XIENCE ALPINE 1125400-23Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 08717648199639), received between Aug 3, 2016 and Nov 30, 2017 — classified as 6 injuries, 1 malfunction.

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.

• InjuryNov 30, 2017Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE PATIENT PRESENTED EMERGENTLY WITH A NON-ST-ELEVATION MYOCARDIAL INFARCTION WHERE THEY WERE TAKEN TO THE CATH LAB AND PRE-DILATED, AND A XIENCE ALPINE 4 X 23 MM STENT WAS DEPLOYED IN THE MID-RIGHT CORONARY ARTERY. DURING THIS INITIAL PROCEDURE, THE PATIENT WAS GIVEN ANGIOMAX. AFTER THE STENT WAS IMPLANTED THERE WAS NO POST-DILATATION OR IMAGING PERFORMED. THIRTY MINUTES POST-PROCEDURE, THE PATIENT CODED AND CARDIOPULMONARY RESUSCITATION WAS SUCCESSFULLY ADMINISTERED. THE PATIENT THEN RETURNED TO THE CATH LAB WHERE IT WAS DISCOVERED VIA ANGIOGRAPHY THAT THE STENT HAD THROMBOSED. THE PATIENT WAS ASPIRATED AND POST-DILATATION WAS PERFORMED WITH A HIGH PRESSURE, NON-COMPLIANT BALLOON. THE PATIENT WAS GIVEN HEPARIN AND INTEGRILIN AND WAS DOING WELL POST-PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Myocardial Infarction; Thrombus

  MAUDE report 7073387 ↗
• MalfunctionSep 14, 2017Device Dislodged or Dislocated

  IT WAS REPORTED THAT WHEN THE STYLET AND PROTECTIVE SHEATH WERE BEING REMOVED FROM THE STENT DELIVERY SYSTEM, WITHOUT RESISTANCE, THE STENT IMPLANT DISLODGED WITH THE SHEATH. THERE WAS NO PATIENT INVOLVEMENT. THE DEVICE WAS NOT USED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 6867509 ↗
• InjuryApr 24, 2017Device Damaged by Another Device; Material Deformation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED RIGHT CORONARY ARTERY (RCA). A 4.0 X 38 MM XIENCE ALPINE STENT DELIVERY SYSTEM WAS BEING ADVANCED; HOWEVER, THE DEVICE COULD NOT CROSS THE LESION DUE TO THE ANATOMY. A 4.0 X 15 MM XIENCE ALPINE STENT WAS DEPLOYED IN THE DISTAL RCA. A 4.0 X 23 MM XIENCE ALPINE STENT WAS DEPLOYED IN THE MID RCA, OVERLAPPING THE DISTAL STENT. A 4.0 X 15 MM XIENCE ALPINE STENT WAS DEPLOYED IN THE PROXIMAL RCA, OVERLAPPING THE MIDDLE STENT. THERE WERE NO ISSUES DURING DEPLOYMENT; HOWEVER, WHEN ATTEMPTING TO REMOVE THE NON-ABBOTT GUIDE WIRE, THE WIRE WAS STUCK IN THE STENTS AND COULD NOT BE REMOVED. SEVERAL ATTEMPTS WERE MADE TO REMOVE THE GUIDE WIRE WITH BALLOON CATHETERS, BUT IT COULD NOT BE REMOVED. FORCE WAS APPLIED TO TRY TO REMOVE THE GUIDE WIRE, BUT IT STARTED CRUMPLING THE PROXIMAL AND MIDDLE STENTS. THE PHYSICIAN PULLED HARD ON THE GUIDE WIRE AND IT SEPARATED LEAVING APPROXIMATELY 2 CM OF THE GUIDE WIRE IN THE RCA AND STICKING OUT OF THE OSTIUM. THE PATIENT HAD ST ELEVATION AND ANGIOGRAPHY CONFIRMED THROMBOSIS IN THE ENTIRE LENGTH OF THE RCA. THE PATIENT WAS PREPPED AND SENT FOR BYPASS SURGERY. THERE WAS A CLINICALLY

