XIENCE ALPINE 1125350-12Recalls & reported problems

Summary

The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 08717648199516), received between Aug 5, 2016 and Apr 7, 2021 — classified as 1 death, 18 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 28 reports, in the reporter's own words as published by the FDA.

• InjuryApr 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2017, THE PATIENT HAD A 3.5X12MM XIENCE ALPINE STENT IMPLANTED WITH NO ISSUES; HOWEVER, IT WAS NOTED THE PATIENT HAS BEEN SUFFERING FROM AN ALLERGIC REACTION EVER SINCE. THE REACTION IS DESCRIBED AS AN ITCHY PERSISTENT RASH. THE PATIENT HAS VISITED A DERMATOLOGIST ON AND OFF; HOWEVER, TREATMENT IF ANY IS UNKNOWN. THE DEVICE CURRENTLY REMAINS IMPLANTED IN THE PATIENT. THE INITIAL PROCEDURE HAD NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 11631469 ↗
• MalfunctionSep 14, 2020Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT ON 08/24/2020, A 3.50X12MM XIENCE ALPINE STENT WAS SUCCESSFULLY IMPLANTED IN THE MID CIRCUMFLEX ARTERY, AFTER THE EXPIRATION DATE WHICH WAS 07/03/2020. 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 10532270 ↗
• InjuryDec 14, 2018Difficult to Remove; Failure to Advance; Device Damaged by Another Device; Device Dislodged or Dislocated; Difficult to Remove; Failure to Advance; Device Damaged by Another Device; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE DISTAL LEFT MAIN (LM) CORONARY ARTERY WITH MILD CALCIFICATION AND RESTENOSIS. FOLLOWING THE DEPLOYMENT OF A 4.0 X 12 MM NON-ABBOTT STENT IN THE OSTIUM OF THE LM, A 3.50 X 12MM XIENCE ALPINE STENT DELIVERY SYSTEM (SDS) WAS ADVANCED; HOWEVER COULD NOT CROSS INTO THE OSTIUM OF THE CIRCUMFLEX ARTERY DUE TO INTERACTION WITH THE PREVIOUSLY DEPLOYED STENT. AN ATTEMPT TO WITHDRAW THE SDS INTO THE GUIDE CATHETER WAS MADE, BUT THE STENT OF THE SDS WAS STUCK AND DISLODGED. THE DISLODGED STENT WAS LOCATED OUTSIDE THE LM CLOSE TO THE AORTA AND PROXIMAL TO THE DEPLOYED STENT. THE DEPLOYED NON-ABBOTT STENT WAS NOTED TO BE STRETCHED. AN ADDITIONAL NON-ABBOTT STENT WAS DEPLOYED TO SECURE BOTH THE DISLODGED AND DEPLOYED STENTS AND TREAT THE TARGET LESION. THE PATIENT WAS REPORTED TO BE STABLE WITH GOOD BLOOD FLOW. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Vessel Or Plaque, Device Embedded In

  MAUDE report 8166605 ↗
• MalfunctionJun 7, 2018Failure to Advance; Material Deformation

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A HEAVILY CALCIFIED AND HEAVILY TORTUOUS LESION IN THE LEFT CIRCUMFLEX CORONARY ARTERY. THE VESSEL WAS PREDILATED AND THE 3.5X12 MM XIENCE ALPINE STENT WAS INSERTED, BUT MET A LOT OF RESISTANCE WITH THE CALCIFIED ANATOMY. IT WAS UNABLE TO ADVANCE FURTHER AND THE STENT DELIVERY SYSTEM (SDS) WAS RETRACTED FROM THE ANATOMY. THERE WAS NO RESISTANCE REMOVING THE SDS FROM THE ANATOMY. AFTER THE SDS WAS REMOVED, LONGITUDINAL STENT DAMAGE WAS NOTED; THE STENT WAS ALSO FLARED AND PROLAPSED. A NON-ABBOTT STENT WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. THIS IS BEING FILED FOR THE PROXIMAL SHAFT SEPARATION FOUND DURING DEVICE INVESTIGATION ON THE RETURNED DEVICE. FOLLOW-UP WITH THE CUSTOMER INDICATED THE CUSTOMER WAS NOT AWARE OF THE SHAFT SEPARATION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7580760 ↗
• InjuryJun 6, 2018Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 3.5 X 12MM XIENCE ALPINE STENT AND A 3.0 X 12 MM XIENCE ALPINE STENT WERE IMPLANTED ON (B)(6) 2018. ON (B)(6) 2018 THE PATIENT WAS RE-ADMITTED WITH HEMOPTYSIS 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 7574128 ↗
• InjuryJun 4, 2018Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE 3.50X12MM AND 3.50X18MM XIENCE ALPINE STENTS WERE 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. THE TREATMENT PERFORMED WAS NOT REPORTED AND THE FINAL PATIENT OUTCOME IS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina

