XIENCE ALPINE 1125225-28Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 08717648199103), received between Nov 1, 2016 and Sep 2, 2020 — classified as 2 deaths, 6 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (6 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• InjurySep 2, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT ID: (B)(6). IT WAS REPORTED THAT ON (B)(6) 2019 TWO XIENCE ALPINE STENTS WERE IMPLANTED IN THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY. THE PATIENT UNDERWENT A LEFT HEART CATHETERIZATION ON (B)(6) 2019 AND WAS FOUND TO HAVE RE-STENOSIS OF THE DISTAL LAD STENT. A STENT WAS PLACED IN THE LEFT CIRCUMFLEX AND THE LAD. PATIENT IS NOW CHEST PAIN FREE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina; Occlusion

  MAUDE report 10485442 ↗
• DeathDec 17, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 2.25X28MM XIENCE ALPINE STENT WAS IMPLANTED ON (B)(6) 2018. ON (B)(6) 2018 THE PATIENT WAS RE-ADMITTED FOR ACUTE MYOCARDIAL INFARCTION, NON-ST-ELEVATION MYOCARDIAL INFARCTION AND OTHER UNSPECIFIED CARDIOVASCULAR SYMPTOMS. UNSPECIFIED TREATMENT WAS ADMINISTERED TO THE PATIENT. THE FINAL PATIENT OUTCOME HAS BEEN REPORTED AS DEATH DUE TO MAJOR COMPLICATIONS AND COMORBIDITIES. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Myocardial Infarction

  MAUDE report 8170025 ↗
• InjuryJun 12, 2018Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT MULTI-VESSEL LESIONS IN THE RAMUS AND LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERIES. THE RAMUS WAS TREATED WITH A 2.25 X 28 MM AND A 2.25 X 12 MM XIENCE ALPINE STENTS SUCCESSFULLY. HOWEVER, DURING TREATMENT OF THE LAD, THE PATIENT EXPERIENCED EKG CHANGES. ANGIOGRAPHY REVEALED THAT THE RAMUS WAS CLOTTING UP. THEREFORE, THE PHYSICIAN SWITCHED TO TREAT THE RAMUS BY USING HIGH PRESSURE BALLOONS TO 26 ATMOSPHERES AND ADMINISTERED MEDICATION. AFTER, THE PHYSICIAN CONTINUED WITH THE LAD WITH A SUCCESSFUL OUTCOME. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Non specific EKG/ECG Changes; Thrombosis

  MAUDE report 7592925 ↗
• MalfunctionDec 12, 2017Difficult to Remove; Failure to Advance; Material Deformation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A DE NOVO LESION LOCATED IN THE CIRCUMFLEX ARTERY THAT WAS NON-CALCIFIED AND MILDLY TORTUOUS. THE XIENCE ALPINE 2.25 X 28 MM STENT DELIVERY SYSTEM FAILED TO CROSS DUE TO THE PATIENT ANATOMY AND DURING REMOVAL THERE WAS ALSO RESISTANCE WITH THE ANATOMY. WHEN REMOVED, THE STENT STRUTS WERE FLARED. ANOTHER XIENCE ALPINE 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 7110663 ↗
• InjuryDec 1, 2017Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 2.25 X 28 MM AND A 3.25 X 15 MM XIENCE ALPINE STENTS WERE IMPLANTED ON (B)(6) 2017. ON (B)(6) 2017, THE PATIENT WAS RE-ADMITTED FOR CARDIOVASCULAR SYMPTOMS. IT WAS FURTHER REPORTED THAT THE PATIENT HAD GASTRITIS WITH BLEEDING. SURGICAL INTERVENTION WAS PERFORMED. THE FINAL PATIENT OUTCOME IS UNKNOWN NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7077349 ↗
• DeathNov 15, 2017Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2016, THE PATIENT UNDERWENT A CORONARY STENTING PROCEDURE WITH IMPLANTATION OF THREE XIENCE ALPINE STENTS (2.25X28MM, 3.0X38MM, 3.0X33MM ). IT IS UNKNOWN IF THE STENTS WERE IMPLANTED IN THE SAME VESSEL OR IN DIFFERENT VESSELS. ON AN UNSPECIFIED DATE, 100% OCCLUSION WAS NOTED AT AN UNKNOWN LOCATION AND THE PATIENT DIED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Death; Occlusion

