XIENCE ALPINE 1125275-28Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 08717648199288), received between Sep 16, 2016 and Jul 26, 2018 — classified as 12 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (2 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. 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• InjuryJul 26, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY (LAD). ON (B)(6) 2018, THE PATIENT PRESENTED WITH NON-ST-ELEVATION MYOCARDIAL INFARCTION (NSTEMI). ON (B)(6) 2018, A 2.75 X 28 MM XIENCE ALPINE STENT WAS IMPLANTED IN THE PROXIMAL LAD. ON (B)(6) 2018, THE PATIENT WAS RE-HOSPITALIZED FOR ANGINA. ANGIOGRAPHY REVEALED PARTIAL THROMBOSIS OF THE PREVIOUSLY IMPLANTED STENT AND WAS SUCCESSFULLY TREATED WITH BALLOON ANGIOPLASTY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina; Thrombosis

  MAUDE report 7723992 ↗
• MalfunctionJun 19, 2018Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT AN EXPIRED XIENCE ALPINE STENT WAS IMPLANTED IN A CORONARY ARTERY. THERE WAS NO DEVICE ISSUE AND THERE WAS NO ADVERSE PATIENT EFFECT. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THIS ISSUE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7614029 ↗
• InjuryMar 13, 2018Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 2.75 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 7334078 ↗
• InjuryJan 5, 2018Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE LEFT ANTERIOR DESCENDING (LAD) ARTERY AND THE RIGHT CORONARY ARTERY (RCA). THE PATIENT PRESENTED WITH AN ST ELEVATED MYOCARDIAL INFARCTION (STEMI). TWO XIENCE ALPINES STENTS (2.75 X 23 MM AND 3.0 X 08 MM) WERE IMPLANTED IN THE LAD AND THREE XIENCE ALPINE STENTS WERE IMPLANTED IN THE RCA. THE PATIENT WAS GIVEN ANGIOMAX. THE PROCEDURE WENT WELL; HOWEVER, WHEN BEING TAKEN TO THE INTENSIVE CARE UNIT (ICU), THE PATIENT WENT INTO CARDIOGENIC SHOCK. THE PATIENT WAS TAKEN BACK TO THE CATH LAB WHERE AN INTRA-AORTIC BALLOON PUMP WAS PUT IN AND THEN THROMBOSIS WAS OBSERVED IN ALL FIVE STENTS. THE THROMBOSIS IN THE PROXIMAL LAD AND THE RCA WAS TREATED WITH BALLOON ANGIOPLASTY AND THE MID LAD WAS TREATED WITH TWO NON-ABBOTT STENTS. THE PATIENTS MEDICATION WAS CHANGED TO INTEGRILIN AND IS NOW STABLE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Cardiogenic Shock; Thrombosis

  MAUDE report 7169169 ↗
• InjuryNov 30, 2017Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2017 THE 2.75 X 28 MM XIENCE ALPINE STENT AND A 4.0 X18 MM XIENCE ALPINE WERE IMPLANTED FOR TREATMENT OF A LESION OF AN UNSPECIFIED VESSEL. ON (B)(6) 2017, THE PATIENT WAS RE-HOSPITALIZED WITH ANGINA AND OTHER CARDIOVASCULAR (CV) SYMPTOMS. UNSPECIFIED TREATMENT WAS ADMINISTERED AND THE FINAL PATIENT OUTCOME IS REPORTEDLY UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina

