XIENCE Sierra™ 1550250-12Recalls & reported problems

Summary

The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 08717648227080), received between Aug 2, 2018 and Sep 8, 2021 — classified as 3 deaths, 19 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (5 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 32 reports, in the reporter's own words as published by the FDA.

• InjurySep 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT ID: (B)(6). IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT PRESENTED IN WITH A RECENT NON-ST ELEVATED MYOCARDIAL INFARCTION (NSTEMI) AND A PERCUTANEOUS INTERVENTION WAS PERFORMED ON THE LEFT ANTERIOR DESCENDING (LAD), 80% STENOSED LESION. PRE-DILATATION WAS PERFORMED AND A 2.5X38MM XIENCE SIERRA AND A 2.5X12MM XIENCE SIERRA STENT WERE SUCCESSFULLY IMPLANTED WITH ACCEPTABLE RESULTS. 0% RESIDUAL STENOSIS AND WITHOUT COMPLICATIONS. ON (B)(6) 2021, THE PATIENT PRESENTED WITH INTERMITTENT LEFT LOWER PARASTERNAL CHEST DISCOMFORT, UNSTABLE ANGINA, FOR APPROXIMATELY ONE WEEK. ELEVATED CARDIAC LABS WERE OBSERVED. THE PATIENTS VITAL SIGNS AND HEART FAILURE LAB PROBNP WERE WITHIN NORMAL RANGE. THE EKG REVEALED T WAVE INVERSION AND ST ELEVATION IN LEAD 4 AND A NON-ST ELEVATED MYOCARDIAL INFARCTION (MI) WAS DIAGNOSED. THE CHEST X-RAY REVEALED NO ACUTE ABNORMALITY. MEDICATION WAS PROVIDED. ON (B)(6) 2021, A TARGET VESSEL REVASCULARIZATION WAS PERFORMED, PLACING ANOTHER STENT IN THE 99% STENOSED LESION. REPORTEDLY, BOTH XIENCE SIERRA STENTS HAD RESTENOSED. THERE WAS NO DEVICE MALFUNCTION. THE EVENT RESOLVED WITHOUT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THIS ISSUE.

  Patient problems: Angina; Myocardial Infarction; Stenosis

  MAUDE report 12442834 ↗
• InjuryAug 31, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2021 THE PATIENT PRESENTED WITH A ST-ELEVATION MYOCARDIAL INFARCTION AND A 2.5X12MM XIENCE SIERRA STENT WAS IMPLANTED. ON (B)(6) 2021, THE PATIENT WAS RE-ADMITTED WITH UNSPECIFIED CARDIOVASCULAR SYMPTOMS AND ACUTE PERICARDITIS. UNSPECIFIED TREATMENT WAS PROVIDED AND THE FINAL PATIENT OUTCOME IS NOT KNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Unspecified Infection

  MAUDE report 12395309 ↗
• MalfunctionAug 24, 2021Difficult to Remove; Failure to Advance; Difficult to Remove; Failure to Advance

  IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT PRESENTED WITH A PROXIMAL LEFT ANTERIOR DESCENDING (LAD) 99% STENOSED LESION. A XIENCE SIERRA STENT DELIVERY SYSTEM FAILED TO CROSS DUE TO THE LESIONS CALCIFICATION. DURING DEVICE REMOVAL, RESISTANCE WAS NOTED AGAIN WITH THE LESION. ANOTHER DEVICE WAS USED IN REPLACEMENT. THERE WAS NO ADVERSE PATIENT EFFECT AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12360505 ↗
• MalfunctionAug 6, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT THIS WAS A PERCUTANEOUS CORONARY INTERVENTION IN THE HEAVILY CALCIFIED MID LEFT CIRCUMFLEX CORONARY ARTERY. THE 2.5X12 MM XIENCE SIERRA STENT DELIVERY SYSTEM (SDS) WAS ADVANCED WITHOUT RESISTANCE WHEN THE PROXIMAL SHAFT SEPARATED IN TWO PIECES OUTSIDE THE BODY. THE SEPARATED SEGMENT WAS REMOVED FROM THE SHEATH USING A HEMOSTAT. THE ENTIRE SDS WAS REMOVED WITHOUT INCIDENT. ANOTHER XIENCE SIERRA WAS INSERTED AND USED WITHOUT FURTHER INCIDENT. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12288461 ↗
• MalfunctionJun 18, 2021Inflation Problem; Activation Failure; Inflation Problem; Activation Failure

