XIENCE ALPINE 1125400-15Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 08717648199615), received between Sep 28, 2016 and Jul 7, 2020 — classified as 1 death, 15 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (6 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 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 7, 2020Difficult to Remove; Improper or Incorrect Procedure or Method; Failure to Advance; Difficult to Advance; Device Dislodged or Dislocated; Difficult to Remove; Improper or Incorrect Procedure or Method; Failure to Advance; Difficult to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE RIGHT CORONARY ARTERY. A 4.0X18MM XIENCE ALPINE STENT DELIVERY SYSTEM (SDS) FAILED TO CROSS DUE TO RESISTANCE WITH THE ANATOMY. THE SDS WAS REMOVED. A 4.0X15MM XIENCE ALPINE SDS WAS ADVANCED THROUGH A NON-ABBOTT MICROCATHETER; HOWEVER, RESISTANCE WAS FELT WITH BOTH THE MICROCATHETER AND THE ANATOMY. THE SDS WAS FORCEFULLY PULLED BACK INTO THE MICROCATHETER AND AN ATTEMPT TO ADVANCE IT FURTHER WAS MADE. AFTER ADVANCING THE MICROCATHETER AN ATTEMPT TO ADVANCE THE SDS AGAIN WAS MADE, BUT RESISTANCE WAS FELT AND THE SDS WAS FORCED OUT OF THE MICROCATHETER RESULTING IN STRIPPING THE STENT OFF OF THE BALLOON LEAVING IT BEHIND IN THE MICROCATHETER. IT WAS NOTED THAT THE STENT WAS NOT ON THE BALLOON RIGHT AWAY AND WAS ABLE TO REMOVE THE SDS THROUGH THE MICROCATHETER RETRIEVING THE STENT WITH THE STENT BALLOON ON THE WAY OUT. THE PROCEDURE WAS SUCCESSFULLY COMPLETE WITH A 4.0X12MM XIENCE ALPINE 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 10241971 ↗
• MalfunctionApr 2, 2020Deflation Problem; Difficult to Remove; Improper or Incorrect Procedure or Method; Deflation Problem; Difficult to Remove; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE LEFT MAIN CORONARY ARTERY. A 4X15MM XIENCE ALPINE STENT DELIVERY SYSTEM (SDS) WAS ADVANCED, AND THE STENT WAS DEPLOYED. THE SDS WAS REMOVED FROM THE ANATOMY, BUT THEN THE SDS WAS REINSERTED AND USED FOR DILATATION. THE BALLOON OF THE SDS ONLY PARTIALLY DEFLATED AND WAS REMOVED ALONG WITH AN UNSPECIFIED GUIDE WIRE. 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 9916606 ↗
• InjuryJul 11, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2018 THE 4.0X15 MM XIENCE ALPINE STENT WAS IMPLANTED IN THE PROXIMAL RIGHT CORONARY ARTERY (RCA). ON (B)(6) 2019 THERE WAS IN-STENT RESTENOSIS WITH AN 85% STENOSIS IN THE PROXIMAL RCA. PERCUTANEOUS REVASCULARIZATION IN THE TARGET LESION WAS PERFORMED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Stenosis

  MAUDE report 8781953 ↗
• InjuryDec 10, 2018Adverse 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 UNDERWENT A CORONARY STENTING PROCEDURE, WITH IMPLANTATION OF A 4.0 X 15 MM XIENCE ALPINE STENT. ON (B)(6) 2018, THE PATIENT WAS RE-ADMITTED WITH CHEST PAIN AND UNSPECIFIED TREATMENT WAS PROVIDED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina

  MAUDE report 8149449 ↗
• InjurySep 5, 2018Adverse 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 UNDERWENT A CORONARY STENTING PROCEDURE, WITH IMPLANTATION OF THREE XIENCE ALPINE STENTS - A 4.0 X 15 MM, A 4.0 X 18 MM, AND A 4.0 X 28 MM. ON (B)(6) 2018, THE PATIENT WAS RE-HOSPITALIZED WITH CHEST PAIN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina

  MAUDE report 7844832 ↗
• InjuryMar 6, 2018Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 4.00 X 15 MM XIENCE ALPINE WAS IMPLANTED ON (B)(6) 2017. ON (B)(6) 2017 THE PATIENT WAS RE-ADMITTED WITH CARDIOVASCULAR SYMPTOMS INCLUDING CHEST PAIN. 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: Angina

