XIENCE Sierra™ 1550300-28Recalls & reported problems

Summary

The FDA's MAUDE database contains 33 adverse event reports that list this exact device (DI 08717648227288), received between Aug 20, 2018 and Jan 10, 2023 — classified as 3 deaths, 25 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Difficult to Advance” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 33 reports, in the reporter's own words as published by the FDA.

• InjuryJan 10, 2023Patient-Device Incompatibility; Patient-Device Incompatibility

  PATIENT ID: (B)(6). IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED ON (B)(6) 2019, TREATING A TARGET LESION IN THE MID RIGHT CORONARY ARTERY (RCA). A 3.0 X 33 MM XIENCE SIERRA STENT AND A 3.0 X 28 MM XIENCE SIERRA STENT WERE IMPLANTED. ON (B)(6) 2019, THE PATIENT PRESENTED WITH CHEST PAIN, SHORTNESS OF BREATH AND NAUSEA. ELECTROCARDIOGRAM WAS PERFORMED, CONFIRMING ST ELEVATION MYOCARDIAL INFARCTION. ANGIOGRAPHY REVEALED THAT THE 3.0 X 28 MM XIENCE SIERRA STENT WAS UNDER-DEPLOYED AND IN-STENT RESTENOSIS WAS NOTED. MEDICATIONS WERE ADMINISTERED. A REVASCULARIZATION PROCEDURE WAS PERFORMED AND THE EVENT RESOLVED ON (B)(6) 2019. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina; Dyspnea; Myocardial Infarction; Nausea; Stenosis; Thrombosis/Thrombus

  MAUDE report 16134576 ↗
• InjuryJul 28, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2020, TWO XIENCE SIERRA DRUG ELUTING STENTS (3X38MM; 3X28MM) WERE IMPLANTED, OVERLAPPING, IN A 90% STENOSED LESION IN THE MILDLY TORTUOUS MID TO DISTAL RIGHT CORONARY ARTERY (RCA). ON (B)(6) 2021, RESTENOSIS WAS CONFIRMED IN THE OVERLAPPED SECTION OF THE IMPLANTED STENTS AND REVASCULARIZATION WAS PERFORMED. THERE WAS NO ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Stenosis

  MAUDE report 12240281 ↗
• DeathJun 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) 2021, A PERCUTANEOUS CORONARY INTERVENTION (PCI) WAS PERFORMED ON THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD), LEFT MAIN (LM), AND LEFT CIRCUMFLEX (LCX) CORONARY ARTERIES. PRE-DILATATION WAS PERFORMED WITHOUT COMPLICATION. A 3.0X48MM ABT NG DES WAS UNABLE TO BE DELIVERED PAST THE ELBOW DUE TO ANATOMY. THE ABT NG DES WAS SUCCESSFULLY WITHDRAWN. A GUIDE-LINER WAS PLACED AND A NON-FLOW LIMITING DISSECTION OF THE LM WAS OBSERVED. AN INTRA-AORTIC BALLOON PUMP (IABP) WAS PLACED, THE PATIENT WAS INTUBATED AND CARDIOVASCULAR WAS CONSULTED, RECOMMENDING A STENT TO THE LM. IN REPLACEMENT, A 2.5X23MM AND A 3.0X23MM XIENCE SIERRA STENTS WERE IMPLANTED IN THE PROXIMAL LAD WITHOUT A DEVICE ISSUE REPORTED. REPORTEDLY, THE SECOND STENT WAS OBSERVED MAL-DEPLOYED POST-IMPLANT. POST-DEPLOYMENT OF THE LAD STENTS, A SMALL DISSECTION IN THE PROXIMAL CX WAS OBSERVED. AS TREATMENT FOR THE DISSECTION, A 3.0X28MM XIENCE STENT WAS PLACED FROM THE LM TO THE PROXIMAL LCX. POST-DEPLOYMENT, A LM DISSECTION WAS OBSERVED. AS TREATMENT, A 3.25X18MM XIENCE STENT WAS PLACED IN THE LM WITHOUT AN ISSUE REPORTED. AS ADDITIONAL TREATMENT, AN UNSPECIFIED XIENCE STENT DELI