  IT WAS REPORTED THAT THE 2.5X12 MM XIENCE SIERRA STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TO THE TARGET LESION, HOWEVER THE BALLOON FAILED TO INFLATE AND THE STENT DID NOT DEPLOY. THE SDS WAS REMOVED WITHOUT ISSUE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. A NEW SAME SIZE SIERRA SDS WAS USED TO COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12029137 ↗
• InjuryJun 1, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2021 TWO XIENCE SIERRA STENTS (2.5X12 AND 3.0X8) WERE IMPLANTED. ON (B)(6) 2021, THE PATIENT WAS RE-ADMITTED DUE TO HYPERTENSIVE HEART AND OTHER CARDIOVASCULAR SYMPTOMS. TREATMENT WAS NOT SPECIFIED AND THE FINAL PATIENT OUTCOME IS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: High Blood Pressure/ Hypertension

  MAUDE report 11917934 ↗
• InjuryFeb 23, 2021Device Dislodged or Dislocated; Migration; Device Dislodged or Dislocated; Migration

  USER FACILITY MEDWATCH REPORT RECEIVED [MW5098703] THAT STATES: [WHILE PLACING XIENCE STENT, STENT DISPLACED AND REQUIRED SNARE TO RETRIEVE. PATIENT WAS UNDERGOING LEFT HEART CATH WITH STENT PLACEMENT.] ADDITIONAL REPORTED INFORMATION WAS RECEIVED FROM THE ACCOUNT REPORTING THAT THE TARGET LESION WAS 100% STENOSED IN THE LEFT POSTERIOR DESCENDING ARTERY. A 2.5X12 XIENCE SIERRA STENT DELIVERY SYSTEM WAS ADVANCED WITHOUT RESISTANCE; HOWEVER, THE STENT COMPLETELY DISLODGED OFF THE BALLOON INSIDE THE PATIENT'S ANATOMY. A SNARE DEVICE WAS ATTEMPTED BUT THE STENT WAS NOT RETRIEVED. THE STENT WAS THEN DEPLOYED IN THE MID CIRCUMFLEX ARTERY BUT MIGRATED AND WAS ULTIMATELY DEPLOYED IN THE PROXIMAL CIRCUMFLEX. THE PROCEDURE WAS COMPLETED WITH PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY ONLY. THERE WERE NO REPORTED ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 11369331 ↗
• InjuryFeb 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 A TARGET LESION IN THE RAMUS ARTERY. A 2.5 X 12 MM XIENCE SIERRA STENT WAS IMPLANTED IN THE RAMUS CORONARY ARTERY. ON (B)(6) 2021, THE PATIENT HAD COMPLAINTS OF CHEST PAIN. CARDIAC CATHETERIZATION WAS PERFORMED ON (B)(6) 2021 AND SHOWED IN-STENT RESTENOSIS IN THE TARGET LESION. A REVASCULARIZATION PROCEDURE WAS PERFORMED, WITH IMPLANTATION OF AN ADDITIONAL STENT. THE EVENT RESOLVED ON (B)(6) 2021. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina; Stenosis

  MAUDE report 11263975 ↗
• MalfunctionDec 9, 2020Failure to Advance; Device Dislodged or Dislocated; Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A MODERATELY CALCIFIED, MODERATELY TORTUOUS DE NOVO PROXIMAL DIAGONAL. THE 2.50X12MM XIENCE SIERRA FAILED TO CROSS THE LESION DUE TO THE ANATOMY AND THE STENT DISLODGED. THE STENT REMAINED PARTIALLY ATTACHED TO THE DELIVERY SYSTEM AND THEY WERE BOTH REMOVED AS A SINGLE UNIT. A NEW SAME 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 Consequences Or Impact To Patient

  MAUDE report 10979079 ↗
• InjuryDec 8, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2020 A 2.50X12MM XIENCE SIERRA STENT WAS SUCCESSFULLY IMPLANTED. ON (B)(6) 2020, 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 10972278 ↗
• InjuryNov 26, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2020 THE PATIENT HAD A 2.50X12 MM XIENCE SIERRA STENT IMPLANTED. ON (B)(6) 2020 THE PATIENT WAS RE-HOSPITALIZED DUE TO ATRIAL FIBRILLATION AND CHEST PAIN. THE TYPE OF TREATMENT WAS UNSPECIFIED AND THE FINAL PATIENT OUTCOME IS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina; Atrial Fibrillation

  MAUDE report 10909312 ↗
• InjurySep 14, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2020 THE PATIENT PRESENTED WITH ACUTE ISCHEMIC HEART DISEASE AND A 2.5X12MM XIENCE SIERRA STENT WAS IMPLANTED. ON (B)(6) 2020, THE PATIENT WAS RE-ADMITTED WITH UNSPECIFIED CARDIOVASCULAR SYMPTOMS, CARDIOMYOPATHY AND CHEST PAIN. UNSPECIFIED TREATMENT WAS PROVIDED AND THE FINAL PATIENT OUTCOME IS NOT KNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina

  MAUDE report 10531994 ↗
• InjurySep 10, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH SEPSIS BEFORE THE PROCEDURE. TWO XIENCE SIERRA STENTS (2.5X12MM AND 3X12MM) WERE IMPLANTED ON (B)(6) 2020. ON (B)(6) 2020, THE PATIENT WAS RE-ADMITTED WITH HYPERTENSION. UNSPECIFIED TREATMENT WAS PERFORMED, AND THE FINAL PATIENT OUTCOME IS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: High Blood Pressure/ Hypertension

  MAUDE report 10516346 ↗
• InjurySep 10, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2020 THE PATIENT HAD A 2.50X12 MM, 3.25X18 MM AND 3.25X33 MM XIENCE SIERRA STENT IMPLANTED. ON (B)(6) 2020 THE PATIENT WAS READMITTED FOR CHEST PAIN AND ATRIAL FIBRILLATION. TREATMENT IS NOT SPECIFIED AND THE FINAL PATIENT OUTCOME IS REPORTED AS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina; Atrial Fibrillation

  MAUDE report 10515824 ↗
• MalfunctionJun 23, 2020Failure to Advance; Device Dislodged or Dislocated; Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT A 3.5X23MM XIENCE SIERRA STENT DELIVERY SYSTEM (SDS) WAS NOT PREPPED (AIR ASPIRATED) PRIOR TO USE. THE SDS WAS ADVANCED; HOWEVER, RESISTANCE WITH THE ANATOMY WAS FELT. ONCE AT THE TARGET LESION, AN ATTEMPT TO INFLATE THE SDS WAS MADE BUT IT WAS NOTED THAT THE SHAFT NEAR THE GUIDE WIRE PORT WAS TORN. NO LEAK WAS NOTED; HOWEVER, THIS RESULTED IN THE INABILITY TO INFLATE THE SDS AND DEPLOY THE STENT. THE SDS WITH STENT WERE REMOVED. AN ATTEMPT TO ADVANCE A 2.5X12MM XIENCE SIERRA SDS WAS MADE; HOWEVER, THE SDS COULD NOT CROSS DUE TO RESISTANCE WITH THE ANATOMY. THE SDS WAS REMOVED AND IT WAS NOTED THAT THE STENT HAD DISLODGED AND WAS MISSING. THE STENT WAS FOUND OUTSIDE THE BODY ON THE GAUZE USED TO WIPE DOWN THE WIRE AFTER THE SDS WAS REMOVED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH OTHER UNSPECIFIED STENTS. 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 10186694 ↗
• MalfunctionMar 25, 2020Inflation Problem; Leak/Splash; Inflation Problem; Leak/Splash

  IT WAS REPORTED THE PROCEDURE WAS PERFORMED TO TREAT A LESION WITH MODERATE CALCIFICATION AND MILD TORTUOSITY TIN THE LEFT ANTERIOR DESCENDING CORONARY ARTERY. THE XIENCE SIERRA STENT DELIVERY SYSTEM (SDS) WAS PREPARED WITHOUT ISSUE. THE XIENCE SIERRA SDS WAS ADVANCED BUT THE BALLOON FAILED TO INFLATE AND BLOOD WAS NOTED COMING BACK INTO THE INDEFLATOR. THEREFORE, THE SDS WAS REMOVED WITHOUT ISSUE FROM THE PATIENT ANATOMY. A NEW XIENCE SIERRA SDS WAS USED SUCCESSFULLY TO COMPLETE THE PROCEDURE. 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 9880118 ↗
• DeathMar 16, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT ID: (B)(6). IT WAS REPORTED THAT A PERCUTANEOUS CORONARY INTERVENTION WAS PERFORMED ON (B)(6) 2020. A 2.5X12MM XIENCE SIERRA STENT (1550250-12, 9100241) WAS SUCCESSFULLY IMPLANTED IN THE FIRST OBTUSE MARGINAL (OM) CORONARY ARTERY LESION. THERE WERE NO PROCEDURE COMPLICATIONS. ON (B)(6) 2020, THE PATIENT HAD EXPIRED WHILE AT HOME. REPORTEDLY, THERE WAS NO IMAGING PERFORMED AFTER THE INDEX PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THIS ISSUE.

