XIENCE ALPINE 1125300-23Recalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 08717648199363), received between Sep 23, 2016 and Apr 24, 2019 — classified as 2 deaths, 20 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (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 25 most recent of 26 reports, in the reporter's own words as published by the FDA.

• InjuryApr 24, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 3.00 X 23 MM XIENCE ALPINE STENT WAS IMPLANTED ON (B)(6) 2017. AFTER AN UNKNOWN PERIOD OF TIME, THE PATIENT PRESENTED TO AN ALLERGY CLINIC WITH POSSIBLE SYMPTOMS OF AN ALLERGIC REACTION/ RASH. IT IS NOT KNOWN IF THE ALLERGIC REACTION/ RASH IS RELATED TO THE IMPLANTED STENT. NO TREATMENT OR INTERVENTION HAS BEEN PERFORMED AT THIS TIME. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 8546598 ↗
• InjuryMar 18, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2018, A XIENCE ALPINE STENT WAS IMPLANTED IN THE RIGHT CORONARY ARTERY (RCA) WITHOUT A DEVICE ISSUE NOTED. SINCE IMPLANTATION, THE PATIENT HAS HAD AN ALLERGIC REACTION OF HIVES AND A RASH WITH BOILS ALL OVER HIS BODY. HE HAS TRIED TREATMENT WITH MEDICATION AND HAS ALREADY FOLLOWED UP WITH HIS PHYSICIANS BUT NOTHING HAS HELPED. HE HAS ANOTHER APPOINTMENT TO TALK WITH THE PHYSICIAN ABOUT THIS ISSUE. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THIS ISSUE.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 8430429 ↗
• InjuryDec 13, 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 3.0X23MM XIENCE ALPINE AND 3.50X18MM XIENCE ALPINE STENT WERE IMPLANTED. ON (B)(6) 2018 THE PATIENT WAS RE-ADMITTED WITH ACUTE MYOCARDIAL INFARCTION (MI) AND RENAL FAILURE. THE TREATMENT PERFORMED AND PATIENT OUTCOME IS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Myocardial Infarction; Renal Failure

  MAUDE report 8161491 ↗
• DeathAug 30, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A ST ELEVATED MYOCARDIAL INFARCTION WITH CONFIRMED MULTI VESSEL DISEASE (PROXIMAL AND MID LEFT ANTERIOR DESCENDING (LAD), CIRCUMFLEX AND OBTUSE MARGINAL CORONARY ARTERIES). FOLLOWING PRE-DILATATION WITH THREE UNSPECIFIED BALLOONS, DUAL ANTI-PLATELET MEDICATION WAS GIVEN. THE ACTIVATED CLOTTING TIME (ACT) WAS NOTED TO BE OUT OF NORMAL RANGE. A 3.00X23 MM XIENCE ALPINE STENT WAS DEPLOYED IN THE MID LAD AND A 3.25X23 MM XIENCE ALPINE STENT WAS DEPLOYED IN THE PROXIMAL LAD. HAZINESS OF UNKNOWN CAUSE WAS NOTED AT THE OSTIUM OF THE LAD AND CIRCUMFLEX. FOLLOWING PRE-DILATATION OF THE CIRCUMFLEX WITH A 3.0X15 BALLOON, FURTHER DUAL ANTIPLATELET THERAPY WAS GIVEN. A 3.25X18 MM XIENCE ALPINE STENT WAS DEPLOYED IN THE CIRCUMFLEX. BLOOD FLOW TO THE LAD AND CIRCUMFLEX WAS LOST. VASODILATOR MEDICATION WAS GIVEN. A 4.00X18 MM XIENCE ALPINE STENT WAS DEPLOYED IN THE LEFT MAIN; HOWEVER, BLOOD FLOW WAS NOT ABLE TO BE RE-ESTABLISHED. THE PATIENT ARRESTED. AN ASPIRATION CATHETER WAS UNABLE TO BE ADVANCED AND CARDIOPULMONARY RESUSCITATION WAS ATTEMPTED. THE PATIENT EXPIRED DURING THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Cardiac Arrest; Occlusion

