XIENCE ALPINE 1125300-33Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 08717648199387), received between Aug 16, 2016 and Jul 9, 2021 — classified as 7 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Device Damaged by Another Device” (3 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryJul 9, 2021Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2018, THE PATIENT PRESENTED DUE TO AN ACUTE MYOCARDIAL INFARCTION (AMI). DUE TO THE PRESENCE OF THROMBUS, ASPIRATION WAS PERFORMED AND THEN TWO XIENCE ALPINE STENTS (3.5X23MM, 3.0X33MM) WERE IMPLANTED IN THE MID TO PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY. REPORTEDLY, THE OVERLAPPED SECTION WAS NOT WELL APPOSED TO THE VESSEL WALL, AND POST DILATATION WAS ATTEMPTED BUT UNABLE TO BE PERFORMED DUE TO THE SLOW BLOOD FLOW, RESULTING IN SOME ISCHEMIA AND TIMI FLOW ONLY 2.5. DUAL ANTIPLATELET THERAPY WAS GIVEN. ON (B)(6) 2019, DAPT WAS DISCONTINUED BUT THE PATIENT CONTINUED TO TAKE ASPIRIN. ON (B)(6) 2021, THE PATIENT WAS HOSPITALIZED DUE TO AN AMI. THE 3.5X23MM XIENCE ALPINE STENT WAS NOTED TO BE 100% OCCLUDED WITH THROMBUS. THE THROMBUS WAS ASPIRATED. A NON-ABBOTT STENT WAS IMPLANTED FOLLOWED BY POST DILATATION. INTRAVASCULAR ULTRASOUND (IVUS) WAS PERFORMED CONFIRMING GOOD WALL APPOSITION OF ALL 3 STENTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Ischemia

  MAUDE report 12147353 ↗
• InjuryOct 23, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DETAILS ARE LISTED IN THE ATTACHED ARTICLE, TITLED ¿SYSTEMATIC REVIEW OF THE EVALUATION AND MANAGEMENT OF CORONARY PSEUDOANEURYSM AFTER STENT IMPLANTATION". IT WAS REPORTED THAT THE PATIENT PRESENTED WITH A POSTERIOR ST-ELEVATION MYOCARDIAL INFARCTION FROM OCCLUSION OF THE PROXIMAL CIRCUMFLEX ARTERY 2 MONTHS PRIOR TO PRESENTATION. THE PATIENT UNDERWENT EMERGENT PERCUTANEOUS CORONARY INTERVENTION (PCI) COMPLICATED BY A DISSECTION AND PERFORATION AFTER MULTIPLE ATTEMPTS TO PREDILATE A SEVERELY CALCIFIED LESION WITH SEMI-COMPLIANT, NONCOMPLIANT, AND CUTTING BALLOONS. A 3.0X33MM XIENCE ALPINE STENT WAS IMPLANTED WITH TIMI 3 FLOW. THE PATIENT WAS DISCHARGED HOME ON DUAL ANTI-PLATELET THERAPY. TWO MONTHS LATER, THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT WITH CHEST PAIN. TROPONIN I WAS ELEVATED (9.96 NG/ML; NORMAL 0¿1 NG/ML). ANGIOGRAPHY SHOWED CIRCUMFLEX STENT WITH LARGE FILLING DEFECT THROUGHOUT ITS COURSE WITH TIMI 3 FLOW. THERE WAS A DYE STAIN OBSERVED OUTSIDE THE LIMIT OF VESSEL SUGGESTING A CONTAINED PERFORATION. BALLOON ANGIOPLASTY WITH A 3.0×15MM UNSPECIFIED NON-COMPLIANT BALLOON RESULTED IN RESIDUAL 50% STENOSIS BUT WITH RESOLUTION OF THE FILLING DEFECT. OPTICAL COHERENCE

