XIENCE ALPINE 1125350-38Recalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 08717648199578), received between Sep 6, 2016 and Jul 31, 2020 — classified as 1 death, 11 injuries, 15 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (9 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 27 reports, in the reporter's own words as published by the FDA.

• InjuryJul 31, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A 50% STENOSED, FIBROUS PLAQUE, AND MILDLY CALCIFIED DE NOVO LESION IN THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY (LAD) AND A 75-90% STENOSED, FIBROUS PLAQUE, MILDLY TORTUOUS, AND MILDLY CALCIFIED DE NOVO LESION IN THE MID LAD. ON (B)(6) 2015, A 3.5X15MM XIENCE ALPINE STENT WAS IMPLANTED IN THE PROXIMAL LAD AND 3.5X38MM XIENCE ALPINE STENT WAS IMPLANTED IN THE MID LAD. THE STENTS EXPANDED TO 3.5MM AND WERE APPOSED TO THE VESSEL WALLS. ON (B)(6) 2016, DURING A FOLLOW-UP VISIT IT WAS CONFIRMED THAT THERE WAS NO RE-STENOSIS. ON (B)(6) 2020, AN EXERCISE ECHOCARDIOGRAPHY WAS PERFORMED AND CONFIRMED ISCHEMIA IN THE LAD WAS NEGATIVE. ON (B)(6) 2020, THE PATIENT STOPPED TAKING ASPIRIN. ON (B)(6) 2020, THE PATIENT HAD SUDDEN CHEST PAIN AND WAS TAKEN TO THE HOSPITAL. V1-4 AND CLEAR ST INCREASE WERE SHOWN AND ECHO CONFIRMED WALL MOVEMENT OF THE LEFT VENTRICLE ANTEROSEPTAL. A ST-ELEVATION MYOCARDIAL INFARCTION WAS CONFIRMED IN THE LAD. AN ANGIOGRAPH CONFIRMED STENT THROMBOSIS IN THE 3.5X15MM XIENCE ALPINE STENT. A PERCUTANEOUS CORONARY INTERVENTION WAS PERFORMED AND LARGE AMOUNTS OF RED THROMBOSIS WAS SUCTIONED OUT AND A NON-ABBOTT ST

  Patient problems: Angina; Myocardial Infarction; Thrombosis

  MAUDE report 10353845 ↗
• InjurySep 10, 2018Difficult to Remove; Failure to Advance; Device Dislodged or Dislocated; Difficult to Remove; Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED AND TORTUOUS LESION IN THE RIGHT CORONARY ARTERY. ROTABLADING WAS PERFORMED. AN ATTEMPT WAS MADE TO ADVANCE THE 3.50X38MM RX XIENCE ALPINE STENT DELIVERY SYSTEM; HOWEVER, IT FAILED TO CROSS THE LESION DUE TO THE ANATOMY. RESISTANCE WAS MET DURING RETRACTION AND THE STENT DISLODGED. A SNARE DEVICE WAS USED TO REMOVE THE DISLODGED STENT FROM THE PATIENT ANATOMY. A NEW ALPINE STENT WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND NO ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7862181 ↗
• MalfunctionMay 14, 2018Detachment Of Device Component; Kinked; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT DURING DEVICE PREPARATION AND PRIOR TO USE IN A PROCEDURE, THE XIENCE ALPINE STENT DELIVERY SYSTEM (SDS) WAS NOTED TO BE KINKED AND SEPARATED. ADDITIONALLY, THE PLASTIC HOLDER WAS FOUND TO BE KINKED. THE DEVICE WAS NOT USED. THERE WAS NO PATIENT INVOLVEMENT. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. A DIFFERENT DEVICE WAS USED IN THE PROCEDURE WITHOUT REPORTED ISSUE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 7512469 ↗
• MalfunctionMay 9, 2018Difficult To Position; Difficult to Remove; Stretched

