SYNERGY MEGATRON™ H7493942808450Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08714729985556), received between Mar 13, 2023 and Mar 13, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 13, 2023Break; Difficult to Remove; Break; Difficult to Remove

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE PATIENT PRESENTED WITH CORONARY ARTERY DISEASE (CAD). PERCUTANEOUS CORONARY INTERVENTION (PCI) WAS PERFORMED IN RIGHT CORONARY ARTERY. A 4.50 X 8MM SYNERGY MEGATRON DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, THE SHAFT WAS BROKEN. A 4.5 X 12 MM NC EMERGE BALLOON CATHETER WAS USED AND COMPLETED THE PROCEDURE SUCCESSFULLY. NO PATIENT COMPLICATIONS WERE REPORTED. IT WAS FURTHER REPORTED THAT THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND SEVERELY CALCIFIED OSTIAL RIGHT CORONARY ARTERY. AFTER THE 4.50 X 8MM SYNERGY MEGATRON DRUG-ELUTING STENT WAS IMPLANTED, THE BALLOON WAS DEFLATED BUT WAS NOT ABLE TO BE REMOVED EASILY FROM THE STENT. THE PHYSICIAN PULLED THE DEVICE BACK BUT THE SHAFT BROKE AT APPROXIMATELY 100 CM FROM THE HUB INSIDE THE GUIDING CATHETER. THE DISTAL PORTION OF THE DEVICE WAS REMOVED WITHOUT ANY ISSUES AND POST-DILATATION WAS PERFORMED WITH THE 4.5 X 12 MM NC EMERGE BALLOON CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16529992 ↗