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XIENCE ALPINE 1125225-12Recalls & reported problems

Abbott Vascular Inc. · XIENCE Alpine Everolimus Eluting Coronary Stent System 2.25 mm x 12 mm / Rapid-Exchange · Class 3 · Implant

All models of XIENCE ALPINE (72)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports
23
Deaths reported
0
Injuries reported
20
Recalls naming it
0

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 08717648199066), received between Sep 16, 2016 and Sep 25, 2018 — classified as 20 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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

Device problems

  • Adverse Event Without Identified Device or Use Problem16
  • Device Dislodged or Dislocated5
  • Difficult to Remove2
  • Failure to Advance2
  • Improper or Incorrect Procedure or Method2
  • Detachment Of Device Component1
  • Entrapment of Device1

Patient problems

  • Angina9
  • No Consequences Or Impact To Patient4
  • Myocardial Infarction3
  • No Code Available2
  • Thrombosis2
  • Dyspnea1
  • Fatigue1
  • Foreign Body In Patient1

Recent adverse event reports

The 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

  • InjurySep 25, 2018Entrapment of Device; Entrapment of Device

    IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A MODERATELY TORTUOUS LESION IN THE CIRCUMFLEX ARTERY. A 014 WHISPER EXTRA SUPPORT GUIDE WIRE WAS ADVANCED TO THE LESION; HOWEVER, RESISTANCE WITH THE ANATOMY WAS FELT. A 2.25X12MM XIENCE ALPINE STENT WAS ADVANCED AND SUCCESSFULLY DEPLOYED. AN ATTEMPT TO REMOVE THE GUIDE WIRE WAS MADE; HOWEVER, IT BECAME STUCK WITH THE DEPLOYED STENT AND THE GUIDE WIRE COULD NOT BE ADVANCED OR REMOVED. AN UNINFLATED BALLOON WAS ADVANCED TO HELP RELEASE THE GUIDE WIRE, BUT WAS UNSUCCESSFUL. IT WAS NOTED THAT THE TIP OF THE GUIDE WIRE SEPARATED. THE TIP WAS LEFT IN THE ANATOMY AND THE PATIENT WAS SENT BACK TO THE INTENSIVE CARE UNIT FOR OBSERVATION. A FEW HOURS LATER THE PATIENT HAD CHEST PAIN AND WAS SENT BACK TO THE CATHETER LAB. ANGIOGRAPHY CONFIRMED STENT THROMBOSIS. BALLOON ANGIOPLASTY WAS PERFORMED; HOWEVER, SINCE THE HOSPITAL DOES NOT HAVE A SURGICAL CENTER IT WAS DECIDED TO SEND THE PATIENT TO ANOTHER HOSPITAL FOR FURTHER INTERVENTION. THE PATIENT WAS TRANSFERRED TO ANOTHER HOSPITAL AND ADDITIONAL UNSPECIFIED STENTS WERE DEPLOYED TO SUCCESSFULLY TREAT THE THROMBOSIS. THE PATIENT IS DOING WELL. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Patient problems: Angina; Thrombosis

    MAUDE report 7908117 ↗
  • InjuryJun 26, 2018Adverse Event Without Identified Device or Use Problem

    ON (B)(6) 2017, A 2.25 X 12MM XIENCE ALPINE WAS IMPLANTED IN THE PROXIMAL CIRCUMFLEX ARTERY AND A 3.50 X 18MM XIENCE ALPINE WAS IMPLANTED IN THE MID RIGHT CORONARY ARTERY. THE NEXT DAY AFTER THE PROCEDURE, THE PATIENT EXPERIENCED A RASH ON HER TORSO, TREATMENT WAS NOT PROVIDED AT THE TIME. ADDITIONALLY, TWO DAYS LATER, THE PATIENT STARTED EXPERIENCING BREATHING ISSUES (COULDN'T BREATHE PROPERLY), AND EXCESSIVE YAWNING. IN (B)(6) 2017, THE PATIENT WENT TO THE HOSPITAL TO GET CHECKED FOR THE SHORTNESS OF BREATH AND RASH ON HER TORSO. PATIENT WAS GIVEN TWO ADVIL TABLETS. PHYSICIAN NOTED NO COMPLICATIONS OR ADVERSE EFFECTS ON THE PATIENT. THE PATIENT LEFT THE SAME DAY. IN (B)(6) 2018, THE PATIENT VISITED THE HOSPITAL FOR ANOTHER CHECK-UP AND WAS GIVEN A STRESS TEST. PER THE PHYSICIAN, THE STRESS TEST RESULT WAS NORMAL. THE PATIENT LEFT THE SAME DAY. IN (B)(6) 2018, THE PATIENT OPTED FOR A NEW PHYSICIAN. THE RASH REMAINS THE SAME AND HAS NOT WORSENED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Patient problems: Dyspnea; Fatigue; Hypersensitivity/Allergic reaction

