XIENCE ALPINE 1125250-18Recalls & reported problems

Summary

The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 08717648199172), received between Aug 1, 2016 and Aug 29, 2018 — classified as 21 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (4 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 25 most recent of 28 reports, in the reporter's own words as published by the FDA.

• InjuryAug 29, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT FOUR XIENCE ALPINE STENTS (2.5X18MM, 2.25X18MM, 2.5X33MM, AND 3.0X18MM) WERE DEPLOYED; HOWEVER, THE PATIENT WAS RE-ADMITTED WITHIN 30 DAYS FOR UNKNOWN REASONS. AN ADDITIONAL XIENCE STENT WERE PLACED AS TREATMENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7829019 ↗
• InjuryJun 6, 2018Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE 2.50X18MM 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 CHEST PAIN. THE TREATMENT PERFORMED WAS NOT REPORTED AND THE FINAL PATIENT OUTCOME IS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina

  MAUDE report 7575877 ↗
• MalfunctionJun 6, 2018Break; Kinked; Physical Property Issue

  IT WAS REPORTED THAT UPON LOADING THE 2.5X18 MM XIENCE ALPINE STENT DELIVERY SYSTEM (SDS) ON THE GUIDE WIRE, IT WAS NOTED THAT THE MIDSHAFT DID NOT LOOK RIGHT AND IT DID NOT FEEL RIGHT; IRREGULAR APPEARANCE AND IRREGULAR FEEL. THE MIDSHAFT WAS NOT STRETCHED OR SEPARATED. HOWEVER, THERE WAS A SLIGHT KINK ON THE SHAFT. THE DEVICE DID NOT ENTER THE PATIENT ANATOMY. AN UNSPECIFIED SDS WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. RETURNED DEVICE ANALYSIS FOUND THAT THE INNER MEMBER WAS SEPARATED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7573615 ↗
• InjuryJun 4, 2018Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE 2.5X18MM XIENCE ALPINE STENT WAS IMPLANTED ON (B)(6) 2018. THE PATIENT PRESENTED WITH UNSTABLE ANGINA 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 7566677 ↗
• InjuryMay 22, 2018Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE INDEX PROCEDURE TOOK PLACE ON (B)(6) 2018 DURING WHICH A 2.5 X 18 MM AND A 2.5 X 15 MM XIENCE ALPINE STENT WERE IMPLANTED FOR TREATMENT OF AN UNSPECIFIED VESSEL. THE PATIENT WAS READMITTED TO THE HOSPITAL ON (B)(6) 2018 FOR 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 7535908 ↗
• InjuryApr 23, 2018Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED ON (B)(6) 2018 TO TREAT A LESION IN THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY. A 2.5 X 18 MM XIENCE ALPINE STENT WAS IMPLANTED SUCCESSFULLY. THE STENT IMPLANT WAS FULLY APPOSED. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED. THE PATIENT WAS DISCHARGED WITH NO COMPLICATIONS. THE PATIENT WAS COMPLIANT WITH DUAL ANTIPLATELET DRUG THERAPY AFTER THE PROCEDURE. ON (B)(6) 2018, THE PATIENT WAS RE-HOSPITALIZED WITH UNSTABLE CHEST PAIN WITH NON- ST-ELEVATION MYOCARDIAL INFARCTION (STEMI) AND WAS TREATED WITH MEDICATION. HOWEVER, IT WAS NOTED THAT THE PATIENT HAD A LUMP ON HER NECK. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. ON (B)(6) 2018, THE PATIENT RETURNED WITH CHEST PAIN AND IT WAS NOTED THAT THE LAD HAD CLOSED OFF. ANGIOGRAPHY CONFIRMED A DISTAL EDGE DISSECTION WHICH CAUSED IN-STENT THROMBOSIS. ANGIOPLASTY WAS PERFORMED WITH AN NC TREK BALLOON CATHETER AND A 2.75 X 23 XIENCE ALPINE STENT WAS USED TO TREAT THE IN-STENT THROMBOSIS SUCCESSFULLY. POST DILATATION WAS PERFORMED WITH A 3.0 X 20 MM NC TREK BALLOON CATHETER. THE PATIENT WAS DISCHARGED WITH A GOOD OUTCOME. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina; Intimal Dissection; Myocardial Infarction; Thrombosis

