XIENCE Sierra™ 1550250-28Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 08717648227127), received between Oct 10, 2018 and Mar 15, 2024 — classified as 2 deaths, 15 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Material Separation” (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 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 15, 2024Difficult to Remove; Difficult to Advance; Difficult to Remove; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A DE NOVO LESION LOCATED IN THE DISTAL LEFT ANTERIOR DESCENDING CORONARY ARTERY THAT WAS MILDLY CALCIFIED AND NON TORTUOUS. REPORTEDLY, THE XIENCE SIERRA DES 2.50X28 RX STENT DELIVERY SYSTEM WAS ADVANCED OVER A NON-ABBOTT PRESSURE WIRE AND IT FROZE ON THE WIRE. IT WAS REMOVED WITH RESISTANCE AS A UNIT WITHOUT ISSUE. THE LESION WAS RE-WIRED WITH A DIFFERENT WIRE AND A NEW XIENCE WAS SUCCESSFULLY DEPLOYED. THERE WERE NO REPORTED 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 18914630 ↗
• InjuryApr 26, 2022Adverse 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 10/02/2020 TO TREAT A LESION IN THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY. A 2.75 X 15 MM XIENCE SIERRA STENT AND A 2.5 X 28 MM XIENCE SIERRA STENT WERE IMPLANTED. ON 04/04/2022, THE PATIENT WAS RE-HOSPITALIZED WITH SHORTNESS OF BREATH AND LOWER EXTREMITY EDEMA. CORONARY CATHETERIZATION WAS PERFORMED AND NOTED 80% IN-STENT RESTENOSIS IN THE PROXIMAL AND MID LAD, IN THE 2.5 X 28 MM XIENCE SIERRA STENT AND A PREVIOUSLY IMPLANTED UNSPECIFIED STENT, AND 90% STENOSIS IN THE CIRCUMFLEX (CX) ARTERY. ANGIOPLASTY WAS PERFORMED TO TREAT THE IN-STENT RESTENOSIS IN THE 2.5 X 28 MM XIENCE SIERRA STENT. THE EVENT RESOLVED ON (B)(6) 2022. A STAGED PROCEDURE WILL BE PERFORMED AT A LATER DATE TO TREAT THE CX ARTERY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Dyspnea; Stenosis; Swelling/ Edema

  MAUDE report 14212378 ↗
• InjuryMay 25, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 2.50X28MM XIENCE SIERRA STENT WAS IMPLANTED ON (B)(6) 2021. THE PATIENT PRESENTED WITH CHRONIC ATRIAL FIBRILLATION BEFORE THE PROCEDURE. ON (B)(6) 2021, THE PATIENT WAS READMITTED WITH CARDIOVASCULAR SYMPTOMS INCLUDING ATHEROSCLEROTIC HEART DISEASE. TREATMENT UPON RE-ADMISSION WAS REPORTED AS MEDICAL INTERVENTION AND THE FINAL PATIENT OUTCOME IS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Arteriosclerosis/ Atherosclerosis

  MAUDE report 11881067 ↗
• 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 10814026 ↗
• InjuryOct 19, 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. THE 2.5 X 28 MM XIENCE SIERRA STENT WAS IMPLANTED AT 12 ATMOSPHERES. APPROXIMATELY 20 MONTHS POST STENTING PROCEDURE, ON (B)(6) 2020, THE PATIENT EXPERIENCED SHORTNESS OF BREATH AND FATIGUE. THE PATIENT WAS ADMITTED FOR A CORONARY PROCEDURE AND IN-STENT RESTENOSIS WAS NOTED IN THE OBTUSE MARGINAL ARTERY. A SCULPTING BALLOON WAS USED. THE EVENT RESOLVED WITHOUT SEQUELA AND THE PATIENT WAS DISCHARGED HOME THE SAME DAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Dyspnea; Fatigue; Stenosis

  MAUDE report 10702308 ↗
• MalfunctionJul 30, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN UNSPECIFIED LESION. A 2.50X28 XIENCE SIERRA STENT IMPLANT DISLODGED WHILE BEING ADVANCED. THE STENT IMPLANT REMAINED ON THE DELIVERY SYSTEM AND WAS ABLE TO BE SIMPLY REMOVED. THERE WAS NO RESISTANCE NOTED WHILE ADVANCING THE 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 10344062 ↗
• InjuryJul 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) 2020 ONE 2.5X28 MM XIENCE SIERRA STENT WAS IMPLANTED IN THE PROXIMAL LEFT ANTERIOR DESCENDING CORONARY ARTERY (LAD). ON (B)(6) 2020 THE PATIENT HAD CARDIAC SYMPTOMS AND RESTENOSIS. AN ADDITIONAL STENT WAS IMPLANTED FOR TREATMENT AND WAS PLACED AT THE OSTIAL LAD, ADJACENT TO THE INDEX STENT. THE CONDITION RESOLVED. THE RESTENOSIS IS RELATED TO THE XIENCE STENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina; Stenosis