  MAUDE report 7317356 ↗
• InjuryJan 30, 2018Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 75% STENOSED, MILDLY TORTUOUS AND MILDLY CALCIFIED DE NOVO LESION IN THE MID RIGHT CORONARY ARTERY. ON (B)(6) 2017, THE PATIENT PRESENTED WITH A SUB-ACUTE MYOCARDIAL INFARCTION. A 4.0X15MM XIENCE ALPINE STENT WAS IMPLANTED AND THE PATIENT WAS DISCHARGED ON (B)(6) 2017. ON (B)(6) 2018, THE PATIENT WAS RE-HOSPITALIZED WITH CHEST PAIN. AN ANGIOGRAM AND OPTICAL COHERENCE TOMOGRAPHY (OCT) CONFIRMED THROMBOSIS. THE THROMBOSIS WAS TREATED WITH A THROMBUS-ASPIRATION CATHETER, BALLOON DILATATION, AND A 3.5X22MM NON-ABBOTT STENT WAS IMPLANTED. THE PHYSICIAN SUSPECTED THAT THE STENT THROMBOSIS OCCURRED DUE TO THE PATIENT NOT TAKING DUAL ANTIPLATELET DRUG THERAPY AFTER STENTING. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina; Thrombosis

  MAUDE report 7229645 ↗
• InjuryJan 8, 2018Difficult to Remove; Device Dislodged or Dislocated

  IT WAS REPORTED THE PROCEDURE WAS A TRANSCATHETER AORTIC VALVE IMPLANTATION (TAVI). THE PHYSICIAN HAD CONCERNS REGARDING PROTECTION OF THE LEFT MAIN ARTERY; THEREFORE, A 4.0 X 15 MM XIENCE ALPINE STENT DELIVERY SYSTEM (SDS) WAS ADVANCED WITHOUT RESISTANCE INTO THE LEFT MAIN ARTERY TO MANAGE CORONARY OBSTRUCTION DURING TAVI. HOWEVER, THE PHYSICIAN DECIDED THAT THE STENT WAS TOO SHORT AND DECIDED TO REMOVE THE SDS. REPORTEDLY, THERE WAS NO ISSUE WITH LABELING, THE PHYSICIAN JUST CHOSE THE WRONG SIZE. DURING REMOVAL OF THE SDS, RESISTANCE WAS MET WITH THE CALCIFIED VESSEL AND WHEN THE STENT REACHED THE OSTIUM OF THE GUIDING CATHETER, THE STENT BECAME STUCK. THEREFORE, ALL DEVICES WERE REMOVED AS ONE UNIT, BUT THE STENT GOT HUNG UP WITH THE VESSEL AND DISLODGED IN THE RADIAL ARTERY. A SNARE DEVICE WAS USED TO RECOVER THE DISLODGED STENT SUCCESSFULLY. A NON-ABBOTT SDS WAS USED SUCCESSFULLY IN THE PROCEDURE. THERE WAS NO ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7172852 ↗
• InjuryOct 30, 2017Detachment Of Device Component

