XIENCE Sierra™ 1550300-18Recalls & reported problems

Summary

The FDA's MAUDE database contains 38 adverse event reports that list this exact device (DI 08717648227264), received between Jun 1, 2018 and Apr 29, 2022 — classified as 1 death, 28 injuries, 9 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 25 most recent of 38 reports, in the reporter's own words as published by the FDA.

• InjuryApr 29, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED, MODERATELY TORTUOUS LESION IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. A 3X18MM XIENCE SIERRA DRUG ELUTING STENT (DES) WAS ADVANCED TO THE TARGET LESION WITHOUT ISSUE. DURING DEPLOYMENT, THE STENT CAME OFF THE BALLOON AND MIGRATED INTO THE PATIENT'S ARM. AN ATTEMPT WAS MADE TO SNARE THE STENT, HOWEVER IT MIGRATED AGAIN INTO THE PATIENT'S HAND. THE STENT BECAME EMBEDDED IN THE ULNAR ARTERY WHERE IT REMAINS WITH NO FURTHER ATTEMPTS TO REMOVE. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE OR THERAPY.

  Patient problems: Foreign Body In Patient

  MAUDE report 14254464 ↗
• MalfunctionAug 19, 2021Difficult 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 TORTUOUS LESION IN AN UNSPECIFIED ARTERY. A 3.00X18MM XIENCE SIERRA STENT DELIVERY SYSTEM (SDS) WAS ADVANCED; HOWEVER, FAILED TO CROSS DUE TO RESISTANCE WITH THE ANATOMY. THE SDS WAS REMOVED BUT RESISTANCE WITH THE ANATOMY WAS FELT. ADDITIONALLY, IT WAS NOTED THAT THE STENT STRUT WAS FLARED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH PRE-DILATATION AND THE DEPLOYMENT OF A NON-ABBOTT STENT. 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 12345627 ↗
• MalfunctionAug 10, 2021Material Separation; Failure to Advance; Material Separation; Failure to Advance

  IT WAS REPORTED THAT THIS WAS A PROCEDURE TO TREAT THE RADIAL ARTERY WITH HEAVY TORTUOSITY. A 3.0X18MM XIENCE SIERRA STENT DELIVERY SYSTEM (SDS) WAS ADVANCING TOWARDS THE TARGET LESION; HOWEVER, RESISTANCE MET DURING ADVANCEMENT DUE TO THE HEAVY TORTUOSITY. PRIOR TO REACHING THE TARGET LESION, THE MID SHAFT BECAME SEPARATED. SINCE THE SDS DID NOT ADVANCE FAR ENOUGH (BOTH PARTS STILL WITHIN REACH OUTSIDE THE BODY), BOTH SEPARATED PARTS WERE ABLE TO BE SIMPLY REMOVED. THE TARGET LESION WAS SUCCESSFULLY TREATED WITH A NEW 3.0X18MM XIENCE SIERRA SDS. 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 12303750 ↗
• InjuryJul 23, 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 TWO XIENCE SIERRA STENTS, SIZES 3.0X18 AND 3.5X28 WERE IMPLANTED IN THE MID RIGHT CORONARY ARTERY (RCA). ON (B)(6) 2021 THE PATIENT REPORTED ANGINAL SYMPTOMS DURING AN OFFICE VISIT. A LEFT HEART CATHETERIZATION WAS PERFORMED ON (B)(6) 2021 ALTHOUGH THE PATIENT NO LONGER HAD CHEST PAIN OR SHORTNESS OF BREATH. A STENT WAS PLACED IN THE RCA. THE TROPONIN LEVELS WERE NEGATIVE. THE PATIENT WAS DISCHARGED THE SAME DAY, (B)(6) 2021. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina; Dyspnea; Stenosis

  MAUDE report 12221483 ↗
• MalfunctionJun 16, 2021Break; Inflation Problem; Break; Inflation Problem

