XIENCE ALPINE 1125300-08Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 08717648199325), received between Apr 10, 2017 and May 14, 2018 — classified as 1 death, 4 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Detachment Of Device Component” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 14, 2018Detachment Of Device Component

  IT WAS REPORTED THAT DURING DEVICE UNPACKAGING AND PRIOR TO USE, THE HUB OF THE 3.0 X 8 MM XIENCE ALPINE WAS DETACHED. THE DEVICE REMAINED IN THE PLASTIC HOLDER. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 7512781 ↗
• 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 7169120 ↗
• InjuryOct 9, 2017Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY THAT WAS HEAVILY CALCIFIED AND NON-TORTUOUS. DURING ADVANCEMENT, THE XIENCE ALPINE 3.0 X 8 MM STENT CAME OFF THE BALLOON IN THE LAD AND WAS FREE-FLOATING, SO IT WAS CRUSHED INTO THE VESSEL WALL WITH ANOTHER STENT. THERE WAS NO REPORTED RESISTANCE PRIOR TO DISLODGEMENT. ANOTHER XIENCE ALPINE 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: Vessel Or Plaque, Device Embedded In

  MAUDE report 6929313 ↗
• InjuryAug 23, 2017Improper or Incorrect Procedure or Method; Physical Resistance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE HEAVILY CALCIFIED, PROXIMAL LEFT ANTERIOR DESCENDING ARTERY. BALLOON DILATATION WAS PERFORMED NUMEROUS TIMES; HOWEVER, THE 3.0 X 8 MM XIENCE ALPINE STENT DELIVERY SYSTEM (SDS) WOULD NOT CROSS. THE DEVICE WAS REMOVED AND ADDITIONAL BALLOON DILATATION WAS PERFORMED AND A SECOND ATTEMPT WAS MADE TO CROSS WITH THE SAME SDS; HOWEVER, IT WOULD NOT CROSS. THE DEVICE WAS REMOVED AND ADDITIONAL DILATATION WAS PERFORMED AND A THIRD ATTEMPT WAS MADE TO CROSS TO THE LESION AND THIS TIME IT REACHED THE LESION; HOWEVER, DURING POSITIONING OF THE STENT DELIVERY SYSTEM IN THE LESION, THE STENT IMPLANT DISLODGED FROM THE BALLOON WAS LOCATED PARTIALLY IN THE LESION. A BALLOON CATHETER WAS ADVANCED AND THE STENT WAS DEPLOYED WHERE IT DISLODGED; HOWEVER, NOT FULLY COVERING THE LESION. ANOTHER 3.0 X 8 MM XIENCE ALPINE SDS WAS USED SUCCESSFULLY TO TREAT THE REMAINING LESION. NO ADVERSE PATIENT EFFECTS OR CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE WERE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6815251 ↗
• DeathJun 15, 2017Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 3.0 X 08 MM XIENCE ALPINE, A 3.0 X 12 MM XIENCE ALPINE AND A 3.0 X 18 MM XIENCE ALPINE STENT WERE IMPLANTED ON (B)(6) 2017. ON (B)(6) 2017 THE PATIENT WAS READMITTED WITH SHORTNESS OF BREATH. AFTER CARDIAC CONSULTATION, BRONCHOSCOPY WAS PERFORMED. THE PATIENT SUBSEQUENTLY EXPIRED (DATE NOT SPECIFIED). NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Death; Dyspnea

  MAUDE report 6643470 ↗
• InjuryMay 25, 2017Improper or Incorrect Procedure or Method; Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED DISTAL LEFT ANTERIOR DESCENDING ARTERY (LAD). THE PATIENT PRESENTED WITH A NON-ST ELEVATED MYOCARDIAL INFARCTION (NSTEMI). A 3.5 X 23 MM XIENCE ALPINE STENT WAS IMPLANTED IN THE MID LEFT ANTERIOR DESCENDING ARTERY AND A 3.5 X 15 MM XIENCE ALPINE STENT WAS IMPLANTED IN THE PROXIMAL LAD OVERLAPPING THE 3.5 X 23 MM STENT. POST DILATATION WAS PERFORMED WITH A 3.5 X 08 MM BALLOON CATHETER. ANGIOGRAPHY CONFIRMED A DISSECTION AT THE DISTAL END OF THE 3.5 X 23 MM XIENCE ALPINE STENT. THEREFORE, A 3.0 X 08 MM XIENCE ALPINE STENT WAS ADVANCED TO THE 3.5 X 23 MM XIENCE ALPINE STENT. HOWEVER, THE 3.0 X 08 MM XIENCE ALPINE STENT FAILED TO CROSS DUE TO THE ANATOMY AND THE IMPLANTED STENT. THEREFORE, THE STENT DELIVERY SYSTEM WAS REMOVED AND A GUIDELINER AND AN UNSPECIFIED GUIDE WIRE WAS ADVANCED AND THE SAME 3.0 X 08 MM XIENCE ALPINE STENT WAS REINSERTED, BUT IT STILL COULD NOT ADVANCE PAST THE DEPLOYED STENT. DURING REMOVAL, THE STENT DISLODGED IN THE IMPLANTED STENT. ACCESS WAS LOST AND COULD NOT BE RE-ESTABLISHED. THE PROCEDURE ALREADY LASTED FOR 2 HOURS SO AN INTRA-AORTIC BALLOON PUMP WAS PLACED, AND THE PATIENT WAS TAKEN TO

  Patient problems: Foreign Body In Patient

  MAUDE report 6592669 ↗
• MalfunctionApr 10, 2017Detachment Of Device Component; Difficult to Remove; Physical Resistance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE CIRCUMFLEX ARTERY THAT WAS HEAVILY TORTUOUS. SEVERAL ATTEMPTS WERE MADE TO ADVANCE THE XIENCE ALPINE SDS TO THE LESION BUT WHEN IT FINALLY REACHED, THE STENT CATHETER BROKE NEAR THE HUB WHEN THE DEVICE WAS HELD. THE DEVICE WAS REMOVED AS A SINGLE UNIT. BALLOON ANGIOPLASTY WAS PERFORMED TO COMPLETE THE PROCEDURE. ALTHOUGH THE PROCEDURE TOOK TWO HOURS, THERE WAS NO CLINICALLY SIGNIFICANT DELAY OR ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6478507 ↗