  Patient problems: Cardiac Enzyme Elevation; Cardiogenic Shock; Heart Failure/Congestive Heart Failure; Low Blood Pressure/ Hypotension; Pulmonary Edema; Respiratory Failure; Tachycardia; Vascular Dissection

  MAUDE report 11958686 ↗
• InjuryApr 16, 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, A PERCUTANEOUS INTERVENTION WAS PERFORMED ON THE DISTAL RIGHT CORONARY ARTERY (RCA), 95% STENOSED LESION. PRE-DILATATION WAS PERFORMED AND A 3.0X28MM XIENCE SIERRA STENT WAS IMPLANTED IN THE DISTAL RCA, WITHOUT A DEVICE ISSUE REPORTED. FOLLOWING, INTRA-STENT PLAQUE PROTRUSION IN THE DISTAL STENT SEGMENT WAS OBSERVED, TREATED WITH ADDITIONAL DILATATION. TIMI FLOW III AND 0% RESIDUAL STENOSIS WAS OBSERVED. ELEVATED CARDIAC ENZYMES WERE OBSERVED POST-PROCEDURE. THERE WAS NO MYOCARDIAL INFARCTION, NO TREATMENT, AND NO SERIOUS ASSOCIATION WITH THE ELEVATED ENZYMES. THE PATIENT WAS DISCHARGED HOME THE SAME DAY THE ELEVATION WAS OBSERVED. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THIS ISSUE.

  Patient problems: Cardiac Enzyme Elevation; Prolapse

  MAUDE report 11679143 ↗
• InjuryMar 7, 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) 2019, THE PATIENT PRESENTED WITH A NON-ST ELEVATED MYOCARDIAL INFARCTION AND A PERCUTANEOUS CORONARY INTERVENTION WAS PERFORMED ON THE MID LEFT ANTERIOR DESCENDING (LAD), 95% LESION. PRE-DILATATION WAS PERFORMED AND A 3.0X28MM (1550300-28, 9050841) XIENCE SIERRA STENT WAS IMPLANTED. FOLLOWING, A DISTAL EDGE DISSECTION WAS OBSERVED, TREATED WITH BALLOON ANGIOPLASTY. TIMI FLOW III WITH 0% RESIDUAL STENOSIS WAS OBSERVED FOLLOWING. POST-PROCEDURE, ELEVATED CARDIAC ENZYMES WERE OBSERVED. PER PHYSICIAN, THE ELEVATION WAS NOT SERIOUS. THERE WAS NO PROLONGED HOSPITALIZATION AND NO ADDITIONAL TREATMENT PROVIDED. THE EVENT RESOLVED WITHOUT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THIS ISSUE.

  Patient problems: Cardiac Enzyme Elevation; Vascular Dissection

  MAUDE report 11426508 ↗
• InjuryFeb 10, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A MODERATELY TORTUOUS DE NOVO LEFT ANTERIOR DESCENDING (LAD) ARTERY THAT WAS 90% STENOSED. A 3.0X28MM XIENCE SIERRA STENT WAS DEPLOYED IN THE PROXIMAL AND MID LAD WHICH CAUSED THE 2ND DIAGONAL (D2) BRANCH TO BECOME OCCLUDED. AN UNSPECIFIED WIRE WAS ADVANCED TO THE D2 BRANCH THROUGH THE STENT STRUTS. IT WAS THEN ATTEMPTED TO CROSS THROUGH THE STRUTS INTO THE D2 WITH A 1.50X12MM MINI TREK BALLOON DILATATION CATHETER (BDC), HOWEVER THE BDC FAILED TO CROSS DUE TO RESISTANCE WITH THE XIENCE SIERRA STENT. THE BDC WAS REMOVED WITHOUT ISSUE AND REPLACED WITH A NON-ABBOTT BALLOON TO SUCCESSFULLY WIDEN THE STRUTS TO ALLOW FLOW INTO THE DIAGONAL. THERE WAS NO ADVERSE PATIENT SEQUELA REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Occlusion

