XIENCE Sierra™ 1550275-08Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08717648227158), received between Dec 19, 2019 and Apr 23, 2021 — classified as 3 injuries.

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryApr 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, THE PATIENT PRESENTED WITH A SEVERELY CALCIFIED, PROXIMAL CIRCUMFLEX (CX) CORONARY ARTERY WITH A CHRONIC TOTAL OCCLUSION AND 70% STENOSED LESION. PRE-DILATATION WAS PERFORMED AND A 2.75X8MM XIENCE SIERRA STENT (1550275-08, 8092641) WAS IMPLANTED IN THE PROXIMAL CX, WITHOUT A DEVICE ISSUE REPORTED. FOLLOWING, PRE-DILATATION WAS PERFORMED ON THE 2ND OBTUSE MARGINAL (OM) CORONARY ARTERY, 95% STENOSED LESION AND A 2.75X8MM XIENCE SIERRA STENT (1550250-08, 9020541) WAS IMPLANTED WITHOUT A DEVICE ISSUE REPORTED. ON (B)(6) 2021, THE PATIENT WAS HOSPITALIZED FOR CHEST PAIN. PER IMAGING, THE PROXIMAL CX WAS 90% STENOSED. AS TREATMENT, ANOTHER DRUG-ELUTING STENT WAS PLACED IN THE PROXIMAL CX. IN ADDITION, ANOTHER STENT WAS ALSO IMPLANTED IN THE 80% STENOSED PROXIMAL RIGHT CORONARY ARTERY LESION. PER PHYSICIAN, THERE WAS NO DEVICE MALFUNCTION AND THE EVENT WAS UNRELATED TO THE XIENCE DEVICE. THE EVENT RESOLVED WITHOUT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THIS ISSUE.

  Patient problems: Angina; Stenosis

  MAUDE report 11716780 ↗
• 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, A 2.75X08MM AND 2.75X18MM XIENCE SIERRA STENT WERE IMPLANTED WITHOUT A DEVICE ISSUE NOTED. ON (B)(6) 2020, THE PATIENT WAS ADMITTED TO THE HOSPITAL DUE TO HYPERTENSION. THE PATIENT WAS DISCHARGED HOME 4 DAYS LATER. THE DEVICE RELATIONSHIP TO THE EVENT IS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THIS ISSUE.

  Patient problems: High Blood Pressure/ Hypertension

  MAUDE report 10169438 ↗
• InjuryDec 19, 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, THE PATIENT UNDERWENT A CORONARY PROCEDURE, TREATING A TARGET LESION IN THE CIRCUMFLEX (CX) ARTERY. A 2.75 X 8 MM XIENCE SIERRA STENT WAS IMPLANTED. ON (B)(6) 2019, THE PATIENT WAS SEEN FOR A FOLLOW UP VISIT AND REPORTED ANGINA. THE PATIENT¿S IMDUR MEDICATION DOSAGE WAS INCREASED. THE PATIENT CONDITION CONTINUES. NO ADDITIONAL INTERVENTION WAS PERFORMED. ON (B)(6) 2019, THE PATIENT UNDERWENT CORONARY ANGIOGRAPHY, DUE TO ONGOING CHEST PAIN. IN-STENT RESTENOSIS WAS NOTED IN THE TARGET LESION, AS WELL AS THE LEFT MAIN ARTERY. SURGICAL CONSULT WAS OBTAINED AND THE PATIENT UNDERWENT CORONARY ARTERY BYPASS GRAFT (CABG) ON (B)(6) 2019. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina; Stenosis

  MAUDE report 9492825 ↗