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SYNERGY™ H7493926112350Recalls & reported problems

Boston Scientific Corporation · Everolimus-Eluting Platinum Chromium Coronary Stent System · Class 3 · Implant

All models of SYNERGY (74)

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

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08714729840541), received between Oct 21, 2019 and Oct 21, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Deformation” (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

  • Material Deformation1

Patient problems

  • No Consequences Or Impact To Patient1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionOct 21, 2019Material Deformation; Material Deformation

    IT WAS REPORTED THAT STENT DAMAGE OCCURRED. AFTER A SYNERGY STENT WAS DEPLOYED IN THE PROXIMAL PORTION OF THE VESSEL, A 3.50X12MM SYNERGY STENT WAS ADVANCED BUT FAILED TO CROSS THE PREVIOUSLY DEPLOYED STENT. THE DEVICE WAS REMOVED AND THE STENT APPEARED TO BE DAMAGED. NO PATIENT COMPLICATIONS WERE REPORTED.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 9213614 ↗

Other Coronary drug-eluting stent devices

All Coronary drug-eluting stent devices →

Sources and updates

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