XIENCE Sierra™ 1550250-15Recalls & reported problems

Summary

The FDA's MAUDE database contains 42 adverse event reports that list this exact device (DI 08717648227097), received between Nov 29, 2018 and Jun 27, 2022 — classified as 3 deaths, 29 injuries, 10 malfunctions.

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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 42 reports, in the reporter's own words as published by the FDA.

• DeathJun 27, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PROCEDURE IN A LESION IN AN UNKNOWN ARTERY. AT AN UNSPECIFIED TIME AFTER STENT IMPLANTATION OF A XIENCE STENT THE PATIENT DIED. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

  Patient problems: Angina; Cardiac Arrest; Insufficient Information; Myocardial Infarction

  MAUDE report 14838293 ↗
• InjuryDec 1, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT ID: (B)(6). IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED ON (B)(6) 2020, TREATING LESIONS IN THE MID RIGHT CORONARY ARTERY (RCA) AND IN THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY. A 2.5 X 15 MM XIENCE SIERRA STENT WAS IMPLANTED IN THE RCA AND A 3.5 X 38 MM XIENCE SIERRA STENT WAS IMPLANTED IN THE LAD. ON (B)(6) 2021, THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT WITH CHEST PAIN, RELIEVED WITH NITROGLYCERIN. A CORONARY ARTERY BYPASS GRAFT (CABG) PROCEDURE WAS PERFORMED. POST PROCEDURE, THE PATIENT REMAINED ON INTRA-AORTIC BALLOON PUMP (IABP) FOR LOW EJECTION FRACTION. THE PATIENT WAS DISCHARGED TO HOME ON (B)(6) 2021. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina

  MAUDE report 12913287 ↗
• MalfunctionOct 19, 2021Failure to Advance; Contamination /Decontamination Problem; Failure to Advance; Contamination /Decontamination Problem

  IT WAS REPORTED THAT ON (B)(6) 2021, A PERCUTANEOUS INTERVENTION WAS PERFORMED ON THE CIRCUMFLEX AND MARGINAL CORONARY ARTERIES. THE XIENCE SIERRA STENT DELIVERY SYSTEM HAD FAILED TO CROSS DUE TO ANATOMY. THE DEVICE WAS REMOVED WITHOUT ISSUE AND ADDITIONAL DILATATION WAS PERFORMED. ONCE OUTSIDE THE ANATOMY, AN UNKNOWN STRING FIBER/WIRE WAS NOTED ON THE STENT'S PROXIMAL END. THERE WAS NO FOREIGN OBJECT LEFT IN THE ANATOMY. THE PATIENT HAD NO ADVERSE EVENT ASSOCIATED WITH THIS ISSUE. A GUIDELINER WAS PLACED AND ANOTHER XIENCE SIERRA WAS SUCCESSFULLY USED IN REPLACEMENT WITHOUT FURTHER ISSUES. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12661147 ↗
• InjuryAug 18, 2021Failure to Advance; Device Dislodged or Dislocated; Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A CIRCUMFLEX LESION. THE XIENCE SIERRA STENT WAS ADVANCED BUT ONCE REACHING THE LEFT MAIN IT MET RESISTANCE WITH A PREVIOUSLY DEPLOYED STENT (FROM A DIFFERENT PROCEDURE) AND DISLODGED. THE XIENCE SIERRA WAS RETRIEVED VIA SNARE. ANOTHER STENT WAS USED TO SUCCESSFULLY 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 12339304 ↗
• MalfunctionJun 24, 2021Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE ON (B)(6) 2021 WAS TO TREAT AN OBTUSE MARGINAL ARTERY. AN 2.5X15MM XIENCE SIERRA STENT WAS IMPLANTED AT THE LESION WITHOUT ISSUE. AFTER THE PROCEDURE IT WAS NOTED THAT THE STENT HAD ALREADY EXPIRED ON 6/1/21. THERE WERE NO ADVERSE PATIENT EFFECTS OR CLINICALLY SIGNIFICANT DELAY TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12063925 ↗
• InjuryApr 5, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBSEQUENT TO THE FINAL MDR REPORT, ADDITIONAL INFORMATION WAS PROVIDED. IN LATE FEBRUARY / EARLY MARCH OF 2021, THE PATIENT HAD 6 EPISODES OF INTERMITTENT HEMODIALYSIS (IHD) AND HAD BEEN GAINING WEIGHT AFTER EACH SESSION. THE PATIENT WAS RE-HOSPITALIZED WITH CHEST PAIN AND HYPOTENSION, AND WAS DETERMINED TO BE IN RESPIRATORY ARREST WITH HEART BLOCK GRADE III. ST ELEVATION AND ELEVATED CARDIAC ENZYMES WERE NOTED, CONCERNING FOR MYOCARDIAL INFARCTION. THE PATIENT UNDERWENT URGENT CARDIAC CATHETERIZATION TO TREAT OCCLUSION WHILE ON MAXIMAL VASOPRESSOR SUPPORT. THE PATIENT WENT INTO PULSELESS ELECTRIC ACTIVITY ARREST. CARDIOPULMONARY RESUSCITATION WAS PERFORMED, AND SPONTANEOUS CIRCULATION WAS RESTORED. THE PATIENT WAS INTUBATED AND VENTILATED. THE EVENT RESOLVED ON (B)(6) 2021. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina; Arrhythmia; Cardiac Arrest; Ischemia; Low Blood Pressure/ Hypotension; Myocardial Infarction; Obstruction/Occlusion; Respiratory Failure

