XIENCE Sierra™ 1550300-23Recalls & reported problems

Summary

The FDA's MAUDE database contains 45 adverse event reports that list this exact device (DI 08717648227271), received between Jul 31, 2018 and Dec 16, 2021 — classified as 3 deaths, 36 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (8 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 45 reports, in the reporter's own words as published by the FDA.

• InjuryDec 16, 2021Difficult to Remove; Failure to Advance; Device Dislodged or Dislocated; Difficult to Remove; Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 99% STENOSED, DE NOVO LESION IN THE RIGHT CORONARY ARTERY (RCA). THE PATIENT PRESENTED WITH A CLOT. THE CLOT WAS REMOVED, AND AN UNSPECIFIED BALLOON WAS USED TO PRE-DILATATE THE LESION. A 3X23MM XIENCE SIERRA DRUG ELUTING STENT (DES) WAS THEN ADVANCED BUT DID NOT REACH THE LESION. THE DEVICE WAS ATTEMPTED TO BE REPOSITION, BUT RESISTANCE WAS MET WITH THE ANATOMY. THE DEVICE WAS THEN ATTEMPTED TO BE PULLED BACKED INTO THE GUIDE CATHETER; HOWEVER, MORE RESISTANCE WAS MET, AND THE DES COULD NOT BE PULLED BACK IN. THE GUIDE CATHETER WAS PULLED BACK INTO THE SHEATH AND THE DELIVERY SYSTEM WAS REMOVED; HOWEVER, THE STENT DISLODGED INTO THE FEMORAL ARTERY AT SOME POINT DURING THE REMOVAL OF THE DEVICES FROM THE ANATOMY. THE PHYSICIAN THEN ADVANCED ANOTHER SIERRA STENT WITHOUT ISSUE TO COMPLETE THE STENTING, AND WENT BACK IN, AND SNARED THE DISLODGED STENT OUT OF THE ANATOMY. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13022200 ↗
• InjuryJul 27, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAS A HISTORY OF SHORTNESS OF BREATH WITH EXERTION. A CTA (COMPUTED TOMOGRAPHY ANGIOGRAPHY) WAS PERFORMED WHICH FOUND SOME OCCLUSION WITH HEMODYNAMIC SIGNIFICANCE. ON (B)(6) 2021 THE PATIENT UNDERWENT A PERCUTANEOUS CORONARY INTERVENTION IN THE MID (LAD) LEFT ANTERIOR DESCENDING CORONARY ARTERY. THE 3.0X23 MM XIENCE SIERRA STENT WAS IMPLANTED IN THE MID LAD. SHE HAS A NICKEL ALLERGY BUT DID NOT DISCLOSE THIS ALLERGY TO THE HOSPITAL AND PHYSICIAN UNTIL AFTER THE STENT WAS IMPLANTED. SHE WAS GIVEN PREDNISONE MEDICATION PRIOR TO THE PROCEDURE AS SHE IS ALLERGIC TO MANY THINGS SUCH AS IODINE, LIDOCAINE, CONTRAST, LATEX, POLLEN, AND ANIMALS. WHEN SHE TOOK THE PREDNISONE ON (B)(6) 2021, HER BLOOD SUGAR WENT TO THE 340S, SO SHE REDUCED THE PREDNISONE DOSE. THE NEXT DAY, ON (B)(6) 2021, SHE STARTED FEELING FLUSHED AND ITCHY ON HER FACE AND TRUNK. THIS IS A COMMON REACTION FOR HER WHEN SHE IS ALLERGIC TO SOMETHING. ON 07/15/2021 THE ITCHING ON HER TRUNK HAD RESOLVED, BUT HER FACE WAS STILL FLUSHED. THE FLUSHED FACE IS NOT AS INTENSE THOUGH. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 12228788 ↗
• InjuryJun 28, 2021Inflation Problem; Difficult to Remove; Material Rupture; Material Separation; Device Damaged by Another Device; Difficult to Advance; Device Dislodged or Dislocated; Activation Failure; Inflation Problem; Difficult to Remove; Material Rupture; Material Separation; Device Damaged by Another Device; Difficult to Advance; Device Dislodged or Dislocated; Activation Failure

