITHDRAWAL OF THE XIENCE ALPINE INTO THE GUIDING CATHETER (GC), THE PROXIMAL SIDE OF THE STENT BECAME STUCK AT THE TIP OF THE GC. THEN THE GUIDING CATHETER AND THE XIENCE ALPINE SDS WERE ATTEMPTED TO BE REMOVED TOGETHER. HOWEVER, AS IT WAS BEING REMOVED, THE STENT THEN GOT TRAPPED AT THE DISTAL TIP OF THE SHEATH AND HAD DISLODGED IN THE RADIAL ARTERY. A SNARE DEVICE WAS USED TO RETRIEVE THE STENT. SINCE THE SNARED STENT WAS UNABLE TO BE WITHDRAWN INTO THE SHEATH, BOTH THE STENT AND THE SHEATH WERE REMOVED. THE PROCEDURE WAS DISCONTINUED LEAVING THE LESION INTACT, AND TREATMENT WOULD BE DECIDED LATER. THE PHYSICIAN CONSIDERED THERE WAS NO CAUSAL RELATIONSHIP BETWEEN THE INCIDENT AND THE

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7289934 ↗
• InjuryDec 8, 2017Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE INDEX PROCEDURE TOOK PLACE ON (B)(6) 2017 DURING WHICH A 2.75 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 DEPRESSION 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 7100020 ↗
• InjuryNov 29, 2017Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2017 THE 2.75 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 FOR HYPERTENSIVE URGENCY AND OTHER CARDIOVASCULAR (CV) SYMPTOMS. UNSPECIFIED TREATMENT WAS ADMINISTERED AND THE FINAL PATIENT OUTCOME IS REPORTEDLY UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: High Blood Pressure/ Hypertension

  MAUDE report 7067985 ↗
• InjuryAug 29, 2017Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 2.75X18 MM XIENCE ALPINE STENT WAS IMPLANTED ON (B)(6) 2017. ON (B)(6) 2017 THE PATIENT WAS RE-ADMITTED FOR UNSPECIFIED CARDIOVASCULAR SYMPTOMS INCLUDING HYPOTENSION AND HEART FAILURE. UNSPECIFIED TREATMENT WAS ADMINISTERED TO THE PATIENT. FINAL PATIENT OUTCOME IS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Heart Failure; Low Blood Pressure/ Hypotension

  MAUDE report 6828743 ↗
• MalfunctionFeb 8, 2017Torn Material

  IT WAS REPORTED THAT WHILE LOADING THE 2.75X18MM XIENCE ALPINE STENT DELIVERY SYSTEM (SDS) ONTO A NON-ABBOTT GUIDE WIRE, THE GUIDE WIRE PIERCED THROUGH THE BALLOON, BETWEEN THE STENT AND THE SHAFT. THE XIENCE ALPINE SDS DID NOT ENTER THE PATIENT, AND WAS REPLACED WITH A SAME SIZE XIENCE ALPINE SDS TO COMPLETE THE PROCEDURE. 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 6310706 ↗
• InjurySep 23, 2016Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2016 THE PATIENT HAD A 2.75X18 MM XIENCE ALPINE STENT IMPLANTED IN AN UNSPECIFIED CORONARY ARTERY. ON (B)(6) 2016, THE PATIENT WAS RE-ADMITTED FOR A SUBSEQUENT SEGMENT ELEVATED MYOCARDIAL INFARCTION (STEMI) INEFERIOR WALL. THROMBECTOMY TOTAL OCCLUSION WITH PERCUTANESOUS TRANSLUMINAL CORONARY ANGIOPLASTY WAS PERFORMED AS TREATMENT. THE PATIENT WAS DISCHARGED TO HOME. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Myocardial Infarction; Thrombosis

  MAUDE report 5975479 ↗
• InjuryAug 12, 2016Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN ECCENTRIC DE NOVO LESION IN THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY WITH MILD CALCIFICATION AND 90% STENOSIS. THE PATIENT WAS TAKING ANTI-PLATELET MEDICATION ON 2016. THE PATIENT WAS DIAGNOSED WITH ANGINA AND WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2016. AFTER PERFORMING PRE-DILATATION WITH AN UNSPECIFIED BALLOON, A 2.75X18MM XIENCE ALPINE RX STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TOWARD THE TARGET LESION, THE SYSTEM WAS INFLATED UP TO 14 ATMOSPHERES AND THE STENT WAS IMPLANTED. POST-DILATATION WAS PERFORMED PER STANDARD PROCEDURE. NO THROMBOSIS WAS OBSERVED PRIOR TO OR DURING THE PROCEDURE. ON (B)(6) 2016 WHILE IN THE HOSPITAL, THE PATIENT COMPLAINED OF ANGINA. ANGIOGRAPHY WAS PERFORMED AND THE STENT WAS FOUND TO BE OCCLUDED WITH THROMBOSIS. THE THROMBOSIS WAS TREATED VIA ANGIOPLASTY. IT WAS CONFIRMED THAT THE PATIENT WAS COMPLIANT WITH DUAL ANTIPLATELET THERAPY (DAPT). THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina; Thrombosis

  MAUDE report 5873002 ↗