XIENCE ALPINE 1125275-23Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 08717648199271), received between Aug 16, 2016 and Oct 5, 2018 — classified as 2 deaths, 13 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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. 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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• DeathOct 5, 2018Adverse 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) 2018, THE PATIENT DIED AT HOME. NO INTERVENTION WAS PERFORMED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina; Cardiac Enzyme Elevation; Death; Stenosis

  MAUDE report 7940673 ↗
• MalfunctionAug 22, 2018Material Separation; Material Separation

  IT WAS REPORTED THAT DURING DEVICE PREPARATION AND PRIOR TO USE IN THE PROCEDURE, THE HYPOTUBE SHAFT NEAR THE HUB SEPARATED. THE DEVICE WAS NOT USED. THERE WAS NO REPORTED PATIENT INVOLVEMENT OR A CLINICALLY SIGNIFICANT DELAY IN PROCEDURE. A DIFFERENT DEVICE WAS USED TO COMPLETE THE PROCEDURE WITHOUT ISSUE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 7806007 ↗
• DeathJun 12, 2018Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS ADMITTED WITH ST ELEVATION MYOCARDIAL INFARCTION (MI). THE CORONARY PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE LEFT ANTERIOR DESCENDING ARTERY. NITROGLYCERIN WAS ADMINISTERED DUE TO VESSEL SPASM. PRE-DILATATION WAS PERFORMED AT THE TARGET LESION. A 2.25 X 18 MM XIENCE ALPINE STENT WAS IMPLANTED FIRST IN THE DISTAL PORTION OF THE LESION AND A 2.75 X 23 MM XIENCE ALPINE WAS THEN IMPLANTED IN THE PROXIMAL TO MID PORTION OF THE LESION. NITROGLYCERIN WAS ADMINISTERED DUE TO CONTINUED VESSEL SPASM. POST-DILATATION WAS PERFORMED AND THE STENTS WERE WELL APPOSED TO THE VESSEL WALL. GOOD BLOOD FLOW WAS NOTED. ONE DAY POST-PROCEDURE, THE PATIENT WAS PENDING DISCHARGE, BUT DID NOT FEEL WELL. A PAUSE WAS NOTED ON TELEMETRY. CARDIOPULMONARY RESUSCITATION WAS STARTED AND THE PATIENT WAS TRANSFERRED TO THE CATH LAB. THROMBUS WAS NOTED WITHIN THE ENTIRE STENTED PORTION OF THE LAD. DESPITE RESUSCITATION ATTEMPTS, THE PATIENT DIED ON (B)(6) 2018. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Arrhythmia; Death; Fatigue; Thrombosis; Vasoconstriction

  MAUDE report 7592639 ↗
• InjuryMay 23, 2018Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 2.75 X 23MM 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 MYOCARDIAL INFARCTION. TREATMENT PERFORMED WAS UNSPECIFIED AND THE FINAL PATIENT OUTCOME IS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Myocardial Infarction

  MAUDE report 7537674 ↗
• MalfunctionMar 14, 2018Difficult to Remove; Improper or Incorrect Procedure or Method; Failure to Advance; Material Deformation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE MID LEFT ANTERIOR DESCENDING (LAD) ARTERY. FIRST, AN UNSPECIFIED STENT WAS IMPLANTED IN THE LEFT MAIN AND PROXIMAL LAD. THEN, A 2.75 X 23 MM XIENCE ALPINE STENT WAS ADVANCING TO THE MID LAD WHEN IT FAILED TO CROSS DUE TO THE PREVIOUSLY IMPLANTED UNSPECIFIED STENT. THE XIENCE ALPINE STENT WAS REMOVED WITH RESISTANCE DUE TO THE PREVIOUSLY IMPLANTED UNSPECIFIED STENT AND IT WAS NOTED THAT THE PROXIMAL EDGE OF THE XIENCE ALPINE STENT BECAME FLARED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A 2.5 X 23 MM UNSPECIFIED STENT. 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 7339501 ↗
• InjuryJan 5, 2018Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE LEFT ANTERIOR DESCENDING (LAD) ARTERY AND THE RIGHT CORONARY ARTERY (RCA). THE PATIENT PRESENTED WITH AN ST ELEVATED MYOCARDIAL INFARCTION (STEMI). TWO XIENCE ALPINES STENTS (2.75 X 23 MM AND 3.0 X 08 MM) WERE IMPLANTED IN THE LAD AND THREE XIENCE ALPINE STENTS WERE IMPLANTED IN THE RCA. THE PATIENT WAS GIVEN ANGIOMAX. THE PROCEDURE WENT WELL; HOWEVER, WHEN BEING TAKEN TO THE INTENSIVE CARE UNIT (ICU), THE PATIENT WENT INTO CARDIOGENIC SHOCK. THE PATIENT WAS TAKEN BACK TO THE CATH LAB WHERE AN INTRA-AORTIC BALLOON PUMP WAS PUT IN AND THEN THROMBOSIS WAS OBSERVED IN ALL FIVE STENTS. THE THROMBOSIS IN THE PROXIMAL LAD AND THE RCA WAS TREATED WITH BALLOON ANGIOPLASTY AND THE MID LAD WAS TREATED WITH TWO NON-ABBOTT STENTS. THE PATIENTS MEDICATION WAS CHANGED TO INTEGRILIN AND IS NOW STABLE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Cardiogenic Shock; Thrombosis