  MAUDE report 10267872 ↗
• 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 ST ELEVATED MYOCARDIAL INFARCTION (STEMI) THEREFORE THE 2.5X28MM XIENCE SIERRA WAS IMPLANTED. ON (B)(6) 2020 THE PATIENT WAS RE-ADMITTED DUE TO POST PROCEDURAL HEMATOMA, AND OTHER CARDIOVASCULAR SYMPTOMS. SURGICAL TREATMENT WAS PERFORMED. THE FINAL PATIENT OUTCOME IS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Hematoma

  MAUDE report 10173996 ↗
• MalfunctionJun 10, 2020Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT AN EXPIRED XIENCE SIERRA STENT WAS IMPLANTED. THERE WERE NO DEVICE ISSUES AND THERE WERE NO ADVERSE PATIENT EFFECTS. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10140589 ↗
• MalfunctionApr 8, 2020Material Separation; Failure to Advance; Material Separation; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN ECCENTRIC LESION LOCATED IN THE PROXIMAL LEFT ANTERIOR DESCENDING CORONARY ARTERY THAT WAS NON TORTUOUS. WHEN THE XIENCE SIERRA STENT DELIVERY SYSTEM (SDS) WAS BEING ADVANCED ON THE BALANCE MIDDLEWEIGHT GUIDE WIRE, THE PROXIMAL SHAFT SEPARATED OUTSIDE THE PATIENT. THE SDS DID NOT CROSS THE LESION AND ANOTHER SAME SIZE XIENCE SIERRA WAS USED TO COMPLETE THE PROCEDURE. 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 9938514 ↗
• InjuryMar 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 A XIENCE SIERRA STENT WAS IMPLANTED IN AN UNSPECIFIED CORONARY ARTERY. SINCE THE PROCEDURE THE PATIENT HAS EXPERIENCED HIVES, SWELLING IN LIPS AND HANDS. ON (B)(6) 2020, THE PATIENT VISITED THE EMERGENCY ROOM DUE TO THE ALLERGIC REACTION. BENADRYL WAS ADMINISTERED DURING THE EMERGENCY ROOM VISIT. THE PATIENT WAS NO FURTHER HOSPITALIZATION FROM THE EMERGENCY VISIT. THERE WAS NO DEVICE ISSUE REPORTED. THERE WAS NO ADDITIONAL ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 9886116 ↗
• InjuryFeb 17, 2020Adverse 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 CIRCUMFLEX ARTERY. ON (B)(6) 2019, A 2.25X12MM (DISTAL), 2.25X23MM (MIDDLE), AND 2.50X28MM (PROXIMAL) XIENCE SIERRA STENTS WERE DEPLOYED. ON (B)(6) 2020, THE PATIENT WAS RE-ADMITTED FOR IN-STENT RESTENOSIS. BALLOONING WAS PERFORMED TO TREAT THE STENOSIS; HOWEVER, WHILE BALLOONING THE 2.25X23MM IMPLANTED STENT, THE STENT FRACTURED. A 2.5X15MM NON-ABBOTT STENT WAS DEPLOYED TO TREAT THE FRACTURE, BUT THIS CAUSED A PERFORATION. A SECOND NON-ABBOTT STENT WAS USED TO SUCCESSFULLY TREAT THE PERFORATION. THERE WERE NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Stenosis

  MAUDE report 9717909 ↗
• MalfunctionFeb 17, 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 LESION WITH MODERATE CALCIFICATION AND MODERATE TORTUOSITY IN THE CIRCUMFLEX CORONARY ARTERY. THE 2.5 X 28 MM XIENCE SIERRA STENT DELIVERY SYSTEM (SDS) WAS ADVANCED BUT COULD NOT CROSS THE LESION DUE TO A SHARP TAKE OFF IN THE ARTERY. WHEN THE SDS WAS BEING REMOVED, RESISTANCE WAS FELT WITH THE GUIDING CATHETER. THEREFORE, BOTH DEVICES WERE REMOVED TOGETHER. OUTSIDE THE PATIENT ANATOMY, IT WAS NOTICED THAT THE PROXIMAL STENTS WERE FLARED. A NEW GUIDING CATHETER AND NEW SDS WERE USED TO COMPLETED 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 9716697 ↗
• MalfunctionJan 9, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT THE SHAFT OF A 2.5X28MM XIENCE SIERRA STENT DELIVERY SYSTEM (SDS) SEPARATED DURING PREPARATION. THE DEVICE WAS NOT USED AND THERE WAS NO PATIENT INVOLVEMENT. AN UNSPECIFIED 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 Patient Involvement

