XIENCE Sierra™ 1550400-28Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 08717648227523), received between Sep 21, 2018 and Jan 16, 2023 — classified as 11 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (2 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 16, 2023Difficult 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 75% STENOSED DE NOVO LESION IN THE PROXIMAL RIGHT CORONARY ARTERY (PRCA) WITH HEAVY CALCIFICATION AND MODERATE TORTUOSITY. THE 4.00X28MM XIENCE SIERRA STENT DELIVERY SYSTEM (SDS) WAS ATTEMPTED TO BE ADVANCED TO THE TARGET LESION; HOWEVER, FAILED TO CROSS DUE TO THE ANATOMY. THEREFORE THE SDS WAS REMOVED WITH DIFFICULTY ALSO DUE TO THE ANATOMY AND THE STENT STRUT WAS NOTED TO BE FLARED. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16174187 ↗
• InjuryMar 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE 4.0X28MM XIENCE SIERRA STENT WAS IMPLANTED IN THE LEFT ANTERIOR DESCENDING ON (B)(6) 2019, TO TREAT A ST-ELEVATION MYOCARDIAL INFARCTION STEMI. SOON AFTER THE PROCEDURE, SOMETIME IN (B)(6) 2019, (DATE NOT PROVIDED), THE PATIENT WAS RE-HOSPITALIZED WITH STRONG HEART PALPITATIONS, NO TREATMENT WAS PERFORMED. THE PATIENT CONTINUED WITH PALPITATIONS AND CONTINUED TO RETURN TO THE HOSPITAL 7-8 TIMES. NO TREATMENT WAS PERFORMED. BERLINTA WAS CONTINUED TO BE TAKEN FOR MORE THAN TWO YEARS AFTER THE PROCEDURE. A CARDIAC CATHETERIZATION WAS PERFORMED ABOUT A YEAR AGO; THE STENT APPEARED CLEAR, WITH NO OBSTRUCTION. THE PATIENT OBTAINED A SECOND OPINION WITH A NEW CARDIOLOGIST. THE CARDIOLOGIST INSTRUCTED THE PATIENT TO STOP TAKING BERLINTA AND TO TAKE ASPIRIN. RECENTLY THE PATIENT HAD A RIGHT FOOT WOUND IN WHICH SURGICAL TAPE WAS USED. THE TAPE CAUSED A SECOND-DEGREE BURN TO THE FOOT. AN ALLERGY TEST WAS PERFORMED. THE RESULTS CAME BACK THE PATIENT IS ALLERGIC TO NICKEL SULFATE HEXAHYDRATE, POTASSIUM DICHROMATE, AND CHROME/CHROMIUM METAL. THE PATIENT IS CONCERNED THAT THE PALPITATIONS HE HAS BEEN EXPERIENCING HAVE BEEN DUE TO THE SIERRA STENT, BECAUSE HE IS ALLERGIC TO CHR

  Patient problems: Arrhythmia; Hypersensitivity/Allergic reaction

  MAUDE report 13930326 ↗
• InjuryAug 31, 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). A 4X28MM XIENCE SIERRA STENT WAS IMPLANTED. ON (B)(6) 2021 THE PATIENT WAS RE-HOSPITALIZED WITH CHEST PAIN. IT IS UNKNOWN WHAT TREATMENT WAS PERFORMED AND WHAT THE FINAL PATIENT OUTCOME WAS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina

  MAUDE report 12402987 ↗
• 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 HAD A XIENCE SIERRA STENT IMPLANTED. ON (B)(6) 2020, THE PATIENT WAS RE-HOSPITALIZED WITH HYPOTENSION AND OTHER CARDIOVASCULAR SYMPTOMS. THE FINAL PATIENT OUTCOME IS REPORTED AS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Low Blood Pressure/ Hypotension

  MAUDE report 10954052 ↗
• InjurySep 14, 2020Failure to Advance; Failure to Advance

  IT WAS REPORTED THAT DURING A HEAVILY CALCIFIED RIGHT CORONARY ARTERY INTERVENTION, THE 4.0 X 28 MM XIENCE SIERRA STENT DELIVERY SYSTEM WAS ADVANCED INTO THE PATIENT ANATOMY; HOWEVER, DUE TO THE PATIENT ANATOMY, THE DEVICE WAS UNABLE TO CROSS TO THE TARGET LESION. THE DEVICE WAS REMOVED WITHOUT RESISTANCE AND ANGIOGRAPHY NOTED A DISSECTION, PRESUMED TO BE CAUSED DURING THE XIENCE SIERRA FAILURE TO CROSS. THE PHYSICIAN IMPLANTED A 4.0 X 33 MM XIENCE SIERRA STENT TO TREAT THE DISSECTION AND THE TARGET LESION. INTRAVASCULAR ULTRASOUND (IVUS) NOTED THAT THE DISSECTION WAS SEALED AND THE TARGET LESION WAS FULLY TREATED. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Intimal Dissection

  MAUDE report 10532684 ↗
• MalfunctionAug 19, 2020Inflation Problem; Material Rupture; Inflation Problem; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE MID LEFT ANTERIOR DESCENDING CORONARY ARTERY. A 4X28MM XIENCE SIERRA STENT DELIVERY SYSTEM (SDS) WAS ADVANCED WITHOUT RESISTANCE. HOWEVER, DURING INFLATION, A LEAK WAS NOTED FROM THE STENT BALLOON. THE BALLOON PARTIALLY INFLATED ENOUGH FOR THE STENT TO DEPLOY AT THE INTENDED SITE. STANDARD POST-DILATATION WAS PERFORMED, AND A 3.5X33MM XIENCE SIERRA STENT, WHICH WAS PLANNED PRIOR, 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 Consequences Or Impact To Patient

