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

Model Number	H7493942832350
Medical Device Problem Codes	Obstruction of Flow (2423); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cardiac Arrest (1762); Thrombosis/Thrombus (4440)
Date of Event	11/24/2021
Type of Reportable Event	Death
Event or Problem Description
It was reported that death occurred.The target lesion was located in the calcified proximal left anterior descending artery (lad).The physician rotablated with a 1.5 burr followed by a 3.5 balloon.A 3.50 x 32mm synergy megatron implanted to treat the lesion and post dilated with a nc emerge balloon.Angiography showed patent flow post stenting.As the patient was leaving the cath lab, they began to code and the staff began immediate cardiopulmonary resuscitation (cpr).The patient was brought back to the cath lab with an automatic cpr machine.Repeated angiogram revealed a clotted lad.The lad was wired and ballooned to restore flow.Cpr continued and ventricular assist device was inserted as well as a temporary pacemaker.Two hours after cpr was initiated, time of death was called.
Additional Manufacturer Narrative
B5 - updated event.H6 - updated device codes.
Event or Problem Description
It was reported that death occurred.The target lesion was located in the calcified proximal left anterior descending artery (lad).The physician rotablated with a 1.5 burr followed by a 3.5 balloon.A 3.50 x 32mm synergy megatron implanted to treat the lesion and post dilated with a nc emerge balloon.Angiography showed patent flow post stenting.As the patient was leaving the cath lab, they began to code and the staff began immediate cardiopulmonary resuscitation (cpr).The patient was brought back to the cath lab with an automatic cpr machine.Repeated angiogram revealed a clotted lad.The lad was wired and ballooned to restore flow.Cpr continued and ventricular assist device was inserted as well as a temporary pacemaker.Two hours after cpr was initiated, time of death was called.It was further reported that the stented vessel clotted off soon after the patient left the cath lab.

• Brand Name: SYNERGY MEGATRON
• Common Device Name: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 12884162
• Report Number: 2134265-2021-14966
• Device Sequence Number: 4828417
• Product Code: NIQ
• UDI-Device Identifier: 08714729985778
• UDI-Public: 08714729985778
• Combination Product (Y/N): Y
• Initial Reporter State: GA
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/07/2021

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: 04/27/2022
• Device Model Number: H7493942832350
• Device Lot Number: 0027278199
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/24/2021
• Supplement Date Received by Manufacturer: 11/28/2021
• Initial Report FDA Received Date: 11/29/2021
• Supplement Report FDA Received Date: 12/07/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/27/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Age: 71 YR
• Patient Sex: Male