XIENCE ALPINE 1125250-12Recalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 08717648199158), received between Aug 16, 2016 and Nov 20, 2020 — classified as 20 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (7 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 25 most recent of 25 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 20, 2020Difficult to Remove; Failure to Advance; Difficult to Remove; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A DE NOVO LESION IN THE HEAVILY CALCIFIED, MILDLY TORTUOUS, 99% STENOSED RIGHT POSTERIOR DESCENDING CORONARY ARTERY. A 2.5X12MM XIENCE ALPINE STENT DELIVERY SYSTEM (SDS) FAILED TO CROSS DUE TO THE ANATOMY. THE DEVICE WAS REMOVED BUT EXPERIENCED RESISTANCE WITH THE ANATOMY. A NON-ABBOTT BALLOON WAS USED TO SUCCESSFULLY 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 10875685 ↗
• InjuryDec 11, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2018 A 2.50X12MM XIENCE ALPINE STENT AND A 2.75X28MM XIENCE ALPINE STENT WERE IMPLANTED. ON (B)(6) 2018 THE PATIENT WAS RE-ADMITTED FOR CIRRHOSIS WITH ASCITES AND OTHER CARDIOVASCULAR SYMPTOMS. THE TYPE OF INTERVENTION WAS NOT REPORTED AND FINAL PATIENT OUTCOME IS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8153572 ↗
• InjuryDec 11, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2018 A 2.50X12MM XIENCE ALPINE STENT AND A 2.50X15MM XIENCE ALPINE STENT WERE IMPLANTED. ON 07/19/2018 THE PATIENT WAS RE-ADMITTED FOR ANGINA AND OTHER CARDIOVASCULAR SYMPTOMS. THE TYPE OF INTERVENTION WAS NOT REPORTED AND FINAL PATIENT OUTCOME IS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina

  MAUDE report 8153556 ↗
• InjuryAug 17, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2018, TWO 2.5X12MM XIENCE ALPINE STENTS WERE IMPLANTED, ONE IN THE 2ND OBTUSE MARGINAL AND ONE IN THE 3RD OBTUSE MARGINAL CORONARY ARTERIES. A 2.5X23MM XIENCE ALPINE STENT WAS ALSO IMPLANTED IN THE 1ST DIAGONAL CORONARY ARTERY. REPORTEDLY, STENT PLACEMENT ANGIOGRAPHIC APPEARANCES WERE ACCEPTABLE. POST PROCEDURE AND PRIOR TO HOSPITAL DISCHARGE, THE PATIENT REPORTED ABDOMINAL CRAMPING AND TRIDIL INFUSION WAS PROVIDED. CHEST PAIN GRADE 9/10 WAS REPORTED AND AGGRASTAT INFUSION WAS INITIATED. ANOTHER ANGIOGRAM WAS PERFORMED. STENT THROMBOSIS WAS NOTED IN THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY, 1ST DIAGONAL, MID CIRCUMFLEX, AND OSTIAL 2ND OBTUSE MARGINAL. ANOTHER PERCUTANEOUS INTERVENTION WAS PERFORMED AS TREATMENT WITH ADDITIONAL STENT PLACEMENT. THE EVENT RESOLVED WITHOUT SEQUELA. THERE WAS NO DEVICE MALFUNCTION. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THIS ISSUE.

  Patient problems: Angina; Thrombosis

  MAUDE report 7794874 ↗
• InjuryAug 17, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2018, TWO 2.5X12MM XIENCE ALPINE STENTS WERE IMPLANTED, ONE IN THE 2ND OBTUSE MARGINAL AND ONE IN THE 3RD OBTUSE MARGINAL CORONARY ARTERIES. A 2.5X23MM XIENCE ALPINE STENT WAS ALSO IMPLANTED IN THE 1ST DIAGONAL CORONARY ARTERY. REPORTEDLY, STENT PLACEMENT ANGIOGRAPHIC APPEARANCES WERE ACCEPTABLE. POST PROCEDURE AND PRIOR TO HOSPITAL DISCHARGE, THE PATIENT REPORTED ABDOMINAL CRAMPING AND TRIDIL INFUSION WAS PROVIDED. CHEST PAIN GRADE 9/10 WAS REPORTED AND AGGRASTAT INFUSION WAS INITIAT ED. ANOTHER ANGIOGRAM WAS PERFORMED. STENT THROMBOSIS WAS NOTED IN THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY, 1ST DIAGONAL, MID CIRCUMFLEX, AND OSTIAL 2ND OBTUSE MARGINAL. ANOTHER PERCUTANEOUS INTERVENTION WAS PERFORMED AS TREATMENT WITH ADDITIONAL STENT PLACEMENT. THE EVENT RESOLVED WITHOUT SEQUELA. THERE WAS NO DEVICE MALFUNCTION. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THIS ISSUE.

