XIENCE ALPINE 1125350-23Recalls & reported problems

Summary

The FDA's MAUDE database contains 40 adverse event reports that list this exact device (DI 08717648199547), received between Sep 7, 2016 and Jul 9, 2021 — classified as 22 injuries, 18 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (11 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 40 reports, in the reporter's own words as published by the FDA.

• InjuryJul 9, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2018, THE PATIENT PRESENTED DUE TO AN ACUTE MYOCARDIAL INFARCTION (AMI). DUE TO THE PRESENCE OF THROMBUS, ASPIRATION WAS PERFORMED AND THEN TWO XIENCE ALPINE STENTS (3.5X23MM, 3.0X33MM) WERE IMPLANTED IN THE MID TO PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY. REPORTEDLY, THE OVERLAPPED SECTION WAS NOT WELL APPOSED TO THE VESSEL WALL, AND POST DILATATION WAS ATTEMPTED BUT UNABLE TO BE PERFORMED DUE TO THE SLOW BLOOD FLOW, RESULTING IN SOME ISCHEMIA AND TIMI FLOW ONLY 2.5. DUAL ANTIPLATELET THERAPY (DAPT) WAS GIVEN. ON (B)(6) 2019, DAPT WAS DISCONTINUED BUT THE PATIENT CONTINUED TO TAKE ASPIRIN. ON (B)(6) 2021, THE PATIENT WAS HOSPITALIZED DUE TO AN AMI. THE 3.5X23MM XIENCE ALPINE STENT WAS NOTED TO BE 100% OCCLUDED WITH THROMBUS. THE THROMBUS WAS ASPIRATED. A NON-ABBOTT STENT WAS IMPLANTED FOLLOWED BY POST DILATATION. INTRAVASCULAR ULTRASOUND (IVUS) WAS PERFORMED CONFIRMING GOOD WALL APPOSITION OF ALL 3 STENTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 12147352 ↗
• InjuryJun 21, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 3.5 X 23MM XIENCE ALPINE STENT WAS IMPLANTED ON (B)(6) 2019. ON (B)(6) 2019, THE PATIENT WAS RE-ADMITTED WITH TRAUMATIC ISCHEMIA OF MUSCLE AND OTHER UNSPECIFIED CARDIO 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 8724489 ↗
• InjuryJun 21, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 3.5 X 23MM XIENCE ALPINE AND 4.0 X 18MM XIENCE SIERRA STENTS WERE IMPLANTED ON (B)(6) 2019. ON (B)(6) 2019, THE PATIENT WAS RE-ADMITTED WITH A GASTRIC ULCER WITH HEMORRHAGE AND OTHER UNSPECIFIED CARDIO VASCULAR SYMPTOMS. SURGERY WAS PERFORMED AND THE FINAL PATIENT OUTCOME IS REPORTEDLY UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8724439 ↗
• 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 3.50X23MM XIENCE ALPINE STENT WAS IMPLANTED. ON (B)(6) 2018 THE PATIENT WAS RE-ADMITTED WITH ACUTE MYOCARDIAL INFARCTION (MI). THE TREATMENT PERFORMED AND THE FINAL PATIENT OUTCOME IS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Myocardial Infarction

  MAUDE report 8161380 ↗
• MalfunctionNov 27, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE STENT DISLODGED OFF A 3.5X23MM XIENCE ALPINE STENT DELIVERY SYSTEM (SDS) WHEN THE PROTECTIVE SHEATH WAS REMOVED. NO RESISTANCE WAS FELT WHEN REMOVING THE SDS FROM THE DISPENSER COIL OR WHEN REMOVING THE PROTECTIVE SHEATH. THE DEVICE WAS NOT USED IN THE PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A NEW XIENCE ALPINE STENT. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 8107698 ↗
• InjuryJul 27, 2018Adverse 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 LESION IN THE PROXIMAL RIGHT CORONARY ARTERY (RCA). ON (B)(6) 2018, THE PATIENT PRESENTED WITH ST ELEVATION MYOCARDIAL INFARCTION (STEMI) AND A 3.5 X 23 MM XIENCE ALPINE STENT WAS IMPLANTED IN THE PROXIMAL RCA. ON (B)(6) 2018, THE PATIENT WAS RE-HOSPITALIZED FOR CHEST PAIN [ANGINA]. ON (B)(6) 2018, PERCUTANEOUS CORONARY INTERVENTION OF THE PROXIMAL RCA [OCCLUSION] WAS PERFORMED FOR ADDITIONAL TREATMENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina; Occlusion