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A DE NOVO LESION IN THE MID CIRCUMFLEX CORONARY ARTERY. WHEN ADVANCING THE 3.0X23 MM XIENCE SIERRA STENT DELIVERY SYSTEM (SDS), RESISTANCE WAS FELT WITH THE ANATOMY AND THE STENT GOT CAUGHT ON A PREVIOUSLY IMPLANTED STENT, POSSIBLY MANGLING THE PREVIOUSLY IMPLANTED STENT. AN ATTEMPT WAS MADE TO INFLATE THE BALLOON; HOWEVER, THE BALLOON DID NOT INFLATE PROPERLY. THE BALLOON ONLY INFLATED ON THE DISTAL END. IT IS SUSPECTED THE PROXIMAL END OF THE BALLOON LEAKED. THE STENT DID NOT DEPLOY AND DISLODGED INSIDE THE PREVIOUSLY IMPLANTED STENT. RESISTANCE WAS FELT DURING REMOVAL OF THE SDS. ONCE THE SDS WAS OUTSIDE OF THE ANATOMY, THE PROXIMAL SHAFT SEPARATED. AN ATTEMPT WAS MADE TO GET BACK IN THE VESSEL WITH A BALLOON TO TRY TO EXPAND THE STENT STRUTS INSIDE THE PREVIOUSLY IMPLANTED STENT; HOWEVER, THE ARTERY COULD NOT BE RE-ENGAGED, THEREFORE THE LESION WAS LEFT UNTREATED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 12081691 ↗
• DeathJun 17, 2021Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem; Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT AN IN-STENT RESTENOSIS IN THE LEFT ANTERIOR DESCENDING (LAD). A 3.0 X 23 MM XIENCE SIERRA STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TO THE TARGET LESION AND THE STENT WAS IMPLANTED. HOWEVER, IT WAS NOTED THAT PLAQUE SHIFT HAD OCCURRED WHICH CAUSED AN OBSTRUCTION TO THE SEPTAL AND DIAGONAL BRANCHES. THE PHYSICIAN WAS ABLE TO USE A GUIDE WIRE TO OPEN UP THE BRANCHES. THE PROCEDURE WAS COMPLETED. WHEN THE PATIENT WAS TAKEN OFF THE TABLE, THE PATIENT CODED (CARDIOPULMONARY ARREST). CARDIOPULMONARY RESUSCITATION (CPR) DEFIBRILLATOR AND INTRA-AORTIC BALLOON PUMP THERAPY WERE USED THE PATIENT WAS PUT BACK ON THE TABLE AND STENT THROMBOSIS WAS NOTED. ASPIRATION WAS PERFORMED TO TREAT THE THROMBUS. ADDITIONALLY, A 4.0 X 23 MM XIENCE SIERRA STENT WAS IMPLANTED IN LAD TO THE LEFT MAIN ARTERY. THE PATIENT WAS TAKEN TO THE RECOVERY ROOM AND DIED SHORTLY AFTER ON (B)(6) 2021 DUE TO ACUTE THROMBOSIS. IN THE PHYSICIAN'S OPINION, THE XIENCE SIERRA STENTS DID NOT CAUSE OR CONTRIBUTE TO THE DEATH, BUT THE STENTS WERE SUSPECTED TO BE NOT FULLY EXPANDED. ADDITIONALLY, THE PATIENT HAD A HISTORY OF BEING NOT COMPLIANT WITH THE DUAL ANTIPLATELET DRU

  Patient problems: Cardiac Arrest; Obstruction/Occlusion; Prolapse; Thrombosis/Thrombus

  MAUDE report 12017318 ↗
• InjuryJun 8, 2021Patient-Device Incompatibility; Patient-Device Incompatibility

  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: Vascular Dissection

  MAUDE report 11958727 ↗
• InjuryMay 27, 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 NON-ST ELEVATED MYOCARDIAL INFARCTION (NSTEMI) THEREFORE TWO XIENCE SIERRA STENTS (3.00X23MM, 3.50X12MM) WERE IMPLANTED. ON (B)(6) 2021 THE PATIENT WAS RE-ADMITTED WITH AN INFECTION. IT IS UNKNOWN WHAT TREATMENT WAS PERFORMED AND THE FINAL PATIENT OUTCOME IS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Unspecified Infection

  MAUDE report 11898956 ↗
• InjuryMay 27, 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 HAD A 3X23MM XIENCE SIERRA AND 3X28MM XIENCE SIERRA STENT IMPLANTED. ON (B)(6) 2021 THE PATIENT WAS RE-HOSPITALIZED DUE TO OTHER CARDIOVASCULAR SYMPTOMS SUCH AS VENTRICULAR TACHYCARDIA. THE TYPE OF TREATMENT WAS SURGICAL INTERVENTION AND THE FINAL PATIENT OUTCOME IS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Tachycardia

