XIENCE ALPINE 1125300-28Recalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 08717648199370), received between Sep 27, 2016 and Jun 2, 2020 — classified as 19 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (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 25 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 2, 2020Deflation Problem; Difficult to Remove; Material Separation; Improper or Incorrect Procedure or Method; Deformation Due to Compressive Stress; Material Too Soft/Flexible; Deflation Problem; Difficult to Remove; Material Separation; Improper or Incorrect Procedure or Method; Deformation Due to Compressive Stress; Material Too Soft/Flexible

  IT WAS REPORTED THAT DURING A CORONARY ARTERY INTERVENTION, AFTER DEPLOYING THE XIENCE ALPINE STENT, THE STENT DELIVERY SYSTEM (SDS) BALLOON WAS USED TO POST DILATE THE IMPLANTED STENT; HOWEVER, AFTER THE SECOND OR THIRD INFLATION, THE BALLOON FAILED TO DEFLATE AND BECAME SOFTENED. THE SDS WAS PULLED WITH FORCE TO THE GUIDING CATHETER AND THE SHEATH, RESULTING IN THE DISTAL SHAFT SEPARATING. THE ENTIRE SYSTEM, INCLUDING THE SEPARATED DISTAL SHAFT, WAS REMOVED AS ONE UNIT. UPON REMOVAL, IT WAS NOTED THAT THE PROXIMAL SHAFT WAS DISTORTED AND SMASHED. THERE WAS NO ADVERSE PATIENT EFFECT OR A CLINICALLY SIGNIFICANT DELAY IN PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10112788 ↗
• InjuryDec 23, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT ID: (B)(6). IT WAS REPORTED THAT THE 3.0X28 MM XIENCE ALPINE STENT WAS IMPLANTED IN THE MID LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY. AT THE END OF THE CASE, PLAQUE SHIFT WAS NOTED TO HAVE SHIFTED FROM THE LAD INTO THE DIAGONAL ARTERY. THERE WERE ST ELEVATIONS ON THE ELECTROCARDIOGRAM. AFTER THE PROCEDURE, THE PATIENT HAD CHEST PAIN WITH NAUSEA. MEDICATIONS (TRIDIL, ZOFRAN, CANGELOR) WERE ADMINISTERED, BUT NONE OF THESE MEDICATIONS WERE GIVEN TO TREAT THE PLAQUE SHIFT; THEREFORE, THE CONDITION IS ONGOING. TRIDIL WAS GIVEN FOR THE CHEST PAIN. NO INTERVENTION WAS PERFORMED FOR THE PLAQUE SHIFT BECAUSE THE VESSEL SIZE OF THE DIAGONAL WAS TOO SMALL. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina; Nausea; Non specific EKG/ECG Changes; Prolapse

  MAUDE report 9510965 ↗
• InjuryNov 14, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBSEQUENT TO THE INITIAL 30-DAY MEDWATCH REPORT, THE FOLLOWING INFORMATION WAS RECEIVED: ON (B)(6) 2019, THE PATIENT UNDERWENT A REVASCULARIZATION PROCEDURE. THE RESTENOSIS IN THE 3.0 X 28 MM XIENCE ALPINE STENT WAS TREATED WITH A 3.0 X 26 MM NON-ABBOTT DRUG ELUTING BALLOON AND A 2.5 X 20 MM NON-ABBOTT DRUG ELUTING BALLOON. POST PROCEDURE, THE PATIENT WAS DOING WELL. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina; Dyspnea; Stenosis

  MAUDE report 9324526 ↗
• InjuryOct 11, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2017, THREE XIENCE ALPINE STENTS WERE IMPLANTED IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY AND DIAGONAL BIFURCATION LESIONS. ON (B)(6) 2019, THE PATIENT PRESENTED, SYMPTOMATIC, AND WAS DIAGNOSED WITH ST-ELEVATION MYOCARDIAL INFARCTION (STEMI). ANGIOGRAPHY REVEALED THROMBOSIS IN ALL 3 STENTS. BALLOON ANGIOPLASTY WAS PERFORMED TO TREAT THE THROMBOSIS AND FLOW WAS RESTORED. NO ADDITIONAL TREATMENT WAS PERFORMED, AND THE PATIENT HAD A GOOD OUTCOME. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina; Myocardial Infarction; Thrombosis

