XIENCE Sierra™ 1550400-18Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 08717648227509), received between Aug 22, 2018 and Apr 6, 2022 — classified as 14 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• InjuryApr 6, 2022Adverse 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 ELEVATION MYOCARDIAL INFARCTION (NSTEMI). A 4.0X18MM XIENCE SIERRA DRUG ELUTING STENT (DES) WAS IMPLANTED. ON (B)(6) 2021, THE PATIENT WAS RE-HOSPITALIZED WITH CHEST PAIN DUE TO A THROMBOSED STENT. MEDICAL INTERVENTION AND PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) WAS PERFORMED. THERE WAS NO ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina; Thrombosis/Thrombus

  MAUDE report 14030300 ↗
• MalfunctionFeb 21, 2022Difficult or Delayed Positioning; Difficult or Delayed Positioning

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. THE 4.0X18MM XIENCE SIERRA STENT DELIVERY SYSTEM (SDS) WAS ADVANCED AND DEPLOYED WITHOUT ISSUE; HOWEVER, THE STENT WAS NOT VISIBLE IN THE IMAGES. THERE WAS NO OTHER DEVICE USED AS THE STENT REMAINS IMPLANTED. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13569361 ↗
• MalfunctionMay 26, 2021Material Rupture; Activation Failure; Material Rupture; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY WITH MODERATE TORTUOSITY AND CALCIFICATION. THE 4.00X18 MM XIENCE SIERRA STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TO THE LESION BUT THE BALLOON WOULD NOT INFLATE AND WOULD NOT HOLD PRESSURE. THEREFORE, A NEW INFLATION DEVICE WAS USED. AGAIN THE BALLOON WOULD NOT INFLATE OR HOLD PRESSURE. INFLATION WAS ATTEMPTED 3 TIMES AT AN UNKNOWN PRESSURE. THE INFLATION DEVICE AND THE SDS WERE REPLACED. A NEW, 4.00X23 XIENCE SIERRA SDS WAS ADVANCED AND THE DEVICE WAS IMPLANTED SUCCESSFULLY. 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 11891101 ↗
• InjuryMar 15, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) THE PATIENT PRESENTED WITH NON-ST ELEVATED MYOCARDIAL INFARCTION (NSTEMI). A 4.0X18MM XIENCE SIERRA DRUG ELUTING STENT (DES) WAS IMPLANTED.ON (B)(6) 2020 THE PATIENT WAS RE-HOSPITALIZED WITH A NSTEMI. IT IS UNKNOWN WHAT TREATMENT WAS PERFORMED AND WHAT THE FINAL PATIENT OUTCOME WAS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Myocardial Infarction

  MAUDE report 11487687 ↗
• InjuryMar 2, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH A MYOCARDIAL INFARCTION. A 4.0X18MM XIENCE SIERRA STENT WAS IMPLANTED ON (B)(6) 2020. ON (B)(6) 2020, THE PATIENT WAS READMITTED WITH CARDIOVASCULAR SYMPTOMS INCLUDING A CHEST PAIN. TREATMENT PERFORMED WAS UNSPECIFIED AND THE FINAL PATIENT OUTCOME IS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina

  MAUDE report 11401988 ↗
• InjuryJan 16, 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 LESION IN THE RIGHT CORONARY ARTERY. THE PATIENT PRESENTED WITH A MYOCARDIAL INFARCTION. ON (B)(6) 2020, TWO XIENCE XPEDITION STENTS (4X38MM & 4X18MM) WERE IMPLANTED WITHOUT ISSUE. ON (B)(6) 2021 DURING THE BEGINNING OF A DIFFERENT PROCEDURE, THROMBOSIS WAS IDENTIFIED IN THE STENTS DESPITE THE PATIENT SHOWING NO SYMPTOMS. MEDICATION WAS GIVEN AS TREATMENT, AND THE PATIENT IS FINE. THERE WERE NO ADVERSE PATIENT SEQUELAE AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Thrombosis

  MAUDE report 11182623 ↗
• InjurySep 15, 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 ATHEROSCLEROTIC HEART DISEASE. A 4.0X18MM XIENCE SIERRA DRUG ELUTING STENT (DES) WAS IMPLANTED. ON (B)(6) 2020 THE PATIENT WAS RE-ADMITTED WITH HYPERTENSION AND OTHER CARDIOVASCULAR SYMPTOMS. THE REPORTED TREATMENT AND PATIENT OUTCOME IS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: High Blood Pressure/ Hypertension