    MAUDE report 7639750 ↗
  • InjuryJun 12, 2018Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT MULTI-VESSEL LESIONS, THE RAMUS AND LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERIES. THE RAMUS WAS TREATED WITH A 2.25 X 28 MM AND A 2.25 X 12 MM XIENCE ALPINE STENTS SUCCESSFULLY. HOWEVER, DURING TREATMENT OF THE LAD, THE PATIENT EXPERIENCED EKG CHANGES. ANGIOGRAPHY REVEALED THAT THE RAMUS WAS CLOTTING UP. THEREFORE, THE PHYSICIAN SWITCHED TO TREAT THE RAMUS BY USING HIGH PRESSURE BALLOONS TO 26 ATMOSPHERES AND ADMINISTERED MEDICATION. AFTER, THE PHYSICIAN CONTINUED WITH THE LAD WITH A SUCCESSFUL OUTCOME. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Patient problems: Non specific EKG/ECG Changes; Thrombosis

    MAUDE report 7592996 ↗
  • InjuryJun 5, 2018Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT THE 2.25 X 12 MM XIENCE ALPINE STENT WAS IMPLANTED ON (B)(6) 2018. THE PATIENT PRESENTED WITH CARDIAC THROMBOSIS BEFORE THE PROCEDURE. ON (B)(6) 2018, THE PATIENT WAS READMITTED WITH CARDIOVASCULAR SYMPTOMS, INCLUDING MYOCARDIAL INFARCTION. THE TREATMENT PERFORMED IS UNKNOWN AND THE FINAL PATIENT OUTCOME IS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Patient problems: Myocardial Infarction

    MAUDE report 7569223 ↗
  • InjuryMar 2, 2018Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT TWO XIENCE ALPINE STENTS (2.25 X 12 MM AND 2.25 X 18 MM) WERE 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 7311497 ↗
  • InjuryMar 2, 2018Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT TWO XIENCE ALPINE STENTS (2.25 X 12 MM AND 2.25 X 18 MM) WERE 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 7311491 ↗
  • InjuryMar 2, 2018Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT TWO XIENCE ALPINE STENTS (2.25 X 12 MM AND 2.25 X 18 MM) WERE 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 7311470 ↗
  • InjuryFeb 7, 2018Improper or Incorrect Procedure or Method; Failure to Advance; Device Dislodged or Dislocated

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE NON-TORTUOUS, MODERATELY CALCIFIED, 80 - 85% STENOSED, MID LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY. A 2.25 X 12 MM XIENCE ALPINE STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TO THE LESION, MET RESISTANCE WITH THE CALCIUM AND WOULD NOT CROSS THE LESION. ABOUT A DOZEN UNSUCCESSFUL ATTEMPTS WERE MADE TO CROSS THE LESION AND DURING SEVERAL OF THOSE ATTEMPTS, THE SDS WAS PULLED BACK INTO THE GUIDE CATHETER. DURING REMOVAL OF THE SDS FROM THE ANATOMY, THE STENT DISLODGED AND A SNARE WAS USED TO RETRIEVE THE STENT FROM THE ANATOMY. A NON-ABBOTT BALLOON CATHETER WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. 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 7248410 ↗
  • MalfunctionFeb 2, 2018Device Dislodged or Dislocated

    IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A TARGET LESION IN THE DIAGONAL ARTERY. A 6FRENCH GUIDE CATHETER AND A 6FRENCH GUIDE CATHETER EXTENSION WERE USED. THE 2.25 X 12 MM XIENCE ALPINE STENT DELIVERY SYSTEM WAS ADVANCED THROUGH THE GUIDE CATHETER EXTENSION; HOWEVER, UPON EXITING THE GUIDE CATHETER EXTENSION, THE STENT WAS NOT ON THE STENT DELIVERY SYSTEM BALLOON. IT WAS ASSUMED THAT THE STENT REMAINED IN THE GUIDE CATHETER EXTENSION. THE GUIDE CATHETER, GUIDE CATHETER EXTENSION AND STENT DELIVERY SYSTEM WERE REMOVED AS A SINGLE UNIT AND THE STENT WAS FOUND IN THE GUIDE CATHETER EXTENSION. NEW DEVICES WERE PREPARED AND A 2.25 X 12 MM XIENCE ALPINE STENT WAS DEPLOYED AT THE TARGET LESION WITHOUT ISSUE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 7236018 ↗
  • InjuryDec 20, 2017Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE MODERATELY TORTUOUS, HEAVILY CALCIFIED, MID LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY. A 2.25 X 12 MM XIENCE ALPINE STENT IMPLANT WAS SUCCESSFULLY DEPLOYED. FOLLOWING STENT DEPLOYMENT, SOMETHING HAZY WAS SEEN UNDER ANGIOGRAPHY IN THE LEFT MAIN CORONARY ARTERY, POSSIBLE DISSECTION. HOWEVER, NOTHING WAS DONE TO CONFIRM THAT IT WAS A DISSECTION AND NO TREATMENT WAS PERFORMED. THE PATIENT'S BLOOD PRESSURE DROPPED, DOPAMINE WAS ADMINISTERED, AND AN INTRA-AORTIC BALLOON PUMP (IABP) WAS USED TO HELP BRING UP THE PATIENT'S BLOOD PRESSURE. THE PATIENT LEFT THE CATH LAB IN STABLE CONDITION. NO OTHER INFORMATION WAS PROVIDED.