  MAUDE report 7453005 ↗
• InjuryMar 13, 2018Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 2.50 X 18 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 7334274 ↗
• InjuryMar 2, 2018Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 2.5 X18 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 RE-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 7311640 ↗
• MalfunctionJan 17, 2018Difficult to Remove; Failure to Advance; Material Deformation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN ECCENTRIC, DE NOVO LESION LOCATED IN THE HEAVILY CALCIFIED, MODERATELY TORTUOUS, 99% STENOSED LEFT ANTERIOR DESCENDING CORONARY ARTERY. AFTER PRE-DILATATION WAS PERFORMED, A 2.5 X 18 MM XIENCE ALPINE STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TO THE TARGET LESION; HOWEVER, IT WAS UNABLE TO CROSS. DURING REMOVAL OF THE SDS FROM THE ANATOMY THE STENT IMPLANT CAUGHT ON THE TIP OF THE GUIDING CATHETER WHICH RESULTED IN FLARED PROXIMAL STENT STRUTS. A NEW SAME SIZE DEVICE WAS ABLE TO CROSS THE TARGET LESION WITH THE USE OF A GUIDELINER CATHETER. THE PROCEDURE WAS COMPLETED AFTER STENTING. NO ADVERSE PATIENT EFFECTS OR CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE WERE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7202420 ↗
• InjuryOct 13, 2017Improper or Incorrect Procedure or Method; Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT THE HEAVILY CALCIFIED PROXIMAL TO MID SAPHENOUS VEIN GRAFT (SVG) IN THE RIGHT CORONARY ARTERY (RCA). THROMBECTOMY WAS PERFORMED FOLLOWED BY HEAVY PRE-DILATATION WITH BALLOON CATHETERS. THE 2.5X18MM RX ALPINE STENT DELIVERY SYSTEM (SDS) WAS ADVANCED; HOWEVER, WOULD NOT CROSS THE LESION AFTER SEVERAL ATTEMPTS. DURING RETRACTION, THE STENT DISLODGED FROM THE BALLOON. AN ATTEMPT WAS MADE TO ADVANCE A BALLOON CATHETER INTO THE DISLODGED STENT; HOWEVER THIS WAS UNSUCCESSFUL. NO ATTEMPTS WERE MADE TO SNARE THE DISLODGED STENT AND IT REMAINS IN THE PROXIMAL SVG. NO FURTHER ATTEMPTS WERE MADE TO TREAT THE LESION AS THE PATIENT WAS IN STABLE CONDITION. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND NO ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 6948742 ↗
• InjuryAug 30, 2017Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 2.5 X 18 MM XIENCE ALPINE STENT WAS IMPLANTED ON (B)(6) 2017. ON (B)(6) 2017 THE PATIENT WAS RE-ADMITTED WITH SHORTNESS OF BREATH. UNSPECIFIED TREATMENT WAS ADMINISTERED TO THE PATIENT. FINAL PATIENT OUTCOME IS REPORTEDLY UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Dyspnea

  MAUDE report 6831748 ↗
• InjuryAug 29, 2017Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 2.5X18 MM XIENCE ALPINE STENT WAS IMPLANTED ON (B)(6) 2017. ON (B)(6) 2017 THE PATIENT WAS RE-ADMITTED WITH ANGINA AND OTHER UNSPECIFIED CARDIOVASCULAR SYMPTOMS. UNSPECIFIED TREATMENT WAS ADMINISTERED TO THE PATIENT. FINAL PATIENT OUTCOME IS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina

  MAUDE report 6829077 ↗
• InjuryJun 21, 2017Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE INDEX PROCEDURE TOOK PLACE ON (B)(6) 2017 DURING WHICH A 2.5 X 18 MM XIENCE ALPINE WAS IMPLANTED FOR TREATMENT OF AN UNSPECIFIED VESSEL. THE PATIENT WAS READMITTED TO THE HOSPITAL ON (B)(6) 2017 FOR FEVER AND PAIN. MEDICATION WAS ADMINISTERED TO THE PATIENT, AND THE PATIENT WAS DISCHARGED AND SENT HOME. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Fever; Pain