  Patient problems: Angina; Thrombosis

  MAUDE report 7794871 ↗
• InjuryJun 7, 2018Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE 2.5X12MM 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 HYPERTENSION AND ON (B)(6) 2018 FOR CEREBRAL INFARCT. TREATMENT WAS PERFORMED AND THE FINAL PATIENT OUTCOME IS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: High Blood Pressure/ Hypertension; Stroke/CVA

  MAUDE report 7579541 ↗
• MalfunctionMay 22, 2018Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED LEFT ANTERIOR DESCENDING CORONARY ARTERY. AS A 2.50 X 12MM XIENCE ALPINE STENT DELIVERY SYSTEM WAS BEING BACKLOADED ONTO THE GUIDE WIRE, THE STENT CAME OFF THE BALLOON (OUTSIDE OF THE BODY) BEFORE ENTERING THE ROTATING HEMOSTATIC VALVE. THE DEVICE WAS THEN DISCARDED. ANOTHER STENT DELIVERY SYSTEM WAS 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 7534233 ↗
• InjuryApr 24, 2018Difficult to Remove; Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT DE NOVO LESIONS LOCATED IN THE CIRCUMFLEX AND BIFURCATION OF THE CIRCUMFLEX, THE LEFT MAIN WHICH WAS 80% STENOSED, AND THE LEFT ANTERIOR DESCENDING ARTERY USING XIENCE ALPINE STENT DELIVERY SYSTEMS (SDS). REPORTEDLY, A 2.5 X 28 MM AND 2.5 X 15 MM XIENCE ALPINE WERE ATTEMPTED TO CROSS; HOWEVER, NEITHER SDS WOULD CROSS DUE TO THE 80% STENOSIS IN THE LEFT MAIN. THE DECISION WAS MADE TO PLACE A 4.0 X 15 MM XIENCE ALPINE IN THE LEFT MAIN TO FACILITATE THE CROSSING OF THE SDS. AN ATTEMPT WAS MADE TO CROSS WITH A 2.5 X 12 MM XIENCE ALPINE WHICH CROSSED THROUGH THE DEPLOYED STENT EASILY; HOWEVER, DID NOT REACH THE LESION. DURING RETRACTION OF THE STENT DELIVERY SYSTEM, THE STENT IMPLANT CAUGHT INSIDE THE DEPLOYED STENT CAUSING THE STENT TO DISLODGE FROM THE BALLOON. A SNARE DEVICE WAS USED IN AN ATTEMPT TO CAPTURE THE STENT IMPLANT; HOWEVER, THIS FAILED. A NON-ABBOTT BALLOON CATHETER WAS ADVANCED AND INFLATED INSIDE THE DISLODGED STENT AND THE STENT WAS DEPLOYED INSIDE THE 4.0 X 15 MM STENT. THE PROCEDURE CONTINUED ON WITH THE SUCCESSFUL PLACEMENT OF THREE NON-ABBOTT STENTS. THE PATIENT WAS STABLE POST-PROCEDURE. NO ADDITIONAL INFORMATION WAS

  Patient problems: Foreign Body In Patient

  MAUDE report 7456951 ↗
• InjuryFeb 27, 2018Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THREE XIENCE ALPINE STENTS (2.5 X 12 MM (X2) AND 3.5 X 18 MM) WERE DEPLOYED SUCCESSFULLY ON (B)(6) 2017. THE PATIENT WAS READMITTED TO THE HOSPITAL ON (B)(6) 2017 FOR OTHER CARDIOVASCULAR SYMPTOMS AND CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD). 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: No Code Available