  MAUDE report 7566579 ↗
• InjuryApr 4, 2018Difficult or Delayed Positioning

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 99% STENOSED AND HEAVILY CALCIFIED LESION IN THE OSTIUM ARTERY. FOLLOWING PRE-DILATATION, A 3.5X12MM XIENCE ALPINE STENT WAS BEING DEPLOYED; HOWEVER, THE STENT MIGRATED FORWARD DURING DEPLOYMENT AND WAS DEPLOYED OUTSIDE OF THE TARGET LESION. A 3.5X8MM XIENCE ALPINE STENT DELIVERY SYSTEM (SDS) WAS BEING ADVANCED TO BE PLACED PROXIMAL TO THE 3.5X12MM XIENCE ALPINE STENT; HOWEVER, THE SDS WAS ADVANCED FURTHER THAN NEEDED AND WHEN ATTEMPTING TO PULL BACK THE STENT TO THE TARGET LESION THE STENT GOT STUCK ON THE STRUTS OF THE PREVIOUSLY DEPLOYED STENT AND THE 3.5X8MM XIENCE ALPINE STENT DISLODGED. AN ATTEMPT TO RETRIEVE THE STENT WITH AN ADDITIONAL GUIDE WIRE UTILIZING A GUIDE LINER FOR SUPPORT WAS MADE BUT FAILED. AN UNKNOWN 1.5MM BALLOON CATHETER WAS USED TO SLIGHTLY EXPAND THE STENT SO THAT AN UNKNOWN 3.5MM BALLOON CATHETER COULD BE USED TO SUCCESSFULLY DEPLOY THE STENT INSIDE THE PREVIOUSLY IMPLANTED 3.5X12MM XIENCE ALPINE STENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A NEW 3.5X8MM XIENCE ALPINE DEPLOYED AT THE TARGET LESION. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 7398060 ↗
• InjuryFeb 2, 2018Improper or Incorrect Procedure or Method; Device Dislodged or Dislocated

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A LESION WITH MILD TORTUOSITY AND HEAVY CALCIFICATION IN THE LEFT ANTERIOR DESCENDING CORONARY ARTERY. A 3.5 X 12 MM XIENCE ALPINE STENT DELIVERY SYSTEM (SDS) WAS ADVANCED WITHOUT RESISTANCE TO THE TARGET LESION. THE XIENCE ALPINE WAS PREPPED INSIDE THE ANATOMY AND JUST WHEN STARTING TO INFLATE TO 1 ATMOSPHERE, THE PHYSICIAN REALIZED THAT THE STENT WAS TO LONG FOR THE LESION AND STOPPED THE PROCEDURE. THE PHYSICIAN HAD MISJUDGED THE LESION LENGTH; THERE WAS NO LABELING ISSUE. THE XIENCE ALPINE WAS WITHDRAWN FROM THE PATIENTS ANATOMY WITHOUT RESISTANCE. OUTSIDE THE ANATOMY, IT WAS NOTED THAT THE STENT WAS NOT ON THE BALLOON. THE STENT HAD DISLODGED AT THE LESION; THEREFORE, A SNARE DEVICE WAS USED TO RETRIEVE THE DISLODGED STENT WITHOUT PATIENT CONSEQUENCES. A 3.5 X 8 MM XIENCE ALPINE STENT WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7236310 ↗
• MalfunctionDec 14, 2017Difficult To Position; Difficult to Remove; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY TORTUOUS AND HEAVILY CALCIFIED PROXIMAL CIRCUMFLEX (CX), LEFT ANTERIOR DESCENDING ARTERY (LAD), AND LEFT MAIN ARTERIES. PRE-DILATATION WAS PERFORMED WITH AN UNSPECIFIED BALLOON CATHETER. A 3.5 X 12 XIENCE ALPINE STENT DELIVERY SYSTEM (SDS) WAS BEING ADVANCED TO THE LESION THROUGH A GUIDELINER THAT HAD BEEN ADVANCED PAST THE LESION. AS THE XIENCE ALPINE GOT TO THE TIP OF THE GUIDELINER, THERE WAS RESISTANCE, SO THE GUIDE LINER WAS PULLED BACK, MET RESISTANCE WITH THE SDS, AND THE STENT DISLODGED INSIDE THE GUIDELINER. THE SDS AND GUIDELINER WERE REMOVED AS A SINGLE UNIT, WITH THE STENT STILL IN THE GUIDELINER. A 3.5 X 8 MM XIENCE ALPINE SDS WAS ADVANCED TO THE LAD, HOWEVER, IT WOULD NOT CROSS DUE TO THE ANATOMY. A 3.0 X 09 NON-ABBOTT STENT WAS DEPLOYED. A 3.5 X 18 MM XIENCE ALPINE SDS WAS ADVANCED TO THE PROXIMAL LAD, HOWEVER, IT WOULD NOT CROSS DUE TO THE ANATOMY. A 3.5 X 18 MM NON-ABBOTT STENT WAS DEPLOYED. A 4.0 X 12 MM XIENCE ALPINE AND A 4.0 X 8 MM XIENCE ALPINE STENTS WERE IMPLANTED IN THE LEFT MAIN TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE AND NO ADVERSE PATIENT EFFE

