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SYNERGY™ H7493926128250Recalls & 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
1
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08714729840756), received between Dec 15, 2020 and Dec 15, 2020 — classified as 1 death.

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

  • Death1

Recent adverse event reports

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

  • DeathDec 15, 2020Material Deformation; Material Deformation

    IT WAS REPORTED THAT THE PATIENT DIED. THE PATIENT HAD ST-SEGMENT ELEVATION MYOCARDIAL INFARCTION (STEMI). FOLLOWING PRE-DILATION WITH A 2.5 X 15 EMERGE BALLOON CATHETER, A 2.50 X 28 SYNERGY DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT BUT FAILED TO CROSS THE LESION. WHEN THE DEVICE WAS REMOVED, IT WAS NOTICED THAT THE UNDEPLOYED STENT STRUTS WERE BUCKLED. THE PATIENT DIED ON THE TABLE. NO FURTHER INFORMATION WAS PROVIDED.

    Patient problems: Death

    MAUDE report 11014176 ↗

Other Coronary drug-eluting stent devices

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Sources and updates

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