  Patient problems: Angina; Cardiac Enzyme Elevation; Perforation; Pseudoaneurysm

  MAUDE report 10731353 ↗
• InjuryAug 29, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT TWO XIENCE ALPINE STENTS (3.0X33MM AND 3.5X18MM) WERE DEPLOYED; HOWEVER, THE PATIENT WAS RE-ADMITTED WITHIN 30 DAYS FOR UNKNOWN REASONS. AN ADDITIONAL XIENCE STENT WAS PLACED AS TREATMENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7828638 ↗
• MalfunctionMay 31, 2018Difficult To Position; Difficult to Remove; Failure to Advance; Material Deformation

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE MID LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY WITH MILD TORTUOSITY AND MILD CALCIFICATION. A 3.00X33 MM XIENCE ALPINE STENT DELIVERY SYSTEM (SDS) WAS ADVANCED WITH A NON- ABBOTT GUIDE CATHETER WITH RESISTANCE AND BECAME STUCK PROXIMALLY TO THE TARGET LESION. THE SDS WAS MANIPULATED BUT FAILED TO CROSS THE LESION. THE SDS WAS REMOVED AS A SINGLE UNIT FROM THE PATIENT ANATOMY WITH RESISTANCE AND ON REMOVAL THE STENT WAS NOTED TO BE CRUSHED. RESISTANCE DURING ADVANCEMENT AND REMOVAL, WAS REPORTED TO BE UNKNOWN AND CONSIDERED TO BE RELATED TO THE ANATOMY, THE GUIDE CATHETER OR OTHER FACTORS. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A 3.00X28 MM XIENCE ALPINE SDS. 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 7557517 ↗
• MalfunctionFeb 6, 2018Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING PREPARATION, THE STENT OF A 3.0 X 33MM XIENCE ALPINE STENT DELIVERY SYSTEM, FELL OFF THE BALLOON. ANOTHER SAME SIZE 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 Patient Involvement

  MAUDE report 7246342 ↗
• MalfunctionSep 18, 2017Kinked; Torn Material

  IT WAS REPORTED THAT THE 3.0 X 33 MM XIENCE ALPINE STENT DELIVERY SYSTEM WAS REMOVED FROM THE DISPENSER COIL. THE SCRUB NURSE MADE AN ATTEMPT TO LOAD THE STENT DELIVERY SYSTEM ONTO THE GUIDE WIRE; HOWEVER, THE DEVICE COULD NOT BE LOADED AND WAS NOTED TO HAVE A KINK AT THE TIP. THE DEVICE WAS NOT USED AND THERE WAS NO PATIENT INVOLVEMENT. A SECOND 3.0 X 33 MM XIENCE ALPINE STENT DELIVERY SYSTEM WAS USED WITHOUT ISSUE. NO ADDITIONAL INFORMATION WAS PROVIDED. RETURNED DEVICE ANALYSIS NOTED THAT THERE WAS A JAGGED RADIAL TEAR AT THE TIP OF THE DEVICE.

  Patient problems: No Patient Involvement

  MAUDE report 6874369 ↗
• 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 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 6065064 ↗
• InjuryOct 11, 2016Entrapment of Device; Improper or Incorrect Procedure or Method; Failure to Advance; Device Damaged by Another Device

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A RIGHT CORONARY ARTERY (RCA). A 3.0 X 33 MM XIENCE ALPINE STENT WAS IMPLANTED WITHOUT ISSUE. A SECOND 3.0 X 33 MM XIENCE ALPINE STENT WAS ADVANCED THROUGH THE IMPLANTED STENT; HOWEVER, IT COULD NOT CROSS TO THE DESIRED LOCATION FOR DEPLOYMENT. A DECISION WAS MADE TO REMOVE THE UNDEPLOYED XIENCE ALPINE SO A GUIDELINER COULD BE USED FOR ADDITIONAL SUPPORT. WHEN ATTEMPTING TO REMOVE THE STENT DELIVERY SYSTEM, IT CAUGHT HALFWAY INSIDE THE GUIDING CATHETER AND THE DEPLOYED STENT. THE DEVICE COULD NOT BE REMOVED SO THE PATIENT WAS TAKEN TO SURGERY WHERE THEY DID A BYPASS OF THE RCA AND ALSO OF THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. DURING THE SURGERY, THE IMPLANTED XIENCE ALPINE WAS EXPLANTED. THE PATIENT IS DOING WELL AND HAS BEEN MOVED FROM THE INTENSIVE CARE UNIT. THERE WAS A CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6017903 ↗
• MalfunctionOct 11, 2016Device Damaged by Another Device

