XIENCE ALPINE 1125275-15Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 08717648199257), received between Feb 8, 2017 and Jul 22, 2020 — classified as 12 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (3 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• InjuryJul 22, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT ID: (B)(6). IT WAS REPORTED THAT ON (B)(6) 2018, THE PATIENT PRESENTED WITH ANGINA, AND A SEVERELY CALCIFIED, 95% STENOSED LESION WITHIN THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY. PRE-DILATATION AND AN ATHERECTOMY WAS PERFORMED. A 2.75X15MM XIENCE ALPINE STENT (1125275-15) WAS IMPLANTED WITH ACCEPTABLE RESULTS, TIMI FLOW III AND 0% VISUAL DIAMETER STENOSIS. ON (B)(6) 2019, THE PATIENT WAS ADMITTED FOR CHEST PAIN. PER RECENT CATHERITIZATION, THE PATIENT HAD TRIPLE VESSEL CORONARY ARTERY DISEASE. AS TREATMENT, A CORONARY ARTERY BYPASS GRAFT X4 PROCEDURE WAS PERFORMED. POST-OPERATION DAY 1, ATRIAL FIBRILLATION/FLUTTER WAS OBSERVED AND THE PATIENT PRESENTED WITH AN ALTERED MENTAL STATUS. THE PATIENT WENT INTO RESPIRATORY FAILURE AND WAS RE-INTUBATED. CARDIOVERSION WAS PROVIDED FOR THE ARRHYTHMIAS. MEDICATIONS WERE PROVIDED FOR HYPOTENSION. NEUROLOGY WAS CONSULTED. THE CT SCAN WAS NEGATIVE AND THE PATIENTS MENTAL STATUS IMPROVED OFF SEDATION. POST-OP DAY 5, THE PATIENT WAS EXTUBATED AND WAS OBSERVED IN SINUS RHYTHM. THE PATIENT WAS STARTED ON MEDICATIONS FOR ATRIAL FIBRILLATION. POST-OPERATION DAY 12, THE PATIENT WAS DISCHARGED TO A SUBACUTE REHAB FACILITY. THE

  Patient problems: Angina; Stenosis

  MAUDE report 10310971 ↗
• InjurySep 5, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 2.75 X 15MM XIENCE ALPINE STENT WAS IMPLANTED ON (B)(6) 2018. THE PATIENT PRESENTED WITH ST-ELEVATION MYOCARDIAL INFARCTION (STEMI) BEFORE THE PROCEDURE. ON (B)(6) 2018, THE PATIENT WAS READMITTED WITH CARDIOVASCULAR SYMPTOMS, INCLUDING MYOCARDIAL INFARCTION. TREATMENT PERFORMED WAS UNSPECIFIED AND THE FINAL PATIENT OUTCOME IS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Myocardial Infarction

  MAUDE report 7848084 ↗
• InjurySep 4, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 2.75 X 15MM XIENCE ALPINE STENT WAS IMPLANTED ON (B)(6) 2018. THE PATIENT PRESENTED WITH ST-ELEVATION MYOCARDIAL INFARCTION (STEMI) BEFORE THE PROCEDURE. ON (B)(6) 2018, THE PATIENT WAS READMITTED WITH CARDIOVASCULAR SYMPTOMS, INCLUDING CHEST PAIN. TREATMENT PERFORMED WAS UNSPECIFIED AND THE FINAL PATIENT OUTCOME IS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina

  MAUDE report 7843939 ↗
• InjuryJun 6, 2018Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE 2.75X15MM XIENCE ALPINE STENT WAS IMPLANTED ON MARCH 29, 2018. THE PATIENT PRESENTED WITH NON ST-ELEVATION MYOCARDIAL INFARCTION (NSTEMI) BEFORE THE PROCEDURE. ON APRIL 4, 2018, THE PATIENT WAS READMITTED WITH CARDIOVASCULAR SYMPTOMS, INCLUDING DRESSLERS SYNDROME. THE TREATMENT PERFORMED WAS NOT REPORTED AND THE FINAL PATIENT OUTCOME IS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7576215 ↗
• InjuryJun 6, 2018Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE 2.75X15MM XIENCE ALPINE STENT WAS 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, INCLUDING ACUTE PERICARDITIS. THE TREATMENT PERFORMED WAS NOT REPORTED AND THE FINAL PATIENT OUTCOME IS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7576188 ↗
• MalfunctionJun 4, 2018Detachment Of Device Component; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED RAMUS INTERMEDIUS ARTERY. THE PATIENT PRESENTED WITH ST-ELEVATION MYOCARDIAL INFARCTION (STEMI)BEFORE THE PROCEDURE. A 2.75 X 15MM XIENCE ALPINE STENT DELIVERY SYSTEM (SDS) FAILED TO CROSS THE LESION DUE TO THE ANATOMY. DURING REMOVAL OF THE SDS, THE PROXIMAL SHAFT SEPARATED INSIDE THE GUIDING CATHETER (GC) (INSIDE THE BODY). THE ENTIRE GC WAS REMOVED AS A SINGLE UNIT WITH THE REST OF THE SEPARATED SDS. THERE WAS NO RESISTANCE NOTED DURING REMOVAL. ANOTHER SAME SIZE XIENCE ALPINE AND GC WERE 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 7567255 ↗
• InjuryMay 23, 2018Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 2.75 X 15MM XIENCE ALPINE STENT AND A 2.25 X 18 XIENCE ALPINE STENT WERE IMPLANTED ON (B)(6) 2018. THE PATIENT PRESENTED WITH ST-ELEVATION MYOCARDIAL INFARCTION (STEMI) BEFORE THE PROCEDURE. ON (B)(6) 2018, THE PATIENT WAS READMITTED WITH CARDIOVASCULAR SYMPTOMS AND PRECORDIAL PAIN. TREATMENT PERFORMED WAS UNSPECIFIED AND FINAL PATIENT OUTCOME IS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina

  MAUDE report 7537426 ↗
• MalfunctionFeb 2, 2018Crack; Leak/Splash

  IT WAS REPORTED THAT THE 2.75X15 MM XIENCE ALPINE STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TO THE LEFT ANTERIOR DESCENDING CORONARY ARTERY TARGET LESION. THE HUB OF THE SDS CRACKED WHEN IT WAS BEING ATTACHED TO THE INDEFLATOR. THE HUB DID NOT LEAK WHEN IT CRACKED. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. THERE WAS NO ADDITIONAL INFORMATION PROVIDED. DEVICE ANALYSIS IDENTIFIED A LEAK COMING FROM THE CRACK ON THE HUB OF THE XIENCE ALPINE SDS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7235929 ↗
• InjurySep 8, 2017Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A SUCCESSFUL PROCEDURE ON (B)(6) 2015 DURING WHICH ONE XIENCE ALPINE STENT (3.0 X 15 MM) WAS DEPLOYED SUCCESSFULLY IN THE RIGHT CORONARY ARTERY (RCA). APPROXIMATELY 2-3 MONTHS AGO THE PATIENT BEGAN TO EXPERIENCE SHORTNESS OF BREATH. A STRESS TEST CONFIRMED NEW LESIONS/BLOCKAGES LOCATED IN THE CIRCUMFLEX (CX) AND THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE STENT IMPLANT LOCATED IN THE RCA WAS PATENT. ALTHOUGH THE PATIENT HAD TRIPLE ARTERY DISEASE, THE DECISION WAS MADE NOT TO PERFORM TRIPLE CORONARY ARTERY BYPASS, BUT TO PERFORM STENTING. ON (B)(6) 2017, THE PATIENT UNDERWENT A NEW PROCEDURE FOR TREATMENT OF THE CX AND LAD. TWO XIENCE ALPINE STENTS (3.0 X 28 MM AND 3.0 X 15 MM) WERE PLACED IN THE CX AND ONE XIENCE ALPINE STENT (2.75 X 15 MM) WAS PLACED IN THE LAD. SINCE THAT PROCEDURE THE PATIENT HAS BEEN EXPERIENCING A SENSATION OF TIGHTNESS IN THE CHEST AND HAS TO BREATHE DEEPLY TO CATCH HIS BREATH. AN EKG WAS PERFORMED; HOWEVER, NOTHING OF NOTE WAS FOUND. ON (B)(6) 2017, THE PATIENTS PLAVIX WAS CHANGED TO BRILINTA. THE PATIENT HAS BEEN FEELING LIGHT HEADED WITH TIGHTNESS ACROSS THE CHEST AND ALSO HAS OBSERVED RED BLOTCHES ON HIS CHES