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7118629 ↗
• InjuryNov 30, 2017Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2017 THE 3.5 X 12 MM XIENCE ALPINE STENT AND A 4.0 X 23 MM XIENCE ALPINE WERE IMPLANTED FOR TREATMENT OF A LESION OF AN UNSPECIFIED VESSEL. ON (B)(6) 2017, THE PATIENT WAS RE-HOSPITALIZED WITH ANGINA AND OTHER CARDIOVASCULAR (CV) SYMPTOMS. UNSPECIFIED TREATMENT WAS ADMINISTERED AND THE FINAL PATIENT OUTCOME IS REPORTEDLY UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina

  MAUDE report 7070952 ↗
• DeathNov 3, 2017Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH AN ACUTE MYOCARDIAL INFARCTION. THE PATIENT WAS ADMINISTERED ASPIRIN 300 MG WHILE BEING TRANSFERRED TO THE HOSPITAL BY AMBULANCE AND EFFIENT WAS ADMINISTERED JUST PRIOR TO THE PROCEDURE. THE PROCEDURE WAS TO TREAT A NON-TORTUOUS, NON-CALCIFIED DISTAL LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY WITH A THROMBOTIC OCCLUSION THAT WAS 99% STENOSED. THROMBOSIS WAS CONFIRMED BY ANGIOGRAPHY AND WAS ASPIRATED. PRE-DILATATION WAS PERFORMED AND A 3.5 X 18MM XIENCE ALPINE STENT WAS DEPLOYED IN THE DISTAL LAD. SOME OF THE THROMBOSIS MIGRATED TO THE PERIPHERAL PART OF THE VESSEL AND THERE WAS SOME THROMBOSIS REMAINING PROXIMAL TO THE DEPLOYED 3.5 X 18 XIENCE ALPINE STENT. THUS, A 3.5 X 12MM XIENCE ALPINE STENT WAS DEPLOYED PROXIMAL TO THE OTHER STENT. THE STENTS WERE CONFIRMED TO BE WELL APPOSED TO THE VESSEL WALL. THROMBOSIS STARTED TO FORM AGAIN AND THE VESSEL WAS OCCLUDED. THROMBOSIS ALSO FORMED IN THE LEFT CIRCUMFLEX (CX). THEREFORE, THROMBUS ASPIRATION WAS PERFORMED REPETITIVELY, BUT THE OCCLUSION CONTINUED. ALGATROBAN WAS ADMINISTERED BUT THE PATIENTS CONDITION DETERIORATED AND THE PATIENT DIED DUE TO CARDIAC ARREST AS A RESULT OF THE THRO