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A CORONARY PROCEDURE TO TREAT A TARGET LESION IN THE LEFT ANTERIOR DESCENDING ARTERY. NO DIFFICULTY WAS NOTED DURING ADVANCEMENT OF THE 4.0 X 15 MM XIENCE ALPINE STENT DELIVERY SYSTEM THROUGH THE RADIAL ACCESS AND THE STENT WAS DEPLOYED WITHOUT ISSUE. THE STENT DELIVERY SYSTEM WAS REMOVED FROM THE PATIENT ANATOMY AND NO DIFFICULTY WAS NOTED. ANGIOGRAPHY WAS PERFORMED AND IT WAS NOTED THAT THE BALLOON MARKERS REMAINED WITHIN THE STENT. IT WAS THEN NOTED THAT THE BALLOON OF THE STENT DELIVERY SYSTEM HAD SEPARATED AT THE GUIDEWIRE EXIT NOTCH. A SNARE DEVICE WAS ADVANCED AND WAS SUCCESSFULLY ABLE TO RETRIEVE THE SEPARATED BALLOON SEGMENT. NO PORTION OF THE STENT DELIVERY SYSTEM BALLOON REMAINS IN THE PATIENT ANATOMY. THERE WERE NO ADVERSE PATIENT SEQUELAE OR A CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6988946 ↗
• MalfunctionOct 19, 2017Difficult to Remove; Failure to Advance; Device Dislodged or Dislocated; Material Deformation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY TORTUOUS AND MODERATELY CALCIFIED CIRCUMFLEX ARTERY. A 4.0 X 15 MM XIENCE ALPINE STENT DELIVERY SYSTEM WAS BEING ADVANCED WHEN IT COULD NOT CROSS THE LESION DUE TO THE ANATOMY. AS THE DEVICE WAS BEING REMOVED, THE STENT CAUGHT IN THE TUOHY VALVE AND THE STENT WAS DAMAGED AND THEN DISLODGED FROM THE DELIVERY SYSTEM. THE STENT WAS REMOVED FROM THE TUOHY WITHOUT ISSUE. A NON-ABBOTT STENT WAS SUCCESSFULLY IMPLANTED 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 6963530 ↗
• InjuryAug 22, 2017Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A 4.0 X 15 MM XIENCE ALPINE STENT IMPLANTED ON (B)(6) 2016. THE PATIENT WAS REFERRED BY HER PRIMARY CARE PHYSICIAN TO AN ALLERGIST FOR A RASH THAT IS LOCATED ON HER CHEST. THE PATIENT HAS BEEN EXPERIENCING THE RASH SINCE THE DATE OF IMPLANT. NO TREATMENT HAS BEEN PERFORMED AT THIS TIME. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 6811989 ↗
• MalfunctionJun 28, 2017Collapse; Unstable

  IT WAS REPORTED THAT THE 4.0 X 15 MM XIENCE ALPINE WAS NOTED TO HAVE A DEFORMED TIP UPON REMOVAL FROM THE DISPENSER HOOP. THERE WAS NO PATIENT INVOLVEMENT AND NO CLINICALLY SIGNIFICANT DELAY. RETURNED DEVICE ANALYSIS NOTED THAT THE STENT WAS STATIONARY ON THE BALLOON, BUT WAS NOT BETWEEN THE MARKERS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 6676038 ↗
• MalfunctionJun 28, 2017Detachment Of Device Component; Device Difficult to Setup or Prepare

  IT WAS REPORTED THAT DURING PREPARATION OF THE 4.0 X 15 MM XIENCE ALPINE STENT DELIVERY SYSTEM, NEGATIVE WAS PULLED; HOWEVER, THE DEVICE WAS UNABLE TO BE CORRECTLY PREPPED. THE DEVICE WAS NOT USED. THERE WAS NO PATIENT INVOLVEMENT AND NO CLINICALLY SIGNIFICANT DELAY. RETURNED DEVICE ANALYSIS NOTED THAT THE TIP WAS SEPARATED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 6676034 ↗
• InjuryApr 24, 2017Device Damaged by Another Device; Material Deformation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED RIGHT CORONARY ARTERY (RCA). A 4.0 X 38 MM XIENCE ALPINE STENT DELIVERY SYSTEM WAS BEING ADVANCED; HOWEVER, THE DEVICE COULD NOT CROSS THE LESION DUE TO THE ANATOMY. A 4.0 X 15 MM XIENCE ALPINE STENT WAS DEPLOYED IN THE DISTAL RCA. A 4.0 X 23 MM XIENCE ALPINE STENT WAS DEPLOYED IN THE MID RCA, OVERLAPPING THE DISTAL STENT. A 4.0 X 15 MM XIENCE ALPINE STENT WAS DEPLOYED IN THE PROXIMAL RCA, OVERLAPPING THE MIDDLE STENT. THERE WERE NO ISSUES DURING DEPLOYMENT; HOWEVER, WHEN ATTEMPTING TO REMOVE THE NON-ABBOTT GUIDE WIRE, THE WIRE WAS STUCK IN THE STENTS AND COULD NOT BE REMOVED. SEVERAL ATTEMPTS WERE MADE TO REMOVE THE GUIDE WIRE WITH BALLOON CATHETERS, BUT IT COULD NOT BE REMOVED. FORCE WAS APPLIED TO TRY TO REMOVE THE GUIDE WIRE, BUT IT STARTED CRUMPLING THE PROXIMAL AND MIDDLE STENTS. THE PHYSICIAN PULLED HARD ON THE GUIDE WIRE AND IT SEPARATED LEAVING APPROXIMATELY 2 CM OF THE GUIDE WIRE IN THE RCA AND STICKING OUT OF THE OSTIUM. THE PATIENT HAD ST ELEVATION AND ANGIOGRAPHY CONFIRMED THROMBOSIS IN THE ENTIRE LENGTH OF THE RCA. THE PATIENT WAS PREPPED AND SENT FOR BYPASS SURGERY. THERE WAS A CLINICALLY

