XIENCE ALPINE 1125225-23Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 08717648199097), received between Aug 19, 2016 and Oct 17, 2018 — classified as 9 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (7 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 17, 2018Difficult to Remove; Difficult to Advance; Material Deformation; Material Twisted/Bent; Difficult to Remove; Difficult to Advance; Material Deformation; Material Twisted/Bent

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A CALCIFIED LESION IN THE MID CIRCUMFLEX CORONARY ARTERY. A 2.25 X 23 MM XIENCE ALPINE STENT DELIVERY SYSTEM (SDS) WAS ADVANCED BUT MET RESISTANCE WITH AN UNSPECIFIED GUIDE WIRE AND BECAME STUCK. THE SHAFT OF THE SDS WAS NOTED TO BUNCH. THE SDS AND THE GUIDE WIRE WERE REMOVED TOGETHER AS A SINGLE UNIT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH AN UNSPECIFIED GUIDE WIRE AND A NON-ABBOTT STENT. 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 7974547 ↗
• InjurySep 11, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT 2.25 X23 MM, 2.25 X 18 MM AND 2.5 X8 MM XIENCE ALPINE STENTS WERE IMPLANTED ON (B)(6) 2018. ON (B)(6) 2018, THE PATIENT WAS RE-ADMITTED WITH CARDIOVASCULAR SYMPTOMS INCLUDING UNSTABLE ANGINA AND SEPSIS. 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: Angina; Sepsis

