XIENCE Sierra™ 1550225-38Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 08717648227066), received between Jun 13, 2018 and Dec 21, 2021 — classified as 1 death, 17 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (4 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 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• InjuryDec 21, 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 MID-RIGHT CORONARY ARTERY (RCA) PERCUTANEOUS INTERVENTION WAS PERFORMED. TWO XIENCE SIERRA STENTS WERE IMPLANTED IN THE MID RCA WITHOUT A DEVICE ISSUE REPORTED. ON (B)(6) 2021, THE PATIENT WAS HOSPITALIZED WITH CHEST PAIN AND MEDICATIONS WERE PROVIDED. RESTENOSIS WAS OBSERVED IN THE DISTAL PORTION OF THE 2.25X38MM XIENCE SIERRA STENT. AS TREATMENT, ADDITIONAL ANGIOPLASTY WAS PERFORMED. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THIS ISSUE.

  Patient problems: Angina; Stenosis

  MAUDE report 13054432 ↗
• InjuryOct 15, 2021Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED CIRCUMFLEX ARTERY. TWO XIENCE SIERRA STENT DELIVERY SYSTEMS (SDS) (2.25X38 AND 3.0X38MM) WERE IMPLANTED WITHOUT ISSUE; HOWEVER, THE PHYSICIAN DID NOT LIKE THE APPOSITION OF WHERE BOTH STENTS OVER LAPPED IN THE MIDDLE. THEREFORE, THE 3.50X18MM XIENCE SIERRA SDS WAS ADVANCED WITH NO ISSUE, BUT THE BALLOON RUPTURED AT 2 ATMOSPHERES. THERE WAS DIFFICULTY REMOVING THE SDS DUE TO THE ANATOMY AND THE STENT BECAME DISLODGED. A 3.5X15MM NON-COMPLIANT BALLOON WAS ADVANCED AND USED TO TREAT THE MALPOSITION. THEN AN UNSPECIFIED TREK BALLOON WAS USED TO BRING THE DISLODGED STENT BACK INTO THE UNSPECIFIED GUIDE CATHETER AND REMOVE ALL OF THE DEVICES AS ONE UNIT. ONCE THE DEVICE WAS REMOVED IT WAS NOTED THE STENT WAS NOT IN THE GUIDE CATHETER AND REMAINED STUCK AT THE RIGHT GROIN. THE PATIENT WAS SENT TO SURGERY AND A CUT DOWN WAS PERFORMED TO SUCCESSFULLY REMOVE THE STENT. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12639831 ↗
• MalfunctionOct 11, 2021Difficult to Remove; Failure to Advance; Difficult to Remove; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE HEAVILY TORTUOUS RIGHT CORONARY ARTERY. THE 2.25X38 MM XIENCE SIERRA STENT DELIVERY SYSTEM (SDS) COULD NOT BE ADVANCED TO THE TARGET LESION DUE TO THE ANATOMY, EVEN WITH A NON-ABBOTT GUIDE EXTENSION CATHETER. THE XIENCE SIERRA SDS WAS REMOVED WITH RESISTANCE NOTED WITH THE ANATOMY. A NON-ABBOTT DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12610405 ↗
• MalfunctionAug 30, 2021Difficult 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 LESION LOCATED IN THE MID LEFT ANTERIOR DESCENDING CORONARY ARTERY THAT WAS HEAVILY CALCIFIED, MILDLY TORTUOUS AND 90% STENOSED. THE LESION WAS NOT PRE-DILATED. A GUIDE WIRE WAS PLACED. THEN, THE 2.25 X 38 XIENCE SIERRA STENT DELIVERY SYSTEM (SDS) WAS ADVANCED BUT FAILED TO CROSS INTO THE LESION, AND THE STENT EDGE FLARED. RESISTANCE WAS MET DURING REMOVAL. A SMALL BALLOON DILATATION CATHETER (BDC) WAS ADVANCED FOR PRE-DILATATION; HOWEVER, THE BDC FAILED TO CROSS ALSO. THE PROCEDURE WAS ABANDONED. 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 12389522 ↗
• InjuryJul 15, 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 HEAVILY CALCIFIED LESION IN THE ANTERIOR TIBIAL ARTERY. FOLLOWING ROTATIONAL ATHERECTOMY, A 2.5X38MM XIENCE SIERRA STENT AND A 2.25X38MM XIENCE SIERRA STENT WERE SUCCESSFULLY DEPLOYED. AFTER DEPLOYMENT OF THE 2.25X38MM STENT, A SMALL MID ANTERIOR TIBIAL ARTERY PERFORATION WAS NOTED. A 2.8X19MM GRAFTMASTER RX COVERED STENT WAS DEPLOYED TO TREAT THE PERFORATION, BUT A SMALL AMOUNT OF RUN OFF WAS NOTED AROUND THE STENT SO A 2.8X16MM GRAFTMASTER RX COVERED STENT WAS DEPLOYED BACK TO BACK TO SUCCESSFULLY SEAL THE PERFORATION. COMPLETE HEMOSTASIS WAS ACHIEVED AND THERE WAS A 0% RESIDUAL STENOSIS POST INTERVENTION. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Perforation of Vessels

