XIENCE ALPINE 1125300-18Recalls & reported problems

Summary

The FDA's MAUDE database contains 33 adverse event reports that list this exact device (DI 08717648199356), received between Aug 19, 2016 and Mar 30, 2020 — classified as 1 death, 25 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Inflation Problem” (3 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 33 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 30, 2020Leak/Splash; Product Quality Problem; Leak/Splash; Product Quality Problem

  IT WAS REPORTED THAT DURING UNPACKING OF THE 3.0 X 18 MM XIENCE ALPINE STENT DELIVERY SYSTEM (SDS) , THE STENT WAS NOTED TO BE DEFECTIVE. THEREFORE, THE SDS WAS NOT USED. THERE WAS NO PATIENT INVOLVEMENT. A NEW 3.0 X 18 MM XIENCE ALPINE SDS WAS USED TO THE COMPLETE THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. RETURN DEVICE ANALYSIS FOUND A LEAK COMING OUT FROM THE CRACK ON THE HUB. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 9899562 ↗
• InjuryJan 7, 2020Patient-Device Incompatibility; Patient-Device Incompatibility

  PATIENT ID: (B)(6). IT WAS REPORTED THAT ON (B)(6) 2018, A 3.0X18MM (1125300-18, 8021261) XIENCE ALPINE STENT WAS IMPLANTED IN THE MID LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY LESION. STENT MALPOSITION AND A PROXIMAL EDGE DISSECTION WAS OBSERVED. ADDITIONAL POST-DILATATION WAS PERFORMED AS TREATMENT. REPORTEDLY, FOLLOWING THE ADDITIONAL POST-DILATATION (USING THE MAXIMUM BALLOON SIZE AND MAXIMUM PRESSURE), THERE REMAINED SUB-OPTIMAL, DISTAL STENT EXPANSION. NO ADDITIONAL TREATMENT WAS PROVIDED. ON (B)(6) 2019, THE PATIENT WAS HOSPITALIZED FOR INCREASING DYSPNEA, CHEST TIGHTNESS/PAIN, AND FATIGUE. ANOTHER CARDIAC CATHETERIZATION WAS PERFORMED AND LAD IN-STENT RESTENOSIS WAS OBSERVED ALONG WITH SEVERE THREE VESSEL DISEASE. ON (B)(6) 2019, A CORONARY ARTERY BYPASS SURGERY WAS PERFORMED AS TREATMENT. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THIS ISSUE.

  Patient problems: Angina; Dyspnea; Fatigue; Intimal Dissection; Stenosis

  MAUDE report 9560331 ↗
• MalfunctionSep 4, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED PROXIMAL CIRCUMFLEX ARTERY. A 3.0 X 18 MM XIENCE ALPINE WAS ADVANCED TO THE LESION WITHOUT RESISTANCE AND WAS INFLATED ONCE AT 16 ATMOSPHERES. IT WAS THEN NOTED THAT THE BALLOON WAS LOSING PRESSURE. THE STENT WAS ULTIMATELY DEPLOYED. STANDARD POST-DILATATION WAS PERFORMED WITH AN NC BALLOON AFTERWARDS. PER THE PHYSICIAN, THERE WAS NO LEAK NOTED PRIOR TO THE PROCEDURE AND THE LOST OF PRESSURE CANNOT BE EXPLAINED. THERE WAS NO CLINICALLY SIGNIFICANT DELAY OR ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8960804 ↗
• InjuryFeb 19, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2016, A 3.0 X 18 MM XIENCE ALPINE 3 X 18 MM STENT WAS IMPLANTED IN THE MID LEFT ANTERIOR DESCENDING CORONARY ARTERY. SINCE THIS TIME, THE PATIENT HAS CONTINUED TO EXPERIENCE ANGINA. ON (B)(6) 2017, A NON-ABBOTT STENT WAS IMPLANTED, POSSIBLY OVERLAPPING THE ALPINE STENT; HOWEVER, THE PATIENT CONTINUES TO EXPERIENCE CHEST PAIN. OVER THE LAST 3 MONTHS, THE PATIENT HAS SEEN THEIR CARDIOLOGIST, BUT HAS NOT RECEIVED ANY FURTHER TREATMENT, ONLY STRESS TESTS. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: Angina