  MAUDE report 10535902 ↗
• InjurySep 11, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH A NON-ST-ELEVATION MYOCARDIAL INFARCTION AND HEART BLOCK. A 4.0X18MM XIENCE SIERRA STENT WAS IMPLANTED ON (B)(6) 2020. ON (B)(6) 2020, 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 10522589 ↗
• 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 NON-ST ELEVATED MYOCARDIAL INFRACTION (NSTEMI) THEREFORE THE 4.00X18MM XIENCE SIERRA WAS IMPLANTED. ON (B)(6) 2020 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; Stenosis

  MAUDE report 9788864 ↗
• InjuryMar 3, 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 THROMBOTIC LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY RESULTING IN AN ST ELEVATED MYOCARDIAL INFARCTION (STEMI). A XIENCE SIERRA STENT WAS SUCCESSFULLY IMPLANTED, WITHOUT A DEVICE ISSUE. OCT WAS PERFORMED WITH GOOD RESULTS REPORTED. APPROXIMATELY 8.5 HOURS LATER THAT SAME DAY, THE PATIENT EXPERIENCED DYSPNEA AND CHEST PAIN. PER IMAGING, THE PATIENT HAD AN ACUTE XIENCE SIERRA THROMBUS, OCCLUDING DISTAL FLOW. ADDITIONAL MEDICATIONS WERE PROVIDED, ASPIRATION AND ANOTHER STENT WAS IMPLANTED AS TREATMENT. PER IMAGING, THERE WAS NO DEVICE ISSUE. THE PATIENT WAS PLACED ON A BALLOON PUMP FOR (HYPOTENSION) AND REMAINED IN STABLE CONDITION. REPORTEDLY, THE PATIENT REMAINED IN STABLE CONDITION AND THE BALLOON PUMP IS EXPECTED TO BE REMOVED AS THE EVENT RESOLVED. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THIS ISSUE.

  Patient problems: Angina; Dyspnea; Low Blood Pressure/ Hypotension; Thrombosis

  MAUDE report 9781272 ↗
• InjuryJan 23, 2020Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2019 THE 4.0X18 MM XIENCE SIERRA STENT WAS IMPLANTED IN THE MILDLY TORTUOUS LEFT CIRCUMFLEX CORONARY ARTERY WITHOUT INCIDENT. THE STENT WAS WELL APPOSED AND INTACT, BUT OPTICAL COHERENCE TOMOGRAPHY WAS NOT PERFORMED. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL AND WAS COMPLIANT WITH THE DUAL ANTI-PLATELET THERAPY. ON (B)(6) 2020 THE PATIENT HAD CHEST PAIN AND WAS RE-ADMITTED TO THE HOSPITAL. ANGIOGRAM FOUND IN-STENT THROMBUS IN THE 4.0X18 XIENCE SIERRA. THE PHYSICIAN REPORTED THAT THE THROMBUS WAS LIKELY CAUSED BY THE XIENCE SIERRA STENT HAVING A STENT FRACTURE, BUT A FRACTURE WAS NOT VISUALIZED. THERE WAS ALSO A HEMATOMA IN THE VESSEL. THE PATIENT DID NOT HAVE A MYOCARDIAL INFARCTION. A SECOND 4.0X18 MM XIENCE SIERRA WAS IMPLANTED INSIDE THE FIRST SIERRA. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina; Thrombosis

  MAUDE report 9624269 ↗
• MalfunctionDec 23, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE MID-LEFT ANTERIOR DESCENDING CORONARY ARTERY. THE XIENCE SIERRA WAS ADVANCED TO THE LESION AND INFLATED TO 10 ATMOSPHERES WHEN IT WAS NOTED THAT CONTRAST WAS LEAKING. THE STENT WAS DEPLOYED AND POST-DILATATION WAS PERFORMED. IT WAS DETERMINED THAT THE BALLOON RUPTURED DURING EXPANSION OF THE STENT. 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 9514072 ↗
• InjuryNov 20, 2019Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE HEAVILY CALCIFIED AND MODERATELY TORTUOUS POSTERIOR LEFT ANTERIOR DESCENDING (LAD) ARTERY. PRE-DILATATION WAS PERFORMED. THE 4.0 X 18 MM XIENCE SIERRA STENT WAS DEPLOYED. NO STENT DELIVERY SYSTEM BALLOON ISSUES WERE NOTED; HOWEVER, THE XIENCE SIERRA STENT WAS NOTED TO BE ONLY EXPANDED TO 3.3 MM. AS THE LESION DIAMETER WAS 4.2 MM, POST-DILATATION WAS PERFORMED, USING A 4.5 MM BALLOON, BUT THE STENT WAS UNABLE TO FULLY APPOSE TO THE VESSEL WALL. THE PROCEDURE ENDED WITHOUT ADDITIONAL INTERVENTION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9349427 ↗
• MalfunctionAug 7, 2019Difficult to Remove; Difficult to Advance; Material Deformation; Difficult to Remove; Difficult to Advance; Material Deformation