  MAUDE report 11894153 ↗
• InjuryFeb 18, 2021Material Separation; Material Separation

  ON (B)(6) 2019, THE PATIENT HAD A 3.0X23MM XIENCE SIERRA IMPLANTED IN THE LEFT ANTERIOR DESCENDING ARTERY WITH NO ISSUES. ON (B)(6) 2020 THE PATIENT EXPERIENCED A HEART ATTACK DUE TO BLOCKAGE FROM THE XIENCE STENT BECOMING SEPARATED INTO DIFFERENT PIECES. SOME BLOOD FLOW WAS COMING THROUGH, BUT NOT A LOT. A QUADRUPLE BYPASS WAS PERFORMED ON THE (B)(6) TO TREAT THE HEART ATTACK. THE SEPARATED STENT STILL REMAINS IN THE PATIENT AFTER THE SURGERY. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Ischemia; Myocardial Infarction

  MAUDE report 11343518 ↗
• InjuryFeb 4, 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 WITH A RECENT NON-ST ELEVATED MYOCARDIAL INFARCTION (NSTEMI) AND A PERCUTANEOUS CORONARY INTERVENTION WAS PERFORMED. A 2.5X12MM (1550250-12, 0022741) XIENCE SIERRA STENT WAS IMPLANTED IN THE MID LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY. FOLLOWING, A 3.0X23MM (1550300-23, 0021241) XIENCE SIERRA STENT WAS IMPLANTED IN THE PROXIMAL LAD. A DEVICE MALFUNCTION WAS NOT REPORTED AND 0% RESIDUAL STENOSIS WITH TIMI FLOW GRADE III WAS OBSERVED POST-PROCEDURE. ON (B)(6) 2021, THE PATIENT PRESENTED LEFT SIDED CHEST PAIN, RADIATING TO THE LEFT SCAPULA, AND SHORTNESS OF BREATH. PER IMAGING, THE PROXIMAL LAD WAS 80% RESTENOSED, WITHOUT A DEVICE MALFUNCTION OBSERVED. AS TREATMENT, ANOTHER STENT WAS IMPLANTED IN THE PROXIMAL LAD, TARGET LESION. THE EVENT DID NOT REQUIRE HOSPITALIZATION AND RESOLVED WITHOUT SEQUALA THAT SAME DAY. NO ADDITIONAL INFORMATION AS PROVIDED REGARDING THIS ISSUE.

  Patient problems: Angina; Dyspnea; Stenosis

  MAUDE report 11279522 ↗
• MalfunctionDec 7, 2020Difficult to Remove; Failure to Advance; Difficult to Remove; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE LEFT MAIN ARTERY. THE XIENCE SIERRA STENT DELIVERY SYSTEM FAILED TO CROSS DUE TO THE ANATOMY, AND WHEN REMOVED THERE WAS ALSO RESISTANCE WITH THE ANATOMY. THE PROCEDURE WAS COMPLETED WITH A DRUG COATED BALLOON. 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 10963355 ↗
• InjuryNov 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 THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE MID LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE 3.0 X 23 MM XIENCE SIERRA STENT DELIVERY SYSTEM WAS ADVANCED AND THE STENT WAS IMPLANTED WITHOUT ISSUE. POST PROCEDURE, THE PATIENT EXPERIENCED CHEST PAIN. ELECTROCARDIOGRAM (EKG) CHANGES WERE NOTED. THE PATIENT WAS HYPERTENSIVE AND TRACE PERICARDIAL EFFUSION WAS NOTED. MEDICATION WAS ADMINISTERED AS TREATMENT. THE ADVERSE EVENT RESOLVED AND THE PATIENT WAS DISCHARGED THE FOLLOWING DAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina; High Blood Pressure/ Hypertension; Non specific EKG/ECG Changes; Pericardial Effusion

