XIENCE ALPINE 1125250-15Recalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 08717648199165), received between Sep 28, 2016 and May 31, 2019 — classified as 3 deaths, 23 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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 27 reports, in the reporter's own words as published by the FDA.

• DeathMay 31, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2018, A 2.5X15MM XIENCE ALPINE STENT WAS SUCCESSFULLY IMPLANTED IN THE DISTAL LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY LESION. ON (B)(6) 2019, THE PATIENT EXPIRED DUE TO UNKNOWN CAUSES. AUTOPSY WAS NOT PERFORMED. PER PATIENT'S DAUGHTER, THE PATIENT WAS NOT GOOD AT MANAGING HIMSELF SINCE HIS WIFE HAD PASSED AWAY AND THE PATIENT HAD DISCONTINUED PLAVIX USE AFTER ONE MONTH. PER STUDY PHYSICIAN, THE DEATH IS POSSIBLY RELATED TO THE DEVICE. THERE WAS NO REPORTED DEVICE MALFUNCTION. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THIS ISSUE.

  Patient problems: Death

  MAUDE report 8659693 ↗
• InjuryApr 3, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2018, A 2.50X15MM XIENCE ALPINE STENT WAS IMPLANTED AT THE MID LEFT ANTERIOR DESCENDING ARTERY. THE NEXT DAY ((B)(6) 2018), THE PATIENT HAD SHORTNESS OF BREATH. PATIENT BELIEVES THIS IS DUE TO HER NICKEL ALLERGY FROM THE PREVIOUSLY IMPLANTED STENT. NO TREATMENT HAS BEEN REPORTED. PHYSICIAN HAS NOT CONFIRMED ALLERGY DIAGNOSIS AND IS UNCERTAIN ABOUT DEVICE RELATIONSHIP TO EVENT. NO ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Dyspnea; Hypersensitivity/Allergic reaction; No Code Available

  MAUDE report 8479949 ↗
• InjuryOct 2, 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 2.5X15 MM XIENCE ALPINE STENT WAS IMPLANTED IN THE SECOND DIAGONAL CORONARY ARTERY. ON (B)(6) 2018 THE PATIENT WOKE UP WITH CHEST PAIN RADIATING FROM THE LEFT SIDE OF THE JAW DOWN THE LEFT ARM. THE PATIENT WAS RE-ADMITTED TO THE HOSPITAL. A MYOCARDIAL PERFUSION SCAN WAS PERFORMED AND THE CHEST PAIN RESOLVED ON (B)(6) 2018. ON (B)(6) 2018 THE PATIENT HAD INCREASED CHEST PAIN OVER THE LAST COUPLE OF WEEKS. LABS WERE DRAWN AND AN ELECTROCARDIOGRAM WAS PERFORMED. THE CONDITION RESOLVED ON (B)(6) 2018. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina

  MAUDE report 7925817 ↗
• InjuryJun 5, 2018Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE INDEX PROCEDURE TOOK PLACE ON (B)(6) 2018 DURING WHICH A 2.5 X 18 MM AND A 2.5 X 15 MM XIENCE ALPINE STENT WERE IMPLANTED FOR TREATMENT OF AN UNSPECIFIED VESSEL. THE PATIENT WAS READMITTED TO THE HOSPITAL ON (B)(6) 2018 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 7571698 ↗
• DeathMar 9, 2018Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 2.50 X 15 MM XIENCE ALPINE WAS IMPLANTED ON (B)(6) 2017. ON (B)(6) 2017 THE PATIENT WAS RE-ADMITTED WITH CARDIOVASCULAR SYMPTOMS INCLUDING MYOCARDIAL INFARCTION AND PULMONARY EMBOLIS. THE PATIENT EXPIRED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Death; Myocardial Infarction