  MAUDE report 11614405 ↗
• InjuryMar 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2020 A XIENCE SIERRA STENT WAS SUCCESSFULLY IMPLANTED. ON (B)(6) 2020 THE PATIENT WAS RE-HOSPITALIZED FOR HYPERTENSION AND OTHER CARDIOVASCULAR SYMPTOMS. PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) WAS PERFORMED, AND THE FINAL PATIENT OUTCOME IS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: High Blood Pressure/ Hypertension

  MAUDE report 11438380 ↗
• MalfunctionDec 4, 2020Difficult to Remove; Failure to Advance; Difficult to Remove; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A DE NOVO LESION IN THE HEAVILY CALCIFIED, MODERATELY TORTUOUS, 90% STENOSED DISTAL RIGHT CORONARY ARTERY. A 2.5X15MM XIENCE SIERRA STENT DELIVERY SYSTEM (SDS) FAILED TO CROSS DUE TO THE ANATOMY. THE DEVICE WAS REMOVED BUT EXPERIENCED RESISTANCE WITH THE ANATOMY. A NON-ABBOTT BALLOON WAS USED TO SUCCESSFULLY 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 10949671 ↗
• InjuryJun 12, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON 1/10/2020 THE PATIENT PRESENTED WITH NON-ST ELEVATED MYOCARDIAL INFARCTION. TWO (2.5 X 15, 3.25 X 15 MM) XIENCE SIERRA STENTS WERE IMPLANTED. ON (B)(6) 2020 THE PATIENT WAS RE-HOSPITALIZED WITH CHEST PAIN AND OTHER CARDIOVASCULAR SYMPTOMS. IT IS UNKNOWN WHAT TREATMENT WAS PERFORMED AND WHAT THE FINAL PATIENT OUTCOME WAS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina

  MAUDE report 10151154 ↗
• InjuryJun 12, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 2.5X15MM XIENCE SIERRA STENT WAS IMPLANTED ON (B)(6) 2020. THE PATIENT PRESENTED WITH CONGESTIVE AND HYPOTENSIVE HEART FAILURE BEFORE THE PROCEDURE. ON (B)(6) 2020, THE PATIENT WAS RE-ADMITTED WITH HYPERTENSIVE HEART. UNSPECIFIED TREATMENT WAS PERFORMED, AND THE FINAL PATIENT OUTCOME IS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: High Blood Pressure/ Hypertension

  MAUDE report 10149141 ↗
• MalfunctionMar 31, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED, DE NOVO LESION IN THE PROXIMAL CIRCUMFLEX BRANCH. DURING ADVANCEMENT OF THE 2.50X15MM RX XIENCE SIERRA STENT DELIVERY SYSTEM (SDS), THE STENT PARTIALLY DISLODGED BEFORE THE SDS REACHED THE TARGET LESION. THE SDS WITH THE STENT WAS COMPLETELY REMOVED FROM THE ANATOMY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH AN UNSPECIFIED DEVICE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND NO ADVERSE PATIENT EFFECT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9907688 ↗
• InjuryMar 8, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON 10/03/2019 THE PATIENT PRESENTED WITH NON-ST ELEVATED MYOCARDIAL INFARCTION (NSTEMI). FOUR (2.5X15MM, 2.50X33MM, 3.50X23MM, 3.0X38MM) XIENCE SIERRA STENTS WERE IMPLANTED. ON (B)(6) 2019 THE PATIENT WAS RE-ADMITTED WITH SEPSIS. SURGERY WAS PERFORMED ;HOWEVER, THE FINAL PATIENT OUTCOME IS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Sepsis

