XIENCE ALPINE 1125300-38Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 08717648199394), received between Aug 26, 2016 and Jun 30, 2022 — classified as 10 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• InjuryJun 30, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED THROUGH A RESEARCH ARTICLE THAT A NON-ABBOTT STENT WAS IMPLANTED IN THE LEFT CIRCUMFLEX ARTERY, BUT PROTRUDED INTO THE LEFT MAIN ARTERY. ONE MONTH LATER, DURING IMPLANTATION OF A 3.0X38MM XIENCE ALPINE STENT IN THE LEFT MAIN ARTERY TO THE ANTERIOR DESCENDING CORONARY ARTERY, IT WAS NOTED THAT THE WALL APPOSITION WAS POOR AROUND THE AREA OF THE PREVIOUSLY IMPLANTED NON-ABBOTT STENT. AT THE AREA OF MALAPPOSITION, THROMBUS WAS NOTED. TREATMENT IS UNKNOWN. FOR COMPLETE REPORTED INFORMATION, PLEASE SEE THE ATTACHED ARTICLE, TITLED ¿NAPKIN RING FORMATION IN CULOTTE STENTING USING CURRENT-GENERATION DRUG-ELUTING STENTS IN LEFT MAIN CORONARY ARTERY BIFURCATION."

  Patient problems: Thrombosis/Thrombus

  MAUDE report 14881840 ↗
• InjuryJun 12, 2018Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE PROXIMAL MID LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY. A 3.0 X 38 MM XIENCE ALPINE STENT WAS IMPLANTED SUCCESSFULLY. AFTER THE PROCEDURE, WHILE STILL ON THE TABLE, THE PATIENT COMPLAINED OF CHEST PAIN. ANGIOGRAPHY REVEALED THROMBUS OF THE STENT IMPLANT. THE PATIENT WAS ADMINISTERED MEDICATION. THE THROMBUS WAS ASPIRATED SUCCESSFULLY AND ADDITIONAL BALLOON ANGIOPLASTY WAS PERFORMED. THE PATIENT RECOVERED WELL IN THE POST PROCEDURE AREA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina; Thrombosis

  MAUDE report 7592974 ↗
• InjuryJun 5, 2018Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 3.0 X 38MM XIENCE ALPINE CORONARY STENT SYSTEM WAS IMPLANTED ON (B)(6) 2018. ON (B)(6) 2018 THE PATIENT WAS RE-ADMITTED WITH HEMORRHAGE OF TRACH AND CARDIOVASCULAR SYMPTOMS. 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 7571917 ↗
• MalfunctionMay 1, 2018Difficult To Position; Difficult to Remove

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE RIGHT COMMON ILIAC ARTERY. A 3.0 X 38 MM XIENCE ALPINE STENT DELIVERY SYSTEM WAS ADVANCED, BUT GOT STUCK WITH THE COMMAND GUIDE WIRE DUE TO A KINK IN THE GUIDE WIRE THAT OCCURRED DURING THE PROCEDURE. THE DEVICES WERE REMOVED TOGETHER AS ONE UNIT. 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 7477551 ↗
• InjuryNov 9, 2017Difficult to Remove; Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE RIGHT CORONARY ARTERY THAT WAS MODERATELY TORTUOUS AND MODERATELY CALCIFIED. AFTER A FAILED ATTEMPT TO CROSS, DURING RETRACTION, THE XIENCE ALPINE 3 X 38 MM STENT CAUGHT ON THE SHEATH AND DISLODGED IN THE ANATOMY. A SNARE DEVICE WAS USED TO RETRIEVE THE STENT. ANOTHER XIENCE ALPINE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. 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 7014007 ↗
• InjuryOct 24, 2017Difficult or Delayed Positioning

