XIENCE ALPINE 1125400-12Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 08717648199608), received between Sep 27, 2016 and Jan 16, 2019 — classified as 2 deaths, 11 injuries, 3 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• InjuryJan 16, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 75% STENOSED, CONCENTRIC, MODERATELY CALCIFIED LESION IN THE HEAVILY TORTUOUS CIRCUMFLEX CORONARY ARTERY. A 4.0X12 MM XIENCE ALPINE STENT WAS BEING ADVANCED THROUGH A NON-ABBOTT GUIDE CATHETER EXTENSION AND THE STENT DISLODGED PROXIMAL TO THE TARGET LESION. WHEN THE STENT DISLODGED IT WAS PUSHED OFF THE DISTAL SIDE OF THE BALLOON. AN ATTEMPT WAS MADE TO RETRIEVE THE STENT USING A SNARE, BUT FAILED AND THE STENT WAS ULTIMATELY DEPLOYED IN THE REGION WHERE IT DISLODGED, PARTIALLY IN THE TARGET LESION. TWO MORE XIENCE ALPINE STENTS, A 4.0X12 MM AND A 4.0X15 MM WERE SUCCESSFULLY DEPLOYED TO TREAT THE TARGET LESION AS PLANNED. THE DISLODGED STENT PARTIALLY OVERLAPPED THEM. THE PATIENT OUTCOME IS REPORTED AS RECOVERED AND DISCHARGED FROM THE HOSPITAL. REPORTEDLY, SINCE TWO 4.0X12 MM XIENCE ALPINE STENTS WERE USED DURING THE PROCEDURE (LOT 6051841 AND 8010861), THE LOT NUMBER FOR THE DISLODGED STENT COULD NOT BE IDENTIFIED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8255125 ↗
• InjurySep 4, 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 4.0 X 12 MM XIENCE ALPINE STENT WAS IMPLANTED FOR TREATMENT IN A LESION OF AN UNSPECIFIED VESSEL. ON (B)(6) 2018, THE PATIENT WAS RE-HOSPITALIZED FOR SYNCOPE AND OTHER CARDIOVASCULAR (CV) SYMPTOMS. UNSPECIFIED TREATMENT WAS ADMINISTERED AND THE FINAL PATIENT OUTCOME IS REPORTEDLY UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Syncope

  MAUDE report 7844581 ↗
• InjuryJun 25, 2018Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE 4.0X12 MM XIENCE ALPINE STENT WAS IMPLANTED IN THE PROXIMAL LEFT ANTERIOR DESCENDING CORONARY ARTERY (LAD) AND THE 3.5X28 MM XIENCE ALPINE STENT WAS IMPLANTED IN THE PROXIMAL RIGHT CORONARY ARTERY. AFTER THE LAD STENT WAS POST DILATED, THERE WAS NO REFLOW. INTRACORONARY CARDIZEM WAS ADMINISTERED AND REFLOW RETURNED. THE CONDITION RESOLVED. THE DOCTOR DOES NOT BELIEVE THE REFLOW ISSUE WAS DUE TO A VASOSPASM. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: Cardiac Enzyme Elevation; Occlusion

  MAUDE report 7636170 ↗
• DeathJun 7, 2018Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE 4.0X12MM, 2.5X28MM, AND 2.5X38MM XIENCE ALPINE STENTS WERE IMPLANTED ON (B)(6) 2018. ON (B)(6) 2018, THE PATIENT WAS READMITTED WITH GASTRO INTESTINAL (GI) HEMORRHAGE AND CARDIOVASCULAR SYMPTOMS. THE TREATMENT PERFORMED WAS NOT REPORTED AND THE PATIENT DIED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Death; No Code Available

  MAUDE report 7579604 ↗
• MalfunctionMar 2, 2018Difficult To Position; Difficult to Remove