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY TORTUOUS, HEAVILY CALCIFIED, LESION IN THE RIGHT CORONARY ARTERY. RESISTANCE WAS FELT WHEN ADVANCING THE 3.5X38 MM XIENCE ALPINE STENT DELIVERY SYSTEM (SDS), THROUGH THE GUIDING CATHETER. THE DECISION WAS MADE TO REMOVE THE SDS FROM THE GUIDE CATHETER. WHEN ATTEMPTING TO REMOVE THE SDS, RESISTANCE WAS FELT WITH THE GUIDE CATHETER AND THE SHAFT OF THE SDS STRETCHED. THE GUIDE CATHETER AND SDS WERE REMOVED TOGETHER AS A SINGLE UNIT. A SAME SIZE XIENCE ALPINE SDS WAS USED TO COMPLETE THE PROCEDURE. 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 7500717 ↗
• MalfunctionMay 7, 2018Difficult to Remove; Failure to Advance; Material Deformation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY TORTUOUS AND HEAVILY CALCIFIED LESION IN THE RIGHT CORONARY ARTERY. A 3.5X38MM XIENCE ALPINE STENT DELIVERY SYSTEM (SDS) FAILED TO CROSS DUE TO THE ANATOMY. AN ATTEMPT TO REMOVE THE SDS WAS MADE; HOWEVER, THE SDS GOT CAUGHT WITH THE GUIDELINER. THE SDS AND GUIDLINER WERE REMOVED AS A UNIT. THE SDS WAS INSPECTED AFTER REMOVAL AND IT WAS NOTICED THAT THE STENT STRUTS WERE FLARED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A 3.5X33MM 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 Consequences Or Impact To Patient

  MAUDE report 7492951 ↗
• MalfunctionMay 7, 2018Torn Material

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A NON-TORTUOUS AND NON-CALCIFIED LESION LOCATED IN THE RIGHT CORONARY ARTERY. A 3.5 X 38 MM XIENCE ALPINE STENT DELIVERY SYSTEM (SDS) WAS ADVANCED OVER A FILTER WIRE WITH A GUIDING CATHETER WHEN THE WIRE PIERCED THROUGH THE STENT/BALLOON AND CAME OUT OF THE SIDE OF THE SDS CAUSING A TEAR. THE WIRE WAS SIMPLY REMOVED FROM THE SDS AND GUIDING CATHETER. THE DEVICES NEVER ENTERED THE PATIENT. THE FILTER WIRE WAS PREVIOUSLY BROKEN TO REDUCE THE LENGTH FROM 300 CM TO 190 CM. AND THEREFORE, THE PHYSICIAN USED HEMOSTATS ON THE WIRE TO AVOID SHARPNESS AND PREVENT TEARING ON A ANOTHER DEVICE. THE FILTER WIRE WAS SUCCESSFULLY USED WITH ANOTHER 3.5 X 38 MM XIENCE ALPINE SDS TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE OR THERAPY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 7490829 ↗
• MalfunctionApr 11, 2018Inflation Problem; Physical Resistance

  IT WAS REPORTED THAT THIS WAS A PROCEDURE TO TREAT A CHRONIC TOTAL OCCLUSION IN THE LEFT ANTERIOR DESCENDING CORONARY ARTERY (LAD). THE XIENCE ALPINE STENT DELIVERY SYSTEM WAS ADVANCED TO THE LESION WITH MORE RESISTANCE THAN AVERAGE DUE TO ANATOMY. ONCE AT THE LESION SITE, THE XIENCE ALPINE BALLOON FAILED TO INFLATE. THE UNDEPLOYED STENT REMAINED IN PLACE ON THE DELIVERY SYSTEM AND THE DEVICE WAS REMOVED FROM THE ANATOMY WITHOUT ISSUE. A NON-ABBOTT DEVICE WAS USED IN REPLACEMENT. THERE WERE NO ADVERSE PATIENT EFFECTS AND THERE WAS NO CLINICALLY SIGNIFICANT PROCEDURAL DELAY. THERE WAS NO ADDITIONAL INFORMATION PROVIDED REGARDING THIS ISSUE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7423694 ↗
• InjuryMar 6, 2018Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 3.5 X 38 MM XIENCE ALPINE WAS IMPLANTED ON (B)(6) 2017. ON (B)(6) 2017 THE PATIENT WAS RE-ADMITTED WITH CARDIOVASCULAR SYMPTOMS INCLUDING MYOCARDIAL INFARCTION. ALTHOUGH THE TREATMENT PERFORMED IS UNSPECIFIED, THE FACT THAT HOSPITALIZATION OCCURRED, INDICATES THAT SOME FORM OF TREATMENT WAS PERFORMED. THE FINAL PATIENT OUTCOME IS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Myocardial Infarction