  IT WAS REPORTED THAT THE HIGH RISK PATIENT PRESENTED FOR LEFT HEART ANGIOGRAPHY, WITH MULTI-VESSEL CORONARY ARTERY DISEASE. AN IMPELLA, LEFT VENTRICLE ASSIST DEVICE, WAS PLACED FOR SUPPORT. MULTIPLE NON-ABBOTT BALLOONS WERE USED AND STENTS IMPLANTED IN THE OBTUSE MARGINAL ARTERIES AND SEPTAL PERFORATOR BRANCH. A 3.0X38MM XIENCE ALPINE (XA) STENT WAS IMPLANTED IN THE MID LEFT ANTERIOR DESCENDING CORONARY ARTERY (LAD), FOLLOWED BY A 2.75X15MM XA IN THE DISTAL LAD, TWO XA (4.0X12MM, 3.5X28MM) STENTS IN THE PROXIMAL LAD AND A 2.5X23MM XA STENT IN THE 1ST DIAGONAL ARTERY. UPON INTRAVASCULAR ULTRASOUND (IVUS) EXAM, THE 3.5X28MM XA IN THE PROXIMAL LAD WAS NOTED TO BE COMPRESSED AND SHORTENED. NO TREATMENT WAS PROVIDED. THE 3.0X38MM XA IN THE MID LAD WAS MILDLY UNDER-EXPANDED AND REQUIRED ADDITIONAL DILATATION. THE PROCEDURE WAS DEEMED SUCCESSFUL AND THE IMPELLA DEVICE WAS REMOVED. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6974496 ↗
• InjuryOct 3, 2017Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2017, THE PATIENT PRESENTED WITH CHRONIC STABLE ANGINA, THE PROCEDURE WAS TO TREAT A LESION IN THE MID RIGHT CORONARY ARTERY (RCA). A 3.0 X 38 MM XIENCE ALPINE STENT WAS IMPLANTED IN THE MID RCA WITH GOOD RESULTS, ACT WAS 236 AND HEPARIN WAS ADMINISTERED. AS SOON AS THE PROCEDURE WAS COMPLETED, THE PATIENT EXPERIENCED CHEST PAIN AND ANGIOGRAPHY CONFIRMED STENT THROMBOSIS IN THE IMPLANTED XIENCE ALPINE STENT. BALLOONING WITH AN UNSPECIFIED WAS PERFORMED AND A 3.5 X 15 MM XIENCE ALPINE WAS IMPLANTED PROXIMAL TO THE IMPLANTED STENT, FOR TREATMENT. THE PATIENT IS DOING WELL. THERE WERE NO ADVERSE PATIENT SEQUELAE AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina; Thrombosis

  MAUDE report 6911352 ↗
• InjurySep 14, 2017Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT 48-HOURS POST-STENTING PROCEDURE WITH TWO XIENCE ALPINE STENTS THE PATIENT EXPERIENCED A RASH ON THE WAIST, ABDOMEN, AND BACK. EXCESSIVE ITCHING WAS ALSO NOTED. THE PATIENT WAS GIVEN CORTISONE INJECT AND TOPICAL CREAM AS TREATMENT. A SMALL AREA REMAINS ON THE TORSO BUT IS RESOLVING. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Hypersensitivity/Allergic reaction; Rash

  MAUDE report 6867490 ↗
• InjuryJul 10, 2017Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PROCEDURE THE PATIENT UNDERWENT WAS TO TREAT AN UNSPECIFIED CORONARY ARTERY. THREE XIENCE ALPINE STENTS WERE IMPLANTED ON (B)(6) 2017: 3.5 X 28 MM, 3.0 X 38 MM AND 3.5 X 18 MM. APPROXIMATELY 2-3 DAYS POST STENTING PROCEDURE, THE PATIENT BEGAN EXPERIENCING HIVES, RASHES, ITCHING AND BRUISING (FROM SCRATCHING) ALL OVER HER BODY AND WAS RE-HOSPITALIZED ON (B)(6) 2017 DUE TO HER SYMPTOMS. THE PATIENT WAS RELEASED FROM THE HOSPITAL ON (B)(6) 2017. SHE HAS SEEN 4 SPECIALISTS (CARDIOLOGIST, INTERNIST, DERMATOLOGIST AND ALLERGIST), AND IT WAS THOUGHT THAT THE ADVERSE REACTION IS LIKELY DUE TO THE DRUG (EVEROLIMUS) ON THESE STENTS. THE PATIENT HAS NO MEDICAL HISTORY OF ALLERGIES. SHE UNDERWENT A STENTING PROCEDURE APPROXIMATELY 8 YEARS AGO, WITH IMPLANTATION OF ONE STENT; THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS AFTERWARDS. THE DOSAGE OF HER MEDICATIONS HAVE BEEN INCREASED. SHE WAS PRESCRIBED EPIFOAM AND VISTARIL, AS WELL AS PREDNISONE. HER PHYSICIAN ORIGINALLY PRESCRIBED PLAVIX; THIS WAS CHANGED TO BRILINTA. THE BRILINITA WAS THEN CHANGED TO EFFIENT, WHICH CONTINUES. BEFORE THE THREE XIENCE ALPINE IMPLANTS, THE PATIENT WAS TAKING BABY ASPIRIN BUT THIS WAS

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 6699155 ↗
• MalfunctionJun 15, 2017Positioning Failure

  IT WAS REPORTED THAT THE 3.0X38 MM XIENCE ALPINE STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TO THE TARGET LESION, HOWEVER THE STENT DID NOT DEPLOY. 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 6644990 ↗
• MalfunctionFeb 23, 2017Device Dislodged or Dislocated

