XIENCE ALPINE 1125400-18Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 08717648199622), received between Sep 7, 2016 and Dec 11, 2018 — classified as 7 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (5 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.

• InjuryDec 11, 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 4.00X18 MM XIENCE APLINE STENT AND A 3.50X12 XIENCE SIERRA STENT WERE IMPLANTED. ON (B)(6) 2018 THE PATIENT WAS RE-ADMITTED WITH NON-ST-ELEVATION MYOCARDIAL INFARCTION (NSTEMI) AND OTHER CARDIOVASCULAR SYMPTOMS. THE TYPE OF INTERVENTION WAS NOT REPORTED AND FINAL PATIENT OUTCOME IS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Myocardial Infarction

  MAUDE report 8153503 ↗
• MalfunctionApr 18, 2018Improper or Incorrect Procedure or Method; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE RIGHT CORONARY ARTERY (RCA). THE LESION WAS PRE-DILATED WITH A BALLOON CATHETER. THE 4.0X18MM RX ALPINE STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TO THE LESION; HOWEVER THE STENT WAS NOTED TO BE MISSING FROM THE BALLOON. THE STENT WAS FOUND INSIDE THE PROTECTIVE SHEATH; THEREFORE THE SDS WAS REMOVED FROM THE PATIENT ANATOMY. NO RESISTANCE WAS NOTED DURING REMOVAL OF THE PROTECTIVE SHEATH AND THE DEVICE WAS PREPPED FOR USE AFTER THE SHEATH WAS REMOVED. ANOTHER SAME SIZE ALPINE SDS WAS USED TO 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 7441136 ↗
• InjuryApr 12, 2018Difficult to Remove; Device Damaged by Another Device; Material Deformation

  IT WAS REPORTED THAT THE 4.0X18 XIENCE ALPINE WAS DEPLOYED PROXIMAL TO A NON-ABBOTT STENT IN THE MID RIGHT CORONARY ARTERY (RCA). A NON-ABBOTT FILTER WAS BEING REMOVED THROUGH THE XIENCE ALPINE, BUT THE FILTER WAS ONLY PARTIALLY ENCLOSED IN ITS RETRIEVAL CATHETER. THE FILTER INADVERTENTLY REMOVED THE XIENCE STENT FROM THE MID RCA. WHEN THIS WAS NOTED, THE FILTER, STENT, AND GUIDE CATHETER WERE REMOVED FROM THE ANATOMY AS ONE UNIT, BUT THE STENT HAD BECOME MANGLED AND WAS LEFT BEHIND IN THE RADIAL ARTERY ACCESS SITE. THE MANGLED STENT WAS SURGICALLY REMOVED THROUGH A ONE AND A HALF INCH CUTDOWN AT THE RADIAL ARTERY. THE PATIENT REMAINED HEMODYNAMICALLY STABLE. THERE WAS NO ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7427426 ↗
• InjuryMar 13, 2018Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 4.0 X 18 MM XIENCE ALPINE WAS IMPLANTED ON (B)(6) 2017. ON (B)(6) 2017 THE PATIENT WAS RE-ADMITTED WITH CARDIOVASCULAR SYMPTOMS INCLUDING NON ST ELEVATED 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 7334272 ↗
• InjuryMar 13, 2018Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 4.0 X 18 MM XIENCE ALPINE WAS IMPLANTED ON (B)(6) 2017. ON (B)(6) 2017 THE PATIENT WAS RE-ADMITTED WITH CARDIOVASCULAR SYMPTOMS INCLUDING NON ST ELEVATED 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 7334203 ↗
• InjuryMar 13, 2018Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 4.0 X 18 MM XIENCE ALPINE WAS IMPLANTED ON (B)(6)2017. ON (B)(6) 2017 THE PATIENT WAS RE-ADMITTED WITH CARDIOVASCULAR SYMPTOMS AND URINARY DIAGNOSIS. 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: No Code Available

  MAUDE report 7334176 ↗
• InjuryDec 15, 2017Device Dislodged or Dislocated

  IT WAS REPORTED THAT THIS WAS A TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE. TWO STENTS WERE ADVANCED TO THE AREA AS A PRECAUTION IN CASE THE PATIENT LOST BLOOD FLOW TO THE HEART DURING THE PROCEDURE; HOWEVER, THE STENTS WERE NOT DEPLOYED. AFTER COMPLETION OF THE TAVR PROCEDURE, THE FIRST STENT DELIVERY SYSTEM (SDS) THAT WAS ADVANCED TO THE LEFT ANTERIOR DESCENDING (LAD) WAS REMOVED SUCCESSFULLY FROM THE PATIENT BUT WHEN THE XIENCE ALPINE 4.0 X 18 MM STENT DELIVERY SYSTEM WAS BEING REMOVED FROM THE RIGHT CORONARY ARTERY, THE STENT DISLODGED IN BETWEEN THE STRUTS OF THE TAVR DEVICE. THE STENT WAS POSITIONED IN A U-SHAPE IN BETWEEN THE STRUTS OF THE TAVR DEVICE AND IT WAS DETERMINED THAT IT WAS SECURE IN THAT POSITION. THERE WAS NO REPORTED RESISTANCE DURING REMOVAL OF THE STENT DELIVERY SYSTEM. NO ATTEMPTS WERE MADE TO REMOVE THE UNDEPLOYED STENT FROM THE ANATOMY. THERE WAS NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Vessel Or Plaque, Device Embedded In