  IT WAS REPORTED THAT THE FILTRAP CATHETER WAS ADVANCED INTO THE ANATOMY AND THE FILTER WAS EXPANDED. WHEN THE 4.0X12 XIENCE ALPINE STENT DELIVERY SYSTEM (SDS) WAS ADVANCED OVER THE FILTER SHAFT, THE SDS BECAME STUCK AND THE TIP OF THE SDS DID NOT REACH THE PROXIMAL END OF THE GUIDING CATHETER OUTSIDE OF THE PATIENT ANATOMY. AN ATTEMPT WAS MADE TO RETRACT THE SDS; HOWEVER STRONG RESISTANCE WAS NOTED AND THE SDS COULD NOT BE REMOVED. THE PHYSICIAN CUT THE FILTER SHAFT WHERE THE SDS WAS STUCK SO VESSEL ACCESS WAS MAINTAINED. ANOTHER 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 7311076 ↗
• InjuryFeb 2, 2018Difficult to Remove; Physical Resistance; Device Dislodged or Dislocated

  IT WAS REPORTED THE PROCEDURE WAS PERFORMED TO TREAT A LESION WITH HEAVY TORTUOSITY AND HEAVY CALCIFICATION IN PROXIMAL RIGHT CORONARY ARTERY. PRE-DILATATION WAS PERFORMED SUCCESSFULLY. THE 4.0 X 12 MM XIENCE ALPINE STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TO THE TARGET LESION WITH RESISTANCE DUE TO THE HEAVILY CALCIFIED VESSEL. DURING THE ATTEMPT TO RE-POSITION THE SDS, THE STENT BECAME STUCK IN THE CALCIFICATION. THEREFORE, THE SDS WAS PULLED BACK TO RE-POSITION, BUT THE STENT DISLODGED AT THE LESION. THE DISLODGED STENT REMAINED ON THE GUIDE WIRE; THEREFORE, A BALLOON CATHETER WAS ADVANCED TO DEPLOY THE STENT PROXIMALLY AT THE TARGET LESION, PARTIALLY IN THE LESION AND PARTIALLY IN HEALTHY TISSUE. POST DILATATION WAS PERFORMED WITH A SERIES OF BALLOONS. THEN, A 4.0 X 8 MM XIENCE ALPINE STENT WAS DEPLOYED DISTALLY OVERLAPPING THE 4.0 X 12 MM XIENCE ALPINE STENT TO COMPLETELY COVER THE LESION SUCCESSFULLY. THE PATIENT OUTCOME WAS GOOD. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7236305 ↗
• InjuryJan 26, 2018Improper or Incorrect Procedure or Method; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THIS WAS A TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE. A XIENCE ALPINE 4 X 12 MM STENT WAS ADVANCED TO THE AREA AS A PRECAUTION IN CASE THE PATIENT LOST BLOOD FLOW TO THE HEART DURING THE PROCEDURE; HOWEVER, THE STENT WAS NOT DEPLOYED. WHEN THE DEVICE WAS BEING REMOVED FROM THE ANATOMY, THE STENT DISLODGED. A SNARE DEVICE WAS USED TO RETRIEVE THE STENT. THERE WAS NO REPORTED RESISTANCE DURING REMOVAL OF THE STENT DELIVERY SYSTEM. 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 7222800 ↗
• InjuryDec 22, 2017Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT AN ECCENTRIC LESION WITH HEAVY CALCIFICATION IN THE PROXIMAL TO MID RIGHT CORONARY ARTERY. A 4.0 X 38 MM XIENCE STENT WAS SUCCESSFULLY DEPLOYED IN THE MORE DISTAL SEGMENT OF THE LONG MID LESION AND THEN THE REST OF THE LESION WAS COVERED WITH A 4.0 X 12 MM XIENCE STENT, OVERLAPPING THE PREVIOUSLY DEPLOYED STENT. POST-DILATATION OF THE MIDDLE SEGMENT WAS PERFORMED USING THE STENT DELIVERY BALLOON, BUT SUBSEQUENT ANGIOGRAPHY SHOWED A SEVERE ECCENTRIC CORONARY RUPTURE. THE PHYSICIAN COMMENTED THAT THE PERFORATION DID NOT OCCUR BECAUSE OF THE STENTS, BUT BECAUSE OF THE CALCIFICATION AND FRAILTY OF THE VESSEL. THE PATIENT DID HAVE SIGNIFICANT CHEST DISCOMFORT. A 4.0 MM NON-COMPLIANT (NC) BALLOON WAS INFLATED ACROSS THE LESION FOR TAMPONADE PURPOSES WITH SIGNIFICANT IMPROVEMENT AFTER SEVERAL INFLATIONS. AN EMERGENT ECHOCARDIOGRAM REVEALED A MODERATE CONCENTRIC PERICARDIAL EFFUSION WITH TAMPONADE FEATURES, ACCOMPANIED BY HYPOTENSION AND REQUIREMENT OF MEDICATION. THEREFORE, A 3.5 X 19 MM GRAFTMASTER WAS USED TO COVER THE PERFORATION SUCCESSFULLY. POST-DILATATION WAS PERFORMED WITH A 4.0 MM NC BALLOON. ANGIOGRAPHY SHOWED A SEAL OF THE PERFORATION.