  MAUDE report 7834596 ↗
• InjuryJun 4, 2018Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE 3.0X23MM AND 2.75X33MM 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 MYOCARDIAL INFARCTION. THE TREATMENT PERFORMED WAS NOT REPORTED AND THE FINAL PATIENT OUTCOME IS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Myocardial Infarction

  MAUDE report 7567799 ↗
• InjuryMay 31, 2018Difficult or Delayed Positioning; Inflation Problem

  IT WAS REPORTED THAT DURING A PROCEDURE OF THE NON-CALCIFIED, NON-TORTUOUS LEFT ANTERIOR DESCENDING (LAD) ARTERY WITHOUT PRE-DILATATION THE 3.0 X 23 MM XIENCE ALPINE STENT WAS IMPLANTED INFLATED AT 12 ATMOSPHERE (ATM), THEN UP TO 18 ATM. IT WAS FELT THAT THE STENT BALLOON DID NOT SUFFICIENTLY EXPAND THE STENT TO THE FULL SIZE AND THE DEPLOYED STENT REMAINED MALAPPOSED TO THE VESSEL WALL; HOWEVER, NO POST-DILATATION WAS PERFORMED AND THE PATIENT WAS TRANSFERRED TO THE RECOVERY AREA. APPROXIMATELY 30 MINUTES LATER, THE PATIENT EXPERIENCED CHEST PAIN. ANGIOGRAPHY REVEALED STENT THROMBOSIS. THE AREA WAS ASPIRATED AND MINIMAL CLOT WAS REMOVED. POST-DILATATION PERFORMED WITH A 2.5 X 25 MM NON-ABBOTT BALLOON AT 8 ATM FOLLOWED BY IMPLANTATION OF 2 NON-ABBOTT STENTS. NO ADDITIONAL POST-DILATATION WAS PERFORMED. THE PATIENT WAS REPORTED AS DOING FINE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina; Thrombosis

  MAUDE report 7557644 ↗
• InjuryMay 9, 2018Difficult to Remove; Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED, NON-TORTUOUS RIGHT CORONARY ARTERY. PRE-DILATATION WAS PERFORMED WITH A 2.5 X 15MM NON-ABBOTT BALLOON DILATATION CATHETER. WHILE A 3.0 X 23MM XIENCE ALPINE STENT DELIVERY SYSTEM (SDS) WAS BEING ADVANCED, RESISTANCE WAS MET WITH THE ANATOMY. MULTIPLE ATTEMPTS WERE MADE TO ADVANCE, BUT FAILED. THEREFORE, IT WAS DECIDED THAT THE XIENCE ALPINE SDS BE REMOVED. DURING REMOVAL OF THE SDS, RESISTANCE WAS MET WITH THE GUIDING CATHETER (GC). THE PHYSICIAN DECIDED TO REMOVE THE SDS AND GC AS A SINGLE UNIT, AND WHILE REMOVAL, THE STENT DISLODGED IN THE SUPERFICIAL FEMORAL ARTERY. A SNARE DEVICE WAS USED TO SUCCESSFULLY RETRIEVE THE STENT. ANOTHER 3.0 X 23MM XIENCE ALPINE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT SEQUELA REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7500704 ↗
• InjuryApr 5, 2018Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A NON-TORTUOUS, NON-CALCIFIED LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY. A 3.0 X 23MM XIENCE ALPINE STENT WAS DEPLOYED AT 12 ATMOSPHERES. POST-STENT IMPLANTATION, A PERFORATION OF THE LAD WAS NOTED. TWO RX GRAFTMASTERS (2.8 X 16MM AND 2.8 X 19MM) WERE USED TO TREAT THE LESION. THE 2.8 X 16MM RX GRAFTMASTER WAS ATTEMPTED TO SEAL THE PERFORATION, BUT WAS TOO SMALL. THEN A 2.8 X 19MM RX GRAFTMASTER WAS ADDITIONALLY USED TO SUCCESSFULLY SEAL THE PERFORATION. THE PATIENT EXPERIENCED SOME CHEST PAIN AFTER THE TWO RX GRAFMASTERS WERE IMPLANTED. AN ECHOCARDIOGRAM WAS PERFORMED AND IT WAS NOTED THAT THERE WAS A SMALL PERICARDIAL EFFUSION AROUND THE XIENCE ALPINE AND 2.8 X 16MM GRAFTMASTER, HOWEVER, THE AREA WHERE THE 2.8 X 19MM GRAFTMASTER WAS PLACED WAS FULLY SEALED. THE SMALL PERICARDIAL EFFUSION WAS NOT TREATED. PATIENT RECOVERED FINE. THERE WAS NO ADVERSE PATIENT SEQUELA REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina; Perforation