  MAUDE report 6658645 ↗
• InjuryMay 23, 2017Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE INDEX PROCEDURES TOOK PLACE ON (B)(6) 2017 DURING WHICH A 2.5 X 15 MM XIENCE ALPINE AND A 2.5 X 18 MM XIENCE ALPINE WERE IMPLANTED FOR TREATMENT OF UNSPECIFIED VESSELS. THE PATIENT WAS READMITTED TO THE HOSPITAL ON (B)(6) 2017 FOR SEPSIS AND OTHER UNSPECIFIED CARDIAC VASCULAR SYMPTOMS. UNSPECIFIED TREATMENT WAS ADMINISTERED TO THE PATIENT. FINAL PATIENT OUTCOME IS REPORTEDLY UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Sepsis

  MAUDE report 6585393 ↗
• MalfunctionMay 22, 2017Leak/Splash

  IT WAS REPORTED THAT DURING A PROCEDURE OF THE MODERATELY CALCIFIED, NON-TORTUOUS, MID LEFT ANTERIOR DESCENDING ARTERY (LAD), AFTER PREDILATATION WITH A 2.5 X 12 MM NON-ABBOTT BALLOON DILATATION CATHETER (BDC), THE 2.5 X 18 MM XIENCE ALPINE STENT DELIVERY SYSTEM (SDS) WAS BEING INFLATED AT THE LESION, WHEN CONTRAST LEAKAGE WAS NOTED NEAR THE GUIDE WIRE EXIT NOTCH IN THE SHAFT. THE SDS AND THE STENT WERE CAREFULLY REMOVED FROM THE ANATOMY WITHOUT ISSUE. ANOTHER 2.5 X 18 MM XIENCE ALPINE WAS USED SUCCESSFULLY IN 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 6581921 ↗
• InjuryApr 21, 2017Difficult to Remove

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH UNSTABLE ANGINA AND THE PROCEDURE WAS TO TREAT A LESION IN THE NON-TORTUOUS, HEAVILY CALCIFIED, MID LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY. A 2.50 X 18 MM XIENCE ALPINE STENT DELIVERY SYSTEM (SDS) WAS SELECTED FOR THE PROCEDURE. AFTER THE SUCCESSFUL DEPLOYMENT OF THE STENT IN THE LESION, RESISTANCE WAS FELT DURING REMOVAL OF THE SDS FROM THE ANATOMY. AT SOME POINT DURING OR AFTER THE PROCEDURE THE PATIENT EXPERIENCED VENTRICULAR FIBRILLATION (VFIB) WHICH NECESSITATED THE USE OF A DEFIBRILLATOR TO SHOCK THE HEART BACK INTO SINUS RHYTHM. THE PATIENT WAS REPORTED TO HAVE RECOVERED AND DOING FINE. IN THE PHYSICIAN'S OPINION, THE RESISTANCE FELT DURING REMOVAL OF THE SDS DID NOT HAVE ANYTHING TO DO WITH THE VENTRICULAR FIBRILLATION THAT THE PATIENT EXPERIENCED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: Ventricular Fibrillation

  MAUDE report 6512013 ↗
• InjuryApr 21, 2017Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2016, A 2.5X18 RX XIENCE ALPINE AND A 2.75X18 RX XIENCE ALPINE DRUG-ELUTING STENT WAS EACH IMPLANTED FOR TREATMENT OF AN UNSPECIFIED VESSEL. ON (B)(6) 2016, THE PATIENT WAS REHOSPITALIZED DUE TO CHRONIC OBSTRUCTIVE PULMONARY DISEASE 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 6511493 ↗
• MalfunctionJan 30, 2017Difficult to Insert; Device Dislodged or Dislocated; Material Deformation