  IT WAS REPORTED THAT THE HUB OF A 3.00X18MM XIENCE SIERRA STENT DELIVERY SYSTEM (SDS) WAS CRACKED AND THE BALLOON FAILED TO INFLATE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A NEW UNSPECIFIED XIENCE STENT. 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 12009902 ↗
• InjuryJun 2, 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 NON-ST-ELEVATION MYOCARDIAL INFARCTION AND A 3.0X18MM XIENCE SIERRA STENT AND A NON-ABBOTT STENT WERE IMPLANTED. ON (B)(6) 2021, THE PATIENT WAS RE-ADMITTED WITH UNSPECIFIED CARDIOVASCULAR SYMPTOMS 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 11924533 ↗
• InjuryMay 26, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH ATHEROSCLEROTIC HEART DISEASE BEFORE THE INITIAL PROCEDURE. A 3X18MM XIENCE SIERRA STENT WAS IMPLANTED ON (B)(6) 2021. ON (B)(6) 2021, 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 11890469 ↗
• InjuryJan 18, 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 3.0 X 18 MM XIENCE SIERRA STENT WAS IMPLANTED IN THE MID LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY. ON (B)(6) 2020, THE PATIENT UNDERWENT A RIGHT AND LEFT HEART CATHETERIZATION AND WAS FOUND TO HAVE RESTENOSIS IN THE PROXIMAL LAD, IDENTIFIED AS THE TARGET LESION. AN ADDITIONAL STENT WAS IMPLANTED. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: Stenosis

  MAUDE report 11190102 ↗
• MalfunctionJan 7, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE RIGHT CORONARY ARTERY (RCA) WITH MILD CALCIFICATION AND NO TORTUOSITY. THE XIENCE STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TO THE TARGET LESION WITHOUT RESISTANCE. THE STENT WAS DEPLOYED; HOWEVER, THE BALLOON RUPTURED AT 12 ATMOSPHERE. A 3.25 X 15 MM NC TREK BALLOON WAS USED FOR POST DILATATION. 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 11132538 ↗
• InjuryDec 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 ON (B)(6) 2019 THE 3.0X18 MM XIENCE SIERRA STENT WAS IMPLANTED IN THE PROXIMAL LEFT ANTERIOR DESCENDING CORONARY ARTERY (PLAD). ON (B)(6) 2020 THE PATIENT WENT TO THE EMERGENCY ROOM WITH CHEST PAIN AND WAS DIAGNOSED WITH AN ST ELEVATION MYOCARDIAL INFARCTION. CORONARY ANGIOGRAM FOUND THAT THE PLAD STENT WAS OCCLUDED WITH THROMBUS. THROMBECTOMY WAS PERFORMED AND THE VESSEL WAS REVASCULARIZED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina; Myocardial Infarction; Thrombosis

  MAUDE report 11020067 ↗
• InjuryDec 5, 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, WITH A HISTORY OF NON-ST ELEVATION MYOCARDIAL INFARCTION, UNDERWENT A CORONARY STENTING PROCEDURE, WITH IMPLANTATION OF A 3.0 X 18 MM XIENCE SIERRA STENT. ON (B)(6) 2020, THE PATIENT WAS RE-ADMITTED WITH VENTRICULAR FIBRILLATION AND SURGICAL INTERVENTION WAS PERFORMED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Ventricular Fibrillation

  MAUDE report 10953960 ↗
• InjuryOct 20, 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, THE PATIENT PRESENTED WITH ANGINA, SEVERE CALCIFICATION WITHIN THE LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY, AND A MID-LAD, 80% STENOSED LESION. PRE-DILATATION WAS PERFORMED AND A 3.0X18MM XIENCE SIERRA STENT WAS IMPLANTED WITH ACCEPTABLE RESULTS AND NO COMPLICATIONS. TIMI FLOW III WITH 0% RESIDUAL STENOSIS WAS OBSERVED. ON (B)(6) 2020, THE PATIENT EXPRESSED EXPERIENCING FATIGUE AND DYSPNEA DURING A FOLLOW-UP VISIT. A STRESS TEST WAS PERFORMED AND A LARGE AREA OF PERFUSION DEFECT WAS OBSERVED IN THE LAD AREA. REGARDING THE XIENCE SIERRA STENT, THERE WAS NO RESTENOSIS AND NO DEVICE MALFUNCTION. AS TREATMENT, A NEW STENT WAS PLACED WITHIN THE PROXIMAL LAD AND MEDICATIONS WERE PROVIDED. THE EVENT DID NOT REQUIRE HOSPITALIZATION. THERE WAS NO DEVICE MALFUNCTION. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THIS ISSUE.