  Patient problems: Angina; Hypersensitivity/Allergic reaction

  MAUDE report 6854207 ↗
• InjuryAug 30, 2017Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 2.75X15 MM XIENCE ALPINE STENT WAS IMPLANTED ON (B)(6) 2017. ON (B)(6) 2017 THE PATIENT WAS RE-ADMITTED FOR A TRANSIENT ISCHEMIC ATTACK 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: No Consequences Or Impact To Patient

  MAUDE report 6832731 ↗
• InjuryAug 1, 2017Difficult to Remove; Improper or Incorrect Procedure or Method; Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A CORONARY PROCEDURE TO TREAT A TARGET LESION IN THE HEAVILY CALCIFIED AND TORTUOUS CIRCUMFLEX ARTERY. PRE-DILATATION WAS PERFORMED. A 2.75 X 15 MM XIENCE ALPINE STENT DELIVERY SYSTEM WAS ADVANCED INTO THE PATIENT ANATOMY, BUT WAS UNABLE TO CROSS TO THE DISTAL LESION AND WAS IMPLANTED IN THE PROXIMAL LESION INSTEAD. ADDITIONAL DILATATION WAS PERFORMED AND A 2.5 X 15 MM XIENCE ALPINE STENT WAS IMPLANTED IN THE DISTAL LESION. THE MID LESION WAS STILL UNTREATED; THEREFORE, ADDITIONAL DILATATION WAS PERFORMED AND THE PHYSICIAN ADVANCED A SECOND 2.75 X 15 MM XIENCE ALPINE TO THE TARGET SITE. THE DEVICE WAS UNABLE TO CROSS AND THE STENT EDGE CAUGHT ON THE EDGE OF THE IMPLANTED 2.75 X 15 MM STENT. THE DEVICE WAS REMOVED AND SOME RESISTANCE WAS FELT. UPON REMOVAL, IT WAS NOTED THAT THE STENT WAS NOT ON THE DELIVERY SYSTEM, AND WAS NOT IN THE GUIDE CATHETER. ANGIOGRAPHY NOTED THAT THE DISLODGED STENT WAS IN THE MID LESION, BETWEEN THE TWO IMPLANTED STENTS, AT THE LOCATION THE PHYSICIAN HAD INTENDED TO DEPLOY IT. A GUIDE WIRE WAS ADVANCED THROUGH THE DISLODGED STENT, AND A 2.5 X 15 MM DILATATION CATHETER WAS ADVANCED THROUGH THE STENT. THE PHYSICIAN

  Patient problems: Embolism

  MAUDE report 6757552 ↗
• MalfunctionMay 25, 2017Crack

  IT WAS REPORTED THAT A XIENCE ALPINE STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TO THE MILDLY TORTUOUS PROXIMAL CIRCUMFLEX ARTERY, MILDLY CALCIFIED LESION WITHOUT ISSUE. AN INDEFLATOR WAS ABOUT TO BE ATTACHED WHEN THE XIENCE ALPINE HUB WAS NOTED TO BE CRACKED. THERE WAS NO OTHER DEVICE ISSUE NOTED. THE DEVICE WAS REMOVED AND ANOTHER XIENCE ALPINE WAS USED IN REPLACEMENT. THERE WERE NO ADVERSE PATIENT EFFECTS AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY. THERE WAS NO ADDITIONAL INFORMATION PROVIDED REGARDING THIS DEVICE ISSUE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6592831 ↗
• InjuryMay 22, 2017Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A PROCEDURE OF THE MULTI-VESSEL PERCUTANEOUS CORONARY INTERVENTION (PCI) A 2.5 X 18 MM XIENCE ALPINE STENT WAS SUCCESSFULLY DEPLOYED IN THE CIRCUMFLEX ARTERY AND A 2.5 X 18 MM XIENCE ALPINE WAS DEPLOYED IN THE LEFT ANTERIOR DESCENDING (LAD) LEFT MAIN ARTERY. IT WAS DETERMINED THAT THE AREA BETWEEN AN EXISTING STENT AND THE 2.5 X 18 MM XIENCE ALPINE STENT IN THE LAD SHOULD ALSO BE TREATED. A 2.75 X 15 MM XIENCE ALPINE STENT DELIVERY SYSTEM (SDS) WAS ADVANCED BUT MET RESISTANCE WITH THE STENT IN THE LAD; WHILE ATTEMPTING TO RETRACT/POSITION THE DEVICE, THE 2.75 X 15 MM XIENCE ALPINE STENT BECAME DISLODGED IN THE ANATOMY. ATTEMPTS TO CRUSH THE STENT OR BALLOON DILATE THE STENT WERE UNSUCCESSFUL AS NO DEVICES COULD SUCCESSFULLY CROSS THE VESSEL/LAD STENT AREA. ALTHOUGH A PROCEDURAL TIME DELAY, THERE WAS NO CLINICAL SIGNIFICANCE. THE PATIENT UNDERWENT CORONARY BYPASS OF THE LEFT INTERNAL MAMMARY ARTERY (LIMA) TO LAD ARTERY WITH A GOOD OUTCOME. THE STENT REMAINS IN THE ANATOMY. HOSPITALIZATION WAS PROLONGED DUE TO THE SURGICAL PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 6581820 ↗
• InjuryApr 18, 2017Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE INDEX PROCEDURE TOOK PLACE ON (B)(6) 2016 DURING WHICH A 2.75 X 15 MM XIENCE ALPINE WAS PLACED FOR TREATMENT. THE PATIENT WAS READMITTED TO THE HOSPITAL ON (B)(6) 2016 EXPERIENCING CONGESTIVE HEART FAILURE. ALTHOUGH THE TREATMENT PERFORMED IS UNSPECIFIED, THE FACT THAT REHOSPITALIZATION OCCURRED INDICATES THAT SOME FORM OF TREATMENT WAS PERFORMED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Heart Failure