  MAUDE report 9182937 ↗
• InjuryApr 22, 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 PATIENT UNDERWENT A CORONARY STENTING PROCEDURE, WITH IMPLANTATION OF A 3.0 X 28 MM XIENCE ALPINE STENT IN THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY AND A 2.25 X 08 MM XIENCE ALPINE STENT IN THE MID LAD. ON (B)(6) 2019, THE PATIENT EXPERIENCED WORSENING CHEST PAIN AND WAS RE-HOSPITALIZED. IN-STENT RESTENOSIS WAS NOTED WITHIN THE XIENCE ALPINE STENT. ON (B)(6) 2019, A REVASCULARIZATION PROCEDURE WAS PERFORMED AND ON (B)(6) 2019, THE EVENT WAS NOTED AS RESOLVED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina; Stenosis

  MAUDE report 8537683 ↗
• MalfunctionMar 8, 2019Difficult to Remove; Improper or Incorrect Procedure or Method; Device Dislodged or Dislocated; Difficult to Remove; Improper or Incorrect Procedure or Method; Device Dislodged or Dislocated

  SUBSEQUENT TO THE INITIALLY FILED REPORT, THE FOLLOWING INFORMATION WAS RECEIVED: THERE WAS NOT RESISTANCE FELT WHEN REMOVING THE 3.0X28MM XIENCE ALPINE STENT DELIVERY SYSTEM FROM ITS DISPENSER COIL. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 8405174 ↗
• InjuryAug 3, 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 3.0 X 28 MM XIENCE ALPINE STENT IN THE PROXIMAL CIRCUMFLEX ARTERY. ON (B)(6) 2018, THE PATIENT EXPERIENCED ANGINA AND VOMITING. MYOCARDIAL INFARCTION WAS DIAGNOSED AND CORONARY ANGIOGRAPHY NOTED THROMBUS WITHIN THE IMPLANTED XIENCE ALPINE STENT. ASPIRATION THROMBECTOMY WAS PERFORMED AND THE EVENT RESOLVED (B)(6) 2018. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina; Myocardial Infarction; Nausea; Thrombosis

  MAUDE report 7749318 ↗
• InjuryJun 11, 2018Adverse 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 3.0 X 28 MM XIENCE ALPINE STENT IN THE PROXIMAL CIRCUMFLEX (CX) ARTERY. ON (B)(6) 2018, THE PATIENT EXPERIENCED CHEST PAIN AND WAS RE-HOSPITALIZED. MEDICATION WAS ADMINISTERED. ELECTROCARDIOGRAM NOTED CHANGES WITH INFERIOR MYOCARDIAL INFARCTION (MI). CORONARY ANGIOGRAPHY WAS PERFORMED AND NOTED THROMBUS IN THE IMPLANTED XIENCE ALPINE STENT. REVASCULARIZATION, WITH THROMBECTOMY, WAS PERFORMED AT THE TARGET LESION AND THE PATIENT CONDITION RESOLVED. ON (B)(6) 2018, THE PATIENT EXPERIENCED ANGINA AND VOMITING AND WAS RE-HOSPITALIZED WITH ACUTE MI. TROPONIN LEVELS WERE ELEVATED AND INDICATED MI. MEDICATION WAS ADMINISTERED AS TREATMENT OF THE ANGINA AND VOMITING. CORONARY ANGIOGRAPHY NOTED THROMBUS IN THE XIENCE ALPINE STENT IN THE CX ARTERY. REVASCULARIZATION, WITH THROMBECTOMY, WAS PERFORMED AS TREATMENT OF THE ANGINA, THROMBUS AND MI. ON (B)(6) 2018, THE PATIENT WAS RE-HOSPITALIZED WITH COMPLAINTS OF ANGINA AND TROPONIN LEVELS WERE NOTED TO BE ELEVATED. MEDICATION WAS ADMINISTERED AS TREATMENT OF THE ANGINA; HOWEVER, NO TREATMENT WAS PROVIDED FOR THE ELEVATED TROPONIN LEVE