  Patient problems: Dyspnea; Fatigue; Ischemia; Test Result

  MAUDE report 10705228 ↗
• InjurySep 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) 2020, A PERCUTANEOUS CORONARY INTERVENTION (PCI) WAS PERFORMED ON THE PROXIMAL CIRCUMFLEX (CX) CORONARY ARTERY, 80% STENOSED LESION. A 3.0X18MM XIENCE SIERRA STENT WAS IMPLANTED IN THE CX AND POST-DILATATION PERFORMED. POST-PROCEDURE THERE WAS TIMI FLOW III AND 0% RESIDUAL STENOSIS. FOLLOWING, PLAQUE SHIFT OCCURRED. AS TREATMENT, ADDITIONAL BALLOON ANGIOPLASTY WAS PERFORMED. ELEVATED CARDIAC ENZYMES WERE ALSO NOTED POST-PROCEDURE. THERE WAS NO DIAGNOSED MYOCARDIAL INFARCTION AND THERE WAS NO ADDITIONAL TREATMENT PROVIDED. THE EVENT RESOLVED WITHOUT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THIS ISSUE.

  Patient problems: Cardiac Enzyme Elevation; Prolapse

  MAUDE report 10494750 ↗
• InjurySep 3, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT TWO XIENCE SIERRA STENTS (4X12MM AND 2.25X12MM) WERE IMPLANTED IN THE LEFT ANTERIOR DESCENDING CORONARY ARTERY (LAD) ON (B)(6) 2020. THE PATIENT PRESENTED WITH UNSTABLE ANGINA AND ATHEROSCLEROTIC HEART DISEASE BEFORE THE PROCEDURE. ON (B)(6) 2020, THE PATIENT WAS RE-ADMITTED WITH ANTERIOR NON-ST ELEVATED MYOCARDIAL INFARCTION AND PALPITATIONS. TWO MORE XIENCE SIERRA STENTS (2.75X38MM AND 3X18MM) WERE IMPLANTED OVER THE PREVIOUS STENTS IN THE LAD ON (B)(6) 2020. ON (B)(6) 2020, THE PATIENT WAS RE-ADMITTED WITH ANTERIOR NON-ST ELEVATED MYOCARDIAL INFARCTION AND PALPITATIONS AGAIN. UNSPECIFIED BALLOONS WERE USED AS TREATMENT, AND THE FINAL PATIENT OUTCOME IS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Arrhythmia; Myocardial Infarction

  MAUDE report 10491638 ↗
• InjuryJul 15, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH ACUTE MYOCARDIAL INFARCTION. THE VESSEL WAS PREPPED WITH A COMPLIANT BALLOON AND THE 3.0X18 MM XIENCE SIERRA STENT WAS IMPLANTED. NO POST DILATATION WAS PERFORMED AND THERE WERE NO ISSUES NOTED WITH DEPLOYMENT OF THE STENT. THERE WAS RESIDUAL STENOSIS NOTED ANGIOGRAPHICALLY, WHICH THE PHYSICIAN STATED WAS THE STENT CLOTTING OFF. THE THROMBOSIS WAS TREATED MEDICALLY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Thrombosis

  MAUDE report 10276932 ↗
• MalfunctionJun 29, 2020Difficult to Remove; Failure to Advance; Difficult to Remove; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A HEAVILY CALCIFIED, HEAVILY TORTUOUS DE NOVO MID-LEFT ANTERIOR DESCENDING ARTERY THAT WAS 99% STENOSED. THE 3.0X18MM XIENCE SIERRA STENT DELIVERY CATHETER FAILED TO CROSS DUE TO THE ANATOMY. RESISTANCE WAS NOTED WITH THE ANATOMY DURING REMOVAL. THE DEVICE WAS REPLACED WITH A 3.0X16MM NON-ABBOTT STENT 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 10209230 ↗
• InjuryJun 18, 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 3.0X18 MM XIENCE SIERRA STENT WAS IMPLANTED IN THE PATIENT WITH A PRE-EXISTING HISTORY OF ACUTE ISCHEMIC HEART DISEASE. ON (B)(6) 2020 THE PATIENT WAS RE-ADMITTED TO THE HOSPITAL WITH CHEST PAIN. TYPE OF TREATMENT WAS NOT SPECIFIED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina

  MAUDE report 10168797 ↗
• InjuryJun 12, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A XIENCE SIERRA STENT WAS IMPLANTED ON (B)(6) 2020. ON (B)(6) 2020, THE PATIENT WAS RE-ADMITTED WITH OTHER CARDIOVASCULAR SYMPTOMS; FLUID OVERLOAD. UNSPECIFIED TREATMENT WAS ADMINISTERED TO THE PATIENT. FINAL PATIENT OUTCOME IS REPORTEDLY UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 10151167 ↗
• 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 9884622 ↗
• InjuryMar 5, 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 3.00X18MM XIENCE SIERRA WAS IMPLANTED. ON (B)(6) 2019 THE PATIENT WAS RE-ADMITTED WITH OTHER CARDIO VASCULAR SYMPTOMS AND ACUTE NONINFECTIVE OTITIS. IT IS UNKNOWN WHAT TREATMENT WAS PERFORMED AND THE FINAL PATIENT OUTCOME IS UNKNOWN.

  Patient problems: No Code Available

  MAUDE report 9794258 ↗
• 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 9787310 ↗
• InjuryJan 16, 2020Inflation Problem; Leak/Splash; Inflation Problem; Leak/Splash

  IT WAS REPORTED THAT DURING A LEFT ANTERIOR DESCENDING CORONARY ARTERY INTERVENTION, THE XIENCE SIERRA STENT WAS ADVANCED TO THE LESION WITHOUT ISSUE; HOWEVER, DURING DEPLOYMENT, THE BALLOON WOULD NOT INFLATE PAST 12 ATMOSPHERES AND A SHAFT LEAK WAS SUSPECTED. THE STENT WAS IMPLANTED, REQUIRING BALLOON DILATATION TO FULLY EXPAND THE STENT AND TREAT THE LESION. THERE WAS NO ADVERSE PATIENT SEQUELA OR A CLINICALLY SIGNIFICANT DELAY IN PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9597387 ↗
• InjuryJan 7, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED ON (B)(6) 2019 TO TREAT A LESION WITH HEAVY CALCIFICATION AND MODERATE TORTUOSITY IN THE LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY. PRE-DILATATION WAS PERFORMED AND A 3.0 X 18 MM XIENCE SIERRA STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TO THE TARGET LESION AND THE STENT WAS IMPLANTED SUCCESSFULLY. HOWEVER, THE NEXT MORNING, (B)(6) 2019, THE PATIENT HAD ST CHANGES AND ECHOCARDIOGRAM SHOWED IN-STENT THROMBOSIS. ON (B)(6) 2019, A SECOND PROCEDURE WAS PERFORMED IN WHICH TWO ADDITIONAL XIENCE SIERRA STENTS WERE IMPLANTED AND ADDITIONAL ANTICOAGULANT WAS GIVEN. ADDITIONAL POST DILATATION WAS PERFORMED WITH THE 3.0 X 18 MM XIENCE SIERRA. THE PATIENT WAS STABILIZED AND HAD A GOOD OUTCOME. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Non specific EKG/ECG Changes; Thrombosis

  MAUDE report 9558086 ↗
• InjurySep 3, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A XIENCE SIERRA STENT WAS IMPLANTED ON (B)(6) 2019. ON (B)(6) 2019, THE PATIENT WAS RE-ADMITTED WITH ANGINA AND OTHER CARDIOVASCULAR SYMPTOMS. UNSPECIFIED TREATMENT WAS ADMINISTERED TO THE PATIENT. FINAL PATIENT OUTCOME IS REPORTEDLY UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina

  MAUDE report 8958426 ↗
• InjurySep 3, 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 A ST ELEVATED MYOCARDIAL INFARCTION AND A 3.00 X 18 MM XIENCE SIERRA STENT WAS IMPLANTED. ON (B)(6) 2019 THE PATIENT WAS RE-ADMITTED WITH UNSPECIFIED CARDIOVASCULAR SYMPTOMS AND ATHEROSCLEROSIS. THE TREATMENT ADMINISTERED ON RE-ADMISSION WAS NOT SPECIFIED AND THE FINAL PATIENT OUTCOME IS NOT KNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8958321 ↗