XIENCE ALPINE 1125225-15Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 08717648199073), received between Sep 16, 2016 and Apr 13, 2021 — classified as 17 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (6 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 18, 2026.

Most reported problems

Recent adverse event reports

The 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• InjuryApr 13, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2017, THE PATIENT PRESENTED WITH CHEST PAIN AFTER A RECENT ANTERIOR ST ELEVATION MYOCARDIAL INFARCTION (MI). THE PATIENT WAS REFERRED FOR PERCUTANEOUS CORONARY INTERVENTION (PCI) OF A CIRCUMFLEX (CX) LESION WHERE THERE WAS 90% STENOSIS. A NON-ABBOTT GUIDE CATHETER AND A NON-ABBOTT GUIDE WIRE WERE ADVANCED TO THE TARGET LESION. ANGIOPLASTY WAS PERFORMED USING AN UNSPECIFIED 2.0 MM DILATATION CATHETER. THE 2.25 X 15 MM XIENCE ALPINE STENT WAS THEN IMPLANTED. DUE TO THE PATIENT ANATOMY, A WAIST WAS NOTED. MULTIPLE ATTEMPTS WERE MADE TO ADVANCE A POST-DILATATION CATHETER, INCLUDING USE OF A BUDDY WIRE AND A GUIDE CATHETER EXTENSION FOR SUPPORT AND DOWNSIZING BALLOONS. ALL ATTEMPTS WERE UNSUCCESSFUL AND THE PROCEDURE ENDED WITH TIMI III FLOW AND 50% REMAINING RESIDUAL STENOSIS. THE PLAN WAS TO KEEP THE PATIENT ON ASPIRIN AND PRASUGREL, AND PERFORM ROTATIONAL ATHERECTOMY IN TWO MONTHS TO IMPROVE EXPANSION. A SECOND PROCEDURE WAS PERFORMED ON (B)(6) 2017 AS THE PATIENT WAS EXPERIENCING CHEST PAIN. A NON-ABBOTT GUIDE CATHETER WAS ADVANCED, BUT WAS EXCHANGED FOR ANOTHER NON-ABBOTT GUIDE CATHETER DUE TO LOSS OF POSITION. THE DISTAL CX WAS NOTED TO BE TOTALLY OC

  Patient problems: Thrombosis/Thrombus

  MAUDE report 11661977 ↗
• InjuryOct 11, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2017, THREE XIENCE ALPINE STENTS WERE IMPLANTED IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY AND DIAGONAL BIFURCATION LESIONS. ON (B)(6) 2019, THE PATIENT PRESENTED, SYMPTOMATIC, AND WAS DIAGNOSED WITH ST-ELEVATION MYOCARDIAL INFARCTION (STEMI). ANGIOGRAPHY REVEALED THROMBOSIS IN ALL 3 STENTS. BALLOON ANGIOPLASTY WAS PERFORMED TO TREAT THE THROMBOSIS AND FLOW WAS RESTORED. NO ADDITIONAL TREATMENT WAS PERFORMED, AND THE PATIENT HAD A GOOD OUTCOME. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina; Myocardial Infarction; Thrombosis

  MAUDE report 9182927 ↗
• InjuryJun 11, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT ON (B)(6) 2018 ONE 2.25X15 MM XIENCE ALPINE STENT WAS IMPLANTED IN THE PROXIMAL LEFT ANTERIOR DESCENDING CORONARY ARTERY AND ONE 3.0X18 MM XIENCE ALPINE STENT WAS IMPLANTED IN THE DISTAL LEFT CIRCUMFLEX CORONARY ARTERY. THE PATIENT WAS COMPLIANT WITH THE DUAL ANTIPLATELET THERAPY, BUT CLOPIDOGREL WAS DISCONTINUED BY THE PHYSICIAN AT THE 3 MONTH ASSESSMENT. ON (B)(6) 2018 THE PATIENT HAD ANGINA THAT LASTED A DAY AND A HALF. THIS WAS DIAGNOSED AS A NON ST ELEVATION MYOCARDIAL INFARCTION. LONG ACTING NITRATES WERE ADMINISTERED AND BRILINTA WAS PRESCRIBED. THE CONDITION RESOLVED ON (B)(6) 2018. THE PHYSICIAN SUSPECTED THAT THE MYOCARDIAL INFARCTION MAY BE RELATED TO AN UNKNOWN DEVICE DEFICIENCY OF THE XIENCE ALPINE STENTS. A CORONARY ANGIOGRAM WAS NOT PERFORMED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina; Myocardial Infarction

