XIENCE ALPINE 1125350-28Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 08717648199554), received between Aug 25, 2016 and Sep 5, 2018 — classified as 9 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (4 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.

• InjurySep 5, 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 3.5 X 28 MM XIENCE ALPINE STENT WAS IMPLANTED FOR TREATMENT IN A LESION OF AN UNSPECIFIED VESSEL. ON (B)(6) 2018, THE PATIENT WAS RE-HOSPITALIZED FOR ACUTE MYOCARDIAL INFARCTION (MI) AND OTHER CARDIOVASCULAR (CV) SYMPTOMS. UNSPECIFIED TREATMENT WAS ADMINISTERED AND THE FINAL PATIENT OUTCOME IS REPORTEDLY UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Myocardial Infarction

  MAUDE report 7847481 ↗
• InjuryMay 22, 2018Difficult to Remove; Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A CALCIFIED LESION IN THE PROXIMAL CIRCUMFLEX (CX) ARTERY. A RADIAL APPROACH WAS USED TO ADVANCE THE 3.50X28MM RX ALPINE STENT DELIVERY SYSTEM (SDS) TO THE LESION HOWEVER THE SDS FAILED TO CROSS DUE TO THE ANATOMY. DURING RETRACTION, RESISTANCE WAS MET AND THE STENT DISLODGED FROM THE BALLOON. ANOTHER DEVICE WAS USED TO PULL THE DISLODGED STENT BACK HOWEVER IT COULD NOT ENTER THE SHEATH. THE DECISION WAS MADE TO DEPLOY A BARE METAL STENT IN THE RADIAL ARTERY, EMBEDDING THE DISLODGED STENT TO THE VESSEL WALL. A FEMORAL APPROACH WAS THEN USED TO TREAT THE TARGET LESION WITH ANOTHER STENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Vessel Or Plaque, Device Embedded In

  MAUDE report 7534862 ↗
• InjuryMay 18, 2018Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY WITH A 3.50 X 28 MM XIENCE ALPINE STENT DELIVERY SYSTEM (SDS). THE STENT WAS SUCCESSFULLY DEPLOYED IN THE TARGET LESION. APPROXIMATELY 25 MINUTES POST PROCEDURE, THE PATIENT DEVELOPED CHEST PAIN. AN ELECTROCARDIOGRAM (EKG) WAS PERFORMED AND SOON AFTER, IN STENT THROMBOSIS WAS OBSERVED. ANOTHER XIENCE ALPINE STENT WAS DEPLOYED TO TREAT THE THROMBOSIS. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina

  MAUDE report 7526477 ↗
• MalfunctionApr 27, 2018Component Missing; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE LEFT ANTERIOR DESCENDING CORONARY ARTERY. WHEN THE XIENCE ALPINE 3.5 X 28 MM STENT DELIVERY SYSTEM WAS REMOVED FROM ITS PROTECTIVE TUBING AND THE MANDREL AND PROTECTIVE SHEATH WERE REMOVED, THERE WAS NO STENT FOUND ON THE BALLOON. THE DEVICE WAS NOT USED AND THERE WAS NO PATIENT INVOLVEMENT. ANOTHER XIENCE ALPINE WAS USED TO COMPLETE THE PROCEDURE. THE PROTECTIVE COIL, STYLET, AND FLOOR WERE ALL INSPECTED; HOWEVER, NO STENT WAS FOUND. 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 Patient Involvement

  MAUDE report 7468443 ↗
• InjuryMar 6, 2018Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 3.50 X 28 MM XIENCE ALPINE WAS IMPLANTED ON (B)(6) 2017. ON (B)(6) 2017 THE PATIENT WAS RE-ADMITTED WITH CARDIOVASCULAR SYMPTOMS INCLUDING MYOCARDIAL INFARCTION. 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: Myocardial Infarction

  MAUDE report 7317299 ↗
• MalfunctionNov 30, 2017Difficult to Remove; Failure to Advance; Material Deformation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY TORTUOUS, ECCENTRIC AND HEAVILY CALCIFIED PROXIMAL LEFT CIRCUMFLEX ARTERY. AFTER PRE-DILATATION, AN ATTEMPT WAS MADE TO ADVANCE A 3.5 X 28 MM XIENCE ALPINE; HOWEVER, IT COULD NOT CROSS THE LESION DUE TO THE ANATOMY. THEREFORE, THE DEVICE WAS REMOVED FROM THE ANATOMY BUT AS IT WAS BEING REMOVED, THE STENT BECAME CAUGHT WITH THE TIP OF A NON-ABBOTT GUIDING CATHETER, WHICH CAUSED THE STENT STRUT TO BECOME FLARED. THE DEVICE WAS THEN REMOVED INDEPENDENTLY AND REPLACED WITH ANOTHER 3.5 X 28 MM XIENCE ALPINE STENT THAT ADVANCED THROUGH AN UNSPECIFIED GUIDELINER 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 7070696 ↗
• MalfunctionOct 24, 2017Material Deformation