  MAUDE report 9571822 ↗
• DeathDec 16, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBSEQUENT TO THE PREVIOUSLY FILED REPORT, THE FOLLOWING INFORMATION WAS PROVIDED: IN THE PHYSICIAN¿S OPINION, THE XIENCE SIERRA DID NOT CAUSE OR CONTRIBUTE TO THE DEATH, AND THE PATIENT DIED DUE TO CARDIOGENIC SHOCK. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Low Blood Pressure/ Hypotension; Thrombosis

  MAUDE report 9476778 ↗
• InjuryDec 13, 2019Adverse 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 LESION IN THE MID LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY. A 2.50X28 MM XIENCE SIERRA STENT WAS IMPLANTED AND AFTER THE PATIENT LEFT THE CATH LAB, THEY EXPERIENCED CHEST PAIN. AN ANGIOGRAPHY WAS PERFORMED AND THROMBUS WAS FOUND IN THE STENT. THE AREA WAS RE-BALLOONED AND STENTED WITH ANOTHER XIENCE SIERRA STENT. THERE WERE NO DEVICE ISSUES NOTED. PATIENT IS DOING FINE NOW. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina; Thrombosis

  MAUDE report 9466832 ↗
• InjuryDec 5, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 2.5X28MM AND 2.75X18MM XIENCE SIERRA STENTS WERE IMPLANTED ON (B)(6) 2019. THE PATIENT PRESENTED WITH ST-ELEVATION MYOCARDIAL INFARCTION (STEMI) BEFORE THE PROCEDURE. ON (B)(6) 2019, THE PATIENT WAS READMITTED WITH CARDIOVASCULAR SYMPTOMS. TREATMENT PERFORMED WAS UNSPECIFIED AND THE FINAL PATIENT OUTCOME IS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 9416569 ↗
• InjurySep 6, 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, A 2.5 X 28 MM XIENCE SIERRA STENT WAS IMPLANTED IN THE 1ST OBTUSE MARGINAL ARTERY. AFTER STENT IMPLANTATION, OPTICAL COHERENCE TOMOGRAPHY NOTED INSIGNIFICANT PLAQUE SHIFT AND ADDITIONAL POST DILATATION WAS PERFORMED. POST PROCEDURE, THE PLAQUE SHIFT RESOLVED. ON (B)(6) 2019, THE PATIENT HAD COMPLAINTS OF SHORTNESS OF BREATH AND WEAKNESS. PERCUTANEOUS CORONARY INTERVENTION WAS PERFORMED AND IN-STENT RESTENOSIS WAS NOTED. ANGIOPLASTY WAS PERFORMED, USING A HIGH PRESSURE SCULPTING BALLOON. THE EVENT RESOLVED THE SAME DAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Dyspnea; Prolapse; Stenosis; Weakness

  MAUDE report 8972560 ↗
• InjurySep 4, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 2.50X28MM, 3.0X23MM, AND 2.25X38MM XIENCE SIERRA STENTS WERE IMPLANTED ON (B)(6) 2019. THE PATIENT PRESENTED WITH ST-ELEVATION MYOCARDIAL INFARCTION (STEMI) BEFORE THE PROCEDURE. ON (B)(6) 2019 THE PATIENT WAS RE-ADMITTED WITH CARDIOVASCULAR SYMPTOMS INCLUDING ATHEROSCLEROTIC HEART DISEASE. TREATMENT PERFORMED WAS UNSPECIFIED AND THE FINAL PATIENT OUTCOME IS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8960239 ↗
• MalfunctionMay 13, 2019Difficult to Insert; Material Separation; Difficult to Insert; Material Separation