  MAUDE report 6501614 ↗
• InjuryApr 11, 2017Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2016, A 2.75X15 RX XIENCE ALPINE DRUG-ELUTING STENT WAS IMPLANTED FOR TREATMENT OF AN UNSPECIFIED VESSEL. ON (B)(6) 2016, THE PATIENT WAS REHOSPITALIZED DUE TO OTHER UNSPECIFIED CARDIOVASCULAR SYMPTOMS, INCLUDING SYNCOPE. UNSPECIFIED TREATMENT WAS ADMINISTERED AND THE FINAL PATIENT OUTCOME IS REPORTEDLY UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Syncope

  MAUDE report 6482091 ↗
• MalfunctionFeb 10, 2017Material Rupture

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A CORONARY STENTING PROCEDURE TO TREAT A TARGET LESION IN THE MILDLY CALCIFIED AND TORTUOUS LEFT ANTERIOR DESCENDING ARTERY. ONE XIENCE ALPINE STENT WAS IMPLANTED IN THE MID PORTION OF THE TARGET LESION. THE PHYSICIAN THEN POSITIONED THE 2.75 X 15 MM STENT AT THE PROXIMAL PORTION OF THE TARGET LESION AND DEPLOYED THE STENT; HOWEVER, DURING INFLATION, THE STENT DELIVERY SYSTEM BALLOON RUPTURED AT 17-18 ATMOSPHERES. THE STENT WAS DEPLOYED WITHOUT DIFFICULTY AND THE STENT DELIVERY SYSTEM WAS REMOVED WITHOUT DIFFICULTY. POST-DILATATION WAS PERFORMED PER SITE PROTOCOL. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6324463 ↗
• MalfunctionFeb 8, 2017Inflation Problem; Kinked; Physical Resistance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE MILDLY TORTUOUS, HEAVILY CALCIFIED, 90% STENOSED DISTAL RIGHT CORONARY ARTERY (RCA). A 2.75 X 15 MM XIENCE ALPINE STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TO THE LESION AND WOULD NOT CROSS. USING THE DOUBLE GUIDE WIRE TECHNIQUE THE SDS WAS ABLE TO CROSS THE LESION. AN ATTEMPT WAS MADE TO INFLATE THE BALLOON AND THE PRESSURE ON THE INDEFLATOR GAUGE DID NOT RISE. THE SDS WAS REMOVED FROM THE ANATOMY AND THE SHAFT OF THE SDS WAS FOUND TO BE KINKED PROXIMAL TO THE GUIDE WIRE EXIT NOTCH. THE SDS WAS REPLACED WITH A NEW 2.75 X18 MM XIENCE ALPINE SDS. USING A SINGLE GUIDE WIRE, NEW SDS WAS ADVANCED TO THE LESION AND WOULD NOT CROSS. USING THE DOUBLE GUIDE WIRE TECHNIQUE THE NEW SDS WAS ABLE TO CROSS THE LESION AND THE STENT IMPLANT WAS SUCCESSFULLY DEPLOYED. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6312675 ↗