SYNERGY™ H7493926108300Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08714729840473), received between Aug 20, 2018 and Oct 15, 2021 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 15, 2021Difficult to Remove; Failure to Advance; Material Deformation; Difficult to Remove; Failure to Advance; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE AND REMOVAL DIFFICULTY OCCURRED. A 3.00 X 8 SYNERGY II DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT BUT IT FAILED TO CROSS THE LESION. IT WAS NOTED THAT THE STENT WAS FRAYED AND THAT IT WAS HARD TO REMOVE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12638588 ↗
• MalfunctionAug 20, 2018Material Deformation; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. A 3.00X8MM SYNERGY DRUG-ELUTING STENT WAS SELECTED FOR USE TO TREAT THE LESION. HOWEVER, WHEN THE DEVICE WAS OUT OF THE BOX, IT WAS NOTED THAT THE STENT STRUTS WERE STICKING UP AND THE PHYSICIAN WAS NOT COMFORTABLE USING THE DEVICE. THE DEVICE NEVER INTRODUCED INTO THE PATIENT'S BODY. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 7797963 ↗