  MAUDE report 12173842 ↗
• InjuryJan 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT ID: (B)(4). IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A TARGET LESION IN THE MID RIGHT CORONARY ARTERY (RCA). A 3.25 X 18 MM XIENCE SIERRA STENT AND A 2.25 X 38 MM XIENCE SIERRA STENT WERE IMPLANTED IN THE MID RCA. AFTER THE 2.25 X 38 MM XIENCE SIERRA STENT WAS IMPLANTED, A DISSECTION WAS NOTED. AN ADDITIONAL UNSPECIFIED STENT WAS IMPLANTED TO TREAT THE DISSECTION AND THE EVENT RESOLVED THE SAME DAY. POST PROCEDURE, CARDIAC ENZYMES WERE ELEVATED; HOWEVER, NO ADDITIONAL INTERVENTION WAS PROVIDED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Cardiac Enzyme Elevation; Intimal Dissection

  MAUDE report 11136224 ↗
• InjuryDec 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 WAS IMPLANTED WITH A 2.25X38MM XIENCE SIERRA STENT IN AN UNKNOWN ARTERY AND 4 HOURS LATER EXPERIENCED A STROKE. NO ISSUES OCCURRED DURING THE PROCEDURE. TYPE OF TREATMENT WAS NOT PROVIDED. THE PATIENT WAS DISCHARGED BUT IS STABLE AND IS CURRENTLY WAITING FOR HIS THERAPY TO BE SCHEDULED. THERE WAS NO CLINICALLY SIGNIFICANT DELAY REPORTED DURING THE INDEX PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Stroke/CVA

  MAUDE report 10984056 ↗
• InjuryNov 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 THE PROCEDURE WAS PERFORMED ON (B)(6) 2019, TREATING A TARGET LESION IN THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE 2.25 X 38 MM XIENCE SIERRA STENT DELIVERY SYSTEM WAS ADVANCED AND THE STENT WAS IMPLANTED WITHOUT ISSUE. ON (B)(6) 2020, THE PATIENT PRESENTED FOR AN OUTPATIENT LEXISCAN. RESULTS WERE POSITIVE FOR ISCHEMIA AND THE PATIENT HAD COMPLAINTS OF SHORTNESS OF BREATH DURING THE LEXISCAN. THE SHORTNESS OF BREATH RESOLVED DURING THE RECOVERY PHASE. ON (B)(6) 2020, THE PATIENT WAS RE-HOSPITALIZED. IN-STENT RESTENOSIS WAS NOTED IN THE 2.25 X 38 MM XIENCE SIERRA STENT. REVASCULARIZATION WAS PERFORMED AND THE PATIENT CONDITION RESOLVED ON (B)(6) 2020. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Dyspnea; Ischemia; Stenosis

  MAUDE report 10920249 ↗
• 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 2.25X38 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 10909368 ↗
• MalfunctionNov 3, 2020Difficult to Remove; Failure to Advance; Material Deformation; Difficult to Remove; Failure to Advance; Material Deformation