  Patient problems: Angina; Cardiac Enzyme Elevation; Myocardial Infarction; Nausea; Thrombosis

  MAUDE report 7588827 ↗
• InjuryJun 5, 2018Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 3.0 X 28 MM XIENCE ALPINE WAS IMPLANTED ON (B)(6) 2018. ON (B)(6) 2018 THE PATIENT WAS RE-ADMITTED WITH OCCLUSION OF LOWER EXTREMITY 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 7571856 ↗
• InjuryMay 11, 2018Deflation Problem; Kinked; Stretched

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A DE NOVO LESION IN A MODERATELY TORTUOUS MID LEFT ANTERIOR DESCENDING ARTERY (LAD) THAT WAS 90% STENOSED. AN UNSPECIFIED GUIDE WIRE CROSSED THE LESION AND AN OPTICAL FREQUENCY DOMAIN IMAGING (OFDI) WAS PERFORMED. PRE-DILATATION WAS THEN DONE WITH A 3.0 X 15 MM TRAVELER BALLOON DILATATION CATHETER AT 8 ATMOSPHERES (ATMS) THREE TIMES. A 3.0 X 28 MM XIENCE ALPINE STENT WAS IMPLANTED IN THE LESION AND WAS DILATED THREE TIMES AT 10 ATMS, 12 ATMS AND 12 ATMS, AND THEN A 3.25 X 23 MM XIENCE ALPINE STENT WAS DEPLOYED PROXIMALLY TO THE IMPLANTED STENT (OVERLAPPING IT) AT 10 ATMS FOUR TIMES. ANOTHER OFDI WAS PERFORMED AND IT WAS DETERMINED THAT FURTHER POST-DILATATION WAS NEEDED FOR THE 3.0 X 28 MM XIENCE ALPINE STENT. THEREFORE, THE STENT DELIVERY BALLOON OF THE 3.0 X 28 MM XIENCE ALPINE STENT WAS REINSERTED TO POST DILATE IT AT 18 ATMS. HOWEVER, THE BALLOON WOULD NOT DEFLATE; THEREFORE, NEGATIVE PRESSURE WAS APPLIED SEVERAL TIMES WITH AN INFLATION DEVICE TO INFLATE THE BALLOON BUT IT WAS STILL NOT POSSIBLE TO DEFLATE IT. THEN, AN UNSPECIFIED GUIDE WIRE AND AN UNSPECIFIED MICROCATHETER WERE ADVANCED IN ORDER TO RUPTURE THE BALLOON; HOWEVER, T

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7509002 ↗
• InjuryApr 30, 2018Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PROCEDURE ON (B)(6) 2018 WAS TO TREAT A MILDLY TORTUOUS, PROXIMAL LEFT ANTERIOR DESCENDING ARTERY (LAD) THAT WAS 100% STENOSED. THE PATIENT PRESENTED WITH A MYOCARDIAL INFARCTION (MI). AFTER ASPIRATING THROMBOSIS, A 3.0 X 28 MM XIENCE ALPINE STENT WAS SUCCESSFULLY DEPLOYED AND POST-DILATED. INTRAVASCULAR ULTRASOUND (IVUS) CONFIRMED THE STENT WAS FULLY OPPOSED THE VESSEL WALL. THE PATIENT WAS PRESCRIBED DUAL ANTIPLATELET THERAPY (DAPT) OF ASPIRIN AND PRASUGREL AND DISCHARGED FROM THE HOSPITAL ON (B)(6) 2018. ON (B)(6) 2018 THE PATIENT RETURNED TO THE HOSPITAL WITH ACUTE MI AND CARDIAC FAILURE DUE TO IN-STENT THROMBOSIS. THE PATIENT HAD DISCONTINUED THEIR DAPT. THE CARDIAC FAILURE WAS TREATED WITH DRUG THERAPY. ANGIOGRAPHY WAS PERFORMED TO CONFIRM THROMBOSIS. THROMBUS ASPIRATION AND BALLOON ANGIOPLASTY WERE PERFORMED WITH A GOOD TIMI 3 BLOOD FLOW. AS OF (B)(6) 2018 THE PATIENT REMAINS HOSPITALIZED UNDERGOING CARDIAC REHABILITATION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Heart Failure; Myocardial Infarction; Thrombosis