  MAUDE report 8351247 ↗
• InjuryNov 26, 2018Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT ON (B)(6) 2018 ONE 2.25X15 MM XIENCE ALPINE STENT WAS IMPLANTED IN THE PROXIMAL LEFT ANTERIOR DESCENDING CORONARY ARTERY AND ONE 3.0X18 MM XIENCE ALPINE STENT WAS IMPLANTED IN THE DISTAL LEFT CIRCUMFLEX CORONARY ARTERY. THE PATIENT WAS COMPLIANT WITH THE DUAL ANTIPLATELET THERAPY, BUT CLOPIDOGREL WAS DISCONTINUED BY THE PHYSICIAN AT THE 3 MONTH ASSESSMENT. ON (B)(6) 2018 THE PATIENT HAD ANGINA THAT LASTED A DAY AND A HALF. THIS WAS DIAGNOSED AS A NON ST ELEVATION MYOCARDIAL INFARCTION. LONG ACTING NITRATES WERE ADMINISTERED AND BRILINTA WAS PRESCRIBED. THE CONDITION RESOLVED ON (B)(6) 2018. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina; Myocardial Infarction

  MAUDE report 8102627 ↗
• InjurySep 11, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT PRESENTED WITH NON-ST ELEVATION MYOCARDIAL INFARCTION (N-STEMI). ON (B)(6) 2018, THE 3.0X18MM AND 3.0X28MM XIENCE ALPINE STENTS WERE IMPLANTED. ON (B)(6) 2018 THE PATIENT WAS RE-ADMITTED WITH CARDIOVASCULAR SYMPTOMS INCLUDING SYNCOPE. ON (B)(6) 2018 THE PATIENT WAS RE-ADMITTED WITH HEMORRHAGIC DISORDER. THE TYPE OF INTERVENTION HAS NOT BEEN REPORTED AND FINAL PATIENT OUTCOME IS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Syncope

  MAUDE report 7866749 ↗
• InjurySep 11, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2017, A 3.0X18MM XIENCE ALPINE STENT WAS IMPLANTED. ON (B)(6) 2018, THE PATIENT WAS RE-ADMITTED WITH STENT RESTENOSIS. A 3.0X15MM XIENCE ALPINE STENT WAS DEPLOYED TO TREAT THE RESTENOSIS. ON (B)(6) 2018, THE PATIENT WAS RE-ADMITTED WITH CHEST PAIN 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: Stenosis

  MAUDE report 7866598 ↗
• InjuryAug 1, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE STENT WAS IMPLANTED ON (B)(6) 2018. ON (B)(6) 2018, THE PATIENT WAS RE-ADMITTED WITH CARDIOVASCULAR SYMPTOMS. TREATMENT PERFORMED WAS UNSPECIFIED AND THE FINAL PATIENT OUTCOME WAS DETERMINED AS NO PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7739964 ↗
• InjuryJun 5, 2018Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 3.0 X 18MM XIENCE ALPINE CORONARY STENT SYSTEM WAS IMPLANTED ON (B)(6) 2018 . ON (B)(6) 2018 THE PATIENT WAS RE-ADMITTED WITH A RECTAL ULCER 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 7571959 ↗
• MalfunctionJun 1, 2018Positioning Failure; Material Rupture

