XIENCE ALPINE 1125275-12Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 08717648199240), received between Aug 3, 2016 and Feb 10, 2020 — classified as 2 deaths, 9 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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. 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 10, 2020Difficult to Advance; Device Dislodged or Dislocated; Difficult to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE RIGHT CORONARY ARTERY. A 2.75X12MM XIENCE ALPINE STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TO THE LESION BUT FACED RESISTANCE WITH AN UNSPECIFIED PREVIOUSLY DEPLOYED STENT PROXIMAL TO THE TARGET LESION. PRIOR TO INITIATING DEPLOYMENT, THE STENT DISLODGED OFF THE BALLOON INTO THE TARGET LESION. AN UNSPECIFIED BALLOON DILATATION CATHETER WAS USED TO OPPOSE THE STENT TO THE VESSEL WALL SUCCESSFULLY. 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 9687071 ↗
• DeathOct 3, 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 2.75X12MM XIENCE ALPINE STENT WAS SUCCESSFULLY IMPLANTED IN THE MID RIGHT CORONARY ARTERY (RCA) LESION. ON (B)(6) 2018, THE PATIENT WAS SENT HOME WITH HOSPICE FOR RESPIRATORY FAILURE. PER PHYSICIAN, THE RESPIRATORY FAILURE WAS UNRELATED TO THE XIENCE ALPINE STENT. ON (B)(6) 2018, THE PATIENT WAS TAKEN TO THE HOSPITAL IN FULL CARDIAC ARREST. MEDICATIONS WERE PROVIDED; HOWEVER, THE PATIENT HAD EXPIRED THAT SAME DAY. REPORTEDLY, THERE WAS NO DEVICE MALFUNCTION AND RECENT IMAGING HAD NOT BEEN PERFORMED. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THIS ISSUE.

  Patient problems: Cardiac Arrest

  MAUDE report 7931804 ↗
• DeathJun 5, 2018Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 2.75 X 12 MM, 3.50 X 15 MM, AND 3.0 X 18 MM XIENCE ALPINE STENTS WERE IMPLANTED ON (B)(6) 2018. ON (B)(6) 2018, THE PATIENT WAS RE-ADMITTED WITH CARDIOVASCULAR SYMPTOMS AND PNEUMONIA. THE TREATMENT PERFORMED IS UNKNOWN. THE PATIENT EXPIRED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Death; Unspecified Infection

  MAUDE report 7570205 ↗
• InjuryFeb 19, 2018Difficult to Remove; Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE RIGHT CORONARY ARTERY (RCA) WITH HEAVY TORTUOSITY, HEAVY CALCIFICATION. AN UN-SPECIFIED STENT WAS PREVIOUSLY IMPLANTED IN THE RCA. THE GUIDING CATHETER WAS ADVANCED WITH SOME RESISTANCE NOTED. THE 2.75 X 12 MM XIENCE ALPINE STENT DELIVERY SYSTEM (SDS) WAS ADVANCED AND RESISTANCE WAS NOTED WITH THE PREVIOUSLY IMPLANTED STENT. THE SDS WAS REMOVED WITH RESISTANCE AND THE STENT DISLODGED IN RCA. IT COULD NOT BE DETERMINED IF THE RESISTANCE WAS WITH THE CALCIUM OR THE IMPLANTED STENT. A BALLOON CATHETER WAS ADVANCED IN AN ATTEMPT TO RETRIEVE THE STENT, BUT WAS UNSUCCESSFUL. THE PATIENT WAS SENT TO CORONARY ARTERY BYPASS SURGERY (CABG) TO RETRIEVE THE STENT, AND CONFIRMED TO BE STABLE AFTER SURGERY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7280940 ↗
• InjuryNov 30, 2017Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2017 THE 2.75 X 12 MM XIENCE ALPINE STENT WAS IMPLANTED FOR TREATMENT OF A LESION OF AN UNSPECIFIED VESSEL. ON (B)(6) 2017, THE PATIENT WAS RE-HOSPITALIZED FOR SHORTNESS OF BREATH AND OTHER CARDIOVASCULAR (CV) SYMPTOMS. UNSPECIFIED TREATMENT WAS ADMINISTERED AND THE FINAL PATIENT OUTCOME IS REPORTEDLY UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Dyspnea

  MAUDE report 7070883 ↗
• InjurySep 14, 2017Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT 48-HOURS POST-STENTING PROCEDURE WITH TWO XIENCE ALPINE STENTS THE PATIENT EXPERIENCED A RASH ON THE WAIST, ABDOMEN, AND BACK. EXCESSIVE ITCHING WAS ALSO NOTED. THE PATIENT WAS GIVEN CORTISONE INJECTION AND A TOPICAL CREAM AS TREATMENT. A SMALL AREA REMAINS ON THE TORSO BUT IS RESOLVING. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Hypersensitivity/Allergic reaction; Rash

  MAUDE report 6867492 ↗
• InjuryAug 30, 2017Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2017, A 2.75X12 RX XIENCE ALPINE DRUG-ELUTING STENT (DES), A 2.75X23 RX XIENCE ALPINE DES, AND A 2.0X12 RX MINI VISION BARE METAL STENT WAS EACH IMPLANTED FOR TREATMENT OF AN UNSPECIFIED VESSEL. ON (B)(6) 2017, THE PATIENT WAS REHOSPITALIZED DUE TO ENCEPHALOPATHY AND OTHER UNSPECIFIED CARDIOVASCULAR SYMPTOMS. UNSPECIFIED TREATMENT WAS ADMINISTERED TO THE PATIENT. FINAL PATIENT OUTCOME IS REPORTEDLY UNKNOWN. NO ADDITIONAL ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 6830638 ↗
• MalfunctionMay 18, 2017Peeled/Delaminated; Material Deformation

