SYNERGY MEGATRON™ H7493942824400Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08714729985709), received between Dec 27, 2021 and Nov 18, 2025 — classified as 1 death, 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Device Contaminated During Manufacture or Shipping” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryNov 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ANGINA AND IN-STENT RESTENOSIS OCCURRED. ON (B)(6) 2024, IN-STENT RESTENOSIS IN THE PROXIMAL RIGHT CORONARY ARTERY (RCA) WAS TREATED WITH A 4.00 X 24 MM SYNERGY MEGATRON EVEROLIMUS-ELUTING STENT. ON (B)(6) 2025, THE PATIENT PRESENTED TO THE HOSPITAL WITH SYMPTOMS OF RECURRENT ANGINA. AT THE TIME OF EVENT THE PATIENT WAS ON ASPIRIN AND CLOPIDOGREL, WHICH WERE CONTINUED. THE PATIENT WAS DIAGNOSED WITH CORONARY ARTERY DISEASE. CORONARY ANGIOGRAPHY REVEALED A 70% IN-STENT RESTENOSIS AT THE PROXIMAL RCA. A 70% IN STENT RESTENOSIS AT PROXIMAL RCA EXTENDING TO MID RCA DUE TO NEO INTIMAL HYPERPLASIA WAS NOTED AND WAS INITIALLY TREATED WITH A CUTTING BALLOON AND FURTHER SUCCESSFULLY TREATED WITH AN NC BALLOON AND BRACHYTHERAPY. POST REVASCULARIZATION, THE RESIDUAL STENOSIS WAS NOTED AS 30% WITH TIMI FLOW 3. THE EVENT WAS CONSIDERED AS RECOVERED/RESOLVED.

  Patient problems: Angina; Restenosis

  MAUDE report 23586223 ↗
• MalfunctionDec 27, 2022Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT FOREIGN MATTER WAS FOUND IN THE STERILE PACKAGE. UPON OPENING OF A 4.00 X 24MM SYNERGY MEGATRON DRUG-ELUTING STENT, A HAIR WAS FOUND INSIDE THE STERILE PACKAGE. THE DEVICE WAS NOT USED INSIDE THE PATIENT AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16051798 ↗
• DeathDec 27, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  EVOLVE LV XLV STUDY. IT WAS REPORTED THAT A 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 AS LOCATED IN THE MID RIGHT CORONARY ARTERY (RCA) AND WAS 16MM LONG, WITH A REFERENCE VESSEL DIAMETER OF 4MM. THE LESION WAS TREATED WITH PREDILATION AND PLACEMENT OF 4.00MM X 24MM AND 4.00MM X 28MM STUDY STENTS. FOLLOWING POST DILATATION, RESIDUAL STENOSIS WAS 0%. NON TARGET LESIONS WERE ALSO TREATED. THE RAMUS LESION WAS TREATED WITH THE PLACEMENT OF A 2.50MM X 24MM SYNERGY STENT. ON THE SAME DAY, THE SUBJECT WAS DISCHARGED ON ASPIRIN AND CLOPIDOGREL. ON (B)(6) 2021, A STAGED PROCEDURE WAS PERFORMED. THE NON TARGET LESION LOCATED IN THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY (LAD) AND MID LAD WERE TREATED USING 3.00MM X 38MM SYNERGY AND 3.50MM X 32MM SYNERGY STENTS IN AN OVERLAPPING FASHION. ON (B)(6) 2021, THE SUBJECT EXPIRED DUE TO UNKNOWN CAUSE OUTSIDE THE HOSPITAL. IN RESPONSE TO THE EVENT, NO ACTION OR DIAGNOSTICS WERE PERFORMED. IT IS UNKNOWN WHETHER AN AUTOPSY WAS PERFORMED. IT WAS FURTHER REPORTED THAT THE PATIENT PASSED AWAY AT HOME. IT WAS FURTHER REPORTED THAT

  Patient problems: Cardiac Arrest; No Clinical Signs, Symptoms or Conditions

  MAUDE report 13087787 ↗