SYNERGY MEGATRON™ H7493942820350Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 08714729985655), received between Jun 23, 2021 and Aug 21, 2025 — classified as 1 death, 1 injury, 6 malfunctions.

The most frequently reported specific device problem is “Break” (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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 21, 2025Break; Difficult to Remove; Break; Difficult to Remove

  IT WAS REPORTED THAT REMOVAL DIFFICULTY AND SHAFT BREAK OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND SEVERELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A 3.50 X 20MM SYNERGY MEGATRON DRUG-ELUTING STENT WAS DEPLOYED AT 16 ATMOSPHERES FOR 30 SECONDS. DURING STENT BALLOON REMOVAL, SIGNIFICANT RESISTANCE WAS ENCOUNTERED. AS FORCE WAS APPLIED TO REMOVE THE DEVICE, THE CATHETER SHAFT FRACTURED INTO TWO SEGMENTS. THE PROCEDURE WAS SUCCESSFULLY COMPLETED, AND NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22865333 ↗
• MalfunctionNov 26, 2024Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 3.50 X 20 MM SYNERGY MEGATRON DRUG-ELUTING STENT (DES) WAS SELECTED FOR TREATMENT. HOWEVER, DURING INSERTION, THE SHAFT OF THE DELIVERY SYSTEM BROKE BETWEEN THE PHYSICIAN'S FINGERS. THE PHYSICIAN WAS ABLE TO REMOVE AND RETRIEVE THE STENT BEFORE IT WAS DEPLOYED. A NEW 3.5 X 20 MM SYNERGY MEGATRON DES WAS THEN USED AND SUCCESSFULLY IMPLANTED. THE PROCEDURE WAS COMPLETED WITH ANOTHER STENT OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20783633 ↗
• DeathFeb 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCURATE IDE STUDY. IT WAS REPORTED THAT THE PATIENT DIED. ON (B)(6) 2023, THE SUBJECT WAS BROUGHT TO THE EMERGENCY DEPARTMENT WITH CHIEF COMPLAINTS OF ACUTE CHEST PRESSURE, CONFUSION WITH ALTERED MENTAL STATUS, DIZZINESS, AND NAUSEA/EMESIS. THE SUBJECT WAS DIAGNOSED WITH INFERIOR ST ELEVATION MYOCARDIAL INFARCTION. THE SUBJECT RECEIVED 324 MG ASPIRIN AS WELL AS HEPARIN BOLUS AND WAS REFERRED FOR IMMEDIATE PERCUTANEOUS CORONARY INTERVENTION (PCI). CORONARY ANGIOGRAPHY REVEALED A 99% STENOSED OSTIUM TO PROXIMAL RIGHT CORONARY ARTERY (RCA) LESION. OWING TO THE NEED FOR RCA INTERVENTION, DUE TO BRADYCARDIA, HYPOTENSION AND HEART BLOCK, THE SUBJECT WAS IMPLANTED WITH A TEMPORARY PACER. THE VESSEL WAS PRE-DILATED WITH A 1.50 MM NON-BOSTON SCIENTIFIC (BSC), 2.00 MM EMERGE, 2.50 MM EMERGE, 2.50 MM NC EMERGE, AND 3.00 MM NC EMERGE BALLOONS. HOWEVER, THERE WAS EXTENSIVE RECOIL OF THE BALLOONS. WITH EACH BALLOONING, THE SUBJECT BECAME PROFOUNDLY HYPOTENSIVE RESULTING IN CARDIOGENIC SHOCK WHICH REQUIRED IV EPINEPHRINE, LEVODOPA. THE SUBJECT ALSO BECAME PROFOUNDLY HYPOXIC AND UNRESPONSIVE WHICH REQUIRED TRANSIENT CHEST COMPRESSION. THE SUBJECT WAS INTUBATED IN THE CATH LAB, AND A NON-BSC HEART

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18695836 ↗
• MalfunctionSep 5, 2023Break; Break

  IT WAS REPORTED THAT THE SHAFT BREAK OCCURRED. A 3.50 X 20MM SYNERGY MEGATRON DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, DURING INSERTION OF THE DEVICE THE PROXIMAL SHAFT FRACTURED. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT METHOD. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED. IT WAS FURTHER REPORTED THAT THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY AND THE DEVICE BROKE AT 12-15CM FROM THE HUB.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17683675 ↗
• InjuryAug 30, 2023Obstruction of Flow; Activation Failure; Obstruction of Flow; Activation Failure