  MAUDE report 7169155 ↗
• InjuryJan 5, 2018Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE LEFT ANTERIOR DESCENDING (LAD) ARTERY AND THE RIGHT CORONARY ARTERY (RCA). THE PATIENT PRESENTED WITH AN ST ELEVATED MYOCARDIAL INFARCTION (STEMI). TWO XIENCE ALPINES STENTS (2.75 X 23 MM AND 3.0 X 08 MM) WERE IMPLANTED IN THE LAD AND THREE XIENCE ALPINE STENTS WERE IMPLANTED IN THE RCA. THE PATIENT WAS GIVEN ANGIOMAX. THE PROCEDURE WENT WELL; HOWEVER, WHEN BEING TAKEN TO THE INTENSIVE CARE UNIT (ICU), THE PATIENT WENT INTO CARDIOGENIC SHOCK. THE PATIENT WAS TAKEN BACK TO THE CATH LAB WHERE AN INTRA-AORTIC BALLOON PUMP WAS PUT IN AND THEN THROMBOSIS WAS OBSERVED IN ALL FIVE STENTS. THE THROMBOSIS IN THE PROXIMAL LAD AND THE RCA WAS TREATED WITH BALLOON ANGIOPLASTY AND THE MID LAD WAS TREATED WITH TWO NON-ABBOTT STENTS. THE PATIENTS MEDICATION WAS CHANGED TO INTEGRILIN AND IS NOW STABLE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Cardiogenic Shock; Thrombosis

  MAUDE report 7168937 ↗
• InjuryDec 6, 2017Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THREE XIENCE ALPINE STENTS (2.75X23MM, 3.0X18MM, 3.25X8MM) WERE IMPLANTED ON (B)(6) 2017. ON (B)(6) 2017, THE PATIENT WAS RE-ADMITTED WITH CARDIOVASCULAR SYMPTOMS INCLUDING SYNCOPE. IT WAS FURTHER REPORTED THAT ON (B)(6) 2017, THE PATIENT WAS RE-ADMITTED AGAIN WITH ANGIODYSPLASIA OF STOMACH. SURGICAL INTERVENTION WAS PERFORMED. THE FINAL PATIENT OUTCOME IS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Syncope

  MAUDE report 7088588 ↗
• InjuryDec 6, 2017Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE INDEX PROCEDURE TOOK PLACE ON (B)(6) 2017 DURING WHICH A 2.75 X 23 MM XIENCE ALPINE STENT WAS IMPLANTED FOR TREATMENT OF AN UNSPECIFIED VESSEL. THE PATIENT WAS READMITTED TO THE HOSPITAL ON (B)(6) 2017 FOR NON-SEGMENT ELEVATED MYOCARDIAL INFARCTION (NSTEMI) 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: Myocardial Infarction

  MAUDE report 7087576 ↗
• MalfunctionNov 28, 2017Difficult To Position; Difficult to Remove; Stretched; Unstable