  MAUDE report 7299500 ↗
• InjuryDec 1, 2017Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT TWO 2.5 X 12 MM XIENCE ALPINE STENTS WERE IMPLANTED ON (B)(6) 2017. ON (B)(6) 2017, THE PATIENT WAS RE-ADMITTED WITH CARDIOVASCULAR SYMPTOMS. IT WAS FURTHER REPORTED THAT THE PATIENT HAD KIDNEY FAILURE. ALTHOUGH THE TREATMENT PERFORMED IS UNSPECIFIED, THE FACT THAT REHOSPITALIZATION 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 7077362 ↗
• InjuryDec 1, 2017Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 2.5 X 12 MM AND A 3.0 X 8 MM XIENCE ALPINE STENTS WERE IMPLANTED ON (B)(6) 2017. ON (B)(6) 2017, THE PATIENT WAS RE-ADMITTED WITH CARDIOVASCULAR SYMPTOMS INCLUDING ANGINA. 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: Angina

  MAUDE report 7077357 ↗
• InjuryOct 27, 2017Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A HEAVILY CALCIFIED, MODERATELY TORTUOUS LEFT MAIN CORONARY ARTERY TO OSTIAL CIRCUMFLEX ARTERY, THE 2.5X12 MM XIENCE ALPINE STENT DELIVERY SYSTEM MET RESISTANCE AND THE STENT DISLODGED IN THE LEFT MAIN. ATTEMPTS TO REMOVE THE DISLODGED STENT WITH A BALLOON WERE UNSUCCESSFUL. BALLOON DILATATION WAS PERFORMED AND A NON-ABBOTT STENT WAS USED TO EMBED THE DISLODGED STENT IN THE LEFT MAIN. ANOTHER NON-ABBOTT STENT WAS IMPLANTED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Vessel Or Plaque, Device Embedded In

  MAUDE report 6984505 ↗
• MalfunctionOct 18, 2017Difficult to Remove; Material Deformation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY. AFTER PLACING THE 2.5 X 12 MM XIENCE ALPINE STENT DELIVERY SYSTEM (SDS) INTO THE PATIENT IT WAS DETERMINED ON ANGIOGRAPHY THAT THE STENT WAS TOO SHORT FOR THE LESION. DURING RETRACTION OF THE SDS THE CATHETER CAUGHT ON THE TIP OF THE GUIDE CATHETER. AFTER RETRACTION THE STENT IMPLANT WAS OBSERVED TO HAVE A FLARED STENT STRUT. A NEW, LONGER STENT WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WAS NO ADVERSE PATIENT EFFECTS OR CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE REPORTED DUE TO THE DEVICE ISSUE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6960090 ↗
• MalfunctionOct 18, 2017Difficult to Remove; Improper or Incorrect Procedure or Method; Failure to Advance; Material Deformation

  IT WAS REPORTED THAT DURING A SAPHENOUS VEIN GRAFT PROCEDURE IN THE CIRCUMFLEX ARTERY, WHICH DID NOT HAVE ANY TORTUOSITY OR CALCIFICATION, AN ATTEMPT WAS MADE TO CROSS A 2.5 X 12 MM XIENCE ALPINE STENT THROUGH AN UNSPECIFIED IMPLANTED STENT IN THE LESION. HOWEVER, THE XIENCE ALPINE STENT FAILED TO CROSS THE LESION BECAUSE IT GOT STUCK WITH THE IMPLANTED STENT, AND THE STRUTS OF THE XIENCE ALPINE STENT BECAME FLARED AS WELL. THE ALPINE STENT CATHETER SYSTEM WAS THEREFORE PULLED OUT OF THE ANATOMY, AND DILATATION WAS DONE IN THE LESION. ANOTHER 2.5 X 12 MM XIENCE ALPINE STENT WAS THEN IMPLANTED 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 6959732 ↗
• InjuryAug 28, 2017Physical Resistance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A PROCEDURE OF THE MILDLY CALCIFIED, HEAVILY TORTUOUS, MID RIGHT CORONARY ARTERY (RCA), THE 2.5 X 12 MM XIENCE ALPINE STENT WAS BEING ADVANCED WITH THE ASSISTANCE OF A GUIDELINER WHEN, DURING MANIPULATION AT THE LESION, THE STENT DISLODGED IN THE ANATOMY. SEVERAL UNSUCCESSFUL ATTEMPTS TO SNARE THE DISLODGED STENT WERE MADE. ANOTHER 2.5 MM XIENCE ALPINE STENT WAS USED TO CRUSH THE STENT AGAINST THE VESSEL WALL IN THE MID RCA. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA OR A CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Vessel Or Plaque, Device Embedded In