  IT WAS REPORTED THAT WHEN THE PROTECTIVE SHEATH WAS REMOVED FROM THE 3.0 X 38 MM XIENCE ALPINE STENT DELIVERY SYSTEM (SDS), THE STENT IMPLANT DISLODGED FROM THE BALLOON. IT WAS OBSERVED THAT THE STENT REMAINED IN THE PROTECTIVE SHEATH AFTER IT DISLODGED. THERE WAS NO PATIENT INVOLVEMENT AND NO CLINICALLY SIGNIFICANT DELAY REPORTED. A NEW 3.0 X 38 MM XIENCE ALPINE WAS USED TO COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 6355262 ↗
• InjuryFeb 9, 2017Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2015 THE PATIENT UNDERWENT CORONARY INTERVENTION FOR TREATMENT OF A HEAVILY CALCIFIED MID LEFT ANTERIOR DESCENDING ARTERY AND THE DIAGONAL ARTERY WITH A 3.0 X 38 MM XIENCE ALPINE STENT AND A 2.5 X 23 MM XIENCE ALPINE STENT AND WAS PLACED ON DUAL ANTIPLATELET THERAPY. IN (B)(6) 2016, HE WAS TAKEN OFF HIS MEDICATIONS BY HIS STOMACH DOCTOR AS HE WAS EXPERIENCING A STOMACH BLEED. THE PATIENT WAS NOT ABLE TO SEE HIS CARDIOLOGIST PRIOR TO THIS OCCURRING. ON (B)(6) 2016 THE PATIENT EXPERIENCED AN ACUTE MYOCARDIAL INFARCTION AND WAS REHOSPITALIZED AND UNDERWENT REVASCULARIZATION OF THE STENTS AS HIS STENTS HAD CLOTTED OFF DUE TO BEING TAKEN OF HIS MEDICATIONS. HE WAS INFORMED AT THE TIME OF THE REINTERVENTION THAT ONE OF HIS STENTS HAD POSSIBLY MOVED OR WAS DAMAGED BUT HE DOES NOT KNOW WHICH ONE BUT ASSUMED IT WAS THE DIAGONAL. THE THROMBUS WAS TREATED WITH BALLOON ANGIOPLASTY SUCCESSFULLY. THE PATIENT IS ASKING IF HAVING A POSSIBLE FRACTURED STENT OR HAVING A STENT THAT MAY HAVE MOVED WOULD MAKE IT DIFFICULT FOR HIM TO HAVE AN MRI OF HIS HIP. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Myocardial Infarction; Thrombosis

  MAUDE report 6316210 ↗
• MalfunctionSep 30, 2016Kinked; Stretched; Torn Material

  IT WAS REPORTED THAT A 3X38MM XIENCE ALPINE RX STENT DELIVERY SYSTEM (SDS) WAS REMOVED FROM THE PACKAGING, PREPPED AND ADVANCED TOWARD THE TARGET LESION AND THE PHYSICIAN FELT EITHER A KINKED OR STRETCHED DISTAL SHAFT. NO RESISTANCE WAS NOTED WHILE REMOVING THE SDS FROM THE PACKAGING. NO RESISTANCE WAS NOTED WHILE ADVANCING INTO THE PATIENT ANATOMY. A SAME SIZE ALPINE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. RETURNED DEVICE ANALYSIS REVEALED THAT THE DISTAL SHAFT WAS TORN AT THE GUIDE WIRE EXIT NOTCH EXTENDING DISTALLY FOR A LENGTH OF 7.7 CM. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5992047 ↗
• InjurySep 29, 2016Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT FOUR XIENCE ALPINE STENTS (3X15MM, 3X33MM, 3X38MM AND 3.5X38MM) WERE IMPLANTED ON (B)(6) 2016. ON (B)(6) 2016 THE PATIENT PRESENTED WITH DYSPNEA AND WAS RE-ADMITTED. THE SITE DOES NOT HAVE ANY FURTHER INFORMATION ON THIS INCIDENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Dyspnea

  MAUDE report 5988982 ↗
• MalfunctionSep 14, 2016Difficult to Remove; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN ECCENTRIC LESION (DIAMETER 3 MM X LENGTH 38 MM) LOCATED IN THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY WITH MILD TORTUOSITY AND HEAVY CALCIFICATION THAT WAS 90% STENOSED. A 3.0 X 38 MM XIENCE ALPINE STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TO THE LESION AND MET WITH RESISTANCE AT THE LESION AND WOULD NOT CROSS. THE SDS WAS REMOVED WITH RESISTANCE FROM THE ANATOMY. A NON-ABBOTT SDS WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WAS NO ADVERSE EFFECTS OR CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5951464 ↗
• MalfunctionAug 26, 2016Leak/Splash; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE 3.0X38MM XIENCE ALPINE STENT DELIVERY SYSTEM (SDS) WAS PREPARED INSIDE THE PATIENTS ANATOMY. WHILE PULLING NEGATIVE, BLOOD WAS NOTED COMING BACK. A LEAK WAS SUSPECTED. THE DEVICE WAS REMOVED AND A NON-ABBOTT SDS WAS USED IN REPLACEMENT. THERE WERE NO ADVERSE PATIENT EFFECTS AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5907091 ↗