  MAUDE report 7034451 ↗
• MalfunctionNov 15, 2017Difficult to Remove; Failure to Advance; Material Deformation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED, HEAVILY TORTUOUS CIRCUMFLEX ARTERY. THE 2.25 X 28 XIENCE ALPINE STENT COULD NOT CROSS DUE TO THE ANATOMY. REPORTEDLY, THERE WAS RESISTANCE DURING REMOVAL OF THE STENT FROM THE GUIDING CATHETER. THE STENT WAS FLARED WHEN IT WAS PULLED OUT OF THE GUIDING CATHETER. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER 2.25 X 28 XIENCE STENT. 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 7034245 ↗
• InjuryOct 26, 2017Kinked; Difficult to Remove

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A HEAVILY TORTUOUS, MILDLY CALCIFIED LESION IN THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE 2.25X28MM XIENCE ALPINE STENT WAS DEPLOYED; HOWEVER, DURING ATTEMPTED REMOVAL RESISTANCE WAS FELT WITH THE ANATOMY AND THE BALLOON BENT. THE STENT DELIVERY SYSTEM (SDS) WAS UNABLE TO BE REMOVED. A 1.2 MM BALLOON DILATATION CATHETER (BDC) WAS INSERTED AND ADVANCED TOWARD THE ALPINE SDS. THE ALPINE SDS WAS ABLE TO BE PULLED PROXIMALLY WITH REACTION FORCE GENERATED BY PUSHING THE BDC FORWARD. THE SDS WAS REMOVED FROM ANATOMY AND THE PROCEDURE WAS COMPLETED. 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 6981454 ↗
• MalfunctionOct 5, 2017Difficult to Remove; Material Deformation

  IT WAS REPORTED THAT A 2.25X28MM XIENCE ALPINE STENT DELIVERY SYSTEM (SDS) FAILED TO CROSS THE CIRCUMFLEX CORONARY ARTERY, MODERATELY CALCIFIED LESION. FOLLOWING, A STENT STRUT WAS NOTED TO HAVE BEEN LIFTED. WHILE ATTEMPTING TO REMOVE THE SDS, RESISTANCE WAS MET AT THE GUIDE CATHETER ENTRY AND THE SDS COULD NOT BE REMOVED. THEREFORE, ALL DEVICES WERE REMOVED AS A SINGLE UNIT. THERE WERE NO ADVERSE PATIENT EFFECTS AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY. THERE WAS NO ADDITIONAL INFORMATION PROVIDED REGARDING THIS ISSUE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6915953 ↗
• InjuryAug 30, 2017Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 2.25 X 28 MM XIENCE ALPINE STENT WAS IMPLANTED ON (B)(6) 2017. ON (B)(6) 2017 THE PATIENT WAS RE-ADMITTED WITH EPISODIC PAROXYSMAL HEMICRANIA 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 6831803 ↗
• MalfunctionJul 3, 2017Improper or Incorrect Procedure or Method; Failure to Advance; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT DURING THE PROCEDURE TO TREAT A MILDLY CALCIFIED LESION IN THE MILDLY TORTUOUS RIGHT CORONARY ARTERY (RCA), A FEW ATTEMPTS WERE MADE TO CROSS THE VESSEL WITH A 2.25X28 RX XIENCE ALPINE STENT DELIVERY SYSTEM (SDS), BUT THIS DEVICE FAILED TO CROSS DUE TO PATIENT ANATOMY, DESPITE PERFORMING ADDITIONAL DILATATION WITH UNSPECIFIED TREK BALLOONS. DURING RE-INSERTION FOR ANOTHER CROSSING ATTEMPT, A THREAD OR STRING (OF UNKNOWN ORIGIN) WAS NOTED ON THE XIENCE ALPINE DISTAL SHAFT; REPORTEDLY, AS THE THREAD / STRING WAS PULLED, IT FELT AS IF IT MAY HAVE BEEN UNRAVELING FROM THE DEVICE. NONE OF THE STRING / THREAD WAS LEFT INSIDE OF PATIENT VASCULATURE AND NO OTHER DEVICE ISSUES WERE NOTED. REPORTEDLY, IT IS UNKNOWN IF THIS MATERIAL ORIGINATES FROM THE DEVICE ITSELF OR IF IT IS FOREIGN MATERIAL. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO OCCURRENCE OF A CLINICALLY SIGNIFICANT DELAY. A NON-ABBOTT STENT CROSSED THE LESION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6684925 ↗
• MalfunctionApr 10, 2017Difficult to Remove; Failure to Advance; Material Deformation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 99% STENOSED, MODERATELY TORTUOUS, AND MODERATELY CALCIFIED LESION IN THE RIGHT CORONARY ARTERY. FOLLOWING PRE-DILATATION, AN ATTEMPT TO ADVANCE A 2.25X28MM XIENCE ALPINE STENT DELIVERY SYSTEM (SDS) WAS MADE; HOWEVER, THE STENT CAME IN CONTACT WITH THE CALCIFICATION AND BECAME STUCK. THE SDS WAS PULLED WITH FORCE AND THE PROXIMAL STENT STRUTS BECAME FLARED. THE STENT AND SDS WERE REMOVED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ADDITIONAL DILATATION AND A 2.25X23MM 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 Consequences Or Impact To Patient