  MAUDE report 10840289 ↗
• DeathNov 9, 2020Adverse 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 ON (B)(6 2020 WAS TO TREAT 90% STENOSED DE NOVO LESIONS IMPLANTED IN THE MID, AND PROXIMAL LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY. TWO XIENCE SIERRA STENTS (2.5X28 MM AND 3.0X23 MM) WERE SUCCESSFULLY IMPLANTED OVERLAPPING. PRE AND POST-DILATATION WERE PERFORMED. STENT APPOSITION WAS CONFIRMED WITH INTRAVASCULAR ULTRASOUND (IVUS) WITH 0% STENOSIS. THE PATIENT WAS DISCHARGED ON (B)(6) 2020, HOWEVER, IT WAS REPORTED THAT THE PATIENT EXPIRED ON (B)(6) 2020 DUE TO AN UNKNOWN CAUSE. IN THIS STUDY, DEATH OF AN UNKNOWN CAUSE WITHIN 30 DAYS AFTER STENT DEPLOYMENT IS DEFINED AS PROBABLE STENT THROMBOSIS. THE PATIENT HAD BEEN ON CLOPIDOGREL, AND RIVAROXABAN PRIOR TO THE PROCEDURE TO PREVENT STENT THROMBOSIS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Death; Thrombosis

  MAUDE report 10814139 ↗
• InjuryNov 3, 2020Improper or Incorrect Procedure or Method; Failure to Advance; Device Dislodged or Dislocated; Improper or Incorrect Procedure or Method; Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED, MILDLY TORTUOUS, MID-RIGHT CORONARY ARTERY (MRCA). PRE-DILATION WAS SUCCESSFULLY PERFORMED AND A 3X23MM XIENCE SIERRA DRUG ELUTING STENT (DES) DELIVERY SYSTEM WAS ADVANCED; HOWEVER, THE STENT WAS UNABLE TO CROSS THE LESION. THE DES WAS REMOVED, AND ADDITIONAL PRE-DILATION WAS PERFORMED A SECOND TIME WITH A DIFFERENT SIZE CATHETER. THE STENT WAS ADVANCED A SECOND TIME BUT DID NOT CROSS THE LESION ONCE AGAIN. THE STENT WAS REMOVED AND A THIRD, DIFFERENT SIZED CATHETER WAS ATTEMPTED BUT THE DES WAS STILL UNABLE TO CROSS THE LESION AND WAS WITHDRAWN FROM THE ANATOMY. AFTER REMOVING THE DEVICE ON THE THIRD ATTEMPT, IT WAS OBSERVED THAT THE STENT WAS NO LONGER ON THE BALLOON. IMAGING SHOWED THAT THE STENT WAS STILL CRIMPED AND WAS STUCK IN THE PROXIMAL RCA. THE PROCEDURE WAS DISCONTINUED, AND THE PATIENT WAS IMMEDIATELY TRANSFERRED TO A NEARBY HOSPITAL FOR ADDITIONAL INTERVENTION. THERE WAS NO ADVERSE PATIENT SEQUELA REPORTED IN THE PROCEDURE OR THERAPY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 10781903 ↗
• MalfunctionOct 9, 2020Difficult to Remove; Improper or Incorrect Procedure or Method; Device Dislodged or Dislocated; Material Deformation; Difficult to Remove; Improper or Incorrect Procedure or Method; Device Dislodged or Dislocated; Material Deformation

  SUBSEQUENT TO THE INITIAL REPORT, ADDITIONAL REPORTED INFORMATION INDICATES THAT THE PHYSICIAN RECOGNIZED THE STENT HAD DISLODGED BEFORE THE SDS REACHED THE TARGET LESION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10659368 ↗
• InjurySep 18, 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) 2020 TWO XIENCE SIERRA STENTS (3.0X8, 3.0X23) WERE IMPLANTED IN THE FIRST DIAGONAL (D1) CORONARY ARTERY. ON (B)(6) 2020 THE PATIENT HAD CHEST PAIN. THE STENT WAS PATENT, BUT BOTH STENTS WERE PINCHING THE LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY. ACCORDING TO THE PHYSICIAN, THIS WAS NOT AN OCCLUSION. ANGIOPLASTY WAS PERFORMED WITH A KISSING BALLOON TECHNIQUE TO THE LAD AND D1. THE PATIENT HAD GOOD RESULTS AND THE CONDITION RESOLVED THE SAME DAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina; Vasoconstriction

  MAUDE report 10557121 ↗
• InjurySep 16, 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 XIENCE SIERRA STENT WAS IMPLANTED. ON (B)(6) 2020, PATIENT WAS RE-ADMITTED WITH POST-PROCEDURAL CARDIAC DISTURBANCES. BYPASS SURGERY WAS PERFORMED. ON (B)(6) 2020, PATIENT WAS RE-ADMITTED WITH SYNCOPE AND COLLAPSE. THE FINAL PATIENT OUTCOME IS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Syncope

