SYNERGY MEGATRON™ H7493942816350Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 08714729985617), received between May 4, 2021 and Sep 19, 2024 — classified as 1 death, 3 injuries, 4 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.

• MalfunctionSep 19, 2024Fracture; Device Dislodged or Dislocated; Material Deformation; Fracture; Device Dislodged or Dislocated; Material Deformation

  IT WAS REPORTED THAT THE STENT MOVED ON BALLOON AND WAS FRACTURED. A 3.50 X 16MM SYNERGY MEGATRON DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT BUT UNABLE TO CROSS THE LESION. HOWEVER, DURING THE PROCEDURE, IT WAS NOTICED THAT THE STENT WAS STRETCHED ON THE SHAFT AND THE STRUTS WERE LIFTED. NO FURTHER DETAILS WERE PROVIDED IF THERE WERE PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20256048 ↗
• MalfunctionFeb 28, 2024Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT CATHETER DIFFICULTY REMOVAL OCCURRED. THE 70% STENOSED TARGET LESION WAS LOCATED IN THE NOT VERY TORTUOUS AND MODERATELY CALCIFIED LEFT CIRCUMFLEX ARTERY (LCX). A NON-BSC GUIDE WAS USED TO PREDILATE THE LESION WITH A 3 X 12MM NC EMERGE AND SUCCESSFULLY IMPLANTED A 3.50 X 16MM SYNERGY MEGATRON DRUG-ELUTING STENT. HOWEVER, DURING THE REMOVAL OF THE STENT DELIVERY SYSTEM (SDS), IT WOULD NOT COME BACK THROUGH THE GUIDE. EVERYTHING WAS SUCCESSFULLY REMOVED AFTER MULTIPLE ATTEMPTS OF INFLATING AND DEFLATING THE BALLOON AT BOTH LOW AND HIGH PRESSURES. THE PROCEDURE WAS COMPLETED WITH THE ORIGINAL DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18796619 ↗
• MalfunctionFeb 26, 2024Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE STENOSED TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY. A 3.50 X 16MM SYNERGY MEGATRON DRUG-ELUTING STENT WAS SELECTED FOR TREATMENT. HOWEVER, DURING INSERTION OF THE DEVICE OVER THE WIRE, THE DISTAL SHAFT BENT, AND BROKE. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18778253 ↗
• InjurySep 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  EVOLVE_LV_XLV CLINICAL STUDY IT WAS REPORTED THAT ANGINA RECURRED. IN (B)(6) 2021, THE SUBJECT QUALIFYING CONDITION WAS STABLE ANGINA AND THE SUBJECT WAS REFERRED FOR CARDIAC CATHETERIZATION. THE INDEX PROCEDURE WAS PERFORMED ON THE NEXT DAY. THE FIRST TARGET LESION WAS LOCATED IN THE DISTAL RIGHT CORONARY ARTERY (RCA) WITH 80% STENOSIS AND WAS 12 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 4.0 MM. THE FIRST TARGET LESION WAS TREATED WITH PRE-DILATION AND PLACEMENT OF A 3.50 MM X 16MM STENT. FOLLOWING POST-DILATION, RESIDUAL STENOSIS WAS NOTED TO BE 0% WITH TIMI FLOW 3. THE SECOND TARGET LESION WAS LOCATED IN THE MID RCA WITH 80% STENOSIS AND WAS 28 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 4.0 MM. THE SECOND TARGET LESION WAS TREATED WITH PRE-DILATION AND PLACEMENT OF A 3.50 MM X 32 MM STENT. FOLLOWING POST-DILATION, RESIDUAL STENOSIS WAS NOTED TO BE 20% WITH TIMI FLOW 3. THE SUBJECT WAS DISCHARGED ON ASPIRIN AND CLOPIDOGREL. IN (B)(6) 2023, THE SUBJECT WAS NOTED WITH SYMPTOMS OF RECURRENT CLASS III ANGINA. THE ANGINAL SYMPTOMS HAD BEEN PROGRESSIVE OVER THE PAST SEVERAL WEEKS. THE SUBJECT HAD CHEST BURNING RADIATING TO THE JAW WITH EXERTION. THE SUBJECT HAD ELEVATED BLOOD PRESSU

  Patient problems: Angina

  MAUDE report 17711726 ↗
• MalfunctionSep 30, 2022Break; Break

  IT WAS REPORTED A SHAFT BREAK OCCURRED. IN PREPARATION FOR PROCEDURE, A 3.50 X 16MM SYNERGY MEGATRON MR US WAS SELECTED FOR USE. WHEN REMOVED FROM THE HOOP, IT WAS NOTED THE SHAFT WAS NOTABLE BENT AND BROKEN. THE STENT WAS NOT USED AND WAS REPLACED TO COMPLETE THE PROCEDURE WITH NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15520367 ↗
• InjuryAug 22, 2022Break; Material Rupture; Break; Material Rupture