  MAUDE report 7070970 ↗
• InjuryMay 10, 2017Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE HEAVILY CALCIFIED TIBIAL ARTERY. A 014 WHISPER MS GUIDEWIRE WAS SELECTED FOR THE PROCEDURE. WHILE CROSSING THE LESION THE TIP OF THE 014 WHISPER MS GUIDEWIRE BROKE OFF. THE PHYSICIAN DECIDED TO EMBED THE GUIDEWIRE TIP INTO THE VESSEL WALL WITH A STENT IMPLANT. AN UNSPECIFIED STENT IMPLANT WAS USED BUT THE STENT ONLY COVERED 70% OF THE GUIDEWIRE TIP AS IT HAD MIGRATED A LITTLE. THE PHYSICIAN DECIDED TO USE A SECOND STENT IMPLANT TO COVER THE REMAINING PART OF THE GUIDEWIRE TIP. A 2.75 X 28 MM XIENCE ALPINE STENT DELIVERY SYSTEM (SDS) WAS SELECTED. THE SDS WAS ADVANCED OVER A NEW UNSPECIFIED GUIDEWIRE AND WHILE TRAVERSING THROUGH THE PREVIOUSLY IMPLANTED STENT, THE STENT IMPLANT DISLODGED FROM THE SDS ONTO THE GUIDEWIRE. THE SDS WAS REMOVED FROM THE ANATOMY AND THE STENT IMPLANT REMAINED ON THE GUIDEWIRE. THE PHYSICIAN WAS ABLE TO MASSAGE OVER THE SKIN, AND MASSAGED THE STENT OUT OF THE ACCESS SITE. THE PROCEDURE WAS ABORTED AT THAT POINT AND THE PATIENT WAS STABLE. 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 6559308 ↗
• InjuryApr 13, 2017Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2016, A 2.75X28 RX XIENCE ALPINE AND A 3.0X23 RX XIENCE ALPINE DRUG-ELUTING STENT WERE IMPLANTED FOR TREATMENT OF AN UNSPECIFIED VESSEL. ON (B)(6) 2016, THE PATIENT WAS REHOSPITALIZED DUE TO OTHER UNSPECIFIED CARDIOVASCULAR SYMPTOMS AND SEPSIS. UNSPECIFIED TREATMENT WAS ADMINISTERED AND THE FINAL PATIENT OUTCOME IS REPORTEDLY UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Sepsis

  MAUDE report 6488978 ↗
• MalfunctionJan 20, 2017Leak/Splash

  IT WAS REPORTED THAT DURING PREPARATION OF A 2.75 X 28 MM XIENCE ALPINE STENT DELIVERY SYSTEM, A LEAK WAS OBSERVED FROM THE HUB. THE DEVICE WAS NOT USED IN THE PATIENT AND THERE WAS NO PATIENT INVOLVEMENT. A NEW SAME SIZE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS OR CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 6266710 ↗
• InjuryDec 30, 2016Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 2.75 X 28 MM XIENCE ALPINE STENT WAS IMPLANTED ON (B)(6) 2016. ON (B)(6) 2016 THE PATIENT WAS RE-ADMITTED WITH SHORTNESS OF BREATH. THE PATIENT HAD CHRONIC HEART FAILURE. IT IS UNKNOWN WHAT TREATMENT WAS PERFORMED OR WHAT THE FINAL PATIENT OUTCOME WAS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Dyspnea

  MAUDE report 6216660 ↗
• InjuryDec 6, 2016Device Damaged by Another Device

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT LESIONS LOCATED IN THE DISTAL LEFT MAIN TO THE CIRCUMFLEX (LM TO CX). THE LESION WAS TREATED WITH A 2.75 X 28 MM XIENCE ALPINE STENT DEPLOYED AT 16 ATMOSPHERES. A SHIFT IN PLAQUE WAS OBSERVED TO THE LAD CAUSING A SLOW BLOOD FLOW; THEREFORE, AN ATTEMPT WAS MADE TO CROSS A NON-ABBOTT GUIDE WIRE THROUGH THE IMPLANTED STENT STRUTS TO REACH THE LAD FOR TREATMENT OF THE PLAQUE SHIFT; HOWEVER, IT WOULD NOT CROSS THROUGH THE STENT STRUT AND THE TIP OF THE GUIDE WIRE BECAME STUCK ON THE STENT STRUTS. RETRACTION OF THE GUIDE WIRE RESULTED IN THE IMPLANTED STENT BEING EXPLANTED ALONG WITH THE GUIDE WIRE. ANOTHER 2.75 X 28 MM XIENCE ALPINE STENT WAS SUCCESSFULLY DEPLOYED IN THE LESION AND WAS POST-DILATED. AN ATTEMPT WAS THEN MADE TO GO THROUGH THE SIDE STRUTS OF THE DEPLOYED STENT WITH A 2.25 X 8 MM XIENCE ALPINE STENT; HOWEVER, IT WOULD NOT GO THROUGH THE STRUTS. AFTER ADDITIONAL PRE-DILATATION WAS PERFORMED, ANOTHER ATTEMPT WAS MADE WITH A 2.25 X 12 MM XIENCE ALPINE WHICH WAS ABLE TO CROSS THROUGH THE STRUTS FOR TREATMENT OF THE LAD. THE PATIENT WAS STABLE POST-PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Ischemia; Prolapse