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A 90% STENOSED, MODERATELY TORTUOUS, AND MILDLY CALCIFIED CONCENTRIC LESION IN THE RIGHT CORONARY ARTERY. FOLLOWING PRE-DILATATION, AN ATTEMPT TO ADVANCE A 2.25X38MM XIENCE SIERRA STENT DELIVERY SYSTEM (SDS) WAS MADE; HOWEVER, THE SDS FAILED TO CROSS DUE TO RESISTANCE WITH THE ANATOMY. THE SDS WAS FORCIBLY PUSHED BUT STILL FAILED TO CROSS. THE SDS WAS REMOVED, BUT RESISTANCE WITH THE ANATOMY WAS FELT. ONCE OUTSIDE THE ANATOMY IT WAS NOTED THAT THE EDGE OF THE STENT STRUT WAS FLARED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A NEW UNKNOWN DEVICE. 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 10781434 ↗
• MalfunctionOct 13, 2020Leak/Splash; Activation Failure; Leak/Splash; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A 100% STENOSED, CHRONIC TOTALLY OCCLUDED, MILDLY TORTUOUS, AND MODERATELY CALCIFIED LESION IN THE PROXIMAL TO MID LEFT ANTERIOR DESCENDING ARTERY. FOLLOWING PRE-DILATATION, A 2.25X38MM XIENCE SIERRA STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TO THE TARGET LESION AND AN ATTEMPT TO INFLATE THE BALLOON WAS MADE; HOWEVER, THE STENT DID NOT EXPAND AND THE BALLOON FAILED TO INFLATE. THE SDS WAS REMOVED WITH THE STENT ON THE BALLOON WITHOUT ISSUES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A NON-ABBOTT DRUG-ELUTING STENT. AFTER THE PROCEDURE, THE BALLOON INFLATION WAS ATTEMPTED OUTSIDE THE ANATOMY AND A LEAK WAS NOTED PROXIMAL TO THE GUIDE WIRE EXIT NOTCH. 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 10674570 ↗
• DeathSep 22, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBSEQUENT TO THE PREVIOUS MEDWATCH REPORT, THE ADDITIONAL INFORMATION WAS OBTAINED: ON (B)(6) 2020, THE PATIENT WAS ADMITTED TO THE HOSPITAL. ON (B)(6) 2020, DURING DIALYSIS, THE PATIENT BECAME TACHYCARDIC WHEN WALKING, HEART RATE IN THE 130¿S. THE PATIENT BECAME HYPOTENSIVE AND UNRESPONSIVE, RAPID RESPONSE AND CODE BLUE WERE CALLED. AS TREATMENT, MEDICATIONS WERE PROVIDED AND ANOTHER CARDIAC CATHETERIZATION WAS PERFORMED. SIGNIFICANT CORONARY ARTERY DISEASE WAS OBSERVED ALONG WITH IN-STENT RESTENOSIS OF THE XIENCE STENT. ADDITIONAL STENTS WERE PLACED AS TREATMENT, INCLUDING A NON-ABBOTT STENT TO THE LAD. THE PATIENT WAS PLACED ON AN INTRA-AORTA BALLOON PUMP (IABP).

  Patient problems: Cardiac Arrest; Death; Intimal Dissection; Low Blood Pressure/ Hypotension; Myocardial Infarction; Occlusion; Stenosis; Tachycardia

  MAUDE report 10566812 ↗
• InjuryMar 24, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: Angina; Myocardial Infarction; Stenosis

  MAUDE report 9875966 ↗
• InjuryMar 10, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ON (B)(6) 2020 VIA CHIBA VASCULAR INTERVENTION CONFERENCE, IN A PRESENTATION TITLED ¿STENT THROMBOSIS WHICH OCCURRED AFTER AN EMERGENT PCI FOR SEVERE NSTEMI PRESENTING CULPRIT SHOCK,¿ THAT THE FOLLOWING OCCURRED: A PATIENT WAS HOSPITALIZED ON (B)(6) 2019, AS THEY PRESENTED WITH NON-ST ELEVATION MYOCARDIAL INFARCTION, HYPERTENSION, CARDIOGENIC SHOCK AND DIABETES. ADDITIONALLY, HEPATOPATHY AND NEPHROPATHY WERE ALSO NOTED. ANGIOGRAPHY WAS PERFORMED WHICH SHOWED 99% STENOSIS AT THE MID-DISTAL RIGHT CORONARY ARTERY (RCA), 90% STENOSIS AT THE PROXIMAL-DISTAL LEFT ANTERIOR DESCENDING ARTERY (LAD) AND 100% STENOSIS AT THE DISTAL CIRCUMFLEX (CX) WITH 20% EJECTION FRACTION (EF). THE RCA LESION WAS TREATED FIRST AND PREDILATATION WAS PERFORMED. A 2.25X38MM XIENCE SIERRA STENT WAS DEPLOYED AT 8 ATMOSPHERES (ATM) TO 16 ATM FROM THE POSTERIAL LATERAL TO THE DISTAL RCA. THEN THE SECOND STENT IMPLANTED AT 11 ATMOSPHERES WAS A 2.5X48MM XIENCE XPEDITION AT THE MID RCA. FINALLY A THIRD STENT (3.25X23MM XIENCE SIERRA) WAS IMPLANTED AT 12 ATM AT THE PROXIMAL RCA. POST-DILATATION WAS PERFORMED AND INTRAVASCULAR ULTRASOUND WAS CONDUCTED. ALTHOUGH BAD-FLOW WAS NOTED, THE LESION WAS OPENED