  MAUDE report 10544298 ↗
• InjurySep 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 THE PATIENT HAD A 3.00X23MM XIENCE SIERRA STENT IMPLANTED. ON (B)(6) 2020 THE PATIENT WAS RE-ADMITTED FOR HYPOTENSION AND WAS TREATED WITH MEDICATION. THE FINAL PATIENT OUTCOME IS REPORTED AS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Low Blood Pressure/ Hypotension

  MAUDE report 10505174 ↗
• MalfunctionSep 4, 2020Difficult to Remove; Improper or Incorrect Procedure or Method; Failure to Advance; Difficult to Advance; Material Deformation; Difficult to Remove; Improper or Incorrect Procedure or Method; Failure to Advance; Difficult to Advance; Material Deformation

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED LESION IN THE RIGHT CORONARY ARTERY (RCA). THE 3.0X23 MM XIENCE SIERRA STENT DELIVERY SYSTEM (SDS) FAILED TO CROSS THE TARGET LESION DUE TO THE CALCIFICATION. THE SDS WAS REMOVED WITHOUT ISSUES AND AN UNSPECIFIED 3.0X20MM BALLOON WAS USED TO FURTHER DILATE THE LESION. A GUIDELINER CATHETER WAS ADVANCED AND THE SAME SDS WAS ATTEMPTED TO BE ADVANCED THROUGH THE GUIDELINER CATHETER, HOWEVER THE SDS COULD NOT ADVANCE THROUGH THE GUIDELINER CATHETER. RESISTANCE WAS FELT WITH THE GUIDELINER CATHETER DURING REMOVAL AND THE STENT STRUTS FLARED. THE GUIDELINER AND SDS WERE REMOVED TOGETHER. THERE WAS NO ADVERSE PATIENT EFFECT OR A CLINICALLY SIGNIFICANT DELAY IN PROCEDURE. AN UNSPECIFIED BALLOON WAS USED TO TREAT THE VESSEL, AND A DISSECTION WAS OBSERVED. PER THE PHYSICIAN THE DISSECTION WAS CAUSED BY THE GUIDELINER CATHETER AND THE SDS DID NOT CAUSE OR CONTRIBUTE TO THE DISSECTION. THE DISSECTION WAS MEDICALLY TREATED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10496874 ↗
• InjuryJun 16, 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 AN ST-ELEVATION MYOCARDIAL INFARCTION. A 3.00X23MM XIENCE SIERRA STENT WAS IMPLANTED. ON (B)(6) 2020, THE PATIENT WAS RE-ADMITTED WITH HYPERTENSIVE HEART FAILURE AND OTHER CARDIOVASCULAR SYMPTOMS. UNSPECIFIED TREATMENT WAS PERFORMED, AND THE FINAL PATIENT OUTCOME IS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Heart Failure

  MAUDE report 10159013 ↗
• InjuryMar 26, 2020Difficult to Remove; Device Damaged by Another Device; Material Deformation; Difficult to Remove; Device Damaged by Another Device; Material Deformation

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE SAPHENOUS VEIN GRAFT TO THE POSTERIOR DESCENDING ARTERY. AN UNSPECIFIED FILTER WIRE WAS ADVANCED TO THE LESION AND 3.0X18MM AND 3.0X23MM SIERRA STENTS WERE DEPLOYED. DURING REMOVAL OF THE FILTER WIRE, IT BECAME STUCK WITH THE DEPLOYED STENTS AND IT CAUSED THE STENTS TO ACCORDION [COMPRESS]. THE STENTS COMPRESSING STOPPED THE FLOW TO THE LESION AND THE PATIENT HAD A HEART ATTACK. THE PATIENT WAS TAKEN TO THE OPERATING ROOM FOR SURGICAL REMOVAL OF THE FILTER BASKET, WIRE, AND COMPRESSED STENTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Myocardial Infarction; Occlusion