  Patient problems: Cardiac Arrest; Thrombosis

  MAUDE report 6999771 ↗
• InjuryOct 19, 2017Migration or Expulsion of Device

  IT WAS REPORTED THAT PRE-DILATATION OF THE OSTIAL LEFT MAIN WAS PERFORMED WITH A 3.0 X 12 MM TREK BALLOON. THEN, A 3.5 X 12 MM XIENCE ALPINE STENT WAS DEPLOYED AT THE OSTIAL LEFT MAIN AND POST-DILATED WITH A NON-COMPLIANT BALLOON. A 3.0 X 23 MM ABSORB GT1 SCAFFOLD WAS IMPLANTED IN THE MID LAD LESION; HOWEVER, A PERFORATION OCCURRED. MULTIPLE ATTEMPTS WERE MADE TO BALLOON TAMPONADE IT; HOWEVER, THE PERFORATION REMAINED. THEREFORE, A 2.8 X 19 MM GRAFTMASTER STENT WAS DEPLOYED TO TREAT THE PERFORATION. THIS HELPED TO DECREASE THE AMOUNT OF EXTRAVASATION AND PERFORATION, BUT MILD EXTRAVASATION REMAINED; THEREFORE, A SECOND 2.8 X 19 MM GRAFTMASTER WAS DEPLOYED WITH 1 MM OVERLAP. DURING THIS TIME, PERICARDIOCENTESIS WAS PERFORMED USING A 5 FR MICROPUNCTURE SHEATH. IMPROVEMENT WAS NOTED IN THE PATIENT'S HEMODYNAMICS WITH THE PLACEMENT OF PERICARDIOCENTESIS DRAIN AND THE GRAFTMASTER STENTS; HOWEVER, POST ANGIOGRAPHY REVEALED THAT THE XIENCE ALPINE STENT HAD MIGRATED, LIKELY DUE TO INTERACTION WHEN THE GRAFTMASTER STENTS WERE DEPLOYED. DILATATION OF THE LEFT MAIN WAS AGAIN PERFORMED WITH A 2.5 X 12 MM TREK BALLOON. A NEW 3.5 X 12 MM XIENCE ALPINE STENT WAS DEPLOYED IN THE OSTIAL OF THE LEFT

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6963292 ↗
• InjuryOct 10, 2017Difficult to Remove; Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A LESION WITH HEAVY TORTUOSITY AND HEAVY CALCIFICATION IN THE CIRCUMFLEX (CX) CORONARY ARTERY. PRE-DILATATION WAS PERFORMED AND THE 3.5 X 12 MM XIENCE ALPINE WAS ADVANCED, BUT COULD NOT CROSS THE LESION DUE TO THE ANATOMY. DURING WITHDRAWAL, THE XIENCE ALPINE STENT DISLODGED IN THE LEFT MAIN ARTERY DUE TO THE RESISTANCE WITH THE ANATOMY. A BALLOON CATHETER WAS USED TO COMPRESS THE DISLODGED STENT AGAINST THE VESSEL (HEALTHY TISSUE) IN THE LEFT MAIN ARTERY. THE PATIENT WAS IN STABLE CONDITION, BUT REFERRED FOR SURGERY DUE TO THE HEAVILY CALCIFIED VESSEL AND NOTHING WAS ABLE TO CROSS THE LESION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Vessel Or Plaque, Device Embedded In

  MAUDE report 6939143 ↗
• InjuryAug 30, 2017Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 3.5 X 12 MM XIENCE ALPINE STENT WAS IMPLANTED ON (B)(6) 2017. ON (B)(6) 2017 THE PATIENT WAS RE-ADMITTED FOR 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 6831751 ↗
• MalfunctionAug 16, 2017Unstable; Failure to Advance; Material Deformation