  Patient problems: Myocardial Infarction; Test Result

  MAUDE report 9812033 ↗
• InjuryMar 10, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ON (B)(6) 2020 VIA CHIBA VASCULAR INTERVENTION CONFERENCE, IN A PRESENTATION TITLED ¿STENT THROMBOSIS WHICH OCCURRED AFTER AN EMERGENT PCI FOR SEVERE NSTEMI PRESENTING CULPRIT SHOCK,¿ THAT THE FOLLOWING OCCURRED: A PATIENT WAS HOSPITALIZED ON (B)(6) 2019, AS THEY PRESENTED WITH NON-ST ELEVATION MYOCARDIAL INFARCTION, HYPERTENSION, CARDIOGENIC SHOCK AND DIABETES. ADDITIONALLY, HEPATOPATHY AND NEPHROPATHY WERE ALSO NOTED. ANGIOGRAPHY WAS PERFORMED WHICH SHOWED 99% STENOSIS AT THE MID-DISTAL RIGHT CORONARY ARTERY (RCA), 90% STENOSIS AT THE PROXIMAL-DISTAL LEFT ANTERIOR DESCENDING ARTERY (LAD) AND 100% STENOSIS AT THE DISTAL CIRCUMFLEX (CX) WITH 20% EJECTION FRACTION (EF). THE RCA LESION WAS TREATED FIRST AND PREDILATATION WAS PERFORMED. A 2.25X38MM XIENCE SIERRA STENT WAS DEPLOYED AT 8 ATMOSPHERES (ATM) TO 16 ATM FROM THE POSTERIAL LATERAL TO THE DISTAL RCA. THEN THE SECOND STENT IMPLANTED AT 11 ATMOSPHERES WAS A 2.5X48MM XIENCE XPEDITION AT THE MID RCA. FINALLY A THIRD STENT (3.25X23MM XIENCE SIERRA) WAS IMPLANTED AT 12 ATM AT THE PROXIMAL RCA. POST-DILATATION WAS PERFORMED AND INTRAVASCULAR ULTRASOUND WAS CONDUCTED. ALTHOUGH BAD-FLOW WAS NOTED, THE LESION WAS OPENED

  Patient problems: Ischemia; Myocardial Infarction; Test Result; Thrombosis

  MAUDE report 9811767 ↗
• InjuryFeb 4, 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, TWO XIENCE SIERRA STENTS, SIZES 2.25X38 AND 3.0X18, WERE IMPLANTED IN THE LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY. ON (B)(6) 2019 THE PATIENT HAD CHEST PAIN. THE ANGIOGRAM SHOWED SEVERE CORONARY ARTERY DISEASE. ON (B)(6) 2019, CORONARY ARTERY BYPASS GRAFT SURGERY WAS PERFORMED IN TWO VESSELS, THE LAD AND THE FIRST OBTUSE MARGINAL CORONARY ARTERY. THE PATIENT HAD A GOOD RECOVERY AND WAS DISCHARGED HOME ON (B)(6) 2019. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina; Stenosis