  MAUDE report 9884674 ↗
• 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 ATHEROSCLEROTIC HEART DISEASE THEREFORE THE 3.00X23MM XIENCE SIERRA WAS IMPLANTED. ON (B)(6) 2019 THE PATIENT WAS RE-ADMITTED WITH ATHEROSCLEROTIC HEART DISEASE 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 9805113 ↗
• MalfunctionFeb 21, 2020Difficult to Remove; Material Separation; Difficult to Advance; Difficult to Remove; Material Separation; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE LEFT ANTERIOR DESCENDING CORONARY ARTERY. THE XIENCE SIERRA STENT DELIVERY SYSTEM (SDS) COULD NOT ADVANCE ON THE NON-ABBOTT GUIDE WIRE AND WHILE TRYING TO REMOVE THE SDS FROM THE GUIDE WIRE, THE SDS TIP DETACHED OUTSIDE THE PATIENT. ANOTHER SAME SIZE XIENCE SIERRA WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT OR A CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9742310 ↗
• 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 3.0X23 XIENCE SIERRA STENT WAS IMPLANTED IN THE DISTAL LEFT CIRCUMFLEX CORONARY ARTERY AND THE 2.25X18 XIENCE SIERRA STENT WAS IMPLANTED IN THE FIRST DIAGONAL CORONARY ARTERY. ON (B)(6) 2019 THE PATIENT WAS IN CARDIAC ARREST AND EMERGENCY RESPONSE ARRIVED. THE PATIENT WAS SUCCESSFULLY RESUSCITATED AND THE PATIENT WAS TRANSPORTED TO THE HOSPITAL WHERE VENTRICULAR TACHYCARDIA OCCURRED. THE PATIENT WAS DEFIBRILLATED SEVERAL TIMES. ON (B)(6) 2019 THE PATIENT HAD ACUTE METABOLIC ENCEPHALOPATHY RELATED TO THE CARDIAC ARREST. THE PATIENT WAS INTUBATED AND RE-WARMED FOR HYPOTHERMIA. ON (B)(6) 2019 HEMODIALYSIS WAS PERFORMED FOR CHRONIC KIDNEY DISEASE, STAGE 4. ON (B)(6) 2019 THE PATIENT'S VENTRICULAR IRRITABILITY PROGRESSED TO VENTRICULAR FIBRILLATION/ARREST AND THE PATIENT EXPIRED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Cardiac Arrest; Neurological Deficit/Dysfunction; Respiratory Failure; Ventricular Fibrillation; Ventricular Tachycardia

  MAUDE report 9483833 ↗
• InjuryDec 10, 2019Adverse 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 LESION IN THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY. THE PATIENT WAS PRESENTED WITH UNSTABLE ANGINA ON (B)(6) 2019. THE 99% STENOSED SECOND DIAGONAL BRANCH CORONARY ARTERY WAS TREATED WITH AN UNSPECIFIED DRUG-ELUTING BALLOON. THEN A 3X23MM XIENCE SIERRA STENT WAS IMPLANTED IN THE PROXIMAL LAD, AND POST-DILATATION WAS PERFORMED WITH AN UNSPECIFIED BALLOON DILATATION CATHETER (BDC). IT WAS CONFIRMED BY IVUS THAT THE STENT WAS APPOSED TO THE VESSEL WALL. IT WAS NOTED UNDER ANGIOGRAPHY THAT THE FIRST DIAGONAL BRANCH WAS NOT VISIBLE, SO AN UNSPECIFIED BDC WAS USED. THROMBOSIS WAS CONFIRMED IN THE PROXIMAL LAD WHERE THE STENT WAS IMPLANTED, SO A NON-ABBOTT BDC WAS USED BUT FAILED. A 3.5X23MM XIENCE SIERRA STENT WAS IMPLANTED IN THE SAME PROXIMAL LAD, AND A 2.25X15 XIENCE SIERRA STENT WAS IMPLANTED AT THE JUNCTION OF THE MID LAD AND THE FIRST DIAGONAL BRANCH. THE THROMBUS HAD MOVED TO THE DISTAL LAD, BUT THE PROCEDURE WAS INTERRUPTED. ON (B)(6) 2019, BLOOD FLOW WAS RESTORED TO TIMI 1-2 WITH AN UNSPECIFIED BDC, AND THE PATIENT IS SCHEDULED TO BE DISCHARGED ON (B)(6) 2019. THE HOSPITALIZATION OF THE PATIENT WAS NO

  Patient problems: Embolism; Thrombosis

  MAUDE report 9445936 ↗
• InjuryDec 9, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 3X23MM XIENCE SIERRA STENT WAS IMPLANTED ON (B)(6) 2019. THE PATIENT PRESENTED WITH NON-ST-ELEVATION MYOCARDIAL INFARCTION BEFORE THE PROCEDURE. ON (B)(6) 2019, THE PATIENT WAS RE-ADMITTED WITH UNSPECIFIED ANGINA. UNSPECIFIED TREATMENT WAS PERFORMED, AND THE FINAL PATIENT OUTCOME IS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina

  MAUDE report 9438064 ↗