  IT WAS REPORTED THE PROCEDURE WAS PERFORMED TO TREAT A LESION WITH MODERATE CALCIFICATION AND TORTUOSITY IN THE LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY WITH A 4.0 X 18 MM XIENCE SIERRA STENT DELIVERY SYSTEM (SDS). THE 4.0 XIENCE SIERRA SDS WAS ADVANCED BUT MET RESISTANCE WITH THE 6FR GUIDING CATHETER. THEREFORE, IT WAS DECIDED TO REMOVE THE 4.0 XIENCE SIERRA AND RESISTANCE WAS MET AS WELL WITH THE GUIDING CATHETER DURING WITHDRAWAL. OUTSIDE THE PATIENT ANATOMY, IT WAS NOTED THAT THE PROXIMAL END STENT STRUTS WERE FLARED. A 3.5 X 8 MM XIENCE SIERRA SDS WAS ADVANCED AND ENCOUNTERED THE SAME RESISTANCE DURING ADVANCING AND WITHDRAWAL. THE PROXIMAL END STENT STRUTS WERE FLARED AS WELL. A NEW GUIDING CATHETER WAS ADVANCED AND A NEW 4.0 XIENCE SIERRA WAS ADVANCES SUCCESSFULLY TO COMPLETE THE 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 8870392 ↗
• InjuryJun 21, 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 AND (B)(6) 2019, THE PATIENT WAS RE-HOSPITALIZED FOR CHEST PAIN AND HYPERTENSIVE HEART FAILURE. TREATMENT WAS PROVIDED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina; Heart Failure

  MAUDE report 8725266 ↗
• InjuryJun 14, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 4.0X18MM XIENCE SIERRA STENT WAS 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, INCLUDING CHEST PAIN. TREATMENT PERFORMED WAS UNSPECIFIED AND THE FINAL PATIENT OUTCOME IS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina

  MAUDE report 8700757 ↗
• InjuryOct 31, 2018Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A DE NOVO, HEAVILY CALCIFIED, ECCENTRIC LESION IN THE HEAVILY TORTUOUS, PROXIMAL RIGHT CORONARY ARTERY. A 2.75X15 MM XIENCE SIERRA STENT WAS IMPLANTED AND AFTER CONFIRMATION WITH INTRAVASCULAR ULTRASOUND (IVUS), THE STENT WAS FOUND TO BE MAL-APPOSED. THERE WERE NO OTHER ISSUES NOTED WITH THE XIENCE SIERRA STENT. A 3.75X8 MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS USED FOR POST DILATATION; HOWEVER, THE BDC COULD NOT CROSS THE LESION DUE TO RESISTANCE WITH THE LESION. RESISTANCE WAS FELT WITH THE LESION DURING REMOVAL OF THE BDC. NO DAMAGE WAS NOTED TO THE NC TREK BDC. A NON-ABBOTT BDC WAS USED TO COMPLETE THE PROCEDURE AND THE XIENCE SIERRA WAS FULLY APPOSED TO THE VESSEL WALL. NO DAMAGE WAS NOTED TO THE STENT IMPLANT. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8026677 ↗
• InjuryOct 17, 2018Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED THAT A 4.0X18MM XIENCE SIERRA STENT WAS IMPLANTED IN THE RIGHT CORONARY ARTERY LESION. REPORTEDLY, POST IMPLANTATION, THE STENT ANGIOGRAPHIC APPEARANCE WAS NOT ACCEPTABLE DUE TO STENT UNDEREXPANSION. AS TREATMENT, POST-DILATATION WAS PERFORMED USING A NON-COMPLIANT BALLOON. FOLLOWING, A PROXIMAL EDGE DISSECTION WAS NOTED, TREATED WITH A 4.0X8MM XIENCE SIERRA STENT. NO FURTHER TREATMENT WAS REPORTED AND THE PROCEDURE WAS COMPLETED WITH REPORTED ACCEPTABLE RESULTS. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THIS ISSUE

  Patient problems: Intimal Dissection

  MAUDE report 7976186 ↗
• MalfunctionAug 22, 2018Unintended System Motion; Unintended System Motion

  IT WAS REPORTED THAT DURING A PROCEDURE OF THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY, DURING STENT DEPLOYMENT, THE 4.0 X 18 MM XIENCE SIERRA STENT MOVED PROXIMALLY, RESULTING IN THE STENT IMPLANTING AND MISSING THE DISTAL PORTION OF THE LESION. A DIFFERENT 4.0 X 8 MM XIENCE SIERRA STENT WAS IMPLANTED IN THE DISTAL LESION SEGMENT. EXCELLENT ANGIOGRAPHIC RESULT WAS ACHIEVED. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT OR A CLINICALLY SIGNIFICANT DELAY IN PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7806580 ↗