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE MID-LEFT ANTERIOR DESCENDING CORONARY ARTERY THAT WAS MODERATELY TORTUOUS, NON-CALCIFIED AND 75% STENOSED. THE 2.75 X 23 MM XIENCE ALPINE STENT DELIVERY SYSTEM (SDS) WAS ADVANCED IN THE GUIDING CATHETER (GC) WITHOUT RESISTANCE BETWEEN THE INNER DIAMETER OF THE GUIDING CATHETER AND THE SDS UNTIL THE SDS REACHED THE VERY DISTAL PART OF THE GUIDING CATHETER. WHEN THE SDS REACHED THE DISTAL END OF THE GC, THE STENT AREA GOT STUCK INSIDE THE TIP OF THE GC. THE STENT IMPLANT HAD SLIGHTLY EXITED FROM THE TIP OF THE GC WHEN THIS OCCURRED. THEN, ATTEMPTS WERE MADE TO ADVANCE AND REMOVE THE SDS BY PUSHING THE SDS AND PULLING IT, BUT IN VAIN. THE SDS REMAINED STUCK IN THE GUIDING CATHETER. WHEN THE FINAL ATTEMPT TO REMOVE/PULL THE SDS WAS MADE, THE BALLOON OF THE XIENCE ALPINE WAS STRETCHED, CAUSING THE STENT IMPLANT TO SHIFT ON THE BALLOON OF THE SDS BUT DID NOT DISLODGE IN THE CORONARY ARTERY. THE ENTIRE SYSTEM WAS REMOVED FROM THE ANATOMY AS A SINGLE UNIT. ONCE OUTSIDE THE ANATOMY, ATTEMPTS TO SEPARATE THE DEVICES WERE MADE. HOWEVER, AS THE NON-ABBOTT GUIDE WIRE REMAINED STUCK INSIDE THE XIENCE ALPINE SDS, THE SHAFT OF

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7065580 ↗
• InjuryAug 28, 2017Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED LESION IN THE VERY TORTUOUS RAMUS CORONARY ARTERY. A 2.75X38MM RX XIENCE ALPINE STENT DELIVERY SYSTEM (SDS) WAS ADVANCED THROUGH A 6FR NON-ABBOTT GUIDING CATHETER BUT FAILED TO CROSS DUE TO PATIENT ANATOMY AND WAS WITHDRAWN. THERE WERE NO OTHER DEVICE ISSUES, NO ADVERSE PATIENT EFFECTS, AND NO DELAY RELATED TO THE FAILURE TO CROSS. A 2.75X23MM RX XIENCE ALPINE SDS WAS THEN ADVANCED THROUGH THE GUIDING CATHETER AND PAST THE LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY WITHOUT ANY RESISTANCE AND SUCCESSFULLY CROSSED THE RAMUS WHEN A DISSECTION IN THE PROXIMAL LAD WAS DISCOVERED. THERE WAS NO DEVICE ISSUE FOR THE 2.75X23MM RX XIENCE ALPINE, HOWEVER, THE PHYSICIAN DECIDED NOT TO DEPLOY THE 2.75X23MM RX XIENCE ALPINE STENT DUE TO THE LAD DISSECTION; THUS, THE UNDEPLOYED 2.75X23MM RX XIENCE ALPINE WAS WITHDRAWN (WITHOUT DIFFICULTY). WHILE IT IS PHYSICIAN OPINION THAT THE DISSECTION WAS LIKELY DUE TO THE GUIDING CATHETER, IT WAS REPORTED THAT IT CANNOT BE STATED WITH CERTAINTY THAT THE 2.75X23MM RX XIENCE ALPINE DID NOT CAUSE OR CONTRIBUTE TO THE DISSECTION. ANTICOAGULANTS WERE DISCONTINUED AS A PRECAUTION AND THE DISSE

