XIENCE ALPINE 1125350-15Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 08717648199523), received between Sep 23, 2016 and Jul 31, 2020 — classified as 20 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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. How this data works · Data updated Oct 13, 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.

• InjuryJul 31, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A 50% STENOSED, FIBROUS PLAQUE, AND MILDLY CALCIFIED DE NOVO LESION IN THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY (LAD) AND A 75-90% STENOSED, FIBROUS PLAQUE, MILDLY TORTUOUS, AND MILDLY CALCIFIED DE NOVO LESION IN THE MID LAD. ON (B)(6) 2015, A 3.5X15MM XIENCE ALPINE STENT WAS IMPLANTED IN THE PROXIMAL LAD AND 3.5X38MM XIENCE ALPINE STENT WAS IMPLANTED IN THE MID LAD. THE STENTS EXPANDED TO 3.5MM AND WERE APPOSED TO THE VESSEL WALLS. ON (B)(6) 2016, DURING A FOLLOW-UP VISIT IT WAS CONFIRMED THAT THERE WAS NO RE-STENOSIS. ON (B)(6) 2020, AN EXERCISE ECHOCARDIOGRAPHY WAS PERFORMED AND CONFIRMED ISCHEMIA IN THE LAD WAS NEGATIVE. ON (B)(6) 2020, THE PATIENT STOPPED TAKING ASPIRIN. ON (B)(6) 2020, THE PATIENT HAD SUDDEN CHEST PAIN AND WAS TAKEN TO THE HOSPITAL. V1-4 AND CLEAR ST INCREASE WERE SHOWN AND ECHO CONFIRMED WALL MOVEMENT OF THE LEFT VENTRICLE ANTEROSEPTAL. A ST-ELEVATION MYOCARDIAL INFARCTION WAS CONFIRMED IN THE LAD. AN ANGIOGRAPH CONFIRMED STENT THROMBOSIS IN THE 3.5X15MM XIENCE ALPINE STENT. A PERCUTANEOUS CORONARY INTERVENTION WAS PERFORMED AND LARGE AMOUNTS OF RED THROMBOSIS WAS SUCTIONED OUT AND A NON-ABBOTT ST

  Patient problems: Angina; Myocardial Infarction; Thrombosis

  MAUDE report 10353820 ↗
• InjuryDec 13, 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 3.50X15MM XIENCE ALPINE AND A 3.0X18MM XIENCE ALPINE STENT WERE IMPLANTED. ON (B)(6) 2018 THE PATIENT WAS RE-ADMITTED WITH GROSS HEMATURIA. THE TREATMENT PERFORMED AND THE FINAL PATIENT OUTCOME IS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 8161330 ↗
• InjurySep 12, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE INDEX PROCEDURE TOOK PLACE ON (B)(6) 2018 DURING WHICH A 3.5 X 15 MM XIENCE ALPINE STENT AND A 5.0 X 38 MM ULTRA MULTI-LINK STENT WERE IMPLANTED FOR TREATMENT OF AN UNSPECIFIED VESSEL. THE PATIENT WAS READMITTED TO THE HOSPITAL ON (B)(6) 2018 FOR 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 7870818 ↗
• InjurySep 4, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 3.5 X 15MM 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 CHEST PAIN. TREATMENT PERFORMED WAS UNSPECIFIED AND THE FINAL PATIENT OUTCOME IS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina

  MAUDE report 7844049 ↗
• MalfunctionAug 13, 2018Difficult to Remove; Material Deformation; Difficult to Remove; Material Deformation