  MAUDE report 7865868 ↗
• InjuryJan 19, 2018Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY TORTUOUS AND MODERATELY CALCIFIED LESION IN THE LEFT MAIN TO PROXIMAL CIRCUMFLEX ARTERY. FOLLOWING PRE-DILATATION, A 2.25X23MM XIENCE ALPINE STENT DELIVERY SYSTEM WAS ADVANCED IN AN ATTEMPT TO CROSS THE LESION; HOWEVER, FORCE WAS APPLIED AND RESISTANCE WITH THE ANGULAR PORTION OF THE ARTERY WAS FELT CAUSING THE STENT TO DISLODGE BEFORE REACHING THE LESION SITE. THE STENT FLOATED TO THE AORTA AND INTO THE FEMORAL ARTERY OF THE LEG. AN ATTEMPT TO RETRIEVE THE STENT WITH A SNARE DEVICE WAS MADE BUT WAS UNSUCCESSFUL. THE STENT REMAINS FREE-FLOATING IN THE ANATOMY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A 2.25X12MM XIENCE ALPINE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND NO ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 7207197 ↗
• InjuryNov 6, 2017Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A HEAVILY TORTUOUS AND HEAVILY CALCIFIED LESION IN THE MID RAMUS. RESISTANCE WAS FELT WITH THE ANATOMY WHEN ADVANCING THE 2.25X23 MM XIENCE ALPINE STENT DELIVERY SYSTEM (SDS). WHILE ATTEMPTING TO ADVANCE THE SDS THROUGH A TIGHT BEND, THE STENT DISLODGED. A 3.0X12 NC TREK BALLOON CATHETER WAS USED TO DEPLOY THE DISLODGED STENT PROXIMAL TO THE TARGET LESION IN HEALTHY TISSUE. THE NC TREK WAS THEN USED DILATE THE TARGET LESION WITH GOOD RESULTS. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 7003894 ↗
• MalfunctionNov 2, 2017Difficult to Remove; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY TORTUOUS, HEAVILY CALCIFIED ECCENTRIC DE NOVO LESION IN THE FIRST DIAGONAL CORONARY ARTERY THAT WAS 99% STENOSED. A NON-ABBOTT BALLOON WAS USED FOR PRE-DILATATION. A 2.25 X 23MM XIENCE ALPINE STENT DELIVERY SYSTEM FAILED TO CROSS THE LESION DUE TO RESISTANCE WITH THE ANATOMY. DURING REMOVAL, RESISTANCE WAS MET WITH THE ANATOMY AS WELL. A NON-ABBOTT STENT WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE AND NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6997915 ↗
• InjuryOct 23, 2017Difficult to Remove; Failure to Advance; Device Damaged by Another Device; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE 2.25X23MM XIENCE ALPINE STENT DELIVERY SYSTEM (SDS) FAILED TO CROSS THROUGH A NON-ABBOTT IMPLANTED STENT. WHEN REMOVING THE SDS, THE ALPINE STENT WAS CAUGHT ON THE IMPLANTED STENT AND THE ALPINE STENT DISLODGED IN THE ANATOMY. A BALLOON DILATATION CATHETER AND SNARE DEVICE WERE USED TO REMOVE THE DISLODGED STENT FROM THE PATIENT ANATOMY. WHEN SNARING THE DISLODGED STENT, THE NON-ABBOTT STENT WAS EXPLANTED. A LARGER XIENCE ALPINE STENT WAS IMPLANTED. THE PATIENT IS STABLE. THERE WAS CLINICALLY SIGNIFICANT DELAY DURING THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6969582 ↗
• MalfunctionOct 5, 2017Difficult to Remove; Improper or Incorrect Procedure or Method; Failure to Advance; Material Deformation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A CONCENTRIC DE NOVO LESION LOCATED IN THE RIGHT CORONARY ARTERY THAT WAS MODERATELY TORTUOUS, HEAVILY CALCIFIED AND 90% STENOSED. AFTER PRE-DILATATION, A 2.25 X 23 XIENCE ALPINE WAS ADVANCED; HOWEVER, FAILED TO CROSS. WHEN THE XIENCE ALPINE WAS BEING REMOVED, THE STENT GOT CAUGHT BY THE TIP OF GUIDING CATHETER. AFTER RETRIEVING THE STENT DELIVERY SYSTEM WITH FORCE, THE STENT STRUT WAS FOUND TO BE FLARED. FURTHER PRE-DILATATION WAS PERFORMED AND A NEW SAME-SIZE XIENCE ALPINE SDS WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6918487 ↗
• InjurySep 8, 2017Difficult to Remove; Improper or Incorrect Procedure or Method; Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE DISTAL CIRCUMFLEX (CX) AND MARGINAL ARTERIES. AFTER IMPLANTING AN UNSPECIFIED 2.25 X 28 MM STENT IN THE CX, THE 2.25 X 23 MM XIENCE ALPINE WAS BEING ADVANCED THROUGH THE SIDE STRUTS TO TREAT THE MARGINAL BRANCH. HOWEVER, AFTER PUSHING THE XIENCE ALPINE STENT BACK AND FORTH FOR PLACEMENT, IT BECAME CAUGHT THROUGH THE SIDE STRUT OF THE OTHER STENT AND THE STENT DISLODGED FROM THE DELIVERY SYSTEM. THEREFORE, THREE UNSPECIFIED BALLOONS WERE USED TO DEPLOY AND FULLY APPOSE THE XIENCE ALPINE INSIDE THE 2.25 X 28 MM STENT. A NON-ABBOTT STENT WAS USED TO SUCCESSFULLY TREAT THE TARGET LESION. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 6852973 ↗
• InjuryApr 18, 2017Difficult To Position; Material Rupture; Improper or Incorrect Procedure or Method; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 90% STENOSED AND HEAVILY CALCIFIED LESION IN THE MID LEFT ANTERIOR DESCENDING ARTERY. FOLLOWING PRE-DILATATION OF THE LESION SEVERAL TIMES, A 2.25X23MM XIENCE ALPINE STENT DELIVERY SYSTEM (SDS) WAS ADVANCED OVER A NON-ABBOTT GUIDE WIRE. RESISTANCE WAS FELT BETWEEN THE SDS AND GUIDE WIRE. THE SDS WAS REMOVED OFF THE GUIDE WIRE AND THE GUIDE WIRE WAS RE-INSERTED INTO THE GUIDE WIRE LUMEN OF THE SDS. THIS TIME THE SDS ADVANCED OVER THE GUIDE WIRE SMOOTHLY. THE SDS REACHED THE TARGET LESION AND WAS PRESSURIZED TO 3 ATMOSPHERES (ATMS); HOWEVER, THE NEEDLE GAUGE ON THE INFLATION DEVICE DROPPED TO 0 ATMS. THE SDS WAS REMOVED FROM THE ANATOMY AND IT WAS CONFIRMED THAT THE STENT DISLODGED AND REMAINED AT THE LESION SITE. A 2.0X12MM NC TREK BALLOON DILATATION CATHETER WAS ADVANCED TO THE STENT AND THE STENT WAS DEPLOYED SUCCESSFULLY AT THE INTENDED SITE. 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 6501213 ↗
• InjuryApr 11, 2017Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2016, A 2.25X23 RX XIENCE ALPINE AND A 2.5X15 RX XIENCE ALPINE DRUG-ELUTING STENT WERE IMPLANTED FOR TREATMENT OF AN UNSPECIFIED VESSEL. ON (B)(6) 2016, THE PATIENT WAS REHOSPITALIZED DUE TO MALNUTRITION AND OTHER UNSPECIFIED CARDIOVASCULAR SYMPTOMS. THE PATIENT WAS TREATED WITH UNSPECIFIED SURGERY. FINAL PATIENT OUTCOME IS REPORTEDLY UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 6483507 ↗
• InjuryOct 3, 2016Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 2.25 X 23 MM XIENCE ALPINE STENT WAS IMPLANTED ON (B)(6) 2016. ON (B)(6) 2016, THE PATIENT WAS RE-ADMITTED FOR OTHER CARDIOVASCULAR SYMPTOMS AND CHEST PAIN. THE TREATMENT WAS UNSPECIFIED AND THERE WERE NO ADVERSE PATIENT EFFECTS. THE PATIENT WAS DISCHARGED TO HOME. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina

  MAUDE report 5993865 ↗
• MalfunctionAug 24, 2016Leak/Splash

  IT WAS REPORTED THAT DURING PREPARATION OF THE XIENCE ALPINE RX 2.25 X 23 STENT DELIVERY SYSTEM, WHEN PULLING NEGATIVE, THERE WAS A CONTINUOUS FLOW OF AIR. THIS OCCURRED 3 TIMES. THERE APPEARS TO BE A LEAK IN THE DEVICE AT THE HUB. THE DEVICE WAS NOT USED IN THE PATIENT. THERE WAS NO CLINICALLY SIGNIFICANT DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 5900979 ↗
• InjuryAug 24, 2016Difficult to Remove; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY. A 2.25 X 23 MM XIENCE ALPINE STENT DELIVERY SYSTEM (SDS) WAS ADVANCED, WITHOUT RESISTANCE FELT, IN AN ATTEMPT TO CROSS AN ALREADY DEPLOYED STENT. AT THIS TIME IT WAS DETERMINED THAT THE STENT IMPLANT WAS THE WRONG SIZE FOR THE VESSEL SO THE SDS WAS REMOVED. AS THE SDS WAS BEING REMOVED THROUGH THE GUIDING CATHETER, RESISTANCE WAS FELT AT THE TIP OF THE GUIDING CATHETER AND THE STENT IMPLANT DISLODGED FROM THE BALLOON. THE STENT IMPLANT WAS LOCATED IN THE LAD; THEREFORE, BUDDY WIRES AND A BALLOON WERE USED TO MOVE IT FURTHER DOWN INTO THE LAD IN AN ATTEMPT TO PLACE THE STENT IN THE LESION AND DEPLOY IT. THE DECISION WAS THEN MADE NOT TO DEPLOY THE STENT BUT TO PULL THE STENT IMPLANT BACK; HOWEVER, THE LAD BECAME OCCLUDED DUE TO THE DISLODGED STENT; THEREFORE, THE PATIENT WAS PREPARED AND SENT FOR BYPASS SURGERY. THE STENT IMPLANT WAS NOT REMOVED DURING THE BYPASS SURGERY AND REMAINS IN THE PATIENT. THE PATIENT IS DOING WELL. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient; Occlusion

  MAUDE report 5900526 ↗
• MalfunctionAug 19, 2016Difficult to Remove

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE MID LEFT ANTERIOR DESCENDING ARTERY WITH MODERATE CALCIFICATION. TWO XIENCE ALPINE STENT DELIVERY SYSTEMS (A 2.25X23MM AND 3X18MM) WERE ADVANCED TOWARD THE TARGET LESION, THE SYSTEMS WERE INFLATED UP TO 10 ATMOSPHERES AND THE STENTS WERE IMPLANTED IN AN OVERLAPPING FASHION. HOWEVER, THE BALLOONS COULD NOT BE REMOVED FROM THE STENTS AFTER DEPLOYMENT. IT WAS SUSPECTED THAT THE BALLOONS WERE STUCK WITHIN THE STENTS AFTER DEPLOYMENT. THE PHYSICIAN RE-INFLATED THE BALLOONS UP TO 2 ATMOSPHERES AND THEN DEFLATED THE BALLOONS. THE BALLOONS WERE FINALLY WITHDRAWN WITH RESISTANCE DUE TO THE STENTS. POST DILATATION WAS PERFORMED ON BOTH STENTS PER STANDARD 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 5889871 ↗