  MAUDE report 11307992 ↗
• InjuryDec 7, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH A NON ST-ELEVATION MYOCARDIAL INFARCTION (NSTEMI). TWO XIENCE SIERRA STENTS (3.0X28MM AND 3.25X15MM) WERE IMPLANTED ON (B)(6) 2020. ON (B)(6) 2020, THE PATIENT WAS READMITTED WITH CARDIOVASCULAR SYMPTOMS INCLUDING HEMORRHAGIC DISORDER. SURGERY WAS PERFORMED AND THE FINAL PATIENT OUTCOME IS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 10959095 ↗
• InjuryDec 2, 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 3X28 MM XIENCE SIERRA STENT IMPLANTED. ON (B)(6) 2020, THE PATIENT WAS RE-HOSPITALIZED DUE TO OTHER CARDIOVASCULAR SYMPTOMS AND CHEST PAIN. THE TYPE OF TREATMENT WAS UNSPECIFIED AND THE FINAL PATIENT OUTCOME IS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina

  MAUDE report 10935784 ↗
• InjuryNov 20, 2020Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON (B)(6) 2018, THE PROCEDURE WAS PERFORMED TO TREAT THE RIGHT CORONARY ARTERY. TWO XIENCE SIERRA STENTS (2.75X38MM AND 3.0X28MM) WERE IMPLANTED. ON (B)(6) 2020, THE PATIENT UNDERWENT A HEART CATHERIZATION DUE TO CHEST PAIN AND TROUBLE BREATHING. IT WAS THEN CONFIRMED THAT BOTH STENTS HAD COLLAPSED. THE STENTS WERE OPENED WITH ANGIOPLASTY AND TWO NEW XIENCE SIERRA STENTS (3.5X12MM AND 3.5X28MM). THERE WAS NO ADVERSE PATIENT SEQUELA REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. AS THE IMPLANT DATE WAS NOT CONFIRMED, THE LAST DATE PROVIDED ((B)(6) 2018) WILL BE USED AS THE ESTIMATED DATE.

  Patient problems: Angina; Occlusion; Respiratory Distress

  MAUDE report 10879892 ↗
• InjurySep 15, 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 PATIENT PRESENTED WITH SILENT ISCHEMIA AND SEVERE CALCIFICATION WITHIN THE PROXIMAL CIRCUMFLEX (CX) CORONARY ARTERY, 75% STENOSED LESION. ATHERECTOMY WAS PERFORMED AND A 2.75X33MM (1550275-33, 8080241) AND 3.0X28MM (1550300-28, 8080941) XIENCE SIERRA STENTS WERE IMPLANTED IN THE CX WITH ACCEPTABLE RESULTS. POST-IMPLANTATION, INTRA-STENT PLAQUE PROTRUSION WAS OBSERVED WITH THE 3.0X28MM XIENCE SIERRA STENT. ADDITIONAL BALLOON DILATATION WAS PERFORMED. ON (B)(6) 2020, THE PATIENT WAS ADMITTED TO THE HOSPITAL WITH CHEST PAIN, ELEVATED TROPONIN, AND A NON-ST ELEVATED MYOCARDIAL INFLATION (NSTEMI) WAS DIAGNOSED. MEDICATION HAD BEEN TAKEN PRIOR AND A HEPARIN DRIP WAS INITIATED. THE PATIENT WENT INTO VENTRICULAR TACHYCARDIA/VENTRICULAR FIBRILLATION ARREST. CARDIOPULMONARY RESUSCITATION WAS PERFORMED AND CARDIOVERSION SHOCKS WERE PROVIDED TWO TIMES. ON (B)(6) 2020, THE PROXIMAL CX, 3.0X28MM XIENCE SIERRA STENT, WAS OBSERVED WITH 90% OCCLUSION, IN-STENT RESTENOSIS WITHIN THE PROXIMAL 5MM OF THE STENT. AS TREATMENT, ANOTHER STENT WAS IMPLANTED. THE EVENT RESOLVED. THERE WAS NO DEVICE MALFUNCTION. NO ADDITIONAL INFORMATION WAS PROVID

