XIENCE ALPINE 1125400-38Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 08717648199660), received between Sep 7, 2016 and Jun 27, 2018 — classified as 4 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (4 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryJun 27, 2018Difficult to Remove; Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE HEAVILY TORTUOUS RIGHT CORONARY ARTERY. THE 4.0X38 MM XIENCE ALPINE STENT DELIVERY SYSTEM (SDS) WAS ADVANCED IN THE PATIENT ANATOMY HOWEVER THE SDS FAILED TO CROSS THE TARGET LESION DUE TO THE ANATOMY. WHEN REMOVING THE SDS, RESISTANCE WAS NOTED AND THE STENT DISLODGED IN THE ANATOMY. A SNARE DEVICE WAS USED TO REMOVE THE DISLODGED STENT. A 3.5X38 MM XIENCE ALPINE SDS WAS ATTEMPTED TO BE ADVANCED AND IT TOO FAILED TO CROSS DUE TO THE ANATOMY. THE SDS WAS REMOVED WITHOUT ISSUE AND AN UNSPECIFIED STENT WAS IMPLANTED TO COMPLETE THE PROCEDURE. THE PATIENT IS STABLE. THERE WAS CLINICALLY SIGNIFICANT DELAY DURING THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7641852 ↗
• 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 7144615 ↗
• MalfunctionAug 23, 2017Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING DEVICE UNPACKAGING WHEN REMOVING THE STYLET/MANDREL, THE STENT IMPLANT DISLODGED WITH THE 'WIRE' [STYLET]. THE DEVICE WAS NOT USED; 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 6815534 ↗
• MalfunctionJun 22, 2017Detachment Of Device Component; Difficult to Insert; Kinked; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE TIBIAL-FIBULAR TRUNK THAT WAS NON-TORTUOUS. THE XIENCE ALPINE 4 X 38 MM STENT DELIVERY SYSTEM COULD NOT BE LOADED IN THE 6FR SHEATH AND WHEN REMOVED, THE STENT SHAFT WAS KINKED. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED. DEVICE ANALYSIS ON 6/8/2017 REVEALED THE HYPOTUBE WAS SEPARATED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6662098 ↗
• MalfunctionJun 7, 2017Difficult to Remove; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING UNPACKING THE 4.0 X 38 MM XIENCE ALPINE STENT DELIVERY SYSTEM, THERE WAS RESISTANCE REMOVING THE PROTECTIVE SHEATH AND STYLET AND THE STENT IMPLANT DISLODGED. THE DEVICE WAS NOT USED. A NEW XIENCE ALPINE WAS SUCCESSFULLY USED TO COMPLETE THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE AND NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 6620778 ↗
• MalfunctionFeb 23, 2017Detachment Of Device Component; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN ARTERY IN THE TIBIAL. A 4.0 X 38 MM XIENCE ALPINE STENT DELIVERY SYSTEM WAS BEING ADVANCED OVER AN UNKNOWN GUIDE WIRE WHEN THE PROXIMAL SHAFT SEPARATED BEFORE ENTERING THE ANATOMY. IT WAS REPORTED THAT THERE WAS NO RESISTANCE ADVANCING THE CATHETER. THE DEVICE WAS EASILY REMOVED FROM THE GUIDE WIRE. A PERIPHERAL STENT DELIVERY SYSTEM WAS SUCCESSFULLY USED TO COMPLETE THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE AND NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6355239 ↗
• MalfunctionNov 18, 2016Difficult To Position; Device Dislodged or Dislocated

  IT WAS REPORTED THAT WHILE ADVANCING IN THE HEAVILY TORTUOUS, NON-CALCIFIED DISTAL RIGHT CORONARY ARTERY (RCA), THE 4.0 X 38 MM ALPINE STENT DELIVERY SYSTEM (SDS) MET RESISTANCE WITH THE NON-ABBOTT GUIDE SUPPORT CATHETER AND BECAME DISLODGED FROM THE BALLOON ONTO THE SHAFT. THE DEVICE AND STENT WERE REMOVED WITH THE GUIDE SUPPORT CATHETER FROM THE ANATOMY. A 4.0 X 18 AND A 4.0 X 28 MM XIENCE ALPINE STENT WERE SUCCESSFULLY IMPLANTED WITHOUT REPORTED ISSUE. 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 6112981 ↗
• InjuryOct 31, 2016Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS ADMITTED EMERGENTLY WITH ACUTE MYOCARDIAL INFARCTION (MI) AND HYPOTENSION. CORONARY ANGIOGRAPHY WAS PERFORMED AND NOTED A TOTAL OCCLUSION OF THE RIGHT CORONARY ARTERY (RCA). THE VESSEL WAS OPENED WITH AN UNSPECIFIED GUIDE WIRE AND UNSPECIFIED DILATATION CATHETER. THROMBUS WAS NOTED AT THE LESION AND WAS TREATED WITH AN ASPIRATION CATHETER. PRE-DILATATION WAS PERFORMED AND THE 3.5 X 38 MM XIENCE ALPINE STENT WAS DEPLOYED AT THE TARGET LESION. A SECOND LESION WAS NOTED IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY; THIS WAS TREATED WITH IMPLANTATION OF A 3.0 X 23 MM XIENCE ALPINE. ST ELEVATION WAS NOTED AND CORONARY ANGIOGRAPHY NOTED THROMBUS IN THE 3.5 X 38 MM XIENCE ALPINE STENT IMPLANTED IN THE RCA. THE THROMBUS WAS REMOVED USING A FILTER AND AN ASPIRATION CATHETER; HOWEVER, THE THROMBUS FORMED AGAIN. THE PATIENT ONLY RECEIVED HEPARIN DURING THE PROCEDURE, AS BLEEDING WAS NOTED COMING FROM THE PATIENT'S EAR AND IT WAS THOUGHT THAT THERE WAS A POSSIBLE BRAIN BLEED. THE ACTIVATED CLOTTING TIME (ACT) WAS NOTED TO BE >300. AS THE THROMBUS KEPT RE-FORMING, A 4.0 X 38 MM XIENCE ALPINE WAS IMPLANTED WITHIN THE 3.5 X 38 MM XIENCE ALPINE; HOWEVER, THE TH

  Patient problems: Thrombosis

  MAUDE report 6068366 ↗
• InjurySep 7, 2016Difficult or Delayed Positioning; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PATIENT WAS ADMITTED (B)(6) 2016 WITH ST-ELEVATION MYOCARDIAL INFARCTION (STEMI) AND A 3.5X23MM XIENCE ALPINE STENT WAS IMPLANTED WITHOUT ISSUE IN THE DISTAL RIGHT CORONARY ARTERY. THE NEXT DAY AND WHILE THE PATIENT WAS STILL IN THE HOSPITAL THE PATIENT WAS EXPERIENCING ANGINA AND THE PHYSICIAN BROUGHT THE PATIENT BACK FOR AN ANGIOGRAPHY CHECK. ANGIOGRAPHY CONFIRMED THROMBUS IN THE 3.5X23MM ALPINE STENT AND THROMBECTOMY WAS PERFORMED. A 4X38MM XIENCE ALPINE STENT WAS INSERTED THROUGH THE 3.5X23MM ALPINE STENT TO TREAT THE THROMBOSIS AND DUE TO THE LENGTH OF THE LESION. IT WAS NOTED THAT BOTH STENTS WERE NOT FULLY APPOSED TO THE VESSEL WALL. THUS, POST-DILATATION WAS PERFORMED USING A 4.5MM BALLOON TO ENSURE APPROPRIATE WALL APPOSITION. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5933601 ↗