  IT WAS REPORTED THAT THE 3.5X15MM XIENCE ALPINE RX STENT DELIVERY SYSTEM (SDS) WAS UNPACKED AND THE PROTECTIVE SHEATH WAS REMOVED FROM THE SDS WITH RESISTANCE. UPON INSPECTION, THE STENT WAS OBSERVED TO BE FLARED. THE SDS WAS NOT USED AND THERE WAS NO PATIENT INVOLVEMENT. ANOTHER XIENCE ALPINE RX SDS WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION AS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 7779301 ↗
• InjuryAug 1, 2018Difficult to Remove; Failure to Advance; Device Dislodged or Dislocated; Difficult to Remove; Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE HEAVILY TORTUOUS SAPHENOUS VEIN GRAFT. THE 3.5 X 15 MM XIENCE ALPINE STENT DELIVERY SYSTEM (SDS) WAS ADVANCED INTO THE PATIENT ANATOMY AND AN ATTEMPT WAS MADE TO CROSS THROUGH A PREVIOUSLY IMPLANTED UNSPECIFIED STENT TO GET TO THE TARGET LESION THAT WAS DISTAL TO THE IMPLANTED STENT. THE SDS WAS UNABLE TO CROSS AND THE GUIDE CATHETER WAS ADVANCED FURTHER INTO THE VESSEL. AN ATTEMPT WAS MADE TO REMOVE THE SDS; HOWEVER, RESISTANCE WAS NOTED WITH THE ANATOMY AND ALL DEVICES WERE REMOVED AS A SINGLE UNIT. UPON REMOVAL, IT WAS NOTED THAT THE STENT WAS NO LONGER ON THE SDS. THE STENT COULD NOT BE LOCATED ON THE DEVICES OR IN THE PATIENT ANATOMY. IT IS POSSIBLE THAT THE STENT REMAINS IN THE ANATOMY, AS IT COULD NOT BE LOCATED WITHIN THE DEVICES. THE PROCEDURE CONTINUED WITH IMPLANTATION OF A 3.5 X 16 MM NON-ABBOTT STENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 7741076 ↗
• InjuryJun 5, 2018Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE 3.50X15MM 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 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 7571626 ↗
• InjuryJun 5, 2018Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE 3.50X15MM AND 3.0X28MM XIENCE ALPINE STENTS WERE IMPLANTED ON (B)(6) 2018. THE PATIENT PRESENTED WITH SEPSIS BEFORE THE PROCEDURE. ON (B)(6) 2018, THE PATIENT WAS READMITTED WITH CARDIOVASCULAR SYMPTOMS, INCLUDING POST PROCEDURE HEMATOMA. TREATMENT PERFORMED IS OTHER AND THE FINAL PATIENT OUTCOME IS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Hematoma

  MAUDE report 7571589 ↗
• InjuryJun 5, 2018Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE 3.50X15MM AND 2.75X33MM XIENCE ALPINE STENTS WERE 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 HYPERTENSION. THE TREATMENT PERFORMED WAS NOT REPORTED AND THE FINAL PATIENT OUTCOME IS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: High Blood Pressure/ Hypertension

  MAUDE report 7570225 ↗
• InjuryMay 25, 2018Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE MID LEFT ANTERIOR DESCENDING ARTERY WITH NO TORTUOSITY AND NO CALCIFICATION. A 3.5 X 15 MM XIENCE ALPINE STENT WAS IMPLANTED. THEN A COUPLE OF HOURS LATER, THE PATIENT STARTED TO EXPERIENCE CHEST PAIN. AN OPTICAL COHERENCE TOMOGRAPHY (OCT) TEST REVEALED THE STENT CLOSED, THE VESSEL HAD TOTAL OCCLUSION DUE TO THROMBOSIS AND A DISSECTION WAS OBSERVED. AND, THEREFORE A 4.0 X 18 MM XIENCE STENT WAS IMPLANTED IN THE PROXIMAL AREA, ADJACENT TO THE FIRST STENT TO OVERLAP FOR TREATMENT. THE PATIENT STAYED AN ADDITIONAL DAY DUE TO THE TREATMENT AND WAS THEN DISCHARGED IN GOOD CONDITION. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina; Intimal Dissection; Thrombosis

  MAUDE report 7546721 ↗
• InjuryMay 24, 2018Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 3.50 X 15MM XIENCE ALPINE AND A 2.50 X 23MM XIENCE ALPINE STENTS WERE IMPLANTED ON (B)(6) 2018. THE PATIENT PRESENTED WITH NON-ST-ELEVATION MYOCARDIAL INFARCTION BEFORE THE PROCEDURE. ON (B)(6) 2018, THE PATIENT WAS READMITTED WITH CARDIOVASCULAR SYMPTOMS AND A PANIC DISORDER. TREATMENT PERFORMED WAS UNSPECIFIED AND THE FINAL PATIENT OUTCOME IS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7542819 ↗
• MalfunctionMay 16, 2018Device Damaged by Another Device