  Patient problems: Angina; Myocardial Infarction; Prolapse; Stenosis; Tachycardia; Ventricular Fibrillation

  MAUDE report 10537644 ↗
• InjuryAug 20, 2020Difficult to Advance; Device Dislodged or Dislocated; Difficult to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A SLIGHTLY TORTUOUS LESION IN THE RIGHT CORONARY ARTERY (RCA). THE 3.0X28MM RX XIENCE SIERRA STENT DELIVERY SYSTEM (SDS) WAS ADVANCED HOWEVER RESISTANCE WAS MET WITH THE GUIDING CATHETER AND THE STENT DISLODGED FROM THE BALLOON. THE STENT WAS RETRIEVED USING A GUIDE LINER. 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 10431024 ↗
• MalfunctionAug 19, 2020Improper or Incorrect Procedure or Method; Failure to Advance; Improper or Incorrect Procedure or Method; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE, ON AN UNSPECIFIED DATE, WAS TO TREAT AN UNSPECIFIED LESION. A 3.0X28MM XIENCE SIERRA, WHICH MAY HAVE BEEN USED PAST EXPIRATION, WAS NOTED TO HAVE FAILED TO REACH THE LESION. THERE WERE NO ADVERSE PATIENT EFFECTS NOR SIGNIFICANT DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10426883 ↗
• MalfunctionJul 17, 2020Difficult to Remove; Failure to Advance; Material Deformation; Difficult to Remove; Failure to Advance; Material Deformation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 90% STENOSED, MODERATELY TORTUOUS, AND HEAVILY CALCIFIED DE NOVO LESION IN THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY. A 3.0X28MM XIENCE SIERRA STENT DELIVERY SYSTEM (SDS) WAS ATTEMPTED TO ADVANCE; HOWEVER, THE STENT EDGE BECAME FLARED AND THE SDS FAILED TO CROSS DUE TO THE PATIENT'S ANATOMY. RESISTANCE WAS MET WITH THE LESION DURING REMOVAL OF THE SDS. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER STENT THAT CROSSED WITHOUT ANY ISSUE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND NO ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10290885 ↗
• MalfunctionJul 7, 2020Difficult to Remove; Difficult to Advance; Material Deformation; Difficult to Remove; Difficult to Advance; Material Deformation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN UNSPECIFIED LESION. THE 3.0X28MM XIENCE SIERRA STENT WAS BEING ADVANCED ON THE GUIDE WIRE WHEN IT BECAME STUCK, AS IT COULDN¿T REACH THE GUIDE CATHETER. ONCE THE DEVICE WAS REMOVED, IT WAS NOTED THAT THE STENT IMPLANT BECAME KINKED AND DISFIGURED. A SAME SIZE XIENCE SIERRA WAS USED TO SUCCESSFULLY TREAT THE LESION. 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 10239307 ↗
• InjuryJun 19, 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 A NON-ST ELEVATED MYOCARDIAL INFARCTION (NSTEMI) THEREFORE THE 3.0X28MM XIENCE SIERRA WAS IMPLANTED FOR TREATMENT. ON (B)(6) 2020 THE PATIENT WAS RE-ADMITTED DUE TO AN ENCOUNTER WITH THE AUTOMATIC IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (AICD), 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: No Code Available

  MAUDE report 10173913 ↗
• InjuryMar 13, 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, A PERCUTANEOUS CORONARY INTERVENTION WAS PERFORMED ON THE MID RIGHT CORONARY ARTERY (RCA), HEAVILY CALCIFIED LESION. ATHERECTOMY AND PRE-DILATATION WERE PERFORMED. FOLLOWING, A 3.0X28MM AND A 3.25X28MM XIENCE SIERRA STENT WERE IMPLANTED WITH ACCEPTABLE RESULTS. TIMI FLOW III WITH 0% STENOSIS WAS NOTED. INTRA-PROCEDURE, THE PATIENT DEVELOPED RAPID ATRIAL FIBRILLATION, SUCCESSFULLY TREATED WITH CARDIOVERSION. THE EVENT RESOLVED WITHOUT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THIS ISSUE.