  IT WAS REPORTED THAT THE STENT STRUTS WERE NOTED TO BE FLARED AFTER THE 2.75X12 MM XIENCE ALPINE STENT DELIVERY SYSTEM WAS REMOVED FROM THE PACKAGING. THIS DEVICE WAS NOT USED IN THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED. DURING DEVICE ANALYSIS, IT WAS NOTED THAT THE BALLOON WAS SHREDDING.

  Patient problems: No Patient Involvement

  MAUDE report 6575234 ↗
• InjuryJan 5, 2017Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 2.75 X 12 MM XIENCE ALPINE STENT WAS IMPLANTED ON (B)(6) 2016. ON (B)(6), 2016 THE PATIENT WAS RE-ADMITTED TO THE HOSPITAL WITH CHEST PAIN LESS THAN 30 DAYS FROM THE DATE OF IMPLANT. IT IS UNKNOWN WHAT TREATMENT WAS PERFORMED AND THE PATIENT OUTCOME IS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina

  MAUDE report 6227225 ↗
• InjuryOct 5, 2016Failure to Advance; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A DE NOVO LESION WITH MODERATE TORTUOSITY AND HEAVY CALCIFICATION IN THE RIGHT CORONARY ARTERY (RCA). PRE-DILATATION WAS PERFORMED WITH MULTIPLE BALLOONS AND THE 2.75 X 12 MM XIENCE ALPINE WAS ADVANCED. HOWEVER, THE XIENCE ALPINE STENT GOT HUNG UP ON CALCIUM AND DISLODGED PRIOR TO THE LESION. A BALLOON WAS USED TO COMPRESS THE DISLODGED STENT AGAINST THE VESSEL WALL (HEALTHY TISSUE) SUCCESSFULLY. A 2.75 X 8 MM XIENCE ALPINE WAS ADVANCED SUCCESSFULLY TO TREAT THE LESION. THE PATIENT IS DOING WELL. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Vessel Or Plaque, Device Embedded In

  MAUDE report 6001909 ↗
• InjuryOct 3, 2016Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 2.75 X 12 MM XIENCE ALPINE STENT WAS IMPLANTED ON (B)(6) 2016. ON (B)(6) 2016, THE PATIENT WAS RE-ADMITTED WITH CARDIOVASCULAR SYMPTOMS AND EPISTAXIS. IT IS UNKNOWN WHAT TREATMENT WAS PERFORMED. THE FINAL PATIENT OUTCOME IS UNKNOWN; THE PATIENT WAS DISCHARGED TO A NURSING HOME. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 5993975 ↗
• InjuryAug 30, 2016Device Dislodged or Dislocated

  USER FACILITY MEDWATCH: DURING DELIVERY AND DEPLOYMENT OF STENT, GUIDE WIRE CAME OUT OF CORONARY ARTERY. STENT STRIPPED OFF OF DELIVERY CATHETER. MULTIPLE ANGULATIONS FAILED TO FIND UNDEPLOYED STENT IN ARTERY. FLOURO SCAN WAS NEGATIVE. UNABLE TO LOCATE STENT IN ROOM. ADDITIONAL REPORTED INFORMATION INDICATES THAT THE 2.75X12 MM XIENCE ALPINE STENT IMPLANT WAS CONFIRMED TO BE ON THE STENT DELIVERY SYSTEM (SDS) PRIOR TO INSERTING THE SDS INTO THE PATIENT ANATOMY. IT IS NOT KNOWN IF THE BALLOON WAS INFLATED IN AN ATTEMPT TO DEPLOY THE STENT PRIOR TO THE GUIDE WIRE COMING OUT OF THE CORONARY ARTERY. THERE IS A DEFINITE POSSIBILITY THE STENT REMAINS SOMEWHERE IN THE PATIENT ANATOMY BUT WAS NOT ABLE TO BE LOCATED. THE TARGET LESION WAS ULTIMATELY TREATED WITH ANOTHER STENT. THE PATIENT WAS FINE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 5914886 ↗
• MalfunctionAug 3, 2016Detachment Of Device Component; Improper or Incorrect Procedure or Method; Physical Resistance

  IT WAS REPORTED THAT DURING A PROCEDURE OF THE RIGHT ANTERIOR TIBIAL ARTERY USING A CONTRALATERAL APPROACH IN A HEAVILY TORTUOUS GROIN, THE 2.75 X 12 MM XIENCE ALPINE STENT WAS ADVANCED WITH ANATOMICAL RESISTANCE AND SUCCESSFULLY DEPLOYED AT THE TARGET LESION WITHOUT ISSUE. DURING REMOVAL OF THE STENT DELIVERY SYSTEM (SDS) WITHOUT RESISTANCE THE SHAFT BECAME SEPARATED NEAR THE TUOHY AND WAS EASILY REMOVED FROM THE ANATOMY WHILE ON THE GUIDE WIRE. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT. ANOTHER STENT WAS IMPLANTED TO 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 5844173 ↗