  MAUDE report 7727656 ↗
• MalfunctionJun 11, 2018Improper or Incorrect Procedure or Method; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY WITH HEAVY CALCIFICATION AND NO TORTUOSITY. A 3.5 X 23 MM XIENCE ALPINE STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TO THE TARGET LESION AND WHEN ATTEMPTING TO INFLATE THE SDS, IT WAS OBSERVED THAT THE STENT WAS NOT ON THE BALLOON. REPORTEDLY, THE STENT HAD DISLODGED AND WAS FOUND INSIDE THE PROTECTIVE SHEATH, OUTSIDE THE ANATOMY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A NON-ABBOTT STENT. 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 7588035 ↗
• InjuryMay 9, 2018Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE RIGHT CORONARY ARTERY. THE 3.5X23 MM XIENCE ALPINE STENT DELIVERY SYSTEM (SDS) FAILED TO CROSS A PREVIOUSLY IMPLANTED STENT. THE SDS WAS REMOVED WITHOUT ISSUE, HOWEVER UPON REMOVAL OF THE SDS IT WAS NOTED THAT THE STENT HAD DISLODGED IN THE ANATOMY. AN ATTEMPT TO SNARE THE STENT WAS UNSUCCESSFUL, THE STENT REMAINS FREE FLOATING IN THE ANATOMY. A NON-ABBOTT STENT WAS USED TO COMPLETE THE PROCEDURE. THE PATIENT IS STABLE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 7500816 ↗
• InjuryApr 13, 2018Device Damaged by Another Device

  IT WAS REPORTED THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE MID CIRCUMFLEX WITH NO TORTUOSITY OR CALCIFICATION. THE 3.5 X 23 MM XIENCE ALPINE STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TO THE LESION WITHOUT ISSUE, AND DEPLOYED SUCCESSFULLY. THE SDS WAS REMOVED WITHOUT ISSUE AND STANDARD POST-DILATATION WAS PERFORMED. THE UN-SPECIFIED PROCEDURE GUIDE WIRE WAS LEFT IN PLACE AND A SECOND NON-ABBOTT GUIDE WIRE WAS ADVANCED FOR TREATMENT OF THE OBTUSE MARGINAL; HOWEVER, THE GUIDE WIRES BECAME ENTANGLED. AN UNKNOWN BALLOON WAS ADVANCED IN AN ATTEMPT TO UNTANGLE THE GUIDE WIRES, BUT THE BALLOON COULD NOT BE FULLY ADVANCED. THE GUIDE WIRES WERE GRADUALLY RETRACTED, AND IT WAS OBSERVED THAT THE SECOND GUIDE WIRE HAD CAUGHT ON THE ALPINE STENT AND DISLODGED IT FROM ITS DEPLOYED LOCATION. THE GUIDE WIRE WAS REMOVED AND THE STENT WAS FREE FLOATING IN THE AORTA. A SECOND ACCESS SITE WAS USED TO ADVANCE A SNARE DEVICE, AND THE STENT WAS SUCCESSFULLY RETRIEVED FROM THE ANATOMY. A NEW NON-ABBOTT STENT WAS USED TO RE-TREAT THE LESION AND THE PATIENT HAD A GOOD OUTCOME. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7431297 ↗
• InjuryMar 28, 2018Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A PROXIMAL LEFT ANTERIOR DESCENDING CORONARY ARTERY. AFTER A 3.5 X 23MM XIENCE ALPINE STENT WAS IMPLANTED, A PERFORATION WAS NOTED. THE LESION WAS DILATED WITH A 3.0 X 30 TREK BALLOON DILATATION CATHETER. THEN A 3.5 X 16MM RX GRAFTMASTER WAS ADVANCED, BUT RESISTANCE WITH THE ANATOMY WAS FELT, THEREFORE IT WAS REMOVED. ANTI-COAGULATION WAS REVERSED WHILE PERICARDIOCENTESIS WAS PERFORMED AND A BALLOON PUMP WAS PLACED. PERFORATION WAS NOT SEALED. PATIENT REMAINS IN STABLE CONDITION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Perforation