  MAUDE report 7317416 ↗
• InjuryJan 22, 2018Failure to Advance; Device Dislodged or Dislocated; Material Deformation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE OBTUSE MARGINAL CORONARY ARTERY. A 3.50 X 38 MM XIENCE ALPINE STENT DELIVERY SYSTEM (SDS) WAS SELECTED FOR THE PROCEDURE. THE SDS WAS ADVANCED TO THE LESION AND WOULD NOT CROSS. WHILE TRYING TO PULL THE SDS BACK INTO THE 6 FR GUIDE CATHETER, THE STRUTS ON THE PROXIMAL END OF THE STENT BECAME FLARED AND THE STENT DISLODGED IN THE RIGHT RADIAL ARTERY. A SNARE WAS USED TO RETRIEVE THE STENT FROM THE ANATOMY WITH NO VESSEL DAMAGE NOTED. AN UNSPECIFIED BALLOON CATHETER WAS USED TO COMPLETE THE PROCEDURE AS NO STENT COULD CROSS. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7210023 ↗
• InjuryNov 29, 2017Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 3.5X38MM 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 7067934 ↗
• MalfunctionNov 17, 2017Difficult to Remove; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY TORTUOUS, MODERATELY CALCIFIED, AND CONCENTRIC MID RIGHT CORONARY ARTERY THAT WAS 90% STENOSED. THE 3.5 X 38 XIENCE ALPINE STENT ADVANCED TOWARDS THE LESION, BUT FAILED TO CROSS DUE TO THE ANATOMY. REPORTEDLY, THERE WAS RESISTANCE DURING REMOVAL OF THE STENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER XIENCE ALPINE STENT. 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 7042038 ↗
• MalfunctionNov 9, 2017Detachment Of Device Component; Difficult To Position; Difficult to Remove

  IT WAS REPORTED THAT DURING A PROCEDURE OF THE UNSPECIFIED VESSEL, THE 3.5X38 MM XIENCE ALPINE WAS BEING ADVANCED OVER THE GRAND SLAM GUIDE WIRE, WHILE STILL OUTSIDE OF THE ANATOMY, BUT BECAME STUCK ON THE WIRE. WHILE ATTEMPTING TO SEPARATE THE DEVICES USING EXCESSIVE MANIPULATION, THE SHAFT OF THE XIENCE ALPINE SEPARATED. THE DEVICES WERE NOT USED IN THE PROCEDURE AND WERE REMOVED AS A SINGLE UNIT. REPORTEDLY, THERE WAS NO ISSUE WITH THE GRAND SLAM WIRE. 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 7014690 ↗
• MalfunctionAug 24, 2017Difficult To Position; Difficult to Remove; Improper or Incorrect Procedure or Method; Failure to Advance; Material Deformation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A CORONARY PROCEDURE TO TREAT A TARGET LESION IN THE DISTAL RIGHT CORONARY ARTERY. THE 3.5 X 38 MM XIENCE ALPINE STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TO THE TARGET LESION; HOWEVER, THE DEVICE WAS UNABLE TO CROSS. THE SDS WAS REMOVED AND A GUIDE CATHETER EXTENSION WAS USED TO PROVIDE SUPPORT. THE XIENCE ALPINE WAS RE-ADVANCED; HOWEVER, THERE WAS RESISTANCE NOTED BETWEEN THE XIENCE ALPINE AND THE GUIDE CATHETER EXTENSION. THE SDS WAS ABLE TO EXIT THE DISTAL END OF THE GUIDE CATHETER EXTENSION, BUT WAS STILL UNABLE TO CROSS THE TARGET LESION. DURING ATTEMPTS TO PULL THE SDS BACK INTO THE GUIDE CATHETER EXTENSION, THE SDS BECAME STUCK. THE PROXIMAL STENT STRUTS WERE FLARED. NO ADDITIONAL ATTEMPTS WERE MADE TO REMOVE THE SDS FROM THE GUIDE CATHETER EXTENSION, AND THE GUIDE CATHETER EXTENSION WAS REMOVED SEPARATELY. THE XIENCE ALPINE SDS WAS THEN REMOVED WITH THE GUIDING CATHETER AS A SINGLE UNIT. AN UNSPECIFIED STENT DELIVERY SYSTEM WAS THEN USED, WITH THE SAME GUIDE WIRE, GUIDE CATHETER AND GUIDE CATHETER EXTENSION, WITHOUT ISSUE. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA OR A CLINICALLY SIGNIFICANT DELAY IN PROCEDURE. NO ADDITIONAL IN