  MAUDE report 6825206 ↗
• InjuryJul 3, 2017Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED LESION IN THE LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY. THE VESSEL WAS PRE-DILATED WITH AN UNSPECIFIED BALLOON DILATION CATHETER. THE 2.25X08 MM XIENCE ALPINE STENT DELIVERY SYSTEM (SDS) FAILED TO CROSS A PREVIOUSLY IMPLANTED STENT. THE SDS WAS REMOVED AND IT WAS NOTED THAT THE STENT HAD DISLODGED IN THE LAD. AN UNSPECIFIED STENT WAS USED TO CRUSH THE STENT AGAINST THE VESSEL WALL. AN ATTEMPT WAS MADE TO ADVANCE A 2.5X12 MM XIENCE ALPINE SDS IN THE PATIENT ANATOMY, HOWEVER THE SDS FAILED TO CROSS THE SAME PREVIOUSLY IMPLANTED STENT AND THE STENT DISLODGED IN THE LAD. ANOTHER STENT WAS USED TO CRUSH THE STENT AGAINST THE VESSEL WALL. NO ADDITIONAL TREATMENT WAS REQUIRED; THE PROCEDURE WAS COMPLETE AT THIS TIME. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Vessel Or Plaque, Device Embedded In

  MAUDE report 6684791 ↗
• MalfunctionMay 18, 2017Device Dislodged or Dislocated; Material Deformation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED PROXIMAL LEFT ANTERIOR DESCENDING ARTERY. A 2.5 X 12 MM XIENCE ALPINE STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TO THE LESION WITHOUT RESISTANCE AND INFLATED. THE DEVICE WAS REMOVED FROM THE ANATOMY WITHOUT ISSUE. ANGIOGRAPHY WAS PERFORMED AND THERE WAS NO STENT VISIBLE IN THE ANATOMY. A 2.5 X 23 MM XIENCE ALPINE SDS WAS BEING ADVANCED THROUGH THE CO-PILOT AND WHEN REACHING THE CONNECTION BETWEEN THE GUIDING CATHETER AND THE CO-PILOT THERE WAS STRONG RESISTANCE AND THE XIENCE ALPINE SDS COULD NOT BE ADVANCED. THE STENT DELIVERY SYSTEM WAS REMOVED AND THE CO-PILOT AND GUIDING CATHETER WERE PULLED BACK SLIGHTLY TO REVEAL THE 2.5 X 12 MM XIENCE ALPINE STENT THAT HAD DISLODGED WHEN ATTEMPTING TO ADVANCE EARLIER IN THE PROCEDURE. THE STENT WAS IN A BALL. THE STENT WAS REMOVED AND 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 6577111 ↗
• InjuryMay 5, 2017Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE CHRONIC TOTAL OCCLUDED LESION IN THE LEFT MAIN CORONARY ARTERY. THE 2.5X12 MM XIENCE ALPINE STENT DELIVERY SYSTEM (SDS) WAS ADVANCED IN THE PATIENT ANATOMY; HOWEVER, THE SDS FAILED TO CROSS THE TARGET LESION DUE TO RESISTANCE WITH A PREVIOUSLY IMPLANTED UNSPECIFIED STENT. WHILE ATTEMPTING TO ADVANCE THE SDS, THE STENT DISLODGED IN THE PATIENT ANATOMY. A SNARE DEVICE WAS USED TO REMOVE THE DISLODGED STENT FROM THE PATIENT ANATOMY. THE PATIENT IS STABLE. THERE WAS CLINICALLY SIGNIFICANT DELAY DURING THE PROCEDURE. A NEW XIENCE ALPINE SDS WAS USED TO COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6549606 ↗
• InjuryApr 18, 2017Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2016, A 2.5X12 RX XIENCE ALPINE DRUG-ELUTING STENT WAS IMPLANTED FOR TREATMENT OF AN UNSPECIFIED VESSEL. ON (B)(6) 2016, THE PATIENT WAS REHOSPITALIZED DUE TO ABNORMAL ECHOCARDIOGRAM TEST RESULTS WITH ATRIAL FIBRILLATION. UNSPECIFIED TREATMENT WAS ADMINISTERED AND THE FINAL PATIENT OUTCOME IS REPORTEDLY UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Atrial Fibrillation; Non specific EKG/ECG Changes