  MAUDE report 9803955 ↗
• InjuryMar 8, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2019 THE PATIENT PRESENTED WITH SEPSIS. A 2.5X15MM XIENCE SIERRA WAS IMPLANTED. ON (B)(6) 2019 THE PATIENT WAS RE-HOSPITALIZED WITH ATHEROSCLEROSIS HEART DISEASE. IT IS UNKNOWN WHAT TREATMENT WAS PERFORMED AND WHAT THE FINAL PATIENT OUTCOME WAS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 9803855 ↗
• InjuryMar 4, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2019 THE PATIENT PRESENTED WITH NON-ST ELEVATED MYOCARDIAL INFARCTION (NSTEMI) THEREFORE THE 2.50X15MM XIENCE SIERRA WAS IMPLANTED. ON (B)(6) 2019 THE PATIENT WAS RE-ADMITTED WITH CHEST PAIN AND OTHER CARDIOVASCULAR SYMPTOMS. IT IS UNKNOWN WHAT TREATMENT WAS PERFORMED AND THE FINAL PATIENT OUTCOME IS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina

  MAUDE report 9787869 ↗
• InjuryMar 4, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2019 THE PATIENT PRESENTED WITH NON-ST ELEVATED MYOCARDIAL INFARCTION (NSTEMI) THEREFORE THE 2.50X15MM XIENCE SIERRA WAS IMPLANTED. ON (B)(6) 2019 THE PATIENT WAS RE-ADMITTED WITH OTHER CARDIOVASCULAR SYMPTOMS INCLUDING COMPLICATION OF ANOTHER ARTERY. IT IS UNKNOWN WHAT TREATMENT WAS PERFORMED AND THE FINAL PATIENT OUTCOME IS UNKNOWN.

  Patient problems: No Code Available

  MAUDE report 9787437 ↗
• InjuryMar 4, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2019 THE PATIENT PRESENTED WITH ATHEROSCLEROTIC HEART DISEASE THEREFORE THE 2.50X15MM AND 3.0X18MM XIENCE SIERRA STENTS WERE IMPLANTED. ON (B)(6) 2019 THE PATIENT WAS RE-ADMITTED WITH OTHER CARDIOVASCULAR SYMPTOMS AND STENOSIS OF THE CORONARY STENT. PERCUTANEOUS TRANSLUMINAL AND CORONARY ANGIOPLASTY WAS PERFORMED, AND THE FINAL PATIENT OUTCOME IS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Stenosis

  MAUDE report 9787169 ↗
• InjuryFeb 11, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A MODERATELY CALCIFIED, MODERATELY TORTUOUS CIRCUMFLEX ARTERY. THE 2.50X15MM XIENCE SIERRA STENT DELIVERY SYSTEM (SDS) WAS ADVANCED ON AN UNSPECIFIED GUIDE WIRE DISTAL TO THE LESION BUT NOT DEPLOYED. THE USER DECIDED TO PULL BACK ON THE SDS, AT WHICH POINT THE STENT CAME OFF THE DELIVERY CATHETER. THE CATHETER WAS REMOVED, AND IT WAS NOTED THAT THE STENT REMAINED ON THE GUIDE WIRE. AN UNSPECIFIED 1.2MM BALLOON WAS USED TO EXPAND THE STENT WHICH WAS IMPLANTED IN THE PROXIMAL SIDE OF THE CIRCUMFLEX IN HEALTHY TISSUE. THE TARGET LESION WAS LEFT UNTREATED. THERE WAS NO ADVERSE PATIENT SEQUELA REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 9696336 ↗
• MalfunctionDec 26, 2019Failure to Advance; Device Dislodged or Dislocated; Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A DE NOVO LESION LOCATED IN THE MID LEFT ANTERIOR DESCENDING CORONARY ARTERY THAT WAS BOTH MODERATELY CALCIFIED AND TORTUOUS. AFTER A FAILED ATTEMPT TO CROSS WITH THE CALCIFIED LESION, WHEN THE DELIVERY SYSTEM WAS REMOVED WITHOUT RESISTANCE, THE STENT WAS OBSERVED TO BE LOOSE ON THE BALLOON. ANOTHER XIENCE SIERRA WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO REPORTED 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 9521101 ↗
• InjuryDec 19, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT ID (B)(6). IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE DISTAL RIGHT CORONARY ARTERY (RCA). A 2.5 X 16 MM XIENCE SIERRA STENT WAS IMPLANTED. POST STENTING, THE PATIENT HAD COMPLAINTS OF CHEST PAINT. ELECTROCARDIOGRAM (ECG) REVEALED ST ELEVATION AND REPEAT ANGIOGRAPHY REVEALED 100% TOTAL OCCLUSION IN THE MID PORTION OF THE FIRST MARGINAL BRANCH. THERE WAS NO OBVIOUS LESION NOTED IN THIS LOCATION PRIOR TO STENT PLACEMENT IN THE DISTAL RCA AND THERE WAS SUSPICION FOR SPONTANEOUS DISSECTION; HOWEVER, ATHEROEMBOLI COULD NOT BE EXCLUDED. REVASCULARIZATION WAS PERFORMED IN THE 1ST OBTUSE MARGINAL, WITH IMPLANTATION OF AN ADDITIONAL STENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina; Cardiac Enzyme Elevation; Embolism; Non specific EKG/ECG Changes

