SYNERGY MEGATRON™ H7493942808500Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08714729985563), received between Nov 23, 2022 and Jan 12, 2024 — classified as 1 death, 1 injury, 2 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryJan 12, 2024Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED WITH UNRETRIEVED DEVICE FRAGMENT. THE TARGET LESION WAS LOCATED IN THE LEFT MAIN. A 5.00 X 8MM SYNERGY MEGATRON DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT, DURING DEFLATION OF THE BALLOON, THE STENT STRUTS WERE CAUGHT AND THE SHAFT WAS BROKEN. THE DISTAL END OF THE SHAFT WAS LEFT INSIDE THE PATIENT AND THE PHYSICIAN NEEDED TO TRAP THE BROKEN PIECES. THE GUIDE CATHETER WAS REMOVED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 18502659 ↗
• DeathSep 15, 2023Break; Difficult to Remove; Failure to Deflate; Break; Difficult to Remove; Failure to Deflate

  IT WAS REPORTED THAT THE REMOVAL DIFFICULTIES AND SHAFT BREAK OCCURRED; AND THE PATIENT DIED. THE PATIENT PRESENTED WITH SEVERE AORTIC STENOSIS (AS) AND WAS SENT TO CATHETERIZATION LAB AS ST ELEVATION MYOCARDIAL INFARCTION. VASCULAR ACCESS WAS OBTAINED VIA RIGHT RADIAL ACCESS. THE 90% OCCLUDED TARGET LESION WAS LOCATED IN THE MODERATELY CALCIFIED AND NON-TORTUOUS OSTIAL LEFT MAIN (LM) ARTERY. A 6F JL 3.5 GUIDE WITH SIDE HOLES TOGETHER WITH A .014 NON- BOSTON SCIENTIFIC (BSC) GUIDEWIRE WAS ADVANCED FOR TREATMENT. THE LESION WAS DIRECTLY STENTED WITH A 5.00 X 8 MEGATRON DRUG ELUTING STENT AT THE OSTIUM OF THE LM. WHEN ATTEMPTING TO REMOVE THE BALLOON OF THE STENT DELIVERY SYSTEM (SDS), THE SDS BECAME STUCK IN THE STENT IN LM AND THE DISTAL SHAFT WAS SEPARATED. THE PROXIMAL SHAFT OF THE SDS WAS REMOVED BUT THE DISTAL PART REMAINED IN THE PATIENT. THE PHYSICIAN ATTEMPTED TO PULL NEGATIVE ON THE BALLOON MULTIPLE TIMES WITHOUT SUCCESS AND ALSO ATTEMPTED TO INFLATE AND THEN DEFLATE THE BALLOON WITH GENTLE PULL BACK OF THE SDS; HOWEVER, THESE WERE UNSUCCESSFUL. PHYSICIAN ATTEMPTED TO IMPLANT MECHANICAL CIRCULATORY SUPPORT (MCS), BUT DUE TO SEVERE AS IT COULD NOT BE COMPLETED. THE PATIENT T

  Patient problems: Foreign Body In Patient

  MAUDE report 17760383 ↗
• MalfunctionJan 11, 2023Difficult to Remove; Failure to Deflate; Difficult to Remove; Failure to Deflate

  IT WAS REPORTED THAT REMOVAL DIFFICULTIES AND BALLOON DEFLATION FAILURE OCCURRED. THE CHRONIC TOTALLY OCCLUDED TARGET LESION WAS LOCATED IN THE LEFT MAIN ARTERY. A 5.00 X 8MM SYNERGY MEGATRON DRUG-ELUTING STENT (DES) AND A 5.00X16 SYNERGY MEGATRON DES WERE DEPLOYED FOR TREATMENT. HOWEVER, IT WAS NOTED THAT THE STENT BALLOONS WERE STICKY AND STUCK IN THE LESION WHERE THE STENTS WERE IMPLANTED. IT WAS ALSO NOTED THAT THE BALLOONS WERE NOT DEFLATING PROPERLY AND ONE OF THE BALLOONS GOT STUCK AND COULD NOT PASS THROUGH THE GUIDE CATHETER. THE PHYSICIAN HAD TO PULL NEGATIVE AND DEFLATE THE BALLOONS MULTIPLE TIMES AND HAD TO TAKE THE BALLOONS AND GUIDE CATHETER SYSTEM OUT, AS A WHOLE UNIT. BOTH STENTS WERE IMPLANTED INTO THE PATIENT AND THE PROCEDURE WAS COMPLETED. NO HARM WAS CAUSED TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16137341 ↗
• MalfunctionNov 23, 2022Difficult to Remove; Failure to Deflate; Difficult to Remove; Failure to Deflate

  IT WAS REPORTED THAT BALLOON DEFLATION ISSUES OCCURRED. THE TARGET LESION WAS LOCATED IN A NON- TORTUOUS AND MODERATELY CALCIFIED LEFT MAIN CORONARY ARTERY. A 5.00 X 8MM MEGATRON DRUG-ELUTING STENT WAS SELECTED TO USE BUT DURING NSTEMI, THERE WAS EXTREME DIFFICULTY REMOVING THE STENT AND IT WAS NOTED THAT THERE WAS AN UNCOMFORTABLE AMOUNT OF TIME REQUIRED TO DEFLATE THE BALLOON. DURING BALLOON DEFLATION, THE PATIENT WAS STABLE AND DID NOT FEEL ANY SYMPTOMS. WHEN THE BALLOON WAS ABOUT TO BE REMOVED, IT GOT STUCK IN THE 6F CLS 3.5 GUIDE CATHETER. EVENTUALLY, THE WHOLE GUIDE SYSTEM AND STENT DELIVERY HAD TO BE REMOVED AS A UNIT. THE STENT WAS DEPLOYED AT 18 ATMOSPHERES (ATM) AND THE BALLOON WAS RE-INFLATED TO 20 ATMOSPHERES (ATM). THE PROCEDURE WAS COMPLETED WITH THIS DEVICE AND NO PATIENT COMPLICATIONS NOR INJURIES REPORTED. IT WAS FURTHER REPORTED THAT THERE WAS NO DIFFICULTY ADVANCING THE DEVICE OVER THE WIRE THROUGH THE 6F RUNWAY GUIDE CATHETER. THE STENT WAS DEPLOYED WITH NO ISSUE USING TWO INFLATIONS WITH AN ENCORE INFLATION DEVICE, THE FIRST AT 18 ATM AND THE SECOND AT 20 ATM FOR 10 SECONDS. THE STENT WAS FULLY DEPLOYED WITH NO ISSUES AND REMAINED IN THE LESION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15852138 ↗