  MAUDE report 6501497 ↗
• 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 2.5 X 12 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 6501493 ↗
• InjuryApr 11, 2017Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2016, A 2.5X12 RX XIENCE ALPINE, A 2.75X8 RX XIENCE ALPINE, AND A 3.5X18 RX XIENCE ALPINE DRUG-ELUTING STENT WERE IMPLANTED FOR TREATMENT OF AN UNSPECIFIED VESSEL. ON (B)(6) 2016, THE PATIENT WAS REHOSPITALIZED DUE TO ABNORMAL ECHOCARDIOGRAM TEST RESULTS WITH VENTRICULAR TACHYCARDIA. UNSPECIFIED TREATMENT WAS ADMINISTERED AND THE FINAL PATIENT OUTCOME IS REPORTEDLY UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Non specific EKG/ECG Changes; Ventricular Tachycardia

  MAUDE report 6483363 ↗
• InjuryJan 11, 2017Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT WITHIN 30-DAYS POST-STENTING OF A CORONARY VESSEL WITH A XIENCE ALPINE STENT, THE PATIENT WAS RE-ADMITTED TO THE HOSPITAL WITH ABDOMINAL PAIN AND OTHER CARDIOVASCULAR SYMPTOMS. IT IS UNKNOWN WHAT TREATMENT WAS PERFORMED OR WHAT THE FINAL PATIENT OUTCOME WAS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Pain

  MAUDE report 6244428 ↗
• InjurySep 30, 2016Adverse Event Without Identified Device or Use Problem

  CORRECTION: THE STENT IMPLANT IS A 2.5 X 12 MM XIENCE ALPINE, NOT A 3.5 X 18 MM XIENCE ALPINE AS PREVIOUSLY REPORTED.

  Patient problems: Angina

  MAUDE report 5992099 ↗
• InjurySep 29, 2016Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2016 A 2.5X12 MM XIENCE ALPINE STENT WAS IMPLANTED IN AN UNSPECIFIED ARTERY. ON (B)(6) 2016, THE PATIENT WAS RE-ADMITTED FOR UNSPECIFIED CARDIOVASCULAR SYMPTOMS AND SURGERY WAS PERFORMED AS TREATMENT. ADDITIONALLY, THE PATIENT HAD A RIGHT CAROTID OCCLUSION REQUIRING A VASCULAR STENT. THE PATIENT WAS DISCHARGED TO HOME. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 5988008 ↗
• InjuryAug 16, 2016Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PRIOR TO THE INITIAL PROCEDURE ON (B)(6) 2014, THE PATIENT PRESENTED WITH MYOCARDIAL INFARCTION (MI). A 3.0 X 15 XIENCE XPEDITION STENT AND A NON-ABBOTT STENT WERE IMPLANTED IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. A NON-ABBOTT STENT WAS IMPLANTED IN THE DIAGONAL (D1). ANTI-PLATELET WAS PRESCRIBED. ON (B)(6) 2015, THE PATIENT STOPPED TAKING THE ANTI-PLATELET MEDICINE. ON (B)(6) 2016, THE PATIENT PRESENTED WITH ACUTE CORONARY SYNDROME (ACS), STENOSIS WAS OBSERVED NEAR THE DISTAL EDGE (IN-SEGMENT) OF THE 3.0 X 15 MM XIENCE XPEDITION STENT IN THE LAD AND AT THE PROXIMAL EDGE OF THE NON-ABBOTT STENT IN THE D1. THROMBUS ASPIRATION WAS PERFORMED AND A 2.5 MM BALLOON WAS USED FOR PRE-DILATATION OF THE LESION. A 2.5 X 12 XIENCE ALPINE STENT WAS IMPLANTED OVERLAPPING WITH THE 3.0 X 15 MM XIENCE XPEDITION. ANTI-PLATELET WAS PRESCRIBED. ON (B)(6) 2016, THE PATIENT WAS TRANSFERRED TO THE HOSPITAL BY AMBULANCE WITH MI. ANGIOGRAPHY WAS PERFORMED, 99% STENOSIS WAS CONFIRMED AROUND THE OVERLAPPED AREA OF A 3.0 X 15 MM XIENCE XPEDITION STENT AND THE 2.5 X 12 MM XIENCE ALPINE STENT. AS THE STENOSIS WAS OBSERVED 50 DAYS AFTER THE DEPLOYMENT OF THE 2.5 X 12 MM XIENCE ALPINE, THROM

  Patient problems: Myocardial Infarction; Nausea; Stenosis; Thrombosis

  MAUDE report 5880113 ↗