    Patient problems: Intimal Dissection; Low Blood Pressure/ Hypotension

    MAUDE report 7134716 ↗
  • InjuryAug 30, 2017Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT THREE XIENCE ALPINE STENTS (2.25 X 12 MM, 2.5 X 15 MM AND 2.5 X 18 MM) WERE IMPLANTED ON (B)(6) 2017. ON (B)(6) 2017 THE PATIENT WAS RE-ADMITTED WITH ANGINA AND AN ST ELEVATED MYOCARDIAL INFARCTION. UNSPECIFIED TREATMENT WAS ADMINISTERED TO THE PATIENT. FINAL PATIENT OUTCOME IS REPORTEDLY UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Patient problems: Angina; Myocardial Infarction

    MAUDE report 6831695 ↗
  • InjuryAug 30, 2017Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT THREE XIENCE ALPINE STENTS (2.25 X 12 MM, 2.5 X 18 MM AND 3.0 X 23 MM) WERE IMPLANTED ON (B)(6) 2017. ON (B)(6) 2017 THE PATIENT WAS RE-ADMITTED FOR CHOLECYSTITIS 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 Code Available

    MAUDE report 6831150 ↗
  • InjuryAug 30, 2017Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT ON 22 MAY 2017, A 2.25X12 RX XIENCE ALPINE DRUG-ELUTING STENT (DES), A 2.5X15 RX XIENCE ALPINE DES, AND A 2.0X8 RX MINI VISION BARE METAL STENT WAS EACH IMPLANTED FOR TREATMENT OF AN UNSPECIFIED VESSEL. ON (B)(6) 2017, THE PATIENT WAS REHOSPITALIZED DUE TO DIABETIC KETOACIDOSIS 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 Code Available

    MAUDE report 6830806 ↗
  • MalfunctionJun 13, 2017Improper or Incorrect Procedure or Method; Device Dislodged or Dislocated

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN UNKNOWN LESION. WHEN THE XIENCE ALPINE 2.25 X 12 MM STENT DELIVERY SYSTEM WAS ADVANCED IN THE PATIENT ANATOMY IT WAS NOTICED UNDER FLUOROSCOPY THAT THE STENT WAS NOT ON THE BALLOON. THE SDS WAS REMOVED FROM THE ANATOMY AND IT WAS DISCOVERED THAT THE STENT WAS FOUND ON A 4 X 4 CLOTH THAT WAS USED DURING PREPARATION. ANOTHER SAME SIZE XIENCE ALPINE WAS USED TO 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 6638230 ↗
  • 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 2.25 X 12 MM XIENCE ALPINE STENT AND A 3.25 X 12 XIENCE ALPINE STENT WAS PLACED FOR TREATMENT. THE PATIENT WAS READMITTED TO THE HOSPITAL ON (B)(6) 2016 EXPERIENCING SYMPTOMS ANGINA. ALTHOUGH THE TREATMENT PERFOMED IS UNSPECIFIED, THE FACT THAT REHOSPITALIZATION OCCURRED INDICATES THAT SOME FORM OF TREATMENT WAS PERFORMED. NO OTHER INFORMATION WAS PROVIDED.

    Patient problems: Angina

    MAUDE report 6501486 ↗
  • MalfunctionMar 24, 2017Detachment Of Device Component

    IT WAS REPORTED THAT THE PROXIMAL SHAFT OF THE 2.25 X 12 MM XIENCE ALPINE STENT DELIVERY SYSTEM SEPARATED DURING ADVANCEMENT INTO THE GUIDE CATHETER. BOTH DEVICES WERE REMOVED FROM THE ANATOMY. ANOTHER XIENCE ALPINE WAS USED WITH THE SAME GUIDE CATHETER 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 6434352 ↗
  • InjuryJan 5, 2017Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT A 2.25X12 MM XIENCE ALPINE STENT WAS IMPLANTED ON (B)(6) 2016. ON (B)(6) 2016 THE PATIENT WAS RE-ADMITTED TO THE HOSPITAL WITH CHEST PAIN LESS THAN 30 DAYS FROM THE DATE OF IMPLANT. IT IS UNKNOWN WHAT TREATMENT WAS PERFORMED AND THE PATIENT OUTCOME IS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Patient problems: Angina

