XIENCE ALPINE 1125250-33Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 08717648199202), received between Oct 19, 2016 and Feb 13, 2018 — classified as 4 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 13, 2018Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED DE NOVO DISTAL RIGHT CORONARY ARTERY THAT DID NOT HAVE ANY TORTUOSITY. A 2.5 X 33 MM XIENCE ALPINE STENT DELIVERY SYSTEM (SDS) WAS USED; HOWEVER, IT WAS NOTED UNDER FLUOROSCOPY THAT THE STENT WAS MISSING FROM THE BALLOON. THE STENT WAS DISLODGED INSIDE AN UNSPECIFIED GUIDING CATHETER. THE SDS WAS THEN PULLED BACK AND THE SDS BALLOON WAS INFLATED. THE SDS AND THE GUIDING CATHETER WERE REMOVED WITH THE STENT INSIDE THE GUIDING CATHETER. A NEW UNSPECIFIED GUIDING CATHETER WAS THEN ADVANCED AND A 2.5 X 23 MM XIENCE ALPINE SDS WAS USED; HOWEVER, THE SDS FAILED TO CROSS THE LESION DUE TO THE ANATOMY. THEREFORE, THE DEVICE WAS REPLACED WITH A 2.5 X 12 MM AND A 2.5 X 18 MM XIENCE ALPINE SDS, AND POST-DILATATION WAS DONE WITH AN UNSPECIFIED BALLOON CATHETER TO SUCCESSFULLY 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 7267549 ↗
• InjuryDec 5, 2017Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 2.5 X 33 MM AND 2.25 X 28 MM XIENCE ALPINE STENTS WERE IMPLANTED ON (B)(6) 2017. ON (B)(6) 2017, THE PATIENT WAS RE-ADMITTED WITH CARDIOVASCULAR SYMPTOMS INCLUDING CONGESTIVE HEART FAILURE. ON (B)(6) 2017, THE PATIENT PRESENTED WITH SYNCOPE. ALTHOUGH THE TREATMENT PERFORMED IS UNSPECIFIED, THE FACT THAT REHOSPITALIZATION OCCURRED INDICATES THAT SOME FORM OF TREATMENT WAS PERFORMED. THE FINAL PATIENT OUTCOME IS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Heart Failure; Syncope

  MAUDE report 7084640 ↗
• MalfunctionOct 7, 2017Difficult To Position; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE MILDLY TORTUOUS, MODERATELY CALCIFIED, 70% STENOSED, LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY AND A LESION IN THE MILDLY TORTUOUS, NON-CALCIFIED, 70% STENOSED, DIAGONAL CORONARY ARTERY UTILIZING THE KISSING STENT METHOD. A 2.50 X 23 MM XIENCE ALPINE STENT DELIVERY SYSTEM (SDS) WAS SELECTED TO TREAT THE LESION IN THE LAD. THE SDS WAS ADVANCED TO THE LESION, POSITIONED, ALTHOUGH IT WAS NOT DEPLOYED AT THAT TIME. A 2.5 X 33 MM XIENCE ALPINE SDS WAS SELECTED TO TREAT THE LESION IN THE DIAGONAL CORONARY ARTERY. THE SDS WAS ADVANCED TOWARD THE LESION, MET RESISTANCE WITH THE GUIDING CATHETER AND WOULD NOT NEGOTIATE THE CURVE INTO THE DIAGONAL. DURING REMOVAL OF THE SDS FROM THE ANATOMY, THE STENT DISLODGED FROM THE BALLOON AND WAS FOUND INSIDE THE GUIDING CATHETER. IT WAS DECIDED TO GO AHEAD AND DEPLOY THE FIRST STENT IN THE LAD. WHEN THEY WENT TO REPOSITION THE STENT PRIOR TO DEPLOYMENT IT WAS OBSERVED UNDER FLUOROSCOPY THAT THE BALLOON AND STENT WERE NOT MOVING AS THE DELIVERY SYSTEM WAS MOVED. IT WAS DETERMINED THAT THE BALLOON AND STENT HAD SEPARATED FROM THE DELIVERY SYSTEM. THE SDS WAS REMOVED FROM THE ANATOMY. N

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6927452 ↗
• InjuryJun 16, 2017Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2017, A 3.0 X 15 MM, A 2.5 X 33 MM, A 2.5 X 15 MM AND A 4.0 X 08 MM XIENCE ALPINES STENTS WERE IMPLANTED. ON (B)(6) 2017, THE PATIENT WAS RE-ADMITTED WITH INCREASED DIFFICULTY BREATHING. UNKNOWN MEDICAL TREATMENT WAS PERFORMED. THE PATIENT WAS DISCHARGED HOME. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Dyspnea

  MAUDE report 6648808 ↗
• InjuryApr 18, 2017Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2016, A 2.5X33 RX XIENCE ALPINE AND A 4.0X18 RX XIENCE ALPINE DRUG-ELUTING STENT WAS EACH IMPLANTED FOR TREATMENT OF AN UNSPECIFIED VESSEL. ON (B)(6) 2016, THE PATIENT WAS REHOSPITALIZED DUE TO OTHER UNSPECIFIED CARDIOVASCULAR SYMPTOMS, INCLUDING PERICARDIAL EFFUSION. UNSPECIFIED TREATMENT WAS ADMINISTERED TO THE PATIENT. FINAL PATIENT OUTCOME IS REPORTEDLY UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Pericardial Effusion

  MAUDE report 6501603 ↗
• MalfunctionNov 11, 2016Difficult to Remove; Failure to Advance; Material Deformation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE MILDLY TORTUOUS, HEAVILY CALCIFIED, 99% STENOSED DISTAL LEFT ANTERIOR DESCENDING CORONARY ARTERY. A 2.5 X 15 MM NON-ABBOTT BALLOON DILATATION CATHETER WAS USED FOR PRE-DILATATION AND WAS INFLATED TO 20 ATMOSPHERES. A 2.50 X 33 MM XIENCE ALPINE STENT DELIVERY SYSTEM (SDS) WAS CHOSEN FOR THE PROCEDURE. THE SDS WAS ADVANCED WITH NO RESISTANCE THROUGH A NON-ABBOTT GUIDING CATHETER EXTENSION TO THE LESION AND WOULD NOT CROSS THE LESION DUE TO THE ANATOMY. THOUGH RESISTANCE WAS FELT WHILE RETRACTING THE SDS INTO THE NON-ABBOTT GUIDING CATHETER EXTENSION, THE SDS WAS ABLE TO BE REMOVED. ONCE THE SDS WAS REMOVED FROM THE ANATOMY, THE PROXIMAL PORTION OF THE STENT IMPLANT WAS OBSERVED TO BE FLARED. A NON-ABBOTT SDS WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. 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 6096802 ↗
• MalfunctionOct 19, 2016Difficult to Remove; Expulsion; Material Deformation

  IT WAS REPORTED THAT DURING PREPARATION OF A 2.50 X 33 MM XIENCE ALPINE STENT DELIVERY SYSTEM (SDS), THE PROTECTIVE SHEATH WAS STUCK TO THE STENT IMPLANT. WHILE ATTEMPTING TO REMOVE THE PROTECTIVE SHEATH, THE STENT IMPLANT BECAME DISLODGED FROM THE BALLOON AND THE STENT IMPLANT WAS STRETCHED OUT. THERE WAS NO REPORTED PATIENT INVOLVEMENT. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 6042390 ↗