  IT WAS REPORTED THE PROCEDURE WAS PERFORMED TO TREAT A HEAVILY CALCIFIED TIGHT LESION IN THE LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY. SEVERAL BALLOONS WERE USED TO COMPLETE PRE-DILATATION BECAUSE THE LESION WAS VERY TIGHT. THE 3.5 X 15 MM XIENCE ALPINE STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TO THE TIGHTEST PART OF THE LESION AND DEPLOYED SUCCESSFULLY. THE STENT WAS FULLY APPOSED; HOWEVER, FURTHER BALLOONING WAS REQUIRED BECAUSE THE LESION WAS STILL TIGHT JUST DISTAL TO THE IMPLANTED STENT DUE TO THE HIGH CALCIUM IN THE LESION. DURING REMOVAL OF THE BALLOON CATHETER AND GUIDELINER CATHETER, THE IMPLANTED STENT WAS EXPLANTED. THE EXPLANTED STENT WAS ON THE BALLOON CATHETER AND ALL DEVICES WERE REMOVED TOGETHER FROM THE PATIENTS ANATOMY. SEVERAL BALLOON CATHETERS WERE USED IN AN ATTEMPT TO CROSS THE LESION A SECOND TIME, BUT NOTHING CROSSED; THEREFORE, THE PROCEDURE WAS ABORTED. 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 7520767 ↗
• MalfunctionMar 29, 2018Material Rupture; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE RIGHT CORONARY ARTERY WHICH DID NOT HAVE ANY TORTUOSITY OR CALCIFICATION. THE PATIENT PRESENTED WITH SEGMENT ELEVATED MYOCARDIAL INFARCTION (STEMI). A 3.5 X 15 MM XIENCE ALPINE STENT DELIVERY SYSTEM WAS USED AND DID NOT MEET ANY RESISTANCE DURING ADVANCEMENT. HOWEVER, THE DEVICE WAS NOT PREPPED OUTSIDE OF THE ANATOMY. THE DEVICE PULLED NEGATIVE WITHOUT ANY ISSUES AND THERE WERE NO BUBBLES; HOWEVER, THE BALLOON WOULD NOT INFLATE AFTER TWO ATTEMPTS TO INFLATE THE DEVICE. THE PRESSURE GAUGE DID NOT CHANGE AND CONTRAST LEAKAGE WAS NOTED TO BE COMING FROM THE BALLOON. THEREFORE, THE DEVICE WAS REMOVED AND ANOTHER 3.5 X 15 MM XIENCE ALPINE 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 7382465 ↗
• InjuryMar 5, 2018Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 3.50 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 7315206 ↗
• InjuryDec 8, 2017Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE RIGHT CORONARY ARTERY (RCA). THE 3.5X15 MM XIENCE ALPINE STENT DELIVERY SYSTEM (SDS) WAS ADVANCED IN THE PATIENT ANATOMY. THE SDS, FAILED TO CROSS DUE TO THE ANATOMY AND THE STENT DISLODGED IN THE RCA. A SNARE DEVICE WAS USED TO REMOVE THE DISLODGED STENT FROM THE PATIENT ANATOMY. A NEW XIENCE ALPINE SDS WAS USED TO COMPLETE THE PROCEDURE. 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 7101452 ↗
• InjuryDec 6, 2017Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED LESION IN THE MID RIGHT CORONARY ARTERY. A 3.50 X 15 MM XIENCE ALPINE STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TO THE LESION, MET RESISTANCE AND BECAME CAUGHT ON THE PROXIMAL EDGE OF THE LESION. WHEN THE SDS WAS PULLED BACK INTO THE GUIDING CATHETER, THE STENT IMPLANT DISLODGED FROM THE BALLOON AND BECAME FREE FLOATING. THE STENT IMPLANT MIGRATED THROUGH THE VASCULATURE AND ENDED UP IN A FEMORAL SIDE BRANCH OFF THE SUPERFICIAL FEMORAL ARTERY. NO ATTEMPTS WERE MADE TO RETRIEVE THE LOOSE STENT AS THE PHYSICIAN FELT THAT IT WAS IN A LOCATION THAT WOULD NOT CAUSE A PROBLEM FOR THE PATIENT. A NEW UNSPECIFIED SDS WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 7089228 ↗
• InjurySep 7, 2017Difficult to Remove; Physical Resistance; Device Dislodged or Dislocated; Material Deformation