  MAUDE report 9492998 ↗
• InjuryDec 13, 2019Difficult to Remove; Failure to Advance; Device Dislodged or Dislocated; Difficult to Remove; Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THIS WAS A PROCEDURE TO TREAT A LESION WITH HEAVY CALCIFICATION AND MODERATE TORTUOSITY IN THE LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY. PRE-DILATATION WAS PERFORMED SUCCESSFULLY. THE 2.50 X 15 MM XIENCE SIERRA RX STENT DELIVERY SYSTEM (SDS) WAS ADVANCED INTO THE VESSEL, BUT AFTER MULTIPLE ATTEMPTS THE SDS COULD NOT CROSS THE LESION. WHEN THE SDS WAS BEING PULLED BACK RESISTANCE WAS NOTED, AND THE STENT DISLODGED IN HEALTHY TISSUE. THE DISLODGED STENT WAS COMPRESSED AGAINST THE VESSEL WITH A XIENCE ALPINE. ANOTHER XIENCE SIERRA STENT WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THE PATIENT OUTCOME WAS GOOD. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Vessel Or Plaque, Device Embedded In

  MAUDE report 9466878 ↗
• InjuryDec 9, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2019 THE PATIENT PRESENTED WITH ATHEROSCLEROTIC HEART DISEASE THEREFORE THE 2.50X15MM AND 2.75X33MM XIENCE SIERRA STENTS WERE IMPLANTED. ON (B)(6) 2019 THE PATIENT WAS RE-ADMITTED WITH ANGINA. IT IS UNKNOWN WHAT TREATMENT WAS PERFORMED AND THE FINAL PATIENT OUTCOME IS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina

  MAUDE report 9440733 ↗
• DeathDec 9, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2019 THE PATIENT PRESENTED WITH ST ELEVATED MYOCARDIAL INFARCTION (STEMI) THEREFORE THE 2.50X15MM, 2.75X23MM, AND 3.50X38MM XIENCE SIERRA STENTS WERE IMPLANTED. ON (B)(6) 2019, (B)(6) 2019, AND (B)(6) /2019 THE PATIENT WAS RE-ADMITTED WITH HYPERTENSIVE HEART DISEASE AND PNEUMONIA. PLAIN OLD BALLOON ANGIOPLASTY (POBA) WAS PERFORMED HOWEVER THE PATIENT EXPIRED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Death

  MAUDE report 9439941 ↗
• InjuryDec 9, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2019 THE PATIENT PRESENTED WITH NON-ST ELEVATED MYOCARDIAL INFARCTION (NSTEMI) THEREFORE THE 2.50X15MM XIENCE SIERRA WAS IMPLANTED. ON (B)(6) 2019 THE PATIENT WAS RE-ADMITTED WITH AORTIC VALVE STENOSIS. SURGERY WAS PERFORMED HOWEVER THE FINAL PATIENT OUTCOME IS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Stenosis

  MAUDE report 9438526 ↗
• InjuryNov 7, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2018 THE PATIENT UNDERWENT CORONARY INTERVENTION WITH THE 2.5X15 MM XIENCE SIERRA STENT IMPLANTED IN THE PROXIMAL LEFT ANTERIOR DESCENDING CORONARY ARTERY. ON (B)(6) 2019 THE PATIENT HAD SUB-STERNAL CHEST PAIN AND SHORTNESS OF BREATH. CORONARY ANGIOGRAM FOUND IN-STENT RESTENOSIS IN THE LAD STENT. REVASCULARIZATION WAS PERFORMED PERCUTANEOUSLY. THE CONDITION RESOLVED ON (B)(6) 2019. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina; Dyspnea; Stenosis

  MAUDE report 9290274 ↗
• MalfunctionOct 21, 2019Component Missing; Component Missing

  IT WAS REPORTED THAT AFTER REMOVAL OF THE PROTECTIVE SHEATH AND DURING DEVICE PREPARATION, THE STENT WAS NOTED TO BE MISSING. THERE WERE NO DIFFICULTIES DURING REMOVAL OF THE PROTECTIVE SHEATH AND THE SHEATH WAS CHECKED AFTER REMOVAL FOR THE MISSING STENT. THE MISSING STENT COULD NOT BE LOCATED. THE DEVICE WAS NOT USED AND THERE WAS NO PATIENT INVOLVEMENT OR A REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 9215519 ↗