  MAUDE report 7474280 ↗
• InjuryApr 13, 2018Difficult or Delayed Positioning

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE MILDLY TORTUOUS, MILDLY CALCIFIED, 75% STENOSED, MID LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY USING A 3.00 X 28 MM XIENCE ALPINE STENT DELIVERY SYSTEM (SDS). THE SDS WAS ADVANCED TO THE LESION AND THE STENT IMPLANT WAS SUCCESSFULLY DEPLOYED. APPROXIMATELY ONE HOUR POST PROCEDURE, THE PATIENT DEVELOPED CHEST PAIN AND A THROMBUS WAS CONFIRMED BY ANGIOGRAPHY AND INTRAVASCULAR ULTRASOUND (IVUS) TO BE WITHIN THE STENT IMPLANT. THERE WAS A POSSIBILITY THAT THE APPOSITION OF THE STENT IMPLANT WAS NOT COMPLETE AS IT WAS AN ANGIOGRAPHY GUIDED PERCUTANEOUS CORONARY INTERVENTION (PCI). THROMBUS ASPIRATION WAS PERFORMED AND AN UNSPECIFIED STENT IMPLANT WAS DEPLOYED OVERLAPPING THE PROXIMAL END OF THE XIENCE ALPINE STENT. THE TIMI FLOW INCREASED FROM 1 TO 3 FOLLOWING THE INTERVENTION. IT WAS THE PHYSICIAN'S OPINION THAT THE RELATIONSHIP BETWEEN THE THROMBUS AND THE XIENCE ALPINE STENT WAS LOW. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: Angina; Thrombosis

  MAUDE report 7430440 ↗
• InjuryMar 13, 2018Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 3.0 X 28 MM XIENCE ALPINE WAS IMPLANTED ON (B)(6) 2017. ON (B)(6) 2017 THE PATIENT WAS RE-ADMITTED WITH CARDIOVASCULAR SYMPTOMS INCLUDING UNSTABLE ANGINA. A 2.75 X 15 MM XIENCE ALPINE STENT WAS SUCCESSFULLY DEPLOYED TO TREAT THE ANGINA. THE FINAL PATIENT OUTCOME IS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina

  MAUDE report 7334244 ↗
• InjuryFeb 20, 2018Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE 3.0X28MM RX XIENCE ALPINE STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TO THE CALCIFIED LESION IN THE PROXIMAL RIGHT CORONARY ARTERY (RCA). THE STENT WAS DEPLOYED HOWEVER AN EDGE DISSECTION WAS NOTED. AN UNKNOWN STENT WAS USED TO TREAT THE DISSECTION. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND NO ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Intimal Dissection

  MAUDE report 7283702 ↗
• InjuryNov 29, 2017Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT TWO XIENCE ALPINE STENTS (3.0X28MM AND 3.5X18MM) WERE IMPLANTED ON (B)(6) 2017. ON (B)(6) 2017 THE PATIENT WAS RE-ADMITTED FOR ATHEROSCLEROSIS HEART DISEASE AND ABNORMAL EKG/ECG. UNSPECIFIED TREATMENT WAS ADMINISTERED TO THE PATIENT. FINAL PATIENT OUTCOME IS REPORTEDLY UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Non specific EKG/ECG Changes

  MAUDE report 7068876 ↗
• InjurySep 20, 2017Difficult to Remove; Improper or Incorrect Procedure or Method; Device Damaged by Another Device