  MAUDE report 7400287 ↗
• InjuryMar 22, 2018Material Rupture

  IT WAS REPORTED THAT FOLLOWING PRE-DILATATION, THE XIENCE ALPINE STENT DELIVERY SYSTEM WAS ADVANCED TO THE RIGHT CORONARY ARTERY LESION WITHOUT ISSUE. BALLOON INFLATION WAS ATTEMPTED; HOWEVER, THE BALLOON RUPTURED AT 6 ATMOSPHERES. THE DELIVERY SYSTEM WAS REMOVED WITHOUT ISSUE. AS TREATMENT, ADDITIONAL POST-DILATATION WAS PERFORMED ON THE IMPLANTED STENT. THE STENT REMAINS WELL APPOSED TO THE VESSEL WALL AT THE INTENDED SITE. 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 7363417 ↗
• InjuryDec 8, 2017Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE INDEX PROCEDURE TOOK PLACE ON (B)(6) 2017 DURING WHICH A 3.0 X 23 MM XIENCE ALPINE STENT WAS IMPLANTED FOR TREATMENT OF AN UNSPECIFIED VESSEL. THE PATIENT WAS READMITTED TO THE HOSPITAL ON (B)(6) 2017 FOR EPIDURAL HEMORRHAGE AND OTHER UNSPECIFIED CARDIAC VASCULAR 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 7100111 ↗
• InjuryDec 1, 2017Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE INDEX PROCEDURE TOOK PLACE ON (B)(6) 2017 DURING WHICH A 3.0 X 23 MM XIENCE ALPINE STENT WAS IMPLANTED FOR TREATMENT OF AN UNSPECIFIED VESSEL. THE PATIENT WAS READMITTED TO THE HOSPITAL ON (B)(6) 2017 FOR LEFT ARM PAIN AND OTHER UNSPECIFIED CARDIAC VASCULAR SYMPTOMS. UNSPECIFIED TREATMENT WAS ADMINISTERED TO THE PATIENT. FINAL PATIENT OUTCOME IS REPORTEDLY UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Pain

  MAUDE report 7075022 ↗
• InjuryNov 21, 2017Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT PRESENTED EXPERIENCING AN ST ELEVATION MYOCARDIAL INFARCTION (STEMI). THE 3.0X23 MM XIENCE ALPINE STENT WAS DEPLOYED SUCCESSFULLY AND WITHOUT INCIDENT IN THE MID RIGHT CORONARY ARTERY. POST DILATATION WAS PERFORMED WITH A 3.5X20 NON-COMPLIANT BALLOON. THE STENT APPEARED WELL APPOSED ON THE ANGIOGRAM. THREE HOURS AFTER THE PROCEDURE, THE PATIENT EXPERIENCED CHEST PAIN AND CHANGES IN THE ELECTROCARDIOGRAM. THE PATIENT WAS DIAGNOSED WITH ANOTHER STEMI AND WAS TAKEN BACK TO THE CATHETERIZATION LAB WHERE THROMBUS WAS FOUND IN THE STENT. INTRAVENOUS INTEGRILIN WAS ADMINISTERED, THE THROMBUS ASPIRATED AND BALLOON ANGIOPLASTY PERFORMED WITH A 3.5X12 MM COMPLIANT BALLOON. THE THROMBUS WAS RESOLVED. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: Angina; Myocardial Infarction; Thrombosis