  MAUDE report 7380021 ↗
• InjuryMar 13, 2018Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 3.50 X 23 MM XIENCE ALPINE WAS IMPLANTED ON (B)(6) 2017. ON (B)(6) 2017 THE PATIENT WAS RE-ADMITTED WITH CARDIOVASCULAR SYMPTOMS INCLUDING ATHEROSCLEROSIS CORONARY ARTERY DISEASE. 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: No Code Available

  MAUDE report 7334172 ↗
• MalfunctionMar 6, 2018Improper or Incorrect Procedure or Method; Device Dislodged or Dislocated; Material Deformation

  IT WAS REPORTED THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE MID CIRCUMFLEX ARTERY. THE PATIENT PRESENTED WITH ST-ELEVATION MYOCARDIAL INFARCTION (STEMI). A 3.5 X 23 MM XIENCE ALPINE STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TO THE TARGET LESION. DURING DEPLOYMENT, IT WAS NOTED THAT THE STENT WAS MISSING. THE SDS WAS WITHDRAWN FROM THE PATIENT ANATOMY. THE DISLODGED STENT WAS FOUND ON THE STYLET. THE STENT WAS NOTED TO BE DAMAGED. ANOTHER 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 7319290 ↗
• InjuryMar 6, 2018Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 3.50 X 23 MM XIENCE ALPINE WAS IMPLANTED ON (B)(6) 2017. ON (B)(6) 017 THE PATIENT WAS RE-ADMITTED WITH CARDIOVASCULAR SYMPTOMS AND DISSECTION OF THE THORACIC AORTA. 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: No Code Available

  MAUDE report 7317126 ↗
• InjuryMar 6, 2018Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 3.50 X 23 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 7316944 ↗
• InjuryMar 5, 2018Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT TWO XIENCE ALPINE STENTS (3.5 X 23 MM, 3.0 X 28 MM) WERE IMPLANTED (B)(6) 2017. ON (B)(6) 2017 THE PATIENT WAS RE-ADMITTED WITH CARDIOVASCULAR SYMPTOMS AND A URINARY TRACT INFECTION (UTI). 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: No Code Available

  MAUDE report 7315233 ↗
• InjuryMar 2, 2018Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ONE XIENCE ALPINE STENT (3.5 X 23 MM) WAS DEPLOYED SUCCESSFULLY ON (B)(6) 2017. THE PATIENT WAS READMITTED TO THE HOSPITAL ON (B)(6) 2017 FOR SYMPTOMS OF CHEST PAIN. ALTHOUGH THE TREATMENT PERFORMED IS UNSPECIFIED, THE FACT THAT HOSPITALIZATION TOOK PLACE INDICATES THAT SOME FORM OF TREATMENT WAS PERFORMED. THE FINAL PATIENT OUTCOME IS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina

  MAUDE report 7311377 ↗
• MalfunctionFeb 6, 2018Difficult to Remove; Failure to Advance