  MAUDE report 9665390 ↗
• InjuryJan 3, 2020Difficult to Insert; Difficult to Remove; Material Separation; Difficult to Advance; Difficult to Insert; Difficult to Remove; Material Separation; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 90% STENOSED, HEAVILY TORTUOUS, AND HEAVILY CALCIFIED DE NOVO LESION IN THE PROXIMAL LEFT ANTERIOR DESCENDING CORONARY ARTERY. REPORTEDLY, A 2.25X38MM XIENCE SIERRA STENT DELIVERY SYSTEM (SDS) WAS ATTEMPTED TO BE ADVANCED WITH A NON-ABBOTT GUIDE EXTENSION CATHETER; HOWEVER, THE SDS COULD NOT BE INSERTED INTO THE GUIDE EXTENSION CATHETER DUE TO INTERACTION WITH THE NON-ABBOTT GUIDE EXTENSION CATHETER. THEREFORE, THE NON-ABBOTT GUIDE EXTENSION CATHETER WAS REPLACED WITH A 5.5FR NON-ABBOTT GUIDE EXTENSION CATHETER. ALTHOUGH RESISTANCE WAS NOTED DUE TO HEAVY TORTUOSITY, THE SDS WAS ADVANCED WITH THE EXTENSION CATHETER AND THE STENT WAS DEPLOYED. WHEN THE SDS WAS REMOVED, STRONG RESISTANCE WAS NOTED WITH 5.5 FR EXTENSION CATHETER. WHILE THE SDS WAS PULLED OUT CAREFULLY, THE SDS BECAME DETACHED INTO 2 PIECES AROUND THE MID SHAFT. THE DISTAL DETACHED PART REMAINED INSIDE THE GUIDING CATHETER; THEREFORE, THE DISTAL PART WAS RETRIEVED BY SNARE DEVICE. NO PARTS REMAINED INSIDE THE ANATOMY. 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 9549236 ↗
• InjuryDec 23, 2019Improper 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 PERFORMED TO TREAT A HEAVILY TORTUOUS AND HEAVILY CALCIFIED LESION IN THE SECOND DIAGONAL CORONARY ARTERY. A 2.75X38MM XIENCE SIERRA STENT DELIVERY SYSTEM (SDS) FAILED TO CROSS DUE TO THE ANATOMY. THE SDS WAS REMOVED WITHOUT ISSUES. AN ATTEMPT TO ADVANCE A 2.25X38MM XIENCE SIERRA SDS WAS MADE, HOWEVER, THIS TOO FAILED TO CROSS DUE TO THE ANATOMY. THE PATIENT WAS RE-WIRED AND A GUIDELINER WAS PLACED. THE SAME 2.25X38MM XIENCE SIERRA SDS WAS RE-ATTEMPTED AND FAILED TO CROSS AGAIN. DURING REMOVAL OF THE SDS, THE STENT DISLODGED AND ALL WAS REMOVED AS A SINGLE UNIT. AT THE TIME IT WAS THOUGHT THAT THE STENT WOULD BE IN THE GUIDELINER; HOWEVER, THIS WAS NOT THE CASE AS THE DISLODGED STENT REMAINED IN THE LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY. THE DISLODGED STENT WAS CRUSHED AGAINST THE VESSEL WALL VIA BALLOON DILATATION. THE LAD THEN DEVELOPED THROMBUS AND AN ATTEMPT TO RE-WIRE WAS MADE FOR ADDITIONAL TREATMENT. DURING RE-WIRING WITH AN UNSPECIFIED GUIDE WIRE, THE WIRE WAS ENTERING THE SUBINTIMAL LAD WHEN A DISSECTION OCCURRED. AN IMPELLA DEVICE WAS IMPLANTED AND THE PATIENT WAS SENT FOR A CORONARY ARTERY BYPASS GRAFT (CABG). THERE WAS NO

  Patient problems: Thrombosis; Vessel Or Plaque, Device Embedded In

  MAUDE report 9511682 ↗
• InjurySep 27, 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 09/10/2018, THE PATIENT UNDERWENT A CORONARY PROCEDURE, PERFORMED TO TREAT A LESION IN THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY. A 2.25 X 38 MM XIENCE SIERRA STENT WAS IMPLANTED. ON (B)(6) 2019, THE PATIENT WAS RE-HOSPITALIZED WITH CHEST PAIN AND SHORTNESS OF BREATH. PERCUTANEOUS CORONARY INTERVENTION WAS PERFORMED AND IN-STENT RESTENOSIS WAS NOTED IN THE MID LAD. A DRUG ELUTING STENT WAS IMPLANTED AND THE PATIENT WAS DISCHARGED TO HOME ON DUAL ANTIPLATELET THERAPY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina; Dyspnea; Stenosis