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE DIAGONAL SAPHENOUS GRAFT. A NON-ABBOTT FILTER WAS PLACED AND THE 3.0X28 MM XIENCE ALPINE STENT WAS IMPLANTED WITHOUT ISSUE. WHEN REMOVING THE FILTER WIRE, THE WIRE GOT CAUGHT ON THE STRUTS OF THE IMPLANTED ALPINE STENT. A GUIDELINER WAS USED TO REMOVE THE WIRE. RETRACTION OF THE GUIDE WIRE RESULTED IN THE DEPLOYED STENT BEING EXPLANTED ALONG WITH THE GUIDE WIRE. A 3.0X33 MM ALPINE STENT WAS IMPLANTED WITHOUT ISSUE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY DURING THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6879558 ↗
• InjuryAug 30, 2017Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH A MYOCARDIAL INFARCTION AND THROMBECTOMY WAS PERFORMED. FOLLOWING, A 3.0X28MM XIENCE ALPINE STENT WAS IMPLANTED IN THE MID LEFT ANTERIOR DESCENDING (MLAD). POST IMPLANTATION, A MLAD PERFORATION OCCURRED. A 2.8X19MM GRAFTMASTER STENT WAS IMPLANTED; HOWEVER, THERE WAS STILL MINIMAL EXTRAVASATION (LEAKING) NOTED. A DILATATION BALLOON CATHETER WAS INFLATED FOR 5 MINUTES AS TREATMENT AND THE PERFORATION SEALED. DURING THIS PROCEDURE, THE PATIENT EXPERIENCED CHEST PAIN; NITROGLYCERIN WAS PROVIDED. THE EVENT RESOLVED WITHOUT ISSUE. FOLLOWING, A 2.5X15MM XIENCE ALPINE STENT WAS IMPLANTED IN ANOTHER LESION WITHOUT ISSUE. THE PATIENT IS IN STABLE CONDITION AND IS REPORTEDLY DOING FINE. PER PHYSICIAN, THE GRAFTMASTER STENT DID NOT CAUSE OR CONTRIBUTE TO COMPLICATIONS OR ADVERSE EVENTS. THERE WAS NO ADDITIONAL INFORMATION PROVIDED REGARDING THIS ISSUE.

  Patient problems: Angina; Perforation

  MAUDE report 6831966 ↗
• MalfunctionAug 8, 2017Improper or Incorrect Procedure or Method; Device Misassembled During Manufacturing /Shipping; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE STENT WAS OBSERVED TO BE SHIFTED ON THE BALLOON DURING PREPARATION OF A 3.0 X 28MM XIENCE ALPINE. THE PHYSICIAN TRIED TO MOVE THE STENT TO THE ORIGINAL POSITION; HOWEVER, THE STENT DISLODGED FROM THE BALLOON. THERE WAS NO PATIENT INVOLVEMENT. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE. A NEW XIENCE ALPINE WAS USED TO COMPLETE THE PROCEDURE. THE PHYSICIAN COMMENTED THAT PREPARATION OF THE DEVICE WAS DONE BY A DOCTOR IN TRAINING AND THE STENT MIGHT HAVE CAUGHT ON THE PROTECTIVE SHEATH DURING REMOVAL, BUT THIS COULD NOT BE CONFIRMED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 6775193 ↗
• MalfunctionMay 3, 2017Detachment Of Device Component; Difficult to Insert

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE LEFT ANTERIOR DESCENDING CORONARY ARTERY. THE XIENCE ALPINE 3.0 X 28 STENT COULD NOT BE LOADED ON THE GUIDE WIRE. ANOTHER SAME SIZE 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. RETURN DEVICE ANALYSIS REVEALED THE INNER MEMBER WAS SEPARATED 8 MM DISTAL TO THE GUIDE WIRE EXIT NOTCH.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6541407 ↗
• InjuryApr 18, 2017Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2016, A 3.0X28 RX XIENCE ALPINE DRUG-ELUTING STENT WAS IMPLANTED FOR TREATMENT OF AN UNSPECIFIED VESSEL. REPORTEDLY, ON (B)(6) 2017, THE PATIENT WAS REHOSPITALIZED DUE TO OTHER UNSPECIFIED CARDIOVASCULAR SYMPTOMS, INCLUDING ACUTE CONGESTIVE HEART FAILURE. UNSPECIFIED TREATMENT WAS ADMINISTERED AND THE FINAL PATIENT OUTCOME IS REPORTEDLY UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Heart Failure