  MAUDE report 10425483 ↗
• InjuryMar 24, 2020Inflation Problem; Leak/Splash; Material Rupture; Difficult to Advance; Material Deformation; Inflation Problem; Leak/Splash; Material Rupture; Difficult to Advance; Material Deformation

  SUBSEQUENT TO FILING THE INITIAL REPORT, THE FOLLOWING ADDITIONAL INFORMATION WAS RECEIVED: THE LEAK CAME FROM THE BALLOON. RESISTANCE WAS NOTED DURING ADVANCEMENT OVER A NON-ABBOTT GUIDE WIRE DUE TO A KINK IN THE PROXIMAL END OF THE GUIDE WIRE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9871386 ↗
• 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 THROMBOSIS DUE TO CARDIAC PROSTHETIC DEVICE THEREFORE THE 4.00X28MM XIENCE SIERRA WAS IMPLANTED. ON (B)(6) 2019 THE PATIENT WAS RE-ADMITTED WITH OTHER CARDIOVASCULAR SYMPTOMS AND VASCULAR DISORDER OF INTESTINE. SURGERY WAS PERFORMED AND THE FINAL PATIENT OUTCOME IS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 9786770 ↗
• 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 A ST ELEVATED MYOCARDIAL INFARCTION (STEMI) THEREFORE THE 4.00X28M XIENCE SIERRA WAS IMPLANTED. ON (B)(6) 2019 THE PATIENT WAS RE-ADMITTED WITH OTHER CARDIOVASCULAR SYMPTOMS AND PULMONARY EMBOLISM. IT IS UNKNOWN WHAT TREATMENT WAS PERFORMED AND THE FINAL PATIENT OUTCOME IS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Pulmonary Embolism

  MAUDE report 9786669 ↗
• InjuryDec 5, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT ID: (B)(6). IT WAS REPORTED THAT THE 4.0X28 MM XIENCE SIERRA STENT WAS IMPLANTED IN THE PROXIMAL LEFT ANTERIOR DESCENDING CORONARY ARTERY. POST DILATATION OF THE STENT WAS PERFORMED. OPTICAL COHERENCE TOMOGRAPHY THEN FOUND A DISSECTION. A 4.0X12 MM XIENCE SIERRA STENT WAS IMPLANTED TO TREAT THE DISSECTION. THE CONDITION RESOLVED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Intimal Dissection

  MAUDE report 9418865 ↗
• InjuryJun 21, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 4.0 X 28MM XIENCE SIERRA STENTS WERE IMPLANTED ON (B)(6) 2019. ON (B)(6) 2019, THE PATIENT WAS RE-ADMITTED WITH POSTHEMORRHAGIC ANEMIA AND OTHER UNSPECIFIED CARDIO VASCULAR SYMPTOMS. 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 8724427 ↗
• InjuryDec 20, 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 4.0X28MM XIENCE SIERRA STENT WAS IMPLANTED WITHOUT REPORTED ISSUES. ON (B)(6) 2018, THE PATIENT WAS ADMITTED FOR GASTRITIS AND OTHER CARDIOVASCULAR SYMPTOMS. ENDOSCOPY AND PERCUTANEOUS DILATION OF THE SUPERIOR MESENTERIC ARTERY WAS PERFORMED. ON (B)(6) 2018, THE PATIENT WAS ADMITTED FOR GASTRITIS AND CHRONIC VASCULAR DISORDER OF THE INTESTINE. THE RELATIONSHIP TO THE DEVICE WAS NOT PROVIDED. NO ADDITIONAL INFORMATION WAS AVAILABLE REGARDING THIS EVENT.

  Patient problems: No Information

  MAUDE report 8187393 ↗
• InjurySep 21, 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 MILDLY TORTUOUS, NON-CALCIFIED DE NOVO LESION THAT WAS IN THE PROXIMAL RIGHT CORONARY ARTERY THAT WAS 100% STENOSED. THE PATIENT PRESENTED WITH ACUTE MYOCARDIAL INFARCTION (MI) AND CORONARY SYNDROME BEFORE THE PROCEDURE. ADDITIONALLY, PRESENCE OF THROMBUS WAS CONFIRMED ON INTRAVASCULAR ULTRASOUND (IVUS) PRIOR TO STENTING. ON (B)(6) 2018, FOLLOWING PLACEMENT OF A NON-ABBOTT EMBOLIC PROTECTION FILTER AND PRE-DILATATION WITH 2.0X15 MM NON-ABBOTT BALLOON AT 10 ATMOSPHERES (ATM) FOR 13 SECONDS; A 4.0X28 MM XIENCE SIERRA WAS DEPLOYED AT THE LESION AFTER THREE INFLATIONS AT 12 ATM FOR 10 SECONDS FOR EACH INFLATION. THE NON-ABBOTT EMBOLIC PROTECTION FILTER WAS RETRACTED AND IVUS WAS PERFORMED SHOWING NO ISSUES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED THEN. HOWEVER, ELECTROCARDIOGRAM VARIATION AND HYPOTENSION WERE NOTED. ANGIOGRAPHY REVEALED ACUTE IN-STENT THROMBOSIS AT THE LESION. THROMBUS ASPIRATION WAS PERFORMED AND THE PATIENT WAS TREATED WITH CONTINUOUS INFUSION OF NOVASTAN, INTRA-AORTIC BALLOON PUMPING, AND RE-ADMINISTRATION OF EFIENT. ON (B)(6) 2018, AN ANGIOGRAPH INDICATED THROMBUS AGAIN AND HIGH-PRESSURE DILATATION WAS PERFORMED TH

  Patient problems: Low Blood Pressure/ Hypotension; Non specific EKG/ECG Changes; Thrombosis

  MAUDE report 7899446 ↗