  MAUDE report 7051233 ↗
• MalfunctionNov 21, 2017Unstable; Failure to Advance

  IT WAS REPORTED THE PROCEDURE WAS PERFORMED TO TREAT AN ECCENTRIC LESION WITH HEAVY TORTUOSITY, MILD CALCIFICATION AND 90% STENOSIS IN THE PROXIMAL CIRCUMFLEX CORONARY ARTERY. A 3.0 X 23 MM XIENCE ALPINE STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TO THE TARGET LESION; HOWEVER, WAS UNABLE TO CROSS THE LESION DUE TO THE ANATOMY. THE PHYSICIAN NOTICED ON CINE THAT THE STENT SHIFTED [LOOSE] ON THE BALLOON. THEREFORE, THE SDS WAS WITHDRAWN FROM THE PATIENT ANATOMY WITHOUT ANY ISSUE. A NON-ABBOTT DEVICE WAS USED TO COMPLETE THE PROCEDURE. 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 7049459 ↗
• InjuryNov 17, 2017Leak/Splash; Improper or Incorrect Procedure or Method; Physical Resistance; Material Twisted/Bent

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY TORTUOUS, MODERATELY CALCIFIED CONCENTRIC DE NOVO LESION IN THE DISTAL CIRCUMFLEX THAT WAS 90% STENOSED. A NON-ABBOTT GUIDE WIRE (GW) WAS ADVANCED TO THE FIRST MARGINAL(OM) AND PRE-DILATATION WAS PERFORMED WITH A 2.0X12MM NON-ABBOTT BALLOON DILATATION CATHETER (BDC). THEN A 2.25X12MM XIENCE ALPINE STENT WAS DEPLOYED IN THE OM. A NON-ABBOTT GW WAS THEN ADVANCED TO THE DISTAL LEFT CIRCUMFLEX AND PRE-DILATATION WAS PERFORMED WITH A 2.75X13MM NON-ABBOTT BALLOON CATHETER. A 3.0X23MM XIENCE ALPINE STENT DELIVERY SYSTEM (SDS) WAS THEN ADVANCED BUT WAS UNSUCCESSFUL, POSSIBLY DUE TO INTERACTION WITH THE PREVIOUSLY DEPLOYED STENT. THE IMPLANTED STENT WAS THEN POST-DILATED WITH A 2.0X12MM NON-ABBOTT BDC AT HIGH PRESSURES. THE NON-ABBOTT BDC WAS LEFT IN THE OM TO BE USED FOR KISSING BALLOON TECHNIQUE AFTERWARDS. THE 3.0X23MM XIENCE ALPINE SDS WAS ADVANCED AGAIN AND MET RESISTANCE AT THE BIFURCATION. THE BALLOON WAS REMOVED AND THE 3.0 X 23MM XIENCE ALPINE WAS ABLE TO CROSS. AN ATTEMPT WAS MADE TO PRESSURIZE THE 3.0X23MM XIENCE ALPINE SDS, BUT PRESSURE INDICATION ON THE INDEFLATOR WAS UNABLE TO INCREASE DUE TO A LEAK ON THE SHAFT OF T

  Patient problems: Air Embolism; Diminished Pulse Pressure; Low Blood Pressure/ Hypotension; Shock

  MAUDE report 7043371 ↗
• DeathSep 1, 2017Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MILDLY TORTUOUS AND MILDLY CALCIFIED DE NOVO LESION IN THE PROXIMAL RIGHT CORONARY ARTERY. FOLLOWING PRE-DILATATION, A 2.75X48MM XIENCE XPEDITION STENT WAS DEPLOYED AT 16 ATMOSPHERES. A DISSECTION WAS NOTICED DURING THE FINAL CINE REVIEW. A 2.5X15MM NON-ABBOTT STENT WAS IMPLANTED TO COVER THE DISSECTION; HOWEVER, ACUTE STENT THROMBOSIS OCCURRED. SUBSEQUENTLY THE PATIENT WENT INTO CARDIAC ARREST. THROMBOLYTIC, CARDIOPULMONARY RESUSCITATION, AND CARDIO VERSION WERE USED IN AN ATTEMPT TO SAVE THE PATIENT; HOWEVER, THE EFFORTS FAILED AND THE PATIENT EXPIRED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Cardiac Arrest; Death; Intimal Dissection; Thrombosis

  MAUDE report 6839645 ↗
• InjuryAug 30, 2017Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 3.0 X 23 MM XIENCE ALPINE STENT WAS IMPLANTED ON (B)(6) 2017. ON (B)(6) 2017 THE PATIENT WAS RE-ADMITTED WITH HEART FAILURE 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: Heart Failure