  MAUDE report 6477307 ↗
• MalfunctionMar 13, 2017Unstable

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE MID CIRCUMFLEX ARTERY. IT WAS NOTICED THAT THE STENT WAS LOOSE ON THE DELIVERY SYSTEM OF A 2.25X28MM XIENCE ALPINE STENT DELIVERY SYSTEM AFTER REMOVAL FROM THE PACKAGING. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER UNKNOWN DEVICE. 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 6400747 ↗
• MalfunctionFeb 22, 2017Improper or Incorrect Procedure or Method; Component Missing; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A DE NOVO LESION IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY WITH NO CALCIFICATION. THE 2.25 X 28 MM XIENCE ALPINE STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TO THE LESION; HOWEVER, THE STENT WAS UNABLE TO BE LOCATED UNDER FLUOROSCOPY. ADDITIONAL EVALUATION WAS PERFORMED UNDER FLUORO AND IT WAS CONFIRMED THAT THE STENT WAS NOT INSIDE THE ANATOMY. THE GUIDING CATHETER WAS REMOVED AND FLUSHED WITH SALINE BUT THE STENT WAS NOT IN THE GUIDING CATHETER. IT WAS REPORTED THAT STENT WAS NOT FOUND IN THE PROTECTIVE SHEATH EITHER. IT WAS STATED THAT THERE WAS NEVER A STENT IMPLANT ON THE BALLOON. THE PROCEDURE WAS SUCCESSFULLY COMPLETED AFTER TWO UNSPECIFIED STENTS WERE IMPLANTED. THERE WERE NO ADVERSE PATIENT EFFECTS OR CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6349566 ↗
• MalfunctionJan 16, 2017Difficult to Remove; Failure to Advance

  IT WAS REPORTED THAT DURING THE STENTING PROCEDURE TO TREAT THE TARGET LESION IN THE MODERATELY CALCIFIED MID DIAGONAL ARTERY, PRE-DILATATION WAS PERFORMED USING A TREK DILATATION CATHETER. AN ATTEMPT WAS MADE TO ADVANCE THE 2.25 X 28 MM XIENCE ALPINE STENT DELIVERY SYSTEM; HOWEVER DUE TO THE PATIENT ANATOMY, THE DEVICE WAS UNABLE TO CROSS. THE DEVICE WAS REMOVED; HOWEVER, IT BECAME CAUGHT AT THE PROXIMAL TIP OF THE GUIDE CATHETER. THE STENT DID NOT DISLODGE AND ALL DEVICES WERE REMOVED AS A SINGLE UNIT. THE STENTING PROCEDURE WAS COMPLETED USING A SECOND SAME DEVICE WITH A NEW GUIDE CATHETER AND GUIDE WIRE. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6254637 ↗
• InjuryNov 1, 2016Failure to Advance

  IT WAS REPORTED THAT DURING A PROCEDURE OF THE LEFT ANTERIOR DESCENDING (LAD) AND DIAGONAL ARTERIES, THE XIENCE ALPINE STENT DELIVERY SYSTEM (SDS) WAS ADVANCED BUT COULD NOT CROSS THE LESION AND WAS REMOVED. ADDITIONAL ANGIOPLASTY TO THE OSTIAL DIAGONAL VESSEL WAS PERFORMED AND TWO DIFFERENT XIENCE ALPINE SDS AND A MINI-VISION SDS WERE ATTEMPTED BUT ALSO COULD NOT ADVANCE THE LESION. NO STENT SYSTEM WAS SUCCESSFUL IN CROSSING THE LESION; A SPIRAL DISSECTION OF THE DIAGONAL VESSEL WAS NOTED; HOWEVER, IT COULD NOT BE DETERMINED EXACTLY WHEN IT OCCURRED. AN UNSPECIFIED PROMUS STENT WAS USED AS TREATMENT AND SOMETIME DURING THE PROCEDURE AN INTRA-AORTIC BALLOON PUMP (IABP) WAS USED. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Intimal Dissection

  MAUDE report 6071360 ↗