  Patient problems: Atrial Fibrillation

  MAUDE report 9831242 ↗
• InjuryMar 9, 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 3.00X28MM, 3.0X38MM, AND 3.0X08MM XIENCE SIERRA STENTS WERE IMPLANTED. ON (B)(6) 2019 THE PATIENT WAS RE-ADMITTED WITH OTHER CARDIOVASCULAR SYMPTOMS AND ATHEROSCLEROTIC HEART DISEASE. IT IS UNKNOWN WHAT TREATMENT WAS PERFORMED AND THE FINAL PATIENT OUTCOME IS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 9806430 ↗
• InjuryJan 30, 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, A PERCUTANEOUS CORONARY INTERVENTION (PCI) WAS PERFORMED. A 3.0X28MM XIENCE SIERRA STENT WAS SUCCESSFULLY IMPLANTED IN THE MID LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY LESION. THERE WERE NO PROCEDURE COMPLICATIONS. ON (B)(6) 2020, THE PATIENT WAS HOSPITALIZED FOR UNSTABLE CHEST PAIN. ELEVATED CARDIAC ENZYMES WERE OBSERVED AND AN ELECTROCARDIOGRAM WAS PERFORMED WITHOUT ANY NEW MYOCARDIAL INFARCTION (MI). ON (B)(6) 2020, ANOTHER PCI WAS PERFORMED IN THE MID LAD RESTENOSED, 3.0X28MM XIENCE SIERRA STENT. ON (B)(6) 2020, REVASCULARIZATION WAS DONE ON A NON-TARGET VESSEL. A DISSECTION WAS OBSERVED, TREATED WITH ANOTHER STENT. REPORTEDLY, THE DISSECTION WAS NOT LOCATED AT THE 3.0X28MM XIENCE SIERRA SITE, WAS UNRELATED TO THE 3.0X28MM XIENCE SIERRA STENT, AND UNRELATED TO THE INDEX PROCEDURE. REPORTEDLY, THERE WAS NO DEVICE MALFUNCTION REGARDING THE MID LAD, 3.0X28MM XIENCE SIERRA STENT. THE EVENT RESOLVED WITHOUT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THIS ISSUE.

  Patient problems: Angina; Cardiac Enzyme Elevation; Stenosis

  MAUDE report 9649493 ↗
• DeathDec 17, 2019Adverse 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 PATIENT PRESENTED WITH A RECENT NON-ST ELEVATED MYOCARDIAL INFARCTION. A 3.0X28MM XIENCE SIERRA STENT WAS SUCCESSFULLY IMPLANTED IN THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY, 99% STENOSED LESION AND A 3.0X12MM XIENCE SIERRA STENT WAS SUCCESSFULLY IMPLANTED IN THE FIRST DIAGONAL CORONARY ARTERY, 99% STENOSED LESION. THE PROCEDURE WAS PERFORMED WITHOUT COMPLICATIONS. ON (B)(6) 2019, THE PATIENT WAS FOUND UNRESPONSIVE AT HOME. MEDICATIONS WERE PROVIDED; HOWEVER, THE PATIENT HAD EXPIRED DUE TO CARDIOPULMONARY ARREST. PER PHYSICIAN, THE EVENT WAS POSSIBLY RELATED TO THE DEVICE. THERE WAS NO RESTENOSIS, NO THROMBUS, AND NO DEVICE MALFUNCTION REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THIS ISSUE.