  Patient problems: Intimal Dissection

  MAUDE report 6825076 ↗
• MalfunctionJul 26, 2017Deflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT CHRONIC TOTAL OCCLUSION OF THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY THAT WAS NON-TORTUOUS, NON-CALCIFIED AND 90% STENOSED. AFTER PERFORMING THROMBUS ASPIRATION, THE XIENCE ALPINE 2.75 X 23 MM STENT WAS DEPLOYED HOWEVER THE BALLOON DID NOT INFLATE OR DEFLATE PROPERLY. THE STENT DELIVERY SYSTEM WAS INFLATED 3 TIMES TO 12 ATMOSPHERES FOR 30 SECONDS EACH TIME. EVERY TIME THE BALLOON WAS INFLATED, THE BALLOON DID NOT INFLATE AT ALL WHEN PRESSURE WAS APPLIED AT 2-3 ATM. THEN, THE BALLOON SUDDENLY INFLATED AFTER A FEW SECONDS. THIS HAPPENED DURING EACH INFLATION. IT IS UNKNOWN HOW MANY SECONDS THAT NEGATIVE WAS HELD TO DEFLATE THE BALLOON HOWEVER IT WAS REPORTED THAT IT TOOK LONGER THAN USUAL TO DEFLATE AFTER EACH INFLATION HOWEVER IT WAS LESS THAN 30 SECONDS EACH TIME. THE BALLOON WAS REMOVED FULLY DEFLATED AND THE PROCEDURE WAS COMPLETED WITHOUT PERFORMING POST-DILATATION WITH BLOOD FLOW IMPROVING TO 90%. THERE WAS NO LEAK OR OTHER ISSUES NOTED DURING PREPARATION AND THE DEVICE WAS PREPPED PER THE INSTRUCTIONS FOR USE. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6745474 ↗
• InjuryJul 23, 2017Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2017, THE PATIENT UNDERWENT A CORONARY PROCEDURE, WITH IMPLANTATION OF A 3.0 X 18 MM ABSORB GT1 BIORESORBABLE VASCULAR SCAFFOLD (BVS) IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY AND A 3.25 X 23MM XIENCE ALPINE STENT IN THE RIGHT CORONARY ARTERY (RCA). THE PATIENT WAS PRESCRIBED DUAL ANTI-PLATELET THERAPY (DAPT) OF ASPIRIN AND CLOPIDOGREL AND WAS DISCHARGED TO HOME. ON (B)(6) 2017, THE PATIENT WAS RE-HOSPITALIZED WITH ANGINA. CORONARY ANGIOGRAPHY WAS PERFORMED AND NOTED THROMBOSIS IN BOTH THE ABSORB BVS AND IN THE XIENCE STENT. THE PATIENT REPORTED BEING NON-COMPLIANT WITH DAPT. THROMBECTOMY WAS PERFORMED. TWO ADDITIONAL XIENCE ALPINE STENTS WERE IMPLANTED; ONE IN THE ABSORB SCAFFOLD IN THE LAD AND ONE IN THE XIENCE ALPINE STENT IN THE RCA. THE CLOPIDOGREL WAS CHANGED TO TICAGRELOR AND THE PATIENT WAS DISCHARGED TO HOME IN STABLE CONDITION. ON (B)(6) 2017, THE PATIENT WAS RE-HOSPITALIZED AGAIN, WITH ANGINA, AND THROMBOSIS WAS NOTED IN BOTH LOCATIONS (LAD AND RCA). THE PATIENT WAS ADMITTED IN CARDIOGENIC SHOCK WITH BLOOD PRESSURE OF 80/59. AN INTRA-AORTIC BALLOON PUMP AND A TEMPORARY PACEMAKER WERE PLACED AND THE BLOOD PRESSURE INCREASED TO THE 150-160

  Patient problems: Angina; Cardiogenic Shock; Low Blood Pressure/ Hypotension; Thrombosis

  MAUDE report 6734927 ↗
• InjuryApr 27, 2017Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY TORTUOUS, MILDLY CALCIFIED, CONCENTRIC, AND DE NOVO FIRST DIAGONAL ARTERY THAT WAS 90% STENOSED. AN UNSPECIFIED XIENCE ALPINE STENT WAS IMPLANTED IN THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY WHEN PLAQUE SHIFT OCCURRED AT THE ENTRANCE OF THE FIRST DIAGONAL. A 1.5 X 12 MM RX TENKU WAS BEING USED TO DILATE THE VESSEL WHEN THE BALLOON RUPTURED ON THE FIRST INFLATION AFTER 10 SECONDS AT 6 ATMOSPHERES. A NON-ABBOTT BALLOON WAS SUCCESSFULLY USED TO COMPLETE THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE AND NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Prolapse

