XIENCE ALPINE 1125275-33Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 08717648199295), received between Dec 1, 2016 and Oct 9, 2018 — classified as 1 death, 4 injuries, 1 malfunction.

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

• InjuryOct 9, 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 RIGHT CORONARY ARTERY (RCA). THE 2.75 X 33 MM XIENCE ALPINE STENT WAS IMPLANTED IN THE PROXIMAL RCA. POST DILATATION WAS PERFORMED AND DECREASED BLOOD FLOW WAS NOTED IN THE DISTAL POSTEROLATERAL ARTERY, LIKELY DUE TO THROMBUS EMBOLIZATION. NO TREATMENT WAS PROVIDED. PER PHYSICIAN, THE EVENT IS NOT RELATED TO THE IMPLANTED STENT, BUT IS RELATED TO THE STENTING PROCEDURE. THE PATIENT IS DOING WELL, WITH NO CHEST PAIN OR OTHER SYMPTOMS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Thrombosis

  MAUDE report 7949637 ↗
• DeathAug 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, THE PATIENT WAS ADMITTED WITH CHEST PAIN AND UNDERWENT A CORONARY STENTING PROCEDURE, WITH PLACEMENT OF A 2.75 X 33 MM XIENCE ALPINE STENT IN THE MID LEFT ANTERIOR DESCENDING ARTERY AND A 3.0 X 12 MM XIENCE ALPINE STENT IN THE PROXIMAL CIRCUMFLEX ARTERY. THE PATIENT RETURNED TO THE EMERGENCY DEPARTMENT TWO DAYS LATER, WITH SEVERE CHEST PAIN. CORONARY ANGIOGRAM NOTED THE STENTS WERE PATENT, BUT COMPUTED TOMOGRAPHY SHOWED A PENETRATING ULCER OF THE DESCENDING THORACIC AND PROXIMAL ABDOMINAL AORTA. THE PATIENT UNDERWENT A THORACIC ENDOVASCULAR AORTIC/ANEURYSM REPAIR (TEVAR) PROCEDURE TO REPAIR THE AORTIC ULCER. THE PATIENT WAS FOUND TO HAVE BILATERAL LOWER EXTREMITY PARALYSIS FOLLOWING THE ENDOVASCULAR REPAIR, WHICH WAS DUE TO PROBABLE SPINAL ISCHEMIA AT THE T10 (THORACIC) LEVEL. THE PATIENT REMAINED HOSPITALIZED UNTIL (B)(6) 2018 AND TRANSFERRED TO A REHABILITATION FACILITY FOR CONTINUED CARE. AT THE REHABILITATION FACILITY, THE PATIENT DEVELOPED SEPSIS, WITH E. COLI CULTURED IN THE URINE AND BLOOD. THE PATIENT WAS TREATED WITH INTRAVENOUS (IV) ANTIBIOTICS. THE PATIENT BECAME SEPTIC, HYPOTENSIVE AND SHORT OF BREATH AND WAS TRANSFERRED BACK TO THE

  Patient problems: Cardiac Arrest; Myocardial Infarction; Ventricular Tachycardia

  MAUDE report 7749051 ↗
• InjuryJun 4, 2018Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE 2.75X33MM XIENCE ALPINE STENT WAS IMPLANTED ON (B)(6) 2018. THE PATIENT PRESENTED WITH NON ST-ELEVATION MYOCARDIAL INFARCTION (NSTEMI) BEFORE THE PROCEDURE. ON (B)(6) 2018, THE PATIENT WAS READMITTED WITH CARDIOVASCULAR SYMPTOMS, INCLUDING LEFT ARM PAIN. THE TREATMENT PERFORMED WAS NOT REPORTED AND THE FINAL PATIENT OUTCOME IS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Pain

  MAUDE report 7567635 ↗
• InjuryMay 23, 2018Difficult to Remove; Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A HEAVILY CALCIFIED LESION IN THE DISTAL DIAGONAL CORONARY ARTERY. THE PATIENT PRESENTED WITH ST-SEGMENT ELEVATION MYOCARDIAL INFARCTION (STEMI). THE 2.75 X 33 XIENCE ALPINE STENT DELIVERY SYSTEM (SDS) WAS ADVANCED, BUT COULD NOT CROSS A PREVIOUSLY IMPLANTED STENT IN THE LEFT ANTERIOR DESCENDING (LAD), AND DURING THE ATTEMPT TO CROSS THE DISTAL END OF THE STENT GOT HUNG UP WITH THE PROXIMAL END OF THE IMPLANTED STENT. WHEN THE XIENCE ALPINE SDS WAS RE-POSITIONED AND WAS PULLED BACK THE XIENCE ALPINE STENT DISLODGED IN THE PROXIMAL LAD. A BALLOON CATHETER WAS USED TO DEPLOY THE DISLODGED STENT IN HEALTHY TISSUE AFTER A SERIES OF INFLATIONS. A NEW SDS WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THE PATIENT HAD GOOD RESULTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 7537321 ↗
• MalfunctionJan 9, 2018Difficult to Remove

  IT WAS REPORTED THAT AT A 2.75 X 33 MM XIENCE ALPINE STENT DELIVERY SYSTEM (SDS) WAS SELECTED FOR THE PROCEDURE. DURING PREPARATION PRIOR TO USE, THE PROTECTIVE STENT SHEATH WAS DIFFICULT TO REMOVE FROM THE SDS. THEREFORE, THE SDS WAS NOT USED IN THE PROCEDURE. A NEW UNSPECIFIED SDS WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 7175107 ↗
• InjuryDec 1, 2016Difficult to Remove; Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED MID LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE PATIENT PRESENTED WITH AN ST ELEVATED MYOCARDIAL INFARCTION. A 2.75 X 33 MM XIENCE ALPINE STENT DELIVERY SYSTEM COULD NOT CROSS THE LESION AND DURING REMOVAL, THERE WAS RESISTANCE AND THE STENT IMPLANT DISLODGED. AN NC TREK BALLOON CATHETER WAS ADVANCED TO THE STENT IN AN ATTEMPT TO DEPLOY IN THE LESION; HOWEVER, IT COULD NOT GO THROUGH A PREVIOUSLY PLACED STENT IN THE PROXIMAL LAD SO THE XIENCE ALPINE STENT WAS IMPLANTED INSIDE THE PREVIOUSLY PLACED STENT. A 2.75 MM UNSPECIFIED STENT WAS DEPLOYED IN THE MID LAD TO SUCCESSFULLY COMPLETE THE PROCEDURE. THE PATIENT IS FINE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 6139291 ↗