    MAUDE report 6227252 ↗
  • InjuryOct 14, 2016Difficult to Remove; Failure to Advance; Device Dislodged or Dislocated

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE OBTUSE MARGINAL. THE 2.25 X 12 MM XIENCE ALPINE STENT DELIVERY SYSTEM (SDS) WAS BEING ADVANCED TO THE LESION AND RESISTANCE WAS FELT DUE TO HEAVY CALCIFICATION. AFTER THE FAILED ATTEMPT TO CROSS, RESISTANCE WAS ALSO FELT DURING REMOVAL OF THE SDS. THE STENT IMPLANT DISLODGED FROM THE BALLOON INTO THE CIRCUMFLEX. ATTEMPTS TO RETRIEVE THE STENT IMPLANT FAILED AND THE STENT REMAINS IN THE CIRCUMFLEX. IT IS UNKNOWN IF THE STENT IMPLANT WAS IMPLANTED OR CRUSHED TO THE VESSEL WALL. THE VESSEL WAS LEFT UNTREATED. THE PATIENT IS DOING WELL POST-PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE REPORTED. NO ADDITIONAL INFORMATION WAS REPORTED.

    Patient problems: Foreign Body In Patient

    MAUDE report 6030458 ↗
  • InjuryOct 11, 2016Difficult to Remove; Device Dislodged or Dislocated

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A POSTERIOR DESCENDING ARTERY OF A DISTAL RIGHT CORONARY ARTERY THAT HAD PREVIOUSLY BEEN TREATED AND WAS COVERED WITH STENTS (FULL METAL JACKET). A 2.25 X 12 MM XIENCE ALPINE STENT DELIVERY SYSTEM COULD NOT CROSS THROUGH ONE OF THE PREVIOUSLY PLACED STENTS AND WHEN ATTEMPTING TO REMOVE THE DEVICE THE STENT CAUGHT ON ONE OF THE DEPLOYED STENTS AND DISLODGED. ANOTHER STENT WAS DEPLOYED TO EMBED THE DISLODGED STENT OVER THE PREVIOUSLY PLACED STENTS. BALLOON ANGIOPLASTY WAS PERFORMED TO COMPLETE THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. THE PATIENT IS DOING FINE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Patient problems: Vessel Or Plaque, Device Embedded In

    MAUDE report 6018370 ↗
  • InjurySep 28, 2016Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT TWO XIENCE ALPINE STENTS, 2.25 X 12 AND 4.0 X 15 MM) WERE IMPLANTED ON (B)(6) 2016. ON (B)(6) 2016, THE PATIENT WAS RE-ADMITTED WITH BI-LATERAL WEAKNESS / FALLS / ACUTE RENAL FAILURE. IT IS UNKNOWN WHAT TREATMENT WAS PROVIDED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Patient problems: Renal Failure; Weakness

    MAUDE report 5985783 ↗
  • InjurySep 23, 2016Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT A 2.25 X 12 MM XIENCE ALPINE STENT WAS IMPLANTED ON (B)(6) 2015. ON (B)(6) 2015 THE PATIENT WAS RE-ADMITTED WITH CARDIOVASCULAR SYMPTOMS, INCLUDING CHEST PAIN. IT IS UNKNOWN WHAT TREATMENT WAS PERFORMED AND THE PATIENT WAS DISCHARGED TO HOME. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Patient problems: Angina

    MAUDE report 5975500 ↗
  • InjurySep 23, 2016Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT THE PATIENT HAD NON-ST ELEVATION MYOCARDIAL INFARCTION (NSTEMI) AND WAS IMPLANTED WITH A 2.25 X 12 MM, 2.50 X 12 MM, AND 3.0 X 08 MM XIENCE ALPINE STENTS ON (B)(6) 2016 WITHOUT REPORTED ISSUE. ON (B)(6) 2016 THE PATIENT WAS RE-ADMITTED TO THE HOSPITAL FOR MYOCARDIAL INFARCTION; OTHER TREATMENT WAS PROVIDED AND THE FINAL PATIENT OUTCOME IS UNKNOWN. THE PATIENT WAS DISCHARGED TO HOME. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Patient problems: Myocardial Infarction

    MAUDE report 5973332 ↗
  • InjurySep 16, 2016Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT A 2.25X12MM XIENCE ALPINE STENT WAS IMPLANTED ON (B)(6) 2016. ON (B)(6) 2016, THE PATIENT WAS RE-ADMITTED WITH CARDIOVASCULAR SYMPTOMS AND CHEST PAIN. IT IS UNKNOWN WHAT TREATMENT WAS PERFORMED. THE PATIENT WAS DISCHARGED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Patient problems: Angina

    MAUDE report 5958278 ↗

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