SYNERGY MEGATRON™ H7493942816450Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 08714729985631), received between Apr 28, 2022 and Oct 1, 2024 — classified as 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (3 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 1, 2024Fracture; Difficult to Advance; Fracture; Difficult to Advance

  IT WAS REPORTED THAT STENT FRACTURE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN A MILDLY TORTUOUS AND MILDLY CALCIFIED VESSEL. WHEN THE 4.50 X 16MM SYNERGY MEGATRON MR DRUG ELUTING STENT WAS INSERTED TO TREAT THE TARGET LESION, RESISTANCE WAS FELT IN THE GUIDE CATHETER. THE STENT WAS REMOVED IN ONE PIECE AND ANALYZED. THE DEVICE APPEARED FRACTURED MID STENT, SO A NEW MEGATRON WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20344485 ↗
• MalfunctionApr 11, 2023Entrapment of Device; Difficult to Remove; Entrapment of Device; Difficult to Remove

  IT WAS REPORTED THAT CATHETER ENTRAPMENT AND REMOVAL DIFFICULTIES OCCURRED. THE PATIENT WAS PRESENTED WITH CORONARY ARTERY DISEASE AND UNDERWENT PERCUTANEOUS CORONARY INTERVENTION. A 4.50 X 16MM SYNERGY MEGATRON DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. AFTER STENT DEPLOYMENT, THE STENT BALLOON WAS DEFLATED BUT REMOVAL DIFFICULTY WAS ENCOUNTERED. THE DISTAL PORTION OF THE BALLOON WAS PROLAPSED AND WAS STUCK ON THE GUIDE CATHETER DESPITE MULTIPLE NEGATIVE PRESSURE PULLS ON THE BALLOON PORT. FINALLY, THE ENTIRE SYSTEM WAS REMOVED, AND A NEW GUIDE CATHETER, GUIDEWIRE, AND BALLOON WERE REINTRODUCED FOR POST-DILATATION TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16715843 ↗
• InjuryJun 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  EVOLVE LV XLV STUDY: IT WAS REPORTED THAT RESTENOSIS OCCURRED. ON (B)(6) 2022, THE SUBJECT'S QUALIFYING CONDITION WAS STABLE ANGINA (CCS CLASSIFICATION: 1). THE SUBJECT , THE SUBJECT WAS REFERRED FOR CARDIAC CATHETERIZATION AND THE INDEX PROCEDURE WAS PERFORMED ON THE SAME DAY. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE PROXIMAL LEFT CIRCUMFLEX (LCX) AND WAS 12 MM LONG, WITH A REFERENCE VESSEL DIAMETER OF 4.5MM AND TIMI FLOW OF 3. THE LESION WAS TREATED WITH DIRECT PLACEMENT OF A 4.50 MM X 16 MM STUDY STENT. FOLLOWING POST DILATATION, RESIDUAL STENOSIS WAS 0% WITH TIMI FLOW OF 3. ON THE SAME DAY, THE SUBJECT WAS DISCHARGED ON DUAL ANTIPLATELET THERAPY. ON (B)(6) 2022, THE SUBJECT WAS NOTED WITH DYSPNEA AND INFREQUENT CHEST TIGHTNESS. THE SYMPTOMS WERE WORSENED WITH EXERTION. ON (B)(6) 2022, THE SUBJECT VISITED THE HOSPITAL FOR A PLANNED LEFT HEART CATHETERIZATION (LHC) FOR COMPLAINTS OF DYSPNEA AND CHEST PAIN ON EXERTION CONCERNING FOR CCS 3 ANGINA. SUBSEQUENTLY, LEFT CORONARY ANGIOGRAPHY WAS PERFORMED WHICH REVEALED A LUMINAL DISEASED LEFT MAIN CORONARY ARTERY (LMCA), A PATENT PROXIMAL STENT AND AN 80% STENOSED MID LEFT ANTERIOR DESCENDING ARTERY (LAD), A 20% IN STENT RESTE

  Patient problems: Angina; Dyspnea; Restenosis

  MAUDE report 14758814 ↗
• InjuryApr 29, 2022Break; Difficult to Remove; Break; Difficult to Remove

  IT WAS REPORTED THAT A SHAFT BREAK OCCURRED. A PERCUTANEOUS CORONARY INTERVENTION WAS PERFORMED ON A CALCIFIED PROXIMAL RIGHT CORONARY ARTERY (RCA). A 4.50 X 16MM SYNERGY MEGATRON WAS ADVANCED THROUGH AN 8F CONVEY GUIDE CATHETER, AND WAS DEPLOYED IN THE PROXIMAL RCA. FOLLOWING DEPLOYMENT, THE BALLOON WAS FULLY DEFLATED AND THERE WAS AN ATTEMPT TO REMOVE THE DELIVERY SYSTEM, BUT IT HAD BECOME STUCK IN THE GUIDE CATHETER. THE STENT DELIVERY SYSTEM WAS STUCK IN THE CONVEY AFTER THE STENT WAS DEPLOYED. IN AN ATTEMPT TO DISLODGE THE BALLOON, A BUDDY WIRE WAS ADVANCED, THE PHYSICIAN CUT THE SHAFT OF THE STENT CATHETER BY THE BACK OF THE HUB, AND PLACED A GUIDEZILLLA OVER THE CUT STENT SHAFT TO ATTEMPT TO SHEATH THE BALLOON, BUT WAS UNSUCCESSFUL. EVERYTHING WAS REMOVED TOGETHER FROM THE PATIENT. A NEW 8 F CONVERY GUIDE CATHETER AND MEGATRON STENT WERE USED TO COMPLETE THE PROCEDURE WITHOUT ISSUES. THE SECOND MEGATRON STENT HAD BEEN DEPLOYED DUE TO THE FIRST MEGATRON HAD MISSED THE OSTIUM PORTION OF THE ARTERY, AND A SECOND STENT WAS NEEDED TO COVER THE ENTIRE LESION. IT WAS NOTED THAT AT THE START OF THE CASE, A ROTAPRO ATHERECTOMY WAS PERFORMED. A 2.0 BURR WAS USED TO TREAT THE OSTIAL LE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14251442 ↗
• MalfunctionApr 28, 2022Break; Difficult to Remove; Adverse Event Without Identified Device or Use Problem; Break; Difficult to Remove; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A SHAFT BREAK OCCURRED. A PERCUTANEOUS CORONARY INTERVENTION (PCI) WAS PERFORMED ON AN OSTIAL LESION. A 4.50 X 16MM SYNERGY MEGATRON WAS INSERTED, BUT A MID SHAFT FRACTURE OCCURRED. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED IN RELATION TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14242568 ↗