  IT WAS REPORTED THAT DURING INFLATION OF THE 3.0X18MM ALPINE STENT, THE BALLOON WAS NOTED TO HAVE A HOLE. THE STENT DELIVERY SYSTEM (SDS) WITH THE STENT STILL ON THE BALLOON WAS RETRACTED FROM THE PATIENT ANATOMY AND THE PROCEDURE COMPLETED WITH A NEW DEVICE. 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 7561709 ↗
• InjuryMar 13, 2018Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 3.0 X 18 MM XIENCE ALPINE AND A 4.0 X 18 MM XIENCE ALPINE WERE IMPLANTED (B)(6) 2017. ON (B)(6) 2017 THE PATIENT WAS RE-ADMITTED WITH CARDIOVASCULAR SYMPTOMS AND PULMONARY EDEMA. 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 7334122 ↗
• InjuryFeb 19, 2018Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2018, THE PATIENT PRESENTED WITH ABNORMAL STRESS TEST AND STABLE ANGINA. THE PROCEDURE WAS TO TREAT A LESION IN THE MILDLY CALCIFIED, MID CIRCUMFLEX CORONARY ARTERY. THE 3.0X18 MM XIENCE ALPINE STENT WAS IMPLANTED IN THE MID CIRCUMFLEX WITH GOOD RESULTS. A FEW MINUTES AFTER THE PROCEDURE WAS COMPLETED AND DEVICES WERE REMOVED; ANGIOGRAPHY CONFIRMED STENT THROMBOSIS IN THE IMPLANTED XIENCE ALPINE STENT. BALLOONING WITH AN UNSPECIFIED WAS PERFORMED AND EVERYTHING WAS FINE. HOWEVER, A FEW MINUTES LATER, AGAIN ANGIOGRAPHY CONFIRMED STENT THROMBOSIS; INTRAVASCULAR ULTRASOUND (IVUS) WAS DONE AND BALLOONING WAS PERFORMED AGAIN. THIS TIME, HEPARIN WAS DISCONTINUED AND IT WAS SWITCHED FOR INTEGRILIN. ACTIVATED CLOTTING TIME (ACT) WAS 200. THE PATIENT IS DOING WELL. THERE WERE NO ADVERSE PATIENT SEQUELAE AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Thrombosis

  MAUDE report 7280349 ↗
• InjuryDec 8, 2017Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE INDEX PROCEDURE TOOK PLACE ON (B)(6) 2017 DURING WHICH A 3.0 X 18 MM XIENCE ALPINE STENT WAS IMPLANTED FOR TREATMENT OF AN UNSPECIFIED VESSEL. THE PATIENT WAS READMITTED TO THE HOSPITAL ON (B)(6) 2017 FOR POST OPERATIONAL COMPLICATIONS IN THE FEMORAL ARTERY 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 7100000 ↗
• InjuryDec 6, 2017Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 3.0 X 18 MM AND 4.0 X 8 MM XIENCE ALPINE STENTS WERE IMPLANTED ON (B)(6) 2017. ON (B)(6) 2017, THE PATIENT WAS RE-ADMITTED WITH CARDIOVASCULAR SYMPTOMS. IT WAS FURTHER REPORTED THAT THE PATIENT HAD GASTROINTESTINAL OBSTRUCTION. 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 7088503 ↗
• InjuryNov 28, 2017Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT TWO 3.0X18MM XIENCE ALPINE STENTS WERE IMPLANTED ON (B)(6) 2017. ON (B)(6) 2017 THE PATIENT WAS RE-ADMITTED FOR ANGINA 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: Angina

  MAUDE report 7065689 ↗
• InjuryAug 29, 2017Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 3.0X18 MM XIENCE ALPINE STENT WAS IMPLANTED ON (B)(6)2017. ON (B)(6) 2017 THE PATIENT WAS RE-ADMITTED WITH CHEST PAIN 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: Angina

  MAUDE report 6829050 ↗
• InjuryAug 29, 2017Difficult or Delayed Positioning

  IT WAS REPORTED THAT ON (B)(6) 2017, THE PATIENT UNDERWENT A CORONARY PROCEDURE. AN ATHERECTOMY DEVICE, FOLLOWED BY A CUTTING BALLOON WAS USED TO PRE-TREAT THE PROXIMAL TO DISTAL RIGHT CORONARY ARTERY (RCA). A 2.5 X 38 MM XIENCE ALPINE STENT WAS DEPLOYED IN THE MID TO DISTAL RCA AND A 3.0 X 18 MM XIENCE ALPINE STENT WAS DEPLOYED IN THE PROXIMAL TO MID RCA. THE STENTS WERE DEPLOYED IN AN OVERLAPPING MANNER. POST DILATATION WAS PERFORMED. OPTICAL FREQUENCY DOMAIN IMAGING (OFDI) WAS PERFORMED AND NOTED THAT THE PROXIMAL EDGE OF THE 3.0 X 18 MM XIENCE ALPINE STENT WAS SLIGHTLY MALAPPOSED; HOWEVER, THIS WAS DEEMED ACCEPTABLE AND THE PROCEDURE WAS COMPLETED. THE PATIENT WAS DISCHARGED TO HOME ON (B)(6) 2017. ON (B)(6) 2017, THE PATIENT BEGAN TO EXPERIENCE EXERTIONAL CHEST PAIN, AND ON (B)(6) 2017, EXPERIENCED CHEST PAIN AT REST. THE PATIENT WAS RE-HOSPITALIZED. CORONARY ANGIOGRAPHY AND INTRAVASCULAR ULTRASOUND (IVUS) NOTED IN-STENT THROMBOSIS, STARTING AT THE PROXIMAL EDGE OF THE 3.0 X 18 MM XIENCE ALPINE STENT, AND EXTENDING TO BOTH STENTS. INTERVENTION WAS PERFORMED, WITH THROMBUS ASPIRATION AND BALLOON ANGIOPLASTY. CORONARY ANGIOGRAPHY PERFORMED ON (B)(6) 2017 NOTED NO ANOMALIES AND T