  MAUDE report 6149913 ↗
• MalfunctionDec 6, 2016Positioning Failure; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A CHRONIC TOTAL OCCLUSION IN THE MID LEFT ANTERIOR DESCENDING ARTERY. A 2.75X28MM XIENCE ALPINE RX STENT DELIVERY SYSTEM (SDS) WAS PREPPED OUTSIDE THE ANATOMY PRIOR TO USE. THE SDS WAS ADVANCED TOWARD THE TARGET LESION. THE SDS WAS INFLATED UP TO 15 ATMOSPHERES IN AN ATTEMPT TO DEPLOY THE STENT AND THE STENT DID NOT DEPLOY. CONTRAST WAS SEEN COMING OUT OF THE HOLE IN THE TIP OF THE BALLOON. UPON REMOVAL THE STENT WAS NOTED TO BE CRIMPED ON THE BALLOON STILL. ULTIMATELY THE LESION WAS TREATED VIA ANGIOPLASTY. 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 6149382 ↗
• InjurySep 29, 2016Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT TWO XIENCE ALPINE STENTS (2.25X18MM AND A 2.75X28MM) WERE IMPLANTED ON (B)(6) 2016. ON (B)(6) 2016 THE PATIENT PRESENTED WITH DYSPNEA AND WAS RE-ADMITTED LESS THAN 30 DAYS FROM THE IMPLANT DATE. THE SITE DOES NOT HAVE ANY FURTHER INFORMATION ON THIS INCIDENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Dyspnea

  MAUDE report 5989001 ↗
• InjurySep 28, 2016Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 2.75 X 28 MM XIENCE ALPINE STENT AND A 3.5 X 23 MM XIENCE ALPINE STENT WERE IMPLANTED ON (B)(6) 2015. ON (B)(6) 2015, THE PATIENT WAS RE-ADMITTED WITH SHORTNESS OF BREATH AND PNEUMONIA. IT IS UNKNOWN WHAT TREATMENT WAS PERFORMED. THE PATIENT WAS DISCHARGED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Dyspnea

  MAUDE report 5985505 ↗
• InjurySep 23, 2016Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 2.75 X 28 MM XIENCE ALPINE STENT WAS IMPLANTED ON (B)(6) 2016. ON (B)(6) 2016 THE PATIENT WAS RE-ADMITTED WITH UNSPECIFIED CARDIOVASCULAR SYMPTOMS AND GASTROINTESTINAL BLEEDING. IT IS UNKNOWN WHAT TREATMENT WAS PERFORMED. THE PATIENT WAS DISCHARGED TO A NURSING HOME. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 5975545 ↗
• InjurySep 23, 2016Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 2.75 X 28 MM, 3.0 X 15 MM AND A 3.0 X 23 MM XIENCE ALPINE STENTS WERE IMPLANTED ON (B)(6) 2016. ON (B)(6) 2016, THE PATIENT WAS RE-HOSPITALIZED WITH UNSTABLE ANGINA. TREATMENT WAS PROVIDED AND THE PATIENT WAS DISCHARGED TO HOME. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina

  MAUDE report 5973477 ↗
• MalfunctionSep 16, 2016Difficult to Remove; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN UNSPECIFIED LESION. THE XIENCE ALPINE 2.75 X 28 MM STENT DELIVERY SYSTEM (SDS) WAS UNABLE TO CROSS DUE TO THE PATIENT ANATOMY. WHEN THE SDS WAS BEING REMOVED THROUGH THE GUIDING CATHETER, THERE WAS RESISTANCE MET; THEREFORE BOTH THE GUIDE WIRE AND THE SDS WERE REMOVED TOGETHER AS SINGLE UNIT. ANOTHER SAME-SIZE 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 5957060 ↗