  MAUDE report 6831711 ↗
• MalfunctionJun 26, 2017Unstable; Failure to Advance; Material Deformation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A CONCENTRIC LESION LOCATED IN THE DISTAL CIRCUMFLEX ARTERY THAT WAS MODERATELY TORTUOUS, HEAVILY CALCIFIED AND 90% STENOSED. WHEN THE XIENCE ALPINE 3.0 X 23 MM STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TO THE LESION, THE STENT IMPLANT HAD SHIFTED ON THE BALLOON DUE TO INTERACTION WITH THE CALCIFIED LESION. WHEN THE SDS WAS REMOVED FROM THE ANATOMY, THE STENT WAS FLARED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THE DEPLOYMENT OF A NEW XIENCE ALPINE STENT. 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 6667951 ↗
• MalfunctionMay 23, 2017Component Missing

  REPORTEDLY, A 3.0X23MM XIENCE ALPINE STENT DELIVERY SYSTEM (SDS) WAS PULLED FROM THE SHELVING AT THE SITE; HOWEVER, WHEN THE DEVICE WAS OPENED FOR USE, THE SDS WAS IN THE DISPENSER COIL WITHOUT THE FOIL AND TYVEK POUCHES. THE DEVICE WAS NOT USED. THERE WAS NO PATIENT INVOLVEMENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A NEW 3.0X23MM XIENCE ALPINE SDS. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 6586478 ↗
• InjuryMar 7, 2017Physical Resistance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY TORTUOUS SAPHENOUS VEIN GRAFT TO THE RIGHT CORONARY ARTERY. A 3.0 X 23 MM XIENCE ALPINE STENT DELIVERY SYSTEM WAS BEING ADVANCED TO THE LESION WHEN THERE WAS RESISTANCE WITH THE ANATOMY WHEN ADVANCING THROUGH THE OSTIUM OF THE VEIN GRAFT AND THE STENT DISLODGED. A TREK BALLOON CATHETER WAS USED TO DEPLOY THE STENT IN AN UNINTENDED AREA OF THE VEIN GRAFT. THE PROCEDURE WAS COMPLETED WITH THE DEPLOYMENT OF ANOTHER XIENCE ALPINE STENT IN THE TARGET LESION. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 6385537 ↗
• InjuryJan 17, 2017Difficult to Remove; Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE MID LEFT ANTERIOR DESCENDING (LAD) ARTERY WITH HEAVY CALCIFICATION. AFTER PRE-DILATATION WAS PERFORMED, A 3.0 X 23 MM XIENCE ALPINE RX STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TO THE LESION; HOWEVER, THE SDS WOULD NOT CROSS THE HEAVILY CALCIFIED LESION. WHEN THE SDS WAS BEING REMOVED FROM THE ANATOMY, RESISTANCE WAS FELT AND THE STENT DISLODGED FROM THE DEVICE. THE DISLODGED STENT WAS OBSERVED TO BE FLOATING IN THE LEFT MAIN ARTERY. AN UNKNOWN BALLOON WAS USED TO PUSH THE DISLODGED STENT INTO THE LAD AND SUBSEQUENTLY IMPLANTED IT IN THE PROXIMAL LAD. IT WAS REPORTED THAT THE PROXIMAL LAD WAS ALSO DISEASED. ANOTHER SDS WAS USED TO COMPLETE THE PROCEDURE BY IMPLANTING A STENT IN THE DISTAL LAD. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6256118 ↗
• InjuryJan 5, 2017Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT 3.0X23 MM AND 2.25X18 MM XIENCE ALPINE STENTS WERE IMPLANTED ON (B)(6) 2016. ON (B)(6) 2016, THE PATIENT WAS RE-ADMITTED TO THE HOSPITAL WITH STENOSIS LESS THAN 30 DAYS FROM THE DATE OF IMPLANT WHICH REQUIRED MEDICAL INTERVENTION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Stenosis