  MAUDE report 7328915 ↗
• InjuryMar 6, 2018Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 2.50 X 15 MM XIENCE ALPINE WAS IMPLANTED ON (B)(6) 2017. ON (B)(6) 2017 THE PATIENT WAS RE-ADMITTED WITH CARDIOVASCULAR SYMPTOMS AND PNEUMONIA. 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 7317476 ↗
• InjuryMar 6, 2018Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 2.50 X 15 MM XIENCE ALPINE WAS IMPLANTED ON (B)(6)2017. ON (B)(6) 2017 THE PATIENT WAS RE-ADMITTED WITH CARDIOVASCULAR SYMPTOMS INCLUDING MYOCARDIAL INFARCTION AND PULMONARY EMBOLIS. 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: Myocardial Infarction

  MAUDE report 7317048 ↗
• InjuryMar 2, 2018Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ONE XIENCE ALPINE STENT (3.5 X 23 MM) WAS DEPLOYED SUCCESSFULLY ON (B)(6) 2017. THE PATIENT WAS READMITTED TO THE HOSPITAL ON (B)(6) 2018 FOR SYMPTOMS OF MYOCARDIAL INFARCTION. ALTHOUGH THE TREATMENT PERFORMED IS UNSPECIFIED, THE FACT THAT HOSPITALIZATION TOOK PLACE INDICATES THAT SOME FORM OF TREATMENT WAS PERFORMED. THE FINAL PATIENT OUTCOME IS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Myocardial Infarction

  MAUDE report 7311434 ↗
• InjuryDec 1, 2017Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2017 THE 2.5 X 15 MM XIENCE ALPINE STENT WAS IMPLANTED FOR TREATMENT OF A LESION OF AN UNSPECIFIED VESSEL. ON (B)(6) 2017, THE PATIENT WAS REHOSPITALIZED FOR UNSTABLE ANGINA AND OTHER CARDIOVASCULAR (CV) SYMPTOMS. UNSPECIFIED TREATMENT WAS ADMINISTERED AND THE FINAL PATIENT OUTCOME IS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina

  MAUDE report 7076404 ↗
• InjuryNov 29, 2017Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT TWO XIENCE ALPINE STENTS (2.5X15MM AND 2.5X23MM) 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 7067901 ↗
• InjuryOct 17, 2017Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2017, TWO XIENCE ALPINE STENTS (2.5X15, 2.5X12) WERE SUCCESSFULLY IMPLANTED. ON (B)(6) 2017, THE PATIENT WAS RE-HOSPITALIZED FOR CHEST PAIN. LABS WERE DRAWN AND AN ELECTROCARDIOGRAM WAS PERFORMED. ADDITIONALLY, THE PATIENT WAS TAKEN TO THE CATH LAB FOR CORONARY ANGIOGRAPHY. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: Angina

  MAUDE report 6955256 ↗
• MalfunctionSep 26, 2017Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING DEVICE PREPARATION, THE 2.5 X 15 MM XIENCE ALPINE STENT DISLODGED FROM THE STENT DELIVERY SYSTEM WHEN THE SHEATH WAS REMOVED. THERE WAS NO DIFFICULTY NOTED WHEN REMOVING THE PROTECTIVE SHEATH AND THE DEVICE WAS NOT USED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 6894693 ↗
• InjuryAug 30, 2017Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 2.5X15MM XIENCE ALPINE STENT WAS IMPLANTED ON (B)(6) 2017. ON (B)(6) 2017 THE PATIENT WAS RE-ADMITTED WITH HYPOTENSION 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: Low Blood Pressure/ Hypotension