  IT WAS REPORTED THAT DURING A CORONARY PROCEDURE, THE 2.5 X 18 MM XIENCE ALPINE STENT DELIVERY SYSTEM WAS INSERTED INTO THE NON-ABBOTT HEMOSTASIS VALVE AND RESISTANCE WAS NOTED. THE STENT DELIVERY SYSTEM WAS REMOVED WITHOUT RESISTANCE; HOWEVER, IT WAS NOTED THAT THE STENT WAS NOT ON THE DELIVERY SYSTEM BALLOON. THE DISLODGED STENT REMAINED ON THE GUIDE WIRE, INSIDE THE HEMOSTASIS VALVE. THE GUIDE WIRE AND STENT WERE REMOVED WITHOUT DIFFICULTY AND THE STENT WAS NOTED TO BE CRUSHED ON THE GUIDE WIRE. A SECOND SAME SIZE XIENCE ALPINE WAS USED WITHOUT ISSUE. 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 6286785 ↗
• InjuryDec 30, 2016Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT TWO XIENCE ALPINE STENTS (2.5 X 18 MM, 3.25 X 23 MM) WERE IMPLANTED ON (B)(6) 2016. ON (B)(6) 2016 THE PATIENT WAS RE-ADMITTED WITH AN ST ELEVATED MYOCARDIAL INFARCTION (STEMI) AND OTHER UNSPECIFIED CARDIOVASCULAR SYMPTOMS. IT IS UNKNOWN WHAT TREATMENT WAS PERFORMED OR WHAT THE FINAL PATIENT OUTCOME WAS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Myocardial Infarction

  MAUDE report 6216656 ↗
• MalfunctionDec 21, 2016Inflation Problem; Leak/Splash

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A LESION IN THE LEFT ANTERIOR DESCENDING CORONARY ARTERY. THE 2.5X18 MM XIENCE ALPINE STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TO THE TARGET LESION WITHOUT RESISTANCE. HOWEVER, WHEN THE BALLOON WAS PRESSURIZED, TO 6 ATMOSPHERES THE BALLOON FAILED TO INFLATE. THE SDS WAS REMOVED, AND WHEN IT WAS FLUSHED A LEAK WAS OBSERVED ON THE DISTAL SHAFT. A SAME SIZE XIENCE ALPINE SDS WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6196440 ↗
• MalfunctionNov 22, 2016Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE LEFT ANTERIOR DESCENDING CORONARY ARTERY. HOWEVER, PRIOR TO ENTERING THE PATIENT ANATOMY WHILE LOADING THE 2.50X18 MM XIENCE ALINE STENT DELIVERY SYSTEM (SDS) ONTO THE GUIDE WIRE; THE STENT DISLODGED ON THE GUIDE WIRE. THE SDS DID NOT ENTER THE PATIENT ANATOMY. AN UNSPECIFIED SDS WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY DURING THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6122010 ↗
• InjuryOct 6, 2016Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2016, A 2.5X18 RX XIENCE ALPINE AND A 3.5X12 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 AND A PERFORATED BOWEL. THE PATIENT WAS TREATED WITH UNSPECIFIED SURGERY THEN THE PATIENT WAS DISCHARGED HOME WITH EXTENDED CARE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Perforation

  MAUDE report 6007956 ↗
• InjuryOct 4, 2016Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 2.5 X 18 MM XIENCE ALPINE STENT WAS IMPLANTED ON (B)(6) 2015. ON (B)(6) 2016, THE PATIENT WAS RE-ADMITTED WITH CARDIOVASCULAR SYMPTOMS INCLUDING HEART FAILURE. IT IS UNKNOWN WHAT TREATMENT WAS PERFORMED. THE FINAL PATIENT OUTCOME IS UNKNOWN AND THE PATIENT WAS DISCHARGED HOME. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Heart Failure

  MAUDE report 5996632 ↗
• MalfunctionSep 30, 2016Device Misassembled During Manufacturing /Shipping

  IT WAS REPORTED THAT DURING PREPARATION OF THE 2.5X18MM XIENCE ALPINE STENT DELIVERY SYSTEM (SDS) IT WAS NOTED THAT THE STENT WAS TIGHTLY CRIMPED BUT WAS NOT BETWEEN THE MARKERS. THE DEVICE WAS NOT USED, NO PATIENT INVOLVEMENT. A SAME SIZE XIENCE ALPINE SDS WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 5990521 ↗
• InjurySep 28, 2016Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 2.50 X 18 MM XIENCE ALPINE STENT WAS IMPLANTED ON (B)(6) 2015. ON (B)(6) 2015 ,THE PATIENT WAS RE-ADMITTED WITH OTHER CARDIOVASCULAR SYMPTOMS AND LEFT ARM PAIN. IT IS UNKNOWN WHAT TREATMENT WAS PERFORMED. THE PATIENT WAS DISCHARGED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Pain

  MAUDE report 5985338 ↗