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6819477 ↗
• MalfunctionAug 3, 2017Kinked; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED MID TO DISTAL RIGHT CORONARY ARTERY THAT WAS 99% STENOSED. PRE-DILATATION WAS PERFORMED WITH A 1.5 MM AND A 2.5 MM UNSPECIFIED BALLOON CATHETERS. A 3.5 X 38 MM XIENCE ALPINE WAS BEING ADVANCED TO THE LESION; HOWEVER, IT COULD NOT CROSS AND THE SHAFT KINKED. DURING REMOVAL OF THE ALPINE, THERE WAS RESISTANCE WITH THE 6F GUIDELINER. A 3.5 X 38 MM NON-ABBOTT 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 6765465 ↗
• InjuryJun 23, 2017Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A TOTAL OCCLUSION IN THE RIGHT CORONARY ARTERY (RCA). A TOTAL OF FIVE XIENCE ALPINE STENTS (2.5 X 33 MM, 3.0 X 38 MM, 3.5 X 38 MM, 4.0 X 18 MM, 4.0 X 33 MM) WERE IMPLANTED FROM DISTAL TO PROXIMAL IN THE RCA. UNSPECIFIED NON-COMPLIANT (NC) BALLOONS WERE USED TO POST-DILATE THE STENTS. ON ANGIOGRAPHY, A PERFORATION WAS OBSERVED IN THE MID RCA. IT IS UNKNOWN AT WHAT POINT THE PERFORATION OCCURRED OR WHAT DEVICE CAUSED THE PERFORATION; HOWEVER, AS THE 3.5 X 38 MM XIENCE ALPINE STENT WAS IN THE MID RCA IT IS BELIEVED THAT THE PERFORATION OCCURRED AT ITS LOCATION. A 4.0 X 16 MM GRAFTMASTER STENT WAS DEPLOYED IN THE MID RCA; HOWEVER, DID NOT SEAL THE PERFORATION. A 5.0 NC BALLOON WAS ADVANCED TO EXPAND THE GRAFTMASTER A LITTLE MORE; HOWEVER, THERE WAS STILL A LEAK OBSERVED. PERICARDIOCENTESIS WAS PERFORMED BUT THE PATIENT STARTING CRASHING. THE PATIENT WAS EXPERIENCING RIGHT VENTRICULAR FAILURE (HEART FAILURE); THEREFORE, THE PATIENT'S CHEST WAS OPENED AND CARDIAC MASSAGE WAS PERFORMED. THE PATIENT WAS PLACED ON AN EXTRACORPOREAL MEMBRANE OXYGENATION MACHINE AND TRANSFERRED TO (B)(6) WHERE THEY UNDERWENT CORONARY ARTERY BYPASS. THE DEPLOYED

  Patient problems: Cardiac Arrest; Heart Failure; Perforation

  MAUDE report 6665459 ↗
• InjuryMay 24, 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 18 MM, 3.5 X 12 MM AND A 3.5 X 38 MM XIENCE ALPINE WERE IMPLANTED FOR TREATMENT OF AN UNSPECIFIED VESSEL. THE PATIENT WAS READMITTED TO THE HOSPITAL ON (B)(6) 2017 FOR ANGINA. UNSPECIFIED TREATMENT WAS ADMINISTERED TO THE PATIENT. FINAL PATIENT OUTCOME IS REPORTEDLY UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina

  MAUDE report 6589168 ↗
• InjuryMar 9, 2017Difficult To Position

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MILDLY TORTUOUS AND MODERATELY CALCIFIED, DE NOVO AND ECCENTRIC PROXIMAL RIGHT CORONARY ARTERY (RCA) THAT WAS 90% STENOSED. PRE-DILATATION WAS PERFORMED WITH TWO NON-ABBOTT BALLOON CATHETERS. A 3.0 X 18 MM XIENCE ALPINE STENT WAS DEPLOYED IN THE DISTAL RCA, A 3.5 X 38 MM XIENCE ALPINE STENT WAS DEPLOYED IN THE MID RCA AND A 4.0 X 28 MM XIENCE ALPINE STENT WAS DEPLOYED IN THE PROXIMAL RCA. THE 3.0 X 18 MM AND 3.5 X 38 MM STENTS WERE NOT OVERLAPPED, THE 3.5 X 38 MM AND 4.0 X 28 MM WERE OVERLAPPED. INTRAVASCULAR ULTRASOUND (IVUS) WAS USED MULTIPLE TIMES BEFORE AND AFTER DEPLOYING THE STENTS. IT WAS CONFIRMED THERE WAS NO MALPOSITION OF THE 3.5 X 38 MM XIENCE ALPINE; HOWEVER, IT WAS OVAL SHAPED DUE TO THE CALCIFIED LESION. ANGIOGRAPHY WAS PERFORMED DUE TO THE PATIENT BLOOD PRESSURE DECLINING AND A PERFORATION WAS NOTED WHERE THE 3.5 X 38 MM XIENCE ALPINE WAS IMPLANTED. PERICARDIOCENTESIS WAS PERFORMED AND A 2.8 X 19 MM GRAFTMASTER COVERED STENT SYSTEM WAS ADVANCED BUT COULD NOT CROSS THROUGH THE IMPLANTED 3.5 X 38 MM XIENCE ALPINE AND WHEN REMOVED FROM THE ANATOMY THE EDGE OF THE STENT WAS FLARED. A GUIDELINER WAS ADVANCED AND A 2.8 X 1

  Patient problems: Low Blood Pressure/ Hypotension; Perforation

  MAUDE report 6393818 ↗
• DeathFeb 27, 2017Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A CHRONIC TOTAL OCCLUSION (CTO) IN THE MID RIGHT CORONARY ARTERY (RCA). MULTIPLE DILATATIONS WERE PERFORMED AND A 3.0X38 XIENCE ALPINE CROSSED AND WAS DEPLOYED AT 11 ATMOSPHERES (ATM), FOLLOWED BY POST-DILATATION TO 18 ATM. A 3.5X38MM XIENCE ALPINE WAS THEN ADVANCED AND DEPLOYED AT 11ATM, PROXIMALLY OVERLAPPING THE 1ST STENT THEN POST-DILATED TO 18ATM. A POST-STENT ANGIOGRAM REVEALED A LARGE FREE PERFORATION OF THE MID RCA WITH EXTRAVASATION INTO THE PERICARDIUM THAT WAS REPORTEDLY CAUSED BY THE 3.5X38 (NOT THE 3.0X38) XIENCE ALPINE STENT. REPORTEDLY, THERE WERE NO OTHER DEVICE ISSUES OR ADVERSE PATIENT EFFECTS RELATED TO THE 1ST IMPLANTED 3.0X38MM XIENCE ALPINE STENT. THE PATIENT DEVELOPED PULSELESS ELECTRICAL ACTIVITY (CARDIAC ARREST), REQUIRING CARDIOPULMONARY RESUSCITATION (CPR) AND INTUBATION.

  Patient problems: Cardiac Arrest; Cardiac Tamponade; Cardiogenic Shock; Death; Hemorrhage/Blood Loss/Bleeding; Low Blood Pressure/ Hypotension; Perforation; Respiratory Failure; Ventricular Fibrillation

  MAUDE report 6360969 ↗
• MalfunctionFeb 23, 2017Difficult To Position; Difficult to Remove; Improper or Incorrect Procedure or Method; Failure to Advance; Material Deformation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE MID RIGHT CORONARY ARTERY (MRCA) THAT HAD HEAVY CALCIFICATION, MODERATE TORTUOSITY AND A 90% STENOSIS. AFTER PRE-DILATATION WITH A NON-ABBOTT BALLOON CATHETER, THE XIENCE ALPINE 3.5 X 38 MM STENT DELIVERY SYSTEM (SDS) WAS ADVANCED BUT FAILED TO CROSS THE LESION. WITH THE SUPPORT OF A NON-ABBOTT GUIDING CATHETER EXTENSION, THE XIENCE ALPINE SDS WAS ADVANCED AGAIN BUT THE SDS GOT STUCK WITH THE PROXIMAL END OF THE NON-ABBOTT GUIDING CATHETER EXTENSION. BOTH DEVICES WERE REMOVED AS A SINGLE UNIT. WHEN THE SDS WAS EXAMINED OUTSIDE THE ANATOMY THE STENT STRUTS WERE FOUND TO BE FLARED. A NEW XIENCE ALPINE WAS ADVANCED WITH THE SUPPORT OF THE SAME NON-ABBOTT GUIDING CATHETER EXTENSION. THERE WAS NO REPORT OF A CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND NO PATIENT EFFECT CAUSED BY THE DEVICE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6352929 ↗
• MalfunctionFeb 9, 2017Improper or Incorrect Procedure or Method; Device Operates Differently Than Expected