  MAUDE report 6832823 ↗
• InjuryAug 25, 2017Improper or Incorrect Procedure or Method; Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A PROCEDURE OF THE NARROW, MILDLY CALCIFIED, DISTAL RIGHT CORONARY ARTERY (RCA), AFTER PRE-DILATATION, THE XIENCE ALPINE STENT DELIVERY SYSTEM (SDS) WAS ADVANCED IN A GUIDELINER, THROUGH A PREVIOUSLY IMPLANTED STENT, BUT COULD NOT CROSS THE LESION. THE SDS WAS REMOVED AND ADDITIONAL PRE-DILATATION WAS PERFORMED. OTHER DEVICES WERE ATTEMPTED, BUT COULD NOT CROSS THE LESION. THE SAME XIENCE ALPINE SDS WAS ADVANCED AGAIN, PAST THE PREVIOUS STENT, BUT STILL COULD NOT CROSS THE LESION. THE SDS WAS REMOVED, BUT THE STENT IMPLANT DISLODGED FROM THE BALLOON IN THE PROXIMAL RCA. SEVERAL ATTEMPTS TO RETRIEVE THE STENT USING A SNARE WERE UNSUCCESSFUL AND EVENTUALLY THE STENT WAS DEPLOYED IN THE RADIAL ARTERY. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA OR A CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 6822768 ↗
• InjuryAug 18, 2017Improper or Incorrect Procedure or Method; Device Dislodged or Dislocated

  THE PROCEDURE WAS TO TREAT A MODERATELY TORTUOUS AND MODERATELY CALCIFIED VEIN GRAFT. A 2.5 X 15 MM XIENCE ALPINE STENT WAS USED; HOWEVER, THE STENT CAME OFF THE BALLOON WHEN AN UNSPECIFIED GUIDELINER WAS BEING PULLED BACK AND HIT THE STENT DELIVERY SYSTEM. THEREFORE, ANOTHER UNSPECIFIED STENT WAS IMPLANTED TO EMBED THE XIENCE ALPINE STENT INTO THE VESSEL WALL, AND SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS A DELAY IN THE PROCEDURE; HOWEVER, THE DELAY WAS NOT CLINICALLY SIGNIFICANT AS THERE WAS NO ADVERSE PATIENT SEQUELA REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Vessel Or Plaque, Device Embedded In

  MAUDE report 6805739 ↗
• InjuryAug 16, 2017Device Dislodged or Dislocated

  IT WAS REPORTED THAT THIS WAS A PROCEDURE TO TREAT A LESION IN THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD). THE 2.5X15 MM XIENCE ALPINE STENT DELIVERY SYSTEM WAS ADVANCED IN THE PATIENT ANATOMY. HOWEVER, DURING ADVANCEMENT OF THE ALPINE SDS, THE STENT DISLODGED IN THE LEFT MAIN. A TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED IN THE ANATOMY, AND THE DISLODGED STENT WAS POSITIONED IN THE TARGET LESION AND WAS IMPLANTED SUCCESSFULLY. THE PROCEDURE WAS COMPLETE AT THIS TIME. 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 6798451 ↗
• InjuryJun 16, 2017Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6)2017, A 3.0 X 15 MM, A 2.5 X 33 MM, A 2.5 X 15 MM AND A 4.0 X 08 MM XIENCE ALPINES STENTS WERE IMPLANTED. ON (B)(6)2017, THE PATIENT WAS RE-ADMITTED WITH INCREASED DIFFICULTY BREATHING. UNKNOWN MEDICAL TREATMENT WAS PERFORMED. THE PATIENT WAS DISCHARGED HOME. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Dyspnea

  MAUDE report 6648818 ↗
• InjuryMay 23, 2017Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE INDEX PROCEDURES TOOK PLACE ON (B)(6) 2017 DURING WHICH A 2.5 X 15 MM XIENCE ALPINE AND A 2.5 X 18 MM XIENCE ALPINE WERE IMPLANTED FOR TREATMENT OF UNSPECIFIED VESSELS. THE PATIENT WAS READMITTED TO THE HOSPITAL ON (B)(6) 2017 FOR SEPSIS 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: Sepsis

