SYNERGY MEGATRON™ H7493942820400Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 08714729985662), received between Jun 23, 2021 and Apr 29, 2025 — classified as 1 death, 3 injuries, 3 malfunctions.

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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryApr 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT RESTENOSIS OCCURRED. ON (B)(6) 2023, THE PATIENT PRESENTED WITH MYOCARDIAL INFARCTION AND WAS TREATED WITH A 4.0 MM X 20 MM SYNERGY MEGATRON DRUG ELUTING STENT (DES) IMPLANTED IN SAPHENOUS VEIN GRAFT TO OBTUSE MARGINAL ARTERY (SVG TO OM GRAFT). ON (B)(6) 2025, THE PATIENT STARTED EXPERIENCING SYMPTOMS ASSOCIATED WITH UNSTABLE ANGINA. AT THE TIME OF THE EVENT THE SUBJECT WAS ON ASPIRIN AND TICAGRELOR. CORONARY ANGIOGRAPHY REVEALED 70 TO 80% IN STENT RESTENOSIS (ISR) AT THE SVG TO OM. THE LEFT CIRCUMFLEX ARTERY AND THE 100% STENOSED LEFT MAIN WERE TREATED WITH PERCUTANEOUS CORONARY INTERVENTION AND THE SUBJECT WAS DISCHARGED. ON (B)(6) 2025, THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT WITH CHEST PAIN AND DYSPNEA FOR WHICH AMIO BOLUS AND AMIO GTT WAS GIVEN AND WAS ADMITTED TO THE HOSPITAL ON THE SAME DAY FOR FURTHER EVALUATION TREATMENT. THE PATIENT WAS DIAGNOSED WITH ACUTE MYOCARDIAL ISCHEMIA/INFARCTION. ON (B)(6) 2025, IN STENT RESTENOSIS (ISR) AT OM WAS TREATED WITH A DES. EVENT WAS CONSIDERED RESOLVED AND THE PATIENT WAS DISCHARGED. IT WAS FURTHER REPORTED THAT ON (B)(6) 2025, THE PATIENT STARTED EXPERIENCING SYMPTOMS ASSOCIATED WITH CHEST PAIN. ON (B)(6

  Patient problems: Angina; Chest Pain; Dyspnea; Myocardial Infarction; Restenosis

  MAUDE report 21930116 ↗
• MalfunctionSep 20, 2023Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 4.00 X 20MM SYNERGY MEGATRON DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, IN THE MIDDLE OF THE PROCEDURE, THE SHAFT BROKE PROXIMALLY PRIOR TO STENT DEPLOYMENT. NO PATIENT COMPLICATIONS WERE REPORTED, AND NO HARM WAS DONE TO THE PATIENT. IT WAS FURTHER REPORTED THAT THE 90% STENOSED TARGET LESION WAS LOCATED IN THE VERY TORTUOUS, CALCIFIED, AND ACUTELY ANGLED PROXIMAL RIGHT CORONARY ARTERY. THE DEVICE WAS REMOVED COMPLETELY, AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17785357 ↗
• InjurySep 20, 2023Obstruction of Flow; Obstruction of Flow

  EVOLVE_LV_CLV CLINICAL STUDY. IT WAS REPORTED THAT MYOCARDIAL INFARCTION AND IN-STENT RESTENOSIS (ISR) OCCURRED. ON (B)(6) 2021, THE SUBJECT PRESENTED WITH STABLE ANGINA AND WAS REFERRED FOR CARDIAC CATHETERIZATION. THE TARGET LESION WAS LOCATED IN THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY (LAD) WITH 80% STENOSIS AND WAS 16 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 5.3 MM AND TIMI FLOW OF 3. THE TARGET LESION WAS TREATED WITH PRE-DILATION AND PLACEMENT OF A 4.00 MM X 20 MM STUDY STENT. FOLLOWING POST-DILATION, RESIDUAL STENOSIS WAS 0% WITH TIMI FLOW OF 3. IN ADDITION, A NON-TARGET LESION LOCATED IN MID LAD EXTENDING TO DISTAL LAD WAS TREATED WITH PLACEMENT OF A 2.50 MM X 16 MM SYNERGY DRUG ELUTING STENT (DES). A SECOND NON-TARGET LESION LOCATED IN 1ST DIAGONAL ARTERY WAS TREATED WITH A 2.25 MM X 12 MM SYNERGY DES. THE SUBJECT WAS DISCHARGED ON ASPIRIN AND CLOPIDOGREL. ON (B)(6) 2023, THE SUBJECT PRESENTED IN THE EMERGENCY DEPARTMENT (ED) WITH PRESSURE-LIKE SUBSTERNAL CHEST PAIN RADIATING TO BILATERAL ARMS AND LASTING 40 MINUTES IN DURATION WITH ASSOCIATED SHORTNESS OF BREATH. THE SUBJECT TOOK NITROGLYCERINE WHICH DID NOT PROVIDE COMPLETE PAIN RELIEF AND PARAMEDICS HAD GIVEN TH