  IT WAS REPORTED THAT THE 2.5X28 MM XIENCE SIERRA STENT DELIVERY SYSTEM (SDS)WAS UNABLE TO BE LOADED ON TO THE GUIDE WIRE. IT WAS THEN NOTED THAT 2 MM AT THE END OF THE SDS CATHETER HAD DETACHED. THERE WAS NO PATIENT INVOLVEMENT. ANOTHER SAME SIZE XIENCE SIERRA WAS USED TO COMPLETE THE PROCEDURE WITHOUT FURTHER INCIDENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8605116 ↗
• InjuryApr 29, 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 WAS ADMITTED WITH ST ELEVATION MYOCARDIAL INFARCTION, THROMBUS AND CARDIAC ARREST. A 2.25 X 18 MM XIENCE SIERRA STENT (8120341) AND A 2.5 X 28 MM XIENCE SIERRA STENT (8102441) WERE IMPLANTED IN THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY. SLUGGISH FLOW WAS NOTED AFTER STENT DEPLOYMENT; HOWEVER, NO ADDITIONAL INTERVENTION WAS PERFORMED. ON (B)(6) 2019, THE PATIENT EXPERIENCED VENTRICULAR TACHYCARDIA AND WAS TAKEN BACK TO THE CATH LAB. CORONARY ANGIOGRAPHY NOTED THROMBUS IN THE STENTED SEGMENT. A 2.5 X 33 MM XIENCE SIERRA STENT AND A 2.25 X 12 MM XIENCE SIERRA STENT (8090341) WERE IMPLANTED TO TREAT THE THROMBUS. POST DILATATION WAS PERFORMED USING AN UNSPECIFIED NC DILATATION CATHETER. A NON-FLOW LIMITING EDGE DISSECTION WAS NOTED AT THE 2.25 X 12 MM XIENCE SIERRA STENT. NO ADDITIONAL INTERVENTION WAS PERFORMED TO TREAT THE DISSECTION. POST PROCEDURE, THE PATIENT WAS IN STABLE CONDITION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Ischemia; Thrombosis; Ventricular Tachycardia

  MAUDE report 8561590 ↗
• InjuryFeb 27, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON 12/29/2018 A 2.50X28MM XIENCE SIERRA STENT WAS IMPLANTED. ON (B)(6)2019 THE PATIENT WAS RE-ADMITTED WITH ORTHO STATIC HYPOTENSION AND OTHER UNSPECIFIED CARDIO VASCULAR SYMPTOMS. THE TREATMENT PERFORMED AND PATIENT OUTCOME IS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Low Blood Pressure/ Hypotension

  MAUDE report 8376205 ↗
• InjuryDec 18, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2018 A XIENCE SIERRA STENT WAS IMPLANTED WITHOUT REPORTED ISSUES. ON (B)(6) 2018, THE PATIENT WAS ADMITTED FOR A CEREBRAL INFARCTION WITH HEMIPLEGIA, RIGHT DOMINANT SIDE. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THIS EVENT.

  Patient problems: Stroke/CVA

  MAUDE report 8176839 ↗
• InjuryOct 10, 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 MODERATELY CALCIFIED LEFT CIRCUMFLEX ARTERY THAT WAS 90% STENOSED. ON (B)(6) 2018, THE PATIENT PRESENTED WITH ISCHEMIA WITHOUT ANY SYMPTOMS. THEREFORE, A 2.5 X 28 MM XIENCE SIERRA STENT WAS IMPLANTED IN THE LESION. IT WAS CONFIRMED THAT THE PATIENT WAS COMPLIANT WITH DUAL ANTIPLATELET DRUG THERAPY AFTER THE PROCEDURE. THEN ON (B)(6) 2018, THE PATIENT WAS URGENTLY RE-HOSPITALIZED FOR RESPIRATORY DISTRESS AND HEART FAILURE. THEREFORE, FUROSEMIDE, NICARDIPINE AND POTASSIUM ASPARTATE WERE ADMINISTERED INTRAVENOUSLY. ADDITIONALLY, OXYGEN THERAPY (BILEVEL POSITIVE AIRWAY PRESSURE (BIPAP)) WAS PERFORMED. ON (B)(6) 2018, SPIRONOLACTONE AND FUROSEMIDE WERE ADMINISTERED ORALLY. ON (B)(6) 2018, INTRAVENOUS INJECTION OF POTASSIUM ASPARTATE WAS STOPPED. ON (B)(6) 2018, OXYGEN THERAPY WAS STOPPED. ON (B)(6) 2018, THE PATIENT RECOVERED AND WAS DISCHARGED FROM THE HOSPITAL. IT REMAINS UNKNOWN WHETHER THE STENT IS PATENT OR NOT. IT WAS REPORTED THAT THE DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE ADVERSE PATIENT EFFECTS. THERE WAS NO ADVERSE PATIENT SEQUELA REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Heart Failure; Respiratory Distress

  MAUDE report 7952346 ↗