  MAUDE report 8689130 ↗
• MalfunctionOct 2, 2018Leak/Splash; Failure to Advance; Material Split, Cut or Torn; Leak/Splash; Failure to Advance; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE MID LEFT ANTERIOR DESCENDING CORONARY ARTERY WITH MILD TORTUOSITY AND HEAVY CALCIFICATION. A 2.25X15 MM XIENCE ALPINE STENT DELIVERY SYSTEM (SDS) WAS ADVANCED, BUT FAILED TO CROSS THE LESION DUE TO THE ANATOMY. THE BALLOON WAS NOT INFLATED; HOWEVER, BLOOD WAS NOTED TO BE COMING OUT OF A LITTLE HOLE IN THE PROXIMAL SHAFT OF THE SDS. DUE TO THE HEAVY CALCIFICATION, THE PROCEDURE WAS COMPLETED WITH BALLOON ANGIOPLASTY USING AN UNSPECIFIED BALLOON DILATATION CATHETER. THERE WAS NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7926778 ↗
• InjuryJun 5, 2018Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE 2.25X15MM AND 3.25X08MM XIENCE ALPINE STENTS WERE IMPLANTED ON (B)(6) 2018. THE PATIENT PRESENTED WITH A NON ST-ELEVATION MYOCARDIAL INFARCTION (NSTEMI) BEFORE THE PROCEDURE. ON (B)(6) 2018, THE PATIENT WAS READMITTED WITH CARDIOVASCULAR SYMPTOMS, INCLUDING CHEST PAIN. THE TREATMENT PERFORMED IS UNKNOWN AND THE FINAL PATIENT OUTCOME IS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina

  MAUDE report 7569294 ↗
• InjuryMay 24, 2018Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 2.25 X 15MM XIENCE ALPINE AND A 2.50 X 28MM XIENCE ALPINE STENTS WERE IMPLANTED ON (B)(6) 2018. THE PATIENT PRESENTED WITH NON-ST-ELEVATION MYOCARDIAL INFARCTION (NSTEMI) BEFORE THE PROCEDURE. ON (B)(6) 2018, THE PATIENT WAS READMITTED WITH CARDIOVASCULAR SYMPTOMS AND ACUTE KIDNEY FAILURE. TREATMENT PERFORMED WAS UNSPECIFIED AND THE FINAL PATIENT OUTCOME IS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available; Renal Failure

  MAUDE report 7542839 ↗
• InjuryApr 11, 2018Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION WITH HEAVY TORTUOSITY AND HEAVY CALCIFICATION IN THE OBTUSE MARGINAL CORONARY ARTERY AFTER THE PATIENT HAD REFUSED TO HAVE CORONARY ARTERY BYPASS (CABG) SURGERY. A 2.25 X 15 MM XIENCE ALPINE STENT DELIVERY SYSTEM (SDS) WAS ADVANCED IN THE VESSEL, BUT MET RESISTANCE DUE TO THE CIRCUMFLEX HAVING AN ACUTE ANGULATION AND BEING VERY TORTUOUS. WHEN THE SDS WAS WITHDRAWN FROM THE PATIENT ANATOMY, IT WAS NOTED THE STENT HAD DISLODGED IN A CALCIUM BED IN THE VESSEL. A SNARE DEVICE WAS USED TO RETRIEVE THE DISLODGED STENT BUT WAS UNSUCCESSFUL. A 3.5 X 15 MM XIENCE ALPINE STENT WAS DEPLOYED CRUSHING THE DISLODGED STENT AGAINST THE CALCIFIED ARTERY WALL. THEREFORE, THE PROCEDURE WAS ABORTED AS THE PATIENT HAD SEVERE CORONARY ARTERY DISEASE AND HAD REFUSED CABG. THE PATIENT WILL CONTINUE WITH MEDICAL MANAGEMENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Vessel Or Plaque, Device Embedded In