  Patient problems: Cardiac Arrest

  MAUDE report 9477613 ↗
• InjuryDec 13, 2019Difficult to Remove; Material Separation; Difficult to Remove; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A CORONARY PROCEDURE ON (B)(6) 2019. A 3.0 X 28 MM XIENCE SIERRA STENT WAS IMPLANTED IN THE MID LEFT ANTERIOR DESCENDING (LAD) ARTERY. DURING REMOVAL OF THE STENT DELIVERY SYSTEM, SPASM OCCURRED IN THE RADIAL ARTERY. THE STENT DELIVERY SYSTEM WAS UNABLE TO BE REMOVED AND THE MARKER BAND SEPARATED. THE DELIVERY SYSTEM WAS REMOVED; HOWEVER, THE MARKER BAND REMAINED IN THE PATIENT ANATOMY. A VASCULAR SURGEON WAS CONSULTED, AND IT WAS DEEMED A GREATER RISK TO THE PATIENT TO UNDERGO A SURGICAL REMOVAL OF THE SEPARATED SEGMENT. THE SEPARATED SEGMENT REMAINS IN THE PATIENT ANATOMY. THE PATIENT REPORTED FEELING PAIN AT THE SITE WHERE THE DEVICE SEPARATION OCCURRED, BUT FEELS NO PAIN AT THIS TIME. THE PATIENT'S PHYSICIAN HAS SUGGESTED SHE HAVE A MAGNETIC RESONANCE IMAGE (MRI) FOR A NON-RELATED HEALTH ISSUE, BUT THE PATIENT IS CONCERNED THAT THE MAGNET MAY AFFECT THE MARKER BAND. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient; Vasoconstriction

  MAUDE report 9468349 ↗
• 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 A 3.0X28MM XIENCE SIERRA AND A NON-ABBOTT STENT WAS IMPLANTED. ON (B)(6) 2019 THE PATIENT WAS RE-ADMITTED WITH THROMBOSIS WITHIN THE TWO IMPLANTED STENTS. PLAIN OLD BALLOON ANGIOPLASTY (POBA) WAS PERFORMED; HOWEVER, THE PATIENT EXPIRED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Thrombosis

  MAUDE report 9440940 ↗
• 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 3.0X28MM AND 3.0X08MM XIENCE SIERRA STENTS WERE IMPLANTED. ON (B)(6) 2019 THE PATIENT WAS RE-ADMITTED WITH HYPERTENSIVE HEART DISEASE WITH HEART FAILURE. IT IS UNKNOWN WHAT TREATMENT WAS PERFORMED AND THE FINAL PATIENT OUTCOME IS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Heart Failure

  MAUDE report 9438431 ↗
• InjurySep 4, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 3.0X28MM AND A 3.50X33MM XIENCE SIERRA STENT WERE IMPLANTED ON (B)(6) 2019. THE PATIENT PRESENTED WITH NON ST-ELEVATION MYOCARDIAL INFARCTION (NSTEMI). ON (B)(6) 2019, THE PATIENT WAS READMITTED WITH CARDIOVASCULAR SYMPTOMS INCLUDING NSTEMI. TREATMENT PERFORMED WAS UNSPECIFIED AND THE FINAL PATIENT OUTCOME IS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Myocardial Infarction

  MAUDE report 8961832 ↗
• InjuryAug 14, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 3.0X28MM, 3.00X12MM AND 3.50X12MM XIENCE SIERRA STENTS WERE IMPLANTED ON (B)(6) 2019. ON (B)(6) 2019, THE PATIENT WAS RE-ADMITTED FOR ANGINA AND ABNORMAL ELECTROCARDIOGRAM. NO TREATMENT WAS PERFORMED. THE PATIENT FINAL OUTCOME WAS REPORTED AS NO PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina; Non specific EKG/ECG Changes

  MAUDE report 8895425 ↗
• MalfunctionAug 7, 2019Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MILDLY TORTUOUS, MODERATELY CALCIFIED, 90% STENOSED LESION IN THE MID-LEFT ANTERIOR DESCENDING CORONARY ARTERY. THE VESSEL WAS NOT PRE-DILATATED. THE 3.0 X 28 MM XIENCE SIERRA STENT DELIVERY SYSTEM (SDS) WAS ADVANCED; HOWEVER, RESISTANCE WAS FELT WITH THE ANATOMY. THE STENT WAS DEPLOYED AND WAS POST DILATED THREE TIMES AT 12 ATMOSPHERES. WHILE THE SDS WAS BEING REMOVED, BLOOD WAS OBSERVED IN THE DEVICE. IT SUSPECTED THE BALLOON RUPTURED DURING THE THIRD INFLATION. THE SDS WAS REMOVED WITHOUT ISSUE. 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 8872016 ↗