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XIENCE Sierra™ 1550325-08Recalls & reported problems

Abbott Vascular Inc. · XIENCE Sierra™ Everolimus Eluting Coronary Stent System 3.25 mm x 08 mm / Rapid-Exchange · Class 3 · Implant

All models of XIENCE Sierra (56)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
3
Deaths reported
0
Injuries reported
2
Recalls naming it
0

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08717648227318), received between Sep 3, 2019 and Mar 24, 2021 — classified as 2 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

Device problems

  • Adverse Event Without Identified Device or Use Problem1
  • Difficult to Remove1
  • Improper or Incorrect Procedure or Method1
  • Unintended System Motion1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1
  • No Code Available1
  • No Consequences Or Impact To Patient1
  • No Information1

Recent adverse event reports

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

  • MalfunctionMar 24, 2021Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

    IT WAS REPORTED THAT THE PATIENT PRESENTED WITH ST-ELEVATED MYOCARDIAL INFARCTION (STEMI) AND ON (B)(6) 2021, A 3.25X08MM XIENCE SIERRA DRUG ELUTING STENT (DES) WAS KNOWINGLY IMPLANTED IN THE PATIENT, PAST THE LABELED EXPIRATION DATE OF 3/1/2021. THERE WERE NO 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 11563346 ↗
  • InjurySep 16, 2019Unintended System Motion; Difficult to Remove; Unintended System Motion; Difficult to Remove

    IT WAS REPORTED THAT THE XIENCE SIERRA STENT WAS READY TO BE DEPLOYED IN THE OSTIUM OF THE MILDLY CALCIFIED RIGHT CORONARY ARTERY (RCA). DURING INFLATION OF THE STENT DELIVERY BALLOON, THE STENT WATERMELON SEEDED INTO THE AORTA. THE STENT WAS SEEN OVER THE SHAFT OF THE GUIDING CATHETER. THE STENT WAS ABLE TO BE RETRACTED TO THE RADIAL ARTERY WITH A BALLOON DILATATION CATHETER, BUT IT GOT STUCK AT THE WRIST. THE STENT WAS SURGICALLY REMOVED. THE PATIENT IS IN STABLE CONDITION. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 9072873 ↗
  • InjurySep 3, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT ON (B)(6) 2019, A 3.25X08, 3.50X12MM, 3.50X23MM XIENCE SIERRA STENTS WERE IMPLANTED WITHOUT REPORTED ISSUES. ON (B)(6) 2019, THE PATIENT WAS RE-ADMITTED TO THE HOSPITAL FOR ATHEROSCLEROTIC HEART DISEASE AND OTHER CARDIOVASCULAR SYMPTOMS. UNSPECIFIED TREATMENT WAS PROVIDED. NO CORONARY IMAGING WAS REPORTED AND THERE WAS NO ADDITIONAL PERCUTANEOUS CORONARY INTERVENTION PERFORMED. THE PATIENT HAS BEEN DISCHARGED HOME. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THIS ISSUE.

    Patient problems: No Code Available; No Information

    MAUDE report 8956875 ↗

Other Coronary drug-eluting stent devices

All Coronary drug-eluting stent devices →

Sources and updates

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