  IT WAS REPORTED THAT DURING A PROCEDURE OF THE HEAVILY CALCIFIED, DISTAL RIGHT CORONARY ARTERY (RCA), THE 3.5 X 23 MM XIENCE ALPINE STENT DELIVERY SYSTEM (SDS) MET ANATOMICAL RESISTANCE AND FAILED TO REACH THE DISTAL LESION. REMOVAL OF THE DEVICE WAS ATTEMPTED, BUT RESISTANCE WAS MET IN THE PROXIMAL PART OF THE LESION, SO THE STENT WAS DEPLOYED WITHOUT ISSUE. OPTICAL COMPUTED TOMOGRAPHY (OCT) SHOWED FULL WALL APPOSITION OF THE STENT. A SECOND STENT WAS ADVANCED AND DEPLOYED IN THE DISTAL RCA WITHOUT ISSUE. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT OR A CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7244985 ↗
• MalfunctionDec 15, 2017Defective Device

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED RIGHT CORONARY ARTERY THAT DID NOT HAVE ANY TORTUOSITY. A 3.5 X 23 MM XIENCE ALPINE STENT WAS USED; HOWEVER, IT WAS NOTED UNDER FLUOROSCOPY THAT THE STENT WAS THE INCORRECT SIZE. THEREFORE, ANOTHER UNSPECIFIED STENT WAS IMPLANTED IN THE LESION. THEN, A 3.5 X 12 MM NC TREK BALLOON CATHETER WAS USED FOR POST-DILATATION; HOWEVER, THE BALLOON RUPTURED BELOW THE RATED BURST PRESSURE. THEREFORE, ANOTHER 3.5 X 12 MM NC TREK BALLOON CATHETER WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. 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 7122017 ↗
• 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 3.5 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 ANGINA 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: Angina

  MAUDE report 7099870 ↗
• InjuryDec 6, 2017Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 3.5 X 23 MM XIENCE ALPINE STENT WAS IMPLANTED ON (B)(6) 2017. ON (B)(6) 2017, THE PATIENT WAS RE-ADMITTED WITH CARDIOVASCULAR SYMPTOMS INCLUDING SYNCOPE. 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: Syncope

  MAUDE report 7088482 ↗
• MalfunctionNov 22, 2017Improper or Incorrect Procedure or Method; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LEFT ANTERIOR DESCENDING ARTERY. PRE-DILATATION WAS PERFORMED WITH AN UNSPECIFIED BALLOON CATHETER. A 3.5 X 23 MM XIENCE ALPINE STENT DELIVERY SYSTEM WAS ADVANCED TO THE LESION WHEN IT WAS NOTED THAT THERE WAS NO STENT ON THE BALLOON. THE DEVICE WAS REMOVED AND A NEW XIENCE ALPINE STENT WAS SUCCESSFULLY USED TO COMPLETE THE PROCEDURE. THE STENT WAS FOUND ON THE PREP TABLE ON THE STYLET, IN THE PROTECTIVE SHEATH. THERE WAS NO RESISTANCE NOTED WHEN THE PROTECTIVE SHEATH WAS REMOVED. 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 7052893 ↗
• InjuryNov 21, 2017Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE HEAVILY CALCIFIED RIGHT CORONARY ARTERY. THE TARGET LESION WAS ROTABLATED AND A 3.5X23 MM XIENCE ALPINE STENT WAS IMPLANTED WITHOUT ISSUES. THIRTY MINUTES AFTER THE PROCEDURE, THE PATIENT EXPERIENCED CHEST PAIN. ANGIOGRAM CONFIRMED THROMBOSIS IN THE ALPINE STENT. THROMBUS ASPIRATION AND ADDITIONAL DILATATION WAS PERFORMED FOR TREATMENT. THE PATIENT IS DOING WELL. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina; Thrombosis

  MAUDE report 7050390 ↗
• MalfunctionAug 18, 2017Difficult to Remove; Failure to Advance; Material Deformation