  Patient problems: Angina; Cardiac Tamponade; Low Blood Pressure/ Hypotension; Perforation

  MAUDE report 7144633 ↗
• DeathDec 5, 2017Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE INDEX PROCEDURE TOOK PLACE ON (B)(6) 2017 DURING WHICH A 4.0 X 12 MM XIENCE ALPINE STENT WAS IMPLANTED FOR TREATMENT OF AN UNSPECIFIED VESSEL. THE PATIENT WAS READMITTED TO THE HOSPITAL ON (B)(6) 2017 FOR SEPSIS AND OTHER UNSPECIFIED CARDIAC VASCULAR SYMPTOMS. UNSPECIFIED TREATMENT WAS ADMINISTERED TO THE PATIENT. FINAL PATIENT OUTCOME IS DEATH. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Death; Sepsis

  MAUDE report 7082665 ↗
• InjuryNov 30, 2017Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2017 THE 4.0 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 PRECORDIAL PAIN (ANGINA) AND OTHER CARDIOVASCULAR (CV) SYMPTOMS. UNSPECIFIED TREATMENT WAS ADMINISTERED AND THE FINAL PATIENT OUTCOME IS REPORTEDLY UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina

  MAUDE report 7070931 ↗
• MalfunctionNov 15, 2017Device Dislodged or Dislocated

  IT WAS REPORTED THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN A RIGHT CORONARY GRAFT. A 4.0 X 12 MM XIENCE ALPINE STENT DELIVERY SYSTEM (SDS) WAS ADVANCED WITHOUT RESISTANCE, BUT THE STENT DISLODGED IN THE GUIDELINER. THE DEVICES WERE WITHDRAWN AS ONE UNIT FROM THE PATIENT ANATOMY AND THE DISLODGED STENT WAS RETRIEVED FROM THE GUIDELINER. ANOTHER 4.0 X 12 MM XIENCE ALPINE WAS ADVANCED WITHOUT RESISTANCE, BUT IT WAS NOTED THAT THE STENT STRUTS BECAME FLARED. THE XIENCE ALPINE WAS WITHDRAWN FROM THE PATIENT ANATOMY WITH NO ISSUES. THE DECISION WAS MADE NOT TO CONTINUE AND THE PROCEDURE WAS ABANDONED. THE PATIENT WAS RELEASED ON MEDICAL MANAGEMENT. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7034238 ↗
• InjuryOct 9, 2017Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE LEFT MAIN ARTERY. A 4.0 X 12 MM XIENCE ALPINE STENT WAS ADVANCED TO THE LEFT MAIN; HOWEVER, THE PHYSICIAN MISJUDGED THE PLACEMENT AND DEPLOYED THE STENT IN THE AORTA. THE STENT WAS REMOVED WITH A SNARE DEVICE AND A 4.0 X 08 MM XIENCE ALPINE STENT WAS SUCCESSFULLY DEPLOYED TO COMPLETE THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6932303 ↗
• MalfunctionAug 8, 2017Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE XIENCE ALPINE STENT DELIVERY SYSTEM (SDS) WAS POSITIONED AT THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY (LAD) LESION WHEN THE STENT IMPLANT WAS NOTED TO BE MISSING. THE PATIENT ANATOMY WAS CHECKED USING FLUOROSCOPY AND THE STENT WAS NOT LOCATED IN THE ANATOMY. THE SDS AND THE NON-ABBOTT GUIDE CATHETER WERE REMOVED FROM THE ANATOMY. A DIFFERENT NON-ABBOTT GUIDE CATHETER WAS USED AND A DIFFERENT STENT WAS DEPLOYED IN THE VESSEL WITHOUT ISSUE. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA OR A CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6774605 ↗
• InjuryMay 23, 2017Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE INDEX PROCEDURE TOOK PLACE ON (B)(6) 2017 DURING WHICH A 4.0 X 12 MM XIENCE ALPINE WAS IMPLANTED FOR TREATMENT OF AN UNSPECIFIED VESSEL. THE PATIENT WAS READMITTED TO THE HOSPITAL ON (B)(6) 2017 FOR GASTROINTESTINAL BLEEDING AND OTHER UNSPECIFIED CARDIOVASCULAR SYMPTOMS. UNSPECIFIED TREATMENT WAS ADMINISTERED TO THE PATIENT. FINAL PATIENT OUTCOME IS REPORTEDLY UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 6586592 ↗
• InjuryMar 24, 2017Difficult or Delayed Positioning