  MAUDE report 6585396 ↗
• DeathMay 17, 2017Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A CALCIFIED LESION IN THE MARGINAL CORONARY ARTERY. THE PATIENT HAD BEEN TURNED DOWN FOR BYPASS SURGERY. FOLLOWING PRE-DILATATION, A 2.5 X 18 MM XIENCE ALPINE STENT DELIVERY SYSTEM (SDS) WAS BEING ADVANCED TO THE LESION; HOWEVER, ONE OF THE STENT STRUTS PULLED UP ON THE END AND THE SDS COULD NOT CROSS THE CALCIFIED LESION. A 2.5 X 15 MM XIENCE ALPINE SDS WAS SUCCESSFULLY IMPLANTED. SHORTLY AFTER THE STENT WAS PLACED THE PATIENT WENT INTO CARDIAC AND RESPIRATORY ARREST AND COULD NOT BE REVIVED. AN ATTEMPT TO RESUSCITATE THE PATIENT FOR 30 MINUTES WAS MADE, BUT WAS UNSUCCESSFUL AND THE PATIENT WAS DECLARED DEAD. AN AUTOPSY WAS NOT PERFORMED. IT WAS REPORTED THAT THE CAUSE OF DEATH WAS NOT DUE TO A DEVICE ISSUE, BUT WAS PROCEDURE RELATED AS THE PATIENT WAS VERY ILL WITH LOW EJECTION FRACTION (EF) FUNCTION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Cardiac Arrest; Death; Respiratory Failure

  MAUDE report 6573163 ↗
• InjuryMay 11, 2017Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING ADVANCEMENT OF THE 2.5X15 MM XIENCE ALPINE STENT DELIVERY SYSTEM (SDS), RESISTANCE WAS MET WITH THE PRE-DILATED, MODERATELY CALCIFIED ANATOMY IN THE RIGHT CORONARY ARTERY (RCA). THE SDS WAS REMOVED FROM THE ANATOMY WITHOUT RESISTANCE; HOWEVER, ONCE OUT, IT WAS NOTED THAT THE STENT WAS NOT ON THE SDS. THE DISLODGED STENT WAS FOUND IN THE RCA AND WAS ABLE TO BE DEPLOYED, USING MULTIPLE BALLOON DILATATION CATHETERS, IN THE PROXIMAL RCA. ADDITIONAL PRE-DILATATION WAS PERFORMED IN THE MID RCA AND ANOTHER 2.5X15 MM XIENCE ALPINE SDS WAS SUCCESSFULLY DEPLOYED IN THE TARGET LESION. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 6561917 ↗
• InjuryMar 16, 2017Physical Resistance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT RESISTANCE WAS FELT WITH THE ANATOMY WHEN ADVANCING THE 2.5X15 MM XIENCE ALPINE STENT DELIVERY SYSTEM (SDS). WHILE ATTEMPTING TO ADVANCE THE SDS, THE STENT DISLODGED IN THE PATIENT ANATOMY. AN UNSPECIFIED XIENCE ALPINE STENT WAS IMPLANTED TO COMPLETE THE PROCEDURE. THE FOLLOWING DAY, AFTER THE PROCEDURE, ON (B)(6) 2017 A SNARE DEVICE WAS USED TO REMOVE THE DISLODGED STENT FROM THE PATIENT ANATOMY. THE PATIENT IS STABLE. THERE WAS A DELAY IN THE PROCEDURE, THE PATIENT HAD TO HAVE THE DISLODGED STENT SNARED TWO DAYS AFTER THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6412102 ↗
• InjuryFeb 8, 2017Difficult or Delayed Positioning