  EVOLVE LV_XLV STUDY. IT WAS REPORTED THAT STENT UNDER EXPANSION, RESTENOSIS AND INTERVENTION OCCURRED. IN (B)(6) 2021, THE SUBJECT PRESENTED WITH ANGINA, WAS REFERRED FOR CARDIAC CATHETERIZATION, AND WAS ENROLLED IN THE MEGATRON COHORT OF THE EVOLVE LV XLV STUDY. THE TARGET LESION WAS LOCATED IN MID RIGHT CORONARY ARTERY (RCA) WITH 90% STENOSIS AND WAS 16 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 4.5 MM. THE TARGET LESION WAS TREATED WITH PRE-DILATION AND PLACEMENT OF A SYNERGY MEGATRON 3.5 MM X 20 MM STENT. FOLLOWING POST-DILATATION, RESIDUAL STENOSIS WAS NOTED TO BE 5% WITH TIMI FLOW 3. ONE DAY LATER, THE SUBJECT WAS DISCHARGED ON ASPIRIN AND CLOPIDOGREL. IN (B)(6) 2022, THE SUBJECT WAS NOTED WITH MEGATRON STENT UNDER EXPANSION AND RESTENOSIS OF THE STENT AND WAS ADMITTED TO THE HOSPITAL. ANGIOGRAPHY WAS PERFORMED WHICH REVEALED SIGNIFICANT OSTIAL RCA IN-STENT RESTENOSIS (ISR), FOCAL MODERATE DISEASE IN THE POSTERIOR DESCENDING ARTERY (PDA) AND OBTUSE MARGINAL (OM) BRANCHES, AS WELL AS MODERATE DISEASE THROUGHOUT THE MID LEFT ANTERIOR DESCENDING ARTERY (LAD). SUCCESSFUL INTRAVASCULAR ULTRASOUND (IVUS) GUIDED PERCUTANEOUS CORONARY INTERVENTION (PCI) WAS PERFORMED TO THE INSTANTA

  Patient problems: Restenosis

  MAUDE report 17652578 ↗
• MalfunctionJun 30, 2022Difficult to Remove; Material Integrity Problem; Difficult to Remove; Material Integrity Problem

  IT WAS REPORTED THAT REMOVAL DIFFICULTIES AND DAMAGE OCCURRED. A 3.50 X 20MM SYNERGY MEGATRON DRUG-ELUTING STENT WAS SELECTED FOR USE IN THE PERCUTANEOUS CORONARY INTERVENTION (PCI) PROCEDURE OF THE SEVERELY TORTUOUS AND MODERATELY CALCIFIED OSTIAL CIRCUMFLEX(CX) AND LEFT MAIN(LM) ARTERY. A SYNERGY MEGATRON WAS DEPLOYED IN THE LM AND OSTIAL CX. AFTER THE STENT WAS IMPLANTED, THE PHYSICIAN ATTEMPTED TO REMOVE THE BALLOON, HOWEVER THE BALLOON WAS UNABLE TO BE REMOVED THROUGH THE GUIDE. THE BALLOON WAS INFLATED AND DEFLATED SEVERAL TIMES BUT THE BALLOON COULD NOT BE REMOVED. THE BALLOON WAS FULLY DEFLATED, THE PHYSICIAN REMOVED THE GUIDE CATHETER, GUIDEWIRE AND THE BALLOON ALL TOGETHER BY PULLING THE GUIDE CATHETER WITH IT. IT WAS NOTICED THE BALLOON LOOKED COMPRESSED IN THE MIDDLE. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14875983 ↗
• MalfunctionSep 2, 2021Failure to Advance; Material Deformation; Failure to Advance; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. A 3.50 X 20MM SYNERGY MEGATRON STENT WAS ADVANCED TO THE TARGET LESION, BUT THE STENT COULD NOT CROSS, AND THE STRUTS OF THE STENT BROKE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS RESULTED IN RELATION TO THIS EVENT AND THE PATIENT WAS STABLE FOLLOWING THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12416177 ↗
• MalfunctionJun 23, 2021Inflation Problem; Device Dislodged or Dislocated; Inflation Problem; Device Dislodged or Dislocated

  IT WAS REPORTED THAT A STENT DISLODGED INSIDE THE PATIENT. DURING A PERCUTANEOUS CORONARY INTERVENTION, WHILE INTRODUCING A 4.00 X 20MM SYNERGY MEGATRON STENT INTO THE PATIENT, BLOOD FLOW RETURNED FROM THE STENT TO THE INFLATION DEVICE. THE MEGATRON STENT WAS IN POSITION TO BE DEPLOYED, WHEN THE BLOOD SUCKED INTO THE BALLOON. THE BALLOON WAS SUSPECTED TO HAVE COME IN DAMAGED. IT WAS NOTED THAT THERE WAS NO SHAFT BREAK AND THE BALLOON WAS NOT INFLATED. THE SYNERGY WAS JUST CONNECTED TO THE INFLATION DEVICE. A 3.5 X 20MM SYNERGY MEGATRON WAS ADVANCED, BUT ONLY HALF OF THE BALLOON INFLATED AND WAS UNABLE TO DELIVER THE STENT TO THE CORONARY ARTERY. WHILE REMOVING THE 3.5 X 20MM SYNERGY MEGATRON STENT, HALF OF THE STENT WAS FLOATING WHILE STILL ATTACHED TO THE BALLOON. THE STENT CAME OFF OF THE BALLOON AND HAD TO BE IMPLANTED IN THE BRACHIAL ARTERY. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS RESULTED IN RELATION TO THIS EVENT AND THE PATIENT WAS REPORTED TO BE STABLE FOLLOWING THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12053343 ↗