  IT WAS REPORTED THAT A BALLOON RUPTURE AND SHAFT FRACTURE OCCURRED. A ROTAWIRE AND ROTAPRO WERE USED FOR A HIGH COMPLEXITY CASE. THE PATIENT HAD SEVERE DISEASE TO THE NATIVE VESSELS. TREATMENT REQUIRED ATHERECTOMY WITH DIFFERENT SIZED BURRS. THE LESION WAS CROSSED WITH A 0.014 GUIDEWIRE THEN EXCHANGED FOR A ROTAFLOPPY WIRE USING A 2.0X8MM EMERGE BALLOON. ATHERECTOMY WAS PERFORMED USING A 1.5MM BURR THEN THE LEFT ANTERIOR DESCENDING ARTERY (LAD) WAS WIRED. ATHERECTOMY WAS PERFORMED WITH A 1.5MM BURR BUT THE LESION COULD NOT CROSS THE LESION. THE BURR WAS EXCHANGED FOR A 1.25MM. THE 1.25MM BURR AND WAS ABLE TO PASS THE LESION. THE LEFT CIRCUMFLEX (LCX) WAS THEN WIRED. A PERFORATION WAS OBSERVED. PATIENT BECAME UNSTABLE AND CODE BLUE WAS INITIATED AND WAS EMERGENTLY INTUBATED. BEDSIDE ECHO WAS PERFORMED WHICH REVEALED A SMALL EFFUSION. A MAMBA MICRO CATHETER AND A NON-BSC WIRE CROSSED THE LESION. PRE-DILATION WAS PERFORMED WITH A 2.5X15MM EMERGE BALLOON. IVUS PERFORMED THEN STENTING WITH A 2.5X22MM NON-BSC DRUG ELUTING STENT. IVUS WAS PERFORMED AND THE LAD WAS PRE-DILATED WITH A 2.5X15MM EMERGE BALLOON. IVUS WAS PERFORMED WITH A NON-BSC CATHETER THAT COULD NOT CROSS THE LESION IN THE

  Patient problems: Foreign Body In Patient; Low Blood Pressure/ Hypotension

  MAUDE report 15265385 ↗
• InjuryJul 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  EVOLVE LV XLV STUDY. IT WAS REPORTED THAT MYOCARDIAL INFARCTION (MI) AND IN-STENT RESTENOSIS OCCURRED. ON (B)(6) 2021, THE SUBJECT PRESENTED WITH STABLE ANGINA (CCS CLASSIFICATION: III) AND WAS REFERRED FOR CARDIAC CATHETERIZATION. THE TARGET LESION WAS LOCATED IN THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY (LAD) WITH 70% STENOSIS AND WAS 15 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 4.0 MM. THE TARGET LESION WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF A 3.50 MM X 16 MM STUDY STENT. FOLLOWING POST-DILATATION, RESIDUAL STENOSIS WAS 0% WITH TIMI FLOW 3. NON-TARGET LESIONS IN THE MID LAD EXTENDING TO THE FIRST DIAGONAL WERE TREATED WITH PLACEMENT OF 2.50 MM X 16 MM, 2.50 MM X 38 MM, 2.50 MM X 38 MM AND 3.00 MM X 48 MM SYNERGY STENTS IN THE OVERLAPPING MANNER. THE SUBJECT WAS DISCHARGED ON ASPIRIN AND TICAGRELOR. ON (B)(6) 2022, THE SUBJECT PRESENTED AT THE EMERGENCY DEPARTMENT VIA EMERGENCY MEDICAL SERVICES (EMS) WITH COMPLAINTS OF SUDDEN ONSET OF MID CHEST PAIN RADIATING TO NECK AND JAW WITH ASSOCIATED SHORTNESS OF BREATH THAT BEGAN WHILE WALKING TO HIS TRUCK WHICH IMPROVED WITH A DOSE OF SUBLINGUAL NITROGLYCERINE. THE SUBJECT WAS ADMINISTERED ASPIRIN AND SUBLINGUAL NITROGLYCE

  Patient problems: Heart Failure/Congestive Heart Failure; Myocardial Infarction; Restenosis

  MAUDE report 15058812 ↗
• DeathMay 4, 2021Activation Failure; Activation Failure

  IT WAS REPORTED THAT STENT THROMBOSIS AND PATIENT DEATH OCCURRED. ON (B)(6) 2021 A PERCUTANEOUS CORONARY INTERVENTION (PCI) WAS PERFORMED ON A 3.50MM, STRAIGHT SEGMENT, MODERATELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY (LAD). FOLLOWING PREDILATATION WITH A BALLOON, A 3.50 X 16MM SYNERGY MEGATRON WAS ADVANCED TO THE TARGET LESION AND DEPLOYED. IT WAS NOTED THAT THERE WAS UNUSUAL FILLING DEFECT IN THE PROXIMAL SEGMENT OF THE MEGATRON. THE DEVICE WAS INFLATED AT 11 ATMOSPHERES FOR 60 SECONDS. THE PROCEDURE WAS COMPLETED AND NO PATIENT COMPLICATIONS RESULTED IN RELATION TO THIS EVENT. FOLLOWING THE PROCEDURE, THE PATIENT WAS ADMINISTERED DUAL ANTIPLATELET THERAPY (DAPT) AND THE PATIENT WAS REPORTED TO BE STABLE. ON (B)(6) 2021, FOLLOWING THE PROCEDURE AND PRIOR TO DISCHARGE, STENT THROMBOSIS LEADING TO ST-ELEVATION MYOCARDIAL INFARCTION (STEMI) OF THE ANTERIOR WALL OCCURRED. ANOTHER PCI WAS PERFORMED. THE PREVIOUSLY PLACED MEGATRON WAS RE-EXPANDED TO A 4.00MM DIAMETER AND A SYNERGY XD WAS DEPLOYED DISTAL TO THE MEGATRON. INTRAVASCULAR ULTRASOUND (IVUS) REVEALED THAT THE MEGATRON WAS UNDERSIZED. IT WAS NOTED THAT THE FILLING DEFECT HAD LIKELY MANIFESTED INTO TISSUE OR THROMBUS. THE P

  Patient problems: Myocardial Infarction; Non specific EKG/ECG Changes; Thrombosis/Thrombus

  MAUDE report 11773083 ↗