MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SYNERGY MEGATRON; CORONARY DRUG-ELUTING STENT

Model Number	H7493942816350
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Codes	Non specific EKG/ECG Changes (1817); Myocardial Infarction (1969); Thrombosis/Thrombus (4440)
Date of Event	04/15/2021
Type of Reportable Event	Death
Additional Manufacturer Narrative
Age at time of event: over 18 years.
Event or Problem Description
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 procedure was completed and the patient was administered dapt following the procedure.No further patient complications resulted.On (b)(6) 2021, a left bundle branch (lbb) with re-catheterization (stent open), and subsequently ventricular tachycardia (vt) with a heart pump was performed.The patient vt arrested and passed away.The official cause of death was stated to be unknown, suspected vt.The patient noted to have been admitted to the hospital beyond the standard of care.It was noted that the device issue which may have caused or contributed to the patient complications were stent thrombosis leading to death.It was further clarified that the physician did not attribute the patient death to the use of the stent devices.

• Brand Name: SYNERGY MEGATRON
• Common Device Name: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 11773083
• Report Number: 2134265-2021-05612
• Device Sequence Number: 17003857
• Product Code: NIQ
• UDI-Device Identifier: 08714729985617
• UDI-Public: 08714729985617
• Combination Product (Y/N): Y
• Initial Reporter State: NV
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2021
• Device Model Number: H7493942816350
• Device Lot Number: 0026472179
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/15/2021
• Initial Report FDA Received Date: 05/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death