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A LESION IN THE HEAVILY TORTUOUS, MODERATELY CALCIFIED PROXIMAL CIRCUMFLEX CORONARY ARTERY. THE 3.5 X 12 MM ALPINE STENT DELIVERY SYSTEM (SDS) FAILED TO CROSS DUE TO THE ANATOMY. THE SDS WAS REMOVED WITHOUT ISSUE, UPON REMOVAL OF THE SDS IT WAS NOTED THAT THE STENT STRUTS WERE FLARED AND THE STENT HAD SHIFTED PROXIMALLY ON THE BALLOON A LITTLE BIT. THE STENT REMAINS ON THE BALLOON. A 3.5 X 08 MM ALPINE SDS WAS USED TO 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 6798513 ↗
• MalfunctionMay 25, 2017Difficult or Delayed Positioning; Material Deformation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY TORTUOUS, ECCENTRIC, AND HEAVILY CALCIFIED DE NOVO SECOND DIAGONAL BRANCH ARTERY THAT WAS 99% STENOSED. A 3.0 X 12 MM NC TRAVELER WAS USED TO PRE-DILATE THE LESION, BUT RESISTANCE WAS MET WITH THE LESION DURING ADVANCEMENT, AND THE BALLOON CATHETER RUPTURED AT 14 ATMOSPHERES (ATM) DURING THE SECOND INFLATION. PRE-DILATION WAS THEREFORE DONE WITH A NON-ABBOTT BALLOON CATHETER. THEN THERE WAS AN ATTEMPT TO DEPLOY A 3.5 X 12 XIENCE ALPINE STENT, BUT THE STENT DID NOT EXPAND ENOUGH DUE TO THE HEAVY CALCIFICATION OF THE LESION. THEREFORE, POST-DILATION WAS ATTEMPTED WITH A 3.5 X 12 MM NC TRAVELER. HOWEVER, RESISTANCE WAS MET WITH THE LESION DURING ADVANCEMENT, AND THE BALLOON CATHETER RUPTURED AT 18 ATM DURING THE FIRST INFLATION. THE STENT DELIVERY SYSTEM WAS THEN USED FOR POST-DILATION FOLLOWED BY FURTHER POST-DILATION WITH A NON-ABBOTT BALLOON CATHETER. THE XIENCE ALPINE STENT WAS SUCCESSFULLY IMPLANTED THOUGH IT WAS DEFORMED DUE TO THE HEAVY CALCIFICATION OF THE LESION. 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 6591845 ↗
• 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 6589172 ↗
• InjuryMay 12, 2017Difficult to Remove; Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY TORTUOUS, MILDLY CALCIFIED, 75% STENOSED LESION IN THE RIGHT CORONARY ARTERY (RCA). AFTER PERFORMING INTRAVASCULAR ULTRASOUND (IVUS) EXAMINATION, THE LESION WAS DILATED WITH A NON-ABBOTT 3.5 X 13 MM BALLOON CATHETER AND THEN THE XIENCE ALPINE 3.5 X 12 MM STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TO THE LESION BUT FAILED TO CROSS AS THE SDS CAME IN CONTACT WITH THE CALCIFICATION PRESENT IN THE DISTAL PART OF THE RCA. THE XIENCE ALPINE SDS WAS PULLED AND THE SDS MET RESISTANCE WITH THE TIP OF THE GUIDING CATHETER (GC). THE SDS WAS PUSHED OUT AND PULLED INTO THE GC A COUPLE OF TIMES. THE SDS WAS FINALLY WITHDRAWN INTO THE GC. ONCE THE SDS WAS TAKEN OUT OF THE ANATOMY THE SDS WAS CHECKED AND IT WAS CONFIRMED THAT THE STENT IMPLANT HAD DISLODGED AND IT WAS FOUND IN THE OSTIUM OF THE RCA. THE DISLODGED STENT WAS RETRIEVED USING A SNARE DEVICE. AFTER THE DISLODGED STENT WAS REMOVED, A NON-ABBOTT 3.5 X 12 MM STENT WAS ADVANCED AND WAS DEPLOYED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6564992 ↗
• MalfunctionApr 18, 2017Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING PREPARATION OF THE 3.5 X 12 MM XIENCE ALPINE STENT DELIVERY SYSTEM, THE PROTECTIVE SHEATH AND STYLET WERE REMOVED WITHOUT DIFFICULTY. IT WAS NOTED THAT THE STENT WAS REMOVED WITH THE STYLET. THE DEVICE WAS NOT USED AND THERE WAS NO PATIENT INVOLVEMENT. A SECOND XIENCE ALPINE WAS USED WITHOUT ISSUE. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 6502460 ↗
• InjuryApr 18, 2017Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2016, A 3.5X12 RX XIENCE ALPINE AND A NON-ABBOTT DRUG-ELUTING STENT WERE BOTH 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 6501569 ↗
• 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 3.5 X 12 MM XIENCE ALPINE STENT WAS DEPLOYED SUCCESSFULLY. ON (B)(6) 2016 THE PATIENT WAS REHOSPITALIZED WITH HEMIPARESIS AND 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; Neurological Deficit/Dysfunction

