XIENCE Sierra™ 1550400-33Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08717648227530), received between May 26, 2020 and Apr 8, 2024 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 8, 2024Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  SUBSEQUENTLY, AFTER THE INITIAL WAS FILED IT WAS NOTED THAT THE STENT WAS IMPLANTED IN THE MID RIGHT CORONARY ARTERY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19061029 ↗
• InjurySep 9, 2020Off-Label Use; Patient-Device Incompatibility; Off-Label Use; Patient-Device Incompatibility

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE TIBIAL ARTERY BELOW THE KNEE. AN UNSPECIFIED GUIDE WIRE WAS ADVANCED AND ATHERECTOMY WAS PERFORMED. AN UNSPECIFIED BALLOON CATHETER WAS ADVANCED AND THE LESION WAS DILATED; HOWEVER, A PERFORATION WAS NOTED. FIVE NON-ABBOTT STENTS WERE DEPLOYED AND TREATED THE PERFORATION IN THE ANTERIOR TIBIAL ARTERY. IN THE POSTERIOR TIBIAL ARTERY (PTA) FIVE XIENCE SIERRA STENTS (3.5X28MM, 3.5X38MM, 4.0X33MM, 4.0X38MM, AND 4.0X38MM) WERE DEPLOYED OVERLAPPING EACH OTHER. THREE OF THE STENTS SEALED THE AREA OF THE PERFORATION SUCCESSFULLY; HOWEVER, TWO OF THE STENTS (4.0X33MM AND 4.0X38MM) DID NOT. PROLONGED BALLOON INFLATION WAS DONE FOR 10 MINUTES AND THE PERFORATION WAS NOT SEALED AND THE PATIENT CONTINUED BLEEDING. A 4.0X19MM GRAFTMASTER COVERED STENT AND A 3.5X19MM GRAFTMASTER COVERED STENT WERE DEPLOYED ON TOP OF THE DEPLOYED 4.0X33MM AND 4.0X38MM XIENCE SIERRA STENTS TO SUCCESSFULLY TREAT THE LONG PERFORATION IN THE PTA. DUE TO THE LONG PERFORATION AND EXCESSIVE BLEEDING DURING TREATMENT THE PATIENT SUFFERED FROM COMPARTMENT SYNDROME AND WAS SENT TO SURGERY FOR A FASCIOTOMY ON THE SAME DAY. NO ADDITIONAL INFORMATION WAS

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10512234 ↗
• MalfunctionMay 26, 2020Difficult to Remove; Failure to Advance; Device Dislodged or Dislocated; Difficult to Remove; Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE PROXIMAL LEFT ANTERIOR DESCENDING CORONARY ARTERY. AFTER A FAILED ATTEMPT TO CROSS WITH THE XIENCE STENT DELIVERY SYSTEM, THERE WAS RESISTANCE DURING REMOVAL AND THE STENT CAME OFF THE SHAFT. THE STENT WAS EASILY REMOVED WITH THE GUIDE WIRE WHEN THE GUIDE WIRE WAS REMOVED. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. A NON-ABBOTT STENT WAS USED TO COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10089799 ↗