  IT WAS REPORTED THAT THE ACCESS SITE WAS THE RADIAL ARTERY. DURING THE HEAVILY CALCIFIED, MODERATELY TORTUOUS LEFT ANTERIOR DESCENDING CORONARY ARTERY STENTING PROCEDURE, THE 3.5 X 23 MM XIENCE ALPINE STENT DELIVERY SYSTEM (SDS) WAS UNABLE TO CROSS THE LESION. DURING REMOVAL OF THE SDS, THE PROXIMAL STENT STRUTS WERE NOTED TO BE FLARED AND THE STENT BECAME STUCK IN THE 6 FRENCH GUIDE CATHETER. THE GUIDE CATHETER, SDS AND GUIDE-WIRE WERE REMOVED TOGETHER AS A UNIT. ADDITIONAL PREDILATATION WAS PERFORMED AND THREE XIENCE STENTS WERE SUCCESSFULLY IMPLANTED. THERE WAS NO 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 6805421 ↗
• InjuryMay 25, 2017Difficult To Position

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED DISTAL LEFT ANTERIOR DESCENDING ARTERY (LAD). THE PATIENT PRESENTED WITH A NON-ST ELEVATED MYOCARDIAL INFARCTION (NSTEMI). A 3.5 X 23 MM XIENCE ALPINE STENT WAS IMPLANTED IN THE MID LEFT ANTERIOR DESCENDING ARTERY AND A 3.5 X 15 MM XIENCE ALPINE STENT WAS IMPLANTED IN THE PROXIMAL LAD OVERLAPPING THE 3.5 X 23 MM STENT. POST DILATATION WAS PERFORMED WITH A 3.5 X 08 MM BALLOON CATHETER. ANGIOGRAPHY CONFIRMED A DISSECTION AT THE DISTAL END OF THE 3.5 X 23 MM XIENCE ALPINE STENT. THEREFORE, A 3.0 X 08 MM XIENCE ALPINE STENT WAS ADVANCED TO THE 3.5 X 23 MM XIENCE ALPINE STENT. HOWEVER, THE 3.0 X 08 MM XIENCE ALPINE STENT FAILED TO CROSS DUE TO THE ANATOMY AND THE IMPLANTED STENT. THEREFORE, THE STENT DELIVERY SYSTEM WAS REMOVED AND A GUIDELINER AND AN UNSPECIFIED GUIDE WIRE WAS ADVANCED AND THE SAME 3.0 X 08 MM XIENCE ALPINE STENT WAS REINSERTED, BUT IT STILL COULD NOT ADVANCE PAST THE DEPLOYED STENT. DURING REMOVAL, THE STENT DISLODGED IN THE IMPLANTED STENT. ACCESS WAS LOST AND COULD NOT BE RE-ESTABLISHED. THE PROCEDURE ALREADY LASTED FOR 2 HOURS SO AN INTRA-AORTIC BALLOON PUMP WAS PLACED, AND THE PATIENT WAS TAKEN TO

  Patient problems: Intimal Dissection

  MAUDE report 6591954 ↗
• MalfunctionMay 9, 2017Difficult to Remove; Device Dislodged or Dislocated; Material Deformation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE RIGHT CORONARY ARTERY. A 3.5X23MM XIENCE ALPINE STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TO THE LESION. AN ATTEMPT TO DEPLOY THE STENT WAS MADE; HOWEVER, THE STENT HAD DISLODGED FROM THE BALLOON ONTO THE SHAFT OF THE SDS. RESISTANCE WAS FELT WHEN REMOVING THE SDS. THE SDS WAS REMOVED WITH THE STENT ON THE SHAFT AND THE BALLOON PARTIALLY INFLATED. ADDITIONALLY, IT WAS NOTICED THAT THE STENT STRUTS WERE BENT AFTER REMOVAL. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A 3.5X30MM NON-ABBOTT DEVICE. 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 6556124 ↗