  MAUDE report 9131395 ↗
• InjuryMay 3, 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 TARGET LESIONS IN THE 1ST OBTUSE MARGINAL (OM1) ARTERY AND PROXIMAL CIRCUMFLEX ARTERY. A 2.25 X 38 MM XIENCE SIERRA STENT WAS IMPLANTED IN THE OM1. AN EDGE DISSECTION WAS NOTED, AND A 2.25 X 12 MM NON-ABBOTT STENT WAS IMPLANTED AS TREATMENT. ADDITIONALLY, THE XIENCE SIERRA STENT WAS NOTED TO BE PROTRUDING FROM THE OBTUSE MARGINAL INTO THE CIRCUMFLEX (CX) ARTERY. THE PROTRUDING END WAS CRUSHED, FOLLOWED BY ANGIOPLASTY IN THE CX ARTERY AND IN THE OM1. A 3.5 X 28 MM XIENCE SIERRA STENT WAS IMPLANTED IN THE PROXIMAL CX ARTERY. IT WAS NOTED THAT THE STENT WAS UNDER-EXPANDED AND ADDITIONAL POST DILATATION WAS PERFORMED, TO FULLY APPOSE THE STENT TO THE VESSEL WALL. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Intimal Dissection

  MAUDE report 8579981 ↗
• InjuryNov 2, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A CIRCUMFLEX ARTERY. TWO XIENCE SIERRA STENTS (2.25X38 AND 3.25X23) WERE SUCCESSFULLY IMPLANTED AT THE LESION. THERE WERE NO DEVICE ISSUES AND THE STENTS WERE WELL-APPOSED TO THE VESSEL WALL. WHILE FINISHING THE CASE, THE PATIENT STATED THEY DIDN'T FEEL RIGHT AND THERE WAS A DROP IN BLOOD PRESSURE. A THROMBUS WAS OBSERVED IN BOTH STENTS AND A THROMBECTOMY WAS PERFORMED. THE PATIENT THEN STOPPED BREATHING AND EXPERIENCED CARDIOPULMONARY ARREST. CARDIOPULMONARY RESUSCITATION WAS PERFORMED, THE PATIENT WAS INTUBATED, MEDICATIONS PROVIDED, AND A BALLOON PUMP (IABP) WAS PLACED TO STABILIZE THE PATIENT. THE PATIENT WAS TAKEN TO CRITICAL CARE FOR OBSERVATION. THE EVENT REQUIRED PROLONGED HOSPITALIZATION. THERE WAS NO ADVERSE PATIENT SEQUELA REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Cardiac Arrest; Low Blood Pressure/ Hypotension; Respiratory Distress; Thrombosis

  MAUDE report 8035373 ↗
• InjuryJun 13, 2018Difficult To Position

  IT WAS REPORTED THAT THE PATIENT WAS ADMITTED WITH ST ELEVATION MYOCARDIAL INFARCTION. CORONARY CATHETERIZATION WAS PERFORMED AND 5000 UNITS OF HEPARIN AND 180 MG OF BRILINTA WERE ADMINISTERED. THE 2.25 X 38 MM XIENCE SIERRA STENT WAS IMPLANTED IN THE 2ND OBTUSE MARGINAL ARTERY. NO ISSUES WERE NOTED DURING STENT IMPLANTATION. THE PATIENT REMAINED IN THE CATH LAB FOLLOWING THE PROCEDURE. ABOUT 20 MINUTES POST PROCEDURE, THE PATIENT BEGAN TO EXPERIENCE CHEST PAIN. ANGIOGRAPHY WAS PERFORMED AND IT WAS NOTED THAT THERE WAS THROMBUS IN THE STENTED AREA. THE VESSEL WAS REWIRED AND BALLOON DILATATION WAS PERFORMED. ADDITIONAL STENTING WAS ATTEMPTED, BUT THE STENT DELIVERY SYSTEM COULD NOT PASS THROUGH THE IMPLANTED STENT. NO ADDITIONAL INTERVENTION WAS PERFORMED, AS THE VESSEL WAS OPENED AFTER THE BALLOON ANGIOPLASTY. THERE WAS NO ADVERSE PATIENT SEQUELA OR A CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina; Thrombosis

  MAUDE report 7599423 ↗