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A PROXIMAL CIRCUMFLEX ARTERY INTO THE FIRST MARGINAL. THE PATIENT CAME IN TO THE HOSPITAL ON (B)(6) 2017 FOR A ROUTINE CHECK-UP. OPTICAL COHERENCE TOMOGRAPHY (OCT) WAS USED THROUGHOUT THE PROCEDURE. THE VESSEL WAS DETERMINED TO BE GREATER THAN 2.5 MM. A ROTOBLADER WAS USED AND MULTIPLE UNSPECIFIED BALLOONS WERE USED FOR PRE-DILATATION. THE RESIDUAL STENOSIS WAS REDUCED TO LESS THAN 40%. A 3.5 X 23 MM ABSORB SCAFFOLD WAS IMPLANTED; HOWEVER, THE CENTER OF THE SCAFFOLD RECOILED, SO A 4.0 X 12 MM XIENCE ALPINE STENT WAS DEPLOYED OVER THE SCAFFOLD FOR A BAIL-OUT AND IT ALSO RECOILED. POST-DILATATION WAS PERFORMED WITH A NC TREK BALLOON CATHETER. THE FINAL ANGIOGRAPHIC RESIDUAL STENOSIS WAS 40-50%. OCT CONFIRMED THAT THE SCAFFOLD AND STENT WERE FULLY APPOSED TO THE VESSEL WALL. ON (B)(6) 2017, THE PATIENT RETURNED WITH CHEST DISCOMFORT AND THROMBOSIS WAS OBSERVED IN BOTH THE SCAFFOLD AND THE STENT AND INTO THE MARGINAL ARTERY. BALLOON ANGIOPLASTY WAS PERFORMED TO REGAIN FLOW TO THE ARTERIES. THE PATIENT HAD BEEN ON PLAVIX AND ASPIRIN AND THE DUAL ANTIPLATELET THERAPY (DAPT) MEDICATION WAS CHANGED TO BRILINTA. THE PATIENT IS STABLE. NO ADDIT

  Patient problems: Angina; Thrombosis

  MAUDE report 6432188 ↗
• InjurySep 27, 2016Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A 4.0 X 12 MM AND A 4.0 X 38 MM XIENCE ALPINE STENTS WERE IMPLANTED ON (B)(6) 2016. ON (B)(6) 2016, THE PATIENT WAS RE-ADMITTED WITH OTHER CARDIOVASCULAR SYMPTOMS AND CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD). IT IS UNKNOWN WHAT TREATMENT WAS PERFORMED. THE PATIENT WAS DISCHARGED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 5980390 ↗