  MAUDE report 6501457 ↗
• MalfunctionFeb 15, 2017Difficult to Remove; Failure to Advance; Material Deformation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MILDLY CALCIFIED, LESION IN THE RIGHT CORONARY ARTERY. THE 3.5X12 MM XIENCE ALPINE STENT DELIVERY SYSTEM (SDS) FAILED TO CROSS THE TARGET LESION DUE TO THE PATIENT ANATOMY. DURING REMOVAL OF THE SDS, RESISTANCE WAS FELT WITH THE ANATOMY. THE XIENCE ALPINE SDS WAS ABLE TO BE REMOVED AND IT WAS NOTED THAT THE DISTAL AND MID STENT STRUTS WERE FLARED. THE PROCEDURE WAS COMPLETED WITH A SAME SIZE XIENCE ALPINE SDS. 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 6332166 ↗
• InjuryDec 22, 2016Detachment Of Device Component; Difficult 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 LEFT MAIN CORONARY ARTERY WITH HEAVY CALCIFICATION. DIRECT STENTING WAS ATTEMPTED USING A 3.50 X 12 MM XIENCE ALPINE DRUG ELUTING STENT (DES) BUT THE DES FAILED TO CROSS THE LESION. PRE-DILATATION WAS THEN PERFORMED USING A 3.5 X 12 MM BALLOON DILATATION CATHETER (BDC) FOLLOWED BY THE RE-ADVANCEMENT OF THE XIENCE ALPINE AND THE DES FAILED TO CROSS AGAIN. DILATATION WAS PERFORMED ONCE MORE USING THE 3.5 X 12 MM BDC FOLLOWED BY THE RE-ADVANCEMENT OF THE XIENCE ALPINE RX, BUT THE DES STILL COULD NOT CROSS THE LESION. A 3.5 X 12 MM NON-ABBOTT DES WAS ATTEMPTED; HOWEVER, IT ALSO DID NOT CROSS THE LESION. THE 3.5 X 12 MM NON-ABBOTT DES WAS RE-ADVANCED WITH THE AID OF A 5F GUIDING CATHETER FOR SUPPORT; HOWEVER, THE NON-ABBOTT DES BECAME LODGED WITHIN THE 5F CATHETER. THE NON-ABBOTT DES WAS ABLE TO BE RETRACTED FROM THE 5F CATHETER WITHOUT DAMAGING THE GUIDING CATHETER. THE SAME 3.5 X 12 MM XIENCE ALPINE WAS ADVANCED WITH THE SUPPORT OF THE 5F GUIDING CATHETER IN AN ATTEMPT TO CROSS THE LESION, BUT THE ALPINE AGAIN FAILED TO CROSS AND WAS REMOVED. RESISTANCE WAS FELT BETWEEN THE DES AND THE GUIDING CATHETER DURING RETRACTION C

  Patient problems: Cardiac Arrest

  MAUDE report 6201285 ↗
• MalfunctionDec 1, 2016Device Misassembled During Manufacturing /Shipping

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE RIGHT CORONARY ARTERY. A 3.50 X 12 MM XIENCE ALPINE STENT DELIVERY SYSTEM (SDS) WAS SELECTED FOR THE PROCEDURE. THE SDS WAS REMOVED FROM THE DISPENSER HOOP/COIL AND THE MANDREL/SHEATH WAS REMOVED WITH NO RESISTANCE FELT. THE SDS GUIDE WIRE LUMEN WAS FLUSHED AND THERE WAS NO MANIPULATION/HANDLING OF THE STENT AT ANY POINT. JUST PRIOR TO LOADING THE SDS ONTO THE GUIDE WIRE IT WAS NOTED THAT THE STENT IMPLANT HAD SHIFTED DISTALLY ON THE BALLOON AND WAS NO LONGER LOCATED BETWEEN THE PROXIMAL AND DISTAL BALLOON MARKERS THOUGH IT REMAINED ON THE BALLOON. THE STENT IMPLANT APPEARED TO BE TIGHTLY CRIMPED ON THE BALLOON. THE DEVICE WAS NOT USED AND THERE WAS NO PATIENT INVOLVEMENT. TO SUCCESSFULLY COMPLETE THE PROCEDURE, ANOTHER 3.50 X 12 MM XIENCE ALPINE SDS WAS USED. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 6138193 ↗
• InjurySep 28, 2016Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A XIENCE ALPINE 3.5 X 12 MM STENT WAS IMPLANTED ON (B)(6) 2016. ON (B)(6) 2016, THE PATIENT WAS RE-ADMITTED WITH CHEST PAIN. PATIENT LEFT AGAINST MEDICAL ADVICE. IT IS UNKNOWN WHAT TREATMENT WAS GIVEN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina

  MAUDE report 5983891 ↗