  MAUDE report 7422555 ↗
• InjuryFeb 9, 2018Improper or Incorrect Procedure or Method; Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED LESION IN THE DIAGONAL. THE 2.25X15MM RX XIENCE ALPINE STENT DELIVERY SYSTEM (SDS) WAS ADVANCED THROUGH PREVIOUSLY DEPLOYED STENTS IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY TO THE DIAGONAL, BUT WAS UNABLE TO CROSS DUE TO THE ANATOMY. THE SDS WAS RETRACTED; HOWEVER, IT WAS NOTED THAT THE STENT WAS NOT ON THE BALLOON. THE DISLODGED STENT WAS FOUND INSIDE ONE OF THE PREVIOUSLY PLACED STENTS IN THE LAD. THE ALPINE SDS WAS RE-ADVANCED AND INFLATED TO 20 ATMOSPHERES (ATM) AND ABLE TO DEPLOY THE DISLODGED STENT INSIDE OF THE PREVIOUSLY PLACED STENT. A 3.0X15MM NC BALLOON WAS INFLATED TO NOMINAL PRESSURE TO POST-DILATE THE STENT. ANOTHER 2.25X15MM ALPINE STENT WAS SUCCESSFULLY DEPLOYED IN THE TARGET DIAGONAL LESION. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 7260399 ↗
• InjuryDec 6, 2017Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 2.25 X 15 MM AND 3.0 X 15 MM XIENCE ALPINE STENTS WERE IMPLANTED ON (B)(6) 2017. ON (B)(6) 2017, THE PATIENT WAS RE-ADMITTED WITH CARDIOVASCULAR SYMPTOMS INCLUDING ATHEROSCLEROSIS HEART DISEASE AND UNSTABLE ANGINA. 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: Angina

  MAUDE report 7088740 ↗
• MalfunctionDec 1, 2017Crack; Leak/Splash

  IT WAS REPORTED THAT A 2.25X15MM XIENCE ALPINE STENT DELIVERY SYSTEM (SDS) WAS PREPARED PER THE INSTRUCTIONS FOR USE; HOWEVER, WHEN IT WAS ATTACHED TO THE INDEFLATOR IT WAS NOTICED THAT THE HUB WAS CRACKED AND IT LEAKED. THE SDS WAS NOT USED AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A NEW 2.25X15MM XIENCE ALPINE SDS. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 7076952 ↗
• InjuryOct 7, 2017Difficult to Remove

  IT WAS REPORTED THAT THE XIENCE ALPINE STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TO THE VERY TORTUOUS PROXIMAL LEFT ANTERIOR DESCENDING CORONARY ARTERY. THE DEVICE WAS UNABLE TO CROSS THE LESION DUE TO ANATOMY. DURING DEVICE REMOVAL, RESISTANCE WAS NOTED AT THE GUIDE CATHETER AND THE STENT DISLODGED FROM THE BALLOON. ANOTHER DILATATION CATHETER WAS PLACED DISTAL TO THE STENT AND USED TO RETRIEVE THE DISLODGED STENT AT THE GUIDE CATHETER LOCATION. THERE WERE NO ADVERSE PATIENT EFFECTS AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY. THERE WAS NO ADDITIONAL INFORMATION PROVIDED REGARDING THIS ISSUE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6926533 ↗
• InjuryJul 14, 2017Difficult to Remove; Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 99% STENOSED, HEAVILY CALCIFIED, AND HEAVILY TORTUOUS SEVERELY ANGULATED LESION IN THE CIRCUMFLEX ARTERY. THE PATIENT HAD SUCCESSFULLY INTERVENTION WITH AN UNKNOWN STENT ON (B)(6) 2017. THE PATIENT FELT ANGINA ON (B)(6) 2017 AND WAS SENT TO THE CATH LAB. FOLLOWING PRE-DILATATION WITH MULTIPLE BALLOON CATHETERS, A 2.25X15MM XIENCE ALPINE STENT DELIVERY SYSTEM (SDS) WAS ADVANCED. HOWEVER, RESISTANCE WITH THE ANGULAR PORTION OF THE ARTERY WAS FELT AND THE DEVICE COULD NOT COMPLETELY REACH THE LESION. AN ATTEMPT TO REMOVE THE SDS WAS MADE, BUT A TUG WAS FELT. THE SDS WAS REMOVED AND IT WAS NOTICED THAT THE STENT WAS MISSING. REIMAGING WAS PERFORMED AND IT WAS THOUGHT THAT THE STENT WAS CAUGHT BETWEEN THE LEFT ANTERIOR DESCENDING ARTERY AND THE CIRCUMFLEX ARTERY. A SMALL SIZE BALLOON CATHETER WAS ADVANCED IN AN ATTEMPT TO DEPLOY THE STENT; HOWEVER, THE STENT WAS CRIMPED AND THE BALLOON COULD NOT BE PLACED IN THE STENT. AN ATTEMPT TO SNARE THE STENT WAS MADE, BUT FAILED. THE PATIENT WAS SENT TO ANOTHER CATH LAB AND THE STENT WAS SUCCESSFULLY RETRIEVED WITH A SNARE. THE PATIENT WAS TREATED WITH ADDITIONAL STENTS AND IS DOING FINE. NO ADDIT