  Patient problems: Death

  MAUDE report 9835802 ↗
• 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 NON-ST ELEVATED MYOCARDIAL INFARCTION (NSTEMI). A 2.5X12MM XIENCE SIERRA STENT WAS IMPLANTED. ON (B)(6) 2020 THE PATIENT WAS RE-HOSPITALIZED WITH OTHER CARDIOVASCULAR SYMPTOMS AND PERIPHERAL VASCULAR DISEASE. IT IS UNKNOWN WHAT TREATMENT WAS PERFORMED AND WHAT THE FINAL PATIENT OUTCOME WAS.

  Patient problems: No Code Available

  MAUDE report 9803937 ↗
• DeathJan 29, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT ID (B)(6). IT WAS REPORTED THAT ON (B)(6) 2019, THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE 1ST OBTUSE MARGINAL ARTERY. A 2.5 X 12 MM XIENCE SIERRA STENT WAS IMPLANTED WITHOUT COMPLICATION. ON (B)(6) 2020, THE PATIENT PRESENTED TO THE EMERGENCY ROOM WITH COMPLAINTS OF SHORTNESS OF BREATH, HYPOXEMIA AND HYPOTENSION. ACUTE RESPIRATORY ACIDOSIS WAS DIAGNOSED AND THE PATIENT WAS PLACED ON BILEVEL POSITIVE AIRWAY PRESSURE (BIPAP). INTRAVENOUS (IV) DOPAMINE WAS ADMINISTERED. CARDIAC ENZYME ELEVATION AND ELECTROCARDIOGRAM CHANGES WERE NOTED. STENT THROMBOSIS WAS SUSPECTED; HOWEVER, NO ADDITIONAL TESTING WAS PERFORMED AND THE PATIENT AND FAMILY REQUESTED TO BE DO NOT RESUSCITATE (DNR) STATUS AND WAS ADMITTED TO HOSPICE. THE PATIENT WAS DISCHARGED TO HOSPICE ON (B)(6) 2020. ON (B)(6) 2020, THE PATIENT PASSED AWAY WITH ACUTE ON CHRONIC RESPIRATORY FAILURE. NO AUTOPSY WAS PERFORMED. PER STUDY PHYSICIAN, THE CONGESTIVE HEART FAILURE, PRECIPITATING ACUTE ON CHRONIC RESPIRATORY FAILURE AND CARDIO-PULMONARY SHOCK WAS CAUSED BY THE POSSIBLE STENT THROMBOSIS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Cardiac Enzyme Elevation; Dyspnea; Low Blood Pressure/ Hypotension; Non specific EKG/ECG Changes; Respiratory Failure; Thrombosis

  MAUDE report 9645243 ↗
• InjuryJan 15, 2020Device Damaged by Another Device; Device Damaged by Another Device

  IT WAS REPORTED THAT THE 2.5X12 MM XIENCE SIERRA STENT WAS IMPLANTED IN THE LEFT CIRCUMFLEX (LCX) CORONARY ARTERY, BUT IT JAILED THE OBTUSE MARGINAL (OM) SIDE BRANCH. THE DOCTOR INTENDED TO ADVANCE A GUIDEWIRE THROUGH THE ALREADY DEPLOYED STENT STRUT IN ORDER TO DEPLOY ANOTHER STENT THROUGH THE SIERRA FOR THE OM. THE GUIDEWIRE WAS ADVANCED THROUGH THE STENT STRUT, BUT ON FLUORO, THE GUIDEWIRE HAD PROLAPSED. THE GUIDEWIRE WAS RETRACTED WHEN IT WAS NOTED THAT THE STENT WAS NO LONGER IN THE LCX. IT WAS SUSPECTED THAT THE GUIDEWIRE HAD PROLAPSED AROUND THE STENT, SUCH THAT, WHEN THE GUIDEWIRE WAS PULLED BACK, THE STENT CAME WITH IT. THE STENT WAS RETRACTED INTO THE GUIDE CATHETER AND WAS REMOVED TOGETHER AS A UNIT WITH THE GUIDEWIRE AND GUIDE CATHETER. THE PROCEDURE CONTINUED WITH A NEW GUIDEWIRE TO THE OM. A XIENCE SIERRA STENT WAS IMPLANTED IN THE OM FOLLOWED BY ANOTHER SIERRA IN THE LCX. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. THE PATIENT WAS FINE AND WAS DISCHARGED HOME. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Occlusion

  MAUDE report 9593263 ↗
• InjuryDec 6, 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 2.5X12 MM XIENCE SIERRA STENT WAS IMPLANTED. THE PATIENT WAS RE-ADMITTED ON (B)(6) 2019 WITH CHEST PAIN. TREATMENT WAS UNSPECIFIED AND THE FINAL PATIENT OUTCOME IS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina

  MAUDE report 9433335 ↗
• MalfunctionSep 5, 2019Difficult to Remove; Improper or Incorrect Procedure or Method; Difficult to Remove; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY TORTUOUS LEFT ANTERIOR DESCENDING ARTERY THAT DID NOT HAVE ANY CALCIFICATION. A 2.5 X 12 MM XIENCE SIERRA STENT DELIVERY SYSTEM (SDS) WAS USED AND WAS PREPPED BEFORE REMOVING THE PROTECTIVE SHEATH. THE STENT WAS IMPLANTED WITHOUT ISSUES AND THE STENT DELIVERY BALLOON DEFLATED SUCCESSFULLY. HOWEVER, THE BALLOON MET SLIGHT RESISTANCE WITH THE IMPLANTED STENT DURING REMOVAL. 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 8966083 ↗
• InjuryJul 9, 2019Patient-Device Incompatibility; Difficult to Advance; Patient-Device Incompatibility; Difficult to Advance

  THE PATIENT PRESENTED WITH A HISTORY OR RECURRENT CHEST PAIN AND THE PROCEDURE WAS PERFORMED TO TREAT LESIONS IN THE PREVIOUSLY STENTED AND CLIPPED SAPHENOUS VEIN GRAFT TO CIRCUMFLEX MARGINAL CORONARY ARTERY. TWO GUIDE WIRES WERE PLACED AND BALLOON ANGIOPLASTY WITH A NON-ABBOTT BALLOON CATHETER WAS PERFORMED DISTALLY. ADVANCEMENT WAS DIFFICULT DUE TO THE PREVIOUSLY STENTED AND CLIPPED PART OF THE GRAFT. A 2.5 X 12 MM XIENCE SIERRA WAS DEPLOYED IN THE DISTAL LESION; HOWEVER, ADEQUATE POST DILATATION WITH A NON COMPLIANT BALLOON WAS NOT POSSIBLE. AN ANEURYSM WAS NOTED IN THE MID GRAFT REGION AND THEREFORE A 4.00 X 19 MM GRAFTMASTER COVER STENT WAS ATTEMPTED TO BE DEPLOYED. THE GRAFTMASTER FAILED TO CROSS THE DIFFICULT ANATOMY DESPITE NUMEROUS ATTEMPTS AND REPLACING THE GUIDE WIRES. THE GRAFTMASTER DID NOT CAUSE OR CONTRIBUTE TO COMPLICATIONS OR ADVERSE EVENTS. SOME SLOW FLOW WAS NOTED AS A RESULT OF THE ANATOMY AND AS THE GRAFT WAS OLD THE PHYSICIAN DECIDED NOT TO CONTINUE WITH FURTHER TREATMENT ATTEMPTS. THE PATIENT WAS REPORTED TO BE STABLE POST PROCEDURE AND TRANSFERRED BACK TO HIS ROOM FOR STANDARD POST PROCEDURE CARE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8772004 ↗
• InjuryJul 8, 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 XIENCE SIERRA 2.5X12 MM STENT WAS IMPLANTED IN THE FIRST OBTUSE MARGINAL CORONARY ARTERY AND THE XIENCE SIERRA 3.25X23 MM STENT WAS IMPLANTED IN THE PROXIMAL LEFT ANTERIOR DESCENDING CORONARY ARTERY (LAD). ON (B)(6) 2019 THE PATIENT WAS SEEN IN THE EMERGENCY ROOM WITH WORSENING SHORTNESS OF BREATH RELATED TO CORONARY ARTERY DISEASE AND PAIN IN THE RIGHT EXTREMITY RELATED TO CORONARY ARTERY DISEASE. REVASCULARIZATION WAS PERFORMED ON (B)(6) 2019 IN THE TARGET LESION TO TREAT RESTENOSIS. THE PATIENT HAD INTERMITTENTLY FORGOTTEN TO TAKE THE DUAL ANTIPLATELET THERAPY MEDICATIONS. THE CONDITION RESOLVED ON (B)(6) 2019. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Dyspnea; Pain; Stenosis

  MAUDE report 8769569 ↗
• InjuryJun 21, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT TWO XIENCE SIERRA STENTS (2.5X12MM AND 2.5X18MM) WERE IMPLANTED ON (B)(6) 2019. ON (B)(6) 2019, THE PATIENT WAS RE-ADMITTED WITH CHEST PAIN AND OTHER UNSPECIFIED CARDIO VASCULAR SYMPTOMS. UNSPECIFIED TREATMENT WAS ADMINISTERED TO THE PATIENT. FINAL PATIENT OUTCOME IS REPORTEDLY UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina

  MAUDE report 8724569 ↗