  MAUDE report 6227420 ↗
• InjuryNov 17, 2016Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON AN UNSPECIFIED DATE, THE PATIENT UNDERWENT A CORONARY STENTING PROCEDURE WITH IMPLANTATION OF AN UNSPECIFIED STENT IN THE CIRCUMFLEX/OBTUSE MARGINAL ARTERY. ON (B)(6) 2016, THE PATIENT WAS RE-HOSPITALIZED AND IN-STENT RESTENOSIS WAS NOTED IN THE UNSPECIFIED STENT. THE 3.0 X 23 MM XIENCE ALPINE STENT WAS IMPLANTED INSIDE THE PREVIOUSLY IMPLANTED STENT AND POST DILATATION WAS PERFORMED USING A 4.0 NC DILATATION CATHETER. ON (B)(6) 2016, THE PATIENT WAS RE-HOSPITALIZED WITH ANGINA AND THE PREVIOUSLY IMPLANTED XIENCE ALPINE STENT WAS NOTED TO BE OCCLUDED WITH THROMBUS. OPTICAL COHERENCE TOMOGRAPHY (OCT) WAS PERFORMED AND IT WAS NOTED THAT THERE APPEARED TO BE A PLAQUE RUPTURE WITH THROMBUS. PRE-DILATATION WAS PERFORMED USING A 2.0 X 20 MM DILATATION CATHETER. A 3.5 X 25 MM NON-ABBOTT STENT WAS IMPLANTED. POST DILATATION WAS PERFORMED USING A 3.75 X 12 MM NC BALLOON. IT WAS REPORTED THAT THE PATIENT WAS COMPLIANT WITH DUAL ANTIPLATELET THERAPY OF EFFIENT AND ASPIRIN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina; Prolapse; Thrombosis

  MAUDE report 6111557 ↗
• MalfunctionNov 16, 2016Difficult to Remove; Improper or Incorrect Procedure or Method; Failure to Advance; Material Deformation

  IT WAS REPORTED THAT AFTER PRE-DILATING A HEAVILY CALCIFIED LESION IN THE HEAVILY TORTUOUS PROXIMAL LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY, A 3.0X23MM RX XIENCE ALPINE STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TOWARD THE TARGET LESION, BUT WAS UNABLE TO CROSS DUE TO PATIENT ANATOMY. IN ORDER TO PERFORM ADDITIONAL PRE-DILATATION, THE SDS WAS WITHDRAWN, BUT RESISTANCE WAS FELT BETWEEN THE SDS AND AN UNSPECIFIED GUIDING CATHETER. UPON COMPLETING WITHDRAWAL AGAINST RESISTANCE, FLARED STRUTS WERE NOTED ON THE PROXIMAL EDGE OF THE XIENCE ALPINE STENT. NO OTHER DEVICE ISSUES WERE NOTED. A NON-ABBOTT SDS WAS USED SUCCESSFULLY WITH THE SAME GUIDING CATHETER AND WAS USED IN SUCCESSFULLY COMPLETING THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO OCCURRENCE OF A CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6108139 ↗
• InjuryOct 7, 2016Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A XIENCE ALPINE 3 X 23 MM STENT WAS IMPLANTED ON (B)(6) 2016. ON (B)(6) 2016, THE PATIENT WAS RE-ADMITTED WITH SUBSEQUENT ST-ELEVATION MYOCARDIAL INFARCTION (STEMI) AND THROMBOSIS. ADDITIONALLY, TREATMENT UPON READMISSION INCLUDED PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) / PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA). NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Myocardial Infarction; Thrombosis

  MAUDE report 6011023 ↗
• InjurySep 28, 2016Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2016, A 3.0X23 RX XIENCE ALPINE DRUG-ELUTING STENT WAS IMPLANTED FOR TREATMENT OF A LESION LOCATED IN AN UNSPECIFIED VESSEL. ON (B)(6) 2016, THE PATIENT WAS REHOSPITALIZED DUE TO OTHER UNSPECIFIED CARDIOVASCULAR SYMPTOMS, INCLUDING AORTIC VALVE RESTENOSIS AND WAS TREATED WITH SURGICAL INTERVENTION (TRANSCATHETER AORTIC VALVE REPLACEMENT) THEN DISCHARGED HOME. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Stenosis

  MAUDE report 5984853 ↗