  IT WAS REPORTED THAT THE 3.5X15 MM XIENCE ALPINE STENT DELIVERY SYSTEM (SDS) REACHED THE OSTIAL LESION IN THE PREDILATED, RIGHT CORONARY ARTERY. THE SDS WAS BEING POSITIONED AND MET RESISTANCE WITH THE MILD CALCIFICATION WHEN THE STENT DISLODGED FROM THE SDS. A SMALL DILATATION CATHETER WAS ADVANCED AROUND THE DISLODGED STENT AND THE STENT WAS PULLED INTO THE TIP OF THE GUIDE CATHETER WITH THE INFLATED DILATATION CATHETER. THE GUIDE CATHETER WAS RETRACTED INTO THE INTRODUCER SHEATH AT THE GROIN WHEN THE STENT BECAME STUCK IN THE SHEATH. IT WAS SUSPECTED THAT THE STENT BECAME FLARED WITH THE CALCIUM DURING POSITIONING AND THE FLARED STENT STRUT MAY HAVE CAUGHT AT THE GUIDE CATHETER/INTRODUCER SHEATH. A SMALL CUT-DOWN WAS PERFORMED, BUT THE STENT WAS UNABLE TO BE LOCATED IN THE GROIN. A CT SCAN WAS PERFORMED WHICH FOUND THE STENT IN TISSUE, ABOVE THE VASCULATURE. THE PATIENT WAS SENT FOR A SURGICAL CUT-DOWN TO REMOVE THE DISLODGED STENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6848207 ↗
• InjuryJun 15, 2017Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2017, A 3.25 X 15 MM XIENCE ALPINE STENT WAS IMPLANTED AND ON (B)(6) 2017 A 3.5 X 15 MM XIENCE ALPINE STENT WAS IMPLANTED. ON (B)(6) 2017, THE PATIENT RETURNED WITH CHEST PAIN. PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) WAS PERFORMED AND MEDICATIONS WERE OPTIMIZED. NO ADDITIONAL INFORMATION WAS PROVIDED

  Patient problems: Angina

  MAUDE report 6645580 ↗
• InjuryApr 11, 2017Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2016, A 3.5X15 RX XIENCE ALPINE DRUG-ELUTING STENT WAS IMPLANTED FOR TREATMENT OF AN UNSPECIFIED VESSEL. ON (B)(6) 2017, THE PATIENT WAS REHOSPITALIZED DUE TO OTHER UNSPECIFIED CARDIOVASCULAR SYMPTOMS, INCLUDING CHEST PAIN. UNSPECIFIED TREATMENT WAS ADMINISTERED AND THE FINAL PATIENT OUTCOME IS REPORTEDLY UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina

  MAUDE report 6483526 ↗
• InjuryMar 7, 2017Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MILDLY CALCIFIED LESION IN THE RIGHT CORONARY ARTERY. THE STENT OF A 3.5X15MM XIENCE ALPINE DISLODGED WHEN THE DEVICE WAS PULLED BACK INTO THE GUIDE CATHETER AND MIGRATED DOWN TO THE SUPERFICIAL FEMORAL ARTERY. THE STENT WAS SNARED AND REMOVED SUCCESSFULLY THROUGH THE LEFT GROIN. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND NO ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6385726 ↗
• InjuryFeb 10, 2017Difficult to Remove; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A DE NOVO LESION IN THE NON-TORTUOUS, NON-CALCIFIED, PROXIMAL RIGHT CORONARY ARTERY (RCA). A 3.50 X 15 MM XIENCE ALPINE STENT DELIVERY SYSTEM (SDS) WAS SELECTED FOR THE PROCEDURE. THE SDS WAS ADVANCED TO THE LESION AND CROSSED. WHILE PULLING BACK THE SDS TO POSITION THE STENT IMPLANT, THE EDGE OF THE STENT IMPLANT CAUGHT ON THE END OF THE GUIDING CATHETER AND DISLODGED. AN UNSPECIFIED SNARE WAS USED IN FIVE ATTEMPTS TO RETRIEVE THE DISLODGED STENT, HOWEVER THE ATTEMPTS WERE UNSUCCESSFUL. A NON-ABBOTT STENT IMPLANT WAS USED TO CRUSH AND EMBED THE XIENCE ALPINE STENT IMPLANT TO THE VESSEL WALL. THERE WAS A CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Vessel Or Plaque, Device Embedded In

  MAUDE report 6323703 ↗
• InjuryOct 4, 2016Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 3.50 X 15 MM XIENCE ALPINE STENT WAS IMPLANTED ON (B)(6) 2016. ON (B)(6) 2016, THE PATIENT WAS RE-ADMITTED DUE TO OTHER UNSPECIFIED CARDIOVASCULAR SYMPTOMS, INCLUDING CHEST PAIN. IT IS UNKNOWN WHAT TREATMENT WAS PERFORMED IN THE HOSPITAL. THE PATIENT WAS DISCHARGED HOME. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina

  MAUDE report 5997301 ↗
• InjurySep 23, 2016Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 3.5 X 15 MM XIENCE ALPINE STENT WAS IMPLANTED ON (B)(6) 2015. ON (B)(6) 2015 THE PATIENT WAS RE-ADMITTED WITH CARDIOVASCULAR SYMPTOMS INCLUDING SHORTNESS OF BREATH. IT IS UNKNOWN WHAT TREATMENT WAS PERFORMED AND THE PATIENT WAS DISCHARGED TO HOME. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Dyspnea

  MAUDE report 5974905 ↗