  IT WAS REPORTED THAT THE HIGH RISK PATIENT PRESENTED FOR LEFT HEART ANGIOGRAPHY, WITH MULTI-VESSEL CORONARY ARTERY DISEASE. AN IMPELLA, LEFT VENTRICLE ASSIST DEVICE, WAS PLACED FOR SUPPORT. MULTIPLE NON-ABBOTT BALLOONS WERE USED AND STENTS IMPLANTED IN THE OBTUSE MARGINAL ARTERIES AND SEPTAL PERFORATOR BRANCH. A 3.0X38MM XIENCE ALPINE (XA) STENT WAS IMPLANTED IN THE MID LEFT ANTERIOR DESCENDING CORONARY ARTERY (LAD), FOLLOWED BY A 2.75X15MM XA IN THE DISTAL LAD, TWO XA (4.0X12MM, 3.5X28MM) STENTS IN THE PROXIMAL LAD AND A 2.5X23MM XA STENT IN THE 1ST DIAGONAL ARTERY. UPON INTRAVASCULAR ULTRASOUND (IVUS) EXAM, THE 3.5X28MM XA IN THE PROXIMAL LAD WAS NOTED TO BE COMPRESSED AND SHORTENED. NO TREATMENT WAS PROVIDED. THE 3.0X38MM XA IN THE MID LAD WAS MILDLY UNDER-EXPANDED AND REQUIRED ADDITIONAL DILATATION. THE PROCEDURE WAS DEEMED SUCCESSFUL AND THE IMPELLA DEVICE WAS REMOVED. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6974495 ↗
• InjuryJul 10, 2017Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PROCEDURE THE PATIENT UNDERWENT WAS TO TREAT AN UNSPECIFIED CORONARY ARTERY. THREE XIENCE ALPINE STENTS WERE IMPLANTED ON (B)(6) 2017: 3.5 X 28 MM, 3.0 X 38 MM AND 3.5 X 18 MM. APPROXIMATELY 2-3 DAYS POST STENTING PROCEDURE, THE PATIENT BEGAN EXPERIENCING HIVES, RASHES, ITCHING AND BRUISING (FROM SCRATCHING) ALL OVER HER BODY AND WAS RE-HOSPITALIZED ON (B)(6) 2017 DUE TO HER SYMPTOMS. THE PATIENT WAS RELEASED FROM THE HOSPITAL ON (B)(6) 2017. SHE HAS SEEN 4 SPECIALISTS (CARDIOLOGIST, INTERNIST, DERMATOLOGIST AND ALLERGIST), AND IT WAS THOUGHT THAT THE ADVERSE REACTION IS LIKELY DUE TO THE DRUG (EVEROLIMUS) ON THESE STENTS. THE PATIENT HAS NO MEDICAL HISTORY OF ALLERGIES. SHE UNDERWENT A STENTING PROCEDURE APPROXIMATELY 8 YEARS AGO, WITH IMPLANTATION OF ONE STENT; THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS AFTERWARDS. THE DOSAGE OF HER MEDICATIONS HAVE BEEN INCREASED. SHE WAS PRESCRIBED EPIFOAM AND VISTARIL, AS WELL AS PREDNISONE. HER PHYSICIAN ORIGINALLY PRESCRIBED PLAVIX; THIS WAS CHANGED TO BRILINTA. THE BRILINTA WAS THEN CHANGED TO EFFIENT, WHICH CONTINUES. BEFORE THE THREE XIENCE ALPINE IMPLANTS, THE PATIENT WAS TAKING BABY ASPIRIN BUT THIS WAS