  Patient problems: Angina; Thrombosis

  MAUDE report 6828729 ↗
• InjuryAug 1, 2017Deflation Problem; Inflation Problem; Difficult to Remove; Improper or Incorrect Procedure or Method; Physical Resistance

  FOLLOW UP INFORMATION RECEIVED STATING THAT THE DEVICE WAS NOT PREPPED INSIDE THE PATIENT ANATOMY AS INITIALLY REPORTED. THE DEVICE WAS PREPPED OUTSIDE THE ANATOMY PER THE INSTRUCTIONS FOR USE.

  Patient problems: Angina; Bradycardia; Intimal Dissection; Low Blood Pressure/ Hypotension

  MAUDE report 6757282 ↗
• InjuryJun 15, 2017Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE GRAFTMASTER STENT WAS USED TO TREAT A CORONARY ANEURYSM THAT OCCURRED IN THE PROXIMAL RIGHT CORONARY ARTERY (RCA). THE GRAFTMASTER WAS DEPLOYED COVERING THE ENTIRE LENGTH OF THE ANEURYSM. A 3.0 X 18 MM XIENCE ALPINE WAS PLACED AT THE PROXIMAL SEGMENT OF THE GRAFTMASTER. ANGIOGRAPHY WITH AN IVUS CATHETER SHOWED TIMI 3 FLOW. PRIOR TO LEAVING THE CATHETERIZATION LAB THE PATIENT COMPLAINED OF SEVERE CHEST PAIN AND THE ECHOCARDIOGRAM (ECG/EKG) REVEALED NEW ST ELEVATION OF THE INFERIOR LEADS AND EVIDENCE OF STENT THROMBOSIS IN THE ENTIRE STENTED REGION. BALLOON ANGIOPLASTY WAS PERFORMED, RESOLVING THE THROMBUS AND IMPROVING THE BLOOD FLOW IN THE VESSEL. ANGIOGRAPHY AND INTRAVASCULAR ULTRASOUND (IVUS) REVEALED GREAT APPOSITION OF THE STENTS. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina; Non specific EKG/ECG Changes; Thrombosis

  MAUDE report 6644901 ↗
• InjuryMay 24, 2017Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE INDEX PROCEDURE TOOK PLACE ON (B)(6) 2017 DURING WHICH A 3.0 X 18 MM, 3.5 X 12 MM AND A 3.5 X 38 MM XIENCE ALPINE WERE IMPLANTED FOR TREATMENT OF AN UNSPECIFIED VESSEL. THE PATIENT WAS READMITTED TO THE HOSPITAL ON (B)(6) 2017 FOR ANGINA. UNSPECIFIED TREATMENT WAS ADMINISTERED TO THE PATIENT. FINAL PATIENT OUTCOME IS REPORTEDLY UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina

  MAUDE report 6589159 ↗
• InjuryMay 3, 2017Deflation Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH ANGINA AND THAT THE PROCEDURE WAS TO TREAT A LESION IN THE NON-TORTUOUS, MILDLY CALCIFIED, 90% STENOSED MID LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY. A 3.00 X 18 MM XIENCE ALPINE STENT DELIVERY SYSTEM (SDS) WAS SELECTED FOR THE PROCEDURE. THE SDS WAS ADVANCED WITH NO RESISTANCE TO THE LESION AND THE BALLOON WAS INFLATED TO DEPLOY THE STENT. ONCE THE STENT WAS SUCCESSFULLY DEPLOYED THE BALLOON WOULD NOT FULLY DEFLATE. WHEN THEY PULLED THE SDS BACK THE PARTIALLY DEFLATED BALLOON GOT HUNG UP IN THE UNSPECIFIED GUIDING CATHETER AND THEY WERE REMOVED FROM THE ANATOMY AS ONE UNIT. TWO DAYS LATER THE PATIENT WAS READMITTED TO THE HOSPITAL IN CARDIAC ARREST AND NEEDED TO BE DEFIBRILLATED THREE TIMES IN ORDER TO BRING HER HEART BACK INTO NORMAL RHYTHM. ANGIOGRAPHY REVEALED A THROMBUS IN THE STENT THAT WAS IMPLANTED ON (B)(6) 2017. IT WAS CONFIRMED THAT THE PATIENT WAS COMPLIANT WITH DUAL ANTIPLATELET DRUG THERAPY (DAPT) AFTER THE PROCEDURE THAT WAS PERFORMED ON (B)(6) 2017. AN ADDITIONAL XIENCE ALPINE STENT WAS IMPLANTED AND THE EJECTION FRACTION WENT FROM 60% TO 40%. THE PATIENT IS RECOVERING AND IS SCHEDULED TO BE DISCHARGED THE WEEK O

  Patient problems: Cardiac Arrest; Thrombosis

  MAUDE report 6540347 ↗
• MalfunctionApr 17, 2017Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE PROXIMAL LEFT ANTERIOR DESCENDING CORONARY ARTERY THAT WAS MODERATELY CALCIFIED AND MILDLY TORTUOUS. THE XIENCE ALPINE 3 X 18 STENT DELIVERY SYSTEM BALLOON WAS INFLATED TO 15 ATMOSPHERES WHEN THE BALLOON BEGAN LOSING PRESSURE. IT WAS THEN INFLATED A SECOND TIME TO JUST ABOVE 15 ATMOSPHERES WHEN A PINHOLE WAS NOTED. THE BALLOON WAS DEFLATED AND REMOVED FROM THE ANATOMY AND THE LESION WAS POST DILATED WITH AN NC TREK TO BE SURE THE STENT STRUTS WERE WELL APPOSED. THE XIENCE ALPINE WAS PREPPED ACCORDING TO THE INSTRUCTIONS FOR USE WITH NO ISSUES NOTED. 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 6498948 ↗
• MalfunctionApr 10, 2017Positioning Failure; Inflation Problem

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE MID CIRCUMFLEX CORONARY ARTERY. A 3.0X18MM XIENCE ALPINE STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TO THE LESION; HOWEVER, THE BALLOON WOULD NOT INFLATE. THE DEVICE WAS REMOVED WITHOUT RESISTANCE AND THE STENT REMAINED ON THE BALLOON. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A 3.0X23MM XIENCE ALPINE SDS. 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 6477671 ↗
• MalfunctionApr 10, 2017Inflation Problem

  IT WAS REPORTED THAT A 3.0X18MM XIENCE ALPINE STENT DELIVERY SYSTEM (SDS) ADVANCED TO THE MILDLY TORTUOUS, RIGHT CORONARY ARTERY (RCA), MILDLY CALCIFIED LESION WITHOUT REPORTED ISSUE. FOLLOWING, THE BALLOON FAILED TO INFLATE. ANOTHER INFLATION DEVICE WAS USED; HOWEVER, THE BALLOON STILL FAILED TO INFLATE. THE SDS WAS REMOVED WITHOUT REPORTED ISSUE AND ANOTHER XIENCE ALPINE SDS WAS USED IN REPLACEMENT. THERE WERE NO ADVERSE PATIENT EFFECTS AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY. THERE WAS NO ADDITIONAL INFORMATION PROVIDED REGARDING THIS DEVICE ISSUE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6477656 ↗
• InjuryJan 11, 2017Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT WITHIN 30-DAYS POST-STENTING OF A CORONARY VESSEL WITH TWO XIENCE ALPINE STENTS, THE PATIENT WAS RE-ADMITTED TO THE HOSPITAL WITH ACUTE HEART FAILURE 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: Heart Failure

  MAUDE report 6244397 ↗