  MAUDE report 7121452 ↗
• InjuryJun 15, 2017Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2017, A 4.0 X 18 MM XIENCE ALPINE STENT WAS IMPLANTED. ON (B)(6) 2017, THE PATIENT RETURNED WITH CHEST PAIN WHICH WAS TREATED WITH MEDICATION. THE PATIENT LEFT AGAINST MEDICAL ADVICE. NO ADDITIONAL INFORMATION WAS PROVIDED

  Patient problems: Angina

  MAUDE report 6645607 ↗
• MalfunctionMay 4, 2017Difficult To Position; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE NON-TORTUOUS, HEAVILY CALCIFIED PROXIMAL LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY. A 4.00 X 18 MM XIENCE ALPINE STENT DELIVERY SYSTEM (SDS) WAS SELECTED FOR THE PROCEDURE. DURING ADVANCEMENT OF THE SDS TO THE LESION THE SDS MET RESISTANCE WITH THE NON-ABBOTT GUIDE EXTENSION CATHETER (GEC), THE STENT IMPLANT DISLODGED FROM THE BALLOON AND REMAINED INSIDE THE GEC. THE SDS AND THE GEC WERE REMOVED FROM THE ANATOMY AS ONE UNIT AND THE STENT IMPLANT WAS RETRIEVED FROM INSIDE THE GEC. THE PROCEDURE WAS COMPLETED WITH THE SUCCESSFUL DEPLOYMENT OF A 4.00 X 15 MM XIENCE ALPINE STENT IMPLANT. 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 6545475 ↗
• MalfunctionApr 19, 2017Improper or Incorrect Procedure or Method; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING PREPARATION OF THE 4.0 X 18 MM XIENCE ALPINE STENT DELIVERY SYSTEM (SDS), DURING REMOVAL OF THE SHEATH AND THE STYLET, THE STENT IMPLANT DISLODGED FROM THE BALLOON; HOWEVER, THIS WAS NOT OBSERVED UNTIL THE SDS WAS BEING ADVANCED ON THE GUIDE WIRE AND WAS INSIDE THE PATIENT. ANGIOGRAPHY REVEALED THE STENT IMPLANT WAS MISSING. INVESTIGATION FOUND THE STENT IMPLANT ON THE STYLET AND INSIDE THE PROTECTIVE SHEATH. A NEW SAME SIZE XIENCE ALPINE SDS WAS USED SUCCESSFULLY FOR THE CASE. THERE WERE NO ADVERSE PATIENT EFFECTS OR CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6505430 ↗
• MalfunctionApr 7, 2017Detachment Of Device Component; Difficult To Position; Difficult to Remove

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN AN UNSPECIFIED CORONARY ARTERY. THE 4.0X18 MM XIENCE ALPINE STENT DELIVERY SYSTEM (SDS) COULD NOT ADVANCE OVER 0.14 GUIDE WIRE. RESISTANCE WAS FELT DURING REMOVAL OF THE SDS FROM THE GUIDE WIRE AND THE TIP SEPARATED ONTO THE GUIDE WIRE. THE GUIDE WIRE WAS IN THE PATIENT, THE SDS DID NOT ENTER THE PATIENT ANATOMY. THE SDS AND THE GUIDE WIRE WERE REMOVED AND A NEW XIENCE ALPINE AND GUIDE WIRE WERE USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY DURING THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6473499 ↗
• MalfunctionFeb 14, 2017Difficult to Remove; Failure to Advance

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A CORONARY STENTING PROCEDURE TO TREAT A TARGET LESION IN THE MODERATELY CALCIFIED AND MILDLY TORTUOUS MID RIGHT CORONARY ARTERY. THE XIENCE ALPINE STENT DELIVERY SYSTEM WAS ADVANCED OVER THE BALANCE MIDDLEWEIGHT (BMW) GUIDE WIRE. THE STENT DELIVERY SYSTEM (SDS) WAS UNABLE TO CROSS TO THE TARGET LESION AND AN ATTEMPT WAS MADE TO REMOVE THE DEVICE; HOWEVER, DURING REMOVAL, RESISTANCE WAS NOTED BETWEEN THE SDS AND THE GUIDE WIRE. THE PHYSICIAN TRIED TO REMOVE THE SDS, BUT THE GUIDE WIRE SEPARATED IN THE PATIENT ANATOMY. THE SEPARATED GUIDE WIRE SEGMENT REMAINED CONTAINED IN THE STENT DELIVERY SYSTEM AND THE DEVICES WERE REMOVED AS A SINGLE UNIT. ALL SEGMENTS OF THE GUIDE WIRE WERE REMOVED FROM THE PATIENT ANATOMY. NO PORTION OF THE GUIDE WIRE REMAINED IN THE PATIENT ANATOMY. A SECOND GUIDE WIRE AND XIENCE ALPINE SDS WERE USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6330866 ↗
• MalfunctionSep 7, 2016Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING REMOVAL OF THE PROTECTIVE SHEATH FROM THE 4.0 X 18 MM XIENCE ALPINE STENT DELIVERY SYSTEM BY THE TECHNICIAN IN THE CASE THE STENT IMPLANT DISLODGED AND WAS LOCATED INSIDE THE SHEATH. THE DEVICE COULD NOT BE USED ON THE PATIENT. ANOTHER STENT DELIVERY SYSTEM WAS ABLE TO BE USED SUCCESSFULLY FOR THE CASE. NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE WAS REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 5934785 ↗