  MAUDE report 6501627 ↗
• InjuryApr 11, 2017Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2016, A 3.0 X 28 RX XIENCE ALPINE AND A 3.5 X 28 RX XIENCE ALPINE DRUG-ELUTING STENT WERE IMPLANTED FOR TREATMENT OF AN UNSPECIFIED VESSEL. ON (B)(6) 2016, THE PATIENT WAS REHOSPITALIZED DUE TO OTHER UNSPECIFIED CARDIOVASCULAR SYMPTOMS, INCLUDING FLUID OVERLOAD (HYPERVOLEMIA). 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 6482159 ↗
• MalfunctionFeb 17, 2017Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING UNPACKAGING, THE PROTECTIVE SHEATH WAS REMOVED WITHOUT RESISTANCE FROM THE 3.0 X 28 MM XIENCE ALPINE STENT DELIVERY SYSTEM (SDS) AND THE STENT DISLODGED FROM THE BALLOON AND WAS LOCATED ON THE PREPPING TABLE. THE SDS WAS NOT USED. A SAME SIZE XIENCE APLINE SDS WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE.

  Patient problems: No Patient Involvement

  MAUDE report 6341805 ↗
• InjuryFeb 2, 2017Difficult or Delayed Positioning; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MILDLY TORTUOUS AND HEAVILY CALCIFIED, 90% STENOSED, DE NOVO LESION IN THE RIGHT CORONARY ARTERY. A 3.0X28 MM XIENCE ALPINE STENT DELIVERY SYSTEM (SDS) WAS ADVANCED IN THE PATIENT ANATOMY; HOWEVER, DURING THE FIRST INFLATION ATTEMPT THE BALLOON RUPTURED BEFORE REACHING 12 ATMOSPHERES (ATM). THE STENT WAS ABLE TO BE IMPLANTED, BUT WAS NOT FULLY EXPANDED. THE SDS WAS REMOVED FROM THE PATIENT ANATOMY AND A NON-ABBOTT BALLOON DILATATION CATHETER WAS USED TO POST-DILATE THE 3.0X28 MM 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 6298853 ↗
• MalfunctionDec 23, 2016Break; Kinked; Difficult To Position

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN ECCENTRIC DE NOVO LESION LOCATED IN THE MID LEFT ANTERIOR DESCENDING CORONARY ARTERY THAT WAS MILDLY TORTUOUS, NON-CALCIFIED AND 90% STENOSED. DUE TO A BUILD-UP OF THROMBUS ON THE FILTER GUIDE WIRE AFTER THROMBUS ASPIRATION WAS PERFORMED, THE 3.0 X 28 MM XIENCE ALPINE MET RESISTANCE WITH THE GUIDE WIRE AND WAS UNABLE TO ADVANCE ANY FURTHER SO THE DEVICE WAS REMOVED FROM THE ANATOMY. THE MID-SHAFT WAS CONFIRMED TO BE KINKED. THE DEVICE WAS REPLACED WITH A SAME SIZE XIENCE ALPINE TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO REPORTED ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED. RETURN DEVICE ANALYSIS REVEALED AN INNERMEMBER SEPARATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6203449 ↗
• InjurySep 27, 2016Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 3.25 X 12 MM XIENCE ALPINE, A 3.5 X 18 MM XIENCE ALPINE AND A 3.0 X 28 MM XIENCE ALPINE STENTS WERE IMPLANTED ON (B)(6) 2016. ON (B)(6) 2016, THE PATIENT WAS RE-ADMITTED WITH CARDIOVASCULAR SYMPTOMS INCLUDING PERICARDITIS/DRESSLER SYNDROME. THERE WAS NO TREATMENT PERFORMED. THE FINAL PATIENT OUTCOME IS UNKNOWN AND THE PATIENT WAS DISCHARGED TO HOME. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 5981265 ↗