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6715166 ↗
• MalfunctionApr 24, 2017Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING PREPARATION OF THE 2.25 X 15 MM XIENCE ALPINE STENT DELIVERY SYSTEM IT WAS OBSERVED THAT THE STENT HAD DISLODGED FROM THE BALLOON. THERE WAS NO RESISTANCE FELT DURING REMOVAL OF THE PROTECTIVE SHEATH FROM THE BALLOON AND STENT. THE DEVICE COULD NOT BE USED ON THE PATIENT. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 6517425 ↗
• InjuryApr 18, 2017Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2016, A 2.25X15 RX XIENCE ALPINE, A 2.25X18 RX XIENCE ALPINE, AND A 3.0X12 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 CARDIOVASCULAR SYMPTOMS, INCLUDING CHEST PAIN. UNSPECIFIED TREATMENT WAS ADMINISTERED AND THE FINAL PATIENT OUTCOME IS REPORTEDLY UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina

  MAUDE report 6501485 ↗
• MalfunctionMar 29, 2017Difficult to Remove; Failure to Advance; Material Deformation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN ECCENTRIC DE NOVO LESION IN THE DISTAL CIRCUMFLEX (CX) ARTERY WITH HEAVY TORTUOSITY AND HEAVY CALCIFICATION THAT WAS 90% STENOSED. PRE-DILATATION WAS PERFORMED USING AN UNKNOWN BALLOON DILATATION CATHETER. RESISTANCE WAS FELT DURING ADVANCEMENT OF THE 2.25 X 15 MM XIENCE ALPINE RX STENT DELIVERY SYSTEM (SDS) TO THE LESION AND WOULD NOT CROSS IT. DURING REMOVAL OF THE SDS, THE PROXIMAL EDGE OF THE STENT IMPLANT BECAME STUCK WITH THE DISTAL EDGE OF THE GUIDING CATHETER CAUSING THE STENT TO FLARE. A NEW SDS WAS USED TO COMPLETE THE PROCEDURE. 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 6443560 ↗
• MalfunctionFeb 15, 2017Difficult to Remove; Failure to Advance; Material Deformation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE LEFT MAIN ARTERY. THE 2.25X15 MM XIENCE ALPINE STENT DELIVERY SYSTEM (SDS) FAILED TO CROSS THE TARGET LESION DUE TO THE PATIENT ANATOMY. DURING REMOVAL OF THE SDS, RESISTANCE WAS FELT WITH THE ANATOMY. THE XIENCE ALPINE SDS WAS ABLE TO BE REMOVED AND IT WAS NOTED THAT THE DISTAL STENT STRUTS WERE FLARED. THE PROCEDURE WAS COMPLETED WITH A SAME SIZE XIENCE ALPINE SDS. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6332669 ↗
• MalfunctionFeb 7, 2017Device Dislodged or Dislocated

  IT WAS REPORTED THAT A 2.25 X 15 MM XIENCE ALPINE STENT DELIVERY SYSTEM (SDS) WAS SELECTED FOR THE PROCEDURE. DURING REMOVAL OF THE PROTECTIVE SHEATH WITH NO RESISTANCE FELT, THE STENT IMPLANT BECAME DISLODGED FROM THE SDS INTO THE PROTECTIVE SHEATH. THE SDS WAS NOT USED IN THE PROCEDURE. 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 6309153 ↗
• InjuryDec 30, 2016Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 3.25 X 18 MM XIENCE ALPINE STENT WAS IMPLANTED ON (B)(6) 2016. ON (B)(6) 2016 THE PATIENT WAS RE-ADMITTED WITH CHEST PAIN AND OTHER UNSPECIFIED CARDIOVASCULAR SYMPTOMS. IT IS UNKNOWN WHAT TREATMENT WAS PERFORMED OR WHAT THE FINAL PATIENT OUTCOME WAS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina

  MAUDE report 6216662 ↗
• InjuryDec 21, 2016Device Dislodged or Dislocated

  SUS VOLUNTARY EVENT REPORT RECEIVED STATES: XIENCE ALPINE EVEROLIMUS ELUTING CORONARY STENT SYSTEM 2.25MM X 15 MM 2.5, REF# (B)(4) MANUFACTURED BY ABBOTT. THE DEVICE WAS BEING USED DURING A PROCEDURE. THE STENT FELL OFF THE DEVICE WITHOUT THE STENT DEPLOYING PROPERLY. UNDEPLOYED STENT COULD NOT BE REMOVED SAFELY AND HAD TO BE PUSHED AGAINST THE CORONARY ARTERY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Vessel Or Plaque, Device Embedded In

  MAUDE report 6195558 ↗
• InjuryNov 1, 2016Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH ANGINA AND THAT THE PROCEDURE WAS TO TREAT A CONCENTRIC LESION IN THE NON-TORTUOUS, MODERATELY CALCIFIED 90% STENOSED PROXIMAL LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY AND A LESION IN THE NON-TORTUOUS, MODERATELY CALCIFIED 90% STENOSED MID LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY. A 2.25 X 15 MM XIENCE ALPINE STENT DELIVERY SYSTEM (SDS) WAS SELECTED TO TREAT THE LESION IN THE MID LAD. THE XIENCE ALPINE SDS WAS ADVANCED THROUGH THE LESION IN THE PROXIMAL LAD TO THE LESION IN THE MID LAD AND WAS DEPLOYED AT 10 ATMOSPHERES WITH NO ISSUES NOTED. INTRAVASCULAR ULTRASOUND (IVUS) WAS PERFORMED WHICH CONFIRMED THAT THE STENT IMPLANT WAS WELL APPOSED TO THE VESSEL WALL. THEREFORE, NO POST DILATATION WAS PERFORMED. A NON-ABBOTT STENT IMPLANT WAS SUCCESSFULLY IMPLANTED IN THE LESION IN THE PROXIMAL LAD SO THAT IT OVERLAPPED THE XIENCE ALPINE STENT IMPLANT AND TWO POST DILATATIONS WERE PERFORMED WITH AN UNSPECIFIED BALLOON DILATATION CATHETER. A POST-PROCEDURAL IVUS WAS PERFORMED AND THE STENTS WERE CONFIRMED TO BE WELL APPOSED TO THE VESSEL WALL. THERE WAS NO THROMBOSIS PRESENT PRIOR TO THE PROCEDURE. SIX DAYS POST PROCEDURE, PRIOR T

  Patient problems: Angina; Heart Failure; Thrombosis

  MAUDE report 6070607 ↗
• InjuryOct 4, 2016Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 2.25 X 15 MM AND A 2.5 X 23 MM XIENCE ALPINE STENT WERE IMPLANTED ON (B)(6) 2015. ON (B)(6) 2015 THE PATIENT WAS RE-ADMITTED WITH CHEST PAIN. IT IS UNKNOWN WHAT TREATMENT WAS PERFORMED. THE PATIENT WAS DISCHARGED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina

  MAUDE report 5996981 ↗
• InjurySep 16, 2016Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 2.25X15MM XIENCE ALPINE STENT WAS IMPLANTED ON (B)(6) 2016. ON (B)(6) 2016 THE PATIENT WAS RE-ADMITTED WITH CARDIOVASCULAR SYMPTOMS AND CONGESTIVE HEART FAILURE. IT IS UNKNOWN WHAT TREATMENT WAS PERFORMED. THE PATIENT WAS DISCHARGED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Heart Failure

  MAUDE report 5958284 ↗
• InjurySep 16, 2016Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT 2.25X15MM AND 2.75X18MM XIENCE ALPINE STENTS WERE IMPLANTED ON (B)(6) 2016. ON (B)(6) 2016 THE PATIENT WAS RE-ADMITTED WITH CARDIOVASCULAR SYMPTOMS AND THE FLU. IT IS UNKNOWN WHAT TREATMENT WAS PERFORMED. THE PATIENT WAS DISCHARGED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 5958169 ↗