  Patient problems: Dyspnea; Myocardial Infarction; Restenosis

  MAUDE report 17780476 ↗
• MalfunctionDec 6, 2022Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THERE WAS A DIFFICULTY IN REMOVING THE DEVICE OCCURRED. A 4.00 X 20MM SYNERGY MEGATRON STENT BALLOON WAS INSERTED AND INFLATED. HOWEVER, WHEN THEY ARE PULLING THE BALLOON TWICE NEGATIVELY, THEY HAD DIFFICULTY REMOVING IT. PHYSICIAN WAS ABLE TO REMOVE THE BALLOON, THE ENTIRE STENT DEPLOYMENT SYSTEM, GUIDE CATHETER, HEMOSTASIS VALVE, AND WIRES WERE ALL PULLED OUT SIMULTANEOUSLY AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED AND PATIENT CONDITION WAS GOOD. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15925305 ↗
• InjuryOct 18, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  EVOLVE LV XLV STUDY. IT WAS REPORTED THAT OCCLUSION OCCURRED. IN (B)(6) 2021, THE SUBJECT WAS REFERRED FOR CARDIAC CATHETERIZATION AND THE INDEX PROCEDURE WAS PERFORMED. THE TARGET LESION WAS LOCATED IN SAPHENOUS VEIN GRAFT (SVG) TO LEFT CIRCUMFLEX ARTERY (LCX) WITH 80% STENOSIS AND WAS 12 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 4 MM. THE TARGET LESION WAS TREATED WITH PRE-DILATION AND PLACEMENT OF A 4.00 MM X 20 MM SYNERGY MEGATRON STUDY STENT. FOLLOWING POST-DILATATION, RESIDUAL STENOSIS WAS 0% WITH TIMI FLOW 3. A NON TARGET LESION IN THE SVG WAS TREATED WITH PLACEMENT OF A 5.00 MM X 12 MM SYNERGY STENT. THE SUBJECT WAS DISCHARGED ON ASPIRIN AND CLOPIDOGREL. IN (B)(6) 2022, THE SUBJECT WAS NOTED TO HAVE SYMPTOMS RELATING TO CORONARY ARTERY DISEASE. A WEEK LATER THE SUBJECT VISITED THE HOSPITAL WITH COMPLAINTS OF CONTINUED SYMPTOMS OF CHEST TIGHTNESS AND SHORTNESS OF BREATH WITH MINOR ACTIVITY DESPITE BEING ON A MULTIPLE ANTI-ANGINAL MEDICATION REGIMEN. CARDIAC CATHETERIZATION WAS PERFORMED WHICH REVEALED AN OCCLUDED SVG TO RAMUS AND OBTUSE MARGINAL, WITH TIMI FLOW OF 1. THE SUBJECT WAS ADVISED FOR MEDICAL TREATMENT VERSUS REDO OF BYPASS GRAFT OR PERCUTANEOUS CORONARY INTERVEN

  Patient problems: Angina; Chest Pain; Dyspnea; Obstruction/Occlusion

  MAUDE report 15621065 ↗
• DeathJan 26, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  EVOLVE LV XLV STUDY. IT WAS REPORTED THAT CARDIOGENIC SHOCK AND PATIENT DEATH OCCURRED. ON (B)(6) 2021, THE SUBJECT PRESENTED WITH STABLE ANGINA AND THE INDEX PROCEDURE WAS PERFORMED ON THE SAME DAY. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE SAPHENOUS VEIN GRAFT (SVG) TO RPDA (CASS SITE #4) AND WAS 15MM LONG. WITH A REFERENCE VESSEL DIAMETER OF 4.5MM. THE LESION WAS TREATED WITH PREDILATED AND PLACEMENT OF A 4.00 MM X 20 MM STUDY STENT. FOLLOWING POST DILATATION, RESIDUAL STENOSIS WAS 0%. ON THE SAME DAY, THE SUBJECT WAS DISCHARGED ON CLOPIDGOREL. ON (B)(6) 2021, THE SUBJECT UNDERWENT ABLATION DUE TO RECURRENT PREMATURE VENTRICULAR COMPLEXES. ON (B)(6) 2021, THE SUBJECT PRESENTED TO THE EMERGENCY DEPARTMENT ROOM (ED) WITH COMPLAINTS OF SEVERE SHORTNESS OF BREATH AT REST THAT WORSENED WITH ACTIVITY, ASSOCIATED WITH CHEST HEAVINESS, WHEEZING, AND DRY COUGH FROM PAST ONE DAY. THE SUBJECT ALSO REPORTED SLIGHT ABDOMINAL SWELLING, HEADACHE LOCATED IN THE FRONTAL AND BILATERAL SIDES, CHRONIC SACRAL PAIN DUE TO BROKEN TAIL BONE AND DESCRIBES CHEST HEAVINESS AS CENTRAL, DEEP, ACHY, AND CONSTANT FOR WHICH SHE HAD TAKEN TRAMADOL. BASED ON THE FINDINGS, THE SUBJECT WAS GIVEN DEXAMETHAS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13359338 ↗
• MalfunctionJun 23, 2021Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT BLOOD ENTERED THE DEVICE. 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 12053368 ↗