  IT WAS REPORTED THAT DURING DEVICE PREPARATION FOR A 3.5 X 38 MM XIENCE ALPINE DRUG ELUTING STENT (DES), THE STENT WAS OBSERVED TO BE MISALIGNED ON THE BALLOON; HOWEVER, NO DISLODGEMENT OR LOOSENESS OF THE STENT WAS OBSERVED. THE DEVICE WAS NOT USED IN THE PATIENT. IT WAS ALSO REPORTED THAT THE ALPINE WAS SOAKED IN SALINE DURING PREPARATION. A REPLACEMENT 3.5 X 38 MM XIENCE ALPINE 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 Patient Involvement

  MAUDE report 6315451 ↗
• MalfunctionDec 22, 2016Device Dislodged or Dislocated; Material Deformation

  IT WAS REPORTED THAT DURING REMOVAL OF THE MANDREL AND SHEATH, THE STENT STRETCHED AND DISLODGED; HOWEVER, IT WAS NOT NOTICED UNTIL THE STENT DELIVERY SYSTEM WAS BEING BACK LOADED ON THE GUIDE WIRE. THE DEVICE WAS NOT USED. THERE WAS NO ADVERSE PATIENT EFFECT OR A CLINICALLY SIGNIFICANT DELAY IN PROCEDURE REPORTED. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6201484 ↗
• MalfunctionDec 6, 2016Difficult to Remove; Improper or Incorrect Procedure or Method; Device Dislodged or Dislocated; Material Deformation

  IT WAS REPORTED THAT THE 3.5 X 38 MM XIENCE ALPINE STENT DELIVERY SYSTEM WAS PREPARED FOR USE. THE STYLET AND SHEATH WERE DIFFICULT TO REMOVE. THE STYLET WAS ABLE TO BE REMOVED; HOWEVER, FORCE WAS APPLIED TO REMOVE THE SHEATH. UPON REMOVAL OF THE SHEATH, IT WAS NOTED THAT THE STENT DISLODGED WITH THE SHEATH. THE STENT WAS NOTED TO BE CRUSHED AND THE DEVICE WAS NOT USED. THERE WAS NO PATIENT INVOLVEMENT. THERE WAS NO ADVERSE PATIENT EFFECT OR CLINICALLY SIGNIFICANT DELAY. A SECOND SAME DEVICE WAS USED WITHOUT ISSUE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 6149075 ↗
• 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 6068367 ↗
• InjuryOct 28, 2016Difficult to Remove; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY WITH HEAVY CALCIFICATION. AFTER PLACING TWO UNSPECIFIED STENTS IN THE DISTAL AND MID LAD, A 3.5X38MM XIENCE ALPINE RX STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TOWARD THE TARGET LESION. AN UNSPECIFIED GUIDE CATHETER WAS NOTED TO BE SLIDING AND THE GUIDE CATHETER PUSHED THE SDS TOWARD THE ARTERY. THE SDS WAS QUICKLY PULLED BACK AND THE STENT DISLODGED DUE TO RESISTANCE WITH THE ANATOMY. THE STENT REMAINED ON THE GUIDE WIRE. THE SDS AND GUIDE CATHETER WERE WITHDRAWN FROM THE PATIENT ANATOMY AND AN 8 FRENCH GUIDE CATHETER WAS INSERTED. A SNARE WAS ADVANCED AND SUCCESSFULLY RETRIEVED THE STENT. THE GUIDE CATHETER, SNARED STENT AND GUIDE WIRE WERE WITHDRAWN AS A SINGLE UNIT FROM THE PATIENT ANATOMY. THE PHYSICIAN DECIDED NOT TO TREAT THE PROXIMAL LAD AND CONTINUED TO TREAT LESIONS IN OTHER VESSELS. 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 6065003 ↗
• InjurySep 29, 2016Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 3.5 X 38 MM XIENCE ALPINE STENT WAS IMPLANTED ON (B)(6) 2016. ON (B)(6) 2016, THE PATIENT WAS RE-ADMITTED WITH CARDIOVASCULAR SYMPTOMS INCLUDING CORDIAL PAIN AND ANGINA. IT IS UNKNOWN WHAT TREATMENT WAS PERFORMED. THE FINAL PATIENT OUTCOME IS UNKNOWN AND THE PATIENT WAS DISCHARGED HOME. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina

  MAUDE report 5988563 ↗