  Patient problems: Non specific EKG/ECG Changes; Thrombosis

  MAUDE report 6517114 ↗
• InjuryApr 24, 2017Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED RIGHT CORONARY ARTERY (RCA). A 4.0 X 38 MM XIENCE ALPINE STENT DELIVERY SYSTEM WAS BEING ADVANCED; HOWEVER, THE DEVICE COULD NOT CROSS THE LESION DUE TO THE ANATOMY. A 4.0 X 15 MM XIENCE ALPINE STENT WAS DEPLOYED IN THE DISTAL RCA. A 4.0 X 23 MM XIENCE ALPINE STENT WAS DEPLOYED IN THE MID RCA, OVERLAPPING THE DISTAL STENT. A 4.0 X 15 MM XIENCE ALPINE STENT WAS DEPLOYED IN THE PROXIMAL RCA, OVERLAPPING THE MIDDLE STENT. THERE WERE NO ISSUES DURING DEPLOYMENT; HOWEVER, WHEN ATTEMPTING TO REMOVE THE NON-ABBOTT GUIDE WIRE, THE WIRE WAS STUCK IN THE STENTS AND COULD NOT BE REMOVED. SEVERAL ATTEMPTS WERE MADE TO REMOVE THE GUIDE WIRE WITH BALLOON CATHETERS, BUT IT COULD NOT BE REMOVED. FORCE WAS APPLIED TO TRY TO REMOVE THE GUIDE WIRE, BUT IT STARTED CRUMPLING THE PROXIMAL AND MIDDLE STENTS. THE PHYSICIAN PULLED HARD ON THE GUIDE WIRE AND IT SEPARATED LEAVING APPROXIMATELY 2 CM OF THE GUIDE WIRE IN THE RCA AND STICKING OUT OF THE OSTIUM. THE PATIENT HAD ST ELEVATION AND ANGIOGRAPHY CONFIRMED THROMBOSIS IN THE ENTIRE LENGTH OF THE RCA. THE PATIENT WAS PREPPED AND SENT FOR BYPASS SURGERY. THERE WAS A CLINICALLY SIGNIFICANT

  Patient problems: Non specific EKG/ECG Changes; Thrombosis

  MAUDE report 6517080 ↗
• MalfunctionJan 19, 2017Difficult To Position; Difficult to Remove

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED LESION WITH 75% STENOSIS IN THE PROXIMAL RIGHT CORONARY ARTERY (RCA). AFTER PRE-DILATATION WAS PERFORMED, A 4.0X15MM XIENCE ALPINE STENT DELIVERY SYSTEM (SDS) WAS ADVANCED; HOWEVER, WHILE ADVANCING THROUGH THE GUIDING CATHETER, THERE WAS RESISTANCE NOTED. THE RESISTANCE WAS BETWEEN THE GUIDE WIRE AND THE XIENCE ALPINE SDS DURING ADVANCEMENT AND REMOVAL OF THE DEVICE. THE DEVICES WERE REMOVED AND REPLACED WITH A NEW GUIDE WIRE AND AN UNSPECIFIED 4.0X15MM SDS. THE PROCEDURE WAS SUCCESSFULLY COMPLETED AFTER STENT IMPLANTATION. 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 6264793 ↗
• InjuryJan 18, 2017Difficult To Position; Difficult to Remove; Device Dislodged or Dislocated

