SYNERGY MEGATRON™ H7493942820450Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08714729985679), received between May 5, 2021 and May 16, 2023 — classified as 2 injuries.

The most frequently reported specific device problem is “Break” (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.

• InjuryMay 16, 2023Break; Entrapment of Device; Material Deformation; Break; Entrapment of Device; Material Deformation

  IT WAS REPORTED THAT DEVICE ENTRAPMENT, SHAFT BREAK, AND STENT DAMAGE OCCURRED. THE PATIENT WAS BEING TREATED FOR CORONARY ARTERY DISEASE IN THE LEFT MAIN ARTERY LESION USING IMPELLA SUPPORT. FOLLOWING DEPLOYMENT OF A 4.50 X 20MM SYNERGY MEGATRON DRUG-ELUTING STENT, THE STENT BALLOON WAS WITHDRAWN BUT IT COULD NOT BE REMOVED FROM THE GUIDE CATHETER AND WOULD NOT MOVE. BALLOON ADVANCEMENT WAS ATTEMPTED AND TO RE-INFLATE, BUT ADVANCEMENT WAS NOT POSSIBLE. NO DEVICES WERE ABLE TO MOVE PAST THE BALLOON THAT WAS STUCK IN THE GUIDE CATHETER, AN ATTEMPT TO PULL WAS DONE AND THE BALLOON SHAFT BROKE OFF OF THE DELIVERY SYSTEM. THE BROKEN SHAFT AND BALLOON WERE RETRIEVED AFTER MANY HOURS TRYING TO USE A SNARE. FOLLOWING REMOVAL, IT WAS NOTED THAT THE STENT WAS STILL ATTACHED TO THE BALLOON BUT WAS MANGLED AND DEFORMED. THE PROCEDURE WAS COMPLETED WITH A SYNERGY XD DRUG-ELUTING STENT AND THE PATIENT WAS FULLY RECOVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16940285 ↗
• InjuryMay 5, 2021Break; Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem; Break; Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE STENT MOVED ON THE BALLOON AND A SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN A RE-STENOSED PREVIOUSLY PLACED STENT LOCATED IN THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY (LAD) INTO THE LEFT MEAN. THE 4.50 X 20MM SYNERGY MEGATRON STENT WAS SELECTED FOR TREATMENT. A 7 FRENCH GUIDE CATHETER AND A GUIDEWIRE WAS ADVANCED THROUGH THE LAD AND ANOTHER GUIDEWIRE WAS PLACED IN THE CIRCUMFLEX ARTERY. THE RE-STENOSED STENT WAS EXPANDED AND A SYNERGY XD 3.5 X 20 AND A SYNERGY XD 3.0 X 20 WAS ADVANCED THROUGH THE PREVIOUSLY PLACED STENT WITHOUT STENT INTERACTION. WHEN ATTEMPTING TO STENT FROM THE OSTIUM OF THE CIRCUMFLEX BACK INTO THE LEFT MAIN. THE 4.50 X 20MM SYNERGY MEGATRON WAS ADVANCED THROUGH THE GUIDE AND INTO THE LEFT BEING A CIRQUE AND A POP WAS HEARD. THERE WAS AN ATTEMPT TO REMOVE THE DELIVERY SYSTEM, BUT ONLY 95% OF THE STENT DELIVERY SYSTEM WAS RETRIEVED. FIVE INCHES OF THE STENT DELIVERY SYSTEM REMAINED IN THE GUIDE CATHETER IN THE LEFT MAIN. UPON REMOVAL OF THE GUIDE CATHETER, THE DETACHED PORTION OF THE SYNERGY MEGATRON DELIVERY SYSTEM WAS FLOATING IN THE AORTA. THE DETACHED PORTION WAS REMOVED WITH A SNARE. THE PROCEDURE WAS COMPLETED AND NO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11780031 ↗