XIENCE Sierra™ 1550325-38Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 08717648227387), received between Jun 26, 2018 and May 27, 2021 — classified as 6 injuries, 1 malfunction.

The most frequently reported specific device problem is “Difficult to Remove” (1 report).

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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryMay 27, 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 HAD A 3.25X38 MM AND 3.5X15MM XIENCE SIERRA STENT IMPLANTED. ON (B)(6) 2021 THE PATIENT WAS RE-HOSPITALIZED DUE TO OTHER CARDIOVASCULAR SYMPTOMS AND OTHER POSTPROCEDURAL DISTURBANCES. THE TYPE OF TREATMENT WAS BALLOON ANGIOPLASTY AND THE FINAL PATIENT OUTCOME IS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 11893762 ↗
• InjuryNov 5, 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, A 3.25 X 38 MM XIENCE SIERRA STENT WAS SUCCESSFULLY IMPLANTED IN THE MID LEFT ANTERIOR DESCENDING (LAD) ARTERY. ON (B)(6) 2020, 50-60% OCCLUSION WAS NOTED IN THE PROXIMAL TO MID LAD AND ANOTHER STENT WAS IMPLANTED OVERLAPPING THE 3.25 X 38 MM XIENCE SIERRA STENT. THERE WAS NO ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Ischemia; Stenosis

  MAUDE report 10795777 ↗
• MalfunctionMay 13, 2020Difficult to Remove; Failure to Advance; Material Deformation; Difficult to Remove; Failure to Advance; Material Deformation

  IT WAS REPORTED THAT DURING A LEFT ANTERIOR DESCENDING CORONARY ARTERY INTERVENTION, A 3.25 X 38 XIENCE SIERRA FAILED TO CROSS THE LESION. THE STENT STRUT WAS NOTED TO BE FLARED AND RESISTANCE WAS NOTED DURING REMOVAL. THERE WAS NO ADVERSE PATIENT EFFECT OR A CLINICALLY SIGNIFICANT DELAY IN PROCEDURE. A NON-ABBOTT STENT WAS IMPLANTED TO COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10053549 ↗
• InjuryMar 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 THREE XIENCE SIERRA STENTS, SIZES 3.25X38, 3.5X38, AND 4.0X38 MM, WERE IMPLANTED IN THE DISTAL RIGHT CORONARY ARTERY (DIST RCA). WHEN THE MOST DISTAL STENT, THE 3.25X38, WAS IMPLANTED, OCCLUSION/ PLAQUE SHIFT OCCURRED INTO THE RIGHT POSTERIOR DESCENDING CORONARY ARTERY. THIS WAS TREATED WITH BALLOON ANGIOPLASTY WITH A 2.0 MM BALLOON DILATATION CATHETER ADVANCED THROUGH THE 3.25 STENT STRUTS. THE CONDITION RESOLVED. THERE WAS NO ADVERSE SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Cardiac Enzyme Elevation; Occlusion; Prolapse

  MAUDE report 9785776 ↗
• InjuryJun 14, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 3.25X38MM AND 3.5X18MM 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 UNSTABLE ANGINA. TREATMENT PERFORMED WAS UNSPECIFIED AND THE FINAL PATIENT OUTCOME IS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina

  MAUDE report 8700389 ↗
• InjurySep 5, 2018Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED THAT THIS WAS A PERCUTANEOUS INTERVENTION TREATING A MID LEFT ANTERIOR DESCENDING (LAD), SEVERELY CALCIFIED LONG LESION WITH HEAVY PLAQUE BURDEN. A 3.5X38MM XIENCE SIERRA STENT WAS IMPLANTED WITHOUT ISSUE WHEN PROLAPSED MATERIAL WAS OBSERVED THROUGH THE IMPLANTED STENT STRUTS, RESULTING IN POOR WALL APPOSITION. THERE WAS NO THROMBUS BUT RATHER PLAQUE WITHOUT ANY EMBOLIZATION NOTED. AS TREATMENT BALLOON ANGIOPLASTY WAS PERFORMED AND ANOTHER STENT WAS IMPLANTED. THIS RESOLVED THE ISSUE AND THE PATIENT REMAINED IN STABLE CONDITION. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THIS ISSUE.

  Patient problems: Prolapse

  MAUDE report 7846587 ↗
• InjuryJun 26, 2018Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2018, THE PATIENT PRESENTED WITH CHEST PAIN. THROMBOTIC OCCLUSION WAS CONFIRMED IN THE HEAVILY CALCIFIED PROXIMAL RIGHT CORONARY ARTERY (RCA). A 3.25 X 38MM XIENCE SIERRA STENT WAS DEPLOYED AT 12 ATMOSPHERES (ATM). POST-DILATATION WAS PERFORMED WITH A 3.5 X 15MM BALLOON AT 14 ATM. FLOW WAS IMPROVED TO TIMI 3, AND CHEST PAIN WAS IMPROVED. NO STENT MALAPPOSITION WAS CONFIRMED BY INTRAVASCULAR ULTRASOUND (IVUS). IN THE MORNING OF (B)(6) 2018, PAROXYSMS OF CHEST PAIN OCCURRED, AND CREATINE KINASE (CK) VALUE WAS INCREASED. IN-STENT THROMBOSIS WAS CONFIRMED BY ANGIOGRAPHY. THROMBUS ASPIRATION WAS PERFORMED FOLLOWED BY ANGIOPLASTY WITH A 3.5 X 12MM BALLOON; HOWEVER, THROMBUS REMAINED. A 3.5X20MM PERFUSION BALLOON WAS INFLATED FOR 10 MINUTES AND THE THROMBUS VANISHED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina; Cardiac Enzyme Elevation; Thrombosis

  MAUDE report 7639875 ↗