  REPORTEDLY THE PROCEDURE WAS TO TREAT A GRAFT TO THE OBTUSE MARGINAL ARTERY. A 4.0X15MM XIENCE ALPINE STENT DELIVERY SYSTEM (SDS) WAS ADVANCED OVER A PROWATER GUIDE WIRE THROUGH A 6FR SHEATH; HOWEVER, RESISTANCE WITH THE SHEATH WAS FELT WHILE ADVANCING. IT WAS DECIDED TO REMOVE THE DEVICE; HOWEVER, THE STENT GOT CAUGHT IN THE SHEATH AND DISLODGED. THE STENT DISLODGED IN THE LEFT COMMON FEMORAL ARTERY AND THE PHYSICIAN WENT IN THROUGH THE RIGHT COMMON FEMORAL ARTERY WITH A SNARE AND SNARED THE STENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER XIENCE ALPINE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6260824 ↗
• DeathJan 12, 2017Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE OSTIUM. A 4.0X15MM XIENCE ALPINE STENT WAS IMPLANTED; HOWEVER, IT LOOKED UNDERSIZED. IT WAS DECIDED TO POST-DILATE THE STENT; HOWEVER, THE PATIENT WENT INTO CARDIAC ARREST BEFORE ANOTHER DEVICE COULD BE ADVANCED. CHEST COMPRESSIONS WERE APPLIED, A PERCUTANEOUS VENTRICULAR ASSIST DEVICE WAS PUT IN, AND THE PATIENT WAS TAKEN TO THE INTENSIVE CARE UNIT. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE PATIENT DIED THE SAME DAY AS THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Cardiac Arrest; Death

  MAUDE report 6248349 ↗
• MalfunctionJan 5, 2017Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING PREPARATION OF A 4.0 X 15 MM XIENCE ALPINE STENT DELIVERY SYSTEM, WHEN REMOVING THE PROTECTIVE SHEATH AND STYLET, THE STENT DISLODGED. THERE WAS NO RESISTANCE REMOVING THE PROTECTIVE SHEATH. THE DEVICE WAS NOT USED. ANOTHER XIENCE ALPINE WAS SUCCESSFULLY USED TO COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 6226961 ↗
• InjuryOct 7, 2016Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A XIENCE ALPINE STENT (4X15MM) WAS IMPLANTED ON (B)(6) 2016. ON (B)(6) 2016 THE PATIENT PRESENTED WITH OTHER CARDIOVASCULAR SYMPTOMS AND WAS RE-ADMITTED LESS THAN 30 DAYS FROM THE IMPLANT DATE. THE SITE DOES NOT HAVE ANY FURTHER INFORMATION ON THIS INCIDENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 6011543 ↗
• InjuryOct 5, 2016Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER HAVING THE XIENCE ALPINE STENT IMPLANTED ON (B)(6) 2016, THE PATIENT HAS DEVELOPED AN ALLERGIC REACTION. THE HIVES INITIALLY STARTED ON (B)(6) 2016 AND HAS HAD MULTIPLE OCCURRENCES TO THIS DAY. MEDICATION HAS BEEN PRESCRIBED AND IS SCHEDULED FOR A FOLLOW-UP WITH HER PHYSICIAN TO DISCUSS HER CONTINUOUS SYMPTOM. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 6001929 ↗
• InjuryOct 4, 2016Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A XIENCE ALPINE 4 X 15 MM STENT WAS IMPLANTED ON (B)(6) 2016. ON (B)(6) 2016, THE PATIENT WAS RE-ADMITTED WITH SUBSEQUENT NON-ST SEGMENT ELEVATION MYOCARDIAL INFARCTION THAT WAS TREATED WITH MEDICATION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Myocardial Infarction

  MAUDE report 5996683 ↗
• InjurySep 28, 2016Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A XIENCE ALPINE 4.0 X 15 MM STENT WAS IMPLANTED ON (B)(6) 2016. ON (B)(6) 2016, THE PATIENT WAS RE-ADMITTED WITH DIZZINESS. A CT ANGIOGRAM REVEALED T-WAVE ABNORMALITY. IT IS UNKNOWN WHAT TREATMENT WAS GIVEN. THE PATIENT WAS DISCHARGED HOME. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Dizziness; Non specific EKG/ECG Changes

  MAUDE report 5985780 ↗