  MAUDE report 6528647 ↗
• 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 THE PATIENT WAS RE-ADMITTED TO THE HOSPITAL WITH 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 6244176 ↗
• InjuryDec 13, 2016Difficult to Remove; Device Operates Differently Than Expected; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MID LEFT ANTERIOR DESCENDING (LAD) ARTERY. A 2.75 X 23 MM XIENCE ALPINE STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TO THE LESION WITHOUT ISSUE BUT IT WAS DETERMINED THAT THEY NEEDED A LONGER STENT. AS THE DELIVERY SYSTEM WAS BEING REMOVED, THE STENT CAUGHT ON A PREVIOUSLY PLACED STENT IN THE PROXIMAL LAD AND DISLODGED. THE SDS WAS ADVANCED BACK INTO THE ANATOMY AND IT WAS USED TO PUSH THE DISLODGED STENT FURTHER INTO THE LESION AND A SMALLER SIZE BALLOON WAS SUCCESSFULLY USED TO DEPLOY THE 2.75 X 23 MM STENT IN THE DISTAL END OF THE LESION. ANOTHER STENT WAS DEPLOYED OVERLAPPING THE 2.75 X 23 MM STENT TO COVER THE PROXIMAL PART OF THE LESION. THERE WERE NO ADVERSE PATIENT EFFECTS. THERE WAS A DELAY IN THE PROCEDURE BUT IT WAS NOT A CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6170071 ↗
• InjuryOct 27, 2016Difficult To Position; Device Dislodged or Dislocated

  IT WAS REPORTED THAT TWO XIENCE ALPINE STENTS WERE SUCCESSFULLY IMPLANTED IN THE MODERATE TO HEAVILY CALCIFIED LESION IN THE MID LEFT ANTERIOR DESCENDING CORONARY ARTERY. A THIRD XIENCE ALPINE STENT DELIVERY SYSTEM (SDS), THE 2.75X23, WAS INSERTED THROUGH A GUIDELINER TO GO DISTAL TO THE FIRST TWO STENTS. RESISTANCE WAS MET ADVANCING THE SDS THROUGH THE GUIDELINER. THE SDS WAS PARTIALLY OUT OF THE GUIDELINER IN BETWEEN THE FIRST TWO IMPLANTED MID LAD XIENCE ALPINE STENTS. WHILE REMOVING THE GUIDELINER, THE XIENCE ALPINE STENT DISLODGED FROM THE SDS AND REMAINED BETWEEN THE FIRST TWO IMPLANTED XIENCE ALPINE STENTS. A NON-COMPLIANT BALLOON DILATATION CATHETER WAS ADVANCED TO THE DISLODGED STENT AND EMBEDDED THE STENT AGAINST THE VESSEL WALL. THE PATIENT REMAINED STABLE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Vessel Or Plaque, Device Embedded In

  MAUDE report 6062472 ↗
• InjurySep 30, 2016Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 2.75 X 23 MM XIENCE ALPINE STENT AND A 3.5 X 38 MM XIENCE ALPINE STENT WAS IMPLANTED ON (B)(6) 2015. ON (B)(6) 2015, THE PATIENT WAS RE-ADMITTED WITH CARDIOVASCULAR SYMPTOMS INCLUDING CONGESTIVE HEART FAILURE. IT IS UNKNOWN WHAT TREATMENT WAS PERFORMED. THE FINAL PATIENT OUTCOME IS UNKNOWN AND THE PATIENT WAS DISCHARGED TO A NURSING HOME. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Heart Failure

  MAUDE report 5992399 ↗
• InjuryAug 16, 2016Detachment Of Device Component; Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE 2.75X23MM XIENCE ALPINE STENT DELIVERY SYSTEM (SDS) WAS UNABLE TO CROSS AN OLDER STENT IN THE PROXIMAL LEFT CIRCUMFLEX DUE TO THE CALCIFIED ANATOMY AND THE OLDER STENT. THE SDS WAS BEING RETRACTED FROM THE ANATOMY WHEN THE STENT DISLODGED INTO THE LEFT MAIN AND THEN INTO THE AORTA. THE DISLODGED STENT WAS SUCCESSFULLY SNARED OUT, BUT THE DOCTOR COULD NOT TELL IF PART OF THE DISLODGED STENT MIGHT HAVE REMAINED IN THE OLDER STENT. WITH THE HELP OF A GUIDELINER, A NON-ABBOTT 3.0X32 STENT WAS ABLE TO CROSS THE OLDER STENT. THE LONGER, NON-ABBOTT STENT WAS USED TO TREAT THE INTENDED LESION AND THE POTENTIAL FRAGMENT OF THE DISLODGED STENT. THERE WAS NO DAMAGE NOTED TO THE OLDER STENT IN THE CIRCUMFLEX. THE PATIENT WAS REPORTEDLY FINE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Vessel Or Plaque, Device Embedded In

  MAUDE report 5880740 ↗