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 6699156 ↗
• InjuryFeb 28, 2017Kinked; Difficult To Position; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY. A 3.50 X 28 MM XIENCE ALPINE STENT DELIVERY SYSTEM (SDS) WAS SELECTED FOR THE PROCEDURE. THREE GUIDE WIRES WERE INSERTED THROUGH A NON-ABBOTT 7.5F SHEATHLESS RADIAL GUIDING CATHETER; ONE INTO THE LAD, ONE INTO THE RAMUS AND ONE INTO THE CIRCUMFLEX. THE SDS WAS INSERTED INTO THE GUIDING CATHETER MET RESISTANCE WITH THE GUIDING CATHETER AND WOULD NOT PASS THROUGH. A KINK WAS NOTICED IN THE SDS SHAFT NEAR THE SITE OF ENTRY. AN X-RAY WAS TAKEN; THE STENT IMPLANT WAS NOT ON THE BALLOON AND WAS FOUND IN THE PROXIMAL END OF THE NON-ABBOTT SHEATHLESS RADIAL GUIDING CATHETER AT THE POINT OF INSERTION. AN UNSPECIFIED BALLOON CATHETER WAS USED TO CAPTURE THE STENT IMPLANT AND REMOVE IT FROM THE NON-ABBOTT SHEATHLESS RADIAL GUIDING CATHETER. A NEW UNSPECIFIED GUIDING CATHETER WAS PUT IN AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING ANOTHER UNSPECIFIED SDS. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6366762 ↗
• MalfunctionFeb 7, 2017Difficult to Remove

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A LESION IN THE RIGHT CORONARY ARTERY. THE 3.5X28 MM XIENCE ALPINE STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TO THE TARGET LESION WITHOUT RESISTANCE. THE STENT WAS IMPLANTED SUCCESSFULLY. HOWEVER, DURING REMOVAL OF THE SDS, RESISTANCE WAS FELT WITH THE GUIDING CATHETER. THE SDS AND THE GUIDING CATHETER WERE REMOVED TOGETHER AS A SINGLE UNIT. THERE WERE NO ADVERSE PATIENT EFFECTS. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6309527 ↗
• MalfunctionOct 11, 2016Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE 3.5X28 XIENCE ALPINE STENT CAME OFF WITH THE PROTECTIVE SHEATH WHEN THE SHEATH WAS REMOVED FROM THE STENT DELIVERY SYSTEM. THE STENT REMAINED INSIDE THE SHEATH. THERE WAS NO RESISTANCE REMOVING THE SHEATH. THERE WAS NO PATIENT INVOLVEMENT. ANOTHER XIENCE OF THE SAME SIZE WAS SUCCESSFULLY USED TO COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 6019465 ↗
• InjuryOct 3, 2016Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT SIX XIENCE ALPINE STENTS WERE IMPLANTED ON (B)(6) 2016. ON (B)(6) 2016, THE PATIENT WAS RE-ADMITTED WITH OTHER CARDIOVASCULAR SYMPTOMS INCLUDING AN INFECTION. THE TREATMENT WAS OTHER AND THE FINAL PATIENT OUTCOME IS UNKNOWN; THE PATIENT WAS DISCHARGED TO HOME WITH HOME HEALTH. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 5993972 ↗
• InjurySep 28, 2016Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2016, A 3.5X28 RX XIENCE ALPINE AND A 3.5X18 RX XIENCE ALPINE DRUG-ELUTING STENT WAS IMPLANTED FOR TREATMENT OF AN UNSPECIFIED VESSEL. ON (B)(6) 2016, THE PATIENT WAS REHOSPITALIZED DUE TO OTHER UNSPECIFIED CARDIOVASCULAR SYMPTOMS, INCLUDING CHEST PAIN. UNSPECIFIED TREATMENT WAS ADMINISTERED THEN THE PATIENT WAS DISCHARGED HOME. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina

  MAUDE report 5984969 ↗
• InjuryAug 25, 2016Difficult or Delayed Positioning

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT RESTENOSIS OF THE LEFT ANTERIOR DESCENDING ARTERY. PREDILATATION WAS PERFORMED PRIOR TO THE DEPLOYMENT OF THE 3.5 X 28 MM XIENCE ALPINE STENT. THERE WAS NO RESISTANCE REPORTED DURING ADVANCEMENT OF THE STENT DELIVERY SYSTEM TO THE LESION. DURING DEPLOYMENT IT WAS OBSERVED THAT THE PROXIMAL END OF THE STENT IMPLANT WAS NOT FULLY OPENING BUT WAS ABLE TO BE DEPLOYED; HOWEVER, THE PROXIMAL END OF THE STENT IMPLANT WAS STILL OBSERVED TO BE NOT FULLY OPEN. A 1.5 X 5 MM BALLOON WAS ADVANCED INSIDE THE STENT IMPLANT AND INFLATED TO FULLY APPOSE THE PROXIMAL END OF THE STENT TO THE VESSEL WALL. THIS WAS FOLLOWED BY NORMAL POST-DILATATION OF THE STENT. NO ADVERSE PATIENT EFFECTS OR CLINICALLY SIGNIFICANT DELAY OF THE PROCEDURE WERE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5903770 ↗