  Patient problems: Non specific EKG/ECG Changes; Thrombosis

  MAUDE report 6517120 ↗
• InjuryMar 14, 2017Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 70% STENOSED MID LEFT ANTERIOR DESCENDING ARTERY. ROTATIONAL ATHERECTOMY WAS PERFORMED WITH A 1.75 BURR. A 3.75 X 15 MM NC TREK BALLOON CATHETER WAS INFLATED TO 18 ATMOSPHERES FOR PRE-DILATATION. A 4.0 X 23 MM XIENCE ALPINE STENT WAS DEPLOYED AT 12 ATMOSPHERES. POST-DILATATION WAS PERFORMED WITH A 4.5 X 12 MM NC TREK BALLOON CATHETER TO 14 ATMOSPHERES WHEN A PERFORATION OCCURRED IN THE MIDDLE OF THE STENT. THE PATIENT HAD BEEN HAVING CHEST PAIN SINCE THE USE OF THE ATHERECTOMY CATHETER; HOWEVER, THE PAIN INCREASED AFTER THE PERFORATION. THE 4.5 X 12 MM NC TREK BALLOON WAS ADVANCED AGAIN AND INFLATED TO A LOW PRESSURE TWO TIMES FOR A MINUTE EACH TIME WHICH SEALED THE LEAK. A 3.5 X 19 MM GRAFTMASTER COVERED STENT WAS IMPLANTED INSIDE THE STENT TO PREVENT FUTURE RE-OPENING. THE GRAFTMASTER WAS POST-DILATED WITH A 3.75 X 12 MM NC TREK TO 12 ATMOSPHERES AND A 4.4 X 12 MM NC TREK TO 8 ATMOSPHERES TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina; Perforation

  MAUDE report 6402638 ↗
• InjuryMar 2, 2017Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY WITH MILD TORTUOSITY AND MILD CALCIFICATION. THE 4.0 X 23 MM XIENCE ALPINE RX STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TO THE LESION, BUT WOULD NOT CROSS IT. THE STENT IMPLANT BECAME DISLODGED AND TRAVELED INTO THE DIAGONAL BRANCH. A NEW WHISPER GUIDE WIRE AND A BALLOON DILATATION CATHETER WERE USED TO DEPLOY THE DISLODGED STENT IN THE DIAGONAL BRANCH. AN UNKNOWN SDS WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. IT WAS REPORTED THAT THE TIMI 3 FLOW WAS ESTABLISHED FOR ALL OF THE VESSELS. THERE WERE NO ADVERSE PATIENT EFFECTS OR CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 6374969 ↗
• InjurySep 16, 2016Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 4.00X23MM AND 4.00X08MM XIENCE ALPINE STENTS WERE IMPLANTED ON (B)(6) 2016. ON (B)(6) 2016 THE PATIENT WAS RE-ADMITTED WITH CARDIOVASCULAR SYMPTOMS AND CHEST PAIN. IT IS UNKNOWN WHAT TREATMENT WAS PERFORMED. THE PATIENT WAS DISCHARGED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina

  MAUDE report 5958330 ↗
• InjuryAug 3, 2016Detachment Of Device Component; Deflation Problem; Inflation Problem; Difficult to Remove; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN UNSPECIFIED LESION IN A DISTAL RIGHT CORONARY VEIN GRAFT. A 4X23MM XIENCE ALPINE RX STENT DELIVERY SYSTEM (SDS) STYLET/PROTECTIVE SHEATH WAS REMOVED WITHOUT RESISTANCE. AIR ASPIRATION WAS PERFORMED OUTSIDE THE ANATOMY PRIOR TO USE. AFTER PRE-DILATING WITH AN UNSPECIFIED BALLOON, THE SDS WAS ADVANCED WITHOUT RESISTANCE TOWARD THE TARGET LESION, THE SYSTEM WAS INFLATED ONCE UP TO 12 ATMOSPHERES AND THE STENT WAS IMPLANTED. AN ATTEMPT WAS MADE TO DEFLATE THE BALLOON BY APPLYING NEGATIVE PRESSURE FOR 10-20 SECONDS; HOWEVER, THE BALLOON COMPLETELY FAILED TO DEFLATE. AN ATTEMPT WAS MADE TO WITHDRAW THE SDS AND RESISTANCE WAS NOTED WITH THE GUIDE CATHETER. THE SDS WAS ABLE TO ADVANCE FORWARD BUT WAS NOT ABLE TO RETRACT AFTER DEPLOYMENT. THE GUIDE WIRE WAS ABLE TO MOVE FREELY. THE SDS WAS PULLED HARD BACK AND THE SHAFT SEPARATED NEAR THE GUIDE WIRE PORT. AN ATTEMPT WAS MADE TO SNARE THE SEPARATED PORTION AND THE SNARE WAS UNABLE TO PASS THROUGH TWO PREVIOUSLY IMPLANTED UNSPECIFIED STENTS. GUIDE WIRE LESION ACCESS WAS LOST AS THE GUIDE WIRE WAS ACCIDENTALLY PULLED OUT. A SECOND GUIDE WIRE WAS ADVANCED. THE SEPARATED BALLOON/DISTAL PORTION W

  Patient problems: Vessel Or Plaque, Device Embedded In

  MAUDE report 5843857 ↗