  IT WAS REPORTED THAT ON (B)(6) 2017, THE PATIENT WAS ADMITTED WITH ST ELEVATION MYOCARDIAL INFARCTION (STEMI) AND UNDERWENT A CORONARY ARTERY STENTING PROCEDURE. TWO 2.5 X 15 MM XIENCE ALPINE STENTS WERE IMPLANTED AND THE PATIENT WAS PLACED ON DUAL ANTIPLATELET THERAPY (DAPT). ON (B)(6) 2017, THE PATIENT WAS RE-HOSPITALIZED WITH ANGINA AND STEMI WAS DIAGNOSED. CORONARY ANGIOGRAPHY NOTED THROMBOSIS IN BOTH STENTS. ADDITIONALLY, IT WAS NOTED THAT THE STENTS WERE NOT WELL APPOSED TO THE VESSEL WALL AND NOT WELL EXPANDED. BALLOON ANGIOPLASTY WAS PERFORMED USING A 3.5 UNSPECIFIED NC DILATATION CATHETER, FULLY EXPANDING THE STENTS SO THAT THEY WERE WELL APPOSED TO THE VESSEL WALL. POST PROCEDURE, THE PATIENT WAS IN STABLE CONDITION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina; Myocardial Infarction; Thrombosis

  MAUDE report 6311781 ↗
• InjuryFeb 8, 2017Difficult or Delayed Positioning

  IT WAS REPORTED THAT ON (B)(6) 2017, THE PATIENT WAS ADMITTED WITH ST ELEVATION MYOCARDIAL INFARCTION (STEMI) AND UNDERWENT A CORONARY ARTERY STENTING PROCEDURE. TWO 2.5 X 15 MM XIENCE ALPINE STENTS WERE IMPLANTED AND THE PATIENT WAS PLACED ON DUAL ANTIPLATELET THERAPY (DAPT). ON (B)(6) 2017, THE PATIENT WAS RE-HOSPITALIZED WITH ANGINA AND STEMI WAS DIAGNOSED. CORONARY ANGIOGRAPHY NOTED THROMBOSIS IN BOTH STENTS. ADDITIONALLY, IT WAS NOTED THAT THE STENTS WERE NOT WELL APPOSED TO THE VESSEL WALL AND NOT WELL EXPANDED. BALLOON ANGIOPLASTY WAS PERFORMED USING A 3.5 UNSPECIFIED NC DILATATION CATHETER, FULLY EXPANDING THE STENTS SO THAT THEY WERE WELL APPOSED TO THE VESSEL WALL. POST PROCEDURE, THE PATIENT WAS IN STABLE CONDITION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina; Myocardial Infarction; Thrombosis

  MAUDE report 6311780 ↗
• 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 UNSTABLE ANGINA, MYOPATHY 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: Angina; No Code Available

  MAUDE report 6244146 ↗
• InjuryJan 4, 2017Difficult to Remove; Improper or Incorrect Procedure or Method; Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A CONCENTRIC DE NOVO LESION IN THE MODERATELY TORTUOUS, HEAVILY CALCIFIED, 90% STENOSED MID LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY. A 2.5 X 15 MM XIENCE ALPINE STENT DELIVERY SYSTEM (SDS) WAS SELECTED FOR THE PROCEDURE. THE SDS WAS ADVANCED TO A PREVIOUSLY IMPLANTED NON-ABBOTT STENT, MET RESISTANCE AND WOULD NOT CROSS. WHILE ATTEMPTING TO REMOVE THE SDS FROM THE ANATOMY, THE STENT IMPLANT BECOME STUCK IN THE PREVIOUSLY IMPLANTED NON-ABBOTT STENT. FORCE WAS APPLIED TO THE SDS IN ORDER TO REMOVE THE SDS FROM THE ANATOMY. ONCE THE SDS WAS OUT OF THE ANATOMY, THE STENT IMPLANT WAS FOUND TO BE DISLODGED FROM THE BALLOON AND LOCATED IN THE ANATOMY. ATTEMPTS TO RETRIEVE THE STENT IMPLANT FAILED AND IT REMAINED LODGED IN THE PREVIOUSLY IMPLANTED NON-ABBOTT STENT IMPLANT. THE PATIENT REFUSED TO HAVE THE DISLODGED STENT IMPLANT REMOVED SURGICALLY. THE PATIENT WAS OBSERVED IN THE HOSPITAL FOR A WEEK AND THEN WAS DISCHARGED ON A REGIMEN OF ASPIRIN, EFFIENT AND ELIQUIS. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 6223036 ↗