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A RIGHT CORONARY ARTERY (RCA). A 3.0 X 33 MM XIENCE ALPINE STENT WAS IMPLANTED WITHOUT ISSUE. A SECOND 3.0 X 33 MM XIENCE ALPINE STENT WAS ADVANCED THROUGH THE IMPLANTED STENT; HOWEVER, IT COULD NOT CROSS TO THE DESIRED LOCATION FOR DEPLOYMENT. A DECISION WAS MADE TO REMOVE THE UNDEPLOYED XIENCE ALPINE SO A GUIDELINER COULD BE USED FOR ADDITIONAL SUPPORT. WHEN ATTEMPTING TO REMOVE THE STENT DELIVERY SYSTEM, IT CAUGHT HALFWAY INSIDE THE GUIDING CATHETER AND THE DEPLOYED STENT. THE DEVICE COULD NOT BE REMOVED SO THE PATIENT WAS TAKEN TO SURGERY WHERE THEY DID A BYPASS OF THE RCA AND ALSO OF THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. DURING THE SURGERY, THE IMPLANTED XIENCE ALPINE WAS EXPLANTED. THE PATIENT IS DOING WELL AND HAS BEEN MOVED FROM THE INTENSIVE CARE UNIT. THERE WAS A CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6017883 ↗
• InjuryOct 4, 2016Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 3.00 X 33 MM AND A 3.25 X 18 MM XIENCE ALPINE STENT WERE IMPLANTED ON (B)(6) 2015. ON (B)(6) 2015, THE PATIENT WAS RE-HOSPITALIZED DUE TO OTHER UNSPECIFIED CARDIOVASCULAR SYMPTOMS AND MYOPATHY. IT IS UNKNOWN WHAT TREATMENT WAS PERFORMED. THE PATIENT WAS DISCHARGED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 5997177 ↗
• InjurySep 16, 2016Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 3.0X33MM XIENCE ALPINE STENT WAS IMPLANTED ON (B)(6) 2016. ON (B)(6) 2016, THE PATIENT WAS RE-ADMITTED WITH A NON-ST-ELEVATED MYOCARDIAL INFARCTION (NSTEMI). NO INTERVENTION WAS PERFORMED. THE PATIENT WAS DISCHARGED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Myocardial Infarction

  MAUDE report 5958249 ↗
• MalfunctionAug 16, 2016Difficult to Remove; Device Damaged by Another Device; Material Deformation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A SAPHENOUS VEIN GRAFT TO THE LEFT ANTERIOR DESCENDING ARTERY. A NON-ABBOTT EMBOLIC PROTECTION SYSTEM WAS PLACED AND A 3.0 X 33 MM XIENCE ALPINE STENT WAS IMPLANTED WITHOUT ISSUE IN THE PROXIMAL PORTION OF THE VEIN GRAFT. THE XIENCE ALPINE DELIVERY CATHETER WAS REMOVED WITHOUT ISSUE. WHEN REMOVING THE NON-ABBOTT EMBOLIC PROTECTION FILTER, THERE WAS RESISTANCE WITH THE IMPLANTED STENT AND THERE WAS SIGNIFICANT FORCE APPLIED CAUSING THE GUIDING CATHETER TO MOVE FORWARD AND CRUMPLE THE PROXIMAL END OF THE STENT. ATTEMPTS WERE MADE FOR A COUPLE OF HOURS TO REMOVE THE FILTER BUT IT COULD NOT BE REMOVED. THE PATIENT REMAINED IN STABLE CONDITION THROUGHOUT THE PROCEDURE BUT IS BEING SENT TO SURGERY TO REMOVE THE FILTER. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5880534 ↗